cyrilzakka/clinical-trials huggingface dataset:
Analyzing the Benefits of Using SYMPTOMS-JIT for in Vivo Exposure in Anxiety Disorders

The aim of this study is to develop and test the efficacy of first-of-its-kind, fully instrumented sensor-based smartphone-guided in-vivo exposure therapy using a just-in-time intervention for anxiety disorder. The main hypotheses are:

1. Both treatment conditions (CBT treatment with IVE and CBT treatment with IVE+SYMPTOMS-JIT) will show efficacy and no statistically significant differences will be found between them. The efficacy will be determined for the differences in pre-post treatment in the used outcome measures.
2. The therapeutic gains obtained in both treatment conditions (IVE and (IVE+SYMPTOMS-JIT) will be maintained at 1-, 6-, and 12-month follow-up periods.
3. Both treatment conditions will be efficient, that is, they will be well-valued by patients and therapists. However, IVE+SYMPTOMS-JIT will be preferred and perceived as less aversive than IVE.
4. The main barriers for the use of this technology are not technological, but rather attitudinal and they can be identified through qualitative studies.

Anxiety Disorders are one of the most prevalent psychological problems around the world and if not treated they tend to become chronic. Cognitive Behavioral Therapy (CBT) is the treatment of choice, being the component of in vivo exposure (IVE) the central feature. Despite its efficacy it is still a hard component to implement for the patients. Information and Communication Technologies (ICT) can help assisting and/or applying psychological interventions. The proposed study will fill the existing gap in this sense as it will assess the efficacy of a fully configurable, sensor-guided and location-based (GPS) app for the in vivo exposure component. It will also address the shortage of clinical validation studies of mHealth apps thanks to the proposed RCT. The study will expand our knowledge about the use of technologies in mental health problems and help improve the effectiveness of exposure therapy.

Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years or older.
* Meeting DSM-5 diagnostic criteria (APA, 2013) for anxiety disorder, specifically specific phobia, agoraphobia, panic disorder and social phobia.
* Being willing to follow the study conditions.
* Sign the consent form.

Exclusion Criteria:

* Having another psychological problem that requires immediate attention.
* Having current alcohol or drug dependence or abuse, psychosis or severe organic illness.
* Currently being treated in a similar treatment program.
* Taking anxiolytics during the study (or in the case of taking them, changing drug or dose during the study).
Association Between Types of Pain and Motor Activities Physical Activity

This study will investigate the relationships between: (1) physical activity (PA) and types of chronic pain (nociceptive and neuropathic), and (2) virtual reality (VR) and types of chronic pain (nociceptive and neuropathic).

Chronic pain can be differentiated by its underlying mechanisms. However, this important distinction is not applied to most non-pharmacological treatment approaches. Studies that have shown modulation of chronic pain with physical activity (PA) or virtual reality (VR) have not evaluated differential effects on nociceptive and neuropathic pain. Therefore, it is unknown if neuropathic pain and nociceptive pain respond differently to PA and VR, and if treatment could be optimized through targeted interventions or a combination of interventions. Understanding the relationships between different types of pain and motor activity will provide new insight to inform future recommendations to alter PA levels for pain modulation.

A prospective, cohort design will be employed for this study of individuals with SCI for a duration of one week in the community. This study will identify trends that are different between the responses of different types of pain and motor activities (i.e., PA and VR). The data obtained will also capture fluctuations in PA levels across participants and corresponding pain levels because PA levels will be collected through real-world data in the community.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of spinal cord injury (SCI) (at least six months post-SCI)
* Experienced chronic pain for a duration of at least 6 months
* Functionally able to self-propel a manual wheelchair
* Medically stable

Exclusion Criteria:

* History of motion sickness or epilepsy
* Condition in which PA is medically contraindicated
Robotic Radical Cystectomy Outcomes

Currently, in the treatment of bladder cancer the use of robotics has entered in clinical practice, therefor robotic radical cystectomy with or without reconstruction is offered to patients during counseling procedures, if deemed appropriate and possible. The aim of the study is therefore the long-term evaluation of the peri-post-operative, oncological and functional results of patients undergoing radical cystectomy, both with an open and robotic approach. This study will thus help to clarify the actual impact of robotic surgery


Eligibility Criteria:
Inclusion Criteria:

* Age major or equal 18 years
* Patients who will undergo radical cystectomy
* Consent to participate

Exclusion Criteria:

* Absence of willingness to participate
* Further refusal to participate to the study
Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB

The purpose of this study is to check if lidocaine intravenous administration during surgery and 24 hours after surgery, associated with standardised management of the patient, helps to accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal neoplasms.

