cyrilzakka/clinical-trials huggingface dataset:
Brain-derived Neurotrophic Factor and Cogntive Function

Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction followed by dementia in late life. Obesity, physical inactivity and "systemic low-grade inflammation" are strong risk factors and play a crucial role in this network of diseases.

Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity and type 2 diabetes.

The investigators include 200 individuals divided into three groups: 80 individuals with type 2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose tolerance.

The project will test the hypothesis, that low systemic BDNF are associated with accumulation of abdominal fat, cognitive dysfunction and insulin resistence with different effect in men and women.

Methods:

200 individuals in age 40-65 years are recruited and categorized into 3 groups: 1. Type 2 Diabetes, 2. Impaired glucose Tolerance and 3. Normal Glucose Tolerance. Groups are supposed to be age and BMI-matched.

Measurements of systemic BDNF, cogntive function (memory, attention and langue), fitness, bodycomposition, glucose metabolism and systemic inflammation are done.

Multiple regression analysis are perfomed to explain variablity in cognitive function, with age, visceral fat and BDNF as explanotory varibales.

Eligibility Criteria:
Inclusion Criteria:

* 40-65 years of age

Exclusion Criteria:

* Chronic inflammatory diseases or infectious diseaases within 3 month prior to visit
* Fasting glucose \> 12 mmol/l
* Hypertension: systolic \>180 mmHg and Diastolic \>110 mmHg
* Intake of more than 2 oral antidiabetic drugs or any TZD drung within 3 months before recruitment
Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Subject of French language
* Subject with a moderate bilateral sensorineural hearing loss, severe to profound
* Sensorineural hearing loss post-lingual (after onset of language acquisition)
* Subject paired with the implant Neurelec (Appendix 1) for more than 9 months
* Subject has received an appropriate setting under usual clinical follow-up
* Elderly 18 to 75 years
* Subject giving consent

Exclusion Criteria:

* Sensorineural hearing loss pre-lingual
* Deafness following a meningitis, or neurodegenerative diseases
* Illiteracy
* Pregnant women
* Subject blind
* Subject enjoying a measure of legal protection
* Subject incapable of giving consent
* Subject vulnerable
A Modified Mathematical Model to Calculate Power Received by Mechanically Ventilated Patients With Different Etiologies

Ventilator-induced lung injury is a common complication. The latest and most noticeable theory of its pathogenesis is called 'ergotrauma' by Gattinoni in 2016. The theory uses ventilator-imposed 'energy' or 'power' to encompass several known forms of injury-inducing factors such as pressure,volume, flow, rate, etc. However, to quantify power imposed by ventilator is no easy task in clinical practice. So, Gattinoni proposed a mathematical formula for easy power calculation. However, Gattinoni did not compare the difference between various etiologies of acute lung injury. We will enroll 100 patients (50 with acute respiratory distress syndrome and 50 with normal lung). The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH2O) will be calculated by the formula. The area enclosed by hysteresis of pressure-volume curve, and hence the work it implies, will be measured as a standard. Our study will aim to compare the formula in different patient groups and in Taiwanese people.


Eligibility Criteria:
Inclusion Criteria:

* Intubated patients aged 20 to 90 years old

Exclusion Criteria:

* Fraction of inspired oxygen (FiO2) higher than 60%
* Acute physiology and chronic health evaluation (APACHE) II score more than 30
* Plateau pressure or peak airway pressure more than 30 cmH2O
* High risk for barotrauma
* Unstable hemodynamic status
* Under airway pressure release ventilation or high frequency oscillation ventilation therapy
* Under extra-corporeal membrane oxygenation support
* On prone position
Effectiveness of a Parental Training Programme to Enhance Parent-child Relationship and Reduce Harsh Parenting Practices and Parental Stress in the Preparation of Children for Transition to Primary School

This study tested the effectiveness of a parental training programme to enhance parent-child relationship and reduce harsh parenting practices and parental stress in the preparation of children for transition to primary school. A randomized controlled trial was employed and 142 parents were recruited. Parents in the experimental group engaged in less harsh parenting practices and reported better parent-child relationships than parents in the control group. Findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parental involvement in promoting a smooth transition for children from kindergarten to primary one.

