cyrilzakka/clinical-trials huggingface dataset:
Computerized Personal Interventions for Alzheimer's Patients

The purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least delay its deterioration. In addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.

Reminiscence therapy and cognitive training are two of the most common non-pharmacological therapies used to treat AD. To date, there is no clear evidence regarding the impact of these treatments on the cognitive function of people with AD. The inconclusive evidence may be due to methodological limitations, the availability of a limited number of controlled studies, the lack of standardized interventions and the need for sensitive assessment tools.

Increasingly, computerized systems are being designed to support both the cognitive assessment of patients with Alzheimer's disease and the administration of novel non-pharmacological interventions. Studies suggest that such systems may be of clear benefit. For example, in an initial study involving patients with AD, computerized cognitive training systems have been shown to be of value in providing a more standardized approach to cognitive training. Also, another study found that the use of a computerized system for reminiscence therapy was successful in facilitating patient-caregiver interaction.

Our research is a collaborative effort designed to test the effects of two such computer-supported interventions in patients with mild AD. The purpose of the research is to compare the efficacy of personalized computerized reminiscence therapy and that of computerized cognitive training to a control group. The reminiscence therapy program is based on developing an internet-based personalized reminiscence system, which will facilitate flexible interactive use by patients and caregivers. The importance of a personalized system is especially salient in immigrant, or in highly mobile, societies due to the heterogeneous background of the patients.

Separate preliminary studies have found positive effects of each system. The research will use various measures to evaluate the efficacy of both treatments, including the Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument, which will serve as the cognitive outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease
* MMSE score of 14-26

Exclusion Criteria:

* Visual impairment
* Auditory impairment
* Psychiatric disorders
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
* In need of psychiatric treatment
* Cooperation and willingness to complete all aspects of the study

Exclusion Criteria:

* Current diagnosis other than bipolar I disorder
* History of schizophrenia or schizoaffective disorder
* Drug dependence within 1 month prior to study start or testing positive in a urine drug test
* Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
* Any form of psychotherapy within 1 month prior to study start
JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting


Eligibility Criteria:
Inclusion criteria:

1. Patients who have been started on JARDIANCE® in accordance with the approved label in Korea
2. Age = 19 years at enrolment
3. Patients who have signed on the data release consent form

Exclusion criteria:

1. Known hypersensitivity to empagliflozin or any of its excipients
2. Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis
3. Patients with persistent estimated Glomerular Filtration Rate \<60 mL/min/1.73 m2,end stage renal disease or on dialysis
4. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
5. Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®
Maternal Oral Hydration and External Cephalic Version

The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version


Eligibility Criteria:
Inclusion Criteria:

* single gestation
* breech presentation
* from 37 to 41,5 weeks
* without pregnancy complications
* fetus adequate for gestational age
* without fetal malformations
* intact membranes
* amniotic fluid index between 7 and 24 cm
* placenta properly inserted

Exclusion Criteria:

* age less than 18 years
* maternal disease at risk of fluid overload (cardiac disease, renal impairment, moderate or severe preeclampsia or hypertension and diabetes)
* contraindications for vaginal birth
* vaginal blood loss
* uterine contractions
Salivary Alkaline Phosphatase as a Biomarker for Dental Caries in A Group of Egyptian Children With Different Growth Rates: A Descriptive Cross-Sectional Study

Aim of the study:

1. Assess the correlation between salivary alkaline phosphatase levels and dental caries.
2. Assess the effect of growth of children on the levels of salivary alkaline phosphatase enzyme.
3. Assess the effect of growth of children on caries experience and severity.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 8 years old.
* Children with and without previous dental visits.

Exclusion Criteria:

* Children with any systemic or mental illness.
* Children whose parents refuse to sign the informed consent.
* Children who will not cooperate on participation
Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion

Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.

Patients with Central Retinal Vein Occlusion less than 6 month duration and reduction of vision to 6/21 will go OCT and FANG examinations.

Patient will be operated vitrectomy, and a branch retinal vein will be punctured by small needle and rTPA 200mcg/ml will be injected to the vein.

