cyrilzakka/clinical-trials huggingface dataset:
Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects

stress. Notably, several studies reported that stress could alter impulsivity, source monitoring, and time perception.

Several mechanisms are involved in the response to a stress factor, among them the hypothalamic-pituitary-adrenal (HPA) axis. The cortisol reactivity (it means the cortisol secretion after the exposure to a standardized stress factor) is a reliable tool to assess the function of HPA. Cortisol secretion is bidirectionally influenced by the prefrontal cortex (PFC), which is involved in the expression and regulation of stress as well. The asymmetry of the alpha band (AFα) is a well known electrophysiological parameter to assess the function of PFC. More precisely, AFα is arising a growing interest, as it is believed to be correlated with the cortisol reactivity. Modifying this asymmetry could influence the stress response.

Transcranial Alternating Current Stimulation (tACS) consists in delivering a sinusoidal alternating current between two electrodes placed on the scalp at a predefined frequency. Previous studious reported that tACS, if delivered at the alpha frequency, increased the alpha band in the stimulated areas

The study will focus on the effect of tACS at alpha frequency (α-tACS), delivered on the dorsolateral prefrontal cortex, on the response to a stress factor.

In this study, while receiving a single α-tACS session, the participants will complete a standardized stress test combining cognitive stress (mental calculation) and physical stress (cold pressure): the Maastricht Acute Stress Test. The main objective aims at assessing the effect of a single session of tACS at alpha frequency, delivered on the dorsolateral prefrontal cortex, on the cortisol reactivity in healthy stressed subjects. In that study, the influence of α-tACS on other biological ; electrophysiological, neuropsychological parameters relevant for the stress response will be assessed also.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed Men and Women aged between 18 and 45
* If woman, hormonal contraception required
* Having given their written informed consent
* Affiliated with a social security scheme
* French speakers and readers

Exclusion Criteria:

* Contraindication to the exposure to exposure to tACS
* Current psychiatric disorder as classified in the DSM-5
* Regular intake of any psychotropic drug or Beta Blocker
* Recent exposure to a traumatic event
* Any debilitating condition making the experimental procedure not feasible
* Pregnancy
Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Efficacy Testing

This protocol describes pilot testing of an educational shared decision-making intervention to help men with localized prostate cancer make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.

Primary Objective:

The overall goal of this protocol is to test initial efficacy of three versions of an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance. A pre-post design was selected to provide initial efficacy data of the different versions of the shared decision-making intervention. Thereby, providing preliminary data in preparation for a follow-up comparative study.

Eligibility Criteria:
Inclusion Criteria:

Patients:

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. Have not received curative intent treatment for their prostate cancer
4. Fluent in English

Care partners/caregivers:

1. Aged 18 or older
2. Fluent in English
3. Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)

Exclusion Criteria:

Patients

1. Currently receiving treatment for another cancer (primary or recurrence)

Care partners/caregivers

1. None
Making Healthy Decisions: A Trial Evaluating the "Your Move" Teen Pregnancy-prevention Intervention

The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.

Making Healthy Decisions includes two technology-based interventions designed to improve teen females' healthy decision making in relation to sexual relationships (YM) and nutrition (ES).

Health educators from Planned Parenthood are trained to implement both YM and ES at youth-serving community organizations in their geographic area across several U.S. states. In a multi-site randomized controlled trial, females ages 14-19 are recruited from their local community-based organization (CBO) into groups/cohorts of 8-12.

Each cohort is randomly assigned to participate in one of the two interventions prior to baseline data collection.

Participants attend seven 75-minute program sessions that include facilitator-led games, activities, and discussions as well as personal reflection time in which girls practiced healthy decision making individually on an electronic tablet.

Self-reported survey data related to attitudes, knowledge, and behavior around sex and nutrition are collected at baseline as well as 3 months after the intervention ends.

Eligibility Criteria:
Inclusion Criteria:

* Female (or identify as female); age 14-19

Exclusion Criteria:

* Male (or identify as male); female older than 19 or younger than 14
Piloting "Positive Peer Journaling" a Journaling Practice to Support Recovery From Addiction

The main objective of this study is development of the Positive Peer Journaling (PPJ) intervention and the feasibility, acceptability, and logistics of treatment delivery. A second objective is to observe whether PPJ is associated with improvement in hypothesized outcomes. The primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use. The investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.


Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years of age,
* meet DSM-V criteria for past-year SUD as primary or secondary diagnosis,
* English literacy sufficient to make short written lists needed to complete PPJ and homework assessments,
* minimum 2 weeks sustained abstinence,
* completed first 2 weeks of treatment at Wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site,
* priority will go to participants who are from or moving back to a rural area or small town defined as a population less than 10,500,
* agree to be audio recorded in group meetings and in individual meetings with research staff,
* currently are clients in the Wayside residential program,
* participants must be English speaking and literacy must be strong enough to write short lists and to understand the questions asked in the questionnaires.
* Priority will go to women who will be residing at Wayside for the duration of the study activities (and not moving out after one week, for example).

Exclusion Criteria:

* presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study;
* severe psychiatric illness (current schizophrenia, major depression with suicidal ideation);
* personality disorders that would interfere with satisfactory participation in or completion of the study protocol,
* inability to give informed, voluntary consent to participate,
* lack of sufficient English literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items,
* any impairment, activity, or situation that in the judgement of the research staff would prevent satisfactory participation in or completion of the study protocol.
Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease

The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease

ID1201 is a fruit extract of Melia toosendan. ID1201 alleviates Alzheimer's disease-type pathologies and cognitive deficit through the various actions of its effective components such as α-secretase activation followed to Aβ reduction, RAGE inhibition, neuro-protection, and anti-inflammatory activities.

Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with dementia of Alzheimer's type according to DSM-IV criteria and probable Alzheimer's disease according to the NINCDS-ADRDA
2. modified Hachinski Ischemia Scale score of less than or equal to 4
3. Mini-Mental State Examination score 16 to 26 and Clinical Dementia Rating-Global Scale score 0.5 to 1
4. Amyloid postivie PET image (BAPL score 2 or 3)
5. Patients who have not received AChE inhibitors or NMDA antagonist at least for 3 months prior to the screening visit

Exclusion Criteria:

1. Patients diagnosed or accompanied with Dementia due to other Neurodegenerative disorders other than Alzheimer's disease
2. Chronic alcohol and/or drug abuse within the past 5 years
3. Subjects who have medical history of significant renal disease (ccr\<30ml/min) or hepatic disease( 3\*ULN \<= ALT or AST)
4. Has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, Ginko biloba extract, Vitamin E, hormone replacement therapy etc. in the previous 4 weeks
Glycaemic Index of Foods in Healthy Volunteers

The objective of this study is to assess the effect that dietary carbohydrates have on blood sugar by measuring the glycaemic index. The glycaemic index is a comparison between the effect of equal amounts of carbohydrate from a test food compared to a standard (in this case glucose) on blood sugar.

Different foods that contain different carbohydrates have different effects on blood sugars. This is of interest as a number of studies have shown that the level of sugar in the blood after a meal relates directly to the risk of developing heart disease and diabetes. The aim of collecting this data is to be able to give advice to people about the carbohydrates they eat to reduce the risk of diabetes and heart disease.

The study is a randomized cross-over controlled trial: the order of the test foods will be randomized by an independent internet-based program; each participant will be asked to consume all the products; the test food will be compared with a control (in this case 50g glucose).

Suitable subjects will be invited for a screening visit to check for eligibility criteria. Body weight and height measurements will be taken as well as a standard biochemical and haematological screen. If they are eligible and willing to take part, volunteers will be entered into a database and contacted when a GI test becomes available. Volunteers may take part in more than one GI testing up to a maximum of 40 visits per year. Volunteers may withdraw from the database or the study at any time without giving any reason.

Subjects will be asked to come for a set amount of visits for each GI test depending on the number of product that need to be tested (minimum 3 maximum 12 visits for each testing). The volunteers will be informed of the number of visits before they enter the GI testing. For each visit, subjects are tested in the morning after a 10-12h overnight fast.