One of the purposes of postoperative care is to shorten the duration of recovery, in order to reduce the complications and to improve the quality of life. After abdominal surgery, two factors can be modified: early mobilisation, thanks to optimal pain control, and return to a normal feeding, permitted by transit recovery. Opioids, which are usually used for pain control, delay the intestinal transit and can be responsible for side effects like drowsiness, nausea, urine retention.

Lidocaine is a local anaesthetic, which means that it can stop the pain if it is administrated around the nerves. It can also be used intravenously. In this way, it is supposed to decrease opioid consumption, accelerate intestinal transit and even decrease inflammation. Side effects of lidocaine appear at higher plasma concentrations than those considered in the study.

After randomisation, the patient will receive either intravenous lidocaine during the surgery and 24 hours after the surgery, or physiological serum (like placebo). Every patient will dispose of patient-controlled-analgesia with morphine and of a standardised care management. Data will be collected concerning pain level, morphine consumption, psychomotor performances, duration of ileus, speed of activity recovery, quality of recovery, and side effects. Biological evaluation of lidocaine concentration and inflammation will also be done.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal neoplasm
* Radical surgery
* Median incision

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) score equal to or up to 3
* Unwilling or unable to use patient-controlled analgesia (PCA)
* Chronic consumption of opioids
* Chronic drug or alcohol abuse
* Chronic pain
* Unable to read or write text
* Inflammatory disease of intestinal tract
* Allergy to morphine
* Allergy to lidocaine
* Severe atrioventricular conduction dysfunction without stimulator
* Porphyry
* Uncontrolled epilepsy
* History of malign hyperthermia
* Severe cardiac failure
* Hepatic failure
* Myasthenia
* Treatment with beta blockers, antiarrhythmic calcium blockers, sultopride, nonselective monoamine oxidase inhibitor (MAOI)
* Locoregional anaesthesia planned
* Associated surgery concerning liver, pancreas, or gall bladder
* Laparoscopic surgery
* Severe psychiatric pathology
* Refusal of the patient
The Effect of Oral Hygiene and Full Mouth Scaling on Metabolic Control in Patients With Type II Diabetes

The aim of the study is to evaluate the effect of non-surgical periodontal therapy, consisting of oral hygiene instruction, full mouth scaling and an antimicrobial rinse on the metabolic control of chronic periodontitis patients with type II diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25- 75 years;
2. Type 2 diabetes;
3. Chronic periodontitis with 2 or more teeth with CAL≥6mm and one site with a PD≥5mm ("established periodontitis")16

Exclusion Criteria:

1. Periodontal treatment within the last 3 months
2. The use of antibiotics within the last 4 weeks
3. Pregnancy or the intention to be pregnant in the next 4 months
Treatment With Metformin in Chinese Children With Alport Syndrome

This single-center, prospective, double-blind randomized placebo-controlled trial will evaluate the efficacy and safety of metformin in Chinese children with Alport syndrome who have received (and continue to receive)) ACEi/ARB.


Eligibility Criteria:
Inclusion Criteria:

* (1) The diagnostic of Alport syndrome-hematuria with or without proteinuria meets one or more of the following 4 items: i) Immunofluorescence staining of the α5 (IV) chain of the glomerular basement membrane was abnormal; ii) electron microscopy of renal biopsy showed diffuse changes in the glomerular basement membrane; iii) There was one pathogenic variant in the COL4A5 gene or two pathogenic variants in the COL4A3/COL4A4 gene; iv) Family history of Alport syndrome.

  (2) Age is older than or equal to 10 years old. (3) The 24-hour urine protein quantification was greater than 150mg and the urine microalbumin-creatinine ratio was greater than 30 mg/g.

  (4) The estimated glomerular filtration rate (24-hour creatinine clearance) was greater than 45 mL/min/1.73m2.

