cyrilzakka/clinical-trials huggingface dataset:
The Effects of Dyadic Parent-child Self-compassion Program on Children' Psychological Well-being: A Pilot Randomized Controlled Trial

Suboptimal psychological well-being in children can have substantial negative effects on their physical health, academic performance, and lifelong health. Preliminary evidence supports that self-compassion have positive impacts on psychological well-being in elderly, adults, and adolescents, but there is apparently lack of this kind of evidence in children. Involvement of parents in the program potentially optimize the effects, this study thus designs a dyadic parent-child self-compassion program (DPC-SC) and aim to examine its effects on children's psychological well-being.


Eligibility Criteria:
Inclusion Criteria: (Child)

* Study in Primary three or four.
* Can communicate in Cantonese.

Exclusion Criteria: (Child)

* Have emotional dysregulation
* Have past history of mental illness
* Recently experience trauma
* Are in an acute health crisis

Inclusion Criteria: (Parents)

* Is the primary caretaker of the children
* Is willing to interact and do the practices with their children
* Can communicate in Cantonese
* Commit to attend all sessions

Exclusion Criteria: (Parents)

* Have emotional dysregulation
* Have past history of mental illness
* Recently experience trauma
* Are in an acute health crisis
Posterior Approach to Total Shoulder Arthroplasty

The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking
2. \>18 years of age
3. Underwent posterior approach to total shoulder arthroplasty by Dr. Michael Greiwe at St. Elizabeth Healthcare

Exclusion Criteria:

1. Non-English speaking
2. \<18 years of age
3. Loose bone in the anterior recess of the shoulder
4. Severe arthritis with significant bony deformity
Polyamine-enriched Diet in Healthy Older Adults With Subjective Cognitive Decline

The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance of individuals with subjective cognitive decline.

Memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like subjective, mild cognitive impairment (MCI) and Alzheimer's disease (AD), all of which are a growing public-health concern with devastating effects. Polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular protein degradation pathways) may be a key target of intervention against age-related memory decline. The study will investigate whether a polyamine-enriched dietary supplementation (through capsule intake) could provide positive effects on the cognitive function of elderly individuals (60-80 years old) with subjective cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* Cognitive healthy subjects with subjective memory decline and self-reported concerns
* 60-80 years old
* No manifest dementia (DSM-IV criteria)
* No limitations in activities of daily living
* Capacity for consent

Exclusion Criteria:

* Gluten, histamine or wheat seedling intolerance
* Severe neurological, internal or psychological diseases
* Advanced heart or respiratory diseases, severe arteriosclerosis, untreated thyroid disease or diabetes
* Malignant tumors, current or past history
* Brain tumors, stroke
* Disorders that impair attention
* Dementia
* Coagulation disorder, Marcumar or ASS therapy
* Drug abuse or alcohol dependency
* Current polyamine substitution
Pertussis Maternal Immunization Study

The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease

The purpose of this study is to assess the potential of providing initial immunological protection to the neonate by providing passive placentally transferred serum antibodies and breast milk antibodies against pertussis antigens (PT, FHA, PRN, FIM). This will be accomplished by

* determining the rate of maternal antibody decline from time of immunization until 12 months postpartum by measuring antibody levels in serum, saliva, and breast milk at specified intervals;
* determining levels of antibody transferred to the neonate relative to the interval from immunization to delivery;
* comparing levels of transplacentally transferred antibody with those achieved after the first, second, and third dose of the primary immunization series; and
* determining whether maternal immunization interferes with active antibody production following licensed DTaP-IPV-Hib in infants of women immunized during the mid third trimester of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 years of age and over.
* Women who, at ≥30-\<32 weeks gestation, are at low risk for complications as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
* Signed, informed consent.

