cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus

This study evaluates the efficacy of shunt operation for idiopathic normal pressure hydrocephalus, and determines the diagnostic value of noninvasive procedures commonly practiced in the clinic.

Idiopathic normal pressure hydrocephalus (iNPH) is a syndrome characterized by ventricular dilatation due to disturbed cerebrospinal fluid (CSF) circulation, accompanied by gait disturbance, dementia and/or urinary incontinence without causative disorders. With the aging of Japanese society, the number of patients is increasing, requiring diagnostic and therapeutic guidelines for the improvement of the patients' quality of life and social care. Under such conditions, this project was made as the prospective study of iNPH on Neurological Improvement (SINPHONI ). This study aims 1) to establish methods for non-invasive diagnosis of iNPH, and 2) to demonstrate therapeutic outcome of shunting operation by Codman Hakim programmable valve (CHPV). In this protocol, the evaluation of validity on MRI, tap test, CT cisternography, and CBF (3D-SSP) will be done in the diagnosis, and manual of initial setting pressure in CHPV for prevention of overdrainage problems will be estimated by modified Rankin scale (as primary endpoint) and some another scales during 1 year.

Eligibility Criteria:
Inclusion Criteria:

Patients who had at least one more points of the triad (gait disturbance, cognitive impairment, and urinary incontinence) in Japan NPH grading scale revised, and had disproportionate ventriculomegaly (Evans index \>0.3) with closing of the CSF space at high convexity on MRI. These patients must be diagnosed clinically other causative disorders, and ventricular dilatation due to disturbance of the cerebrospinal fluid (CSF) circulation. Be able to give informed consent.

Exclusion Criteria:

1) Cannot have an MRI scan 2) Has a problem with bleeding tendency and other serological examination. (liver enzyme and renal dysfunction, blood coagulopathy, and etc.) 3) Is unable to understand the risks of the testing and surgical therapy. 4) is tolerable for one year follow up after shunting operation.
Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management

The incidence of cutaneous melanoma (MM) is increasing worldwide. The best therapeutical solution for MM is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses.

Dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. Reflectance confocal microscopy (RCM) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy.

This study hypothesis is that the systematic application of RCM in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. Reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.


Eligibility Criteria:
Inclusion Criteria:

- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), \>= 18 years old

Exclusion Criteria:

* (i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer,
* (ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.),
* (iii) lesion larger than 2 cm in its largest diameter
* (iv) lesion where RCM examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).
Stillbirth Risk Identification Using Multiparametric Ultrasound

The goal of this observational study is to identify a novel biomarker for stillbirth.

Specifically the aim is to predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 and 37 weeks gestation.

Funding: Wellcome Leap, In Utero Program

Primary outcome: Perinatal hypoxia

Background: Perinatal hypoxia is an inadequate supply to or utilization of oxygen by the fetus. It is typically diagnosed at delivery and can lead to serious medical complications, including encephalopathy, and ultimately stillbirth. Fetal hypoxia represents 23% of neonatal deaths worldwide.

Aim: To predict perinatal hypoxia using quantitative ultrasound from the placenta (QUS-P) between 35 weeks gestation and delivery.

Methods: Raw radio frequency data is collected during ultrasounds between 35 and 37 weeks gestation using ClariusTM (handheld ultrasound). All scans take place at BC Women's Hospital. QUS-P parameters are derived from the raw radio frequency data and analyzed using linear regression.

Impact: The ability to identify perinatal hypoxia as early as 35 weeks gestation will allow for additional monitoring as well as efforts to prepare for immediate intervention if necessary (e.g. c-section, resuscitation, neonatal cooling), prevent progression to encephalopathy, and ultimately stillbirth.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant with singleton
2. Age 19 years or older
3. Provision of informed consent
4. Planning to deliver at BC Women's Hospital
5. 38 weeks gestation or less

Exclusion Criteria:

1. Pregnant with multiples
2. Not planning to deliver at BC Women's Hospital
3. Less than 19 years of age
4. Greater than 38 weeks gestation
Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies

The purpose of this research study is to compare the impact of the availability of biopsy results at the time of organ offers on the use and outcomes of kidneys from deceased donors.

