cyrilzakka/clinical-trials huggingface dataset:
A Support Program for Carers of Persons With Dementia

Dementia is one of the most common and devastating diseases in the elderly, it leads to helplessness, no cure exists and therefore care is necessary to provide. The care is associated with a great burden for the family carers and expensive for the society when residential care is required. The purpose of this study is to improve knowledge on how to provide better care for both the patients and their family carers, the investigators want to carry out a controlled trial using a rather cheap form of intervention, a multidimensional support program - an 18 months randomized controlled intervention study.

The 230 dyads of families, patients and carers, will be recruited from 18 municipalities, 18 from each municipality with at least 15 000 inhabitants. Only home dwelling patients and carers with at least weekly face-to face contact with the patient will be included. The patients will be recruited both from memory clinics, outpatients clinics in geriatric medicine and old age psychiatry and from home nurse districts. The patients should have a diagnosis of dementia according to ICD-10 criteria, have a score on Mini Mental State Examination of at least 15 points and have capacity to give informant consent to participation in the study. The carers should score at least five on the Relatives' Stress Scale.

115 family, control group, will receive care 'as usual' in the municipalities. The 115 family intervention group will have a duration of 18 months consisting individual counselling, education about dementia, problem-solving groups and ad-hoc counselling when needed. Effects will be measured at three levels, at patient level, at carer level and at societal level. Measurements will take place at baseline, after three, six, 12 and 18 months. At patient level, the Cornell scale will be used as the primary outcome. At carer's level, the primary outcome is the Relatives' Stress Scale. For the outcome on the social level Resource Utilisation in Dementia will be used.

The carers will be contacted every year up till five years after the intervention ended to give information about their own physical and psychological health and the patient's use of formal help such as day care centre, respite care and permanent nursing home placement.

Eligibility Criteria:
Inclusion Criteria:

* Home dwelling patients and carers with at least weekly face-to face contact with the patients
* The patients should have a diagnosis of dementia according to ISD-10 criteria
* A Mini Mental State Examination (MMSE)og at least 15 point.
* Have capacity to give informant consent to participation in the study
* The carers should score at least five on the Relatives'Stress Scale(RSS)

Exclusion Criteria:

* Result from the inclusion criteria
Antibacterial Effect of Paradontax Toothpaste

The purpose of the study is to test the antibacterial effect of Parodontax toothpaste on plaque formation, and thus gingivitis compared to placebo toothpaste.

Each subject will be given 2 plastic splints that are individually adapted to their quadrant 1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses daily. Each person's set of teeth is otherwise professionally cleaned.

Each subject will be given 2 plastic splints that are individually adapted to their quadrant 1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses daily. Each person's teeth is otherwise professionally cleaned.

Home procedure: The subject first rinses the mouth with water for 30 sec. Then both splints are placed on the teeth in the 1st quadrant and 2nd quadrant, respectively, and the rest (lower jaw) is brushed with the subject's regular toothpaste. The brace should be on for 1 min while cleaning the teeth in the lower jaw as usual, with its usual commercial toothpaste. After 1 minute, rinse your mouth with water for 30 seconds. Then the splints are removed and the mouth is immediately rinsed with water for another 30 sec. The procedure is repeated twice a day (morning and evening) for 3 weeks (21 days). In this way, the test person becomes his own control (1st quadrant versus 2nd quadrant), and the individual plaque quality is subordinate to what it would not otherwise be in a 2-group study. Furthermore, individual brushing technique will not be an issue, as we only test the antibacterial effect of the toothpaste in the splint quadrants. It is the antibacterial effect of Parodontax we test, not affected by brushing technique.

Health information that includes age, medication use, allergies, diseases, and tobacco use. Following the test period, registration of plaque (Silness\&Loe/Quigley\&Hines) and gingival bleeding (Loe\&Silness) will be registered

Eligibility Criteria:
Inclusion Criteria:

Healthy people of both sexes

* age 18-35 years
* Have at least three of the following teeth: 16, 15, 14, 13, 23, 24, 25, 26 with healthy gingiva.
* Non-smokers
* Has signed an informed consent document

Exclusion Criteria:

Pregnancy and breast-feeding.

