cyrilzakka/clinical-trials huggingface dataset:
Multimodal Assessment of Sensory Processing and Brain Features in Patients With Chronic Orofacial Pain

This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in persistent dentoalveolar pain disorder (PDAP) patients with and without temporomandibular disorders (TMD). All measures from patients will be compared to painfree controls.

Chronic orofacial pain disorders may present localized in the mouth such as with persistent dentoalveolar pain disorder (PDAP) or widespread in the head/face/jaw such as with temporomandibular disorders (TMD). PDAP pain manifests in a tooth that usually underwent root canal treatment or in the site formally occupied by such tooth, while TMD pain is usually reported over the preauricular area, jaws and temples. These commonly comorbid disorders have a significant impact on the individual and society. Their mechanisms are poorly understood with evidence suggesting deficient pain modulation and abnormal brain features. PDAP and TMD patients, when compared to controls, have abnormal sensory/pain processing as well as brain structural and functional differences.

This proposal will investigate pain modulatory mechanisms and brain functional and structural characteristics using multiple MRI modalities in PDAP patients with and without TMD. All measures from patients will be compared to painfree controls. This knowledge will support better understanding of mechanisms involved in PDAP and will support development of mechanistic-based clinical treatments for the patients the investigators serve. Findings from these investigations will likely contribute to our understanding of other chronic pain conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Age- and handedness-matched painfree controls using frequency matching to maintain similar group averages:

   * No self-report of persistent pain conditions for the last 6 months;
   * No diagnosis of PDAP or TMD;
2. PDAP only:

   * Fulfilling diagnostic criteria per Nixdorf et al., 20122
   * Characteristic dentoalveolar PDAP pain cannot be increased by pressure provocation from jaw muscle trigger points (referred pain)
3. PDAP with TMD:

   * Fulfilling diagnostic criteria for PDAP2 and chronic TMD myalgia per Schiffman et al. 20143

Exclusion Criteria:

Self-report:

1. Chronic widespread pain
2. Current use of opioids or other pain medications (e.g., ibuprofen/acetaminophen) that cannot be stopped \<3 days prior to testing
3. Conditions/diseases associated with altered pain perception: neurological (e.g., multiple sclerosis, trigeminal neuralgia) psychiatric disorders, diabetes, neoplasm and cardiovascular disorders
4. Injury to hands
5. Substance abuse
6. MRI contraindications including pregnancy
Improving Work Outcome in People With Recent-onset Schizophrenia

This study will determine the effectiveness of combining antipsychotic medication with Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or Brokered Vocational Rehabilitation in facilitating the search for appropriate work or schooling and maintaining work or school activities in people with recent-onset schizophrenia.

The purpose of this protocol is to test, in recent-onset schizophrenia, the efficacy of a rehabilitative intervention that is designed to enhance the search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. Predictors of work outcome are being assessed in the context of this work rehabilitation and treatment with the second-generation antipsychotic medication, risperidone.

The Developmental Processes in Schizophrenic Disorders project involves an ongoing series of longitudinal follow-through studies of individuals with a recent onset of schizophrenia. The current protocol focuses particularly on processes affecting work outcome in this initial period after onset of schizophrenia, drawing on findings that link cognitive deficits in schizophrenia to functional outcome. The protocol is determining the effects on work outcome of a rehabilitative intervention designed to enhance search for appropriate work or schooling and to increase ability to maintain work or school activities more successfully. All entering patients are placed on a common antipsychotic medication, oral risperidone, and are provided clinical treatment by a psychiatrist and a case manager. Participating patients are randomly assigned to a combination of Individual Placement and Support (IPS) and group training with the Workplace Fundamentals Module or to a Brokered Vocational Rehabilitation Model.

The protocol is examining the predictors of level of work functioning attained in the context of the work-focused intervention and maintenance on risperidone. Potential neurocognitive and environmental predictors of work and social functioning and clinical course are being examined. Aspects of early perceptual processing, allocation of attention, working memory, secondary verbal memory, and conceptual flexibility that are implicated as influences on functional outcome are assessed, as are potential stresses and supportive influences in the environment.

Eligibility Criteria:
Inclusion Criteria:

* First major psychotic episode within 2 years of study entry
* RDC schizophrenia or schizoaffective disorder, mainly schizophrenic subtype
* Residence within commuting distance of UCLA
* Interest in trying to resume work or school
* Speaks English

Exclusion Criteria:

* Known neurological disorder
* Significant and habitual drug abuse or alcoholism within 6 months of psychotic episode or evidence that substance abuse will be a prominent factor in course of illness
* Mental retardation
* Treatment with risperidone is contraindicated
Pashto Translation of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale

There is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of neuropathic pain associated with spinal cord injuries in Pashtoon population. . Since Paraplegic center Hayatabad Peshawar is a reputable institute for spinal cord injury patients' rehabilitation in Khyber pakhtun khwa where most of Pashto speaking SCI patients are rehabilitated. While working there as a physical therapist I, my other colleagues and patients felt a need for a screening tool for pain in Pashto language .So I decided to a conduct a tool validation study. This study will help the clinicians to assess their patient's pain type easily through the Pashto version of LANSS pain scale in Pashtoon population and hence will help in timely management of the pain.

The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, a screening questionnaire for identifying patients with neuropathic pain, was developed to identify patients with neuropathic mechanisms dominating their pain experience. The original English version of the LANSS pain scale has been translated and validated in Turkish, Spanish, Swedish, Brazilian, Portuguese, and Chinese Mandarin languages. However, no neuropathic pain questionnaire including the LANSS has yet been established in Pasto language in Pakistan.

Although these screening tools are based on descriptors, their linguistic adaptation and validation into different languages are feasible and this ensures their reliability and validity in languages other than those in which they were initially developed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with traumatic spinal cord injury
* Both Complete and Incomplete SCI patients
* Patients having pain history after spinal cord injury
* Patients having 3 or more than 3 months duration of SCI
* SCI at or below thoracic spine

Exclusion Criteria:

* Patients with other neurological disorders like multiple sclerosis, GBS, etc.
* Congenital conditions, tumor etc.
* Diabetic patients.
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7
* Use of Automated Peritoneal Dialysis
* Serum phosphate \> 5.5 mg/dL or \<5.5 mg/dL on a binder other than velphoro
* Serum albumin ≤ 3.7 g/dL
* Able to provide consent
* Ability to complete self-reported questionnaire

Exclusion Criteria:

* Inadequate dialysis
* Current use of sucroferric oxyhydroxide
* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months
* Active malignancy
* Recent episode of peritonitis
* Pregnancy or planning to become pregnant
* Anticipated kidney transplantation within 6 months
* Factors judged to limit adherence to interventions
* Known adverse side effect to sucroferric oxydroxide
Effect of Citric Acid Demineralization on Autogenous Bone Blocks Consolidation in Humans

This study evaluates the effect of citric acid demineralization in autogenous bone blocks consolidation. Half of participants will receive citric acid treatment at the bone block and recipient site. Other half will receive no demineralization treatment.

Autogenous bone grafts are indicated in areas where there is not enough bone height and/or width for implant installation. Treatment of bone surfaces with citric acid, promote a slight demineralization on surface that mimic natural processes of bone demineralization by osteoclasts. Thus, this treatment could accelerate the process of autogenous bone block consolidation to its recipient site.

Eligibility Criteria:
Inclusion Criteria:

* Presence of atrophic anterior maxilla (width 1.5 to 4 mm)
* Absence of active periodontal disease.
* Enough bone width on donor sites (oblique line or ment)

Exclusion Criteria:

* Systemic disease that impede surgical procedure as blood diseases, endocrine diseases, impaired coagulation
* Smokers
* Pregnant women
* Patients receiving radiotherapy or chemotherapy
* Patients using bisphosphonates
The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury

This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury (TBI). The investigators are testing whether this intervention can help improve the stress response and increase resiliency and mindfulness for patients with TBI, which may lead to improved symptoms and neurocognitive function.


Eligibility Criteria:
Inclusion Criteria:

* TBI \> 1 year prior to enrollment
* Ages 30-50
* Right handed participants
* History of acute inpatient rehabilitation stay of ≥ 1 night

Exclusion Criteria:

* Non-English speaking (because this is a group intervention, it requires a common language)
* Dependent with activities of daily living (ADLs)
* Phone screen (TICS-1) \> 30
* Rivermead Post-Concussion Questionnaire Score \< 21
* Actively practicing meditation and/or yoga or have taken a meditation/yoga class in the last 12 months
* Signs or symptoms of upper motor neuron syndrome
* Any major major systemic illness or unstable condition which could interfere with protocol compliance, including the diagnosis of major depression
* Active psychiatric disease that would interfere with participation in the trial
* Psychotic features, agitation, or behavioral problems within the last 3 months
* History of alcohol/substance abuse or dependence within the past 2 years
* Neurosurgical intervention affecting brain parenchyma
* Reported sequelae from brain lesions or head trauma prior to most recent brain injury
* Seizure activity or treatment for seizures
* Use of investigational agents
* Participating in other clinical studies involving neuropsychological measures collected more than one time per year
* Any involvement in legal matters (workers' compensation, litigation, et al), past, present, or anticipated in the future, related to the TBI
* Unable to undergo MRI for any reason such as claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
T-Cell Vaccination in Multiple Sclerosis (MS)

The purpose of this study is to evaluate the safety of T-cell vaccination in MS patients.

Immunization of MS patients with irradiated autologous encephalitogenic myelin peptides (EMP) specific T-cell lines or clones.

Clinical immunologic and neuroradiologic evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Definite MS (post criteria)
* Relapsing remitting or primary progressive clinical course. At least one relapse in the last two years.
* Disease duration \> 1 year
* Expanded Disability Status Scale (EDSS) between 0-6
* Brain magnetic resonance imaging (MRI) compatible with MS
* Not involved in any other clinical trials
* No other systemic disease

Exclusion Criteria:

* Does not comply with the above
Posterior Nasal Nerve Combined with Anterior Ethmoid Neurotomy for Idiopathic Rhinitis

The present study was a randomised, parallel controlled, open-label, multicentre clinical study. The trial was divided into two groups, the posterior nasal nerve combined with anterior ethmoid neurotomy group (group A) and the conventional drug treatment group (group B). Patients with idiopathic rhinitis (IR) who met the inclusion criteria were included in a 7-day introductory period of nasal spray hormone (Budesonide nasal spray) treatment. Subjects with IR who met the randomization criteria after the introductory period were randomized 1:1 to either group A or group B for a 1-year treatment follow-up study. In group A, subjects will undergo the posterior nasal nerve combined with anterior ethmoid neurotomy. In group B, subjects will be treated with medication according to guideline recommendations when nasal-related symptoms occur. Oral antihistamines (Loratadine) or nasal antihistamines (Azelastine Hydrochloride) are preferred, and nasal hormones (Budesonide nasal spray), or a combination of two or three drugs, may be used in severe cases. Participants will be evaluated for safety and efficacy throughout the entire three-year period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients signed the free and informed consent form and understood the explanation of the study.
2. patients with IR between 18 and 65 years and their body mass index (BMI) should be ≥19 kg/m2 and ≤24 kg/m2.
3. Patients diagnosed with idiopathic rhinitis （IR）that were defined as nonsmoking patients with at least 2 nasal complaints of nasal obstruction, rhinorrhea, itching, and/or sneezing for more than 1 hour a day and for more than 1 year.
4. Patients with negative skin prick test (SPT) responses or sIgE
5. Nasal cytological exam with eosinophilia less than 20%.
6. Patients had a Total Nasal Symptom Score (TNSS) of ≥6 and a subscore of nasal discharge ≥2 and a subscore of nasal congestion ≥1.

Exclusion Criteria:

1. Patients with colored secretions, inflammation，nasal polyps, chronic sinusitis, nasal tumours.
2. Patients with other chronic rhinitis such as occupational rhinitis, drug rhinitis, gustatory rhinitis, hormonal rhinitis, atrophic rhinitis, etc.
3. Patients with anatomic nasal abnormalities responsible for nasal symptoms.
4. Patients with nasal/sinus surgery 3 months before the study.
5. Patients with severe mental illness.
6. Patients with uncontrolled asthma, systemic disorders or malignancies.
7. Patients with history of chronic smoking, substance abuse, drug use, and/or excessive alcohol consumption.
8. Patients in pregnancy or lactation.
Intelligent Customer-driven Solution for Children and Their Parents Undergoing Day Surgery

This research aims to evaluate the effectiveness of web-based mobile intervention (Icory -Solution) developed to pediatric patients and their parents in the pathway of outpatient surgery treatment in pre-intra- and postoperative setting: (1) Examine the effectiveness of the intervention on children's preoperative anxiety and fear, and postoperative pain (2) examine the effectiveness of the intervention on parental anxiety and satisfaction in children´s care path and (3) examine the experiences of the gamification in children in the intervention group.

Children and their families are entitled to know what is going to happen to them before undergoing day surgery and information must be based on the child's age and understanding. It is important to help children to cope with any upcoming surgery because the more anxious and fear they are, the more pain they experience after the day surgery. Digital gaming solutions could help families and children to be better oriented to the coming treatment. Icory -solution is a digital pathway for children and family and it contains a virtual tour to hospital and distraction games for children. The information on the application is aligned with the patient's individual needs based on the type of surgery and requirements.

