cyrilzakka/clinical-trials huggingface dataset:
TMS for Anxiety and Trauma-related Disorders

The present pilot study will apply accelerated intermittent theta burst stimulation (aiTBS) to a novel transcranial magnetic stimulation (TMS) target for anxiety derived via causal network mapping.

Anxiety-related disorders represent the most common class of mental-health disorders and are associated with high rates of non-response and relapse to current treatments. Transcranial magnetic stimulation (TMS) applied to the dorsolateral prefrontal cortex (dlPFC) has been shown to reduce anxiety comorbid with major depressive disorder (MDD). However, anxiety-specific targets have received insufficient attention.

An anxiety specific transcranial magnetic stimulation (TMS) target was recently derived via causal network mapping and was shown to reduce anxiety versus depression symptoms to a greater extent than the conventional dlPFC target in an MDD sample with comorbid anxiety. While potentially promising, this target has yet to be trialed in an anxiety-related disorder sample.

The current open-label study will be the first to evaluate the preliminary effectiveness and safety of this novel right dorsomedial prefrontal cortex (dmPFC) TMS target. MRI-guided neuronavigation will be used to locate this target in each participant. An accelerated intermittent theta-burst (aiTBS) dosing regimen will be used. Based on a 90% resting motor threshold (adjusted for cortical depth), 50 sessions of iTBS will be administered (1800 pulses per session, with a 50-minute inter-session interval) and delivered in a schedule of 10 sessions per day for 5 consecutive days. Clinical assessments and resting-state functional MRI scans will be conducted before and after aiTBS. Heart rate variability (HRV) and eye-movement measures will be collected before and after aiTBS.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), and/or post-traumatic stress disorder (PTSD) as defined by DSM-5 criteria.
2. Male or female between 18 and 60 years old.
3. Right-handed.
4. Can understand and sign an informed consent document.
5. Beck Anxiety Inventory (BAI) score of 16 or higher.
6. On a stable medication/psychotherapy regimen for at least 6 weeks prior to baseline visit and throughout the duration of the study.
7. In good general health, as ascertained by medical history.
8. Pharmacological treatment resistance or psychotherapeutic treatment resistance.

Exclusion Criteria:

1. Substance use disorders, eating disorders, significant suicidal ideation, mental disorder due to a medical or neurocognitive condition, lifetime psychosis, bipolar disorder, developmental disorders.
2. History of brain surgery and epilepsy.
3. Presence of metallic foreign bodies, such as cardiac pacemakers and stents.
4. Any medical condition or medication that increases the risk of seizures.
5. Pregnancy.
6. Intellectual disability.
7. Current severe somatic disease, such as cancer, heart failure, pneumonia, etc.
8. Severe claustrophobia that prevents the use of MRI.
Fizzy Drinks Study

The objective of this study is to compare the effect of different levels of carbonation isocaloric beverages on glycemic response (using protocol based on standardized glycemic index testing methodology), gastric emptying and satiety. It is hypothesized that carbon dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would have important health implications for the beverage industry.

15-20 healthy subjects will be recruited for the study by means of advertisements, flyers and personal communications.

A randomized, cross-over design experiment with three treatments will be carried out. Three different beverages will be prepared:- No carbonation (NC): Potable water + sugar- Low carbonation (LC): Potable water + sugar + little CO2- High carbonation (HC): Potable water + sugar+ high CO2.

The outcome measures assessed will be glycemic response, gastric emptying and satiety. Glycemic response will be measured by taking capillary blood samples (\<5ul) by fingerpricking with one-time use sterilized lancets. Gastric emptying will be assessed by ultrasonography methodology developed by Okabe et al, 2015. Satiety will be measured using electronic visual analogue scales assessing hunger, fullness, desire to eat, prospective consumption and thirst. In addition, participants will be asked to rate the level of effervescence of beverage, sweetness of beverage, amount of beverage consumed, as well as how pleasant the beverage was immediately after drinking of test beverage. Feelings of bloatedness will be assessed using electronic visual analogue scales administered at 0, 15, 30, 45, 60, 90,120 min from drinking of test beverage. At the end of the test session, ad libitum lunch will be served, and the amount of food and drinks consumed will be measured (by weight difference before and after serving).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Aged between 21 - 40 years old
* BMI between 18.0-30.0 kg/m2
* Blood pressure \< 140/80 mmHg
* Fasting blood glucose \< 6.0mmol/L
* Fasting blood glucose \< 6.0mmol/L

