cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia

Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical therapies could activation situations of chronic pain there is no activation of CPM.

Objectives: The purpose of this study is to measure the CPM response and determine whether Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the improvement of CPM, TS, pain intensity, disability.

Design: Double-blind, randomized placebo clinical trial. Methods: Patients with fibromyalgia will be randomly allocated into two groups: the Electro Neuro Adaptative Regulator group (SCENAR) or the sham technique (ST) group.

Main outcomes measures: Pain intensity (with visual analogue scale, Conditioned Pain Modulation (CPM), Temporal Summation (TS) and Pressure Pain Thresholds (PPT´s) were the primary outcomes and will be assessed at baseline and at 3-months follow-up. Secondary outcome measures were the Fibromyalgia Impact Questionnaire to measure disability, Pain Catastrophizing Scale and the Pain Anxiety Symptoms Scale, Beck Depression Inventory, Jenkins Sleep Scale. Questionnaire of quality of life SF36.

Participants will be selected if they met the following inclusion criteria: (a) fulfilled the 1990 and 2010 American College of Rheumatology classification criteria for FM; (b) reported an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement; (c) were on stable doses of medication for FM ≥ 4 weeks; and (d) were aged between 18 and 65 years.


Eligibility Criteria:
Inclusion Criteria:

1. . American College of Rheumatology classification criteria for Fibromyalgia.
2. . reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries;
3. on stable doses of medications for FM ≥ 4 weeks.

Exclusion Criteria:

* Patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak Spanish fluently.
Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer

The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of adenocarcinoma of the prostate
* Completion of local therapy by surgery and/or ablative radiation therapy at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement
* Rising prostate specific antigen (PSA) levels without scan evidence of metastatic disease
* Asymptomatic or mildly symptomatic and life expectancy of at least 4 months

Exclusion Criteria:

* Small cell or other variant prostate cancer histology
* Evidence of immunosuppression
* Prior treatment with androgen deprivation except if given neoadjuvantly or adjuvantly with radiation therapy or at time of prostatectomy. In this situation, no more than 24 months of androgen deprivation must have been given and treatment must not have been within 12 months prior to screening for this study.
* Serum testosterone at screening \< 50 ng/dL
* Known bone metastases or lymph node involvement as determined by bone scan or computed tomography (CT) scan of the abdomen and pelvis within 4 weeks of study entry
* Prior vaccine therapy for prostate cancer
* Known allergic reactions to granulocyte-macrophage colony-stimulating factor (GM-CSF)
* Severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
SSVEP and Distractor Processing During Visual Search

In this line of research, the researchers are utilizing an EEG measure of repeated visual stimulation, the Steady-State Visually Evoked Potential (SSVEP) to examine processing of target and distractor information during visual search. This is a basic science study.

The researchers are interested in how the brain responds to target and distractor information during visual search. The researchers will manipulate the information available to the research participants, and measure research participants brain responses to information matching target or distractor features utilizing an EEG measure of repeated visual stimulation, the Steady-State Visually Evoked Potential (SSVEP).

Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal visual acuity, normal color vision

Exclusion Criteria:

* history of neurological disorders
BOND Study: the Benefit Of Night Splinting in Dupuytrens'

The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.

This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Single digit contractures greater than 30 degrees
2. No prior surgery for their contractures.
3. Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension).

Exclusion Criteria:

1. Multiple digit contractures
2. Prior surgery for their contractures.
3. Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension).
4. Inability to consent to treatment.
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database

Visit 1 will involve the participants being fitted with the F\&P trial full face or nasal mask for use in-home.

The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult (22+ years of age)
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing oronasal and nasal mask user

Exclusion Criteria:

* Inability to give informed consent
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.
Effect of rTMS in Pathological Gamblers

The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.

In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).

One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).

