cyrilzakka/clinical-trials huggingface dataset:
A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining

Participants will be smokers who want to quit, and have visible nicotine stains on their teeth. They will be given toothpaste and a toothbrush to use during the study, and will have an equal chance of being assigned to use either a nicotine gum or microtab. They will visit the study site five times during the 12 week trial to have their teeth examined.

This evaluator-blinded, randomized, 12-week parallel-group controlled trial compares Nicorette® Freshmint gum versus Nicorette® Microtab in healthy smokers who are motivated to quit smoking and who have visible staining of teeth.

The trial is comprised of five visits (baseline, Weeks 1, 2, 6, and 12). At baseline, subjects will be provided with a standardized toothpaste and toothbrush; use of any other oral hygiene or tooth-whitening product is prohibited. At all visits after baseline, smoking status and use of study treatment will be checked. Teeth staining and teeth shade will be rated at baseline and at 2, 6 and 12 Weeks using the Modified Lobene Stain Index and the Vita® Shade Guide, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 65 years
* Daily smoker, current daily smoking for at least 1 year
* Motivated to quit smoking, and willing to use NRT (nicotine gum or nicotine sublingual tablet)
* Normal chewing abilities (able to use chewing gum without any problems)
* Willing to refrain from dental prophylaxis for the duration of the 12-week trial
* Have a minimum of 20 natural teeth, with at least 10 of the 12 anterior teeth present and scorable.
* Have a total extrinsic facial tooth stain score equal or more than 28, according to the MacPherson Modification of the Lobene Stain Index.
* Willing and able to comply with scheduled visits, treatment plan, tests, and other trial procedures.

Exclusion Criteria:

* Use of other tobacco-containing products, such as cigars, pipe, smokeless tobacco products, etc.
* Existing use of any nicotine replacement products for smoking cessation, or undergoing any other treatment for tobacco dependence, such as hypnosis, acupuncture, bupropion, etc.
* Orthodontic appliances
* Gross periodontal disease, or signs of gross oral neglect
* History of oral cancer
* History of temporomandibular joint disorders known to aggravate jaw pain
* Unstable angina pectoris or myocardial infarction during the previous 3 months
* Pregnancy, lactation or intended pregnancy
* Any major metabolic disease, clinically important renal or hepatic disease Suspected alcohol or drug abuse
* Participation in another clinical trial within the previous three months and during study participation
* Any other severe acute or chronic medical or psychiatric condition that might increase the risk associated with trial participation or trial drug administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, makes the subject inappropriate for entry into this trial.
Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study

The purpose of this study is to determine if, in a subset of patients treated with a beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour oral glucose tolerance test (OGTT) compared to fasting glucose measurement.

Beta-blockers and diuretics have a well-established role in treating hypertension and are frequently used first-line. However, it is increasingly evident that these medications have harmful metabolic effects. The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR - NCT00246519) study was a greater than 700 participant, randomized, parallel assignment trial, aimed at determining the genetic factors that influence response to both a beta-blocker (atenolol) and a diuretic (hydrochlorothiazide \[HCTZ\]). The PEAR trial design includes evaluation at baseline, after monotherapy with either medication, and after combination therapy with both medications. This pilot, PEAR sub-study aims to characterize the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an OGTT) to detect prediabetes development prior to blood pressure medication use, after monotherapy (with atenolol or HCTZ) and after combination therapy (with atenolol and HCTZ).

Eligibility Criteria:
Inclusion Criteria:

* participation in PEAR:

  * an average seated home DBP \> 85 mmHg and home SBP \< 180 mmHg.
  * subjects must also have an average seated (\> 5 minutes) clinic DBP between 90 mmHg and 110 mmHg and SBP \< 180 mmHg.

Exclusion Criteria:

* secondary forms of HTN,
* patients currently treated with three or more antihypertensive drugs, isolated systolic HTN,
* other diseases requiring treatment with BP lowering medications,
* heart rate \< 55 beats/min,
* known cardiovascular disease (including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease, including stroke and TIA),
* diabetes mellitus (Type 1 or 2),
* renal insufficiency (serum creatinine \> 1.5 in men or 1.4 in women),
* primary renal disease,
* pregnancy or lactation,
* liver enzymes \> 2.5 upper limits of normal,
* current treatment with NSAIDS,
* COX2-inhibitors,
* oral contraceptives or estrogen.
An Enhanced Package of Care to Reduce Reduce Mortality in Advanced HIV Disease

A community-based Phase III, cluster randomized trial that seeks to determine the 24 week survival with retention in care of point of care CD4 testing with visitect and an enhanced package of screening and prophylaxis for opportunistic infections among patients with advanced HIV disease.

