cyrilzakka/clinical-trials huggingface dataset:
Tongue Dysbiosis Effects on Arterial Pressure of Periodontitis Patients

Blood pressure control is crucial for individuals' wellbeing. However, many daily aspects such as diet could impair blood pressure control. In addition, many people living under different conditions in different countries are affected by some kind of gum disease. These people experience gingival bleeding, bad breath, teeth mobility and pain. Throughout gum disease development the number of oral germs in the mouth increases including their levels in tongue surface. Oral bacterial are able to convert nitrate widely found in food in nitrite which influences blood pressure. Frequently treatment of gum diseases general combines manual instrumentation with mouthwashes. However, it has been suggested that reduction of oral bacteria by mouthwashes, especially chlorhexidine, is accompanied by decreased conversion of nitrate to nitrite and that this minor nitrite availability would increase blood pressure. Therefore, this is a point to be clarified for patients, physicians and dentists.

This study will investigate the relation between treatment with mouthwashes and blood pressure of patients with destructive gum disease based on nitrite levels in saliva, bacterial levels in tongue and values of arterial blood pressure which will be monitored over 6 months. In addition, usual clinical parameters and alteration of oral cells' DNA will be also monitored overtime. Patients will be treated under local anesthesia and manual instrumentation within 24 hours. They will receive oral care products too. There will be 3 treatment groups (manual instrumentation + chlorhexidine mouthwash \[2 times a day for 3 weeks\], manual instrumentation + placebo mouthwash \[2 times a day for 3 weeks\] and manual instrumentation + no mouthwash) and 2 dental appointments before treatment. After treatment, patients will be examined at 7, 14, 21, 90 and 180 days. Saliva, plaque and cell sampling will be fast and by no invasive methods.


Eligibility Criteria:
Inclusion Criteria:

* 12 natural teeth; chronic periodontitis stages II and III; no systemic medication; non smokers; normal blood pressure; no mouthwash regular use; antibiotics \> 3 months prior to study; dental treatment \> 3 months prior to study.

Exclusion Criteria:

- known alergy to chlorhexidine; removable prosthodontics apparatus; pregnant and breast feeding women.
The Efficacy and Safety of Caffeic Acid for Esophageal Cancer

Caffeic acid can target inhibit GASC1 (gene amplified in squamous cell carcinoma 1, also known as KDM4C and JMJD2C) expression and GASC1 is confirmed to be a new oncogene in several cancers including esophageal cancer. This study aims to investigate the efficiency and safety of coffeic acid in chinese advanced esophageal squamous cell cancer (ESCC).

Background: More than half of global esophageal cancer cases came from China.80 percentage patients were diagnosed with advanced disease and suffered from the poor outcome.With the development of target therapy among cancers,the overall survival and life quality of patients has been continuous improved recently.However,there had little reports focusing on target therapy in esophageal cancer . Caffeic acid as an ordinary drug is used for thrombocytopenia when patient received chemotherapy. Newly studies shown caffeic acid can target inhibit GASC1 expression, and GASC1 is confirmed to be a new oncogene in esophageal cancer.

Aim: to investigate the efficiency and safety of caffeic acid in chinese advanced esophageal squamous cell cancer.

Methods: 240 advanced ESCC patients will be randomized to two arms: Arm A (receiving coffeic acid treatment) or Arm B (placebo group). In Arm A, patients will receive coffeic acid treatment: 300mg, tid, po, continue to progress disease (PD) or die or the intolerant adverse events; in Arm B, the same shape placebo tablets will be deliveried to patients. 1 years follow-up for both groups patients.Patients in both arms can receive any other ways of anti cancer therapy in the same time.

Primary endpoints: OS Second endpoints: PFS

Eligibility Criteria:
Inclusion Criteria:

* Chinese
* esophageal squamous cell cancer
* stage IV or disease recurrence
* chemotherapy, or radiotherapy, or palliative care is going on

Exclusion Criteria:

* PS (performance status): ≥ 3
* severe hepatic and renal dysfunction
* hypercoagulability
* thrombocytosis
Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment

This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.

Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.

Eligibility Criteria:
Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
* Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
* Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
* Corneal transplant in either or both eyes
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
* A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study
* Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction

A significant reduction in the incidence of CV death or hospitalization for HF has been observed in randomized trials investigating the CV benefit of Dapagliflozin. Mechanistic investigations are required to interpret the positive clinical effects of Dapagliflozin on heart structure and valvular regurgitation.

A functional mitral regurgitation (MR) occurs when the mitral valve (MV) becomes tethered due to abnormal LV remodelling in individuals with heart failure (HF) and left ventricular (LV) dilatation.

The primary treatment for HF is medical, and it is based on established guidelines, as LV failure is the most common cause of secondary functional MR. Standard medical therapy for patients with functional MR, including beta blockers, ACE inhibitors, and angiotensin receptor blockers (ARB), does not reduce the morbidity or mortality associated with these conditions.

Similar to the neprilysin inhibitor, which promotes sodium excretion and has vasodilatory effects via relaxing blood vessels, Dapagliflozin reduce cardiac preload and afterload by inducing natriuresis and reducing arterial stiffness. Effects on blood pressure reduction and weight loss may also positively affect left ventricular (LV) remodelling.

Using echocardiography, researchers hope to test the hypothesis that dapagliflozin improves MR in patients with functional MR due to LV dysfunction. This hypothesis is based on studies showing the beneficial effects of Dapagliflozin on LV modelling.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥ 18 years of age
* Dilated LV with a reduced ejection fraction and secondary functional MR
* NYHA functional class II or III
* Moderate to Severe MR which lasted \> 6 months under medical treatment with a β-blocker and an ACE inhibitor (or ARB)

Exclusion Criteria:

* Current use or prior use of Dapagliflozin
* Current acute heart failure or prior admission with acute decompensated heart failure in 6 months before entry to study
* NYHA functional class IV
* Chronic renal impairment with GFR \< 30 mL/min/1.73m2
* Pregnant or lactating women
* History of allergy to Dapagliflozin
A Self-guided App-Based Virtual Reality Cognitive Behavior Therapy for Anxiety Disorder in Children

To examine the efficacy of a fully self-guided app-based virtual reality cognitive behavior therapy (VR CBT) using low-cost (cardboard) virtual reality goggles compared with a wait-list control group and to determine its user friendliness. We hypothesize that children with GAD enrolled in the self-guided app will present lower scores of anxiety.

A randomized controlled design will be carried out, in which the effectiveness and user- friendliness of an online app-based VR self-help treatment '0-anxiety' will be evaluated. Our primary objective is to determine the clinical effects (a reduction in anxiety symptoms at post-test \[between the experimental condition and controls\] of 0-anxiety, and whether effects are sustainable at follow-up \[a reduction in anxiety symptoms between baseline and follow-up for those in the experimental condition\]). Our secondary objective is to determine the user-friendliness of 0-anxiety. In this study, 230 children from the Brazilian population will be randomized over 2 conditions: the experimental condition (0-anxiety) and a waitlist condition. The duration of the intervention will be 3 weeks. Measures will be taken at baseline, directly after the intervention (3 weeks) and at 3 months (follow-up). All measures will be completed online. Therefore, the child will participate in the study in his/her natural environment. Subjects in the wait-list condition will receive the intervention after completion of the post-test. Randomization (block-randomization) will be performed by an independent researcher.

Eligibility Criteria:
Inclusion Criteria:

* individuals must be between 8-12 years old;
* subjects must score above 25 on the SCARED questionnaire;
* subjects must have access to a smart phone and internet;
* individuals must be willing to participate in the research study and providing informed consent.