Eligibility Criteria:
Inclusion Criteria:

* crvo less than 6 month
* Visual Acuity less than 6/21
* No prior eye surgery except cataract.

Exclusion Criteria:

* Retinal/iris neovascularization
Health Education During Ramadan Fasting in Type 1 Diabetes

Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season.

People with type 1 Diabetes are among those who are risky to fast this holy month in the Muslim faith and thus are exempted from fasting. Yet many patients fast in spite of medical advice and religious exemption and for those patients, healthcare professionals should provide the utmost care and continuous diabetes education.

Different diabetes education modalities exist like DSME (Diabetes self-management education with proven efficacy. One modality is the Diabetes Conversation Map which delivers diabetes education interactively through a series of maps that address different issues in diabetes management and includes a specially designed Ramadan map.

In this study, two modalities of Diabetes focused Ramadan education will be compared regarding aiding patients to fast Ramadan safely. One modality will be Diabetes conversation maps and the other the International Diabetes Federation Education modules.

Adult Muslims are obliged to start fasting during the month of Ramadan. Fasting entails refraining from all food, drink, tablets and injections(vitamins \& fluids) between sunrise and sunset; a period which varies by geographical location and season. Although exempt, many diabetics refuse to take this concession as they feel psychologically \& spiritually inclined to fast along with other Muslims.

Fasting at Ramadan carries a very high risk for people with T1DM. This risk is particularly exacerbated in poorly controlled patients and those with limited access to medical care, hypoglycemic unawareness, unstable glycemic control, or recurrent hospitalizations.

Structured education interventions have been endorsed by the National Institute for Health and Clinical Excellence as important in empowering patients to improve their jour¬ney with diabetes. In a large observational study, patients who fasted during Ramadan without attending a structured education session had a fourfold increase in hypoglycae¬mic events, whereas those who attended an education pro¬gramme focusing on Ramadan had a significant decrease in hypoglycemic events.

Conversation Map aims to help people with diabetes experience a healthier Ramadan. The interactive Map covers a number of topics including understanding the risks and complications of fasting and the importance of creating a diabetes management plan during this time.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are intending to fast .
2. Duration of diabetes is more than 5 years .
3. Insulin regimen is basal-bolus .

Exclusion Criteria:

1. Acute complications as major events of hypoglycemia or DKA during the last 3 months before Ramadan .
2. Pregnancy .
3. Previous stroke, MI, or unstable angina .
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.

Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. The investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging, brain oxygenation (Sct O₂) evaluated by near-infrared spectroscopy and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging, Sct O2 (3) and troponin levels (4) both markers for ischemia damage.

Eligibility Criteria:
Inclusion Criteria:

* elective cerebral aneurysm clipping surgery
* arteriovenous malformation surgery
* craniotomy
* American Society of Anesthesiologists 1,2 and 3

Exclusion Criteria:

* cardiac abnormalities
* coronary heart disease
* valvular heart disease
* pregnancy
Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and matrix-gla protein. It is important to quantify the dose-response relationship of the interaction between vitamin K and oral anticoagulants and to investigate at what dosage vitamin K will interfere with oral anticoagulants in a clinically relevant way.

From all K-vitamins, menaquinone-7 has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins. In this respect it is important to quantify the dose-response relationship of the interaction between oral anticoagulants and menaquinone-7. The primary objective of the study is to demonstrate at what menaquinone-7 intake the vitamin will interfere with oral anticoagulants in a clinically relevant way. Clinically relevant is defined as a decrease in level of anticoagulation that would require a change in oral anticoagulant treatment in order to stay within target levels. Secondary objective of the study is to investigate changes in carboxylation level of osteocalcin and matrix-gla protein after menaquinone-7 supplementation during the oral anticoagulation treatment period. This will demonstrate whether during oral anticoagulation menaquinone-7 will be transported preferentially to the liver or to other target tissues.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults between 18 and 45 years of age.
* Subjects of normal body weight and height according to BMI \< 30
* Subject has given written consent to take part in the study

Exclusion Criteria:

* Subjects with (a history of) of coagulation disorders
* Subjects with (a history of) metabolic or gastrointestinal disease
* Subjects using (multi)-vitamin supplements containing vitamin K
* Subjects presenting chronic inflammatory diseases
* Subjects using any medication 3 months prior to the study (e.g. corticoϊd treatment, oral anticoagulants)
* Subjects using oral anticonception
* Subject with (a history of) soy allergy
Vitamin D and Pre Cachexia and Cancer Cachexia in Epithelial Ovarian Cancer

Several ex vivo, in vitro, and observational studies on various type of cancer shown positive effect of vitamin D. Vitamin D has widely known as immunomodulator property in various diseases. However, it remains limited studies on immunity and cachexia in cancer, particularly in ovarian cancer. This study will investigate the effect of vitamin D in immune response during chemotherapy among epithelial ovarian cancer patients who have a low level of vitamin D and cachexia

Studies result from laboratory suggested that vitamin D inhibit cancer cell proliferation and upregulate apoptosis pathway. Data from observational and ecology studies showed the inverse relationship between level of vitamin D and cancer risk. Clinical trials on colorectal, prostate, and breast cancer suggested that vitamin D had positive effect and improved clinical markers.

Vitamin D may alter immune response through regulation on cytotoxic CD8 T-lymphocyte and reduce pro inflammatory cytokines. High level of interleukin-6 and other cytokines in cancer may decrease lymphocyte T activity, resulting lowering effect of immune response.

This clinical trial will enroll 54 adults with newly diagnosed epithelial ovarian cancer patients. Following receive of informed consent, they will randomly allocated to receive whether vitamin D 2000 IU or placebo during chemotherapy period (6 cycles).

Subjects will fill out questionnaire on their first visit as well as each chemotherapy cycle (each month). Questionnaire will ask about demographic data, meal intake, sun exposure, and cachexia questionnaire (based on Cachexia Score). Subjects will also be examined on their physical status, anthropometry (weight, height, waist circumference), as well as body composition (fat mass, fat free mass, fat free mass index, phase angle).

Blood samples will be drawn from peripheral vein and sent to National Cancer Referral Hospital laboratory to measure 25(OH)D level, interleukin-6, CD8 cytotoxic level, CD8 cytotoxic activity, and circulating tumor cells. Blood collection will be done on the first visit, 3rd cycle of chemotherapy, and last cycle of chemotherapy. Subjects will be given their samples result during follow-up visit.

Vitamin D3 (Prove D3®) is donated from PT. Kalbe Farma. Departement of Medicine Physic Indonesia University as the third party which provides randomization and capsules containing vitamin D and placebo. Randomization key will be opened by the third party after finishing statistical data analysis. This study is being submitted a grant from Kalbe-BRIN.

Eligibility Criteria:
Inclusion Criteria:

1. age 18-60 years old who are newly diagnosed with ovarian cancer based on histopathology
2. epithelial ovarian cancer stage II-III
3. haven't received chemotherapy
4. pre-cachexia or cachexia
5. level of vitamin D below 30 ng/ml
6. no vitamin D allergy
7. ability and willingness to understand and provide informed consent

Exclusion Criteria:

1. autoimmune disease
2. chronic liver disease
3. chronic renal disease
4. known had hypercalcemia
5. refractory cachexia
Working Memory Training in Huntington's Disease

There is a paucity of investigation into effective interventions to enhance cognitive function and/or mitigate cognitive decline in individuals with Huntington disease (HD). This study targeted working memory (WM), which is the ability to actively hold information in the mind in order to perform complex mental tasks, given reports of WM dysfunction in patients with HD. The investigators examined the feasibility of conducting a 5-week WM training program (Cogmed). Patient adherence and treatment tolerance were assessed. In addition, preliminary evidence for the efficacy of this training program on targeted cognitive abilities was examined. Nine patients with pre-manifest or early stage HD underwent training. Patients were assessed before the intervention and one week after completion.

