cyrilzakka/clinical-trials huggingface dataset:
Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.

The "INTELLIH" (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes.

The proposed pilot program is the first of its kind in the nation to use a product, "IntelliH" - Intelligent Health for All, that combines four key technologies in one platform: 1) Mobile health application (mHealth) App and web portal, 2) wireless sensors and wearable devices, 3) Secure text messaging when both sender and receiver are logged in to the system and video-based patient interaction, and 4) remote health monitoring. The purpose of this pilot program is to understand a) usage and adoption of these technologies by providers and patients, and b) document the short-term improvements in health outcomes in a diabetic population. This pilot study will follow 20 diabetic patients (Type 1 or Type 2) as they beta-test this system, and will acquire data on consented subjects over a period of six months.

Eligibility Criteria:
Inclusion Criteria:

* A1c greater than or equal to 6.5%.
* Age greater than or equal to 18 years.
* Ability to comply with study protocol.
* Available and usable internet facilities at home.
* Availability and usable smart phone.

Exclusion Criteria:

-Inability to comply with instructions and directions.
Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent.
* Histologically or cytologically confirmed diagnosis of advanced solid tumor.
* Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
* ECOG performance status of 0 or 1.
* Adequate bone marrow reserve and hepato-renal function.
* Able to swallow and retain oral medication.
* For combo part, left ventricular ejection fraction within normal range or above 50%.

Exclusion criteria:

* Prior treatment with pazopanib, and with lapatinib for combo part.
* Clinically significant gastrointestinal abnormalities.
* Sevier diseases or conditions other than cancer.
* Poorly controlled hypertension.
* Use of warfarin for therapeutic anticoagulation.
* Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part.
* Unresolved and/or unstable toxicities
* Pregnant or lactating females
Use of Abbott RealTime CT/NG to Detect Chlamydia Trachomatis [CT] & Neisseria Gonorrhoeae [NG] in Men Who Have Sex With Men [MSM]

Julius Schachter, PhD, (Department of Laboratory Medicine, University of California, San Francisco) and Susan S. Philip, MD MPH (Department of Medicine, University of California, San Francisco) are conducting a study to evaluate the Abbott RealTime CT/NG polymerase chain reaction \[PCR\] assay (which is a nucleic acid amplification test \[NAAT\]) for detecting two sexually transmitted bacteria, Chlamydia trachomatis \[CT\] and Neisseria gonorrhoeae \[NG\], using urine samples and swabs from the throat and rectum of men who have sex with men \[MSM\]. Using this test on these swabs is experimental because it has not been approved by the Food \& Drug Administration.

For each subject enrolled in the study, the following clinical data information will be obtained: 1) reason for exam, 2) subject's signs and symptoms and 3) clinical assessment.

For each subject enrolled in the study, two clinician-collected pharyngeal swabs, two clinician-collected rectal swabs, and a first catch urine specimen (approximately 25 ml) will be obtained. The collection order of the clinician-collected swabs will be randomized.

Two pharyngeal swabs will be tested at the research laboratory using: 1) APTIMA COMBO 2® \[AC2\](Gen-Probe Inc, San Diego, CA); and 2) Abbott RealTime CT/NG \[RealTime\](Abbott Molecular, Des Plains, IL). Two rectal swabs will be tested at the research laboratory using: 1) AC2; and 2) RealTime.

A first-catch urine \[FCU\] specimen will be split out at San Francisco Department of Public Health laboratory and sent to the Chlamydia Research Laboratory for analysis using: 1)AC2; and 2) RealTime.

All NAAT specimens are collected in the manufacturer's recommended NAAT transport medium. After specimen processing, samples will be frozen at -70ºC for discrepant analysis.

Eligibility Criteria:
Inclusion Criteria:

* A subject must be MSM. Subjects must provide verbal consent, must be able to submit all required specimens and must not have urinated within 1 hr prior to providing a study urine specimen.

