cyrilzakka/clinical-trials huggingface dataset:
The Anxiety of Parents of Children Undergoing Cardiac Surgery

This is a randomized clinical trial. The population consisted of parents of children undergoing cardiac surgery from December 2010 to April 2011. We included parents aged over 18 years, and the following were considered exclusion criteria: inability to understand and/or answer the questions for any reason, parents of children undergoing surgery for insertion of the pacemaker and defibrillator, surgical death and not take up the case. 22 parents in the intervention group were randomized and received standardized guidelines for nursing and 22 parents participated in the control group received the guidelines and routine of the institution. Anxiety was assessed using the STAI State-Trait Inventory in the preoperative period and 48 hours after surgery the child.

anxiety

Eligibility Criteria:
Inclusion Criteria:

* We included parents aged over 18 years

Exclusion Criteria:

* inability to understand and/or answer the questions for any reason,
* parents of children undergoing surgery for insertion of the pacemaker and defibrillator,
* surgical death and not take up the case
Health Improvement After Pregnancy (HIP) Program Randomized Control Trial

Recent Canadian studies, public opinion polls and the Canadian Heart Health Strategy and Action Plan state that women's heart health is a key national priority; it should be addressed through improving heart health awareness and prevention, and reducing care inequities for women in general and younger women in particular. The investigators have developed an innovative and interactive mobile website based postpartum lifestyle modification program (regular physical activity and nutritional guidance), based on established national guidelines, to improve heart disease risk factors in women. The investigators will conduct a trial to determine if the mobile website based lifestyle modification program can be maintained and reduces a collection of risk factors, which occurring together, greatly increases the risk of developing heart disease. The investigators hypothesize that the interactive mobile website directing regular physical activity and personalized nutritional guidance, compared to standard postpartum care, will be motivational and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the intervention group.


Eligibility Criteria:
Inclusion Criteria:

- must own or have daily access to one or more of the following; smart phone, tablet or laptop computer

Exclusion Criteria:

* Living greater than 100km from Kingston General Hospital
* Having an existing and long term contraindication to exercise at the time of recruitment
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent from participant
2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)

Exclusion Criteria:

1. Lack of informed consent
2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
3. A participant who is unwilling to use medically acceptable contraception methods during participation in study
4. Active perianal abscess or infection at screening or Day 1
5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
6. Confirmed HIV, Hepatitis B, or Hepatitis C infections
7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
8. History of colorectal cancer within 2 years of screening
9. Use of investigational therapy or treatment within 30 days prior to Day 1
Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly

To test the hypothesis that both lack and excess of growth hormone (GH) is associated with cardiac abnormalities. Cardiac function and morphology will be evaluated by MRI before and after treatment.

It is an open prospective noninterventional clinical study. Treatment and follow-up will be according to usual guidelines, and will be unaffected by inclusion in the study. GHD patients will be treated with daily subcutaneous GH injections. Patients with acromegaly will be treated with either transsphenoidal surgery or by medical treatment with long acting somatostatin analogues, dopamine agonist, GH antagonist or combinations of these treatment modalities.

Patients will be examined by Cardiac MRI before treatment and after one year of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Peak GH below 6.0 ng/mL during Pyridostigmine-GHRH test.
* Nadir GH above 0.4 ng/mL and elevated levels of IGF-I during oral glucose tolerance test

Exclusion Criteria:

* Contraindications for magnetic resonance scan
Macular Hole Reopening

The purpose of this investigation was to determine the incidence and the factors that cause a reopening of a macular hole (MH) after a surgical closure.

A reopening of a macular hole (MH) is a well-known complication of successfully closed MHs. Recently, internal limiting membrane (ILM) peeling has become widely used as an adjunctive procedure during MH surgery. The incidence of a reopening of a MH is 0 to 8.6% in eyes in which the ILM was peeled off, and 2 to 16% in which the ILM was not peeled off. Part of the variation in the percentages of reopening was the length of the follow-up period; eyes with longer follow-up periods have higher incidences of reopening.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent vitrectomy with or without internal limiting membrane (ILM) peeling for an idiopathic full-thickness macular hole

Exclusion Criteria:

* eyes with previous vitreous surgery, cystoid macular edema from any cause, and traumatically-induced MH were excluded.
Anger Expression, Self-focus and Coronary Heart Disease Risk Factors

To identify behavioral factors underlying the development of cardiovascular risk in young adults.

BACKGROUND:

The continued number of observations relating the Type A behavior pattern to coronary heart disease underscores the importance of developing a careful theoretical basis that may account for the virulent components of a coronary-prone personality.

CARDIA or Coronary Heart Disease Risk Development in Young Adults is a prospective, epidemiological study of coronary heart disease risk factors in cohorts of Black and white men and women, 18 to 30 years of age.

DESIGN NARRATIVE:

From each of the baseline tape-recorded Type A/B structured interviews administered in CARDIA, eighteen questions were scored for self-references, perceived pressure, anger experience, and anger expression. The anger measures were related to other measures of anger-in and hostility in order to establish their validity. The interrelationships of these factors were assessed separately for each of the socioeconomic status (SES) categories. A major focus of the analyses was to describe SES differences in how pressure was perceived and how anger was experienced and expressed. The study also assessed how these factors were related to data already collected on psychosocial risk factors and primary risk factors including blood pressure, serum cholesterol, and cigarette smoking.

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
Translation and Validation of the "Children and Adolescent Trauma Screen" in French

Child psychotraumatism and complex psychotraumatism, mainly consecutive to child maltreatment, is a major unaddressed public health issue.

The investigators aim to translate and validate a screening scale to help professionals to better detect and refer children at risk of psychotraumatism.

This study aims to validate the psychometric properties of a french version of the CATS 2.0, in partnership with the original authors of the scale.


Eligibility Criteria:
Inclusion Criteria:

* child aged between 7 and 17
* at least an adult of reference (parent or tutor) reachable
* agreement of adult of reference
* for clinical population : have been potentially exposed to a potential traumatic event (according to DSM-V)

Exclusion Criteria:

* non-mastery of French language
The Energize! Study for Adults with Knee Replacement

The purpose is to examine the effects of an online physical activity program on moderate to vigorous intensity physical activity, pain, and physical function in adults with knee replacement at 3 months (post-intervention) and 6 months (maintenance).

Participants with knee replacement will be randomized to start the online physical activity program (Energize!) either immediately or after 3 months. The online program consists of weekly physical activity goals, video lessons, action planning, and homework to help increase physical activity to 200 min/week. Assessments will be completed at baseline, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Have had a partial or total knee replacement ≥12 months ago
* Have regular access to the internet
* Willing to wear activity monitor for 7 days at baseline, 3 \& 6 months
* Engage in less than 60 minutes of self-reported moderate intensity exercise

Exclusion Criteria:

* Have a mobility limiting comorbidity
* Non-English speaking
* Have a scheduled surgery within the next 6 months that would limit activity
Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 2 months (42-98 days) at time of enrolment.
* Available for the entire study period and whose parent/legal guardian can be reached by telephone.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with a pneumococcal conjugate vaccine.
A Randomized Clinical Trial

Acute postoperative pain is a common problem faced by the patient after surgery, most frequently occurring in first 24 hours. Our primary objective was to assess pain score in first 24 hours in PECS block group undergoing mastectomies. Secondary objective was to observe morphine (opioids) and antiemetic consumption in post anesthetic care unit.

Design: Observer Blinded Randomized control trial.

Place and Duration: Department of Anesthesiology, Shaukat Khanum Memorial Cancer Hospital Lahore (SKMCH), from February 2017 to December 2017

Methods: 120 patients more than 18 years, ASA I and II, planned for unilateral elective modified radical mastectomy under general anesthesia were randomly assigned to receive either general anesthesia plus Pectoral Nerve I, II and serratus (PECS) block (n = 60) or general anesthesia alone (n = 60). Pain score at fixed intervals was measured using Numeric Pain Rating Score (NPRS) after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female age 18 or older
* (ASA) I and II
* Scheduled to undergo elective unilateral mastectomy or Modified radical mastectomy (MRM) under general anesthesia.

Exclusion Criteria:

1. Patient's refusal
2. history of allergy to bupivacaine
3. contraindications to regional anaesthesia (coagulopathy and local infection),
4. BMI \> 40 kg/m2,
5. patient scheduled for bilateral mastectomies
6. use of chronic pain medications
7. history of illicit drugs or alcohol abuse and history of psychiatric problems.
Faster Aspart on Insulin-pump Treated T1DM Patients

Observational retrospective study about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.

Cross-sectional retrospective analysis about effectiveness and safety of insulin Faster Aspart on continuous subcutaneous insulin infusion treated adult Type 1 Diabetes Mellitus (T1DM) patients in routine clinical practice.

All clinical variables are gathered from two EMR softwares (Mambrino XXI and Carelink Pro®).

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* Diagnosed of Type 1 Diabetes Mellitus.
* Be attended in Ciudad Real General University Hospital.
* Current treated with CSII (CSII cohort) during ≥6 months.
* Current treated with insulin Faster Aspart during ≥3 months.

Exclusion Criteria:

* Less than 18 years old.
* Other types of diabetes mellitus.
Determine the Frequency of Variants in the GBA/PSAP Genes in Patients with MM or MGUS

No effective specific treatment is currently available for the management of Multiple Myeloma (MM) and Monoclonal Gammopathy of Undetermined Significance (MGUS). A better understanding of the pathophysiological mechanisms would make it possible to propose treatments specifically targeting the deregulated pathways.

This study will characterise the links between rare diseases and complex, chronic diseases. Metabolism can be visualised as a complex network in which the various biomolecules represent metabolic nodes and are linked together by connections. The number of connections at a node influences the effect of that biomolecule on the metabolic network(s) as a whole. If a biomolecule has a large number of connections, altering a metabolic pathway involving it will have an effect that will spread throughout the network. On the other hand, metabolic pathways with a high flux have a major impact on the homeostasis of the network. Thus, alteration of such a metabolic pathway cannot be without consequence: a major alteration could induce a rare hereditary metabolic disease with an early-onset clinic, whereas an alteration with a moderate effect could participate in the pathogenesis of complex diseases, and may open up new therapeutic prospects for these tumour pathologies.

Eligibility Criteria:
Inclusion Criteria:

* Major patients with multiple myeloma (MM) (defined by clonal proliferation of tumour plasma cells (\>10%), presence of a monoclonal peak in serum or urine (excluding non-secretory myeloma) and organ involvement secondary to bone marrow invasion) or with MGUS (defined as bone marrow plasmacytosis of less than 10%, associated with a monoclonal protein of less than 30g/L and no clinical involvement).
* Membership of a social security scheme
* Adult having read and understood the information letter and signed the consent form

Exclusion Criteria:

* Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy

This study is being done to evaluate the potential benefits of using electroacupuncture to reduce the severity of chemotherapy-induced peripheral neuropathy for patients with peripheral neuropathy after chemotherapy.

Chemotherapy-induced peripheral neuropathy (CIPN) refers to symptoms caused by chemotherapy drugs, such as numbness, tingling sensation, decreased sensation, hypersensitivity, or even limb dysfunction and muscle atrophy, which can be divided into five grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). The higher the grade, the more severe the symptoms. The incidence of chemotherapy-induced peripheral neuropathy (CIPN) reached 68.1% within the first month after treatment. About one-third of patients may develop chronic CIPN six months or more after chemotherapy, which significantly impairs the patients' quality of life. Electroacupuncture, as a nonpharmacologic therapy, is minimally invasive, with few side effects, and has demonstrated efficacy in various conditions including chemotherapy-induced nausea and vomiting. However, studies on its effectiveness against CIPN still yields inconsistent results.

This is a parallel-group, double-blinded (participants and statisticians), randomized controlled study that investigates the role of electroacupuncture compared with sham acupuncture for patients receiving chemotherapy. Both groups will receive the standard therapy for CIPN. On this basis, electroacupuncture or sham acupuncture will be randomly administered to the two groups. The investigators will explore the efficiency of electroacupuncture in reducing the severity of CIPN. Primary and secondary outcomes and adverse events will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, of any nationality.
* Patients diagnosed with malignant tumor.
* Eligible patients will report altered sensations and/or pain and/or other neurological symptoms, with a grade between 2-3 for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-version 5.0 (NCI-CTCAE.v-5.0).
* Predicted life expectancy of ≥3 months.
* Intact skin without any breaches or purulent discharge.
* Written informed consent by the patient before enrolment Patients must be able to comply with the study protocol, which includes attending the treatment sessions on time and completing the study questionnaires in accordance with the study protocol.

Exclusion Criteria:

* History of pre-existing peripheral neuropathy before chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, and toxic neuropathy.
* Patients with skin damage, pus or scar at the acupuncture stimulation area.
* Patients who are pregnant or breastfeeding.
* Significant mental conditions.
* Patients not fulfilling the inclusion criteria.
* Patients receiving other acupuncture treatments during the trial.
The Effect of Probiotics on Gingivitis: Part 2

The aim of the study is to assess the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene in young adults.

This will be a double-blind, randomized, placebo-controlled two-arm parallel-group study of the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene. The groups will include young adults with gingivitis diagnosed clinically. To assess the effect of oral probiotics, the following parameters will be used: gingival health (gingival index, GI; gingival bleeding index, GBI) and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-25 years
* Permanent bite;
* Presence of more than 20 teeth;
* Absence of systemic and chronic diseases;
* The diagnosis of gingivitis stated clinically.

Exclusion Criteria:

* Presence of mild, moderate or severe chronic periodontitis;
* Refusal to sign informed consent;
* Taking supplements and medication containing probiotics or prebiotics 1 months before the study;
* Taking antibiotics (within 3 months before the study);
* Allergy to the components of the drugs used in the study;
* Presence of immunodeficiency, taking immunosuppressants.
* Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
* Refusal to take a given medication;
* Failure to attend check-ups.
Gastric Gluten-Degradation Activity of PvP001

This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers;
* Able to maintain a gluten-free diet (GFD) for 24 hours prior to each of visits 1-4;
* Able to abstain from alcohol consumption 72 hours before and 72 hours after each visit;
* Able to tolerate the placement, presence, and manipulation of an oro-gastro-duodenal (OGD) tube;
* Women of child-bearing potential and men whose partners are women of child-bearing potential must be willing to use acceptable birth control for the duration of the study;
* Able to read and understand English;
* Able to provide written informed consent

Exclusion Criteria:

* Any condition or abnormality, current or past, that, in the opinion of the investigator, would compromise the safety of the subject, or would interfere with or complicate study procedures or assessments.
* No current or recent (within 14 days prior to each study visit, clinical laboratory testing, and ECG) use of over-the-counter or prescription medications via any route of administration, except for oral contraceptives for birth control (provided they have been used regularly for at least the past 3 months). Other medications used regularly at stable doses may be acceptable at the discretion of the study doctor.
* Current symptoms of congestion, upper respiratory tract infection, or acute illness
* Chronic viral infection or immunodeficiency condition
* Any female who is pregnant, planning to become pregnant during the study, or breast-feeding
* History of intolerance, hypersensitivity, or reaction to wheat or other grains, gluten, or any other food or food ingredient (including an additive or preservative) in the study meal;
* Receipt of an investigational medication within four weeks prior to the screening visit or from the screening visit through the final visit;
* Alcohol consumption \>5 drinks/week or any alcohol consumption within the 72 hours prior to each study exposure visit or a positive breathalyzer test result at any study visit;
* Illicit or recreational drug use in the past 12 months or positive urine drug screen at the screening visit;
* History of smoking, nicotine, or tobacco use in the past 12 months;
* History or high risk of noncompliance with treatment or visits.