cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Compare Dental Plaque Control

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Evaluation of dental plaque control for two prototype toothpastes will be determined by comparison to two control toothpastes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers at least 18 - 53 years of age
* Good general health
* Must sign informed consent form
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus).
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affecting salivary function
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance which interferes with plaque scoring.
* History of allergy to common dentifrice ingredients.
* History of allergy to arginine (amino acid)
* History of allergy to bicarbonate
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Association of 5-HT3 Receptor Gene Polymorphism With the Efficiency of Ondansetron for Postoperative Nausea and Vomiting

Postoperative nausea and vomiting (PONV) is a common and distressing complication in patients undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have significantly reduced PONV, it is reported that over 35% of patients treated with ondansetron experience PONV. Though the cause of failure in ondansetron treatment is not clear, the investigators assumed that polymorphism in the 5-HT3 receptor gene would contribute to such inter-individual variation. In this study, the investigators examine whether the polymorphisms of 5-HT3 receptor gene affect the efficacy of ondansetron to prevent PONV in patients undergoing general anesthesia for laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-90 years of age) scheduled for undergoing laparoscopic surgery undergoing general anesthesia

Exclusion Criteria:

* Patients with previous history of drug allergy,
* administration of antiemetic drugs within 24 hours,
* nausea/vomiting within 24 hours and liver or kidney disease
A Study to Assess Deucravacitinib Post-marketing Surveillance in Participants With Psoriasis in Japan

The purpose of this study is to determine the safety and effectiveness of deucravacitinib for the treatment of plaque psoriasis (PsO) in Japan participants.


Eligibility Criteria:
Inclusion Criteria:

* Psoriasis (PsO) participants who received Deucravacitinib for the first time of the approved indications at medical institutions in Japan will be enrolled in this PMS

Exclusion Criteria:

* Participants receiving Deucravacitinib for an off-label indication will be excluded from this PMS.
A Registry of COPD Patients to be Used for Future Studies

To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies.

To develop a cohort of COPD participants for study staff to determine the most likely candidates for future studies and to develop a repository of blood from subjects with COPD for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years of age and older who have been diagnosed with COPD by at least one of the following:

  * clinical history-a documented history of COPD, emphysema, or chronic bronchitis;
  * pulmonary function results (defined as an FEV1/FVC less than 0.7;
  * radiographic results (high-resolution CT findings of emphysema

Exclusion Criteria:

* in ability to give informed consent
* prisoners
* pregnancy
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male and female age 18 and above
* Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
* Have an inadequate response to methotrexate
* In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
* Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
* Have hsCRP of ≥ 0.8 mg/dL (8mg/L) \[by central laboratory values\] or an ESR ≥ 28 mm/hr
* Willing to use effective birth control for the entire length of the study

Exclusion Criteria:

* Diagnosed with juvenile Rheumatoid Arthritis
* Have been treated with other biologic treatment than a TNF inhibitor
* Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
* Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
* Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
* Have other autoimmune disease other than RA like lupus, multiple sclerosis
* Have significant concurrent medical condition at the time of screening or baseline visit
Cueing and Pilates in Low Back Pain

The intervention involved two groups participating in supervised Pilates sessions, twice a week for 8 weeks, featuring a mix of mat and props-based exercises. Group 1 received additional cueing training to enhance alignment, muscle engagement, and movement technique, while Group 2 underwent the same Pilates regimen without this cueing component.

The study involved two distinct groups, both of which engaged in Pilates sessions lasting for 60 minutes, held twice a week over eight weeks. These sessions were meticulously overseen by certified Pilates instructors, who brought to the table a wealth of experience. The regimen for the Pilates program was comprehensive, incorporating a blend of exercises performed on mats and with the aid of various props.

The first group, Pilates with cueing, consisted of participants who, before starting the main Pilates sessions, were given additional training. This preliminary phase involved two smaller group sessions where the focus was on learning explicit verbal and tactile cueing. These cues were specifically designed to aid participants in maintaining proper body alignment, engaging the correct muscle groups effectively, and refining their overall movement technique. Throughout the Pilates sessions, instructors provided real-time feedback, aiming to optimize the execution of exercises based on these cues.

The second group, known as Pilates without cueing, participated in an identical Pilates program to that of the first group in terms of the exercises performed, the duration of sessions, and the overall timeframe. However, this group did not receive the preliminary cueing instruction. They performed the Pilates exercises following the same program as the first group but without the added focus on cueing for alignment, muscle engagement, and technique refinement.

