cyrilzakka/clinical-trials huggingface dataset:
Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis

This study aimed to assess clinically and biochemically the effect of intrapocket application of tea tree oil (TTO) gel adjunctive to SRP in the management of stage 2(moderate) periodontitis and to correlate the biochemical levels with clinical response.

A randomized, controlled clinical trial included thirty patients with stage 2 periodontitis. They were equally divided into two groups: Group 1 (control group) treated with scaling and root planning (SRP) alone and Group 2 (test group) managed by SRP and locally delivered 5% tea tree oil (TTO) gel.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stage 2,grade B periodontitis according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
* Patients with CAL 3-4 mm , BOP and radiographic horizontal bone loss related to the coronal third of the root (15%-33%).
* Patients with no teeth loss due to periodontitis.
* Patients with radiographic bone loss/age % of 0.25-1 %.
* Patients who could maintain an O'Leary plaque index ≤10 proceeded into the study.

Exclusion Criteria:

* Patients with CAL caused by non periodontal causes.
* Patients with grade C periodontitis.
* Patients having any systemic disease that may affect the treatment outcomes
* Smokers.
* Pregnant females.
* Patients receiving contraindicated medications, chemotherapy, or radiotherapy in the previous year.
Hypoxia and Heart Rate Variability

The purpose of this study is to evaluate how variations in oxygen demands may change heart electrical activity in individuals with and without oxygen dependence.


Eligibility Criteria:
Healthy Participants

Inclusion Criteria:

• Ability to provide consent

Exclusion Criteria:

* BMI \> 40 kg/m2
* Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, cancer, and active psychiatric disease (e.g., major depression)

Nocturnal Hypoxemia

Inclusion Criteria:

* Ability to provide consent
* Chronic respiratory condition resting Sat \< 95% off oxygen

Exclusion Criteria:

* BMI \> 40 kg/m2
* Prevalent myocardial infarction, coronary revascularization, heart failure, and stroke
* Unstable medical conditions that may preclude enrollment in the protocol such as: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension, severe chronic obstructive pulmonary disease, cancer, and active psychiatric disease (e.g., major depression)
Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring

The purpose of this study is to identify out of up to three doses a safe and effective dose of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.


Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects aged 18-70
* Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring
* Subjects with a peak Snoring Index \[SI\] ≥ 15/ hour of sleep \[h\] at baseline visit
* Subjects with a bed partner for at least three months prior to study start.
* Subjects who understand the nature of the study and provide written Informed Consent at screening visit.
* Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study

Exclusion Criteria:

* Obese subjects (Body Mass Index ≥ 30)
* Subjects with severe obstructive sleep apnea syndrome
* Subjects with Apnea-Hypopnea Index ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index ≥ 25 / hour of sleep at the baseline visit
* Subjects who have undergone any Botulinum neurotoxin treatment in the history
* Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
* Acute infections of the pharynx
Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions

This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
2. Hemoglobin A1c (HbA1c) \<6.5% at screening.
3. BMI ≥30 kg/m².
4. BMI ≥27 kg/m² and \<30 kg/m² with at least 1 weight-related comorbidity:

   * hypertension
   * dyslipidemia
   * cardiovascular (CV) disease
   * obstructive sleep apnea
5. Have a stable body weight (\< 5% change) for the 3 months prior to randomization.

Exclusion Criteria (Obesity Related):

1. Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
2. Have a prior or planned surgical treatment for obesity.
3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner.
4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.

Exclusion Criteria (Medical Conditions)

1. Diabetes.
2. Have a history of acute or chronic pancreatitis.
3. Have current symptomatic gallbladder disease or biliary disease.
4. Have known liver disease other than MASLD.
5. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
6. Have a serum calcitonin ≥20 pg/mL.
7. Have an eGFR \<30 mL/min/1.73 m², as determined by the central laboratory at screening.
8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
9. Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1.
Clinical Effects of Locally-delivered Gel Containing Camella Sinensis Extracts as an Adjunct in Peridontitis Treatment

The purpose of this study is to evaluate clinical result including plaque index, gingival inflammation, bleeding score, pocket depth reduction and clinical attachment level gain after used locally-delivered gel containing Camella sinensis extracts as an adjunctive treatment in periodontal therapy


Eligibility Criteria:
Inclusion Criteria:

* subjects have sound tooth with pocket depth = or \> 5 mm. without caries, restoration, mobility and furcation involvement
* no systemic complicated factors
* no allergy to green tea or product of green tea
* signing in informed consent form

Exclusion Criteria:

* smoking
* pregnancy or lactation
* antibiotic premedication or antibiotic intake in previous 3 month
Vitamin D Deficiency and Pregnancy Rates in Women Undergoing Frozen Embryo Transfer

Vitamin D receptors are present and differently expressed in murine endometrium and ovary throughout the estrous cycle , whereas knock-out experiments have shown that vitamin D receptor null mice experience uterine hypoplasia and impaired folliculogenesis.

