cyrilzakka/clinical-trials huggingface dataset:
Effects of Fish-oil on Mood and Cognitive Functions of Healthy Individuals

The investigators recently found a positive effect of omega-3 supplements on cognitive function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840). The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously depressed individuals will positively affect their cognitive functions.

Secondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some studies have found low HRV in patients with depression. No studies have investigated the effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a history of depression. The investigators will test the hypotheses that omega-3 supplements lead to an improvement of heart rate variability indices in healthy volunteers with a history of depression.


Eligibility Criteria:
Inclusion Criteria:

* Dutch-speaking men and women
* Normal weight (BMI between 18 and 27).
* Regular diets, not containing fish more than once a week.
* History of depression (at least one major depressive episode in the past).

Exclusion Criteria:

* Currently more than mildly depressed (BDI-II-NL score higher than 19, or score on the suicidality item of this scale higher than 1).
* Current or past psychosis
* Current substance abuse or past substance dependence
* Smoking or current use of soft drugs (current = month prior to study till completion)
* Any hard drug use (lifetime)
* More than 3 alcoholic consumptions/day

Participants will be asked to keep their dietary habits constant throughout the study.
Tobacco Treatment Comparison for Cancer Care

This pilot comparative effectiveness trial will compare two active smoking cessation treatments in terms of effectiveness, equity across patient subpopulations, and efficiency among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a cancer focus will be compared against an active comparator modeled after standard quitline treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.

Primary Aim

1. To generate estimates of the size of the comparative effects of enhanced, cancer-specific smoking cessation treatment versus a generic standard care package similar to quitline care in terms of biochemically confirmed 7-day point prevalence abstinence (no smoking in the past 7 days) 26 weeks after a target quit date.

Exploratory Aims

1. To estimate differences in CET arms in exploratory outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness.
2. To estimate the extent to which treatment effects on abstinence and exploratory outcomes differ across patient subpopulations based on demographics (age, race, sex, ethnicity, socioeconomic disadvantage); nicotine dependence; and cancer site, stage, and treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Alive (per medical record)
* Diagnosed with cancer in the past 3 years
* Received care from a participating oncology clinic in the past year
* Has a current tobacco use status
* Does not have a preferred language other than English (missing language preference will be included).
* Valid address that is not a correctional facility or residential treatment/care facility.
* No flag for patient cognitive impairment, activated health care power of attorney, or other health care agent (e.g., legally authorized representative) in the EHR.

The following additional inclusion criteria must be met for inclusion in the CET

* Smoked combustible cigarettes in the past month.
* Able to speak and understand English.
* Willing to set a date to quit smoking in the next 60 days.
* Willing to receive smoking treatment information.
* Willing to complete study activities.

Exclusion Criteria:

* No current suicidal ideation.
* Suicide attempt in the past year.
* Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder.
* Incarceration.
* Unable to provide informed consent to treatment (i.e., cannot answer questions about study procedures or risks after hearing about the study).
The Effect of a Brief Online Behavioral Activation Intervention

Depression is a worldwide phenomena that has a severe personal, social and societal impact. One such impact is an over $200 billion worldwide economic cost. While many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or limited access to therapists. As such, it is important to assess the efficacy of brief online treatments as an alternative to full length, in-person treatments. A series of studies looking at a brief behavioral activation for depression treatment has shown that participants have reported temporarily improved mood, confidence, motivation and reduced depressive symptoms. It is important to test this treatment in multiple groups of people to acquire additional information regarding brief online interventions. This study seeks to collect participants from online social media sources and compare results to historical data that were collected from a prior research study which used Amazon Mechanical Turk as a recruitment source.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* United States Resident

Exclusion Criteria:

* Non-US resident
* Younger than 18 years old
Improving Mental Health of Chinese University Students in Hong Kong: Adventure-based Cognitive Behavioural Intervention

This study delivered an adventure-based cognitive behavioral intervention program to a group of Hong Kong university students. The program effectiveness was evaluated by a randomized controlled trial in reducing psychological distress and improving mental health of these students. The 3-month maintenance effect was also tested.

University students are vulnerable to mental health problems due to the various challenges they have to face in university life. However, few studies have been conducted to evaluate the effectiveness of university counseling programs in Hong Kong. This project aims at developing and systematically evaluating a culturally adapted and adventure-based cognitive behavioral intervention (aCBI) program to decrease psychological distress and improve various mental health outcomes for Chinese university students in Hong Kong. The aCBI program was delivered in a form of general education course in a university setting. Randomized controlled trial (RCT) design was adopted. The program was evaluated its effectiveness in reducing psychological distress, perceived stress, depressive and anxiety symptoms, negative thoughts and negative emotions and increasing positive thoughts and positive emotions.

Eligibility Criteria:
Inclusion Criteria:

* be of Chinese nationality
* be studying in undergraduate programs at Hong Kong Baptist University (HKBU), as the aCBI program will be provided in the form of a general education course at this university
* have GHQ-12 scores of 2-10 (0-0-1-1) (i.e., mild to moderate levels of psychological distress)
* be willing to complete the entire process of the project.

Exclusion Criteria:

* have GHQ-12 scores of 0-1 (i.e., a low level of psychological distress) or 11-12 (i.e., a high level of psychological distress)
* have one or more psychosis
* have experienced severe depression with suicidal attempts/ideation in the past 3 months, as diagnosed by a psychiatrist or a clinical psychologist.
Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)

Activating mutations of the kinases CKIT or PDGFRA can be detected in 90% of cases by DNA sequence analysis of a pathological specimen. These mutated genomic DNA fragments are highly specific for the tumor and are released by the tumor into the circulation. Allele-specific PCR can be used to specifically amplify and quantify mutated CKIT and PDGFR DNA fragments.

The current trial aims to evaluate whether tumor DNA carrying mutations for CKIT and PDGFRA can be detected and quantified in the plasma of patients with active GIST, and whether detection can be correlated with the clinical course of disease either under therapy or in progressive disease irrespective of current therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female patients aged \>= 18 years
* Histologically confirmed GIST
* Known activating mutation of CKIT or PDGFRA and tissue sample can be provided for central mutation analysis or mutation status unknown and tissue sample can be provided for central mutation analysis at baseline
* Routinely planned follow-up visits in no longer than three months intervals (+ 14 days) including local standard of care diagnostic imaging (CT, PET- CT, or MRI)
* At least one GIST lesion that can be measured by CT, PET-CT, or MRI
* Planned surgery of one or more disease manifestations or planned TKI treatment (such as imatinib or sunitinib) in neoadjuvant or palliative intention or disease progression irrespective of current/planned treatment
* Life expectancy of at least three months

Exclusion Criteria:

* Wild type sequence for CKIT exon 9, 11, 13, 14, 17, 18 and PDGFRA exon 18
* Tissue sample can not be provided for central mutation analysis
* Surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions
* Patients currently receiving adjuvant TKI treatment after surgery and no evidence of progressive lesions
* Patients currently receiving palliative TKI treatment and no evidence of progressive lesions
* Planned follow-up intervals including CT, PET-CT or MRI at more than three months intervals (+ 14 days)
* Coexisting medical condition or treatment that could interfere with the ability of the patient to comply with planned treatment interventions (surgery or TKI treatment) or regular follow-up visits
* Patients unwilling to or unable to comply with the planned therapeutic intervention (surgery or TKI treatment) or to comply with the regular follow-up visits including blood sample collection
* Pregnancy and lactation
* Presence of chronic inflammatory diseases, autoimmune diseases, or liver cirrhosis
* Known HIV and/or hepatitis B or C infection
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin
Emotional Support Given at Birth to Women Effect on Birth Duration, Perception and Fear

Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.

Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).

Introduction: Women begin to experience fear long before birth, and the reason for their fear may be related to their baby, themselves, their partner/relatives, and the healthcare professional. Fear can disrupt the natural process of birth, prolong the stages of birth and cause postpartum complications.Minimizing the fears experienced during birth can lead to more successful and comfortable births, a complication-free birth and less pain for both the woman and the baby.Therefore, emotional support from healthcare professionals is important.

Aim: The research was conducted to determine the effect of emotional support given during birth on the woman's birth duration, perception and fear.

Methods:The population of the randomized controlled experimental study consisted of nulliparous women who applied for normal spontaneous birth to the Birth Unit of a State Hospital in the Central Anatolia Region of Turkey (40 experimental subjects, 40 control subjects).While emotional support practices and standard care were applied to women in the experimental group, only standard care practices were applied to women in the control group. Data were collected using the Personal Information Form, Wijma Birth Expectation/Experience Scale (W-DEQ) Version A, Wijma Birth Expectation/Experience Scale (W-DEQ) Version B, and Women's Perceptions of Supportive Care Provided at Birth Scale.The forms were applied twice to women applying for birth: during labor (first follow-up) and the second follow-up within 2-4 hours after birth. Number and percentage distribution, chi-square test, t test in independent groups, Mann-Whitney U test, Wilcoxon test, and Cohen d test were used in the evaluation of the data.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous,
* Between the ages of 18-35,
* Admitted to the delivery room for normal spontaneous vaginal birth,
* Do not have any physical health problems for themselves or their baby,
* Does not have a diagnosed mental illness,
* Not having a risky pregnancy,
* Able to speak and read Turkish,
* Cervical dilatation of 4 cm or more,
* Women who were willing to participate in the study were included in the study.

