cyrilzakka/clinical-trials huggingface dataset:
Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study

The aim of this study was to investigate the immediate effect of neural mobilization techniques, one of the manual therapy methods that can be used in the treatment of cervical radiculopathy.

This study was designed as a randomized controlled experimental study and was conducted in the Physiotherapy and Rehabilitation Department of Istanbul Medicana International Hospital. Population: The study included patients diagnosed with cervical disc herniation who were referred to physiotherapy sessions by a physician Patients were assigned to the Control Group(CG) or Neural Mobilization Group(NMG) by simple randomization. The control group received conventional physiotherapy while the neural mobilization group received neural mobilization of the ulnar median and radial nerves. The pain of the patients was evaluated with Numeric Pain Rating Sacale (NPRS) and Neuropathic Pain Questionnaire (NPQ) at the beginning and end of the intervention, while hand grip strength and pinch grip strength were evaluated with digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) and digital pinchmeter (JAMAR Plus Pinch Gauge). Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Participants meeting the following criteria were included in the study: age between 18 and 65 years, referred to physiotherapy with a diagnosis of cervical disc herniation, self-reported neck pain with a visual analog scale (VAS) score of more than 5, presence of pain radiating from the neck to the arm, and at least 3 of the following tests were positive: Spurling's Test, Upper Extremity Tension Test-1, Distraction Test, and ipsilateral cervical rotation less than 60 degrees. These tests were assessed by a trained examiner according to standardized procedures

Exclusion Criteria:

* Exclusion criteria were surgical intervention in the head and neck region, history of fracture in the head and neck region, known chronic disease, infection and structural disorders in the bone and soft tissue in the cervical spine, malignancy and severe osteoporosis.
DBS Recordings to Characterize Movement Facilitation in Parkinson's Disease

Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use intraoperative recordings during DBS surgery for Parkinson's disease to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during awake surgery performed exclusively for clinical indications. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.

Patients with Parkinson's disease (PD) will perform computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals during deep brain stimulation surgery. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 40 PD patients who are undergoing deep brain stimulation (DBS) surgery for treatment of Parkinson's disease, will perform the tasks during awake surgery and recordings will be obtained from 2 implanted DBS electrodes as well as 2 temporary electrode strips placed on the surface of the brain for research purposes. Study procedures are limited to the intraoperative environment with no additional study visits. All patients will also be asked to perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease based on presence of at least 2 cardinal PD features (tremor, rigidity, or bradykinesia)
* Undergoing deep brain stimulation surgery for treatment of advanced Parkinson's disease, according to clinical evaluation, including the following criteria:
* advanced idiopathic PD as determined by OFF unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale \> 25
* L-dopa responsive symptoms with at least 30% improvement in UPDRS III scores on vs. off medication OR medication refractory disabling tremor
* Persistent disabling motor symptoms or drug side effects (dyskinesias, motor fluctuations, disabling "off" periods) despite optimal medical therapy
* preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
* Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes

Exclusion Criteria:

* medical contraindication to surgery, including use of anticoagulant or antiplatelet therapy within 1 week
* significant cognitive or psychiatric disease based on clinical neuropsychological testing
Affect of Health Education on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP)

The purpose of this study is to assess the affect of multiple health education interventions for statins medication Persistence and clinical prognosis of ischemic stroke patients at 3, 6 and 12 months.

The study is a prospective, multicenter, hospital-based study on secondary prevention for patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic cerebrovascular diseases by professional training, instruction manuals, stratification management software. In order to improve the persistence of taking preventive secondary medicine, IS patients from these 24 hospitals received healthy education through manuals and Digital Video Disc about health education during hospitalization and acquired secondary preventive knowledge of ischemic cerebrovascular diseases through regular health education messages during 6 months after discharge. Patients with IS from other 6 hospitals were used as a control, and no such intervention was given to them.

Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were regarded as persistent antiplatelet drugs or statins taking within one year after the onset of the disease. The main prognostic indicator was the recurrence of IS and persistence of statins medication within 1 year, and the main purpose was to explore the impact of persistent statins use on IS recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects (male or female ≥18 years);
2. Acute ischemic stroke occured within 14 days of symptoms onset
3. Blood low density lipoprotein (LDL) ≧100mg/dl（2.59mmol/L）
4. Patients were prescribed statins at discharge
5. Patients signed informed consent
6. Patients have a cell phone and have the ability to receive and view messages

Exclusion Criteria:

1. Non-cerebrovascular events or hemorrhagic stroke
2. Patients have serious heart, liver, kidney dysfunction or coagulation disorders
3. Patients have circumstances that may affect the follow-up such as disturbance of consciousness, severe depression or other mental disorders, aphasia
4. Modified Rankin Scale score at discharge ≥3
5. Patients with severe vision or vision field impairment which may affect patients to read message in cell phone
6. Those who are participating in other clinical trials
7. Those who can not guarantee with the completion of 6 month follow-up after enrollment
Emotion Focused Family Therapy for Parents of Children With Mental Health Difficulties

Emotion Focused Family Therapy (EFFT) is a promising intervention that aims to teach parents advanced skills to support their child's development of emotion skills and increase their adaptive behaviours, potentially leading to improvements in their child's psychological functioning and family functioning more broadly.

This randomized controlled trial (RCT; EFFT vs waitlist control) will (1) test the efficacy of a 6-week group EFFT program on parent and child outcomes and (2) examine maintenance of treatment gains up to four months post-intervention.

This randomized controlled trial (RCT) will test the efficacy of a 6-week Emotion Focused Family Therapy (EFFT) group program on parent and child outcomes, compared to a waitlist control. Families will be randomized to either the EFFT group treatment or a waitlist. The RCT will evaluate changes in parent functioning, child functioning, and parent-child relationship functioning. A 4-month follow-up will test whether any changes from pre-to-post intervention are maintained at 4 months.

The RCT will also test proposed mechanisms of change (parent-child relationship quality, family functioning) and moderators of treatment effectiveness (parental stress).

Eligibility Criteria:
Inclusion Criteria:

* Parent of child aged 7 to 15 years old with anxiety, depression, or behavioural challenges
* Parent of child is willing to participate in intervention
* Parent is living at home with the child

Exclusion Criteria:

* Parent or child not proficient enough in speaking/understanding English to complete measures or EFFT intervention components
* Parent or child with a severe mental health disorder (e.g., active suicidality and psychosis) is not considered suitable for the trial intervention due to the clinical need for immediate intervention
* Parent or child is actively receiving, or due to receive, intensive psychological intervention focused on cognitive and/or behavioural strategies to intervene with emotional or behavioural difficulties
* Parent or child has any disabilities in language, speech or hearing that would interfere with their completion of the EFFT and measures
* Parent or child are allergic to adhesive electrode gel use in some tasks (i.e., sodium chloride)
A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)

The goal of this study is to evaluate the impact of a chronic care model (CCM) based quality improvement program on 1) outcomes for patients with chronic kidney disease (CKD) and 2) adherence to CKD guidelines. This pilot study will evaluate the feasibility of a CCM based quality improvement program for patients with CKD and assess potential mechanisms for the intervention's effect.

Hypothesis: Implementing a CCM based quality improvement program including system level support in the form of collaborative care, a CKD registry, and provider education will 1) reduce systolic BP in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.

Research Plan:

The experimental design is a prospective, randomized controlled trial evaluating the impact of a Chronic Care Model (CCM) based quality improvement program on CKD guideline adherence. The intervention will focus on three main goals: 1) reduction of BP to target levels, 2) appropriate monitoring of patients for metabolic complications of CKD, and 3) reduced use of dialysis catheters in patients initiating dialysis. The CKD CCM QI program will include a lecture on CKD guidelines and hypertension to all CBOC providers and a centrally located pharmacist with access to the CKD registry.

Methodology:

Veterans receive primary care at Community Based Outpatient Centers (CBOCs) throughout Northeast Ohio. Patients with CKD who receive their primary care at a Northeast Ohio CBOC will be eligible for the study. The hypothesis was formulated before data collection.

Eligibility Criteria:
Inclusion Criteria:

* receipt of primary care at a VISN 10 Northeast Ohio CBOC
* GFR (calculated according to the 4 variable Modification of Diet in Renal Disease study equation) less than 45 mL/min per 1.73m2 with a second GFR less than 60 at least 90 to 730 days prior to the index GFR (26); and
* at least one primary care visit in the year prior to study initiation.

Exclusion Criteria:

* ESRD as defined by chronic renal replacement therapy,
* receipt of a renal transplant,
* hospice care, and
* age greater than 85 years or less than 18 years at the time of study initiation.
Thoracic Paravertebral Block for Postoperative Pain Management After VATS

This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).

This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:

Arm 1: General anesthesia with TPVB;

Arm 2: General anesthesia alone (control group).

Primary Outcome: to assess Opioid requirement in the PACU

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective VATS, ASA physical status II-III, BMI 19-40.

Exclusion Criteria:

* Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness
One Year Skeletal and Dental Arch Changes Following Rapid Maxillary Expansion Treatment in Children

Many author have exposed the rapid and slow expansion, the diversity of activation and containment protocols and the follow-up time, justify the need for more studies to evaluate the effects to the ERM for the long-term.


Eligibility Criteria:
Inclusion Criteria:

* cross-bite with maxillary atresia

Exclusion Criteria:

* patients had undergone orthodontic treatment or had a syndrome
Respiratory Effects of E-Cigarettes in Obese Youth

To determine vaping behaviors and respiratory function in obese and nonobese youth e-cigarette users.

The investigators hypothesize that obese youth e-cigarette users will have increased e-cigarette use that will worsen respiratory function. The approach will involve a clinical trial where vaping behaviors (using puff topography) and respiratory function (spirometry, plethysmography, and diffusion capacity) will be assessed while participants vape with their own e-cigarette and, on a separate visit, with the VUSE e-cigarette.

Eligibility Criteria:
Inclusion Criteria:

* a current e-cigarette user (≥1 vaping bout daily) for at least the past 3 months,
* 21-25 years old,
* willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions,
* willing to complete five lab visits lasting up to 4 hours each,
* able to read and speak English,
* willing to provide informed consent.

Exclusion Criteria:

* self-reported diagnosis of lung disease including asthma or cystic fibrosis
* history of cardiac event or distress within the past 3 months
* history of metabolic disease including thyroid disease or diabetes
* history of orthopedic or neuromuscular problems that preclude exercise
* currently pregnant (determined using urine pregnancy test), planning to become pregnant, delivered a child in the past 6 weeks even if not breastfeeding, or currently breastfeeding
* use of other tobacco products \>10 days in the past month
* current marijuana use \>10 times per month
* currently engaging in a vaping cessation attempt
* ) competitive athlete or individual currently engaged in an exercise training program involving 420min or more (moderate intensity aerobic activity) or 210 min or more (vigorous intensity aerobic activity) per week with the goal of participating in a competitive event or marathon, triathlon, etc. Participants who are engaged in usual physical activity (e.g., walking dog, biking to work, etc.) but not engaged in a "structured exercise training program" will not be excluded.
* plans to leave the Columbus or central Ohio region within the next year.
An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)

A study to determine the safety and efficacy of an investigational drug in patients with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia and sleep apnea).

Exclusion Criteria:

* Patients with serious or unstable current or past medical conditions.
Infiltration of the Vestibulum Vaginae With Botulin Toxin in Patients With Localized Provoked Vulvodynia

In this study we will investigate the efficacy and safety of infiltration of the vestibulum vaginae with botulin toxin in women who were diagnosed with localized provoked vulvodynia. In literature covering this subject we find that the prevalence of this condition is between 10 and 15%. Especially young, sexually active women suffer from this problem and some of them are not capable of having sexual relations with their partner because of this burning pain.

The most probable explanation for the physiopathological mechanism is an increase of nerve endings in the epithelium of the vestibulum, with an increase and activation of pain receptors in the vestibular mucosa. It also seems that patients with vestibulodynia have a higher tonus of the pelvic floor muscles, a greater muscle contraction in response to pain and a lower capacity of relaxation.

Botulin toxin (Botox) is a neurotoxin that causes a temporary paralysis of the muscle cells. That way it can decrease the increased tension of the pelvic floor muscles Botox also inhibits the pain receptors in the vestibulum.

Patients will be recruited through the gynecology consultations. Every patient with localized provoked vulvodynia that has tried previous treatments (pelvic floor muscle therapy, antidepressants, anti-epileptics, local anesthetics) will undergo Q-tip testing. If positive and there are no underlying diseases, the patient will be invited to participate in the study and after oral and written informed consent, will be included in the study population. Every 6 weeks there will be given injections with 50 units of botulin toxin, on 6 different spots in the vestibulum. 50 % of the subjects will receive physiological water instead of Botox (control population). After 3 sessions, we will assess if there is any difference in provoked pain in treated patients vs. placebos through Q-tip testing.


Eligibility Criteria:
Inclusion Criteria:

* +18 years, of sound mind
* Dutch speaking
* Previously treated for this condition with neuropathic pain medication (antidepressants and anti-epileptics)
* in good health

Exclusion Criteria:

* systemic diseases
* pregnancy
Nivolumab for Recurrent/Metastatic Carcinosarcoma

Carcinosarcoma is a malignant neoplasm that is composed of both epithelial and mesenchymal elements and aggressive tumor that are staged as high-grade cancer in NCCN guideline. They are regarded as rare aggressive malignancies with a high potential to develop distant metastases and are associated with an overall poor survival. The aggressive nature of this malignancy coupled with a high relapse rate defines a poor clinical course for most patients. First line treatment of patients with advanced uterine carcinosarcoma with paclitaxel plus carboplatin achieved an objective response rate of 54% of patients. For this orphan tumor, carcinosarcoma, as these drugs would hypothetically act only on tissues with overexpression of PD-L1, they theoretically provide a more precise therapeutic effect on tumor cells with considerably less side effects. Therefore, the investigators suggest phase II trial of nivolumab for metastatic/recurred carcinosarcoma who have progressed after prior chemotherapy.

Single center, prospective phase II trial.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed recurrent/metastatic carcinosarcoma
2. ECOG performance status of 0 to 1
3. ≥ 19 years of age
4. At least 1 prior chemotherapy
5. Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization
6. Subjects who meet the following criteria:

   * Absolute neutrophil count (ANC) ≥ 1500 /µ
   * Platelet count ≥ 75,000/ µL
   * Serum creatinine \< 1.5 x upper limit of normal (ULN)
   * AST (SGOT) and ALT (SGPT) \< 3 x upper limit of normal (ULN) (If there is Liver Metastasis \< 5 x upper limit of normal (ULN))
   * Total bilirubin \< 1.5 x upper limit of normal (ULN)

Exclusion Criteria:

1. More than 4 prior cytotoxic agents
2. Prior treatment with systemic PD-L1-directed therapy
3. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day
4. Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
5. Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
6. History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease
7. Known active infection
Craniectomy Protocol

The objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. Will be measured the quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age\> = 18 years
* Having presented an ischemic stroke involving the sylvian area
* Having received decompressive craniectomy in acute ischemic stroke
* Time between stroke and the inclusion of at least 24 months
* Signed informed consent
* Patient affiliated to a social security system

Exclusion Criteria:

* Patients with a Rankin score before stroke than or equal to 3
* Stroke in multiple territories (contralateral carotid and / or vertebrobasilar) associated with stroke in the acute phase describing which in the opinion of the investigator significantly influence the long-term functional prognosis
* Cognitive deterioration or severe aphasia making it impossible to fill out questionnaires
* Minors
* Major under curators