Introduction Transition creates a time of vulnerability for the child, the parents and their relationship. Failure to adjust to the transition, on the part of either parents or children, might place the family in a psychological devastating position. There is an imperative need to develop and evaluate appropriate interventions for parents so that they can contribute to helping their children enjoy a smooth passage to a pleasurable learning life in primary school.

Aim The aims of this study were to test the effectiveness of a parental training programme to enhance parent-child relationship and reduce harsh parenting practices and parental stress in the preparation of children for transition to primary school.

Methods A randomized controlled trial, two-group pre-test and repeated post-test, between-subjects design was employed. The method of simple complete randomization was adopted. Recruitment and data collection were conducted during the summer in 2009. Participants were recruited through referrals from the Hong Kong Sheung Kung Hui Welfare Council in Tung Chung. Written consent was obtained from parents after they were told the purposes of the study and agreed to participate. Parents were told that they were under no obligation to participate, could withdraw from the study with impunity at any time and were assured of the confidentiality of the data to be collected.

After they had signed consent forms, a research assistant collected demographic and baseline data from parents. Data collection was divided into three phases: at the time of recruitment (pre-intervention), at six weeks and three months after the intervention. Parents were asked to respond to the Chinese version of the parental acceptance-rejection scale, parental stress scale, and self-report scale on parent-child relationship in respect of the transition from kindergarten to primary school.

Eligibility Criteria:
Inclusion Criteria:

* must be able to read and write Chinese
* must have had primary school education or above

Exclusion Criteria:

* with identified cognitive and learning problems were excluded, as also were children with such problems
STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs

The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among Parkland patients who are 18 years or older who have elevated liver functioning test (LFT) results: in reach with electronic medical record alerts and provider education vs. combination of in reach and provider education plus mailed outreach and patient navigation.


Eligibility Criteria:
Inclusion Criteria:

* ages 18 or older
* elevated liver functioning tests (AST or ALT \>35 that are separated by at least one month)
* ≥ 1 outpatient visit during 12 months prior to randomization at Parkland
* no prior HCV screening (prior HCV antibody, viral load, or genotype).
* any active medical coverage
* speaks Spanish or English

Exclusion Criteria:

* a life expectancy less than one year including any history of metastatic cancer, and those who received a palliative care or hospice referral in the past year
* history of HCC.
* non-English or Spanish speakers
* no address or phone number on file
Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)

Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination with Other Anticancer Agents in Patients with Metastatic Castration Resistant Prostate Cancer


Eligibility Criteria:
Inclusion Criteria:

* Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form prior to any study-specific evaluation
* Be ≥18 yrs of age at the time the informed consent form is signed
* Be either AR-directed therapy-naive or have received 1-2 lines of AR-directed therapy in the castration-resistant setting.
* Adequate organ function
* ECOG 0 or 1
* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
* Have disease progression after initiation of most recent therapy

Exclusion Criteria:

* Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
* Have received greater than 2 previous lines of chemotherapy for mCRPC
* Prior treatment with any PARP inhibitor
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
* Spinal cord compression, symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks
* Any clinically significant cardiovascular disease
* Taking any concomitant medications or herbs that could interfere or interact with the study drug
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)

This is a study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-8666 in participants with type 2 diabetes mellitus (T2DM). Participants enrolled in this trial would be either treatment-naive or have washed off of oral anti-hyperglycemic agents. MK-8666 is planned to be administered orally for up to 2 weeks. The primary hypothesis for this study is that after 14 days of once daily treatment with MK-8666, at a dose that is safe and well tolerated, the placebo-corrected fasting plasma glucose reduction from baseline is ≥34 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