Eligibility Criteria:
Inclusion:

* Individuals aged 18 to 65 years.
* Experiencing chronic non-specific low back pain for a minimum of 3 months.
* Ability to participate in supervised exercise programs.
* Absence of medical contraindications for Pilates practice.

Exclusion:

* Vestibular disorders.
* Severe osteoporosis.
* Usual Pilates practitioner.
Trial to Investigate the Influence of the Homeopathic Remedy Naja-comp on Stroke Therapy in Geriatric Rehabilitation

The homeopathic remedy 'naja-comp' will improve functional outcome measured by the Barthel-Index.

The homeopathic remedy 'naja-comp' will decrease complications during geriatric rehabilitation measured by rate of unplanned discharge to hospital.

Secondary outcome for functional improvement are Scandinavian Stroke Scale, 4D+S-Scale and Timed-Up\&Go-Test.

Eligibility Criteria:
Inclusion Criteria:

* stroke within 60 days after onset

Exclusion Criteria:

* stroke by injury or tumor
* stroke older than 60 days
* missing consent for participation
* participation at other clinical trials
Effects of 8 Week Plyometric Training on Physical Fitness and Technical Skills in Young Male Volleyball Players

This study aims to find the effectiveness of Plyometric training on Physical fitness and Technical skills of young male volleyball players. Players would be taken from Prime Sports Academy and Prime Institute of Health Sciences, Islamabad and a well-designed Plyometric training plan will be implied on them for 8 weeks. After the time span, the result would be compared to check the effectiveness of the training plan.

Volleyball, invented by William Morgan in 1895, boasts a global participation of approximately 500 million people, making it a dynamic and fast-paced sport with diverse technical, tactical, and athletic demands. The game places high requirements on players' speed, agility, power, and strength. In the Netherlands, it is one of the most played team sports, with over 12,500 athletes participating. Volleyball is considered safer than other sports like football, handball, and basketball. Plyometric training (PT) is a key focus for coaches and professionals aiming to enhance players' conditioning capacities.

Plyometric jump training (PJT) has been identified as beneficial for both amateur and professional volleyball players, emphasizing the importance of training for repeated jumping, frequent sprinting, and directional changes. A meta-analysis by Ramirez et al. (2020) found that PJT effectively improved players in various age groups and genders while being deemed safe for volleyball players. Gjinovci et al. (2017) conducted a Randomized Control Trial, revealing greater improvements in plyometric group participants compared to skill-based training, particularly for sprinting, jumping, and throwing performance in players above 18 years of age.

Given the lack of a structured training plan for volleyball players, the study proposes implementing a structured plyometric training plan. This approach aims to enhance physical fitness and technical skills, including improved landing mechanics, increased explosive power, muscle strength, and agility. The study anticipates incorporating the structured plyometric training plan into the domestic players' training protocol, with a focus on improving rate of force development (RFD) for explosive movements such as jumping and spiking, as well as enhancing speed and agility for quick and coordinated on-court actions. The ultimate goal is to evaluate whether the proposed training plan positively impacts players' technical skills and physical fitness.

Eligibility Criteria:
Inclusion Criteria:

* Young male healthy volleyball players aged 18-25 years, actively engaged in games for at least 6 months will be included in the study.

Exclusion Criteria:

* Female players
* History of trauma/injury in the last month.
Mapping the Longitudinal, Multidimensional Impact of MS in Relation to Variables Indicative of Neurological Reserve

Some MS patients quickly accumulate neurological deficits, while others remain well for decades. Even though associations with age, sex, health behaviors, comorbidities and social determinants of health are widely acknowledged, the clinical heterogeneity in MS is poorly understood and variables with a robust prognostic value are lacking. Recent data suggest a key role for resilience in the central nervous system, potentially supporting the concept of neurological reserve in MS.

