cyrilzakka/clinical-trials huggingface dataset:
Treatment of Subcutaneous Adipose Tissue in the Thighs Using High Intensity Focused Ultrasound

The purpose of this study is to assess the safety and efficacy of treatment with the Liposonix System (Model 2) for the circumferential reduction of subcutaneous adipose tissue (SAT) of the thighs.

Subjects received a single treatment (Liposonix System) on one randomly assigned thigh. The opposite thigh was not treated and served as a control for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18-60 years of age
* Body Mass Index of ≤30 lb/in2
* Thickness of adipose tissue is at least 1.0 cm beyond the selected focal depth in the area to be treated (≥2.3cm)
* Subjects must agree not to alter their regular diet or exercise routines during the course of the study
* Subjects must be willing and able to comply with all study visit requirements, procedures, and assessments
* Subject must understand the nature of the study and sign an IRB approved Informed Consent

Exclusion Criteria:

* Subjects is pregnant
* Subjects diagnosed with a coagulation disorder or receiving anticoagulant therapy
* Subject has had prior aesthetic procedures in the area to be treated
* Subjects has pacemaker, defibrillator, or other implantable electrical device
* Subject has significant circumferential asymmetry between thighs
Open Label Randomized Clinical Study to Promote a Healthy Lifestyle in Medical Students

The main medical and social purpose of the project "It's trendy to be healthy!" is the promotion of healthy lifestyles and healthy eating among student youth. The relevance of this project is beyond doubt, as the WHO called obesity a non-communicable epidemic, and according to research by the Jane Schiller University of Germany (Germany), as mentioned above, Ukraine topped the list of the countries with high mortality due to malnutrition


Eligibility Criteria:
Inclusion Criteria:

* medical students aged between 18-25 years;
* presence of presence of vitamin D deficiency or insuficiency (serum total vit D3 level less than );
* signed informed consent.

Exclusion Criteria:

* regular intake of probiotics, prebiotics, antibiotics, anticonvulsants, calcium and vit. D supplements for 3 months prior the inclusion;
* previously diagnosed allergy to gut microbiota-based therapy; gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis;
* suffering from any psychiatric illness; presence of diabetes mellitus, chronic cardiovascular or respiratory disease, an active malignant tumor or chronic infections; participation in another clinical trial;
* pregnancy or lactation;
* any condition thought to be associated with poor compliance (e.g., alcoholism or drug addiction) or any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.

This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form;
* Male or female 18\~75 years of age;
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Low FODMAP Diet in Patients With IBS

The aim was aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

in a randomized cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.

Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS.

Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.

Eligibility Criteria:
Inclusion Criteria:

* IBS diagnosed by the Rome III criteria and
* referred to the clinic for treatment by diet

Exclusion Criteria:

* Dementia
* lack of ability to speak Danish
* additional chronic diseases prevailing participation
Emotional Competence and Compassion Training

In this study several different face-to-face workshops about emotional competence and compassion are scientifically evaluated with psychometric questionnaires and heart rate variability measuring.

Stress and stress related diseases are a huge health burden in modern societies. Psycho-emotional stress plays a key role in stress regulation. Therefore this study aims to investigate the effects of online-courses addressing emotion regulation.

For this aim several different workshops about emotional competence and compassion are scientifically evaluated with psychometric questionnaires and heart rate variability measuring. The workshops are planned by the trainers and people register on their own initiative.

The seminars are either single workshops over three days or a yearly program consisting of three three-day-workshops. They consist of lectures and exercises about the character of the different feelings, about the characteristics of emotions and teach practices on how to dael with difficult emotions.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years
* participation in one of the included courses
* e-mail address

Exclusion Criteria:

* participation in another study
* no verbal communication (german) possible
* dementia or another disease that limits cognitive abilities
Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma

The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.

According to Global Initiative for Asthma treatment of asthma is based on avoidance of allergens, pharmacological treatment, and specific immunotherapy.

The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.

Eligibility Criteria:
Inclusion Criteria:

* patients allergic to house dust mites
* patients with moderate bronchial asthma
* patients with controlled asthma
* patients who were qualified for immunotherapy and gave written informed consent for immunotherapy (active treatment group)
* patients who were qualified for immunotherapy and did not agree with this kind of treatment - did not give written informed consent for immunotherapy (control group)

Exclusion Criteria:

* patients allergic for other perennial and seasonal allergens
* patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
* medications that resulted in patient exclusion included:anti-parasites or oral corticosteroids within 6 months before the first visit.
Arab American Women's Health Study

This study evaluates how Arab American women's cultural values and sexual health are related to their physical and emotional health. The study will also examine whether engaging in a sexual health interview affects women's physical and emotional health.

