cyrilzakka/clinical-trials huggingface dataset:
Reinforcement-Based Treatment for Pregnant Drug Abusers

Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment (RBT) to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for substance-using pregnant patients. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=220) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion, and maternal heroin, cocaine, and other illicit substance use. Secondary outcome measures include maternal measures of HIV risk behavior, and psychosocial functioning and neonatal measures of length of hospitalization, and birth outcomes. Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.


Eligibility Criteria:
Inclusion Criteria:

1. Treatment entry at or before 34 weeks EGA with singleton fetus.
2. Evidence of opioid, cocaine and/or other primary illicit substance use.

Exclusion Criteria:

1. Severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization.
2. Age 17 years or younger.
3. Geographical constraints. These women are admitted only for a residential detoxification and often have plans to obtain aftercare in an outpatient or residential facility in closer proximity to their home. Thus, this greater distance from CAP increases the likelihood that these women will not return to CAP and will not deliver in a hospital that functions under similar protocols that operate in Baltimore City for treating drug-exposed neonates.
Project 3/7; Increased Physical Activity for Body and Mind

The association between adequate amount of physical activity and good health is well established and for children and young people, and sufficient physical activity is an important factor for normal growth and development. Contrary, physical inactivity is associated with higher symptom pressure of mental disorders. Adolescents with mental disorders report to be less active compare the general population, with potentially increased risk of health and lifestyle diseases. This project aims to provide new knowledge on the degree of physical activity, motivation for physical activity and subjective perception of health in adolescents in need of mental health care. Further, this project aim to provide possible solution on how to increase physical activity in this patient group. Thus, this project has the potential to impact future guidelines for mental health services for adolescents in need of mental health care.

Children and adolescents are recommended to perform at least 60 minutes per day of moderate-to-vigorous intensity. Further the guidelines state that children and adolescents should, incorporate vigorous-intensity aerobic activities that strengthens muscle and skeleton at least three times a week. High intensity training has been reported to have a positive effect on mental health variables in adults with mental disorders. However, the literature lacks studies on how this exercise regime affect the degree of and motivation for physical activity in inactive adolescents suffering from mental disorders. There are few studies, especially Norwegians, that have been done on this field, and more research on how we can follow up on these guidelines is urgently needed. This project is divided into three research questions:

1. Is it possible to increase the motivation for and degree of physical activity by a 3-joint training intervention including 1) Supervised exercise training group, 2) School based training supported by teacher in physical education, 3) Homebased training supported by caregivers, in adolescence between 12-17 years of age with low physical activity level referred to CAP clinic?
2. Compared to treatment as usual; is it possible to reduce the psychiatric symptom pressure and increase quality of life in adolescents at CAP clinic, by a 12-week training intervention including 1) Supervised exercise training group, 2) School based training supported by teacher in physical education, 3) Homebased training supported by caregivers?
3. Are physical activity level, psychiatric symptom pressure, and quality of life changed 6 months post exercise intervention (after 12-weeks) in adolescents at CAP clinic?

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria is low levels of physical activity, defined as not participating in any sport activity and/or drop-out of PE in school.

Exclusion Criteria:

Exclusion criteria are patients with a serious eating disorder or other health condition where exercise is not recommended.
Comparison of the Efficacy of Dry Needling, Ischemic Compression, and Cross Taping on Masseter Myofascial Pain

The goal of this clinical trial is to learn whether Dry Needling, Ischemic Compression, and Cross Tapes work to treat myofascial pain in masseter muscles in adults. It will also learn about the safety of this treatment. The main questions it aims to answer are:

* Do Dry Needling, Ischemic Compression, and Cross Tapes relieve masseter muscle pain?
* Which of these treatments provides the best relief from masseter muscle pain? Researchers will compare these three treatments to see which is best for treating masseter muscle pain.

Participants will:

Treated with Dry Needling or Ischemic Compression or Cross Tapes only once Visit the clinic one week, three months, and six months after treatment.

The taut band represents the most commonly observed muscular disorder, where myofascial trigger points may arise, causing referred pain in another location. Therapeutic strategies applied for its treatment include dry needling, ischemic compression, and cross-taping.

Objectives: To compare the effectiveness of these treatment methods in reducing or alleviating the intensity of pain in the masseter.