Exclusion Criteria:

* Subjects are excluded if they do not have sex with men, refuse to give verbal consent or refuse to allow such consent to be documented in their chart, are unable to provide all required specimens and minimum specimen volume, have been on antibiotic therapy within the last 21 days, have urinated within 1 hr prior to submitting study specimens, and have already been evaluated as part of this trial. Subjects will be excluded if specimens are mishandled or inappropriately stored.
Evaluating Effectiveness of Stress Reduction Programmes in the Community

The aim was to assess the feasibility and to improve the quality of a definitive Randomised Controlled Trial (RCT) with the purpose to investigate the effectiveness of stress reduction programmes in the community. (A definitive RCT = an RCT with statistical power). Intermediate aims: to investigate 1) the potential generalizability: the accept among the target population (people with perceived stress) of participating in an RCT, including a description of the participant characteristics and the recruitment time ; 2) the risk of intervention effect dilution: the accept of allocated intervention in terms of programme completion ; 3) the risk of contamination: potential participation in (other) stress reduction treatment beyond the allocated intervention or non-intervention ; 4) the risk of selection problems or -bias: the lost to follow-up in the trial arms ; and finally, 5) the risk of information problems: the accept among participants of chosen outcome measurements, sensitivity of chosen outcome measures to detect effects, and indications of potential effects.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* able to understand, speak, and read Danish.

Exclusion Criteria:

* acute treatment-demanding clinical depression or a diagnosis of psychosis or schizophrenia
* abuse of alcohol, drugs, medicine
* pregnancy.
The Psychology of Chinese Breast Cancer Patients

Earlier diagnosis of breast cancer in women and the use of systemic adjuvant therapy have increased the likelihood of long term, disease free survival.women who remain free of breast cancer seem to have levels of functioning and quality of life that are comparable to those of the general female population.It will be assessed the psychology status of women with breast cancer using a clinical interview,

It conducts a questionnaire survey of 300 patients. The questionnaires used are: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Quality of Life Scale for Breast Cancer Patients FACT-B, Social Support Rating Scale SSRS. Caregivers should fill in the following scales: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Caregiver Burden Assessment Scale ZBI. Inclusion criteria: 1,female patients with early breast cancer after surgery; 2,no previous mental and psychological abnormalities; 3,Postoperative and prepare to accept adjuvant chemotherapy ; 4,Patient's know her/his illness .

To explore:

1. Psychological status and dynamic changes of patients and caregivers during adjuvant chemotherapy after breast cancer surgery in China.
2. The influence of psychological status of Chinese breast cancer patients on adverse reactions during adjuvant chemotherapy.
3. Gene susceptibility to psychological abnormalities during adjuvant chemotherapy for breast cancer in China.

Eligibility Criteria:
Inclusion Criteria:

Age：18\~75 years; Early stage breast cancer confirmed by histology examination; Patients had undergone surgery for breast cancer; No distant metastasis; Planned to receive recommended postoperative adjuvant chemotherapy; Voluntarily provided written informed consent.

Exclusion Criteria:

Patients already receiving neoadjuvant chemotherapy before surgery; Patients had metastatic disease at diagnosis; Patients had difficulty understanding the questionnaire or communicating in Chinese; Patients had significant psychiatric or other comorbid disease prohibiting participation; Any other researcher believes that it is not appropriate to participate in this test.
Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation

This study evaluates the effects of a video game embedded in a commercially available mobile application (app) for smoking cessation. Smokers are increasingly turning to mobile health apps for assistance with quitting smoking, and there is a critical need for strategies to engage app users to increase retention and efficacy. Video games are designed to increase users' motivation and engagement, which in turn may increase their exposure and adherence to a smoking cessation program. The hypothesis is that the game increases engagement, retention, and smoking abstinence rates compared with a core version of the app without the game. A two-arm individually randomized pilot trial of 500 adult smokers will test this hypothesis, comparing outcomes for participants randomized to receive the core app plus embedded game with participants randomized to receive the core app only. Primary outcomes relate to user engagement with the app. Secondary outcomes relate to user engagement, efficacy (smoking abstinence), and user satisfaction.

PRIMARY OBJECTIVES:

I. Augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement.

II. Test the feasibility, engagement, and early efficacy of the 'gamified' app, compared to one without gamification.

OUTLINE:

Participants are recruited through the Smoke Free smartphone app and randomized to 1 of 2 arms.

