cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Dietary Milk Polar Lipids on Serum Cholesterol and Gut Microbiota in Healthy Adults

The purpose of this study is to examine whether the daily consumption of 5 g of milk polar lipids influences serum lipids and gut microbiota composition in healthy adults.

Healthy adults will be recruited to participate in a randomized, single-blind, controlled, 13-week crossover trial. Participants will follow a 2-week run-in control period consuming their habitual diets. Participants will then be randomized to consume 20 g of milk fat daily in the form of either a reconstituted milk polar lipid (MPL)-rich dairy beverage (MPL; providing 5.3 g MPL daily) or a control dairy beverage (CTL; providing 0.3 g MPL daily), each for 4- weeks, separated by a 3-week washout period. Participants will be instructed to consume intervention treatment/control beverages at breakfast (50 g) and dinner (50 g) and reconstitute the powders in water immediately prior to consumption. With the exception of the intervention beverages, participants will be asked to maintain their normal diet and exercise habits throughout the study. Venous blood will be collected after a 12-hour overnight fast into EDTA-coated (glucose analysis) and serum (lipid analyses) collection tubes. Passive drool and stool samples will be collected at the end of the run-in period (baseline) and intervention periods (treatment and control). Participants will be asked to complete a 5-day dietary record, food preference/liking/sedentary behavior surveys, and 7-day physical activity diary at the beginning and end of intervention periods.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 50 years
* Body Mass Index \< 30 kg/m\^2
* Willing to consume experimental intervention products on a daily basis

Exclusion Criteria:

* Outside of age range (\<18 or \>50 years old)
* Body Mass Index \> 30 kg/m\^2
* Triglycerides are higher than 500 mg/dL, glucose levels higher than 126 mg/dL, or total cholesterol higher than 240 mg/dL
* Self-reported history of renal or liver disease, diabetes, thyroid disease, gallbladder disease, eating disorders, heart disease, stroke, cancer and gut-associated pathologies
* Weight loss greater than 10% of body weight over preceding 4 weeks
* Taking probiotic supplements or oral antibiotics up to 1 month prior to the study and during the study
* Allergy to dairy or lactose intolerance
* Taking lipid-lowering medications
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.

This project aims to determine the effects of an oral motor stimulation combined with a reading curriculum vs an oral motor stimulation alone vs controls among preterm infants born 23-30 weeks gestation in the NICU. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will start oral feeding at an earlier age, have fewer days to full oral feeding, and fewer days in the NICU compared to infants receiving an oral motor stimulation and controls. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will have increased infant vocalizations, increased conversational turns, increased adult word counts, decreased maternal stress, decreased degree of post-traumatic stress post-discharge, improved receptive and expressive language development at 12 and 24 months, and improved parent reported behavioral outcomes at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* 23-30 weeks
* English and Spanish speaking

Exclusion Criteria:

* Major congenital anomalies
* Surgical necrotizing enterocolitis
* Non-English and Non-Spanish speaking
Acceptance and Commitment Therapy for Insomnia

Insomnia is a common sleep problem that impacts both physical and mental health. Acceptance and Commitment Therapy for Insomnia (ACT-I) is proposed as a promising new treatment for insomnia. However, its effectiveness without overlapping behavioral components of the current standard treatment, cognitive behavioral therapy, remains largely unknown.

The main goal of this clinical trial is to test the efficacy of stand-alone ACT-I in adults with insomnia, compared to a waitlist control group. The second goal is to explore the potential working mechanisms of ACT-I, using network intervention analysis.

Adults with insomnia will be randomized to an ACT-I or waitlist group. Both the ACT-I treatment and waiting period span 7 weeks. Assessments take place at baseline (pre), after 4 weeks (mid), and after 8 weeks (post), followed by a 3- and 6-month follow-up for the ACT-I group.

The main questions this RCT aims to answer are:

* Is ACT-I superior to a waitlist control group in improving insomnia severity (primary outcome) in addition to sleep diary measures, anxiety, depression, general mental health, and sleep-related quality of life (secondary outcomes)?
* How do networks of insomnia symptoms or potential treatment processes (i.e., psychological (in)flexibility, sleep-related arousal, dysfunctional cognitions, and sleep-related safety behaviors) develop during and following ACT-I?


Eligibility Criteria:
Inclusion Criteria:

* insomnia severity index score ≥ 15
* clinical insomnia disorder diagnosis, as confirmed by the SCID-S-5 insomnia interview
* age of 18 years or above
* proficiency in Dutch
* ability to come on-site for the treatment sessions

Exclusion Criteria:

* previously received ACT
* started psychotherapy within the last 6 months or currently awaiting psychotherapy
* changed psychoactive medication in the last 3 months
* diagnosis of psychosis or schizophrenia
* severe depressive complaints (BDI-II score ≥ 29) or active suicidal ideation
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.

Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty.

Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA.

Purpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.

Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled for a primary anatomic or reverse TSA

Exclusion Criteria:

* Allergy to TXA
* Acquired disturbances of color vision
* Pre-op use of anticoagulant therapy within five days before surgery
* History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA
* Pregnancy or breastfeeding
* Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement
* Renal impairment
* Refusal of blood products
* Any patient undergoing a revision TSA
* Patients who decline to participate
Stroke Of Mindfulness: Investigating Physiological and Psychological Well-being

This study evaluates the impact of mindfulness-based interventions on psycho-social and physiological well-being among stroke survivors and their family caregivers. This study will employ a treatment wait-list cross-over design, with half the participants randomized to receive the intervention first (treatment group), while the other half receives the interventions 2 months following the end of the treatment phase (wait-list group).

Stroke survivors face many concerns, including the physical, psychological, cognitive and psychosocial consequences of stroke, as well as impaired function and quality of life. Also important for stroke survivors is the possibility of recurrence that may result in death and further disability. Survivors depend on their caregivers to provide assistance for daily living tasks, emotional support and taking on new roles and responsibilities with changing social dynamics, often causing long-term strain.

Mindfulness-based interventions (MBIs) are psychotherapeutic interventions which have been shown to improve psychological, physiological and psychosocial outcomes such as anxiety, depression, mental fatigue, blood pressure and overall quality of life. However, data is limited for stroke survivors and their caregivers, especially in Asians. This study will evaluate the impact of MBIs on the psychological well-being and perceived quality of life among stroke survivors and their family caregivers in Singapore.

This study employs a randomized treatment-waitlist crossover design with outcome measures administered before and after the intervention as well as at 3 months follow-up for the treatment group.

The intervention consists of 4 weekly 2-hour mindfulness sessions. Participants will be introduced, taught and guided in practice of mindfulness-based interventions that are focused on their (1) breath, (2) senses, (3) body and bodily movement, (4) feelings of empathy and compassion. Pre- and post-intervention questionnaires will be conducted to assess symptoms associated with depression, anxiety, stress and perceived quality of life. Blood pressure and heart rate variability recordings before and after intervention will also be noted.

Eligibility Criteria:
Inclusion Criteria:

* Stroke Survivors
* Family Caregivers
* Able to speak and understand English Fluently
* Comprehends and provides consent independently

Exclusion Criteria:

* Cognitively impaired individuals with a MMSE Score of less than 20, MoCA score of less than 23
* Depression and Anxiety Stress Scale Scores, DASS, Depression \>7, Anxiety \>8, and Stress \>13
The Effect and Safety of Moxibustion Therapy for Overactive Bladder Patients

This pragmatic randomized controlled study aimed to evaluate the effectiveness and safety of moxibustion therapy on overactive bladder (OAB) patients.

Patients who diagnosed as overactive bladder aged 20 to 75 years old will be divided into two groups, one is moxibustion-therapy and the other is waiting-list group.

Patients who belong to moxibustion therapy group will be treated moxibustion for 12 times by a Korean Medicine doctor.

Patients who belong to waiting-list group will be prohibited to get any treatment including moxibustion for relieve the symptoms of overactive bladder, and the same moxibustion therapy with moxbiustion-therapy group will be conducted after 4 weeks.

Overactive bladder symptom score (OABSS), overactive bladder-validated 8-question (OAB-V8) will be measured to evaluate the effectiveness.

The number of side effect will be measured to evaluate the safety.

The skin temperature of CV4, SP6 and LR3, and the tympanic temperature will be measured to study treatment mechanism.

Eligibility Criteria:
Inclusion Criteria:

1. aged from 20 to 75 years old
2. submit written consent
3. no deficit to notify the hotness promptly and exactly
4. diagnosed with overactive bladder
5. suffering the OAB symptoms during greater than or equal to 3 months

Exclusion Criteria:

1. malignancy
2. obstructive disease of urinary tract
3. cystocele, vaginocele or rectocele
4. urinary tract infection finding on urine analysis
5. diabetic mellitus
6. sensory disturbance
7. pregnancy, possibility of pregnancy or planning to pregnancy
8. problems to communication due to any medical problem such as cognitive dysfunction
9. getting other treatment of either Traditional Korean Medicine or conventional medicine for overactive bladder
10. psychiatric disorder or severe systemic disease.
Left Bundle Branch Block (LBBB) After IntuityTM

This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.

It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* rapid-deployment aortic valve replacement (RD-AVR) with the Edwards Intuity™ bioprosthesis for severe aortic valve stenosis
* between July 2012 and May 2018

Exclusion Criteria:

* preoperative permanent pacemaker or defibrillator,
* complete intraventricular conductive disorder defined by a QRS width ≥ 120 ms.
* absence of patient's authorization for anonymous publication of their clinical data for research purposes.
Moisturizer Mediated Prevention of Symptoms of Atopic Dermatitis in Early Childhood

In this study, it will be investigated if symptoms of atopic dermatitis of children with high familial risk will be delayed beyond the 6th or even 12th month of life by applying the SanaCutan Basiscreme.

