cyrilzakka/clinical-trials huggingface dataset:
tVNS for Cognitive Impairments in Community-Dwelling Elderly

The goal of this study is to explore the effects of transcutaneous vagus nerve stimulation(tVNS) on improving cognition in community-dwelling elderly people. The study will recruit 120 subjects. Participants will undergo baseline cognitive assessment, EEG and eye tracking. Participants will be randomized to tVNS group and sham group. All subjects will repeat the baseline assessments after 1st session, 5th session，10th session and within 3 days after 10th session.

Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive neurostimulation technology.Recent studies have found that tVNS may involve in the regulation of cognition and improve the memory of the elderly.However, due to the limited number of studies, the effect of tVNS on improving cognitive function and stimulation parameters are currently unclear.

To investigate the effects of tVNS on improving cognition in community-dwelling elderly people, our study will recruit 120 subjects. Participants will undergo baseline cognitive assessment, EEG and eye tracking. Active vs. sham treatment will be randomly assigned in a 1:1 fashion in groups using computer generated lists. Subjects and evaluators will be blind to treatment. All subjects will repeat the baseline assessments after 1st session, 5th session，10th session and within 3 days after 10th session.

Eligibility Criteria:
Inclusion Criteria:

(1) 65≤age≤75 years old; (2) years of education ≥1 year; (3) normal daily life ability; (4) total score of The Chinese version of Mini-Mental State Examination (MMSE) : Non-illiterate group (not graduated from elementary school)\> 14 points, elementary school group\> 19 points, middle school and above group\> 24 points).

Exclusion Criteria:

(1) People with obvious hearing, vision problems or communication difficulties; (2) People with obvious cognitive dysfunction (such as Alzheimer's disease); (3) People with serious medical diseases (such as heart disease, uremia, severe diarrhea) ; (4) In the stage of radiotherapy and chemotherapy; (5) People with serious neurological diseases (such as Parkinson's disease, infectious encephalopathy); (6) Patients with mental diseases (such as schizophrenia, depression, etc.); 7) Patients with substance abuse or alcohol dependence; (8) patients with implantable medical devices such as cardiac pacemakers; (9) patients with scars or inflammation on the ear skin.
Evaluation of Effect of Exercise on Prescription

The purpose of this study is to evaluate the effect of a primary healthcare intervention called 'Exercise on Prescription' aimed at increasing level of physical activity in a population of sedentary patients with increased risk of developing lifestyle diseases. The effect is evaluated using both objective and patient-reported variables.

Exercise prescriptions are used for initiating a physical active lifestyle in sedentary populations.

A Danish project called 'Exercise on Prescription' (EoP) is implemented in primary healthcare. Patients eligible for EoP are non-institutionalised adults with medically controlled lifestyle diseases or risk factors of lifestyle diseases, who are motivated to change lifestyle, able to improve health status through a physical active lifestyle, and willing to pay a fee of €100 for the intervention.

The purpose of this study is to assess the effect on: 1) maximal oxygen uptake (VO2max), 2) bodyweight and Body Mass Index, 3) glycemic control (in patients with impaired glucose tolerance), 4) physical activity level, and 5) health related quality of life.

The EoP-group is compared to a control group.

Eligibility Criteria:
Inclusion Criteria:

* all patients referred to the Exercise on Prescription scheme by their general practitioner
* volunteer to participate in the randomized trial
Intraindividual Comparison of EMO IOLs

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
* Age 50 to 100
* Visual potential in both eyes of 20/25 or better as determined by investigators estimation
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)

Exclusion Criteria:

* Preceding intraocular surgery or ocular trauma
* Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
* Pupil diameter \< 2.0 mm (photopic)
* Laser treatment
* Uncontrolled systemic or ocular disease
* Pregnancy/Nursing
* childbearing ability
Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants

The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
* Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
* Males must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Women of childbearing potential (WOCBP)
* Known previous exposure to BMS-986235
* History of any significant drug allergy

Other protocol-defined inclusion/exclusion criteria apply
Short Duration 6Fed Sponge For EoE Patients

This research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration SFED (two weeks versus six weeks) would have equal results.

Dietary therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis (EoE). Dietary studies were initially reported in children, but the results appear to be similar in adult patients. Elemental diets are successful in 70-95% of patients but are poorly tolerated.

The six food elimination diet (SFED) involves the elimination of the six most common food allergens (i.e. milk, wheat, soy, eggs, nuts, and fish) for six weeks and has become the mainstay of dietary therapy in EoE. A six week SFED has demonstrated excellent efficacy and durability in both pediatric and adult EoE. However, compliance with the SFED for a total of six weeks can be challenging for patients.

Previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in EoE . The sponge is swallowed as a 12 mm capsule on a string. The capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. In previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy. Therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace EGD esophageal sampling in the evaluation of dietary treatment of EoE.

Although initially described as a six week trial, it is possible that a shorter duration food elimination diet of 2 or 4 weeks would have equal efficacy. This would have important implications for patients as it would make the diet more tolerable.