Exclusion Criteria:

* Are a smoker
* Have symptoms or medical history of gastrointestinal, cardiovascular, diabetes, cancer or other illnesses/diseases/conditions that could affect gastric motility and appetite
* Are on prescription medication
* Had a major medical or surgical event requiring hospitalization within the preceding 3 months.
* Are taking part in other clinical trials concurrently
* Are taking part in sports at competitive/endurance levels
* Have a score equal or greater than 3.7 for restrained eating in Dutch Eating Behaviour Questionnaire.
* Have special dietary requirements or food allergies.
Eze/Simva Switch Study in Diabetics (0653A-807)

A study to assess the effectiveness and tolerability of MK0653A and MK0653A versus Atorvastatin in lowering LDL-C levels.


Eligibility Criteria:
Inclusion Criteria:

* Currently being treated with Atorvastatin 10 mg for at least 6 weeks
* Have Type 2 Diabetes
* Weight must be stable for more than 6 weeks before entering the study

Exclusion Criteria:

* Consume more than 14 alcoholic drinks per week.
* Pregnant or lactating
* Have taken another investigation drug within 3 months of starting this study
* History of congestive heart failure, heart attack, coronary artery bypass surgery
* Uncontrolled high blood pressure
* HIV positive
* History of cancer in the last 5 years
Paleolithic Diet in the Treatment of Diabetes Type 2 in Primary Health Care

There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2.

Fifteen patients with diabetes type 2 have been randomized to

1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
2. a standard diabetes diet as recommended by national health authorities.

The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.


Eligibility Criteria:
Inclusion Criteria:

* Adults with capacity to perform study
* Diabetes Mellitus Type 2
* C-peptide \> 0
* HbA1C \>5.5
* Unchanged diabetes treatment during last 3 months
* Weight and HbA1C varied less than 5% during last 3 months
* No acute heart disease during last 6 months
* Unchanged treatment with betablocker last 6 months
* Unchanged treatment with thyroid hormone substitution last 6 months

Exclusion Criteria:

* Treatment with insulin
* Chronic treatment with steroids (not inhaled)
* Treatment with Waran (anticoagulant cumarin type)
* Creatinin \> 130 micromol/L
* Elevated liver enzymes (ALAT,ASAT,ALP or GT \> 4 X upper reference value)
* Acute heart disease
* Changed treatment with betablocker or thyroid hormone substitution
Opioid Rapid Response System: Naloxone Training in Communities

The pervasive impact of the opioid epidemic has touched all layers of society for the past two decades, resulting in over 115 deaths daily and imposing annual costs of $78.5 billion. Responding swiftly to overdoses, akin to various medical emergencies, poses a significant challenge, particularly in geographically dispersed rural areas and densely populated urban settings. Effectively delivering the life-saving drug naloxone, which counteracts the effects of overdoses, necessitates a well-coordinated and cost-efficient response system.

Simply opting for widespread distribution of naloxone, even with citizen involvement, proves to be a financially burdensome approach when compared to more targeted strategies. Moreover, obstacles such as limited access, inadequate or unavailable naloxone training, and delayed response times from emergency responders compound the problem. Addressing these issues, the proposed Opioid Rapid Response System (ORRS) project seeks to advance prevention science by adopting an innovative approach that incorporates technology and contemporary communication theory.

The primary objective of the ORRS project is to mitigate opioid overdose deaths by enlisting and training citizens to administer naloxone in response to such events. Leveraging the PulsePoint health app, which connects citizens to cardiac events, the ORRS project will extend its capabilities to respond to overdose incidents. This initiative involves comprehensive development of ORRS, followed by a randomized clinical trial on a national scale to assess its effectiveness. The study aims to contribute to both prevention and implementation science by identifying optimal recruitment strategies and testing a model of online training. In pursuit of these objectives, the study is guided by the following Specific Aims:

SA 1: Refine and complete the development of ORRS. SA 2: Conduct a randomized clinical trial to evaluate the effectiveness of the intervention. SA 3: Prepare ORRS for dissemination.


Eligibility Criteria:
Inclusion Criteria:

* Citizens who live in participating PulsePoint communities
* Must to be 18 and older
* Must be fluent in English
* Must have access to the mobile data and able to download and use apps in a smartphone

Exclusion Criteria:

* Citizens who do not live in participating PulsePoint communities
* Under 18-year-old
* Citizens who are not fluent in English
* Citizens who do not have access to mobile data and unable to download and use apps in a smartphone.
Effects of Amantadine on Postoperative Cognitive Dysfunction

Post-operative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon. Investigators will determine whether amantadine can reduce the occurrence of POCD in elderly patients with major abdominal surgery.

