cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease.

Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\&#39;s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\&#39;s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.

Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Parkinson\&#39;s disease diagnosed by the British Parkinson\&#39;s Disease Brain Bank Diagnostic Criteria can come to the hospital accompanied by family members
2. drooling score using the Parkinson\&#39;s Comprehensive Rating Scale (UPDRS) Part II (Item 6) ≥3;
3. MMSE ≥ 10 points (recording the patient\&#39;s education level)
4. Adults over the age of 18
5. The applicant or his/her caregiver must be able to complete the record of the salivation score
6. Patients or family members voluntarily participate and sign an informed consent form.

Exclusion Criteria:

1. Patients with non-primary Parkinson\&#39;s disease
2. Known allergy to dihydroergotamine mesylate
3. Drug-induced hypersalivation, such as olanzapine, antipsychotics, clonazepam and other antiepileptic drugs, as well as direct and indirect cholinergic agonists for the treatment of Alzheimer\&#39;s disease and myasthenia gravis
4. BoNT treatment for saliva within the previous 3 months
5. Patients with symptomatic bradycardia, severe orthostatic hypotension, symptomatic coronary insufficiency, severe organic cardiac damage, severe liver and kidney insufficiency: including ALT≥2.5ULN (upper limit of normal value of the executive laboratory); AST≥2.5ULN (upper limit of normal for the execution laboratory); Creatinine ≥ 1.5 ULN (upper limit of normal at the execution laboratory), active psychosis, pregnancy/pregnant woman
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ

This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
* Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

* Participants taking fluoride supplement
* Pregnant or breast-feeding women
Lumbar Paraspinal Muscle Fatty Infilteration

Introducing a unique clinical case of limb-girdle muscular dystrophy associated with LBP that was initially misdiagnosed as non-specific LBP

This case report describes the history, examination findings, and clinical reasoning used for a patient suffering from LBP as a chief complaint. A new sign appeared in MRI, which prompted the author to change the diagnosis process from lower back pain to a mysterious neurological disease, The MRI revealed widespread fat deposit in the lumbar paraspinal muscles. This MRI sign prompted the authors to do more lab investigation, showing a notably elevated level of creatinine phosphokinase (906 u/L). Further clinical examination revealed proximal muscle weakness, winging of scapula and Bilateral LMN facial palsy. Therefore, the patient was ultimately directed to a neurologist who confirmed the diagnosis of limb-girdle muscular dystrophy

Eligibility Criteria:
Inclusion Criteria:

* experiencing lower back stiffness and a dull back pain

Exclusion Criteria:

* diabetes, heart disease, or muscle disease. any history of previous falls, accidents, surgeries, hospitalizations, and he denied any significant past illnesses, or allergies.
The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation

The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Any condition possibly affecting drug absorption (eg, gastrectomy)
Validation of Urinary Biomarkers of Dietary Intake in Mexican Foods: a Randomize Controlled Trial

A randomized controlled open-label trial will be conducted in Mexico City, recruiting healthy participants who do not consume excessive alcohol or smoke. A selection visit will be conducted during which blood and urine samples will be collected, and assessments of diet, anthropometric measurements, and body composition will be performed.

A randomized controlled open-label trial will be conducted in Mexico City, recruiting healthy participants who do not consume excessive alcohol or smoke. A selection visit will be conducted during which blood and urine samples will be collected, and assessments of diet, anthropometric measurements, and body composition will be performed.

Participants will be randomized into three groups for the intake of meals containing the foods of interest and control without these foods. After the meal consumption including foods of interest, a 24-hour urine sample will be collected by the participants. Urine and blood samples will be analyzed using using untargeted metabolomics in different platforms to determine biomarker concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Body mass index (BMI ) between 18.5 to 30 kg/m2
* Not having allergies to the study foods (ataulfo mango, nopal, guava, avocado, corn tortilla and amaranth).
* Without consumption of dietary supplements at the time of participating in the study.
* Blood chemistry within reference values (glucose \<126 mg/dL, triglycerides \<250 mg/dL, total cholesterol \<250 mg/dL.

Exclusion Criteria:

* The exclusion criteria were participants with any other chronic disease diagnosed by any doctor.
* Were pregnant.
* Smoking habit durig the trial.
* Intake of alcoholic beverages during the trial.
Prognosis of Inpatients Evaluated for Palliative Radiotherapy

Understanding patient's prognosis is of utmost importance to determine radiotherapy's indication and dose/ fractionation. The investigators plan to conduct an observational study of prognosis of inpatients evaluated for palliative radiotherapy at a large cancer hospital in Brazil.