In this multicenter randomized clinical trial, the study sample underwent a clinical examination according to the Diagnostic Criteria for Temporomandibular Disorders to diagnose the presence of orofacial myofascial pain with taut bands in the masseter. Participants were randomly allocated to three groups based on the treatment methods.

Eligibility Criteria:
Inclusion Criteria:

* Patients with myofascial pain diagnosed according Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).

Exclusion Criteria:

* Pregnant women
* Other TMD-spectrum pathologies
* Anticoagulated and antiaggregated individuals
* Diabetes
* Blood disorders
* Fibromyalgia
* Autoimmune diseases in acute stages
* Neurological diseases
* Malignant tumor pathologies
* Patients with aichthyophobia
* Concomitant medication (opioids, antidepressants, myorelaxants)
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients

Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

In the early hours following large vessel occlusion, the ultimate severity of the stroke is largely determined by the ability of collateral flow networks to supply blood to ischemic tissue via circuitous routes that bypass the proximal clot. Robust collateral flow can improve response to thrombolytic therapy and decrease the risk of intracranial hemorrhage. Despite their central importance, collaterals during acute stroke are poorly understood, largely because assessment has required an invasive imaging test, cerebral angiography. This proposal assesses whether a noncontrast MRI perfusion technique, called arterial spin labeling (ASL), can yield important information about collateral flow.

Eligibility Criteria:
Inclusion Criteria:

Moyamoya Patient Inclusion Criteria:

* Men and non-pregnant women, at least 21 years of age.
* Outpatients seen at the Stanford Neurosurgery and Neurology Departments.
* Ability to comply with all studies.
* Inclusion of Moyamoya patients with Sulfa allergies.
* Patients diagnosed with or suspected to have Moyamoya disease.

Stroke Patient Inclusion Criteria:

* Men and non-pregnant women, at least 21 years of age.
* Patients admitted to the inpatient Stanford Stroke Service for stroke-like symptoms, less than 24 hours from last time seen normal.
* Ability to comply with all studies.

Clinical Patient Acetazolamide MRI Inclusion Criteria:

* Men and non-pregnant women, at least 21 years of age.
* Patients admitted to the inpatient Stanford Stroke Service or Neurosurgical -Service for symptoms compatible with cerebrovascular disease.
* Ability to comply with all studies.

Normal Subject Inclusion Criteria:

* Ability to comply with the MRI study.

Exclusion Criteria:

* Level of consciousness score of 2 or greater as defined by the NIH stroke scale.
* Symptoms likely related to psychoactive drugs or patients with symptoms related to an active inflammatory disease such as AIDS, meningitis, or cerebritis.
* Psychiatric or substance abuse disorder or dementia that interferes with evaluation or interpretation of the neurologic and mental assessment of these patients.
* Informed consent cannot be obtained either from the patient or legal representative.
* Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study.
* Symptoms related to an alternative diagnosis such as seizures or migraine.
* Patients receiving any thrombolytic agent or receiving acute stroke investigational drug therapies during the 30-day study.
Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography in Patients With Multiple Sclerosis

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis.

Based on literature, investigators hypothesize that it would be relevant to focus more broadly on subclinical abnormalities of oculomotricity in multiple sclerosis (MS). However, the difficulty of accessing video-oculography platforms (or eye-tracking devices) is probably one of the main limitations to performing this type of assessment.

To respond this problem, the "Resources and Skills Center-Multiple Sclerosis" (CRC SEP) team at the Nice University Hospital Center (France) has developed a mobile application (named e-VOG), usable on mobile phones or tablets, to measure eye movements. e-VOG reproduces the classic paradigms of video-oculography to collect data similar to standard video-oculography recording (saccade latency and speed, anti-saccade error rate, presence of fixation abnormalities).

e-VOG will not replace standard video-oculography platforms, because its technical characteristics are not as high. But investigators hypothesize that this application could constitute a screening tool for subclinical oculomotor abnormalities, usable by neurologists in consultation, directly on their mobile, which would make it possible to select a smaller population of patients in whom a further exploration by standard video-oculography would be indicated.

Memory Center of the Rainier III Gerontologic Center (Princess Grace Hospital - Monaco) is equipped with a standard video-oculography device, also named eye-tracking device (Eye-Tracker®T2), which records eye movements at a high frequency and measures saccades parameters (latency, speed, amplitudes etc...).