Exclusion Criteria:

* Failure to meet eligibility criteria as determined by the obstetrical algorithm for identification of eligible subjects and the obstetrical risk assessment form.
* History of significant medical disorder (such as bleeding disorders, cancer, autoimmune disease, immunodeficiency (including HIV-infected individuals, transplant recipients), seizure disorder or significant psychiatric illness, drug or alcohol dependence).
* Receipt of any high-dose daily corticosteroids (inhaled steroids are acceptable) within 2 weeks of study entry. High dose is defined as a dose of ≥20 mg of prednisone daily or equivalent.
* History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.
* Personal history (verbal or documented) of ever having received Tdap.
* Personal history (verbal or documented) of having received Td immunization within the past 2 years.
* History of febrile illness (\>37.8ºC orally) within the past 72 hours (immunization may be deferred).
* History of sensitivity to any component of Tdap.
* Receipt of blood products or immunoglobulin within 3 months of study entry (except RH-negative women who receive immunoglobulin during pregnancy are eligible).
* Receipt of any vaccines within 2 weeks of study vaccine (except influenza vaccine which may be given concurrently).
* Failure to give written, informed consent.
Acupuncture for Irritable Bowel Syndrome (IBS)

The purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (IBS).

IBS is a disorder that affects colon functioning. Although it does not cause permanent harm or lead to more serious conditions, IBS can cause a great deal of discomfort and distress. The effectiveness of acupuncture in treating various conditions has been investigated in numerous studies. However, little is known about acupuncture's efficacy in treating IBS. This study will determine whether acupuncture can alleviate the symptoms of IBS, including pain relief with defecation, changes in stools, and changes in the frequency of bowel movements.

Participants in this study will be randomly assigned to receive bi-weekly sessions of either active or placebo acupuncture or no treatment for 6 weeks. Study visits will occur at study start, Week 3, and Week 6 (study completion). At each study visit, blood collection will occur to measure levels of cortisol, a stress hormone associated with IBS. Participants will also complete questionnaires about their IBS symptoms. Selected participants will be interviewed at each visit, in order to determine whether participants' interpretations and understanding of IBS influences their response to treatment. Any subject who does not receive active acupuncture during the trial is eligible for 6 free acupuncture treatments after the study is over.

Eligibility Criteria:
Inclusion Criteria:

* Irritable bowel syndrome of moderate severity for at least 12 weeks within 1 year prior to study entry
* Colonoscopy or flexible sigmoidoscopy/air contrast barium enema within 5 years prior to study entry
* Able to walk
* Able and willing to cooperate with the study
* Sufficient knowledge of English to be able to participate in the study

Exclusion Criteria:

* Medications that affect the gastrointestinal tract or visceral sensation, unless the participant is on a stable dose for at least 1 month prior to study entry and for the duration of the study
* History of severe or intractable IBS
* History of acupuncture treatment
* Score between 37 and 150 on the Functional Bowel Disorder Severity Index (FBDSI)
* Any concomitant bowel problem that would interfere with the study
* History of laxative abuse
* Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry
* History of metabolic or inflammatory disease that may affect bowel movement
* History of significant psychiatric, neurological, metabolic, hepatic, renal, infectious, hematological, cardiovascular, gastrointestinal, or pulmonary illness. Participants who are stable for more than 1 year with conditions that will not interfere with the study are not excluded.
* History of drug or alcohol abuse within 2 years prior to study entry
* Positive for opiates at the initial visit drug screen
* Abnormal vital signs, physical examination results, or clinical laboratory values, unless these abnormalities are judged to be clinically insignificant
* Pregnancy or breastfeeding
The Role of Expectations in Experimentally Induced Sadness

The study aimed at identifying whether different expectations have an impact on experiencing emotions in the form of sadness.


Eligibility Criteria:
Inclusion Criteria:

* fluent in German language

Exclusion Criteria:

* major depression
* current intake of psychotropic medication
* drug intake within the last two weeks
* alcohol consumption within the last twelve hours
* allergic to capsaicin
* allergic to sesame oil
* students in medicine, pharmacy, or psychology in their third year or older
Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment

Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM).

The aim of the proposed study is twofold: (1) to evaluate the effectiveness of a brief video-based intervention in reducing self-stigma among individuals who experienced childhood abuse and/or maltreatment, and (2) to increase openness to seeking treatment.

