cyrilzakka/clinical-trials huggingface dataset:
Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)

This research will investigate the neuropsychological mechanisms underlying the eight-week Mindfulness-based Cognitive Therapy (MBCT) programme.

Participants in remission from depression will be seen pre- and post-MBCT to assess the underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess the relationship of these neuropsychological changes with relapse risk.

The research will focus primarily on changes in self-compassion, rumination, attention and structural brain changes, with secondary focus on other mechanisms of emotional processing and memory.

There will be three groups in total.

* The first group will take 36 participants in remission from major depression (rMDD) through the 8 week MBCT program.
* A control group of 36 rMDD participants will not receive the intervention.
* A group of never depressed healthy control participants will also be recruited.

Research visits for participants not undergoing MBCT will be separated by an 8 week gap.

All participants will be seen before and after the 8 weeks for completion of neuropsychological assessments and questionnaires.

rMDD participants will be followed up over the following 12 months to identify any predictors of relapse.

Eligibility Criteria:
Inclusion Criteria:

Participants with remitted depression (rMDD):

* At least two previous episodes of DSM-IV major depression in adulthood, diagnosed using the Mini International Neuropsychiatric Interview (M.I.N.I).
* Full or partial remission for at least three months with two depressive episodes within the last five years.
* A score of less than or equal to 12 on the Montgomery Asberg Depression Rating Scale (MADRS) mood assessment.
* If on medication, no recent or planned major changes

Healthy volunteers:

* In good psychological health screened with the M.I.N.I

All participants:

* in good physical health (to reduce risk of confounding physical health problems).
* sufficiently fluent in English to ensure valid understanding and completion of the tasks.
* minimum I.Q level of 80 to ensure sufficient understanding of the neurocognitive tasks administered.
* colour vision and acuity within normal/corrected to normal limits.

Exclusion criteria:

* Any current mental health diagnosis (DSM-IV diagnosis including current major depression, bipolar disorder, psychosis, Obsessive Compulsive Disorder (OCD), substance abuse or dependence, eating disorders)
* Physical health or neurological disorders that might interfere with the interpretation of the tasks, including a history of significant head injury.
* In addition healthy volunteers will be without a history mental health disorders (DSM-IV)
* Current or previous experience of mindfulness-based treatments or extensive cognitive behavioural treatment, or planned participation in psychological treatments during the key time for the study (between pre and post visits).
* Planned major alteration in drug treatment for depression between pre and post visits.
Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking astaxanthin for 1 and 2 months.

This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. They will divided into 3 groups which are astaxanthin 4 mg group , astaxanthin 6 mg group, and placebo group. They will take the sample 1 capsule once daily for 2 months. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking the sample for 1 and 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Refraction errors, dry eye, or blurred vision
* Have a willingness to participate in the study

Exclusion Criteria:

* Uncontrolled disease
* Have complications during the study
* Have astaxanthin more than 2 weeks
* Allergic to astaxanthin, seafood, or seaweed
* Osteoporosis or thyroid disease
* Immunodeficiency or taking immunosuppressants
* Liver and kidney diseases
* A person with a brain disorder, vision or hearing unusual
* Pregnancy or lactation
* Cannot follow the protocol
* During participated in other studies
The Role of Stress Neuromodulators in Decision Making Under Risk and Selective Attention to Threat

Incidental affective states, i.e., affective states can influence decision making and selective attention to threatening information. Acute stress is such an affective state and is a powerful contextual modulator of decision-making processes and selective attention to threat. In terms of physiological and neurohormonal changes, the stress response has been well characterized: Exposure to stress elicits an array of autonomic, endocrine, and behavioral responses. The physiological stress response is mediated by the hypothalamic-pituitary-adrenal (HPA) axis and the locus coeruleus noradrenergic (LC-NA) system with cortisol and norepinephrine (NE) as their end products. There is compelling evidence that the stress hormones cortisol and NE influence cognitive processes. However, only very few studies so far used pharmacological approaches to specify the role of stress neuromodulators on decision making and selective attention to threat and these studies are hardly comparable due to differences in the experimental design, e.g., the decision making task used. Furthermore, the neural underpinnings of stress effects on decision making and selective attention to threat are uninvestigated so far. The aim of the proposed project is to clarify the role of the major stress neuromodulators, NE and cortisol, in their contribution to different processes related to decision making under risk and selective attention to threat. To this end, combined precise pharmacological stimulation, behavioral modeling, and fMRI methods will be applied to systematically disentangle the effects of stress hormones on risk attitudes and loss aversion as well as their relation to neural correlates of processing subjective value and risk. Using pharmacological manipulation, the influence of noradrenergic and glucocorticoid activity on decision making under risk at the behavioral, computational, and neural level will be investigated. In addition, the influence of noradrenergic and glucocorticoid activity on selective attention to threat at the behavioural and neural level using a dot-probe paradigm with fearful and neutral faces will be examined. Participants are randomly assigned to one of four groups: (A) yohimbine, (B) hydrocortisone, (C) yohimbine and hydrocortisone, or (D) placebo.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* High-school diploma

Exclusion Criteria:

* Former and present DSM-5 axis I disorders according to the Structured Clinical Interview for DSM (SCID)
* Permanent medication of any kind
* Medical conditions associated with adrenal dysfunction or well-known impact on HPA activity or cognitive function
* Steroid use
Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section

The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.

Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean operation
* Able to give informed consent

Exclusion Criteria:

* Patients with neurological or psychological diseases
* patients with chronic analgesic and antidepressant drug use
* Patients unable to communicate
* Patients previously treated with TEAS or acupuncture,
* Patients with heart failure and have pace-maker,
* patient with local infection in the TEAS area
The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index

To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 20 and 50 years old
* Body mass index (BMI) ≥ 22 (kg/m\^2) or body fat mass: male \> 25%, female \> 30%
* Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
* Abidance by the similar diet and exercise habits over the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Menopausal woman
* Diabetes mellitus
* Implementation in weight loss programs before a half year of this study
* Metabolic disorders
* Kidney diseases
* Liver diseases
* Cardiovascular diseases
* Nervous system diseases
* Gastrointestinal diseases
* Heavy drinking or constant drug use.
The Effect of Pasteurized; Pasteurized and Homogenized and UHT Treated Homogenized Cow's Milk on Gastrointestinal Symptoms in Sensitive Adults

This study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as UHT-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.


Eligibility Criteria:
Inclusion Criteria:

* Homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported)
* age 18-65
* BMI 18,5 - 30
* hemoglobin under normal range
* fasting plasma alanine aminotransferase ALAT \< 60 U/l (normal liver function)
* fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* fasting plasma creatinine \< 118 umol/l (normal kidney function)

Exclusion Criteria:

* pace maker
* Crohn's disease or other disease of the intestinal tract
* intestinal operation within the last 3 months
* difficult dysphagia
* smoking
* constipation
* lactose intolerance
* coeliac disease
hCG Priming in Women With Low Ovarian Reserve

The aim of this trial is to examine the possible effects of hCG administration for eight weeks prior to IVF/ICSI in women with low ovarian reserve. Primary outcome is the proportion of the antral follicle count that reach the pre-ovulatory stage.

One of the fundamental goals in In Vitro Fertilisation (IVF) is obtaining a high number of good quality oocytes, in order to select and transfer embryos with the highest possible implantation potential thereby optimizing the chance of a pregnancy and ultimately a live birth. This is done by applying an individualized controlled ovarian stimulation (iCOS) protocol, primarily based on ovarian reserve markers like antral follicle count (AFC) and Anti-Müllerian hormone (AMH), when deciding the follicle stimulating hormone (FSH) stimulation dose. Certain patients, the so called "poor ovarian responders' (PORs), pose a clinical challenge because they have a poor ovarian reserve and develop a limited number of pre-ovulatory follicles in respond to ovarian stimulation despite high FSH stimulation doses, thus experiencing reduced live birth rates.

The aim of the present study is to examine the possible effects of long-term LH activity by the administration of hCG for eight weeks in between two identical IVF/ICSI cycles and compare cycle characteristics and outcome. The primary outcome is the follicular output rate (FORT) which reflects the proportion of antral follicles at the start of controlled ovarian stimulation that reaches the pre-ovulatory state. Secondary outcomes include amongst others AMH and antral follicle count at baseline (cd 2-3), number of pre-ovulatory follicles, oocytes retrieved, and embryos developed.

We hypothesize that eight weeks of androgen priming by hCG increases the proportion of antral follicles that reaches the pre-ovulatory state during controlled ovarian stimulation for IVF/ICSI in women with poor ovarian reserve.

Eligibility Criteria:
Inclusion Criteria:

* Regular menstrual cycle (23-35 days)
* 1.-5. IVF/ICSI cycle at inclusion
* AMH \< 6.29 pmol/L (Elecsys® AMH assay)

Exclusion Criteria:

* Uterine malformations or hydrosalpinx
* Submucosal uterine myomas
* Uterine polyps
* Allergy to standard IVF/ICSI medication
* Endometriosis stage III-IV
* Severe comorbidity
* Preimplantation genetic testing
* Testicular sperm aspiration/extraction
* Tumors in the hypothalamus or pituitary gland
* Active thromboembolic disease
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

The primary objective of this study is:

* To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer

The secondary objectives of this study are:

* To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
* To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
* A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically or cytologically proven adenocarcinoma of the prostate
* Documented metastatic prostate adenocarcinoma
* Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
* Adequate hematologic, renal and hepatic function
* Life expectancy \>= 3 months

Exclusion Criteria:

* Prior chemotherapy, except estramustine
* Prior chemotherapy with docetaxel
* Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
* One or more contraindications to the use of corticosteroids
* History of cancer-related hypercalcemia
Validation of Structured Light Plethysmography: Asthma

Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups.