The first phase of the study will take place at the National MS Center Melsbroek (NMSC). All data from the EDMUS database, a single center database at the NMSC, will be exported and checked (quantity, quality) aiming to come to a well-organized MS data structure. This MS register will be completed with volume data (intracranial, spinal canal) in a subset of patients. As a substantial number of MS patients are followed over the long-term in the MS center, the investigators expect to have longitudinal data well beyond a disease duration of 10 years at least for part of the patients. Following the export and cleaning phase of the data, the investigators will come to the basic descriptive statistics. This allows us to have an overview of all data and determine the most appropriate baseline variables or covariates as well as to define the most appropriate outcome variables. Multivariable regression analysis will be used to predict the value of outcome variables based on the independent variables whose values are known. In view of the relevance of age and disease duration in the context of MS disability and progression, time-to-event analysis will be performed, with the time to reach irreversible milestones of ambulatory disability as outcome.

In case of associations, the second phase of the study will be initiated for further analysis at the AIMS research group, VUB. At the AIMS group, VUB, the potential of false positive findings will be addressed using more sophisticated approaches (splitting cohorts in exploratory and discovery cohort, or cross-fold validation).

Eligibility Criteria:
Inclusion Criteria:

diagnosis of MS needs to be based on diagnostic criteria valid at the time of data entry and confirmed during follow up

Exclusion Criteria:

* Neuromyelitis Optica diagnosis, AQ4 positive or MOG positive
A Psychoeducation Intervention for Caregivers of Patients With Bipolar Disorder

Bipolar disorder is a debilitating chronic illness characterized by periods of elation and depression. Since deinstitutionalization of the mentally ill over 40 years ago, families have become major caregivers for patients with bipolar disorder . This illness imposes a substantial and chronic burden on family caregivers Despite their persistent stress and burden, these caregivers have been largely ignored. Interventions to help them have been very limited. One comprehensive intervention was developed and implemented by Miklowitz (2008) and has shown to be effective in reducing caregiver depression and improving health outcomes. However, this intervention and is highly complex, long, and was given on an individual basis, significantly raising the cost of the program. One core component of the Miklowitz (2008) intervention is psychoeducation, which provides the fundamental support and information needed to caregivers on an individual basis.

In this pilot study, the intervention group will receive 7 weekly psychoeducation sessions. After completion of these sessions in the intervention group, the wait list control group will receive the same weekly sessions. In this study, the investigators plan to test the feasibility and potential efficacy of this specific psychoeducation intervention implemented in a group setting. The investigators will also examine the effects of this psychosocial intervention on biological mechanisms (cortisol and inflammatory biomarkers) and health outcomes.

The specific aims are to:

1. Test the feasibility of implementing a 7-week group psychoeducation program for family caregivers of patients with bipolar disorder by assessing recruitment and retention rates, attendance, satisfaction with the program, and data and sample collection rate.
2. Explore the effect of the intervention on caregiver outcomes (depression, burden, health status, mental wellbeing, cortisol, interleukin (IL)-1 and IL-6 levels.

The intervention will be delivered by at the University of Texas Health Science Center at Houston Center of Excellence for Mood Disorders (CEMD) and at the University of Texas Health Science Center at Houston School of Nursing. Forty family caregivers of patients with bipolar disorder will be recruited into the study.


Eligibility Criteria:
Inclusion Criteria:

* primary family caregiver of a patient with Bipolar Disorder who is age 16 or older;
* live within a 70 mile radius of the Center for Excellence in Mood Disorders (in the Texas Medical Center)

Exclusion Criteria:

* unstable major medical illness;
* health condition that may impact biomarker levels, e.g. is taking corticosteroids or anti-inflammatory drugs;
* unable to read, write, or speak English
Phase II Pre-operative Vitamin D Supplementation to Prevent Post-thyroidectomy Hypocalcemia

One of the major side effects of surgery to remove the thyroid gland is transient (lasting for a short time) low calcium levels in the blood, or "hypocalcemia." Low calcium levels can cause symptoms such as numbness around the mouth, tingling or cramping in the hands and feet, severe muscle spasms, inability to breathe, or heart rhythm (heart beat) abnormalities. Severe symptoms are life threatening, so it is important to start the management of these symptoms in the hospital. Treating low calcium levels sometimes require patients to spend a few extra days in the hospital.