ARM I: Participants receive an educational intervention through the Smoke Free application (core app) with the embedded video game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

ARM II: Participants receive an educational intervention through the Smoke Free application without the video game module (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Eligibility Criteria:
Inclusion criteria:

1. Provides electronic informed consent.
2. Male or female, aged 18 and older
3. Has downloaded and opened the Smoke Free app
4. A smoker of at least 1 cigarette per day
5. Plans to quit smoking within the next 7 days
6. Speaks, reads, and writes English
7. Lives in the United States

Exclusion criteria: None
Theta-burst rTMS in Schizophrenia to Ameliorate Negative and Cognitive Symptoms

The major target of the study is to confirm the safety and efficacy of our augmented protocol of theta-burst TMS in schizophrenia. Our aim is to confirm the beneficial effects of rTMS treatment on multiple aspects of the disorder such as (1) clinical aspect in terms of PANSS, (2) cognitive aspect such as emotion recognition (ER) and working memory (WM) / distractor filtering (DF) performance, and (3) neurobiology in terms of electrophysiology correlates of ER, WM and DF such as event related theta synchronization, resting state theta power, and network connectivity. Response prediction to (theta-burst) TB-rTMS will be the exploratory part of the study.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of schizophrenia or schizoaffective disorder;
2. clinically stabilized on antipsychotic: a stable dose of antipsychotic medication for \>4 weeks;
3. age 18-55 years, and
4. presence of negative symptoms (based on PANSS): a negative subscore ≥16 points and \[one of items N1-N7 scoring ≥4 or two items N1-N7 scoring ≥3\]

Exclusion Criteria:

1. any significant neurological illness;
2. mental retardation
3. history of head injury with loss of consciousness for more than 1 hour
4. history of epileptic seizures or epileptic activity on the baseline EEG (evaluated by an expert in clinical EEG and epilepsy),
5. alcohol or drug abuse within the past 3 months, and
6. depressive episode or antidepressant treatment in the past 4 weeks.
7. Severe positive symptoms inferfere with cognitive tests
8. ECT in the medical history
9. Implanted pacemaker, implanted drug pump, cochlear implant, implanted defibrillator, implanted neurostimulator or any other TMS incompatible implanted metal device
10. Skin surface is severly injured in the stimulated region of the skull
11. Sclerosis multiplex
12. Pregnancy
13. Severe sleep deprivation
14. Severe heart failure
15. Increased intracranial pressure
16. Untreated migrain
A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care

To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type II diabetes, according to medical records, diagnosis, prescription or lab assessments

Exclusion Criteria:

* Patients followed by physician for less than 6 months after diagnosis of Diabetes type II
Effect of the Timing of Cataract Surgery on Complications in Patients With Bilateral Congenital Cataracts

Congenital cataract is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and rigorous postoperative supervision for adverse complication. In this trial, we aimed to compare the difference of postoperative outcome between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 month, 6 month, 9 month, 12 month, 18month and 24month postoperatively.

Congenital cataract is a priority of Vision 2020: the Right to Sight, the global initiative to reduce the world's burden of avoidable blindness, because it is an important treatable cause of visual handicap in childhood throughout the world. Successful management of childhood cataract is dependent on individualized treatment strategies and postoperative supervision for adverse complication is also essential. The timing of surgery of childhood cataract depends on the etiology and on the degree of visual interference. Severe bilateral cataracts with significant obstruction of the visual axis must be treated and surgery is recommended as soon as possible after discovery.

Several previous studies claimed that ideally cataracts should be removed before 3 months of age, while the result of recent researches shows that too early intervention for cataract surgery seems aggressive and would cause serious complications, which might cause poor long-term visual outcomes. Therefore, in order to control childhood blindness and severe visual impairment in China, it is of great importance to ensure that pediatric patients with cataract could have good timing of surgery, postoperative rigorous supervision, accurate optical rehabilitation and comprehensive treatment of amblyopia.

In this trial, we aimed to compare the difference of postoperative outcome between surgical timing at age of 3 month and 6 month. Patients enrolled into the study will be followed for two year and will have study visits at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months, 18months and 24months after cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosis with bilateral congenital cataract for entire lens without other ocular abnormality
* No more than 3 month old
* Have signed a consent form
* Can be followed

Exclusion Criteria:

* Children not identified with congenital cataract
* Have not signed consent form
* Be not able to be followed
the Effect of Calcium Dobesilate on Non Dialysis Patients With CKD

To investigate the feasibility of calcium dobesilate in the treatment of microvascular injury provides new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

The deterioration of renal function is closely related to microvascular damage, calcium dobesilate is known as microcirculation protective agent, the investigators will further study its effect of non dialysis patients with chronic renal failure and explore the feasibility of calcium dobesilate in treatment of renal microvascular injury, the investigators will provide new ideas and theoretical basis for the prevention and treatment of chronic renal failure.

