cyrilzakka/clinical-trials huggingface dataset:
Genetics of CVD Risk Factors in Samoans

To evaluate the role of known genes involved in lipid metabolism on serum lipid and apolipoprotein levels in Samoans residing in American and Western Samoa, who were exposed to the biobehavioral changes of modernization.

BACKGROUND:

Modernizing Samoans are characterized by high levels of certain cardiovascular disease (CVD) risk factors such as extreme adiposity and high prevalences of obesity and hypertension. However, lipid levels in Samoans such as total cholesterol and high density lipoprotein (HDL) cholesterol are not consistent with their obesity and not always consistent with ecological measures of modernization.

DESIGN NARRATIVE:

The cross-sectional study used serum lipid and lipoprotein and dietary data collected in 1994 and 1995 in American and Western Samoa to compare the American and Western Samoans. Quantitative determinations were made of lipid and apolipoprotein levels differences between the two groups. Estimates were made of the effects of dietary intake, body size, and smoking on lipid and apolipoproteins. Cross-sectional analyses were performed on genetic factors influencing lipid and lipoprotein levels. Statistical analyses were conducted to test hypotheses about gene-environment interactions and gene-gene interactions in polynesians from American Samoa and Western Samoa.

Diet, physical activity and body size vary with exposure to the influences of economic modernization and the adoption of non-traditional behaviors. Although adiposity and its central distribution, insulin, blood pressure and dietary cholesterol increase from Western Samoa to American Samoa, saturated fat intakes due to coconuts and cigarette smoking are greater in Western Samoa. Thus, modernization does not produce simple unilineal changes in risk factors. The investigators examined very specific hypotheses, based on the cross-sectional data collected in 1994 and 1995, about the influence of genes on lipids, about genetic interactions on lipids and about concrete environmental and specific gene interactions on lipid outcomes.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Mind and Body:A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention

This study evaluates the use of a mobile-app delivered mindfulness-based intervention for supporting psychosocial resilience in aging patients undergoing rehabilitation treatment. Half of the patients will receive the mobile-app, while the other half will receive the app 6 months later.

Although, several mobile-app based MBTs are available in the marketplace, there is scant evidence of high scientific rigor to support their therapeutic efficacy. Furthermore, the tracking of wellness outcomes, stress resilience and functioning as a result of use of a therapeutic digital product is a challenging task requiring expertise in technology. In this study, the investigators aim to investigate not only the effectiveness of an app-based MBT in aging adults, but also the mechanisms of efficacy - i.e. the therapeutic effects - of app usage, including changes in, depression, anxiety, or mood and the acceptance of the app in older adult populations. The investigators also aim to measure the Return On Investment (ROI) of mobile mindfulness on health services utilization.

The study is a randomized controlled design with 1:1 equal allocation to treatment (Experimental Am app group) or control (treatment as usual). The investigators will recruit 82 participants in total.

The Experimental group will start the 4 week Am app intervention immediately after randomization and baseline intervention questionnaires, while the wait-list control group will receive treatment as usual. Assessments are conducted at four time point: At Baseline (#1), Post-Intervention (#2), Follow-up at 3 months post baseline (#3) and Follow-up at 6 months post baseline (#4).

The clinical champions that referred the patient to the study will complete brief surveys about the quality of their appointments with the patient at two time points: At baseline (#1) and Post-Intervention (#2).

The waitlist control group will be granted access to the mindfulness intervention at 6 months post baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women over the age of 40.
2. Admitted as In-Patients.
3. Access to a smart phone with data connection.
4. Willing to give time for mindfulness practice.
5. Sufficient ability to speak and read English.
6. Willingness to be randomized into immediate or waitlist groups and complete all assessments.