Eligibility Criteria:
Inclusion criteria:

* Adults ages 18-70 years of age
* Diagnosis of EoE, i.e. symptoms of esophageal dysfunction with histologic finding of 15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of high dose proton pump inhibitor therapy.
* Scheduled to initiate a clinical SFED for treatment of EoE

Exclusion criteria:

* Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
* Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
* Esophageal minimal diameter \< 13 mm on structured barium esophagram
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Pregnant women
Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting in urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria (blood in urine).

Pain associated with cystoscopy varies from patient to patient, majority requires local anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of topical anesthesia and duration of cystoscopy are recognized as important factors contributing in severity of pain of which use of intraurethral gel left to individual preference. Various studies are available reporting the pain perception with use of various intraurethral gels. Even the highest level of evidence is unable to resolve the query.

With this study the investigators hypothesize that pain perception (recorded in form of pain score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone.

With better control of pain the investigators aim to increase patient comfort and compliance which will increase the patient satisfaction rate and early return to work.


Eligibility Criteria:
Inclusion Criteria:

* All male patients aged 18 and above
* Visiting for evaluation of Haematuria or
* Lower urinary tract symptoms (which include poor steam of urine,intermittency, hesitancy, incomplete voiding of urine, increase urgency, increase frequency, nocturia and urge incontinence)
* For removal of double J ureteral stent will be included in the study.

Exclusion criteria:

* Patients with clinical evidence of urethral stricture and/or prostatitis,
* Patients in which biopsy will be taken,
* those having psychiatric illness,
* Asthmatics
* Kidney, liver disease
* Those allergic to NSAIDs (non-steroidal anti-inflammatory drugs)
* Those who refuse to participate,
* Having history of chronic analgesia use or
* Having language barrier will be excluded.
Neurofeedback in Visual Snow

Visual snow (VS) is a distressing, life-impacting condition with unrelenting and persistent disturbing visual phenomena. Disease onset is usually around age 20 and is characterized by continuous perception of innumerable flickering dots (like a 'broken television'). The disease is often accompanied by comorbidities such as migraine, tinnitus, depression and anxiety.

Neuronally, VS patients show cerebral hypermetabolism, resulting in altered neuronal excitability, as well as increased grey matter volume in parts of the visual cortex.

For this pilot study, the investigators aim to recruit VS patients. In a double-blind, randomized and placebo-controlled longitudinal experiment, the investigators will use real-time functional magnetic resonance imaging (rtfMRI) neurofeedback to teach patients to downregulate activity in different regions of the visual cortex.

The investigators hypothesize that neurofeedback will allow patients to learn to downregulate their abnormal visual cortex activity. Moreover, the investigators predict that a stronger downregulation of activity from the lingual gyrus will correlate with a more pronounced decrease in VS symptoms.

Currently, there is no pharmacological or non-pharmacological treatment available that significantly reduces the high disease burden produced by VS. Thus, there is an unmet need for an appropriate intervention to treat patients with VS. In this study, the investigators will:

1. Test if rtfMRI-based neurofeedback could serve as therapeutic option for patients with VS.

   Here, the investigators will examine correlations of neurofeedback regulation success with clinical scores 3 after neurofeedback
2. Examine brain function and structure in patients with VS

Primary and secondary endpoint/outcome(s)

* Primary outcome variable: VS symptom severity before and after rtfMRI, using standardized clinical assessment.
* Secondary outcome variables: fMRI and structural MRI, clinical questionnaires (visual function, anxiety, depression, tinnitus, and migraine), parameters from psychophysical data (assessed before and after neurofeedback).
* Linear Mixed model analysis will be performed (using clinical and imaging data) to estimate the impact of rtfMRI on clinical progression and brain function/structure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with VS (≥ 18 to ≤ 60 years), which can read and sign the informed consent form.
* Male and female
* Healthy controls (≥ 18 to ≤ 60 years), which can read and sign the informed consent form.

Exclusion Criteria:

* MR exclusion criteria (patients only): metallic items in the body (i.e. eye splinter, MR incompatible implants), pacemaker, claustrophobia).
* pregnant participants
* participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease and with major psychiatric disorders such as schizophrenia, depression, or anxiety disorder requiring pharmacological treatment (psycho-pharmaca).
The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery

Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .

In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.

The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.

The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of gastric cancer
* The patient who agrees to participate in this study by signing the informed consent form

Exclusion Criteria:

* The patient who refuse to participate in this study
* Have simultaneously other cancer
* Underwent cancer therapy at past time
* Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
* Have a previous upper gastrointestinal surgery
Surveillance for Early Liver Injuries Caused by Yangxue Shengfa Capsule.

This is a prospective registry study to surveil early liver injuries caused by Yangxue Shengfa Capsule (YXSF Capsule) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to YXSF Capsule.