The human body needs vitamin D to function and stay healthy. Vitamin D helps the body get the calcium needed to make strong bones and teeth. The purpose of this study is to determine if taking vitamin D before surgery to remove the thyroid gland affects whether or not you may have low calcium levels after your surgery and to test the hypothesis that those who are given the Vitamin D before surgery will have decreased hypocalcemia and a shortened hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for thyroidectomy
* Agreement to use contraception prior to and during the study

Exclusion Criteria:

* Hypercalcemia (\>10.5mg/dL)
* Chronic kidney or parathyroid disease
* Cardiac or Central Nervous System disease
* Pregnant or breastfeeding women
Risk Factors for Polypharmacy in Older Adults

Patients who were 65 years old or older and applied to Melek Hatun family practice center were enrolled in the study. All patients were seen either in our center or in their homes, and informed consents were obtained. Comprehensive Geriatric Assessment (CGA) was performed for each subject. Data were evaluated by PASW 17. The amount of medicines that the patient used everyday (DDC) was dependent variable. Relationships between DDC and other continuous variables were examined by Pearson's correlation. For categorical independent variables, t-tests were performed.

1000 patients who were 65 years old or older and applied to Melek Hatun family practice center either in person or through a relative between 01 December 2014 and 01 August 2017 were enrolled in the study. All patients were seen either in our center or in their homes, and informed consents were obtained. Comprehensive Geriatric Assessment (CGA) consisting of detailed history and examination, drug consumption information, Body Mass Index (BMI), Waist Circumference (WC), Timed Up \& Go test (TUG), Clock Drawing Test (CD), Activities of Daily Living and Instrumental Activities of Daily Living scales (ADL \& IADL), Mini Mental State Examination (MMSE), Tinetti Gait and Tinetti Balance scores (TG \&TB), 30 items Geriatric Depression Scale (GDS) was performed for each subject\[8-16\]. Additional tests like blood examinations or ECG were performed on the basis of necessity. Metabolic Syndrome (MS) was diagnosed according to WHO criteria \[17\].

Data were evaluated by PASW 17. The amount of medicines that the patient used everyday (Daily Drug Consumption-DDC) were dependent variable. Relationships between DDC and other continuous variables were examined by Pearson's correlation. For categorical independent variables, t-tests were performed. The variables which were found associated with DDC were controlled for confounding variables by linear regressions. To avoid collinearity problems, variables that were strongly interrelated (like CD and MMSE) were not added to the regression model together. For all analyses, the level of significance was assumed as 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 65

Exclusion Criteria:

* Patients under 65 years
* Patients who do not want to participate in the study
Exploring the Perspectives and Experiences of PrEP-eligible Black Women in Texas in Relation to Readiness for PrEP Uptake and Adherence

The aim is to conduct two virtual focus groups (10 participants in each group) with 20 pre-exposure prophylaxis (PrEP)-eligible Black women in Houston and Austin, TX. Participants will be assigned to focus groups with other women based on their position about PrEP uptake (considered use versus not considered use). Focus group questions will build on an ecologic model framework to inquire about participant's intrapersonal, interpersonal, and community-level factors that influence access to and use of HIV prevention services. This strategy aims to examine potential barriers to PrEP uptake among PrEP-eligible women in two Texas' hotspots.


Eligibility Criteria:
Inclusion Criteria:

* assigned female sex at birth
* identify as Black or African American
* 18 years of age or older
* have had condomless sex with a cisgender man within the past 12 months
* fluent in English or Spanish
* have a phone or internet access
* not currently on PrEP and have never taken PrEP

Exclusion Criteria:

* choose not to identify as Black or African American
* unable to provide informed consent for participation (e.g. have severe cognitive impairment that would interfere with their ability to consent)
* have psychological distress that would prohibit them from participating in the study
* unable or unwilling to meet study requirements
* ineligible for HIV prevention services \[i.e., Human Immunodeficiency Virus (HIV) Positive\]
* received a prescription for PrEP within 12 months
* has a history of PrEP uptake or is currently on PrEP
Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure

Incarceration and necrosis of rectal prolapse is rare and often requires urgent management. Perineal rectosigmoidectomy (Altemeir procedure) is a reasonable technique for this condition. The need for a diverting stoma depends on the patient's condition and the experience and judgement of the surgeon. A literature review was performed to determine optimal management of incarcerated and necrotic rectal prolapse, and to determine the indication for fecal diversion.


Eligibility Criteria:
Inclusion Criteria:

* 2 cases incarceration rectalprolapse

Exclusion Criteria:

* N/A
Specified Drug Use-results Survey of Betanis Tablets

To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as OAB and treated with mirabegron
* diagnosed as glaucoma (including normal tension glaucoma)
* having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment