cyrilzakka/clinical-trials huggingface dataset:
Cutaneous Silent Period Assessment in Primary Sjögren's Syndrome

Primary Sjögren's syndrome (pSS) is a chronic, immune-mediated inflammatory disease mainly characterized by exocrine gland involvement. Beyond the wide heterogeneity in clinical presentation, neurological manifestation is one of the important systemic involvement of pSS. The prevalence of neurological involvement varies widely from 10% to 60% in different series.

Small fiber neuropathy (SFN) as a popular clinical entity in recent years targets nociceptive thinly myelinated A-delta and unmyelinated C-fiber nerves and is frequently associated with burning and allodynic pain. Previous studies have demonstrated that SFN is frequently seen in patients with pSS and has an important clinical importance because it cannot be detected by routine electrophysiological studies. Various methods can be used in the detection of SFN, and cutaneous silent period (CSP) measurement is gaining popularity recently due to its non-invasiveness and practical fashion.

In this study, the investigators aimed to compare CSP parameters as an indicator of SFN in patients with pSS and in the healthy population and to reveal its relationship with clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* For the patient group, patients followed up in accordance with the 2016 ACR/EULAR primary Sjögren's Syndrome classification criteria

Exclusion Criteria:

* Any comorbidities that may cause neuropathy
* Any drugs that may cause neuropathy
* Chronic alcohol consumption
* A history of disease that may affect the central nervous system
Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria
* Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator
* ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)
* Patients are required to have at least 3 of 66 joints assessed as swollen
* Patients are required to have at least 6 of 68 joints assessed as painful with pressure

Exclusion Criteria:

* Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
* Previous experience of tacrolimus (ointment excluded)
* Renal impairment or serum creatinine \> 1.4 mg/dL
* Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT \> 2x upper limit normal
* Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level \>110mg/dl before the meal and \>200mg/dl after the meal HbA1c \> 6.4%
* Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
* Other investigational drug within last 30 days
* Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib

The purpose of this study is to evaluate the efficacy and safety of Dovitinib in patients with gastrointestinal stromal tumors refractory and/or intolerant to Imatinib


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed GIST of any anatomical location, which is 1) unresectable and/ or metastatic with documented disease progression while on therapy with imatinib or 2) surgically removed localized GIST, recurrent on adjuvant imatinib or recurrent within the first 3 months after discontinuation of adjuvant imatinib or 3) patients with unresectable and/or metastatic GIST intolerant to imatinib
* Positive immunohistochemical staining for c-KIT (CD117); or negative staining for KIT, but with either positive staining for DOG1 or an identified mutation of KIT or PDGFRA gene
* Documented disease progression according to RECIST (version 1.1) on prior therapy with imatinib at a dose of at least 400mg/day or patients with unresectable and/or metastatic GIST who are intolerant to imatinib
* At least one measurable GIST lesion according to RECIST (version 1.1).
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Patients who have received any other tyrosine-kinase inhibitor but imatinib for GIST
* Patients who received cytotoxic drugs ≤ 4 weeks prior to starting Dovitinib (TKI258)
* Patients who are treated or planned to be treated concomitantly with other cytotoxic or antineoplastic treatments, such as chemotherapy, immunotherapy, biological response modifiers, or radiotherapy
* Patients with another primary malignancy within 3 years prior to starting the study drug
* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting Dovitinib (TKI258) or who have not recovered from the adverse effects of such therapy
* Patients with a history of pulmonary embolism (PE), or untreated deep venous thrombosis (DVT) within the past 6 months
* Patients with impaired cardiac function or clinically significant cardiac diseases
* Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dovitinib
* Patients with prior complete gastrectomy
* Patients with brain metastasis or history of brain metastasis
* Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin or equivalent anticoagulant
* Pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply.
Effect of Yoga Counselling on Quality of Life and Psychological Outcomes of Prostate Cancer Patients

Cancer is second leading cause of death worldwide. The psychological issues are related to all stages of the disease affecting outcome of treatment and overall quality of life. The study evaluated the effectiveness of yoga counselling among prostate cancer patients on their quality of life and psychological outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Prostate Cancer
* Sign a consent form allowing related information to be included in this research.