Sexuality is an important aspect of health, in part because emotional conflicts over sexuality as well as unwanted sexual experiences can impact physical and psychological health; yet no studies have examined sexual health among Arab American women in the U.S. These women face the task of negotiating their heritage culture and the American culture in which they reside. This may result in bicultural identity conflict for some women as they try to negotiate these two identities, which may have implications for sexuality and sexual health due to the two cultures' disparate views on sexuality. Confidential discussion of these sensitive topics with a knowledgeable interviewer may yield beneficial effects.

The overall goal of the current study is to fill the gap in the literature on Arab American sexual health by examining how sexual health is related to physical and psychological health. This will be accomplished using both: a) correlational findings about sexual, physical, and psychological health from information gathered through self-report questionnaires and a 60-minute women's health interview; and b) an experimental test of the effects of the women's health interview on physical and psychological health. A sample of young adult Arab American women will be assessed at baseline via questionnaires for various constructs (sexual attitudes, cultural and religious identity, and physical and mental health), and then randomized to either an immediate or delayed health interview, with a 5-week follow-up reassessment.

It is hypothesized that lower sexual well-being, negative sexual self-schemas, and unwanted sexual experiences will correlate with more somatic and psychological health symptoms and lower satisfaction with life. It is also hypothesized that participants who have the immediate interview will report greater reduction in somatic and psychological symptoms and a greater willingness to discuss sexual health with medical providers compared to participants who are not interviewed (i.e., have a delayed interview after follow-up assessment).

Eligibility Criteria:
Inclusion Criteria:

* Arab American or Chaldean
* Female
* Age 18-35

Exclusion Criteria:

* Non-English speaking
Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer

The purpose of this research is to assess the safety and evaluate the potential of the Multispectral Optoacoustic Tomography (MSOT) device to more precisely identify and assess the neck lymph nodes which might be affected in patients with metastatic head and neck squamous cell carcinomas.

This is a 2-Arm investigational device study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and to determine the ability of MSOT imaging data to correlate with clinical findings identified via pathology. Imaging with the MSOT device is expected to obtain information about the number, size, and appearance of the lymph nodes in the neck. The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical records. All images will be obtained pre-surgery for Arm 1 patients (undergoing surgery for their cancer) and before, during and after radiotherapy in Arm 2 patients (undergoing radiotherapy treatment for their cancer). The temperature of the patient's skin will also be measured prior to and after each MSOT scan. Once radiotherapy treatment has completed, images using the MSOT device will be obtained every 6 months for 2 years to assess for radiation induced fibrosis. MSOT scans will be for research only and no treatment decisions will be based on the MSOT images obtained.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed node positive head and neck squamous cell cancer
* Written informed consent signed and dated by the patient prior to the performance of the MSOT
* At least 18 years-of-age at the time of signature of the informed consent form (ICF)
* Patients planned for curative intent therapy
* Patient available for the study duration
* Patients of childbearing potential must have a negative pregnancy test prior to the study entry.
* Patients of childbearing potential must use an effective form of contraceptive as per the protocol.

Exclusion Criteria:

* History of previous head and neck radiotherapy
* Intent of treatment palliative
* Women who are pregnant
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of the investigational regimen should be included.
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine

The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the pharmacokinetics of intranasally administered esketamine in healthy Caucasian participants.


Eligibility Criteria:
Inclusion Criteria:

* For Cohort 1: healthy Han Chinese participants 20 to 55 years of age, inclusive, who have resided outside of China for no more than 10 years and have parents and maternal and paternal grandparents who are of Han Chinese ethnicity For Cohort 2: healthy Korean participants 20 to 55 years of age, inclusive, who have resided outside of Korea for no more than 10 years and have parents and maternal and paternal grandparents who are of Korean ethnicity For Cohort 3: healthy Japanese participants 20 to 55 years of age, inclusive, who have resided outside of Japan for no more than 10 years and have parents and maternal and paternal grandparents who are of Japanese ethnicity For Cohort 4: healthy Caucasian participants 20 to 55 years of age, inclusive Participants must be within +/-7 years and +/-20 percent (%) of the combined mean age and mean body weight at Screening, respectively, of Cohort 1, Cohort 2, and Cohort 3
* Body mass index (BMI; weight \[kilogram\]/height\^2 \[m\]\^2) between 18 and 30 kilogram per meter square (kg/m\^2), inclusive, and a body weight not less than 47 kilogram (kg)
* If a woman, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 1 month after receiving the last dose of study drug
* Creatinine clearance more than equal to (\>=)80 milliliters per minute (mL/min) based on Cockroft-Gault equation

Exclusion Criteria:

* Current significant psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening or Day -1 of Period 1 as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at Screening or Day -1 of Period 1 as deemed appropriate by the investigator
* History of drug or alcohol abuse disorder within the past 1 year, or a reason to believe a participant has such a history
* Regular use of intranasal tobacco powder within the past 1 year, or a reason to believe a participant has such a history
Hot Flashes and Neurovascular Function in Women

Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers.
* Non-obese.
* Have at least one ovary.
* Free from cardiovascular disease.
* Not taking medications influencing cardiovascular function.