* Any chronic disease Clinical or other symptoms of oral disease
* Any prescribed or over-the-counter systemic or topical medication with the exception of oral contraceptives used within one week prior to the start of the study.
* Haematological and clinical / chemical parameters considered unacceptable by the project manager.
* Use of antibiotics within the last three months before the start of the study.
* Alcohol or drug / drug abuse
* Participation in other clinical studies in the last 4 weeks before the start of the study.
Resect and Discard Extension to FICE of NIcE Classification

The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.

1. In order to create a video-library of endoscopic cases, patients undergoing screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified \<10 mm polyp will be included. A short video-clip (around 15-20 seconds) of each polyp both at white-light and FICE-light will be recorded and stored in an anonymized database.
2. Once the video-library is completed, each of 7 experts will independently review all the cases. For each case, any observer will assess each of the three NICE criteria (colour/vascularization/surface), the degree of confidence (low/high), and classify the lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE technology with high-definition and without magnification, when adopting NICE classification, to differentiate between hyperplastic and adenomatous lesions, and the inter-observer agreement in such differentiation. Secondary end-points are to assess at multivariate measure the role of any individual criteria of NICE classification in the discrimination between the two histotypes, and possible adaptations of NICE classification in order to be applied with FICE.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
2. The patient is at satisfactory risk to undergo abdominal surgery;
3. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1. Patients with inflammatory bowel disease;
2. Patients with a personal history of polyposis syndrome;
3. Patients with diverticulitis or toxic megacolon;
4. Patients with a history of radiation therapy to abdomen or pelvis.
5. Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
6. Personal history of coagulation disorders or use of anticoagulants
7. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Assessment of the Prevalence of Extended-Spectrum Betalactamase Producing Enterobacteriaceae Among ICU Staff

Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff

Prospective epidemiological study with voluntary non-medical staff member (i.e. nurses and nursing assistants) and medical staff in two French ICUs.

Assessment of self-reported risk factors for MDR-bacteria colonization. Self-performed rectal swab with isolation of ESBL-producting Enterobacteriaceae, identification of bacterial species and antibiotic suspectibilities.

Characterization of Escherichia coli ESBL.

Eligibility Criteria:
Inclusion Criteria:

* volunteers

Exclusion Criteria:

-
Flower Print Activity Applied to the Elderly in the Nursing Home

This research will be carried out in order to determine the effect of the flower pressure activity applied to the elderly in the nursing home on the anxiety levels of the elderly.

This research will be carried out in order to determine the effect of the flower pressure activity applied to the elderly in the nursing home on the anxiety levels of the elderly.

Hypotheses H0 = Flower pressure activity applied to the elderly in the nursing home does not affect the anxiety level of the elderly.

H1= Flower pressure activity applied to the elderly in the nursing home reduces the anxiety level of the elderly.

Eligibility Criteria:
Inclusion Criteria:

* Has no physical handicap that may hinder the activity of flower printing,
* No vision or hearing loss that may hinder the activity of flower printing,
* Open to communication and cooperation,
* The elderly who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Have a serious medical disability,
* Having a serious psychiatric diagnosis,
* Severely demented and
* The elderly who do not want to continue the research will be excluded from the research.
MethaLoad Dose-Finding Study

The goal of this proposal is to develop a "loading dose" approach to starting methadone to treat fentanyl opioid use disorder (OUD). We aim to conduct an assessor-blinded dose-finding study of 24 participants with fentanyl OUD recruited to a research unit for monitored methadone dosing. Participants will be randomized to standard methadone initiation vs. one of three loading dose approaches. The primary goal is to identify the maximum tolerated methadone loading dose appropriate for future study.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide a dated written informed consent in English prior to the conduct of any study related procedures
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, female, transgender, or non-binary aged 18 or older
4. In good general health as evidenced by medical history.
5. Fentanyl positive urine drug test
6. Ability to take oral medication and be willing to adhere to the dosage regimen
7. For females of reproductive potential: negative urine pregnancy test on screening and on admission
8. DSM-5 criteria for opioid use disorder, moderate to severe
9. Interest in starting methadone treatment for opioid use disorder at Merakey Parkside (our partner outpatient treatment program where we will send patients on discharge from the study)