Eligibility Criteria:
Inclusion Criteria:

* All inpatients evaluated for palliative radiation therapy at ICESP (Instituto do Cancer do Estado de Sao Paulo)

Exclusion Criteria:

* Inpatients evaluated whose intent of treatment is curative
* Patients who are unwilling to participate in the study or unwilling to sign informed consent
Minimally Invasive Ridge Augmentation

The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a minimally invasive ridge augmentation technique with and without low level laser therapy. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients were treated with subperiosteal minimally invasive aesthetic ridge augmentation technique. the test group of ten were given low level laser therapy as an adjunct. The clinical and radiographic parameters were recorded at baseline and six months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Single or multiple edentulous sites with Seibert's class 1 defects corresponding to colognes 1 and 2
* ASA 1 and 2
* Patients with an esthetic concern
* Good oral hygiene

Exclusion Criteria:

* Seibert's class 2 defects
* ASA 3 and 4
* Osteoporosis
* uncontrolled diabetes
* immunosuppression
* radiation therapy and bisphosphonate therapy
* Gingival thickness less than 2 mm
Well-being Training for Adolescent Depressive Symptoms (TeenWell Study)

This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms. Up to 200 participants will be on study for 20 weeks.

Participants will be randomized into one of two groups: Healthy Minds Program intervention group (HMP) or a water tracking active control group. The groups will use different mobile health apps for eight weeks. All participants will complete assessments pre-intervention, after weeks 2, 4, and 6 of the intervention, at week 8 (post-intervention), and at week 20 (follow-up). Participants will complete a short daily diary set of questions on their social interactions that day. Participants will wear a Biostrap band for continuous collection of heart rate, movement, and daily sleep indices, and geolocation data will be extracted from participant phones using the FollowMee app. Participants will receive access to the app they were not assigned to after follow-up.

Primary Objective

* Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms.

Secondary Objectives

* Investigate effects of the meditation training program on symptoms of anxiety, behavior (social isolation), psychophysiological processes related to health and disease (e.g., sleep). Test changes in behavior and psychophysiology as mechanisms of improved mental health. Test whether improved mental health is associated with improved academic outcomes.

Eligibility Criteria:
1. Age 14 to 19
2. Currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled
3. Proficient in English
4. Able to understand and provide informed consent (greater than or equal to 18 years old) or assent and parent/guardian consent (if less than 18 years old)
5. PROMIS Depression Scale T-score greater than or equal to 60 or sum of Patient Health Questionnaire-2 (PHQ-2) greater than or equal to 2
6. If on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks
7. Willing and able to complete all study procedures

Exclusion Criteria:

1. Has received a high school diploma or a high school equivalency diploma (HSED or GED)
2. Weekly or more frequent meditation practice
3. Prior use of the Healthy Minds Program app
4. Prior use of the water tracking app
5. Endorses current suicidal thoughts on the baseline screen
6. Self-reported history of psychosis or mania
7. Currently receiving, history of receiving in the last 6 months, or planning to start any of the following types of therapy within the next 5 months: Acceptance Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), and other mindfulness-based therapies (e.g., Mindfulness-Based Cognitive Therapy). For history of receiving only, only excluded if the participants has used the techniques on a weekly more frequent basis in the last 6 months.
Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)

The purpose of this study is to perform a randomized, controlled clinical trial to investigate if the phosphate binder sevelamer can improve insulin resistance and glucose handling in patients receiving maintenance hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18-80 years of age with chronic renal failure treated with maintenance HD for \>3 months.

Exclusion Criteria:

* Diabetes mellitus
* Treatment with sevelamer within 3 months prior to enrollment
* Acute, clinically significant inflammation within 1 month prior to enrollment
* Pregnancy or breast-feeding
* Clinically significant obstipation or bowel obstruction
* Discontinuation of previous sevelamer treatment because of side effects
* Expected time in HD \< 1 year
* Unwillingness to undergo the investigations and follow-up required in the the protocol
* Patients who have received any investigational drug within 1 month prior to enrolment
* Participation in another study, which may interfere with the present study
Relaxation Treatment for Anxiety in Adults Aged 60 or Older

The PI developed a self-directed program to treat late-life anxiety called Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This program consists of weekly video lessons that participants watch on digital video disc (DVD) along with weekly telephone check-ins. In BREATHE participants will learn two behavioral interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose of the study is to examine whether the self-directed BREATHE program is superior to a wait list control in reducing anxiety in older adults with anxiety disorders. For those assigned to wait list control, they will be offered opportunity to participate in BREATHE treatment after 8 weeks of wait list.


Eligibility Criteria:
Inclusion Criteria:

* Participants have a diagnosis of an anxiety disorder, specifically, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder or Anxiety Disorder Unspecified/Other Specified).
* Participants speak English.