A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals.

The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device.

participant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic

The SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 2 and 80 years

Exclusion Criteria:

* Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
* obstructive sleep apnea, Apnoea hypopnoea index \> 30 (if known)
* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
* BMI \> 40
* Inability to consent/comply with trial protocol
LIVIA 2.0 : A RCT Of Two French Internet Intervention For Adults Struggling With Prolonged Grief Symptoms

The investigators aim to compare the efficacy of an IBI targeting complicated grief symptoms (LIVIA 2.0) compared to an already investigated IBI (LIVIA 1) using a guidance on demand design in a randomised controlled trial (RCT).

More specifically, the investigators will test the following primary hypotheses:

* Both interventions will significantly increase participants' well-being and decrease their distress, and those changes will be stable until follow-up.
* LIVIA 2.0 will be more efficient than LIVIA 1 on all measure outcomes.
* LIVIA 2.0 will have less dropouts than LIVIA 1.

Secondary objectives are the following:

* Participants of LIVIA 2.0 will require less guidance (number of people requesting support and number of e-mails exchanged) than participants in LIVIA 1. The investigators will also explore which session triggers more requests of guidance.
* Using a monitoring of participants' state throughout the completion of the programme in LIVIA 2.0, the investigators will explore the short-term efficacy of each module on participants' weekly mood, solitude feelings and grief symptoms.
* The investigators will compare participants' satisfaction in both versions of LIVIA.
* The investigators will also explore the role of attachment style, type of loss, relationship quality with the partner, the interpersonal closeness with the lost person, symptom severity and level of solitude at onset as moderators of the efficacy of the programmes.
* The investigators will explore the semantic content of the exercises included in the programme to see if this is related with the improvement over the assessment period.

Eligibility Criteria:
Inclusion Criteria:

* Bereavement or separation/divorce
* Either of these events should have happened more than 6 months before participating in the study
* Feeling the need for support to cope with the loss (a diagnosis of complicated grief is not necessary)
* Age: 18 years or older
* Regular Internet access
* Mastery of the French language - Approved ICF

Exclusion Criteria:

* Moderate to acute current suicidality (SIDAS \> 19)
* Severe psychological or somatic disorders which need immediate treatment.
* Concomitant psychotherapy
* Prescription or change in dosage of psychoactive drugs in the month prior or during the self-help intervention.
* Inability to follow the procedures of the study, e.g. due to comprehension problems
* Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years old
* Patient diagnosed with Stage IV NSCLC (de novo or earlier stage progression to stage IV)
* Absence of oncogene activating mutations eligible patients to targeted therapy (EGFR, ALK)
* Cohort A: Received first line treatment with pembrolizumab monotherapy
* Cohort B: Received first line treatment with chemotherapy and pembrolizumab combination therapy
* Cohort C: Received first line treatment with chemotherapy doublet

Exclusion Criteria:

* Prior anti-cancer therapy for actual stage IV NSCLC
* Critical data missing (e.g., PD-L1 status, baseline millimetric imaging, first evaluation millimetric imaging)
* Patients participating in other clinical trials that modify the standard of care
the Effect of Different Mechanical Ventilation Modes on Optic Nerve Diameter and Conscious Functions

During surgery, researchers use different methods in respiratory equipment. In the study researchers examine the effects of these methods on intraocular pressure changes by looking at the intraocular nerve diameter. Then look at the effects of these effects on patients conscious functions by asking some questions.

According to the mechanical ventilator application to be applied to the patients; Group P (n: 30) pressure controlled ventilation (PCV), Group V (n: 30) volume controlled ventilation (VCV) are randomly assigned to two groups. General anesthesia will be applied to all patients. Mechanical ventilation settings will be able to 8ml / kg TV (tidal volume). Demographic data (age, gender, weight, height) of patients, duration of surgery and peroperative complications will be recorded choosen time intervals.T0: awake, T1: 5th min after induction, T2: Gas insufflation start in supine position, T3: Maximum gas pressure is reached in reverse trendelenburg position, T4:Before extubation. SAB, DAB, OAB, KAH, SpO2, Ppeek, PEEP, EtCO2, optic nerve diameter will be recorded at same times. Cognitive function test will be performed at postoperative 24th hour for comparing the first awaken routin MMDT (Mini Mental Status Detection) scale. The same test will be repeated for patients who are called for routine general surgery outpatient control 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* 18-65 years old

Exclusion Criteria:

* Unable to cooperate
* Presence of eye disease (detachment, retinapathy, glaucoma)
* Presence of a previous eye operation
* Those with symptoms of KIBAS (intracranial pressure increase syndrome) (Intracranial lesion, previous cerebrovascular diseases)
* BMI (body mass index\> 40 kg / m2
* Obstructive and restrictive lung disease
* Pulmonary Hypertension
* Congestive Heart Failure