Eligibility Criteria:
Inclusion Criteria:

* Age between 7-12 years old
* Is scheduled for an elective day surgery
* Is able to speak, and read in Finnish
* Is accompanied by their parents (either mother or father or both) during the perioperative period
* Has access to smart phone/tablet (own or rent from the project)

Exclusion Criteria:

* Cognitive and learning disabilities identified from the medical record
* A chronic illness and/or pain that required special medical care
Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital

This randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo. The types of infection studied included bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis. This study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications.

Prostate cancer screenings will be conducted in all patients aged \>45 years with lower urinary tract symptoms (LUTS) through PSA test and digital rectal examination (DRE). Those with PSA levels of 4.0 ng/mL or higher or other abnormal findings on DRE will be recommended to undergo transperineal prostate biopsy. In addition, participants will be offered to participate in this clinical trial, in which participants will be randomly assigned into two groups: one group will receive prophylactic antibiotic, while the other group will receive placebo.

The randomization process will be conducted before the biopsy procedure. Computers will generate random numbers, which will put the participants into two groups. These numbers can only be accessed by the research monitor (Clinical Research Supporting Unit of IMERI FMUI), while the investigators, surgeons, residents, and nurses involved will be blinded to this information. To ensure patient blinding, the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation.

The primary outcomes of this clinical trial are the rate of perioperative infection complications, including bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis, in 24 hours, 7 days, and 14 days postoperatively. The secondary outcomes of this clinical trial are the rate of readmission.

Eligibility Criteria:
Inclusion Criteria:

* Patient with lower urinary tract symptoms aged \>45 years with either PSA levels of 4.0 ng/mL or higher or abnormal findings on digital rectal examination (DRE)
* Patient with a negative initial urine culture / urinalysis test

Exclusion Criteria:

* Patients who refuses to undergo transperineal prostate biopsy
* Patients who refuses to participate in the research
* Patient who is unable to communicate effectively
* Patient with a documented history of cotrimoxazole allergy
* Patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy
* Patient with urinary tract infection symptoms prior to undergoing prostate biopsy
* Patient with a history of immunodeficiency disorders or long-term corticosteroid use
* Patient with a history of prostate cancer
* Patient with a history of prior prostate biopsy
Long-term Effect of the Physical Activity Promotion on the Clinical Characteristics and Vascular Risk in Patients With Mild-moderate Obstructive Sleep Apnea

Main objective: To assess the effect of the daily physical activity promotion with a pedometer during 12 months on the apnea-hypopnea index (AHI) in patients with mild to moderate obstructive sleep apnea (OSA).

Study patients. Subjects 30-80 years old with diagnosis of mild-moderate OSA (AHI: 5-30 and predominance of obstructive events \[\>80%)\].

Design. Randomized, parallel and open-label clinical trial, controlled with conventional treatment.

Intervention: Patients will be randomized (1:1) to control group \[treatment and follow-up according to conventional clinical practice\] or intervention group \[in addition to conventional treatment and follow-up, the patients will receive a pedometer to measure the number of steps walked daily. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol (\<6000 steps/day: increase by 3000 steps/day; 6000 - 10000 steps/day: reach 10000 steps/day; and \> 10000 steps/day: maintain or increase steps).

Measurements. At , 12, 24 and 52 weeks of randomization, the following determinations will be made: anthropometric characteristics; clinical evaluation (smoking history, sleep symptoms, comorbidities, current medication); questionnaires (ESS, FOSQ, SF-12, EuroQoL and iPAZ); heart rate and blood pressure; analytical determinations (HbA1c, HOMA index, cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, homocysteine, NT-proBNP and hsCRP); plasmatic biomarkers (8-isoprostane, IL1beta, IL6, IL8 and TNFalpha); and evaluation of daily physical activity using an accelerometer.


Eligibility Criteria:
Inclusion Criteria:

* Age from 30 to 80 years
* Diagnosis of mild-moderate obstructive sleep apnea \[apnea-hypopnea index 5-30 h-1\] by polysomnography or respiratory polygraphy
* Predominance of obstructive events (\> 80%)
* Signature of informed consent

Exclusion Criteria:

* Previous diagnosis of chronic obstructive pulmonary disease, asthma, diffuse interstitial lung disease or chest wall disease.
* Evidence of central apneas, hypoventilation syndrome or respiratory failure
* Previous diagnosis of refractory arterial hypertension, congestive heart failure, ischemic heart disease or cerebro-vascular disease.
* Neurological or osteoarticular limitation that prevents ambulation.
* Professional drivers or occupational risk or respiratory
* Previous treatment with CPAP
* Participation in another clinical trial in the 30 days prior to randomization.