Exclusion Criteria:

1. Previously documented hypersensitivity or allergy to methadone
2. Prolonged QTc (=450ms in men, =460ms in women), previously documented long QT syndrome, history of QT prolongation, or history of ventricular arrhythmia (e.g., torsades de pointes)
3. Pregnancy or lactation
4. DSM-5 criteria for benzodiazepine or alcohol use disorder
5. Urine drug testing at screening positive for buprenorphine and/or methadone
6. AST and/or ALT 3x upper limit of normal or total bilirubin or equal to 1.5x upper limit of normal
7. eGFR less than or equal to 60 mL/min
8. Chronic hypotension (\<90/50 mmHg) or episodic symptomatic hypotension (history of active or recurrent orthostatic hypotension or syncope).
9. Significant chronic pulmonary disease: COPD with modified MRC Dyspnea Scale \>=3 ("I stop for breath after walking about one city block") or requiring oxygen (chronically or at bedtime)
10. Active, chronic use of the CYP3A4-inducers or -inhibitors rifampin, phenytoin, St John's wort, phenobarbital, carbamazepine, voriconazole, efavirenz, nelfinavir, nevirapine, ritonavir, and lopinavir+ritonavir, abacavir, or amprenavir
11. Significant medical symptoms, psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study, obtaining informed consent, or ability to safely participant in the study
12. Pending legal action that could prohibit participation and/or compliance in study procedures
A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings

This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects minimum 18 years of age
* Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
* Willing to perform up to 12 finger-pricks during each day of out-patient measurements
* Signed informed consent
* For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
* Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study

Exclusion Criteria:

* For female subjects: Pregnancy or breastfeeding
* Skin phototype VI categorized by Fitzpatrick scale measured on thenar
* Subjects not able to understand and read local language
* Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
* Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
* Extensive skin changes, tattoos or diseases on right thenar (measurement site)
* Reduced circulation in right hand evaluated by Allen's test
* Known allergy to medical grade alcohol
* Hemodialysis
* Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
* Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
* Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
* Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
* Subjects currently participating in another study
* Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-19.
* Incapacity for consent
GW572016 Combined With Trastuzumab For The Treatment Of Previously Trastuzumab-Treated Breast Cancer

This is two-part study (Phase I/Phase II). Part I is designed to find the optimal (best) doses of GW572016 and trastuzumab when given together,Part II is designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving lapatinib and trastuzumab.


Eligibility Criteria:
Inclusion criteria:

* Patients with confirmed breast cancer who have received prior trastuzumab.
* Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity.
* Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion criteria:

* Patients with certain heart problems.
Application of Platelet-rich Plasma (PRP) in Reproductive Medicine

Female fertility is affected by many factors, such as ovarian function, fallopian tube patency, uterine environment, and mental state, among which the ovaries and endometrium are more important. In reproductive medicine, ovarian dysfunction, poor ovarian reaction, intrauterine adhesion, recurrent implantation failure, and thin endometrium are the five most common diseases that affect fertility. These five diseases lack effective treatment, and previous studies have shown that platelet-rich plasma is promising in treating these five diseases, so it is necessary to further explore the therapeutic effect and potential mechanism.


Eligibility Criteria:
Inclusion Criteria:

