cyrilzakka/clinical-trials huggingface dataset:
Internet-Based Treatment of Depression: Comparing Guided With Unguided Self-Help

The study is a randomized controlled trial and to compare the benefits of a 10-week web-based unguided self-help treatment with the same intervention complemented with weekly therapist support via e-mail. A waiting-list control group will be included. The Beck Depression Inventory (BDI-II) will be used as the primary outcome measure. Secondary outcomes include general psychopathology, interpersonal problems, and quality of life.

Depression is a major health problem associated with significant disability and economic costs. Although depression can be treated effectively with several psychological and pharmacological treatment options, many sufferers still seek or receive inadequate therapy or no therapy at all. Internet-based treatments may help to serve this demand, being accessible anytime and anywhere making it easier for underserved populations and people living in remote areas to receive treatment. The present study aims to assess the efficacy of an internet-based CBT intervention for depression (Deprexis), directly comparing the benefits of a low intensity therapist-guided with an unguided self-help version. A waiting-list control group will be included. Individuals meeting the diagnostic criteria of major depression or dysthymia will be randomly assigned to one of the three conditions. While unguided self-help will not include any contact with a therapist or the study team during the treatment, guided self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility to ask questions via e-mail. While in an earlier study Deprexis was assessed as an add-on to TAU, this study will examine the efficacy of the program when delivered as a stand-alone intervention (i.e., only individuals who currently do not receive psychotherapy will be included). Moreover, this study will include a structured diagnostic interview at pretreatment. Only participants fulfilling the criteria of a depressive disorder (major depression or dysthymia) will be included in the trial. Participants will be recruited in Switzerland and Germany via articles in national and regional newspapers and a national television interview. All questionnaires will be administered via the internet. The 21-item BDI-II will be used as the main outcome measure. Secondary outcome measures will include the Brief Symptom Inventory (53-item BSI), the Inventory of Interpersonal Problems (64-item IIP), and the WHOQOL-BREF.

Eligibility Criteria:
Inclusion Criteria:

* access to the internet
* informed consent to participate
* BDI-II score \> 13
* if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior and during study

Exclusion Criteria:

* suicide item of BDI ≥ 2
* other psychological treatment during this study
the Efficacy of Acarbose and Metformin on Blood Glucose Fluctuation When Combined With Premix Insulin

the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin.

Study Design:Prospective, parallel group, active-control, randomized, open-label.

Study Organization:Single-center in China. Endocrinology and metabolism department of 6th affiliated hospital of Shanghai Jiaotong university Study Population: Type 2 diabetes inadequately controlled by premix-insulin therapy,40 patients per arm(acarbose add on/ metformin add on) both acarbose and metformin are widely used with premix-insulin in clinical practice, for the better glucose control and lower hypoglycemia incident.

Acarbose delay the absorption of digested carbohydrates from the small intestine and thus lower both postprandial glucose and insulin levels which sequently improve glucose fluctuation Metformin improve the insulin resistance reduce the gluconeogenesis, glucose output and thus lower the fasting glucose

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed T2DM patients (WHO, 1999).
* Premix Insulin therapy for more than 3 months, the daily dosage of insulin \>20IU and \<1IU/kg
* 30 ≤Age ≤ 70 years old, male or female
* 7.0 ≤ HbA1c ≤10.0%
* 18.5≤ BMI ≤ 35 kg/m2
* Written Informed consent

Exclusion Criteria:

* Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM
* Those who can not tolerate AGI or who is suffering GI disease
* Metformin contradiction
* Concomitant 2 oral anti-diabetes medicine, or 1 OAD with maximum dose
* Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia
* Known or suspected allergy to trial product(s) or related products
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
* Impaired liver function,
* Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection
* Uncontrolled hypertension
* Concomitant treatment which influences blood glucose
* Impaired renal function
Translating Adoption of Improved Varieties Into Nutritional Impact

The purposes of this study are (1) to determine whether child nutrition-focused adoption encouragement messages focused on Quality Protein Maize (QPM) and the availability of small quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for young children, and (2) to determine whether consumption encouragement messages and techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to and health outcomes for young children.


Eligibility Criteria:
Inclusion Criteria:

Households with at least one child in the 6-35 month age range in August 2015, who had at least one household member attend a field day demonstrating Quality Protein Maize, and who provided informed consent for participation and data collection were eligible for inclusion.

Exclusion Criteria:

Households in the study areas that do not have a member who attends a field day demonstrating Quality Protein Maize or who do not have a child in the appropriate age range are excluded from the study. Furthermore, households where the mother or children did not intend on staying in the region for the study duration (until the completion of the endline survey) were excluded from the study. Finally, we excluded participants who do not have access to land for crop cultivation.
Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

This study is to evaluate the effectiveness of a mood management intervention on abstinent alcoholic smokers with a history of major depression. The second aim is to determine the effect of smoking treatments on alcohol abstinence and to identify factors associated with smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design will be used to evaluate the added benefit of mood management compared to a state-of-the-art smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6, and 12-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Currently abstinent from alcohol and other drugs for at least 3 months.
* Meets criteria for history of major depression independent of alcohol use.
* Smoked an average of 10 or more cigarettes per day during the past month.
* Able to fully participate in all aspects of the study.
* Willing to participate in eight 2-hour treatment sessions and 12 months of followup.
* Willing to stop smoking and wear a nicotine patch for six consecutive weeks and refrain from participating in additional smoking interventions for the duration of treatment.