Prior research suggests that social contact-based interventions are the most efficient way of reducing stigma. This study aims to address self-stigma and empower individuals who self-reported experiencing any kind of abuse during childhood and increase their openness to seeking help, if needed.

A total of 1000 adults with self-report experience of any kind of childhood abuse will be recruited to participate in a Randomized Controlled Trial (RCT) testing the efficacy of the intervention. Participants will be randomized into one of two arms: 1) A 2-minute video intervention in which a CM survivor (presented by either a female or male actor) shares their personal CM experience and describes how they were able to overcome feelings of shame and self-blame to seek mental health care; or 2) A 2-minute control video using the same actors, but without CM-related content. Both videos will be preceded by and immediately followed by questionnaires assessing self-stigma and openness to seeking treatment. An additional assessment of emotional engagement will be added immediately following intervention delivery. Following the intervention, there will be a 30-day follow-up to examine potential long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* US resident
* Individuals who endorse yes to one of the following items: physical aggression in family or household, emotional or verbal abuse in family or household, sexual abuse or inappropriate sexual experiences, negligence - physical or emotional, mental illness or substance abuse at home, incarceration of family member
* Fluent in English and able to give informed consent

Exclusion Criteria:

* N/A
Ischemic Heart Disease Incidence and Indices of Body-fat Distribution

To determine the association between ischemic heart disease incidence and anthropometric indices of body-fat distribution.

BACKGROUND:

Previous studies have demonstrated that abdominal obesity can be predictive of ischemic heart disease. These prospective cohort studies employed simple indices of body-fat distribution such as waist-to-hip circumference ratio or subscapular skinfold. Their similar results suggested that increased abdominal obesity conferred a two-fold increased risk of ischemic heart disease among middle-aged men. The two proposed studies permitted testing of alternative fat-distribution indices which might be stronger risk factors for ischemic heart disease incidence than the waist-to-hip-ratio or the subscapular skinfold.

DESIGN NARRATIVE:

Two parallel case-control studies were conducted. In both studies, subjects were measured for girth, skinfold, abdominal sagittal diameter, height, and weight. Analyses for both protocols considered men and women separately. Possible confounders of the association between fat-distribution indices and ischemic heart disease were considered and if required, adjusted for in multivariate analyses. Possible confounders included race, age, tobacco use, alcohol use, diabetes, social class, hypertension, cholesterol levels, and physical activity levels.

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
Adjunct Collection of Additional Biorepository Data From Patients Enrolled in Diabetic Foot Consortium (DFC) Trials

The Biorepository will guide the Diabetic Foot Consortium (DFC) activities for collection and storing biosamples and data from participants enrolled in other current and future DFC research studies.

Participants enrolling in a parent DFC research study will be concurrently approached about participating in the DFC Biorepository as well. If agreeable, participants will be asked to provide blood, urine, wound debridement tissue and wound dressing samples at the time of enrollment and once more if appropriate and as coincides with the primary study visit schedule. Participants will also be contacted via phone for every six months for two years thereafter to gather longitudinal data about their wound. Data and samples from the Biorepository, along with data collected during the primary study will be available to ancillary researchers.

Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Age \> 18 years
* Previous diagnosis of Type 1 or Type 2 diabetes or pre-diabetes per American Diabetes Association (ADA) guidelines
* Inclusion in a part of any planned or approved DFC protocol

Exclusion Criteria:

* An individual who meets exclusion criteria of the primary DFC protocol in which they are enrolled will also be excluded from participation in the biorepository program as well.
Investigating Effects in Intestinal Permeability of Rich in Beta-glucans Pleurotus Eryngii Mushrooms Fermentation Supernatants: an Ex-vivo Study

The aim of the present study was to investigate the ability of Pleurotus eryngii mushrooms fermentation products (FS) to counteract induced intestinal hyperpermeability in human colonic tissues in an ex vivo system.

Collection of colon biopsies through sigmoidoscopy procedure will take place and the collected biopsies will be mounted in Ussing Chambers. Already collected fermentation supernatants will be added to the mucosal side of the biopsy together with a stressor and two permeability markers, in order to investigate the effects of the fibre fractions on both paracellular and transcellular permeability.