* Premature ovarian insufficiency: ① Women aged \>18 and \<40 years old; ② Oligomenorrhea or amenorrhea for more than 4 months (excluding pregnancy); ③ Basal follicle stimulating hormone (FSH) \>25IU/L (interval \>4 weeks) at least 2 times, or total antral follicles (AFC) \<5, or anti-Mullerian hormone (AMH) \<1.1ng/mL.
* Poor ovarian response: ① Advanced age (≥40 years) or other risk factors for poor ovarian response; ② Poor ovarian response in previous IVF cycle, with ≤3 oocytes retrieved using conventional protocols; ③ Decreased ovarian reserve (antral follicle count \<5\~7 or anti-Müllerian hormone \<0.5\~1.1 ug/L). Meeting any 2 of the above 3 criteria is sufficient.
* Intrauterine adhesion: ① Diagnosed by hysteroscopy and scored ≥5 points according to the American Fertility Society criteria (1988); ② With symptoms such as reduced menstrual flow amenorrhea, periodic lower abdominal pain, infertility, or recurrent miscarriage; ③ Adult women with the desire to conceive.
* Thin endometium: ①Endometrial thickness \<7mm on ovulation day or on the day of human chorionic gonadotropin (HCG) injection, or \<7mm on progesterone conversion day when using conventional hormone replacement therapy, ②adult women with the desire to comceive.
* Repeated implantation failure: Women under 40 years old who have failed to achieve clinical pregnancy after transplanting at least three high-quality embryos within three fresh or frozen cycles. High-quality embryos include: Day 3 embryos (with ≥8 cells, evenly sized blastomeres, and \<10% fragmentation) and blastocysts (≥3BB).

Exclusion Criteria:

* Alanine aminotransferase \> 3 times the normal upper limit or estimated glomerular filtration rate (EGFR) \< 90 ml/min;
* Suffering from hemorrhagic diseases (such as hemophilia) or taking anticoagulant or antiplatelet drugs;
* Suffering from serious mental illness, cardiovascular and cerebrovascular diseases and malignant tumors;
* Suffering from diabetes with poor blood sugar control or other systemic diseases;
* Drug abuse, alcoholism or drug addiction;
* Participated in other interventional clinical studies within half a year;
* Poor compliance;
* Other circumstances that are not suitable for participating in the study.
Effects of Cognitive-Oriented Intervention on Major Depressive Disorder

The specific aims of the study were to explore the effects of the cognitive-oriented intervention program for promoting social support on perceived social supports, depression symptoms, and stress-coping strategies for patients with major depressive disorder in Taiwan.

Background: Based on the 2010 World Health Organization declaration, depression will be ranked second among the global disease burden by 2020, second only to cardiovascular disease. It has become a disease that incurs high personal and social costs, and thus warrants considerable concern regarding its mitigation and early prevention.

Purpose: The specific aims of the study were to explore the effects of the cognitive-oriented intervention program for promoting social support on perceived social supports, depression symptoms, and stress-coping strategies for patients with major depressive disorder in Taiwan.

Method: This study adopted a randomized controlled trial (RCT). Patients with major depressive disorder were recruited from acute psychiatric wards in a medical center in Northern Taiwan. The study was conducted from July 1, 2015, to December 31, 2016; 105 patients met the inclusion criteria, and 100 patients agreed to participate in the study and completed the evaluation. The participants were randomly assigned to intervention group or control group. The intervention group received a 40 mins social support intervention program once a week lasting for 6 weeks, and the control group received health education activities with the same frequency as the intervention group. All participants were assessed by questionnaires before and after the intervention. Statistical analyses were performed by using descriptive statistics, independent sample t tests, and linear multiple regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with MDD by a psychiatrist
* over 20 years of age
* able to speak Mandarin or Taiwanese and able to write.

Exclusion Criteria:

* patients who were diagnosed with other psychiatric disorders
* with severe cognitive impairment or who could not make conversation acceptably were excluded.
Physiotherapy and Dysfunctional Breathing

Traditionally, the physiotherapy management of people with dysfunctional breathing or hyperventilation syndrome is breathing re-training. There is increasing clinical evidence that structural and functional changes develop in the muscles and connective tissues of the chest wall, abdomen and back when the upper chest accessory pattern of breathing is used over time. When treatment includes breathing techniques only it is difficult for a person with chronic hyperventilation, who has developed muscle and connective tissue changes, to revert to using the normal lower chest diaphragmatic breathing pattern. In clinical practice when the problems which have developed in the musculoskeletal system are addressed, the patient reverts more quickly to the lower chest pattern of breathing but there is as yet little evidence to support this clinical finding.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of dysfunctional breathing (Nijmegen score of more than 23)

Exclusion Criteria:

* active metastatic disease
* osteoporotic disease
* dysfunctional breathing as a consequence of respiratory or cardiac disease