Only few retrospective studies examining the role of vitamin D levels in infertile patients have been published up to date, whereas results are strongly contradictory, with some supporting that maternal vitamin D deficiency is associated with lower pregnancy rates and others demonstrating that vitamin D deficiency does not affect final reproductive outcome.

Finally, a recent retrospective study postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium, given that vitamin D deficiency was not correlated with ovarian stimulation characteristics or with markers of embryo quality in this study.

In order to examine a potential negative effect of vitamin D deficiency on pregnancy rates, mediated through the endometrium, the aim of the current study was to examine the impact of vitamin D levels on pregnancy rates only in an infertile population undergoing embryo transfer of frozen-thawed embryos.


Eligibility Criteria:
Inclusion Criteria:

* All women undergoing a frozen ET with 1 or 2 Day 5 (blastocyst stage) embryo
* Age 18-39

Exclusion Criteria:

* Women \> or = 40 years old
* IVM ET
* Uterine abnormalities
Real World Study of MPM in China

Malignant pleural mesothelioma (MPM) is a highly aggressive tumor with atypical clinical manifestations. Most patients with MPM are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. Pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for MPM. In recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. Targeted and immunotherapy may bring breakthroughs in MPM therapy. However, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of MPM patients in China.

Focusing on MPM, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. On this basis, we will estimate MPM incidence and mortality rates from 2014 to 2025 based on the data published by the National Cancer Registry. Meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of MPM patients. Also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed as malignant pleural mesothelioma
* Aged over 18

Exclusion Criteria:

* Follow-up less than 3 months
Investigating the Effects of Intensity of Transcranial Direct Current Stimulation on Subjective Appetite

This is a randomized double-blind sham controlled systematic investigation to understand the importance of the brain region that controls the tongue and the submental muscle region on perceived appetite. The results of this study can have clinical implications for a phenomenon called hyperphagia.

After explaning all the procedure and the scientific aims of the project to participants and completing the informed consent form, each participant will be randomly asked to take part in the experiment while fasting for at least 6 hours or completely sated, to enable an investigation of the role of the basic level of hunger on the effects of brain stimulation on subjective appetite. Different intensities of stimulation (1 mA, 1.5 mA, and sham) will be used in three separate groups, to which participants will be randomly assigned, in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

* Normal weight, based on the Body Mass Index (BMI)
* Males and females between 18 and 35

Exclusion Criteria:

* Use of psychoactive drugs
* Presence of metal implants in the brain, skull, scalp or neck
* Use of pacemaker
* Neurological or psychiatric pathologies
* History of severe head injury
* Pregnancy
* Clinical obesity based on BMI
Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder

The "Brain Over Binge Recovery Guide" (Hansen, 2016), is a self-help approach that incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behavioural Therapy, Motivational Enhancement Therapy and addictions treatment. This approach has been streamlined into a guided self-help protocol (Binge Focused Therapy, or BFT) that can be delivered by undergraduate students with minimal mental health experience in 3 group sessions spread over 8 weeks (i.e., Week 1, Week 2, Week 8). The aim of this proof-of-concept study is to provide preliminary data to examine whether this approach is feasible and has clinical potential for patients with binge eating disorder.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Meets DSM-5 criteria for moderate to severe Binge Eating Disorder (BED) as determined through screening interview by an eating disorder psychiatrist and validated with the Eating Disorder Diagnostic Scale (a self-report screening tool);
* Provides written informed consent.

Exclusion Criteria:

* Currently receiving treatment for BED;
* Is taking a psychotropic medication (e.g., antidepressant, stimulant, etc.) AND the dose has been changed 2 weeks prior to baseline;
* Insufficient knowledge of English.
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF

The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.

The objective of this evaluation is to collect and compare short-term factors related to the morbidity of approach using traditional posterior-approach interbody fusion techniques and a less invasive exposure for the same procedure. Perioperative measures and early outcomes will be documented to demonstrate differences in procedural requirements, safety, and early recovery. A total of 100 subjects will be consecutively enrolled in this prospective study from as many as 8 centers. Patients who, in the surgeon investigator's opinion, require instrumented lumbar interbody fusion and have consented to PLIF surgery for their conditions will be included. The following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. All subjects must meet the inclusion/exclusion criteria in order to be considered for enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all inclusion criteria to be eligible for enrollment into this observational study:

  1. Indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between L1 and S1;
  2. 18+ years of age at the date of written informed consent;
  3. Able to undergo surgery based on physical exam, medical history and surgeon judgment;
  4. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol;
  5. Signed and dated informed consent form.