Eligibility Criteria:
Inclusion Criteria:

* Enroll the non dialysis patients with chronic renal failure hospitalized in the Department of Nephrology of the Affiliated Hospital of Xuzhou Medical University.
* According to the glomerular filtration rate, the patients who were not required to be dialysate were at CKD3-5 (GFR between 10 and 59ml/min).

Exclusion Criteria:

* Exclude those patients with diabetes, cardiovascular disease, severe infection, shock, dehydration, abnormal liver function, received glucocorticoid therapy, surgery and emergency dialysis.
* Eliminate those patients with respiratory disease(such as chronic obstructive pulmonary disease, bronchiectasis, asthma), cardiovascular diseases(such as acute and chronic cardiac insufficiency), blood system diseases (such as aplastic anemia, nutritional anemia and polycythemia vera).
Follow Up of Severely Malnourished Children (FUSAM)

The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.

In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.

Eligibility Criteria:
Inclusion Criteria:

* Age: 6-23 months
* 2 sexes
* Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district
* Weight-for-height (WH) \<-3 Standard Deviation compared to the WHO reference and/or MUAC \<115 mm
* And / or nutritional oedema moderate (+ or + +)
* And successful test of appetite
* And no medical complications
* New cases
* Presence of mother / father or legal guardian aged \> 18 years.
* Understanding of the consent and information letter
* Follow-up possible

Exclusion Criteria:

* Age \<6 months or\> 24 months
* Moderate Acute Malnutrition
* Severe Acute Malnutrition complicated
* Weight for height \<-3 Standard Deviation compared to the WHO reference and / or MUAC \<115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe).
* Relapse or if already registered in the past two months;
* Any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,
Prevalence of Chronic Abdominal Pain in Migraneurs

To collect data on the prevalence of Chronic Abdominal Pain in Migraneurs in Germany


Eligibility Criteria:
Inclusion Criteria:

* chronic abdominal pain
* migraine

Exclusion Criteria:

* not able to sign written informed consent
Autologous Bone Marrow Cell Treatment in Peripheral Atherosclerosis

Implantation of bone marrow cells, including endothelial progenitor cells, into ischemic limbs has been shown to improve collateral vessel formation. In the present study the safety and feasibility of autologous blood mononuclear cells implantation will be investigated in patients with severe peripheral atherosclerosis.Twenty cases will be enrolled. Improvement in the ankle-brachial pressure index (ABI:\>0.1), ischemic ulcers and angiography as well as laser doppler flow will be evaluated until six months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of third or fourth class of peripheral atherosclerosis

Exclusion Criteria:

* Insuline dependent diabetes
* Cancer
Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.

Parkinson's Disease (PD) is the second most common neurodegenerative disease, caused by progressive depletion of midbrain dopaminergic neurons in the substantia nigra pars compacta. This clinical study will include the preparation of dopaminergic neural precursor cells derived from neural stem cells through reprogramming of patient's peripheral blood mononuclear cells (PBMCs), and transplantation of the obtained cells into the brains of PD patients by stereotaxic injection. Safety, tolerability, evidence of cell survival (using PET scan), and the efficacy on PD symptoms will be assessed at different time points up to 12 months post-transplantation.

Eligibility Criteria:
Inclusion Criteria:

Ages between 30 and 85 years, males or females; Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria; Disease history over 3 years; Hoehn and Yahr Stage less than or equal to 4 during the medication "on" time; Responsive to levodopa treatment (Maximum rate of improvement in MDS-UPDRS, part 3, is over 30%).

Exclusion Criteria:

Atypical Parkinsonian syndrome or secondary Parkinsonian syndrome; Accompanied with other central nervous system diseases; With other severe systemic diseases or dysfunction; With severe psychiatric disorders; Subjects are using hormone or cytotoxic drugs and cannot stop taking the drug during the trial; With cognitive disorders (MMSE\<24); With severe dyskinesia (MDS-UPDRS part 4, score in 4.1/4.2 ≥ 2); Subjects have undergone previous brain surgery; Subjects are long-term user of anticoagulant; Subjects have intracranial lesions which may affect the surgery or follow-up studies as assessed by imaging; Subjects are unable to undergo MRI or AV133 PET examination; Pregnancy or in preparation for pregnancy; Not suitable to participate in this clinical trial as assessed by the study investigators/physicians.