Exclusion Criteria:

* children that present with symptoms of severe depression or suicidality as measured with KSADS-PL26;
* children that have insufficient knowledge of the Portuguese language;
* subjects that are under any current treatment for anxiety disorder or using psychotropic medication.
Screening of Pulmonary Hypertension in Methamphetamine Abusers

Methamphetamine is misuse if classified as a "likely" risk factor for pulmonary arterial hypertension (PAH). Nevertheless the actual prevalence of and a screening strategy for PAH in methamphetamine users have not been established. In this study, the prevalence of PAH will be investigated and its independent risk factors among methamphetamine users will be identified.

Methamphetamine is a potent central nervous system stimulant originally prescribed for individuals with neuropsychiatric diseases. Owing to its highly addictive nature, illicit use has emerged as a major public health problem worldwide. It causes methamphetamine use disorders and also affects cardiovascular (CV) system.

PAH is one of those CV complications and is devastating and often life-threatening. In a subsequent retrospective cohort, patients with idiopathic PAH were found to have a much higher prevalence of prior use of methamphetamine and/or its related compounds, compared with patients with chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to a known associated condition. Although current international guidelines recognize methamphetamines as a "likely" cause of drug-induced PAH, almost nothing is known about its prevalence and incidence amongst methamphetamine users.

Besides, since patients with PAH often remain asymptomatic in the early phase, the diagnosis is often made late in the course of the disease, when most small pulmonary arteries have been obliterated, rendering therapy ineffective. Although the prognosis of patients with methamphetamine-associated PAH appears to be much worse than for those with idiopathic PAH, international guidelines and expert consensus have not considered screening for PAH in asymptomatic methamphetamine users.

This study will apply a current guideline-recommended PAH screening algorithm for systemic sclerosis to a large cohort of unselected methamphetamine users in Hong Kong. The study objectives include: 1) to describe the prevalence of PAH among methamphetamine users using a current guidelines-recommended screening algorithm for PAH in systemic sclerosis; 2) to identify independent risk factors for PAH in methamphetamine users; and 3) to develop a prediction model for PAH in methamphetamine users.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years at enrollment
* report of methamphetamine use in the last 2 years
* diagnosed as amphetamine dependent according to the Diagnostic and Statistical Manual of Mental Disorders (the 5th edition) (DSM-V)(13)
* voluntarily agree to participate by providing written informed consent

Exclusion Criteria:

* failed or refused to provide written informed consent

Reference:

13. Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas 2013;25(2):191-2.
Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R+ Membranous Nephropathy (aMN) (NewPLACE)

This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy

After treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months.

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form \[ICF\]).
* Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h
* Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m² (eGFR \>30 and \< 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of \< 25% in a kidney biopsy)
* Not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to ACEI and ARBs, the reason must be documented and approval for enrollment be obtained from the Medical Monitor.
* Systolic blood pressure (BP) ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest.
* Serum anti-PLA2R antibodies ≥ 50.0 RU/mL determined by Euroimmun ELISA.
* Female subjects: A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

  1. Not a female of childbearing potential (FCBP)
  2. A FCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of MOR202

Key Exclusion Criteria:

* Hemoglobin \< 80 g/L.
* Thrombocytopenia: Platelets \< 100.0 x 10\^9/L.
* Neutropenia: Neutrophils \< 1.5 x 10\^9/L.
* Leukopenia: Leukocytes \< 3.0 x 10\^9/L.
* Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.

Subjects may receive supportive therapies to meet the above criteria

* B-cells \< 5 x 10\^6/L
* Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows MN without evidence of diabetic nephropathy and diabetes is controlled, as shown by:

  1. Glycated hemoglobin (HbA1c) \<8.0 % or 64 mmol/mol.
  2. No diabetic retinopathy known.
  3. No peripheral neuropathy known.
* Total bilirubin, aspartate aminotransferase or alanine aminotransferase \>1.5 x ULN, alkaline phosphatase \>3.0 x ULN.
A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.