Exclusion Criteria:

-Multiparity
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female aged 18-65 years (both inclusive)
* T2DM diagnosis

Exclusion Criteria:

* Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics
* Use of GLP-1 mimetics or DPP-IV inhibitors
* Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%
The Efficacy of Different Vitamin D Supplementation Delivery Methods

To test the efficacy of different vitamin D delivery methods on serum 25(OH)D. Participants randomly assigned to one of seven groups - three placebo groups and 4 active supplement groups receiving 100,000IU vitamin D3

Various delivery methods of vitamin D supplementation are available to consumers but there have been no studies providing evidence of whether one delivery method is superior to others. The researchers wanted to compare the delivery of 100,000IU vitamin D3 by three methods on serum 25(OH)D levels. Two methods of oral supplementation (pill \[prolonged release\] and liquid \[immediate release\]), and delivery through the skin (with and without a penetrator enhancer. Placebo groups were pill, oral liquid and skin applied oil

Eligibility Criteria:
Inclusion Criteria:

* healthy, female

Exclusion Criteria:

* any participant that was taking vitamin supplementation, had a skin condition that would prevent them from applying oil to their skin or were taking, or had been taking in the past 6-months, oestrogen based contraception
Understanding the Implementation of Cued Exercise Using Wearable Devices and a Custom Smartphone Application Following Bone Marrow Transplant.

The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.

Enrolled patients who have been diagnosed with a hematologic malignancy and are scheduled to undergo an allogeneic bone marrow transplant will use a custom-designed wearable device and smartphone application as a behavioral intervention to cue exercise. Participants will be asked to wear the wearable device for the duration of their post-transplant inpatient hospital stay.

Aim 1. To examine the potential efficacy of the wearable device + smartphone application to prompt alloBMT patients to move.

Aim 2. To receive participant feedback on their experience participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosed with hematologic malignancy
* Scheduled to receive an alloBMT
* Physician consent to participate in the study

Exclusion Criteria:

• Inability to complete 15 minutes walking unassisted
Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury

This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome.

Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission to the neurointensive care unit at Rigshospitalet
* Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions

Exclusion Criteria:

* Brain death before inclusion
* Closest relatives do not understand written and spoken Danish or English
Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?

The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. The transversus abdominis plane block has shown promise for perioperative analgesia, but data on the optimal dose regimen are limited.Following previous research of optimal dose of local anesthesic solution, the investigators aim to evaluate if a "volume effect" would lead to a better diffusion of the local anesthesic solution to the overall nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for "small volume" group or 0,4 ml/kg of 0,1% levobupivacaine for "high volume" group).With the same dose of levobupivacaine, this study aims to assess the impact of volume effect on analgesia efficiency as well as the security as after ultrasound TAP block on one to five years' old children who undergo a peritoneal-vaginal duct surgery.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation in ambulatory surgery and anesthesia unit for surgery of inguinal hernia or ovarian hernia or hydrocele or cord kyst
* Overall status: ASA I-II
* Aged from 1 to 5 years
* Informed consent

Exclusion Criteria:

* Coagulation trouble
* Infection on ponction zone
* Local anesthesia drug or nonsteroidal anti inflammatory intolerance
* Cardiac/Renal/hepacticdysfunction
* Hemorrage, digestive perforation history
Value of Inguinal Exploration for Impalpable Testes

* To determine the percentage of children with impalpable testis who benefit from inguinal exploration after laparoscopic identification of cord structures entering the inguinal canal.
* To determine the factors predicting the presence of inguinal testis in the previously mentioned children.

The undescended testis represents one of the most common disorders of childhood. The most useful classification of undescended testes is distinguishing palpable and non-palpable tests, and the location and presence of the tests decide clinical management. Approximately 80% of all undescended tests are palpable and the other 20% are impalpable. Among the 20% of non-palpable testes, 50-60% are intra-abdominal, canalicular, or peeping (right inside the internal inguinal ring). The remaining 20% are absent and 30% are atrophic or rudimentary.

Diagnostic laparoscopy is the most useful modality for assessing nonpalpable testicles. The four most important structures to identify at laparoscopy are the testis, the testicular vessels, the vase deferens, and the patency of the processus vaginalis. The possible anatomical findings include spermatic vessels entering the inguinal canal (40%), an intra-abdominal (40%) or peeping (10%) testis, or blind-ending spermatic vessels confirming vanishing testis (10%). It permits the identification of three surgical scenarios that will lead to different courses of action:

1. Blind-ending vessels, which indicate a vanishing intra-abdominal testis, and no further exploration is necessary (10%)
2. Testicular vessels and vas entering the inguinal canal through the internal inguinal ring (34%).Inguinal exploration may find a testicular nubbin either in the inguinal region or in the scrotum, which may or may not be removed; or a healthy, palpable, undescended testicle amenable to standard orchidopexy.
3. Peeping (11%) or intra-abdominal tests (37%), which will require either an open or a laparoscopic approach. Although Rozanski et al. reported the first case of intratubular germ cell neoplasia originating from a testicular remnant, the necessity of removing nubbins is controversial.

Eligibility Criteria:
Inclusion Criteria:

* Age 6m-12y
* Impalpable tests (unilateral or bilateral)
* Laparoscopy: cord structures entering the inguinal canal.

Exclusion Criteria:

* Patient refusing participation in the study.
* Any contraindication to laparoscopy
* laparoscopy: cord structures passing through an open inguinal canal through which the laparoscopy could be advanced and visualize the tests.
* Disorders of sexual differentiation.
* Children whose tests became palpable under anesthesia and those with a history of previous inguinal canal exploration (hydrocele or hernia repair) or orchidopexy.