Randomization of biopsy processing will be performed at the level of the deceased donor.

If the participant agrees to be in this study and signs the informed consent, at the time that a kidney is accepted for them, the accepted deceased donor will be randomized, like a flip of a coin, to one of two groups.

* Group 1: biopsies will be processed immediately (routine "frozen section") and results will be available to clinical teams at the time of the organ offers. Frozen section refers to a process where tissue from the biopsy sample is prepared by freezing and then slicing the tissue sample. Importantly, it can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed; however, the quality of the sample is not always optimal.
* Group 2: biopsies will be processed using "permanent sections" - these results will not be available until after the organ is transplanted. Permanent section refers to a process where tissue from the biopsy sample is prepared by placing the tissue sample in a fixative, called formalin, to preserve the tissue, processing it through other additional solutions, and then placing it in paraffin wax. After the wax hardens, the tissue is cut into very thin slices, which are placed on slides and stained. This process normally takes several days.

There is a 50/50 chance that the donor will be randomized to immediate biopsy processing by frozen section, versus permanent processing that yields results after transplant. If for any reason their surgeon feels that it would not be safe to proceed without the biopsy result, he or she will have the ability to receive the results of the biopsy before the transplant. The study team will record any episodes of this occurrence.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant candidate
* On waitlist for kidney transplant at the time of informed consent at one of the participating sites
* Age 18 or older
* Willing and able to provide informed consent for participation in the study

Exclusion Criteria:

* Unable or unwilling to provide informed consent to participate in the study
* Younger than 18 years old
* Not on waitlist for kidney transplant at the time of informed consent at one of the participating centers
* Candidates for or recipients of multi-organ transplants (kidney along with another solid organ)
Etiology of Early Apical Peri-implantitis

A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.

A case-control study was performed following the STROBE statement (17) at the Oral Surgery Department, Faculty of Medicine and Dentistry (University of Valencia, Spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (Figure 1). All patients were informed about the study design and procedures. Prior to participating, they were requested to sign an informed consent document. The study design was approved by the Ethical Committee of the University of Valencia (H1478255958653).

Two groups were established: Test group (patients diagnosed with early apical peri-implantitis diagnosed) and Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).

Eligibility Criteria:
Inclusion Criteria:

* The following inclusion criteria were applied: patients ≥18 years old and controlled medical conditions who received treatment with implants. Additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically.

Exclusion Criteria:

* for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.
BI 2536 Second Line Monotherapy in SCLC

Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
* Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
* Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.

Exclusion Criteria:

* More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
* Symptomatic brain metastases or leptomeningeal disease
* Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
* Absolute neutrophil count (ANC) \<1,500/µl, platelet count \<100,000/µl, or hemoglobin \<9 mg/dl
* Total bilirubin \>1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) \>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>5 x ULN in case of known liver metastases, serum creatinine \>2.0 mg/dl (\>176 µmol/L, SI Unit equivalent)
* Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug
* Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
* Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
* Known or suspected active drug or alcohol abuse
* Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
* Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
* Patients with neuropathy (sensory or motor) CTCAE 3
Staging System for Chronic Symptomatic Pilonidal Sinus Disease

A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

The collected data of patients who underwent surgery for the treatment of pilonidal sinus disease prior to June 2011 were analyzed. Following this analysis, a staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. "Pit-picking" technique was performed under local anesthesia on an outpatient basis in stage I and stage IIa patients. For stage IIb and stage III patients, the Bascom Cleft Lift /modified Bascom Cleft Lift techniques were performed. For stage IV patients, the rhomboid excision with the Limberg flap technique was used. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with symptomatic pilonidal sinus disease.

Exclusion Criteria:

* \<18 y
* Pilonidal sinus disease which identified incidentally and which presented with acute abscesses were not included to the staging system.
* Patients who were treated without the use of the suggested algorithm were excluded from the analysis.
DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes

The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.

The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.

Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.

The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.

The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.

Eligibility Criteria:
Inclusion Criteria:

Age over 18 years Have had T1DM for more than 1 years Be able to use the Danish-language general website on healthcare www.sundhed.dk Be mentally well functioning Understand and read Danish Access to internet
Analysis of 'Tobacco and Alcohol Tax Law' and Its Impact on Cigarette Consumption

This project is the survey on smoking behavior in Taiwan. The survey information will be used to analyze the influence of the earmarked tax of cigarettes on (1)the consumption of cigarette,(2)the substitution between the consumption of domestic and imported cigarettes, and(3)the consumption of other addictive goods.