Exclusion Criteria:

* Current episode of major depression (within the last 3 months) or current or lifetime history of bipolar disorder, schizophrenia or other major psychiatric disorders.
* Current use of antidepressant, other psychotropic medications, smokeless tobacco, nicotine replacement or other smoking cessation therapy.
* Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (within 1 month) of myocardial infarction or stroke, history of severe skin allergies or evidence of severe chronic dermatoses.
* Currently pregnant, breast feeding or likely to become pregnant during the nicotine patch phase of the study.
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women

This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis

Exclusion Criteria:

* Use of estrogen or hormone replacement therapy
* Use of bisphosphonates, strontium ranelate or denosumab
* Use of parathyroid analogues or other bone metabolic agents
* Medical conditions which might alter bone metabolism
* Any known clinically significant disease affecting calcium metabolism or history of metabolic disorders including Paget's disease, osteogenesis imperfecta, or osteomalacia
* Impairment of thyroid function
Metabolic Phenotypes in Childhood Obesity

This study provides a sound basis towards a better understanding of the biochemical mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great importance towards the development of more personalized prevention and treatment in future.

The aim of this study was to identify the plasma metabolic profile associated with childhood obesity and its phenotypes..

This cross-sectional study was set-up to examine the metabolic profile in fasting plasma samples from 65 overweight and obese (OB) children and 37 normal-weight (NW) controls aged 8 to 18 years. The obtained plasma 1H-NMR spectra were rationally divided into 110 integration regions, representing the metabolic phenotype. These integration regions reflect the relative metabolite concentrations and were used as statistical variables to construct a classification model in discriminating between OB and NW children and adolescents. In addition, two metabolic phenotypes were defined within the OB group, i.e. the metabolically "healthy" obese (MHO) and metabolically unhealthy obese (MUO) phenotype which are both classified as obese but with respectively, none (MHO) or at least two components (MUO) of the metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* aged 8 to 18
* normal-weight, overweight or obese according to the International Obesity Task Force (IOTF) Body Mass Index (BMI) criteria
* fasted for at least 8 hours

Exclusion Criteria:

* Subjects taking any medication or having serious chronic or acute illness within two weeks preceding the clinical examination,
Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

This study is an observational study. The purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD. Physical activity is an important determinant of health throughout the whole lifespan. Engaging in regular moderate-to-vigorous physical activity has important health benefits. Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with IBD.

To carry out this study, 120 patients (age ≥6 and \<18 years at the screening visit) will be enrolled in this observational study. After obtaining the informed consent from the parents and the patient, the followings will be performed: clinical examination by a physician, dual-energy X-ray absorptiometry to assess bone density mineral and body composition, collection of a blood sample to assess the inflammatory status of the IBD patient. The patient will be asked also to fill in a questionnaire in order to assess quality of life. He will wear an accelerometer during 7 consecutive days for assessing daily physical activity in free living conditions. The main objective is to assess the relationship between daily physical activity and bone health in children and adolescents with IBD. The secondary objectives are to assess the relationship between daily physical activity and: 1) body composition and 2): quality of life in IBD children and adolescents. To our knowledge, this study is the first to assess the relationship between bone health and daily physical activity in IBD children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Boys or girls aged between 6 and 18 years old
* Chronic, acute or intermittent diseas (other than IBD) that can lead to decreased physical activity (example: fracture, paralysis, blindness ...
* Patient with IBD diagnosed since at least 6 months
* Written informed consent obtained by the the parents and the patient
* To have a health insurance

Exclusion Criteria:

* Acute intercurrent events (less than 15 days) at the inclusion day leading to decreased physical activity according to the investigator judgment (fracture(s), recent arthritis, perineal lesions, severe skin lesions)
* Patient refusing to participate to the study
* One of the child's parents refusing to participate to the study
* Lack of adherence foreseeable
* Participation to another study
* Pregnant girls
* Under a justice protect measure
Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening

The study team's central hypothesis is that the Parkland Diabetes Detection Program (PDDP) screening invitations targeted by race/ethnicity with culturally concordant messaging and tailored by glycemic risk (known PDM vs. unknown glycemic state) plus phone-based navigation of non-responders will be more effective at closing screening gaps than PDDP generic screening invitations and usual care, opportunistic screening alone.

The research team will conduct a pragmatic, split cluster randomized controlled trial (clinic=cluster; patient randomization) in 12 community-based primary care clinics in an integrated safety net health system serving a high-risk, racially/ethnically diverse population.