Exclusion Criteria:

* Diagnosis of Dementia
* Probable presence of significant cognitive impairment according to a brief cognitive screen
* Serious mental illness (schizophrenia, psychosis, bipolar disorder)
RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears

The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.

The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes.

Patients were screened using clinical history and signs.

Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:

* positive vital staining of the ocular surface,
* decreased tear breakup time (TBUT),
* reduced corneal sensitivity, and
* decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.

Eligibility Criteria:
INCLUSION CRITERIA

Patients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:

Group 1: Clinical Dry Eyes

Clinical History Criteria

An Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - \[Appendix #2\]

Clinical Signs Criteria - All of the following must be present

1. Schirmer's Tear Test (with anesthesia) \< 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) \< 10 seconds
3. Total Corneal Staining ≥ 1 \[Appendix #1\]

   * At least 1/2 of all patients enrolled will have a Schirmer's Tear Test \< 5 mm or demonstrate corneal staining ≥ 2 \[Appendix #1\]

Group 2: Clinical Normal Non-Dry Eyes

Clinical History Criteria

An Ocular Surface Disease Index (OSDI) of \< 7 - \[Appendix #2\]

Clinical Signs Criteria - All 3 of the following must be present

1. Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) ≥ 10 seconds
3. Total Corneal Staining = 0 \[Appendix #1\]

EXCLUSION CRITERIA

* Patients with allergy to corn starch, talcum powder, or dacron
* Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months
* Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis
* Patients with history of a recent ocular infection within the prior 1 month
* Use of oral doxycycline or topical macrolides (AzaSite) within 1 month
* Patients currently receiving, or received in the last 2 weeks of the study , certain medications including topical or systemic corticosteroids, topical or systemic Nonsteroidal (NSAIDs) therapy, topical cyclosporine, or other immunosuppressive therapy
* Patients who are pregnant or lactating
* Before initialization of the study, patients must not have used any topical medications, including artificial tears during the previous 2 hours
* The use of Rigid-Gas permeable contact lenses or the use of soft-contact lenses within 1 month of the study
Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years

Eligibility Criteria:
Inclusion Criteria:

* healthy men or women,
* age 18 to 45 years inclusive;
* normal medical history and physical examination; and
* no clinically significant abnormalities from:
* urine dipstick for glucose, protein, and blood
* complete blood count,
* serum hepatic transaminases,
* total bilirubin (direct if abnormal),
* creatinine,
* electrolytes,
* albumin, or
* electrocardiogram.
* Women must have a negative pregnancy test.

Exclusion Criteria:

* travel to a cholera endemic area in the previous 5 years;
* abnormal stool pattern or regular use of laxatives;
* history of eating disorders (such as bulimia), anal or rectal disorders, allergy to tetracycline and/or ciprofloxacin;
* history of cholera or enterotoxigenic E. coli challenge or infection;
* current or recent antibiotic use;
* pregnancy or nursing;
* positive serology for HIV, hepatitis B antigen, or hepatitis C;
* any immunosuppressive medical condition;
* history of hospitalization for psychiatric illness or use of specific psychiatric drugs.
The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.

The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.


Eligibility Criteria:
Inclusion Criteria:

-Without fever for 72 hours prior to vaccination

Exclusion Criteria:

* Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine
* Known or suspected to be immunocompromised
* Functional or anatomic asplenia
* History of autoimmune disease
* Evidence of dementia or cognitive impairment
* Use of any immunosuppressive therapy
* Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
* Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
* Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
* Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
* History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
* Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

The study is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants with Celiac Disease (CeD) on a gluten free diet (GFD). The 3 parts include:

* Part A - Open-label, multiple ascending dose
* Part B - Double-blind, placebo-controlled, parallel design
* Part C - Double-blind, placebo-controlled, parallel design

Part A is a Phase 1b, open-label, multiple ascending dose (MAD) study design to assess the safety, tolerability, and pharmacokinetics (PK) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. Up to 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 dose levels of KAN-101. The overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. There will be a gluten challenge test (GC) on Day 15.

Parts B and C are Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following GC, safety, tolerability, and PK of KAN-101 in adult participants with histology-confirmed CeD. Approximately 16 participants (4 participants per dose group) will be enrolled in Part B and 104 participants (26 participants per dose group) enrolled into Part C. Participants will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with KAN-101 doses based on information obtained from Part A.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of celiac disease based on histology and positive celiac serology
* HLA-DQ2.5 genotype
* Gluten-free diet for at least 12 months
* Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening

Exclusion Criteria:

* Refractory celiac disease
* HLA-DQ8 genotype
* Previous oral gluten challenge within 12 months
* Selective IgA deficiency
* Diagnosis of Type-1 diabetes
* Active gastrointestinal diseases
* History of dermatitis herpetiformis