* If female, must be either postmenopausal or surgically sterile
* A Body Mass Index (BMI) ≥18 kg/m\^2 to ≤40 kg/m\^2, inclusive.
* A diagnosis of T2DM
* Drug naïve or is being treated with no more than 2 oral antihyperglycemic agents (thiazolidenediones are excluded)
* Judged to be in good health except for T2DM
* Willing to follow a standard weight maintaining diet throughout the study
* A nonsmoker or has not used nicotine or nicotine-containing products for at least 3 months

Exclusion Criteria:

* A history of clinically significant endocrine (except T2DM), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* A history of myositis or complaints including diffuse myalgias, muscle tenderness, or weakness.
* A history of cancer (malignancy) excepting adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
* Has clinically unstable diabetic retinopathy, neuropathy, and/or clinical evidence of gastroparesis (frequent nausea, bloating or vomiting, severe gastroesophageal reflux, early satiety)
* A history of type 1 diabetes mellitus and/or history of ketoacidosis
* Taking a medication for a co-morbid condition that is not permitted during the study
* A history of significant multiple and/or severe allergies
* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus
* Had major surgery, donated or lost 1 unit of blood within 4 weeks prior to study participation
* Participated in another investigational trial within 4 weeks prior to study participation
* Consumes excessive amounts of alcoholic or caffeine-containing beverages
* A regular user of illicit drugs or a history of drug or alcohol abuse within the past year
Home Pregnancy Test Study on BioBank Samples

This is a non-clinical lay user study using stored clinical samples from the SPD BioBank.

Volunteers recruited into the study and meeting the criteria will test a randomised pregnant or not pregnant urine sample sourced from SPD's biobank with a new home pregnancy test. Volunteers will be required to follow the product instructions for use (IFU).

The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number. An independent study technician not involved in study conduct will be responsible for blinding the samples.

Women will be informed of the opportunity to participate in a study in which they will be required to use a home pregnancy test to test a urine sample provided to them. Interested applicants will be invited to join the study.

Volunteers will be advised that the product they will be testing is under investigation and that the volunteer will not be testing their own urine and therefore volunteers will not learn their own pregnancy status.

Volunteers will be required to consent to the study prior to participation. Each volunteer will test only one device, they will be provided with one investigational device and one urine sample. The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number.

When ready the volunteer will be required to read the IFU prior to testing the urine sample provided with the investigational device according to the instructions. The volunteer will advise the study technician of the result, who will record this on the result sheet.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged ≥18 years
* Willing to give informed consent

Exclusion Criteria:

* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G or affiliates
* Is a qualified or trainee Healthcare Professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Has previously taken part in this study
* Seen the product within the past 6 months
Survey Tool for Screening of Anemia in Women Before Pregnancy

The goal of this observational and cross-sectional study is to develop and validate a survey that can be used to identify anemia, and its severity, among pre-pregnant women allowing for the timely implementation of focused public health and personalized interventions.

Participants will be asked 26 survey questions about menstrual history and provide a 5 ml venous blood sample to measure hemoglobin, ferritin, and transferrin saturation levels.

Despite a variety of governmental campaigns and funded programs, anemia rates among reproductive age women in low- and middle-income countries (LMICs) have not decreased over the past few decades. Iron deficiency is associated with increases in morbidity and mortality in both non-pregnant and pregnant women, as well as their offspring.

Up to 500 currently married women between 18 and 25 years old who are not pregnant, have never been pregnant, and are not using any type of contraception other than barrier methods will be recruited for this study from primary health centres (PHCs) in Belagavi , Karnataka, India.

Accredited Social Health Activists (ASHAs) will identify potentially eligible participants and bring them to participating primary healthcare centers (PHCs) for screening, consent, and enrollment. Once enrolled, trained female interviewers will administer the PREPSA survey to the participant and a laboratory technician will draw a blood sample (upon completion of the survey or within four weeks) to analyze hemoglobin, ferritin, and transferrin saturation values. The survey responses that most closely align with low iron indices will be identified and become the basis of a scored, validated instrument which may be weighted based upon the strength of the associations found. Results will inform future health outcome trials.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 25 year old women
* Not currently pregnant and have never been pregnant
* Currently married
* If last menstrual period \>6 weeks ago, exclude pregnancy via pregnancy test

Exclusion Criteria:

* Currently using any form of contraception other than barrier methods
Assessment of Low Level Laser Therapy for Late Postoperative Pain After Lumbar Fusion Surgery

The primary objective of this study is to assess whether or not low level laser therapy (LLLT) decreases pain in post-operative orthopedic patients following lumbar fusion surgery.

Lumbar fusion surgery patients typically experience significant post-operative pain for several weeks and their rehabilitation does not start until 8 - 12 weeks postoperatively. We hypothesize that LLLT beginning 4 weeks postoperatively will provide significant reduction in postoperative pain.

Eligibility Criteria:
Inclusion Criteria

* Age \> 18 and \< 85 years
* Post-operative lumbar fusion surgery
* Currently resides within 100 miles of UMC

Exclusion Criteria

* Pregnant
* Pacemaker
* Medications that have heat or light-sensitivity contraindications (such as: steroids, some antibiotics)
* Two or more cardiac risk factors
* Intraoperative complications
* Wound infection
* Spinal fluid leakage
* Open wound
Neuropathic Spinal Pain Descriptors in Ankylosing Spondylitis

The investigators have aimed to explore and interpret the neuropathic pain (NP) descriptors of spinal pain in patients with ankylosing spondylitis (AS). For this purpose they have attempted to initiate a prospective, cross-sectional study with AS patients.

NP descriptors have been investigated in several pain syndromes such as post-herpetic neuralgia, post-surgical nerve trauma, peripheral diabetic neuropathy and low back pain. But there is no study examining descriptors of inflammatory spinal pain with or without neuropathic characteristics seen in AS. To date, only one study reported distribution of sensory descriptors in neuropathic and non-neuropathic pain (nonNP) in AS patients, but in this paper the painful region was not specified and the results related to sensory descriptors were not discussed. Therefore, investigators have aimed to explore and interpret the sensory descriptors of inflammatory spinal pain in patients with AS. For this purpose investigators have attempted to initiate a study investigating whether sensory descriptors in neuropathic pain (NP) are differ from those seen in non-neuropathic pain (nonNP).

The aims of this study are;

1. To determine NP descriptors that associated with spinal pain in ankylosing spondylitis patients
2. To compare the patients with and without NP with respect to sensory descriptors
3. To evaluate the relation between neuropathic pain (NP) descriptors and functional status

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with AS according to the Modified NewYork Criteria
* Visual Analogue Scale spinal pain score ≥ 3

Exclusion Criteria:

1. Diabetes mellitus, renal insufficiency, hypothyroidism
2. Postherpetic neuralgia, spinal cord compression
3. Being diagnosed as fibromyalgia in the last month or widespread pain indicating fibromyalgia
4. Malignancy
5. Pregnancy
6. Severe cardiac disease
7. In the last three months medical treatment leading to neuropathy (colchicine etc.)
8. In the last three months drug use for the treatment of fibromyalgia, depression or anxiety
Study on Complications, EfficAcy and Costs of Large Polypectomy

Colonoscopy has been shown to reduce the incidence and mortality of colorectal cancer, through the recognition and removal of pre-cancerous lesions, which in most cases evolve with a sequence that goes through formation of high-grade dysplasia (HGD).

The probability of HGD increases with the increase of the lesion of the polyp itself. Lesions\> 2 cm are present in 1% of colonoscopy screening. The resection of these lesions presents a greater technical difficulty and consequently a decrease in the efficiency. The rate of incomplete resection reported in the literature reaches 10% while that of recurrence / residual adenoma 16.4 / 31.7%.

The aim of the study SCALP is to evaluate the incidence of complications, efficacy and cost of endoscopic resection of colic lesions\> 2cm in a setting of clinical practice in an unselected population


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing large endoscopic polypectomy

Exclusion Criteria:

* pregnancy
* incapacity to give informed consent