cyrilzakka/clinical-trials huggingface dataset:
A Neurofeedback Treatment for Chronic Musculoskeletal Pain

This study evaluates the effects of a novel neurofeedback treatment on pain specific brainwaves in adults.

Chronic pain patients enrolled in this study will be randomized into a treatment group and a sham group.

Recent research has underlined that central nervous system structures play a key role in the development of pain with significant maladaptive plasticity occurring in several brain areas. Non-pharmacological treatments, such as neurofeedback, are designed to restore normal brain function alongside with relieving pain symptoms. With a neurofeedback approach, the patient is provided with a feedback on specific brain waves recorded using non-invasive recording techniques (electroencephalography - EEG) and visualized on a screen.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from chronic pain due to tennis elbow for at least 3 months
* A clinical diagnosis of chronic lateral epicondylalgia,
* Pain associated with functional activities such as gripping and pain with resisted contraction of the wrist extensors or extensor carpi radialis brevis, or with passive stretching of the wrist extensors.

Exclusion Criteria:

* Clinical diagnosis of chronic lateral epicondylalgia on both sides, cervicothoracic spinal pathology, other upper limb musculoskeletal disorders or neurological disorders
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses defined as an on-going systemic condition
* Lack of ability to cooperate
* Current use of medications that may affect the trial e.g. analgesics, anti- inflammatory drugs
* Consumption of alcohol, caffeine, nicotine or painkillers throughout the study period
* Past history of chronic pain, neurological or psychiatric conditions
* Participation in other pain trials throughout the study period and one month prior to participation
* Participation in more than two sessions of muscle training exercises per week involving the upper limb and/or lower back
* Evidence of other sources of elbow pain such as exacerbation of pain with neck movement or manual examination
* Sensory disturbances
* History of fractures
* Elbow surgery
* Contraindications to the use of TMS
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion criteria:

* Adult patients 18-80 years of age.
* Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
* Receiving outpatient treatment for RA.
* Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
* At screening, either

  * C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or
  * Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour.
* Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.

Exclusion criteria:

* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA.
* Inflammatory joint disease other than RA, or other systemic autoimmune disorder.
* Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16.
* Surgery within 12 weeks of study or planned within 24 weeks of randomization.
* Previous treatment with any approved or investigational biological agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
STATE Trial: SusTained Attention Training to Enhance Sleep - Remote

This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) program in older adults with chronic late-life insomnia. The goal of this study is to employ a computerized attention-training program, TAPAT, designed for chronic late-life insomnia in a remote, randomized, controlled trial to assess feasibility and initial efficacy in this population.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 55 years of age or older.
* Participant must meet criteria for clinical insomnia - moderate severity based on the Insomnia Severity Index.
* Participant must be a fluent English speaker.
* Participant must have adequate visual, auditory, and motor capacity to use computerized intervention.
* Participant must have a computer and access to the Internet.

Exclusion Criteria:

* Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, untreated obstructive sleep apnea, diagnosis of other sleep disorders (e.g., restless legs syndrome), recent hospitalization, ongoing chemotherapy or other cancer treatment, and concurrent engagement in another insomnia treatment.
* Participants enrolled in another concurrent research study.
* Participants using computer-based cognitive training programs or has used them within a month of the consent date.
Programmable Timer in the Bladder Rehabilitation Treatment of OAB

The purpose of this study is to evaluate the effect of bladder rehabilitation in a non-selected group of children with idiopathic overactive bladder and to clarify whether the effect of the treatment can be increased by addition of a programmable timer

Daytime urinary incontinence is common in children. At the age of 7 a prevalence of 2-9 % has been reported. Daytime urinary incontinence is a heterogenic multifactorial illness where the the symptoms has several degrees of severity and can be caused by different mechanisms. Daytime urinary incontinence can be etiologically classified in the rare neurogenic and structural forms and the common functional or idiopathic form (where no neurological or structural cause of the bladder dysfunction can be identified.

The symptom based diagnosis OAB (overactive bladder) is most often used to describe daytime urinary incontinence in children. OAB is defined as a symptom syndrome including urgency with or without urge incontinence in combination with frequency.