Huntington disease (HD) is associated with a variety of cognitive deficits, with prominent difficulties in working memory (WM). WM deficits are notably compromised in early-onset and prodromal HD patients. This study aimed to determine the feasibility of a computer-ized WM training program (Cogmed QM), novel to the HD population. Nine patients, aged 26-62, with early stage HD underwent a 25-session (5 days/week for 5 weeks) WM training program (Cogmed QM). Training exercises involved the manipulation and storage of verbal and visuospatial information, with difficulty adapted as a function of individual performance. Neuropsychological testing was conducted before and after training, and performance on criterion WM measures (Digit Span and Spatial Span) and near-transfer WM measures (Symbol Span and Auditory WM) were evaluated. Post-training inter-views about patient experience were thematically analyzed using NVivo software. Seven of nine patients demonstrated adherence to the training and completed all sessions within the recommended timeframe of 5 weeks. All adherent patients reported that they found training helpful (n=7), and almost all felt that their memory improved (n=6). Compared to baseline scores, patients showed significant improvement on the neuropsychological measures of verbal WM, including Digit Span (p = .047) and Auditory WM (p = .041). This pilot study provides support for feasibility of computerized WM training in early-stage patients with HD. Results suggest that HD patients can improve WM with intensive training, though a full-scale intervention project is needed to understand the reliability of changes over time.

Eligibility Criteria:
Inclusion Criteria:

1. Laboratory-confirmed gene expansion of at least 36 CAG repeats
2. Reported working memory difficulties on the Patient-Reported Outcomes in Cognitive Impairment (PROCOG) questionnaire
3. Total Functional Capacity (TFC) score of at least 3, taken from the UHDRS
4. Montreal Cognitive Assessment (MOCA) score of 19 or greater

Exclusion Criteria:

1. History of head trauma/neurological event such as stroke
2. Untreated psychiatric symptoms or substance abuse
3. Visual or motor symptoms that would impede ability to complete the program and/or neuropsychological testing
4. Nonfluency in English
Blood Pressure Control in African Americans

The purpose of this study is to test the effectiveness of a multi-component evidence-based intervention that targets both patients and physicians, in improving BP control rates in patients followed in 30 Community/Migrant Health Centers (C/MHCs).

BACKGROUND:

African Americans (AA) have the highest prevalence of hypertension (HTN) in the U.S., with a resultant greater HTN-related mortality compared to whites. Barriers to BP Control in AA exist at 3 levels of care: the patient, the physician, and the healthcare system. Using the Chronic Care Model as a framework, the investigators seek to test the effect on BP control of a multicomponent, multi-level intervention targeted at physicians and patients.

DESIGN NARRATIVE:

Using the Chronic Care Model as a framework, the investigators seek to test the effect on BP control of a multicomponent, multi-level intervention targeted at physicians and patients. They will conduct a clustered randomized controlled trial in which 30 C/MHCs will be randomized to either the intervention or usual care. A total of 990 patients with uncontrolled HTN (BP greater than 140/90 mm Hg) will be enrolled for this trial. Components of the patient intervention include an innovative patient education approach known as Self-Paced Programmed Instruction that will be used to educate patients on knowledge of HTN; behavioral counseling by trained C/MHC dieticians on lifestyle modification; and home BP monitoring to activate patients in their own care. The physician intervention comprises online continuing medical education (CME) courses on management of HTN based on the Joint National Committee-7 (JNC-7) guidelines; online HTN rounds or case conferences with HTN specialists; and feedback to physicians on clinical performance measures via computerized decision support systems. The intervention will be delivered to patients every 3 months during regular office visits for 12 months, while the physician intervention will occur every month for the duration of the trial. Patients and physicians at the usual care C/MHCs will receive NHLBI patient education materials and print versions of JNC-7 guidelines respectively.

The primary outcome is the proportion of patients with adequate BP control at 12 months in each condition as defined by JNC-7 criteria (BP less than 130/80 mm Hg for patients with diabetes or kidney disease; and BP less than 140/90 mm Hg for all other patients). The secondary outcomes are within-patient change in systolic BP and diastolic BP from baseline to 12 months; the maintenance of the intervention effects one year after trial; and the cost effectiveness of the intervention at 12 months. The long-term goal of this project is to refine the intervention as a result of the data obtained and to develop a standardized protocol that can be integrated into the usual care procedures of the C/MHCs. Thus, maximizing the likelihood that the intervention will be translated into practice, at each of the participating Community Health Centers.

Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled Hypertension
* African American