Patients who are 60 years old or older for laparoscopic abdominal surgery will be randomly assigned into two groups: 1) no-treatment group, and 2) amantadine-treated group. Each group will have 150 patients. In addition, investigators will need 90 subjects in the control group. The data of these control subjects will be used to normalize the data of the two studied groups to diagnose POCD. The subjects in control groups will also be elderly but without the exposure to anesthesia and surgery.

Eligibility Criteria:
Inclusion Criteria:

1. major elective gynecological, prostate or bladder surgery patients who are ≥ 60 years old.
2. the surgery is laparoscopic surgery and is expected to last for ≥ 2 hours under general anesthesia and the patient will stay in hospital for at least 7 days after surgery.
3. lack of serious hearing and vision impairment and be able to read so that neurobehavioral tests can be performed.

Exclusion Criteria:

1. Patients are not expected to be alive for longer than 3 months.
2. Mini-mental State Examination (MMSE) \[18\] score ≤ 23.
3. history of dementia, psychiatric illness or any diseases of central nervous system.
4. current use of sedatives or antidepressant.
5. alcoholism and drug dependence.
6. patients previously included in this study (for patients who have second intra-abdominal surgery during the study period).
7. difficult to follow up or patients with poor compliance.
8. uncontrolled hypertension (\> 180/100 mmHg)
German Chest Pain Unit (CPU)-Register

The Chest Pain Unit (CPU) register is a nationwide scientific investigation, in which data concerning the hospital-stay within the Chest Pain Unit are documented. Furthermore, a Follow-up via telephone is conducted after 3 months.

The aim of a Chest Pain Unit (CPU) is to clarify unclear chest pain quickly and specifically. Present data from Germany, the USA and England prove that the organisation models of a CPU lead beside a drastic reduction of mortality also to a cost reduction as well as a shortening of the average inpatient hospital stays.

Therefore it seems reasonable to assign a minimum standard to CPUs. Although there are internationally already standards for CPUs up to complete certification programmes, it is an explicit wish of the German society for cardiology (DGK) to create an own standard which considers on the national circumstances.

The aim of the CPU register is the internal and external validation of the care quality of CPU including Benchmark reports and risk-adjusted comparisons.

Eligibility Criteria:
Inclusion Criteria:

All patients that are admitted to a Chest Pain Unit are included in this register.

Exclusion Criteria:

Missing informed consent (informed consent can NOT be given in the acute phase of the disease, if consciousness is limited at that time; instead the patient will be asked for his consent at a later point of time, when he is fully conscious).
Comparison of Exercise and Massage in Fibromyalgia

The present study was designed to analyse and compare the effects of Pilates exercises and connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance, anxiety, progress, and health related quality of life in females with fibromyalgia (FM)

Treatment of FM is difficult. Conventional treatments do not appear to be managing the problem effectively and this has led to other forms of treatment. The aim of treating FM is to decrease pain and increase function by means of a multimodal therapeutic strategy, which, in most cases, includes pharmacological and non-pharmacological interventions. In the literature on non-pharmacological treatment approaches for FM, different managements are described, such as exercise, electrotherapy, patient education, self-management programmes, massage techniques, cryotherapy, and acupuncture. There are a number of reasons why patients choose these complementary and alternative medicine approaches, including dissatisfaction with conventional treatments or concerns over the toxicity of drugs. However, there is no consensus about which treatment approach is the best.The current randomised controlled trial was undertaken as a first pilot study to assess and compare the effectiveness of Pilates exercises, an active-group therapy, and connective tissue massage, a passive-personalised therapy, in the management of FM in females.

Eligibility Criteria:
Inclusion Criteria:

* being female
* being over 25 years old
* meeting the criteria for FM as defined by the American College of Rheumatology
* having pain in the neck and shoulder region
* never having been treated for FM.