When urinary tract infection and neurogenic and structural causes has been excluded the nonpharmacological bladder rehabilitation is first line treatment in children with OAB. It is expected that approximately 50 % of the children can be relieved of symptoms by this treatment. The treatment consist of instruction in good micturition habits including toilet position, sufficient fluid intake and voidings at predefined intervals. The treatment effect is to a large degree dependent upon the ability of the children to void at fixed intervals. Children at the age of 5-10 yrs generally find this difficult and a programmable timer seems be an useful instrument in order to remind the child of voiding at fixed times. However there has not been published studies of the effect of programmable timer.

Hypothesis:

* Daytime urinary incontinence in children aged 5-15 with idiophatic OAB can in 50 % of cases be cured by bladder rehabilitation
* The compliance of the bladder rehabilitation treatment can for each individual be increased by adding a programmable timer to the treatment.

Material and methods:

100 children with idiopathic OAB will be recruited from the Center of Child Incontinence, Skejby University Hospital, Aarhus, Denmark.

After a run-in period of at least 4 weeks the children will be randomized to 12 weeks of bladder rehabilitation with or without programmable timer.

The effect of the treatment will be estimated based on home recordings.

Eligibility Criteria:
Inclusion Criteria:

* Daytime urinary incontinence with at least 1 episode of at least 1 ml per week
* More than 6 voidings per day
* Informed consent

Exclusion Criteria:

* Known diseases of the kidneys or urinary tract besides OAB
* Receiving treatment with drugs that have an effect on the urine production or bladder function
Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers

The investigator believes simeprevir concentrations are unchanged when administered in combination with dolutegravir relative to administration alone. The investigator believes dolutegravir concentrations are unchanged when administered in combination with simeprevir. Additionally, the investigator believes simeprevir and dolutegravir are safe when administered alone and in combination.

To investigate the potential for drug interactions between simeprevir and dolutegravir, participants will receive each drug alone and the drugs in combination for 7 days. The pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-60 years
* Absence of HIV-1 and HCV antibodies at screening,
* Ability and willingness to give written informed consent before the first trial-related activity.

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Active alcohol or drug abuse that, in the opinion of the investigators, would interfere with adherence to study requirements
* Participation in any investigational drug study within 30 days prior to study entry
* Currently active or chronic gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, or infectious disease or malignancy requiring pharmacologic treatment, and/or if in the opinion of the investigator, would affect study participation, safety, or integrity of results
* Use of concomitant medication, including investigational, prescription, and over-the-counter products and dietary supplements with the following exceptions: aspirin, acetaminophen, ibuprofen, hormonal oral contraceptives
* Concomitant medications other than those listed above must have been discontinued at least 14 days before study entry
* Currently active dermatitis or urticaria or diagnosis of eczema or psoriasis,
* History of significant drug allergy (i.e., anaphylaxis and/or angioedema)
* Subjects with the following laboratory abnormalities at screening as defined by the 2004 Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS grading table") and in accordance with the normal ranges of the trial clinical laboratory: serum creatinine grade 1 or greater (≥ 1.1 x upper limit of laboratory normal range (ULN)); hemoglobin grade 1 or greater (≤ 10.9 g/dL); platelet count grade 1 or greater (≤ 124.999 x 109/L); absolute neutrophil count grade 1 or greater (≤ 1.3 x 109/L); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 1 or greater (≥ 1.25 x ULN); total bilirubin grade 1 or greater (≥ 1.1 x ULN), any other laboratory abnormality of grade 2 or above.
Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis

This study evaluates the effectiveness of an electrostimulation treatment with TENS using a needle and a surface electrode combined with an exercise program to fasciitis plantar. Half participants will receive invasive electrostimulation (TENS using a needle) and exercises while the other half will receive electrostimulation placebo and exercises.

There are a lot of treatments to fasciitis plantar. Exercises are the treatments more recommended to fasciitis plantar but not all patients improve only with exercises. Dry needling is recommended to relieve the pain in the heel. TENS is used to decrease the pain in the fasciitis plantar. Investigators will apply to half participants a treatment that combines TENS + Dry needling (invasive electrostimulation ) with exercises while the other half receive electrostimulation placebo (TENS using surface electrodes with non-therapeutic intensity) + exercises.