  (5) Accept the maximum tolerated dose of renin-angiotensin-aldosterone system blockers (Blood pressure in the clinic was in the 50th percentile of the same age, same sex and same height but greater than 90/60mmHg, blood potassium was normal, and the increase of blood creatinine did not exceed 30%) for at least 3 months.

Exclusion Criteria:

* (1) Vitamin B12 deficiency was uncorrected. (2) Treated with Furosemide, amiloride, and nifedipine. (3) Hypertension, chronic liver disease, chronic heart disease, and chronic kidney disease resulting from causes except Alport syndrome.

  (4) History of hyperlactatemia. (5) Allergy to metformin. (6) kidney transplant. (7) Poor compliance. (8) Type 1 diabetes.
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults aged 50 to 85 years at enrollment

Exclusion Criteria:

* Proven or suspected prior episode of Clostridium difficile associated diarrhea.
* Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
MRI Biomarkers for Radiation-Induced Neurocognitive Decline Following SRS of Newly Diagnosed Brain Mets

Brain metastases are a source of much morbidity and mortality in adults with primary solid malignant tumors. With improvements in systemic therapy that prolong survival but have limited central nervous system penetration, patients with brain metastases are at increasing risk of developing and experiencing long-term side effects from treatment of brain metastases. The overarching goal of this study is to better understand the determinants of RT-associated changes in white and gray matter function and associated neurocognitive decline.

The proposed study aims to provide novel and useful information for clinicians, both to help predict potential neurocognitive changes following SRS, and as a possible guide for SRS treatment alteration, whether through adjustment of dose or beam arrangements in relation to white matter tracts. In this observational pilot study of 20 patients, the association between RT-associated brain injury and neurocognitive function will be quantitatively assessed longitudinally over one year following SRS. The study team hypothesizes that, over this time, (1) there will be radiation dose-dependent reductions in regional white matter tract integrity and reduction in functional connectivity in the default mode network of gray matter, (2) there will be measurable decline in neurocognitive function, and (3) there will be an association between severity of radiation-induced brain injury on MRI and magnitude of neurocognitive functional decline. This association will relate, in part, to the location(s) affected.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of cancer
* Newly diagnosed brain metastasis being treated with SRS. Any extent of cranial disease permitted. Subsequent courses of SRS while on study permitted when clinically indicated.
* Patients are permitted to have undergone craniotomy and resection of metastasis/metastases if at least 1 other intact metastasis planned for definitive SRS is present. Receiving or previously received systemic therapy also permitted.
* Anticipated life expectancy at least 1 year
* Age ≥ 18 years
* Ability to read and comprehend written English and follow instructions in English
* Ability to provide informed consent

Exclusion Criteria:

* Previous radiation to the brain or head
* Previous malignancy - other than non-melanomatous skin cancer or cervical carcinoma in situ - and not disease-free for at least 3 years
* Previous severe head or brain injury
* History of a neurological disorder such as Epilepsy, Parkinson's, Alzheimer's, or Dementia
* Prisoners
Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)

The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo to evaluate the effect of daily consumption of a cocoa beverage on anthropometric, metabolic, oxidative stress, physical performance and quality of life.

The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo randomly assigned to consumption of a flavonoid rich mixture (flavonoids; F), alkalinized cocoa which eliminates flavonoid content (no flavonoids; NF) or placebo. All beverages had similar physical characteristics and flavor. Cocoa beverages were provided in individual sachets containing a dry powder that was reconstituted with water just before consumption. Subjects were instructed as above to maintain their usual lifestyle, to limit intake of high caloric foods and flavonoid-containing foods and beverages, and to walk for 30 min/day.

To determine the effect of flavonoids, study evaluates anthropometric measures, metabolic parameters as glycemia and a lipid profile (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol). To evaluate oxidative stress damage as lipid oxidation is measured with the malondialdehyde (MDA) assay. Protein carbonylation is measured using an assay for detection of carbonyl groups that relies on 2,4-dinitrophenylhydrazine (DNPH) as a substrate. The investigators also evaluate interleukin-6 and tumor necrosis factor levels.

For physical performance is evaluated the handgrip strength, and mobility assesment with the following test: Six-minute walk test, two-minute step, sit-up test and the up \& go test.