Eligibility Criteria:
Inclusion Criteria:

1. Signed consent prior to any study related procedures
2. Age 18-65 years
3. Willing to abstain from regular consumption of prebiotics/probiotics products or medication known to alter gastrointestinal functions at least 4 weeks prior to the study visits

Exclusion Criteria:

1. Previous complicated gastrointestinal surgery
2. Presence of gastrointestinal disorder or any disorder which the principal investigator considers to affect the results of the study
3. Current diagnosis of psychiatric disease
4. Current and past diagnosis inflammatory gastrointestinal disease (e.g. Irritable Bowel Disease)
5. Systemic use of antibiotics or steroids medications in the last 3 months
6. Frequent use of NSAID (Non Steroidal Anti Inflammatory Drugs) the last 2 months prior to study visits
7. Regular consumption of prebiotic/probiotic products for the past 4 weeks
8. Abuse of alcohol or drugs
9. Frequent use of laxatives, anti-diarrheal, anti-cholinergic within last 12 weeks prior to study visits
10. Pregnancy and breast-feeding
Ultra Structure Of Peritoneum At Electronic Microscopy In Control Subjects And Patients With Gastric Cancer

Peritoneal metastases appear in a great proportion of patients affected by gastric carcinoma. Involved mechanisms are poorly understood though experimentally it has been demonstrated that neoplastic cells exfoliated from primary tumor can only implant and proliferate in areas of damaged peritoneum. Objectives: to study ultra-structure of peritoneal surface by electronic microscopy in control subjects and in patients with early or locally advanced gastric cancer looking for spontaneous changes in peritoneal surface not related with surgical injury.

18 out of 32 cases were eligible for analysis. Four patients operated on for benign diseases served as control and 14 patients with operable local gastric adenocarcinoma (4 mucosa/submucosa/muscular y 10 serosa lesions) were studied. At the beginning of surgery, a 2 x 2 cm. sample from macroscopically normal visceral peritoneum at mesenterium root was carefully obtained, washed with saline and fixed in glutaraldehyde solution. Besides a sample of peritoneal washing fluid was studied to exclude patients with free cancer cells. Peritoneal tissue was fixed during 24 hours and then all samples were evaluated by electronic microscope.

Eligibility Criteria:
Inclusion Criteria:

* patients with operable local gastric adenocarcinoma

Exclusion Criteria:

* previous abdominal surgery
* previous open or blunt abdominal trauma
* history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity.
* All other gastric malignancies such as lymphomas, GIST, carcinoids
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
2. presence of PVTT with III-IV grade by Cheng's criteria;
3. having PVTT induced portal hypertension;
4. TIPS was performed within 72 hours after the endoscopic hemostasis;
5. metastases with limited five sites and no more two organs involved;
6. number of Intrahepatic tumors were no more than five;
7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
9. no history of other malignancies;
10. agreed to participated in this clinical trial;
11. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion Criteria:

1. recurrent HCC;
2. PVTT at I-II grade by Cheng's criteria;
3. age \< 18 years or \> 75 years;
4. advanced HCC with more than five metastases;
5. Number of Intrahepatic tumors were more than five;
6. no response to Lenvatinib;
7. life expectancy less than 3 months.
Effect of Intraocular Tamponade on Visual Perception

Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.

Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* primary retinal detachment patients.
* patients eligible for 23 gauge pars-plana vitrectomy operation.

Exclusion Criteria:

* patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
* patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.
Hepatitis C-Video vs. Brochure Education Delivery

The purpose of this study is to determine the most effective way to give patients information regarding hepatitis C virus infection. The investigators plan to compare the information retained by some patients who are given a brochure alone versus patients who watch an interactive video about hepatitis C.

Subjects will complete 3 questionnaires, including one about knowledge of Hepatitis C. The subject will then either watch a video or read a brochure about Hepatitis C, then take the same questionnaire again. The subject will then return in one month to take the Hepatitis C questionnaire again.

Eligibility Criteria:
Inclusion Criteria:

* Currently on active treatment for opioid addiction/use
* English as primary language

Exclusion Criteria:

-