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of plantar fasciitis
* Age equal or superior to 18 years old.
* VAS minimum of 2 points int the first steps after a prolonged decreasing period.
* Having an evolution of a month or more of pain.
* Not having received acupuncture or dry needling as treatment.

Exclusion Criteria:

* Peripheral Neuropathies.
* Tarsus tunnel syndrome.
* Rheumatic diseases.
* Contraindication to dry needling: nickel allergy, fear of needles, sky with erosions.
* Clotting disorders such as thrombosis or thrombophlebitis.
* Fractures, infections and/ or tumor processes.
* Have been treated for plantar fasciitis in the las 4 weeks.
* Previous surgery in the foot
* Pregnancy.
* Communication Disorders.
* Holders of pacemakers or electrostimulators.
Stopping Cardiovascular Treatments and Mortality in a MICU

Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified. The question of the study is to investigate wether such treatment interruption might be responsible for prognosis modifications.

Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified.

Few studies have investigated the outcome impact of medications interruption and/or modifications following hospital admission. We did consider that it might be interesting to study whether treatment continuation, interruption, and/or re-introduction following ICU admission may modify patients' outcome either in the ICU or following hospital discharge (at 3,6 and 12 months).

Eligibility Criteria:
Inclusion Criteria:

* All patients with cardiovascular treatment prior to ICU admission

Exclusion Criteria:

* Data unavailability
* Consent withdrawal following information
Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).

The study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination \[FDC\] of grazoprevir 100mg + elbasvir 50mg, and SOF 400mg, in treatment-naive participants with chronic HCV GT1 or GT3. The impact of study treatment regimens of varying duration on SVR12 (undetectable HCV ribonucleic acid \[RNA\] 12 weeks after ending study treatment) in cirrhotic (C) participants and non-cirrhotic (NC) participants will be determined (Part A). Any HCV GT1 participant from study Arms 1-4 in Part A who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with MK-5172/MK-8742 + SOF + ribavirin and 24 weeks of follow-up in Part B.

Eligibility Criteria:
Inclusion Criteria:

* has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening
* has documented chronic HCV GT1 or GT3 infection
* has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
* is treatment naïve to all anti-HCV treatment

Exclusion Criteria:

* has evidence of decompensated liver disease
* is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
* has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
* has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* has clinically-relevant drug or alcohol abuse within 12 months of screening
* has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
* has a history of chronic hepatitis not caused by HCV
Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia

Exotropia is classified as Primary which includes constant and intermittent exotropias. Secondary XT include Sensory and consecutive XT. Management for IXT consists of non-surgical and surgical treatment. There is some controversy regarding the optimal surgical method varying between bilateral lateral rectus recession (BLR), unilateral lateral rectus recession-medial rectus resection (RR) and bilateral medial rectus resection (BMR).

Eligibility Criteria:
Inclusion Criteria:

* Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type.

Exclusion Criteria:

1. Angle of deviation less than 40 PD or more than 55 PD.
2. History of previous surgery.
3. Inconcomitant exotropia.
4. Incomitance in any gaze.
5. Associated vertical deviation(oblique dysfunction,A or V pattern).
6. Patients with neurological deficit.
Efficacy of Costal Mobilization Techniques and Manual Diaphragm Release Technique in Patients COPD

To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity in patients with chronic obstructive pulmonary disease

Study will be a controlled clinical trial in which participants will be randomized into 2 groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique), GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will undergo six sessions of care according to randomization and will be reevaluated in 3 following situations: immediately after the first session, at the end of treatment and one week after the last session. The evaluation will be performed through Optoelectronic plethysmography , Pollar, Ultrasound and 6-minutes walk test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (spirometry with FEV1 \<80% and FEV1 / FVC \<0.7) of both sexes, who are not undergoing another physiotherapeutic treatment, from to 21 years of age, clinically stable without exacerbation in the last 6 weeks.