The study will be carried out in a population of HIV-infected adults with advanced HIV disease (CD4 \<200 cells/µL) in Uganda. It will be a Randomized controlled trial, Phase III in Uganda over a duration of 5 years assessing 24 weeks survival with retention in care. @4 clinic will be randomized to either receive the enhanced package or standard of care.

Description of Intervention Arm

1. Point-of-care CD4 testing via Visitect (point of care semi Quantitaive CD4 LFA) lateral flow assay (LFA)
2. Enhanced package of opportunistic infection screening and prophylaxis for CD4\<200, including:

   * FujiFilm SILVAMP TB LAM (FujiLAM)
   * Isoniazid (INH) + rifapentine: 1 month of therapy for latent TB(Tuberculosis) infection
   * Cryptococcal Antigen semi-quantitative (CrAg-SQ) LFA (Immy)
   * Treatment for disseminated CNS cryptococcal infection if high blood CrAg titer (\>3+ CrAg SQ)

Description of Standard of Care Arm

1. CD4 testing by flow cytometry
2. WHO recommended package of OI screening and prophylaxis, including:

   * Urine TB LAM
   * INH ( isoniazid 6 months)
   * CrAg LFA
   * Fluconazole for asymptomatic CrAg+ o 800mg daily x 2 weeks, then 400mg daily x 8 weeks, then 200mg daily.

Problem statement: Current lab-based CD4 testing results in a delay to either start ART(Antiretroviral therapy) or a delay in screening persons with low CD4s for OIs. At present, prioritization has been on ART initiation without systematic OI screening. Those with subclinical OIs started on ART unmask their OIs, with hospitalization / deaths for OIs such as cryptococcosis and TB.

We hypothesize that with point of care CD4 testing, same-day OI screening can occur, yet not interrupt prompt ART initiation for those at low risk (FujiLAM and CrAg-SQ negative) of unmasking immune reconstitution syndrome.

We hypothesize that point-of-care CD4 testing will improve 6-month survival by reducing lag time in CD4 results, thereby facilitating ART initiation, retention-in-care, and OI screening and prophylaxis.

We hypothesize that enhanced screening with the point-of-care FujiLAM, CrAg-SQ LFA, with enhanced prophylaxis for TB (1 month of INH and rifapentine) and with treatment for disseminated CNS cryptococcal infection in those CrAg+ with high titers (\>3+) will improve 6-month survival compared to current WHO-recommended standard practice in persons with advanced HIV disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* CD4\<200 cells/µL
* Ability and willingness to give informed consent for the enhanced package of care arm.

Exclusion Criteria:

* Known virologic suppression (viral load \<1000 copies/mL) within prior 3 months
* Cannot or unlikely to attend regular clinic visits
Rheumatoid Foot Insole

The present study aims to evaluate the effect of insoles for foot arthritis.

A randomized, controlled, double-blind, prospective trial being conducted involving 80 patients with rheumatoid arthritis, according to American College of Rheumatology (ACR) criteria, and foot pain, selected from outpatient clinics - Federal University of Sao Paulo (UNIFESP).

Patients will be randomized in to two groups: experimental (40) and control (40).

The experimental group will use ethyl-vinyl acetate (EVA) foot orthoses, with support retrocapital and support of medial arch (insole intervention). The control group will use the same material flat insole (insole placebo).

Eligibility Criteria:
Inclusion Criteria:

* Patients with established diagnosis RA according to criteria of the American College of Rheumatology (ACR) functional classes I, II and III
* Foot pain with VAS between 3 - 8 cm for walking
* Age 18-65 years
* Basic medication stable for at least three months
* Not made infiltrations in feet and ankles in the last three months and not during the study
* Agreed to participate and signed term of informed consent

Exclusion Criteria:

* Other musculoskeletal disorders in symptomatic lower limbs
* Diseases of the central and peripheral nervous system
* Decompensated diabetes mellitus
* No walking
* Rigid deformities in the feet
* Use of insoles in the last three months
* Surgery scheduled in the next 12 months
* Allergy to the material
* Mental deficiency
Virtual Reality During Ultrasound Examination of Women With Endometriosis

To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.

A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.

Eligibility Criteria:
Inclusion Criteria:

* patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.

Exclusion Criteria:

* women who reported the use of analgesia 6 hours prior to the procedure
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia

Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.

Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.

This study will take place over 3 years with a recruitment period of 18 months. After verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. The duration of participation of the subjects will be 12 months. Assessments are available in 4 steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at V1 and V4.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic with schizophrénie
* Less than 10 years of the evolution of the disease

Exclusion Criteria:

* History of severe cranial trauma and / or neurological pathology with cognitive impairment
* Ongoing participation in another study for treatment of negative or cognitive symptoms
* Ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms
Measurement of Optic Nerve Sheath Diameter

It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia.