Enrolled healthy newborns with high risk for atopic dermatitis will be 1:1 randomised into treatment and control group. The treatment group receives the SanaCutan Basiscreme for twice daily skin application until the age of 6 months (main phase; half of them until the age of 12 months (main + follow-up phase)), whereas the control group should avoid skin care products. Guardians of both groups are requested to document all applied skin care products in a diary. In regular visits at the study sites, a blinded physician investigates the skin of the children. In case of an atopic dermatitis (= atopic dermatitis has to be diagnosed in at least two visits with an interval of at least four weeks), the severity will be examined (SCORAD) and the treatment with SanaCutan Basiscreme will be terminated. All children will be followed up until the age of 6 months (end of main phase). This is the time when a blood test will be conducted to determine sensitization against food and inhalant allergens and total IgE. If children do not develop an atopic dermatitis in the main phase, the study continues until they receive the diagnosis (up to a maximum of 12 months, end of follow-up phase).

Eligibility Criteria:
Inclusion Criteria:

* Healthy newborns (male or female)
* Age \< 3 weeks (≤ 21st day of life)
* High familial risk of atopic dermatitis in the form of at least one first-degree relative (parent or sibling) with a medically diagnosed atopic dermatitis in the medical history
* Written consent of all guardians

Exclusion Criteria:

* Acute or chronic diseases
* Acute fever (\> 38.5 °C)
* Severe congenital malformations
* Hydrops fetalis
* Immunodeficiency (any kind)
* Severe genetic skin diseases or skin conditions that make the use of skin creams unsuitable
* Corticoid or calcineurin inhibitor use or Ciclosporin intake
* Preterm birth (\< 37 weeks)
* Known hypersensitivity to one of the ingredients of the SanaCutan Basiscreme
* Restricted legal capacity of the guardians
* Inability of the guardians to understand the study instructions
* Obvious unreliability or lack of cooperation of the guardians
* Known alcohol, medicine or drug dependency of the guardians
* Dependence of the child or guardians on the sponsor or the investigator
* Previous participation in another clinical trial (since birth)
* Previous participation in this study
Prostate Impendance Test Project

Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.


Eligibility Criteria:
Inclusion Criteria:

1. age\> 45 years
2. up of total PSA values beyond the normal range (\> 4 ng / ml)
3. presence or absence of suspicious prostate nodule

Exclusion Criteria:

1. previous history of cancer
2. BMI\>30
3. patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance
Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-85 years who have given written informed consent.
* Patients with bilateral ear lobe keloid scars suitable for surgical excision which will result in a single wound on each ear lobe no greater than 2cm long and restricted to the skin, fat and fibrous tissue of the ear lobe.
* Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
* Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose.

Exclusion Criteria:

* Patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteroids, or other pharmacological agents in the three months prior to the first trial dose administration.
* Patients with a history of a bleeding disorder.
* Patients who on direct questioning and/or physical examination have past or present evidence of eczema or psoriasis local to the site of administration, uncontrolled diabetes (fasting plasma glucose concentration consistently at or above 7.0mmol 1-1 (126 mg dl-1), severely immunocompromised patients and/or malignant skin tumours e.g. melanomas, squamous or basal cell carcinomas.
* Patients with a skin disorder, not related to the keloid disease, that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
* Patients with a history of malignancy in the last 5 years.
* Patients with a history of hypersensitivity to any of the drugs or dressings used in this trial.
* Patients who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
* Patients undergoing investigations or changes in management for an existing medical condition.
* Patients who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason.
* Female patients who are pregnant or lactating.
* Patients with a creatinine clearance (CLcr) of 80ml/min or less.
Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Classical Antagonist Protocol

A randomized prospective study of the evaluation of the clinical IVF results after following Long Antagonist protocol for controlled ovarian stimulation versus following classical antagonist protocol

A randomized prospective study of administration of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF: Single dose of Degarelix (24mg, 16mg or 12 mg), on day 24th of previous luteal face cycle, was administered. The Clinical Pregnancy and Live Birth Rates were estimated for this group of patients, comparing to the rates of the group which followed classical antagonist protocol. The number of the formed blastocysts in each group is measured, as well.

Eligibility Criteria:
Inclusion Criteria:

* primary infertility
* age 18-39 years; body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35days,
* presumed to be ovulatory;
* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

Exclusion Criteria:

* women with diabetes and other metabolic disease
* women with heart disease, QT prolongation,heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype;
* polycystic ovarian syndrome,
* endometriosis stage III/IV;
* history of being a 'poor responder',
* defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.