This study is a collaborative study between the Center Rainier III team and the CRC SEP team in Nice. Its objective will be to compare measurements obtained through the e-VOG application with measurements from the standard video-oculography device.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female.
* 18 years old and above.
* referred by a neurologist to perform a video-oculography (Eye-Tracking) examination as part of routine care.
* with Multiple Sclerosis (defined according to McDonald's 2017 criteria).
* covered by a health insurance system
* volunteer, able to give free, informed and written consent.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Neurological, ophthalmological or general pathology preventing the realization of a video-oculography examination.
* Oculomotor abnormality detectable on clinical examination by the neurologist prescribing the standard video-oculography examination.
The PROMPT Pilot Study

The PROMPT Pilot Study is a feasibility mixed methods prospective cohort study following principles of community-based participatory action research. The study recruited 80 people who use drugs and followed them for 6 months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. A notable reduction in average cigarette use per day (20.5 to 9.3) and illicit substance use (18.8%) was observed at study-end. PROMPT's patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalised at-risk populations worldwide.

Objective To determine the feasibility of a Community-Based Participatory Tobacco Dependence Strategy (PROMPT) in the inner city population of Ottawa (Canada).

Design A feasibility mixed methods prospective cohort study following principles of community-based participatory action research.

Intervention Recruited 80 people who use drugs, followed them for 6 months while providing access to counseling, nicotine replacement therapy and peer-support in a community setting.

Setting Community research office in downtown Ottawa, adjacent to low-income housing, shelter services and street-based drug consumption.

Primary outcome Retention rate at 6-month follow-up.

Secondary outcome Biochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm.

Eligibility Criteria:
Inclusion Criteria:

* currently living in Ottawa for at least 3 months prior to enrolment
* 16 years or older
* have used drugs in the past year (excluding marijuana and alcohol)
* have smoked tobacco in the past 7 days

Exclusion Criteria:

* consent declined (refusal from participant or decision maker)
* any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow-up
* any person currently or recently (in the past 30 days) enrolled in a smoking cessation program
* anyone with a terminal illness with a life expectancy of \<3 months.
Different Treatment Modalities for Myofascial Pain

Myofascial pain dysfunction syndrome (MPDS) is the most common reason for pain and limited function of the masticatory system. The low-level laser therapy (LLLT) and occlusal splint therapy (OST) are therapeutic options for MPDS. This study aims to evaluate the effect of LLLT and OST on pain relief and mandibular movement improvement in patients with myofascial pain.

Myofascial pain dysfunction syndrome in the masticatory muscles is the most common temporomandibular disorder. Patients suffer from pain and muscle tenderness and may present with or without restricted mouth opening. The etiology of myofascial pain dysfunction syndrome is multifactorial including psychological factors, occlusion imbalance, and parafunctional habits. Treatments for myofascial pain dysfunction syndrome include education, self-care, physical therapy, use of intra-oral appliances, short-term pharmacotherapy, behavioral therapy, and relaxation techniques.

Temporomandibular disorder is most often treated using occlusal splints safely to reduce temporomandibular joint load, and subsequently, clinical symptoms, as a reversible therapy. Occlusal splints need to be used for at least three months to eliminate temporomandibular disorders.

One of physical therapy is laser treatment. Laser treatment on tissues provides a clinical effect called biostimulation, where the basic mechanism occurs at the molecular level.

The low-level laser has non-invasive and inoffensive characteristics at appropriate parameters.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myofascial pain syndrome according to The Research Diagnostic Criteria for Temporomandibular Disorder.
* Individuals between the ages of 18-60
* Occlusion of individuals with posterior teeth
* Forms of individuals who do not have any systemic disease

Exclusion Criteria:

* Disc displacement with or without reduction, with or without limited mouth opening, arthralgia, arthritis, arthrosis
* Inflammatory connective tissue disease (such as rheumatoid arthritis)
* Psychiatric diseases
* Tumor
* Heart diseases
* Pregnancy
* Diseases that may cause pain symptoms in other orofacial regions (toothache, neuralgia, migraine)
* Having received any treatment for headache or bruxism in the last 2 years
* Skin infections on the masseter and temporal muscles
Prevention of Falls Among Older Adults in Community Settings

Objective: To conduct a comparative efficacy and cost-effectiveness study of an evidence-based fall prevention program-Tai Ji Quan: Moving for Better Balance (TJQMBB).