Patients included in this study will have:

* An anatomical brain MRI (30 minutes).
* Two 20 minute sessions of rTMS (placebo and active) of the left DLPFC, at the frequency of 10 Hz.
* Visual Analogue Scale measuring their desire to gamble before and after a gambling video and test measuring their gambling behavior during the last 7 days (PG-YBOCS).
* Cognitive tests, to be carried out on a computer before and immediately after rTMS sessions.
* Recording heart rate variability (HRV) to measure the autonomic nervous system (ANS) activity

As it is a pilot study, the investigators don't have sufficient data to calculate statistical power and number of participants. The investigators based on previous studies evaluating one rTMS session on craving in SUD and used a crossover design to generate greater power.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of pathological gambling (DSM IV criteria)
* First-time consultants.
* Without psychotropic treatment or treatment with a stable and unchanged for over a month.

Exclusion Criteria:

* Presence of ferromagnetic material or devices implanted neurostimulation in close contact with the coil
* Pregnant women and patients with hearing disorders
* Personal history of epilepsy (untreated or poorly balanced)
* Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
* History of head trauma with loss of consciousness,
* Administration of drugs or substances lowering the seizure threshold
* Sleep deprivation, jet lag, or drug withdrawal.
* Participants with a problem of uncorrected visual acuity.
* Other current addiction (except tobacco, for reasons of feasibility).
* Current Psychiatric comorbidity
* Treatment psychotropic introduced or changed for less than a month.
* Subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs
Extracorporeal Shockwave Therapy for the Treatment of Refractory Chronic Angina Pectoris

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.

At first, the patient undergoes stress- PET testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. Several treatments are required for optimal results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic stable angina pectoris.
* Documented myocardial segments with reversible ischemia
* AP CCS class of III-IV.
* Stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment.
* Exercise tolerance time \< 10 min (modified Bruce)
* Two ETT tests results (within two weeks) averaging no more than 25% of their mean
* Documented epicardial coronary artery disease not amenable to angioplasty or CABG.
* Signed an IRB approved informed consent form.
* Life expectancy of \> 12 months.

Exclusion Criteria:

* Intraventricular thrombus
* Malignancy in the area of treatment
* Severe COPD
* No smoking during the study procedure
* MI less \< 3 months prior to treatment
* Severe Valvular disease
* Child bearing potential
Mid-life Women: Preventing Unintended Pregnancy and STIs

Mid-life women, aged 35-50, are currently an underserved population in the areas of unintended pregnancy and STI prevention interventions. Common perception is that women in this age range are no longer sexually active, or are past the menopause transition, but in reality, sexual activity remains stable through mid-life and into the post-menopausal years. Additionally, physiological and relationship status changes (e.g. divorce or death of a partner) put these women at increased risk for both unintended pregnancy and STI's. This project developed and evaluated a theoretically-based multimedia intervention designed to assist mid-life women in protecting themselves from sexually transmitted infections and unintended pregnancy.

The primary aim of this project was to create and evaluate a theoretically-based, interactive multimedia program for women aged 35-55 to assist them in avoiding unintended pregnancy and sexually transmitted infections (STIs). The intervention, titled "Women's Reproductive Health: A guide to staying healthy," addressed these concerns across the life span and was designed to increase knowledge about (a) pregnancy risk; (b) STI risk; (c) strategies to prevent STIs and unintended pregnancy; (d) influences of sexual partners on risk reduction decisions and behaviors; (e) partner communication techniques; and (f) health care provider communication techniques.Overall features of the program include video, interactive tools, animations, text information pages, and various links both across and within specific modules to link related information. A feature titled "My Notes" allowed the user to save content from the program into an easily retrievable repository.

Motivational videos featuring friendly mid-life hosts could be viewed on the first page of each module, as well as on the home page and topic introduction pages. These videos not only provided specific information about the content, they also provided message framing and set the tone of the program segment. Other videos included testimonials on topics such as contraceptive methods, sexually transmitted infections, and other health information. Interactive materials include an assessment checklist for STI risk, a quiz to help the user identify the types of birth control methods that best fit her lifestyle and preferences, as well as several checklists

Eligibility Criteria:
Inclusion Criteria:

* Women aged 25-55.

Exclusion Criteria:

* Males
* Women under 25 years of age and over 55
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.