This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

It is known that insufficient intraoperative or postoperative management can lengthen the hospital stay with unwanted complications. Therefore, active and proper management using continuous thoracic epidural catheterization is suggested good option to prevent such potential complication.

According to previous study, injection of different volume of local anesthetics (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of ICP can result in headache, syncope, and transient loss of visual acuity.

Although it is very invasive method, ICP can be measured directly at the brain parenchyme. Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath diameter increases when higher volume of medication is injected during epidural anesthesia.

This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline of different speed (3cc/sec vs. 1cc/sec).

Eligibility Criteria:
Inclusion Criteria:

* lung cancer
* liver cancer
* stomach cancer
* pancreas cancer

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
* previous brain surgery
The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula

The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

Eligibility Criteria:
Inclusion Criteria:

* Adult with age of or above 18 years.
* Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
* Patients sable to comply to with the study protocol.

Exclusion Criteria:

* Patients with low perianal fistula
* Patients with preoperative incontinence.
* Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
* Patients diagnosed with acute anal sepsis
* Recurrent cases
Genetics of Diabetes Audit and Research in Tayside Scotland (DOLORisk Dundee)

In 1997, the global prevalence of diabetes was estimated to be 125 million and this has risen to around 400 million in 2015. In addition diabetes has a number of complications including heart disease, blindness, kidney failure and amputation. This represents a significant burden on healthcare services. Type 2 diabetes (T2D) is caused by a combination of genetic and environmental factors. The aim of GoDARTS is to recruit participants with T2D to a registry to provide a platform with which to investigate the genetics of T2D, its complications and response to treatment. This study will investigate the genetic basis of diabetic neuropathic pain.

GoDARTS is the genetics arm of the DARTS study, which was set up to identify all diabetes patients in the Tayside region. Its aim is to improve diabetes care over and above existing practices. Participants are invited to attend to provide blood samples for DNA/RNA analysis, provide baseline anthropometric, biochemical, blood pressure and heart rate measurements as well as completing a lifestyle questionnaire containing smoking, menopausal and physical activity items. Consent is also obtained to allow anonymous linkage to electronic medical records (EMR) through use of the Community Health Index (CHI) number, a unique patient identifier that is issued to everyone registered with a general practitioner in Scotland. GoDARTS is the first EMR linked cohort in the world and provides access to individual participant longitudinal data including biochemical, comorbidity and prescription records. These are live databases and are constantly being updated. This allows for the study of genetic factors influencing T2D, its comorbidities and response to therapy. Consent has also been obtained for re-contact by collaborators, allowing for further studies of related phenotypes to take place. One of these studies is DOLORisk Dundee which aims to identify genetic and environmental risk factors for neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Previous participation with GoDARTS
* Existing consent to be recontacted
* Identified as being currently alive
* Currently has a postal address
* age \> 18 years
* Neuropathic

Exclusion Criteria:

* Unable to give consent
* No current postcode
* Identified as having died
Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients

This project aims at examining the following hypotheses:

* Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine.
* Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain patients treated with opioids over 3 months
* The patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw.
* The patient is motivated for opioid withdrawal
* The patient has experienced withdrawal symptoms
* The patient must be able to understand, speak and write Danish
* The patient must be able to transport himself to the pain center

Exclusion Criteria:

* Children under 18 years old
* External ear infection
* Treatment with benzodiazepines.
* Active substance abuse and alcohol abuse.
* Contraindications for treatment with clonidine:
* Allergy
* Bradyarrhythmias caused by diseased sinus cube or AV block of 2nd or 3rd grade.
* lactose intolerance
* Heart failure
* High medullary damage
* Cardiac conduction disturbances
* Pregnancy and breastfeeding
A Multicenter Clinical Study of Echocardiographic Assessment of Right Heart Function and Implications of Prognosis in Diabetes

The aims of this study are to 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.

This study will recruit 1000 T2DM patients and 500 Prediabetes and 500 healthy controls. Assessing the left heart and right heart structure and function by speckle tracking echocardiography. Patients with T2DM were followed up for adverse cardiovascular outcome events (myocardial infarction, cerebrovascular stroke, or cardiovascular death, hospitalization for heart failure). And the study aimed to 1. 1. Evaluate the right heart structure and function in T2DM and Prediabetes patients by speckle tracking echocardiography, and to further investigate the influence of left heart on right heart structure and function in T2DM and Prediabetes patients. 2. To explore the prognostic value of right ventricular function in T2DM patients.

Eligibility Criteria:
Inclusion Criteria:

people with T2DM according to the WHO 2006 criteria

Exclusion Criteria:

including history or symptoms of CAD valvular heart disease, rhythm disturbances cardiomyopathy congenital heart disease symptomatic heart failure pulmonary disease