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of YXSF Capsule; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to YXSF Capsule.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals in accordance with indications for YXSF Capsule, including xerasia, itchy scalp, alopecia areata, seborrheic dermatitis and alopecia;
2. The age range of 18 to 70 years；
3. Individuals taking YXSF Capsule over 2 weeks;
4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:

   (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;
5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for YXSF Capsule;
2. Inconformity to the YXSF Capsule drug label;
3. Individual taking YXSF Capsule less than 2 weeks;
4. Individuals taking other hepatotoxic drugs combined with YXSF Capsule, simultaneously;
5. Inconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.
Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

The primary objective of this trial is to evaluate analgesic efficacy of Buprenorphine Sublingual (under the tongue) Spray compared with placebo in participants with postoperative pain after bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
Tolvaptan Extension Study in Participants With ADPKD

To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.


Eligibility Criteria:
Inclusion Criteria:

- Participants who had successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment study, with a confirmed diagnosis of ADPKD from prior studies \[either 156-04-251 (NCT00428948) or 156-04-250 (NCT00413777), 156-06-260, 156-09-284 (NCT01336972), 156-09-285 (NCT01210560), and 156-09-290 (NCT01451827)\].

Exclusion Criteria:

* Participants unable to provide written informed consent.
* Participants (men or women) would not adhere to the reproductive precautions as outlined in the Informed Consent Form.
* Participants (women only) with a positive urine pregnancy test.
* Participants who were pregnant or breast-feeding.
* Participants unable to take oral medications.
* Participants who had allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine).
* Participants with disorders in thirst recognition or an inability to access fluids.
* Participants with critical electrolyte imbalances, as determined by the investigator
* Participants with or at risk of significant hypovolemia, as determined by investigator.
* Participants with significant anemia, as determined by investigator.
* Participants with a history of substance abuse (within the last 3 years).
* Participants who were taking other experimental (that is, non-marketed) therapies or were participating in another clinical drug or device study; participating in the off-drug follow-up period of another ADPKD trial with tolvaptan was permitted.
* Participants unable to complete magnetic resonance imaging (MRI) assessments (for example, participants with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia).
* Participants who had taken a vasopressin antagonist (outside of previous participation in a tolvaptan study).
* Participants unable to comply with anti-hypertensive or other important medical therapy.
* Participants with advanced diabetes.
* Participants who were taking medications or had an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting polycystic kidney disease \[PKD\] cysts).
Integrated Community Case Management Study in Eastern Province, Zambia

This study will provide important evidence to the Ministry of Community Development, Mother and Child Health (MCDMCH) and the Ministry of Health (MOH) on how to effectively implement iCCM with a focus on improving both the flow of supplies to CHWs as well as the quality of their supervision and mentorship. The overall aim will be to determine whether improvements in supplies for community health workers (CHWs) and strengthened supervision result in improved early and appropriate treatment for children with malaria, pneumonia, and diarrhea in rural Zambia when compared to CHWs offering iCCM without this logistics and supervision support.

The main objective of this study is to strengthen the delivery of integrated community case management (iCCM) of malaria, diarrhea, and pneumonia in Chadiza and Chipata Districts of Eastern Province, through mHealth supported improved supply chain management of iCCM commodities and enhanced supportive supervision of iCCM-trained CHWs.

Eligibility Criteria:
Inclusion Criteria:

* Age \<5 years
* Treatment for an iCCM condition (malaria, pneumonia, or diarrhea) by a CHW
* Willingness of the child's caregiver to provide informed consent

Exclusion Criteria:
On the Cyberknife Dose Fraction of Liver Cancer Treatment

The research aims to the primary hepatic carcinoma patients whose diameter of the single tumor is equal or less than 5cm.By supervising the changes of liver function, Child-Pugh score, ICG-R15 value, secondary reaction, incidence rate of RILD during and after the radiotherapy, meanwhile combining the outcome of the progression of disease and the condition of survival quality, the optimum proposal could be obtained and apply to clinic thus make the treatment safe, effective and personalized.


Eligibility Criteria:
Inclusion Criteria:

* The participants are from 30 to 80 years of age, without gender restriction
* With the hepatopathy background, the diagnosis of primary hepatic carcinoma is confirmed by image examination and laboratory test(the diagnosis criteria is according to the primary hepatic carcinoma rule of diagnosis and treat in 2007)
* The max diameter of single tumor ≤5cm
* Child-Pugh Classification(CPC) A or B
* ECOG score 0 or 1
* Leukocyte is more than 2×109/L and thrombocyte is more than 60×109/L
* Kidney function is normal
* Unsuitable or rejecting other therapies such as resection, liver transplantation etc
* Anticipated lifetime is longer than six months
* The participants who are voluntary comply with the requirements of research
* The participants agree to sign the informed consent.

Exclusion Criteria:

* The metastasis occur outside of liver
* Child-Pugh Classification(CPC)
* The outline of tumor is not confirmed by image examination
* With hepatic or any other abdomen radiotherapy history before
* With severe internal medicine diseases
* Bone marrow haematopoietic function or kidney function is severe failure
* Intractable ascites
* The position of tumor is nearby esophagus, stomach or intestine
* The normal liver volume less than 700 cm3