Exclusion Criteria:

- None.
Cognitive Changes After Fast-track Colon Surgery

This descriptive study aims to evalaute in a retrospective way the incidence of cogntive changes postoperatively after fast-track colon surgery at Hvidovre Hospital. This survey is based on chart reviews.


Eligibility Criteria:
Inclusion Criteria:

* \> 59 years
* undergoing colon surgery at Hvidovre Hospital
* surgery and perioperative care in a fast-track setting

Exclusion Criteria:
Barriers Affecting Physical Activity

The goal of this research study is learn about how often cancer patients engage in physical activity using the exercise behavior questionnaire.

This is an investigational study.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

If participant agrees to take part in this study, participant will complete a series of questionnaires about exercise and participant's symptoms and physical abilities. These should take about 5 minutes to complete.

Additionally, demographic information (such as participant's age, race, sex, zip code, specifics about participant's cancer type and care) will be collected from participant's medical record.

Participant will complete the questionnaires 1 time, and participation in this study will be over after that.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be 18 years of age or older.
2. Patient must be able to understand, read, write and speak English.
3. Patient must be able to sign an Informed Consent Form.

Exclusion Criteria:

1. Patients with physical limitations (visual, cognitive, motor impairment) causing inability to read, complete or sign the consent form and survey.
2. Wheelchair bound patients who spend all of their day in bed or wheelchair
3. Patients who the attending physician deems unable to participate due to acute physical distress.
4. Previously filled out (EBBS and Stanford) surveys in the Supportive Care Clinic
Improving Adherence to Interventions for Hypertension

To develop effective strategies for enhancing adherence to therapeutic interventions designed to improve care for hypertensive minority populations.

BACKGROUND:

The study was in response to a demonstration and education initiative, "Improving Hypertensive Care for Inner City Minorities", which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992.

DESIGN NARRATIVE:

An aggressive Hypertension Intervention Project (HIP) was developed in the Hypertension Research Section of King/Drew Medical Center in South-Central Los Angeles. The private CHUER clinic (located in the same cachement area) subcontracted with the Drew University Center in a community coalition consisting of several large health advocacy organizations. All subjects were randomized into usual care (controls) or interventional care (experimental) at the initiation of the HIP. The cornerstone of the aggressive intervention was the development of a computerized patient tracking system and the introduction into the clinic of several educational activities including a) exit interviews; b) home visits; c) support group sessions, and d) community health seminars/fairs. Community Health Workers performed the bulk of the patient tracking and educational intervention field work. Outcome measures of pre and post-study blood pressure, renal function, body weight change, and all-cause mortality were compared between experimental and controls at two, three and four years into the study. Quality-of-life questionnaires were obtained pre- and post-study and analyzed for new insights into needs assessment, awareness of hypertension, attitudes towards treatment, compliance with drug therapy, and effectiveness of various educational interventions employed in the study. Concurrent efforts to reduce co-morbid risk factors such as obesity, cigarette smoking, excessive alcohol consumption and stress were assessed as secondary outcomes. The HIP hoped to demonstrate cost-effective innovations for the adaptation of these Medical Center-targeted strategies to community physicians and health clinics of the inner city.

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
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets

To demonstrate the relative bioavailability of Diclofenac Sodium 50 mg enteric-coated tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Antisepsis Regimen in the Surgical Treatment of Human Papilloma Virus Generated Cervical Lesions: Polyhexamethylene Biguanide Versus Chlorhexidine

Treatments for the macroscopic or pathologic lesions caused by HPV infection can be classified as topical, surgical, destructive, or immunomodulatory. Post surgical treatments generally consist of analgesic, anti-inflammatory and topical antimicrobial agents to reduce the risk of local infections.

The aim of this study is to compare the efficacy and safety of polyhexamethylene biguanide-based vaginal suppositories to a similar chlorhexidine-based treatment, in the post recovery regimen after surgical treatment of cervical lesions.

Women who underwent to CO2 laser therapy for cervical lesions are randomly assigned to receive 10 days of antiseptic treatment with chlorhexidine digluconate vaginal suppositories, or polyhexamethylene biguanide vaginal suppositories (Monogin® / BiguanelleTM vaginal suppositories, Lo.Li.Pharma, Italy). A weekly follow-up check was performed for 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* positive colposcopy examination
* positive Papanicolaou smear
* pathological biopsy
* physical ablation by CO2 laser therapy for a number of lesions included between 3 and 5

Exclusion Criteria:

* pregnancy