Exclusion Criteria:

1. Any cognitive or mental impairment that would interfere with completing questionnaires or the intervention (\<6 on the Brief Screen for Cognitive Impairment) .
2. Admitted to Providence as an in-patient to long-term care or palliative care.
3. An existing smartphone app-based mindfulness practice consisting of one or more sessions per week.
Avatar Therapy in Comparison to Cognitive Behavioral Therapy for Treatment-resistant Schizophrenia

Schizophrenia is associated with long-lasting health, social and financial burden for patients, families, caregivers and society. Unfortunately, 25-30% of schizophrenia patients respond poorly to antipsychotic medication. Moreover, psychotherapeutic treatment alternatives are very limited for this suffering population. This unmet clinical need requires innovation and action. Psychotherapeutic treatment alternatives such as Cognitive Behavior Therapy (CBT) provide at best moderate results. Using immersive virtual reality, we recently tested a novel psychotherapeutic intervention, Avatar Therapy (AT), where the therapist engages in a dialogue with the patient through a virtual representation of the patient's distressing voice. This approach, being both relational and experiential, provides a unique opportunity to aid patients gain control over their voice. The results of our pilot study on AT were clinically promising for the severity and distress related to hallucinations, positive symptomatology and emotion regulation. To further research in this field, the primary goal of this randomized-controlled, single-site parallel study is to show that AT is superior to CBT for the treatment of persistent auditory hallucinations in schizophrenia. Our secondary goal is to examine the effects of these interventions on emotion regulation, mood symptoms (anxiety and depression), self-esteem, level of functioning and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* distressing auditory verbal hallucinations
* medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent)
* DSM-5 diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* any change in medication within the past 2 months;
* substance use disorder within the last 12 months
* neurological disorder or unstable and serious physical illness
* ongoing psychotic episode
* Cognitive Behavioral Therapy for psychosis within the last 12 months
Serum Opiorphin Level After Intraoperative Intravenous Lidocaine Infusion

A prospective, double blinded and randomized study included women with breast cancer and underwent mastectomy, and randomly allocated into two groups of equal size. Lidocaine group and control group.

Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, ASA I or II were included in the study.

* Group I (lidocaine): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
* Group II (control):- A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 60 years old with breast cancer and underwent mastectomy, American society of Anesthesiologist I or II

Exclusion Criteria:

* Patients with contralateral breast cancer, metastatic tumor, morbid obesity (BMI\> 40), allergy to an amide local anesthetic, or morphine sulphate, heart block, renal, or liver dysfunction, or substance abuse disorder, or chronic opioid use
Prevention of Reduced Employability With an Expert System With Telephone, Motivational Interviews Supporting Self-management

The purpose of the study is to determine which factors on a personal, social and contextual level will help rehabilitation patients on returning to or continuing to work as well as to stay employable.

For most people work is an integral part of their life which not only secures their life standards, but also forms the basis for social participation and personal growth. If someone's workability is limited as a result of health problems, medical rehabilitation can often help to regain strength and capabilities, and to continue to work in a productive way and remain healthy. In cooperation with the Deutsche Rentenversicherung Oldenburg-Bremen health psychologists at Jacobs University Bremen are investigating what contributes to the success of such medical rehabilitation treatments.

The focus is to understand which measures are helping people during and subsequently to their treatment in the clinic.Therefore voluntary participants will be asked to fill out a questionnaire when arriving at the rehabilitation facility and will subsequently invited to participate in two motivational telephone interviews after six and 12 months. Personal, social and contextual factors, measures and offers, as well as goals, plans and behaviors, will be taken into consideration to evaluate the effectiveness of medical rehabilitation on returning to or continuing to work.

Eligibility Criteria:
Inclusion Criteria:

* insurants of the Deutsche Rentenversicherung Oldenburg-Bremen
* with a granted medical rehabilitation stay
* sufficient knowledge of the German, Turkish or Russian language
* telephone or mobile phone connections

Exclusion Criteria:

* insurants of the Deutsche Rentenversicherung Oldenburg-Bremen who did not receive a granted stay at one of the medical rehabilitation clinics of the Deutsche Rentenversicherung Oldenburg-Bremen
* no proficient language skills (German, Turkish, Russian)
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican Health Authority's AE surveillance system during a specified 24-month study period. The secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico during a specified 24-month study period.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* at least 18 years of age with CHC, GT-1
* treatment-naïve and treatment-experienced (null or partial) responders
* intolerant to interferon (IFN)
* with or without cirrhosis

Exclusion Criteria:

* patients who received DCV and ASV as part of a clinical trial
* patients who received DCV and ASV for any indication other than that which is locally approved
* contraindications included in the approved Mexican prescribing information

Other protocol defined inclusion/exclusion criteria could apply
Clinical Trial of Quantitative Detection Kit for Hsp90α in Hepatic Cancer

Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases.

Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility Criteria:
Inclusion Criteria:

* Liver cancer patients
* Healthy volunteers,
* Benign liver diseases patients

Exclusion Criteria:

* Patients who Previously accepted radiotherapy
Supportive Training After Cardiac Rehabilitation Including Virtual Engagement

The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in CVD risk factors (blood pressure, lipids, HbA1c, BMI) between groups.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 60 years of age
2. History of CVD that qualified patient for Phase II CR (MI, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve replacement, etc.)
3. Adherence to CR ( ≥ 50% sessions for ≥ 1 month)

Exclusion Criteria:

1. Participation in Phase III CR (optional extended CR after outpatient CR for those who pay out-of-pocket)
2. Cognitive impairment (score 0-2 per Mini-Cog)
3. Lack of English or Spanish proficiency/literacy
4. Unstable clinical conditions

   1. Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
   2. Active infection
   3. Uncontrolled hypertension: resting systolic \&gt;180 mmHg, diastolic \&gt;100 mmHg
   4. Decompensated heart failure, NYHA Class III-IV
   5. Current unstable angina
   6. 2nd or 3rd degree heart block or exercise induced arrhythmias
Glycocalyx Damage in Critically Ill Patients

The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related factors and to using organ-supporting measures. There is a correlation between length of organ support and GCX damage.

The aim of the study: Evaluation of the relationship between GCX damage and duration of various organ supporting measures.

Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring organ supporting therapy.

Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and 20 patients with target temperature management for neuroprotection.

Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7 and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.


Eligibility Criteria:
Inclusion Criteria:

* adult patients admitted to ICU
* artifitial ventilation
* renal replacement therapy
* targeted temperatura management

Exclusion Criteria:

* pregnant women
Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial

This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the reduction of swelling and postoperative pain in lower molar extraction procedures. This is a clinical study approved by the Research Ethics Committee, which will be performed in 40 patients between 20 and 60 years. Patients included in the study should have at least one lower molar (first or second molar) with indication of exodontia. Participants will follow the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics; immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making use of medications that interfere with bone remodeling; with cysts or tumors in place. Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy were excluded from the study. After the sample calculation, forty patients will be involved in this project, where forty molars (first and second molars) will be extracted in the mandible, which will be randomly divided into 4 groups. The control group (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way, without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients where 10 molars will be extracted and immediately after extraction, the fresh sockets will receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will present 10 patients, where 10 molars will be extracted that immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity will be assessed through a visual analogue scale and swelling assessed by measuring a perimeter between the tragus, the base of the jaw and the commissure of the lips. The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* patients without systemic limitations that indicate surgical procedures with cooperative behavior
* with full awareness and approval of the guidelines listed in the free and clarified term proposed by the research
* present compromised posterior and inferior teeth requiring exodontia.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with obesity (Body Mass Index - BMI)
* Make use of any activity smokers and ex smoker to 6 months
* Diabetics
* Immunosuppressed
* in osteoporosis
* making use of antimicrobials in the last 3 months
* making use of medications that interfere with bone remodeling
* with cysts or tumors in place
* Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy
Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects

This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD) tablets when administered with water and without water and ticagrelor immediate-release (IR) tablets.

Study to evaluate the bioequivalence of ticagrelor orodispersible (OD) tablets administered with water and without water and ticagrelor immediate-release (IR) tablets.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 20 to 45 years with suitable veins for cannulation or repeated venepuncture.
* Be Japanese. Japanese is defined as having both parents and four grandparents who are Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
* Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:

  * Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
  * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
* Have a body mass index (BMI) between 18.0 and 27.0 kg/m2 inclusive and weigh at least 45 kg and no more than 85 kg inclusive.
* Be able and willing to communicate with the investigator and comply with all study procedures, including reproductive restrictions.

Exclusion Criteria: - History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study.

* Current smokers or those who have smoked or used nicotine products within the previous 3 months.
* History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
* A personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the investigator.
* History of a clinically significant non-traumatic bleed or clinically significant bleeding risk, as judged by the investigator.
* Use of aspirin, ibuprofen, non-steroidal anti-inflammatory drugs (NSAIDs), or any other drug known to increase the propensity for bleeding for 2 weeks before randomization.
* Platelet count less than 150 x 10\^9/L.