The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Sex: both
* Age: 55-90 yo
* Waist circumference: Women \> 80 cm, Men \> 90 cm
* HDL-c: Women \< 50 mg/dL, Men \< 40 mg/dL
* Triglycerides: ≥ 150 mg/dL
* Glycemia: ≈100 mg/dL
* Hand strength: Women\< 20 kg, Men \< 30 kg
* Up \& Go test: \> 10 seconds

Non-inclusion criteria:

* Any active infections
* Malignancies
* Habitual consumers of antioxidant supplements and cocoa products
* Use of benzodiazepines or protein supplements
Biomarkers, TCM Body Constitution, Dietary Pattern and Psychological Factors in Predicting Depression

This study aims to determine the predictors of depression among university students in Universiti Tunku Abdul Rahman (UTAR) Sungai Long Campus.

University students are a high at risk group for development of depression. Identifying the determinants of depression could help in the diagnosis and treatment of this disorder. This study will incorporate questionnaire and blood sample data collection procedures on 397 subjects. Written consent will be obtained from the subjects. Eligible subjects will be given self-administered questionnaires which include Patient health questionnaire (PHQ-9), Constitution in Chinese medicine questionnaire (CCMQ), Dysfunctional Attitude Scale (DAS), Depression Anxiety Stress Scales (DASS-21) - stress and anxiety subscales, Perceived stress scale-10 (PSS-10), Rosenberg self-esteem scale (RSES), and Food frequency questionnaire (FFQ). Once the subjects completed the questionnaires, blood samples will be collected from them by a trained phlebotomist. In addition, 10 most high at risk of depression subjects (with PHQ-9 scores 10 and above) and 10 healthy subjects (with PHQ-9 scores lower than 10) will be selected randomly for protein expression to further identify the proteins that significantly expressed among them.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian citizen
* Able to read and communicate in English

Exclusion Criteria:

* Special education disability (deaf and blind)
* Physical support
* History of infectious diseases
The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System

The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ systems such as the respiratory, circulatory, and urinary systems. It consists of two major components, the parasympathetic nervous system (PNS) and the sympathetic nervous system (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the state of chemical and metabolic balance within an organism; it is disturbed in situations of uncontrolled stress.

Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full body massage, with limited assessment of ANS function, and lacked control groups.

The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been studied before. In this pilot study, we propose that by randomizing 10 participants to sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of measuring the ANS activity (spectral analysis of Heart Rate Variability \[HRV\] as well as Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a better and balanced profile of autonomic nervous system after receiving massage.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy individuals

Exclusion Criteria:

* Use of anti-depressants or drugs that affect the cardiovascular system or ANS
* Smoking more than 10 cigarettes/day
* Inability to provide consent
* Inability to speak and/or understand English
Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are 18 years of age or older.
* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
* Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
* Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken any antiretroviral (anti-HIV) agent.
* Are pregnant or breast-feeding.
* Are unable to absorb food or have trouble taking medicines by mouth.
* Abuse alcohol or drugs to an extent that may make study participation difficult.
* Are not likely to be able to complete the 48 weeks of study treatment.
* Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
* Have received an investigational vaccine within the past 3 months or have received gene therapy.
* Have a severe medical condition such as diabetes or heart trouble.
* Have been diagnosed with AIDS.
* Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
* Are taking medications that affect the immune system within 30 days of study entry.
* Are taking medications that may interact with the study drugs.
A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease

This study involves single and multiple doses of LY3202626 and will evaluate the effects of LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single increasing doses of LY3202626 will be given in capsule form. Part A will also include itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days with the study drug. Part C will last approximately 11-14 weeks. Part D will last approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may only enroll in one part.


Eligibility Criteria:
Inclusion Criteria:

* For Parts A, B, and C, are overtly healthy males or females (nonchildbearing potential), as determined by medical history and physical examination
* Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m\^2)
* For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild to moderate AD
* Have venous access sufficient to allow for blood sampling
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

* Taking over-the-counter or prescription medication with the exception of vitamins or minerals
* Smoke more than 10 cigarettes per day
* Are unwilling or unable to refrain from eating any food or drinking any beverage containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose until completion of the study