Exclusion Criteria:

* Have pre-existing diagnosed psychiatric conditions
* Currently taking psychotropic medications
* Have been diagnosed with cancer other than prostate cancer
* Evidence of active substance abuse.
African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Older Adolescents with Depression Delivered Through Senior High Schools in Navrongo, Ghana

The overarching aim of this pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by school guidance and counselling coordinators, for the treatment of depression among adolescents in senior high schools in Ghana. The study is a parallel arm cluster randomised controlled pilot trial. We will recruit adolescents aged 15 to 18 years in senior high schools. Participants will be randomised to receive the Y-MIND psychological intervention or enhanced usual care.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 15 to 18 years in senior high schools located within the Kassena-Nankana Municipality and Kassena-Nankana West District
* Have scored 10 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9)
* be willing and able to be followed up for 5 months and provide informed consent or assent
* For adolescents 15-17 years participants must have 5) access to a caregiver to obtain informed consent
* All participants must have the ability to read, write and communicate in English language.

Exclusion Criteria:

* are currently receiving any psychological treatment (talking therapy) for any common mental disorder through formal health care services
* have active bipolar disorder or psychosis (assessed through a brief screening tool for bipolar disorder and psychosis)
* have advanced or chronic physical illness (assessed through self-report)
* have significant visual or hearing impairment which would interfere with their ability to take part in the study
* are actively suicidal (assessed through the use of a four-item screening tool administered by a psychiatric nurse and reviewed by the trial clinical psychologist
Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome

Obstructive type sleep apnea syndrome is a clinical condition characterized by apnea, hypopnea and oxygen desaturation due to narrowing of the upper airway during sleep. Obesity is considered a major predisposing factor for OSAS. In addition, various recent studies have reported that various anthropometric measurements such as neck circumference, waist circumference, hip circumference, waist-hip ratio, neck-waist circumference ratio change (increase) in OSAS patients.

Fibromyalgia is a common health problem that is characterized by pain in various parts of the body and is very difficult to diagnose and treat. It affects 2-4% of the population and is more common in women. The presence of OSAS in fibromyalgia patients is more common than in the normal population. There are also common additional symptoms such as excessive daytime sleepiness and delayed sleep latency.

Although it has been reported that the presence of OSAS is more common in fibromyalgia patients, there is no study on the presence of anthropometric measurements, especially neck circumference, that are accepted in OSAS.

The aim of this study is to compare the anthropometric and ultrasonographic measurements of female OSAS patients with and without fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 years old
* Being diagnosed with fibromyalgia and having applied to the sleep disorders outpatient clinic or being followed up with the diagnosis of OSAS in the sleep disorders outpatient clinic.
* Agree to participate in the study

Exclusion Criteria:

* Patients under 18 years of age
* Male patients
* Not agreeing to participate in the study
* Neurological diseases that may cause OSAS such as stroke, Parkinson's disease, multiple sclerosis
* Rheumatological, oncological and hematological diseases
* Central type obstructive sleep apnea syndrome
* Thyroid pathology that affects neck circumference measurement
Effect of Baclofen on Marijuana Withdrawal and Relapse

The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.

Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. The objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this information to improve marijuana treatment outcome. GABAB agonists such as baclofen have been shown to attenuate the self-administration of cocaine, heroin, alcohol and nicotine (see Cousins et al., 2002; Haney et al., 2006). Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers (Akhondzadeh et al., 2000; Addolorato et al., 2000). The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse in our laboratory model. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of three medication conditions for 16 days: placebo and baclofen (60, 90 mg/day). Participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day. Further, clinical studies have shown that baclofen is most effective at decreasing cocaine's effects when administered for several weeks. During the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. This study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence.

Eligibility Criteria:
Inclusion Criteria:

* Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks
* Able to perform study procedures
* 21-45 years of age
* Women practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

Exclusion Criteria:

* Current, repeated illicit drug use (other than marijuana)
* Presence of significant medical illness(e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory clinically significant laboratory abnormalities)
* History of heart disease
* Request for drug treatment
* Current parole or probation
* Pregnancy or current lactation
* Recent history of significant violent behavior
* Major current Axis I psychopathology(e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
* Current use of any prescription or over-the-counter medication
Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)

Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data


Eligibility Criteria:
Inclusion Criteria:

* Capacity and willingness to sign informed consent
* ≥ 21 years of age
* Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI \< 30) within 12 months of the screening visit.
* Able to tolerate using the device during a day time trial/acclimation
* Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)

Exclusion Criteria:

* Nasal deformities
* Severe nasal allergies
* Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
* Co-morbid sleep disorders
* Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
* Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
* Full Face Mask user
* Mouth breather
* Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)
Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Vs Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair

Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.

Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia (ASA) physical status of 1 to 2,
* Body Mass Index (BMI) of less than 30 kg/m²,
* paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.

Exclusion Criteria:

* skin infection on the puncture site,
* coagulopathy
* brachial plexus neuropathy
* alcohol or drug abuse
* diabetes
* severe lung disease
* history of allergy to one or more study drugs.
Effect of Ginseng in Type 2 Diabetes

Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover design, the participants are randomized to receive either placebo or American ginseng extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment. Following ≥4-week washout period the participants are crossed over to another 8-week treatment arm. Throughout the study period, all individuals maintain their original diabetes treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety parameters include liver, kidney and hemostatic functions.


Eligibility Criteria:
Inclusion Criteria:

* Presence of type 2 diabetes of ≥1 year duration
* BMI between 25-35kg/m\^2
* HbA1c between 6.5-8.5%

Exclusion Criteria:

* Patients on insulin therapy
* Impaired hepatic or renal function
* Clinically manifested diabetic complications
* Present cardiac problems
* Uncontrolled hypoglycemia
* Cigarette smokers
* Alcohol consumption (\>2 drinks per week)
* Taking ginseng or other herb with possible hypoglycemic effect
* Involvement in any other investigational drug studies
* Changed medication during the course of the study periods or during the washout period
Safety and Efficacy of Long-term Somatropin Treatment in Children

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.


Eligibility Criteria:
Inclusion Criteria:

* In need of somatropin or current user
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study

Pilot study completed - power calculation performed. Now formal double blind randomized study comparing active with placebo wristbands for nausea in palliative care patients to be carried out.

Terminally ill hospice in-patients suffering with nausea will be randomized to active or placebo acupressure bands. The study will last 3 days and they will be allowed to continue regular or have PRN anti-emetics during the study.

Assessors and patients will both be blinded to whether they patients are receiving active or placebo bands.

Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days.
2. Describe their nausea as at least moderate on a Likert scale OR at have had at least one vomit per day for the last three days.
3. Have an underlying cause for their nausea which is thought to be irreversible OR the patient has made an autonomous choice not to proceed with treatment for any potentially reversible cause (for example surgery for obstruction or drainage of ascites).
4. Can be male or female patients but must be over the age of 18.
5. Have signed a consent form prior to entering the study.
6. If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial.
7. Be thought to be well enough to complete the 3 day trial.

Exclusion criteria:

1. Arm lymphoedema.
2. Weakness, fatigue or confusion sufficient that patient is unable to take part.
3. Previous history of acupuncture/acupressure for nausea or vomiting, or history of use of acupressure by a close relative.
4. History of Parkinsonism or Parkinsonism on examination.
5. Patients will not be enrolled if they are sharing a room with another patient taking part in the study.
6. Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.
Oral Health and Nutrition Integrated Care Model

The purpose of this project is to propose an "Oral Health and Nutrition Integrated Service Model" for the long-term care system based on the establishment of the assessment tools for oral hygiene and health, swallowing ability, nutritional status and food texture. This service model will be as the reference for long-term care policy making. This project includes four aspects such as evaluation tools, professional training, community promotion and policy development which will be completed in 5 stages. In the first stage, we will search and review the domestic and international materials which are related with the tools for evaluating oral hygiene and health (oral health assessment tool, OHAT), swallowing ability (EAT-10, eating assessment tool; functional oral intake scale, FOIS), nutritional status (Taiwan version of mini nutritional assessment, MNA) and food texture (Taiwan food texture grading system). We will also inventory the resources of oral health and nutrition before importing to community. In the second stage, an expert meeting will be held to determine the evaluation tool and the teaching materials of the training courses. In the third stage, an institution (En Chu Kong Nursing Home) will be the filed area to establish the "Oral Health and Nutrition Integrated Service Model". At the same time, assistants and instructors will be trained for conducting the assessment of oral health and nutrition status in the institution. Then, the status of oral health, chewing ability and nutrition will be investigated in the institution. In the fourth stage, we will modified the materials of training programs based on the data from resources inventory for the community (Zhong-He District, for example: Li-Xing Village, De-Xing Village or Zheng-Xing Village). Furthermore, the training programs for assistants and instructors will be also held in the community during the fourth stage. In the fifth stage, based on the evaluation tools and the integrated service models, the practical suggestions will be provided for the long-term care service policy making and implementation.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized people in En Chu Kong Nursing Home (Taiwan)
* Consciousness with expressing ability

Exclusion Criteria:

* Unconscious
* Without expressing ability