The purpose of this clinical trial is to learn about the safety and tolerability of the study medicine (called PF-07941944) in healthy participants.

This study is seeking participants who:

* Are male or female between the ages of 18 and 60
* Are generally healthy

The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and well tolerated.

Participants enrolled in Part 1 will take part in this study for approximately 4 months. Participants enrolled in Part 2 or Part 3 will take part in this study for approximately 2.5 months. Study visits will take place at the study clinic. The study team will also call participants once at the end of the study over the phone.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Body mass index (BMI) of 17.5 to 30.5 kg/m2
* For inclusion of Japanese participants: participants who have 4 Japanese biologic grandparents who were born in Japan.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
* Part 3 only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis, or adverse reaction to midazolam or other benzodiazepines. History of hypersensitivity reaction to midazolam, or any of the formulation components.
Telephone Delivered Weight Loss, Nutrition, Exercise WeLNES Study

This phase III trial compares telephone delivered Acceptance and Commitment Therapy to standard behavioral therapy for improving weight loss in overweight or obese participants. Acceptance and Commitment Therapy focuses on increasing willingness to experience physical cravings, emotions, and thoughts while making values-guided committed behavior changes. Acceptance and Commitment Therapy may work better at improving weight loss compared to standard behavioral therapy.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive ACT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.

ARM II: Participants receive SBT telephone coaching over the course of 12 months, calls 1-16 weekly, calls 17-23 biweekly, and calls 24-25 monthly. Call 1 is 30 minutes in duration, while calls 2-25 are each 15-20 minutes in duration.

Participants are followed up at 6, 12, and 24 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese (body mass index \[BMI\] \>= 27) but not heavier than BMI of 45.5 (measured by weight \& height)
* Wants to lose weight in the next 30 days
* Interested in learning skills to lose weight
* Willing to be randomly assigned to either condition
* Resides in United States (US)
* Has daily access to their own phone and email
* Does not have a medical or psychiatric condition that would limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss, including meeting criteria for binge eating disorder, and meeting criteria for severe depression (CESD \>= 25), or a diagnosis of serious heart disease, diabetes, uncontrolled hypertension, or cancer without written confirmation of approval from their physician office
* Not pregnant, planning to become pregnant or breastfeeding in the next 12 months
* In the past 3 months changed the dosage of prescription medications that can cause a significant change in weight or appetite
* Have not lost more than 5% of their weight in the past 6 months
* Willing and able to read in English
* Not participating in or planning to participate in other weight loss programs
* Has not participated in our other ACT intervention studies
* Does not meet criteria for combined heavy plus binge drinking
* Has access to a Bluetooth-enabled device and Wi-Fi and/or data plan
* Is not planning to have or has not recently had (past 12 months) bariatric surgery
* For outcome data retention, eligibility criteria included: Willing to complete follow-up surveys, and provide email, phone, and mailing address

Exclusion Criteria:

* The reverse of the inclusion criteria
Neural Mechanisms of Successful Intervention in Children With Dyslexia

Dyslexia, an impairment in accurate or fluent word recognition, is the most common learning disability affecting roughly ten percent of children. This proposal capitalizes on cutting edge neuroimaging methods, in combination with reading education programs, to generate a new understanding of how successful reading education shapes the development of the brain circuits that support skilled reading. A deeper understanding of the mechanisms of successful remediation of dyslexia, and individual differences in learning, will pave the way for personalized approaches to dyslexia treatment.


Eligibility Criteria:
Inclusion Criteria:

* Reading difficulties defined as low scores on standardized measures of reading skills

Exclusion Criteria:

* no major contraindication for MRI (braces, metal implants, pacemakers, vascular stents, or metallic ear tubes).
* Because the study involves measurements of reading and language ability, new recruits will be native English speakers.
* Subjects have no history of neurological disorder, significant psychiatric problems
* exclude claustrophobic subjects since an MRI might be uncomfortable for them.