Exclusion Criteria:

* infection
* fever or an increased tendency to bleed
* severe physical impairment
* inflammatory diseases
* cardiopulmonary disorders
* uncontrolled endocrine disorders
* allergic disorders
* pregnancy
* malignancy
* severe psychiatric illnesses
* factors known to affect autonomic function
* medication usage
Exercise for Depressed Smokers

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for helping individuals with elevated depressive symptoms to quit smoking. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in smoking cessation. The long-term goal of this program of research is to disseminate an effective, aerobic exercise (AE) intervention for smoking cessation that can be readily adopted by smokers with elevated depressive symptoms, including those with current major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

1. are between 18 and 65 years of age
2. are current smokers (i.e., smoking at least 10 cigarettes per day)
3. have currently elevated depressive symptoms (CES-D ≥ 6)
4. are sedentary, i.e., have not participated regularly in aerobic exercise (for at least 90 minutes per week during the past three months)

Exclusion Criteria:

1. DSM-IV diagnosis of current mania
2. DSM-IV diagnosis of bipolar rapid cycling
3. lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms
4. DSM-IV diagnosis of current substance abuse or dependence in the past 6 months
5. DSM-IV diagnosis of anorexia or bulimia nervosa
6. current suicidality or homicidality
7. marked organic impairment
8. current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,
9. physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)
10. current pregnancy or intent to become pregnant during the next 12 weeks
11. contraindications for use of the nicotine patch (e.g., pregnancy, recent myocardial infarction, arrhythmia, angina, untreated hypertension, untreated diabetes, and previous adverse reaction to the patch)
12. current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)
13. current use of any pharmacotherapy or other treatment for smoking cessation.
AI Derived Biomarker to Select Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma

To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.

The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria \[35\].
* Availability of archival tumor tissue (diagnostic for PDAC) required
* Have a documented ECOG Performance Status of ≤ 1
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.

Exclusion Criteria:

* Has received prior systemic treatment (standard of care or experimental) for PDAC
* Participant has a concurrent malignancy requiring active treatment during the study.
Intervention to Promote Water Consumption in School Lunchrooms

This study, randomized, delivered, and analyzed at the school level, evaluated the effect of simple, structural changes to school lunch rooms to make drinking water easier for students during lunch time. Half of the schools received posters promoting drinking water and installed cup dispensers stocked with cups next to lunchroom water fountains, while the other half received no intervention. The intervention outcomes were average water consumption and the proportion of students in the lunchroom who opted to drink water, as well as the proportion of students with sugary drinks at lunch. No identifying information on individual children was collected.


Eligibility Criteria:
Inclusion Criteria: School in Boston Public School district in Boston, MA; had to have plumbed drinking water access in school cafeteria -

Exclusion Criteria: School had no plumbed drinking water access in cafeteria.

-
Effect of Statins on Trained Immunity

In this study, the investigators will determine whether patients with elevated levels of LDL are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to control subjects with healthy levels of LDL and whether regular statin treatment influences these changes.

Rationale: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming. Here the investigators hypothesize that monocytes of patients with elevated LDL cholesterol levels show epigenetic changes compared to normocholesterolemic subjects and that this can be reversed by treatment with statins.

Objective: The main objective is to study whether patients with elevated levels of LDL show increased Histone 3 Lysine 4 trimethylation in the promoter regions of pro-inflammatory cytokines and have an augmented ex vivo Toll-Like Receptor agonist-induced cytokine production in isolated monocytes compared to controls. Subsequently the investigators will study the effect of treatment with statins on these responses.

Study design: Observational study Study population: Subjects aged \>18 years who have been referred to the out-patient clinic and have LDL levels that require lipid lowering treatment and matched normocholesterolemic control subjects.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* 18 years or older
* Elevated LDL levels (\>4.9 mmol/l)
* No previous cardiovascular events

Controls:

* Age \> 18 years
* LDL cholesterol \< 3.5 mmol/l
* No previous cardiovascular events

Exclusion Criteria:

* Current lipid lowering treatment
* Known malignant disorders, auto-immune disorder, or diabetes
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
* Clinical signs of acute infection
* Use of anti-inflammatory medication
Efficacy and Safety of AAE581 in Postmenopausal Women With Osteopenia/Osteoporosis.

AAE581 is a specific inhibitor of the cysteine protease cathepsin K. This trial is designed to provide detailed information about the effects( efficacy and safety) of AAE581 on Bone Mineral Density.


Eligibility Criteria:
Inclusion Criteria:

* Low spine Bone Mineral Density
* 0 to 1 prevalent fracture in non lumber spine

Exclusion Criteria:

* History or presence of any bone disease other than osteopenia /osteoporosis
* Previous treatment with other anti-osteoporosis agent(Wash out required)
* Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.