To determine the effectiveness and cost-effectiveness of the two evidence-based exercise programs (Multimodal Exercise,TJQMBB) relative to stretching, a proxy for a minimum practice standard, in reducing falls among older adults at risk of falling.

Eligibility Criteria:
Inclusion Criteria:

* aged 70 years or older living independently in the community
* at least one fall in the preceding 12 months and a referral from a healthcare provider indicating the participant is at risk of falls due to gait/balance impairment or medication use or impaired mobility as evidenced by Timed Up and Go result of \>13.5 seconds
* no participation in daily and/or structured vigorous physical activity or walking for exercise that lasted 15 minutes or longer at a time or muscle-strengthening activities on 2 or more days a week in the previous 3 months
* walking independently, with or without the use of an assistive device,
* no severe cognitive impairment (Mini-Mental State Examination score ≥20)
* able to exercise safely as determined by their healthcare provider,
* a willingness to be randomly assigned to an intervention condition and complete the 6-month intervention and 6 month follow-up.

Exclusion Criteria:

* any medical or physical conditions deemed unacceptable by their physician or healthcare provider,
* planned to leave the study area within the next 12 months.
Sensor-based Technology for Upper Limb Rehabilitation

Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database in order to quantitatively monitoring measures and therapy progress. The aim of this study is to evaluate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limbs functions of MS patients. The training consisting of twelve sessions of upper limb training, was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to the conventional therapy. All patients were evaluated at baseline (T0) and after 4 weeks of training (T1)


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Multiple Sclerosis
* upper limb deficits,
* disability between 5 and 8.5 on the Expanded Disability Status Scale (EDSS).

Exclusion Criteria:

* Modified Ashworth Scale (MAS) \< 3 at the upper limb;
* cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination \< 24
* Medical Research Council (MRC) scale with score 0 or 5;
* presence of clinically evaluated severe comorbidities; pregnancy;
* subjects with artificial pacemaker;
* subjects involved in other studies.
Microbiota and the Lung Cancer

The subject is to study the lung microbiota and the one of upper airways (UAs) (much less studied than the intestinal microbiota) in 40 patients having lung cancer. 20 patients undergo only surgical treatment, while other half receives also chemotherapy. The idea is to explore changes in microbiota of the lung, upper UAs and intestine, and potentially find associations between them. These results will serve us as a base for the future study, focused on manipulation of the microbiota by prebiotics, probiotics or symbiotics and its effect on anti-cancer treatment tolerance and effectiveness.

Lung cancer patients will be divided in two groups, a first one with patients undergoing both chemotherapy and surgery (Pct-chir), and the second one with patients only undergoing surgery (Pchir). Following inclusion, they will be given a 7-days alimentary survey, along with blood and saliva sampling (after buccodental examination and dental panoramic). The Pct-chir group will repeat the same procedure after the chemotherapy and before the surgery.

Day before the surgery, patients are asked to bring their faecal samples (in special box provided in advance) and the filled survey. During the operation the piece of lung tissue as well as the tumour (if the size enables it) will be sampled for further analysis. Lavage will be performed on the lung immediately after its resection.

Saliva, faecal sample, lung and tumour tissue, and lavage will be used for bacterial DNA extraction, followed by qPCR and sequencing analysis.

Lavage and blood samples will be analysed by flow cytometry and ELISA, to establish the immunological profile (interleukines, cell surface markers).

Eligibility Criteria:
Inclusion Criteria:

* non small cell lung carcinoma patient suitable for surgery, or chemotherapy followed by surgery
* BMI \<29.9 kg/m²
* not taking antibiotics, corticosteroids and/or immunosuppressants at least during two months before inclusion
* not taking prebiotics, probiotics or symbiotics at least during two months before inclusion
* signing the written consent before enrollment in the study
* affiliation to the national health insurance (or system alike) according to the law from 9th August 2004

Exclusion Criteria:

* cognitive difficulties
* refusal of participation or inability to give a clear consent
* digestive or pulmonary infection of a long duration during the two months preceding the study (with antibiotic treatment)
* inflammatory digestive pathology
* concurrent treatment with experimental medication, participation in another clinical therapeutic study within 30 days
* presence of colostomy, total or partial gastrectomy
* previous esophageal surgery
* previous ORL (otho-rhino-laryngo) cancer treated by radiotherapy or surgery
* patient enable to follow the requirements of the study
* patient deprived of his rights by administrative or judicial decision