Exclusion Criteria:

* Patients with rheumatic or orthopedic diseases;
* Deformities / abnormalities in the spine that compromise the mechanics of the respiratory system;
* Rib fracture for less than 1 year;
* Respiratory co-morbidities;
* History of thoracic or abdominal surgery for less than 1 year;
* Osteoporosis and IMC \> 30kg / m²
Safety Study of Nicardipine to Treat Cerebral Vasospasm

The purpose of this study is to determine if intrathecal nicardipine is safe for the treatment of cerebral vasospasm.

Subarachnoid hemorrhage accounts for approximately 5% of all strokes and affects 30,000 Americans per year. Poor outcome from aneurysmal subarachnoid hemorrhage (SAH) occurs in 50 to 75% of patients, and this is attributed to secondary ischemia in approximately 30% of patients. This delayed cerebral ischemia has been attributed to the anatomic narrowing of arteries in the cerebral vasculature which occurs following SAH.

Because of this relationship between cerebral vasospasm, cerebral ischemia, and poor outcome, there has been significant effort to establish treatments that decrease the incidence of vasospasm after SAH. Currently, medications and hemodynamic maneuvers are used as standard of care for the treatment of vasospasm and to improve outcome after SAH.

The calcium channel blocker, nimodipine, is one of the few treatments for vasospasm that has been shown to be of proven benefit. Nicardipine is another calcium channel blocker that has been evaluated in several studies via an intravenous administration route. These studies did show significant improvements in symptomatic and angiographic vasospasm, although a benefit in outcome was not seen. However, the intravenous administration of nicardipine was associated with significant systemic side effects that may have affected outcome including hypotension, pulmonary edema, and azotemia.

The administration of nicardipine via an intrathecal route avoids the systemic complications associated with intravenous dosing since the direct cerebrospinal fluid dosing is much lower. The result is that the systemic concentration will remain low avoiding systemic side effects, and central nervous system concentration will remain high. We propose that this difference may improve outcomes while minimizing complication related effects on patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and older
* Subarachnoid hemorrhage documented on head CT
* Fisher Grade 3 or 4
* Hunt Hess Grade 1-5
* Cerebral aneurysm as definitive source of subarachnoid hemorrhage
* Cerebral aneurysm must be treated via open or endovascular techniques
* Presence of external ventricular drain
* Written informed consent obtained from subject or subject's legally authorized representative

Exclusion Criteria:

* Absence or inability to have an external ventricular drain (coagulopathy)
* Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)
* Untreated cerebral aneurysm
* Inability to be randomized prior to post-hemorrhage day 4
* Elevated intra-cranial pressures that would preclude external ventricular drain clamping for 30-60 minutes
* Inability to administer study medication (severe intra-ventricular hemorrhage, occluded external ventricular drain)
* Inability to obtain angiography (coagulopathy, renal failure)
* Pregnant
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Pre-flight Titration of Supplemental Oxygen

The purpose of this study is to evaluate if supplemental oxygen during air travel can be reliably titrated using a Hypoxia-altitude simulation test (HAST). Also, the effect of oxygen supplementation given with the various oxygen equipment allowed for air travel is studied.

International guidelines recommend supplemental oxygen if PaO2 \< 6.7 kPa (50 mmHg) during air travel. Hypobaric chamber exposure is the ideal test but is not widely available. In clinical practice, the HAST has been recommended as the preferable test for pre-flight evaluation, and is used with increasing frequency. The oxygen dose during air travel has been recommended titrated during HAST. In the study, supplemental oxygen titration during hypobaric chamber exposure is compared to oxygen titration during HAST, to evaluate if HAST can be used with confidence to titrate the amount of supplemental oxygen needed during air travel.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients who have performed a Hypoxia-altitude simulation test with a PaO2 \< 6.7 kPa

Exclusion Criteria:

* exacerbation or pneumothorax within the previous six weeks
* LTOT
* anemia
* pulmonary disease other than COPD
* cerebrovascular or symptomatic cardiovascular disease
* claustrophobia
* inability to equalize pressure in the middle ear