Eligibility Criteria:
Inclusion Criteria:

* An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
* No current active caries or periodontal disease that may compromise the study or the health of the subjects
* A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria:

* Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Efficacy and Safety of STBF Photodynamic Therapy for Moderate and Severe Acne Vulgaris

This study is being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.

This study is a split randomized controlled trial and being done to evaluate the efficacy and safety of Shengtaibufen photodynamic therapy (STBF-PDT) for treatment of moderate or severe acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosed with moderate to severe acne;
2. Male and female patients of age between 18-30 years old ;
3. All patients read the instructions of the subject, willing to follow the program requirements;
4. No other topical treatment received within 2 weeks prior to enrollment;
5. No systemic treatment was given within 4 weeks prior to enrollment;
6. Patients were unsuitable for surgery for various reasons,unwilling to undergo surgery, and signed informed consent when they had informed other alternatives and agreed to take pictures of the lesion.

Exclusion Criteria:

1. Those who did not complete the informed consent;
2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound;
3. Patients with skin photoallergic diseases, porphyria;
4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;
5. Patients with other obvious diseases that may affect the evaluation of efficacy;
6. Scars or patients with a tendency to form scars;
7. Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants;
8. Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy
9. Those with severe neurological, psychiatric or endocrine diseases; (10)Women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.
A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus

The goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with Type 2 diabetes mellitus with sleep problems. The main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. Participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. Researchers will compare the control group to the intervention group to see if effects differ between groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Diabetes Mellitus type 2 for longer than 3 months
* Participant is willing and able to give informed consent to take part in the study.
* Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.
* Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.
* Glycated haemoglobin (HbA1c) of 10% or less (86 mmol/mol) or less
* Male or Females.
* ≥ 18 ≤ 75 years of age.
* Able to walk without the use of an assistive device or requiring assistance from another person.
* Not undertaking more than 75 minutes a week of strenuous exercise or sport.
* Not taking opioids
* Be treatment stable for at least 3 months
* Accelerometer measurement of SE ≤ 85%
* An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.

Exclusion Criteria:

* Individuals living with narcolepsy or diagnosed parasomnia
* Individuals with type 1 diabetes or gestational diabetes
* Recent cardiovascular event (within the last 6 months).
* Currently on opioids
* Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).
* Individuals living with epilepsy or seizures.
* Shift workers
* Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.
* Terminal illness.
Therapeutic Omegas for Triglyceride Suppression

This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are \~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between the ages of 21-39 yrs
* Pre-pregnancy BMI 28-39
* Fasting Triglyceride ≥120 mg/dL measured by 15 wks

Exclusion Criteria:

* Pre-gestational diabetes or prediabetes
* History of gestational diabetes,
* History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks
* Tobacco or illicit substance use
* Chronic steroid use
Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.

This randomized, 3-arm Phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome \[MDS\]) to that of single-agent MGCD0103 and to that of combination therapy with MGCD0103 and azacitidine in elderly patients with acute myelogenous leukemia (AML) or intermediate-2 (Int-2) or high-risk MDS, for whom no standard of care exists. The goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent Phase 3 study of elderly subjects with AML or Int-2 or high-risk MDS.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent, and be willing and able to comply with all the study procedures
* Must be 60 years of age or older
* Must have a pathologic confirmation of newly diagnosed (de novo or untreated secondary) AML or newly diagnosed Int-2 or high-risk MDS (IPSS classification) according to WHO criteria
* Must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Must have adequate organ function, including total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST \& ALT ≤ 2.5 x ULN; and serum creatinine ≤ 2.0 x ULN.

Exclusion Criteria:

* Considered fit for intensive chemotherapy and opt to be treated with intensive chemotherapy
* Prior transplantation or any prior anticancer therapy (standard or investigational, including chemotherapy, treatment with HDAC inhibitors, or combination HDAC and azacitidine) administered to treat AML or MDS.
* Clinical evidence of central nervous system (CNS) involvement by leukemia
* A diagnosis of promyelocytic leukemia
* Previous or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry
* Active and uncontrolled clinically significant infection
* Known positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
* Less than 4 weeks elapsed since any major surgery
* Any prior or active disease that may interfere with the procedures or evaluations to be conducted in the study