Eligibility Criteria:
Inclusion Criteria:

* Patient is alive at time of data extraction
* Age \>= 18 at time of data extraction and \<76
* Visit with PCP at Parkland clinic in the last 18 months (548 days), where Encounter type = Virtual Visit or Encounter type = Office Visit
* Patient NOT included in Parkland Diabetes Registry
* Preferred language is Spanish or English
* Ethnicity is Hispanic or Non-Hispanic
* Race is White or Black
* Patient is not pregnant in last 12 months

Exclusion Criteria for Study Population 1: Prediabetes Glycemic Risk Group

* Last A1C value \<5.7 (normal)
* Last A1C value \>6.4 (diabetes)
* Last A1C value = blank (unchecked)
* Last A1C date occurred within last 12 months from date of export

Exclusion Criteria for Study Population 2: Score-Based Glycemic Risk Group

* Risk score \<9
* Last A1C date occurred in last 30 months from date of export
* Last A1C value was \>5.7 (PDM/DM)
Polarity Therapy for American Indian Caregivers of Dementia Patients

The purpose of this study is to assess the effectiveness of polarity therapy (PT), a complementary and alternative medicine treatment, in American Indian caregivers living in the Pacific Northwest.

The caregivers of people with dementia experience high levels of stress and are at particularly high risk for physical and mental illness. Although stress and illness are serious problems among American Indian caregivers in the Northwest, few studies have concentrated on this population. PT is a treatment that involves awareness of one's energy field and touch therapy; it has been shown to provide several physiological, biological, and psychological benefits. This study will determine whether PT is more effective than respite from caregiving in reducing stress, anxiety, and depression and improving health function and overall quality of life in American Indian caregivers.

Participants will be randomly assigned to receive either eight weekly sessions of PT or 3 hours of weekly respite from caregiving for 8 weeks. At the beginning of the study and at Weeks 4 and 8, participants will complete questionnaires and self-report scales on stress, anxiety, depression, and quality of life. In addition, heart rate variability and levels of cortisol will be measured at study entry and Weeks 4 and 8.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver of a family member with dementia for at least 4 hours a day
* American Indian

Exclusion Criteria:

* Nerve disorders caused by diabetes
* Use of beta blockers
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma

Exclusion Criteria:

* A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
Shape Up Somerville: Eat Smart Play Hard

Community-based environmental approach to obesity prevention targeting first, second, and third grade students in Somerville, MA.

This study will demonstrate using measures of effectiveness, the feasibility of partnering with the community to create, disseminate, implement and evaluate Shape Up Somerville: Eat Smart. Play Hard., a community-based environmental change intervention to prevent obesity in culturally diverse, high-risk, early elementary school children. Based on formative work with parents, children, teachers, school food service, school officials, and community members, a community-wide campaign will be developed with targeted environmental change strategies for early elementary school children within the before-, during-, and after-school environments reinforced by changes within the home and community to support behavioral action and maintenance. The intervention targeting children will bring the energy equation into balance by offering numerous physical activity options that total up to 125 kcals per day and by improving the composition of the food served and the dietary options, particularly snack foods, available throughout the day. This study will measure awareness and participation of the partners and residents within the community. In addition the temporal change in BMI z-score will be monitored internally in 700 Somerville children and externally in 1000 control children from 2 demographically-matched communities for one year and will be compared to the change in BMI z-score in children participating in Shape Up Somerville with children from control communities over the one-year intervention and for one year of follow up. If successful, Somerville will serve as the model community that paves the way for cost-effective nationwide environmental action to prevent obesity at the community level.

Eligibility Criteria:
Inclusion Criteria:

* Public school students in 1st, 2nd, and 3rd grade in Somerville, MA

Exclusion Criteria:

* none
Cryoballoon Pulmonary Vein Isolation: Time-to-Isolation Dependent Freeze Protocols Comparison

The purpose of this study is to develop and prospectively test two Cryo-AF (atrial fibrillation) dosing protocols guided exclusively by time-to-isolation (TT-I) in patients undergoing a first-time Cryo-AF.

Both protocols guided by TT-I are associated with shorter cryoapplications as compared to conventional approach.

In the first group freeze duration is TTI +120 s. In the second group freeze duration is 240s if TTI is \< 75 s. In case of TTI\>75s a 240s bonus freeze is applied.

The investigators examine long-term efficacy of Cryo-AF using the two proposed dosing algorithms in a nonrandomized fashion.

The study cohort consists of consecutive patients undergoing a first-time Cryo-AF for symptomatic paroxysmal or persistent AF (atrial fibrillation) at Interventional Cadiology and Cardiac Arrhythmias Clinic of Medical University in Łódź. During 12 months investigators are planning to enroll 40 patients Patients are randomly assigned to the groups. All of them will be followed up 3 and 12 months after the procedure. In addition, ambulatory electrocardiographic monitoring will also be performed at 3 and 12 months.

The study is requested for an approval of the university ethics committee.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Paroxysmal or Persistent Atrial Fibrillation on Electrocardiogram

Exclusion Criteria:

Diagnosis of Sinus Rhythm on Electrocardiogram