Three fasting blood samples are taken (-5, -3, -1) 2 minutes apart after which subjects consume the test meal or reference food at an even rate over 15 min. All subjects are asked to record the time it takes in minutes to consume the test food/reference. Further blood samples are taken at 15, 30, 31, 32, 45, 60, 90 and 120 min after the beginning of the meal. The test meal and reference food should be consumed with a 250ml drink of water. This remains constant for each of the tests in the series.

Blood is obtained by finger-pricking using disposable Unistix needles. In previous studies, capillary blood has yielded less between-subject variation in GI. Instant glucose analysers will be used.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-27 kg/m2
* age 18-65 years
* healthy

Exclusion Criteria:

* diabetes
* chronic disease
* glucose impairment
* pregnancy
Endometriosis and Obstetric Outcomes

The purpose of this study is to assess if endometriosis can be considered a risk factor for adverse obstetric and delivery outcomes

This is a retrospective, observational, case-control study. Pregnancy, delivery and neonatal outcomes will be analyzed in two groups of patients (case and control group): women with diagnosis of endometriosis histologically confirmed and women without endometriosis. Women with endometriosis will be matched to controls by age. A database with general medical and gynecological history, pregnancy course, delivery mode and newborn conditions will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who delivered at Azienda Ospedaliero Universitaria Policlinico di Modena from 2000 to 2020
* Histologic diagnosis of endometriosis before pregnancy for case group
* Age matched healthy patients for control group

Exclusion Criteria:

* Clinical records not available
A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

The intent of this study is to identify and treat fibromyalgia subjects with comorbid depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI (selective norepinephrine reuptake inhibitor) primarily for their depression and to determine whether pregabalin demonstrates improvement relative to placebo in improving pain associated with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of any race or ethnicity who are at least 18 years of age.
* Adult women and men with a diagnosis of fibromyalgia and stable depression (major depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have been taking an antidepressant (SSRI or SNRI) primarily for their depression for at least 3 months.

Exclusion Criteria:

* Have failed pregabalin treatment due to lack of improvement of symptoms at doses of greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of improvement or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
* Patients with severe or unstable depression are not eligible.
* Patients with other types of pain or conditions that may make it difficult to evaluate fibromyalgia symptoms are not eligible
* Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment
Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.


Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to provide informed consent
* Undergoing a procedure that involves repairing an ankle fracture.

Exclusion Criteria:

Patients with medical histories that include:

* Rheumatoid arthritis
* Connective tissue disorders
* Chronic corticosteroid use
* Implanted electrical devices
* Neurological disorders
* Non-ambulatory status
* Recent surgery (within the last 3 months) that is not related to the study
* Scheduled to undergo surgery in the near future
* Epilepsy
* Diagnosed with cancer
* Have suffered acute trauma or recently have had a surgical procedure (not related to the study)
* Have cardiac problems or cardiac disease
* Have an abdominal hernia
* Have venous thrombosis
Effects of Lentil Consumption on Post-prandial Blood Glucose and Insulin

The purpose of this study is to assess the effects of consuming various lentil varieties in mixed-meals (containing either white rice or white potato) on post-prandial blood glucose and insulin as compared to white rice or white potato alone.

Eligible participants will undergo a total of 6 study visits. During each visit, a fasted blood sample will be taken by fingerprick, and approximately 500µL of blood will be dripped into a collection tube. The participant will then consume a meal of either: white bread, white rice (or white potato), or white rice with lentils (or white potato with lentils). White bread will be consumed on the first study visit and the rest of the meals will take place in random order in the visits following. Each meal will provide a total of 50g available carbohydrate. Six more blood samples will be taken by fingerprick at 15, 30, 45, 60, 90 and 120 minutes after the beginning of the meal.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18-40 years
* BMI 20-30 kg/m2

Exclusion Criteria:

* Tobacco use
* Pregnant or breastfeeding
* Fasting blood glucose ≥ 7.0 mmol/L
* Any major medical condition including a history of AIDS or hepatitis
* Medical or surgical event requiring hospitalization within 3 months of randomization
* Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications
* Blood pressure \>140/90 mm Hg
* Natural health products (NHPs) used for glycemic control
* Probiotic supplements
* Dietary fibre supplements
* Consumption of \>4 servings of pulses per week
* Food allergy or non-food life threatening allergy
* Shift workers
* Alcohol consumption \>14 drinks/week or \>4 drinks/sitting
* Recent or intended significant weight loss or gain (\>4 kg in previous 3 months)
* Elite athletes
TIPS in Fundal Variceal Bleeding (the TFB Study)

In the last years, important advances have been done in the treatment and prevention of fundal variceal bleeding in patients with cirrhosis. Experts agree that the combination of pharmacological and endoscopic therapy (with tissue adhesives) should be the first line therapy in the acute bleeding episode from isolated gastric varices (IGV1) or type 2 gastroesophageal varices (GOV2) varices; whereas transjugular intrahepatic portosystemic shunt (TIPS) is considered a rescue therapy. TIPS has been shown to effectively prevent variceal rebleeding but with a potential increase in the incidence of hepatic encephalopathy and/or liver failure. In this sense, a recent randomized controlled trial (RCT) in esophageal variceal bleeding showed that an early TIPS, performed during the first 72h after patient admission resulted in a significant decrease in failure to control bleeding and early and late rebleeding. Moreover, survival was also significantly increased as well as other portal-hypertension related complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, etc).

The present study is directed at comparing the outcome of patients with acute bleeding from fundal varices (IGV1 or GOV2) treated by standard therapy (vasoactive drugs + endoscopic injection of tissue adhesives) with or without early TIPS (performed during the first 1-5 days after admission). Main end-point will be survival free of variceal rebleeding at 1 year from inclusion.


Eligibility Criteria:
Inclusion Criteria:

Patients developing acute variceal bleeding from GOV2 and/or IGV1 defined according to Baveno II criteria, admitted in the Hospital and receiving standard combined medical therapy (somatostatin 3 mg/12h continuous IV infusion or terlipressin, 2mg/4h IV + endoscopic injection of tissue adhesives as per center protocol).

Exclusion Criteria:

* Hepatocarcinoma without therapeutic options (according to Milan criteria).
* Portal or mesenteric vein thrombosis avoiding the performance of TIPS.
* Acute alcoholic hepatitis.
* Platelet count \< 20.000/mm3.
* Previous treatment with portosystemic shunt.
* Pregnancy.
* Previous inclusion in the current study.
* Terminal liver disease (bilirrubin \> 10 mg/dL and/or prothrombin index \< 30%); or other fatal non-liver diseases.
* Denied informed consent.
Therapeutic Potential of Myofascial Structural Integration in Children With Cerebral Palsy

The investigators hypothesize that children with spastic cerebral palsy will show greater improvements in gross motor function, associated developmental skills and growth after the 3 months of myofascial structural integration treatment, a form of deep massage, than they showed after a 3- or 6-month pre-treatment waiting period.

The investigators further hypothesize that children with spastic CP will maintain their gains in gross motor function for ≥ 3 months after completion of MSI treatment.

* The investigators will talk to you by telephone to determine if your child is eligible for the study.
* The study lasts for a total of 12 months with the massage treatment period lasting 12 weeks.
* The study entails a total of 10 sessions of Myofascial Structural Integration therapy over the 12-week period. Each session will last one hour.
* The child will have an evaluation of motor functions and development on enrollment and at three-month intervals for a total of 5 evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Children from 1 up to, but not including, 7 years of age
* Children having the diagnosis of spastic cerebral palsy
* Children who have spasticity in one or both upper or lower limbs
* Children who are classified as either Gross Motor Function Classification System (GMFCS) level 2, 3 or 4 or Manual Ability Classification System (MACS) level 2, 3, 4 or 5

Exclusion Criteria:

* Children with active seizure disorders
* Children taking more than one medication to control their seizures
* Children with severe health problems that could be exacerbated by the treatment (such as severe chronic lung disease)
* Children who have undergone surgical treatments or botulinum injections within 6 months of entering the study
* Children who have planned surgical interventions during the studies time course
* Children with sensory, cognitive or language deficits which would affect their ability to understand directions necessary for assessment.