     Exclusion Criteria:
* Subjects presenting with any of the following will not be included in this observational study:

  1. Mental or physical condition that would limit the ability to comply with study requirements;
  2. Spine abnormality requiring treatment at more than two levels;
  3. Prior surgery at operative or adjacent level(s);
  4. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested);
  5. Significant general illness (e.g., HIV, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease);
  6. Participating in another clinical study that would confound study data.
Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events

Despite the rapid development of medical and nursing technology, the prognosis of valvular heart disease has been greatly improved. However, compared with young patients, the mortality and adverse event rate of elderly patients with valvular heart disease are still high, surgical complications are more frequent and hospitalization time is longer. The complexity of valvular heart disease and the poor prognosis in the elderly forces us to continue to look for other potential prognostic factors. In addition to the adverse outcomes caused by disease factors, elderly patients with valvular heart disease also have the gradual decline of physiological and psychological reserve function caused by age factors. These adverse outcomes include osteopenia, disability, prolonged hospitalization and even death are all closely related to frailty. Frailty is 'a biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems, and causing vulnerability to adverse outcomes. The essence of frailty is the decline of individual resistance, which eventually leads to the increase of individual brittleness and susceptibility to adverse health outcomes. At present, the research in the field of elderly vulnerable groups of cardiovascular disease in China started late, mostly focusing on the study of pathological mechanism, the introduction of evaluation tools, conceptual analysis and so on. Almost all of the existing studies are about the debilitation status of elderly patients with heart valve disease, and most of them mainly try to find the influencing factors of debilitation from the aspects of patients' physical diseases, ignoring the impact of factors such as the mental health status of the elderly on debilitation, there are few reports of short-term adverse events in elderly patients with valvular heart disease. This study will analyze the influencing factors of the weakness of elderly patients with valvular diseases from the multi-dimensional aspects of demographic data, physical diseases, psychology and society, and track the short-term prognosis of patients with death, fall and unconventional rehospitalization, so as to provide a research basis for relevant research in the future.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 65 years;
* Willing to continue to participate in this study;
* Diagnosed as valvular heart disease

Exclusion Criteria:

* suffering from other irreversible serious diseases;
* with severe mental disorders;
* cannot accept frailty assessment due to treatment needs and other factors.
Exercise Training and Kidney Transplantation

The goal of this clinical trial is to investigate the physiological and molecular effects of exercise training in transplant recipients. The main questions it aims to answer are:

1. Can exercise training improve physical fitness and muscle strength in transplant recipients?
2. Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients?
3. Can exercise training improve blood pressure and endothelial health in transplant patients?

Participants will be invited to an exercise training program 6-month after their transplant surgery. Body composition, physical assessment, and blood draw will be assessed at baseline and 12-weeks after exercise or control regimen.

Researchers will compare exercise group vs. routine care group to see if exercise training impact the health-related outcomes of this population.

The study will involve inviting participants to join an exercise training program six months after their transplant surgery. The research will include baseline assessments and measurements, such as body composition, physical assessment, and blood draws. These assessments will be conducted both at the beginning of the study and 12 weeks after participants have undergone either the exercise regimen or a control regimen.

The research team will compare two groups: the exercise group and the routine care group. The goal is to examine whether participating in an exercise training program has a significant impact on various health-related outcomes in transplant recipients when compared to individuals receiving standard care.

This clinical trial seeks to understand the potential benefits of exercise training on physical fitness, quality of life, inflammatory and molecular profiles, as well as cardiovascular health in individuals who have undergone organ transplantation. The comparison between the exercise group and the routine care group will provide valuable insights into the effectiveness of exercise interventions for this specific population.

Eligibility Criteria:
Inclusion Criteria:

* Medical Authorization:
* Stable Health Status
* Medication Consistency
* No History of Severe Cardiovascular Events
* No Major Orthopedic Issues
* Non-Smokers or Consistent Smoking Habits
* Ability to Comply with Study Protocols

Exclusion Criteria:

* Inability to Comply
* Cognitive disorders
* Unwillingness to Continue
* Unstable Health Conditions
* Physical limitations during the protocol
At-Home Care for Subjects With Periodontitis

The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-75 years
* Exhibiting Stage I or II periodontitis
* Minimum of 20 'scorable' teeth (excluding 3rd molars)
* Regular manual toothbrush user
* Have a minimum average plaque score of \> 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation
* Agree to desist use of interproximal cleaning aids and other prohibited devices or medicaments during the study period
* Be a non-smoker (\> 10 years), or never smoker

Exclusion Criteria:

* Have a cardiac pacemaker or implanted cardiac defibrillator
* Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment
* Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion
* Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
* Have had a professional prophylaxis within 4 weeks of the study
* Prior chemotherapy, immunotherapy or radiation therapy within last 10 years