The specific aims of this study are as follows:

Test hypotheses regarding the influence of cigarette tax on the consumption of cigarette and other addictive goods:

To test the hypothesis that the imposition of earmarked tax of cigarettes will cause decrease of cigarette consumption.

To test the hypothesis that the imposition of earmarked tax of alcohol will cause the substitution of consumption of domestic and imported cigarettes.

To test the hypothesis that the imposition of earmarked tax of cigarettes will cause the substitution of consumption of high-priced and low-priced cigarettes.

To test the hypothesis that the imposition of earmarked tax of cigarettes will cause decrease of the consumption of other addictive goods.

To test the hypothesis that the imposition of earmarked tax of alcohol will cause decrease of alcohol consumption.

To test the hypothesis that the imposition of earmarked tax of alcohol will cause decrease of the consumption of other addictive goods.

To test the hypothesis that price effect of earmarked cigarette tax on addicted smokers is less than on non-addicted smokers.

To test the hypothesis that price effect earmarked cigarette tax on heavy smokers is less than on light and moderate smokers.

To test the hypothesis that earmarked cigarette tax and alcohol tax are regressive.

Test hypotheses regarding the influence of information, knowledge attitude on cigarette smoking and smoking cessation.

To test the hypothesis that exposure to anti-smoking information is negatively related to cigarette smoking and positively related to smoking cessation.

To test the hypothesis that exposure to information on cigarette promotion is positively related to cigarette smoking and negatively related to smoking cessation.

To test the hypothesis that people perceiving high risk of cigarette smoking are less likely to smoke.

To test the hypothesis that highly risk averse people are less likely to smoke.

Eligibility Criteria:
Inclusion Criteria:

- The random sample of population over 18 years old.

Exclusion Criteria:

-
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study

Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.

This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Schizophrenia, on stable antipsychotic dose for at least one month
2. Ages 18-65 inclusive
3. Overweight (body mass index of 25 kg/m2 or greater)
4. Daily cigarette smoker (by self-report)

Exclusion Criteria:

1. Inability to provide informed consent
2. Treatment refractory schizophrenia
3. Current treatment with clozapine
4. Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
5. Documented poor compliance with oral antipsychotic medication
Investigation of the Analgesic Effects of Intradermal and Subdermal Sterile Water Injection on Active Labor Pain

Labour pain has different locations, intensity, quality and meaning for each woman, and the experience of pain changes throughout the delivery process. This pain is often associated with varying degrees of fetal malposition, particularly occipito-posterior position, which may apply pressure on pain-sensitive structures within the pelvis. Administration of Injections into the sacral area (both posterior iliac spines and 2 cm downward and medial) is used and have been shown to relieve the pain of labor. Controlling pain with simple methods can reduce the desire of mothers to give birth by cesarean section and make them more diligent for normal birth.

The benefit we expect from the research; Since sterile water injection is a safe, effective and low-cost method, it is important to understand the effectiveness of its use to reduce labor pain. It also aims to increase the knowledge of gynecologists about this method.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnant women with cephalic presentation who are admitted to the delivery room clinic for delivery, who do not have an additional chronic disease, who have not given birth before, and who are in the second stage of labor (active cervical dilatation of 6 cm and above) will be included in the study.

Exclusion Criteria:

* Patients who do not volunteer to participate in the study will be excluded.
Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents

The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.

Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse. Executive-control dysfunction is the main symptom for substance dependents. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization. But it has not been verified among MA or alcohol patients. The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. A random controlled trial will be used to test the effect of θ-tACS treatment. Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests
* Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol addiction
* Have used amphetamine or alcohol for at least one year (at least once a week)
* Normal vision and hearing, or within the normal range after correction
* Agree to cooperate in the follow-up evaluation
* No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity

Exclusion Criteria:

* Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
* Have used drugs promoting cognitive function in the last 6 months
* Have impaired intelligence (IQ\<70)
* Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years