cyrilzakka/clinical-trials huggingface dataset:
In Situ Remineralisation Response of Different Artificial Caries-like Enamel Lesions to Home-care and Professional Fluoride Treatments

This study mainly compared the response of the artificial carious enamel lesions to remineralisation in situ. The tested in vitro demineralising protocols were: MC gel, PA gel, MHDP and Buffer solutions.

The lesions were then remineralised in an in situ model, with crossover and double blind design. Fifteen volunteers wore intra-oral appliances containing 2 bovine enamel samples of each demineralising protocol during 3 experimental phases (3 days each). The experimental phases/treatments were: Control (Placebo dentifrice, saliva effect only), Home-care (fluoride dentifrice, 1,100 ppm F, NaF), and Professional/Home-care (varnish- 22,600 ppm F and dentifrice- 1,100 ppm F, NaF).

During the 3-day phase, the appliance was only removed during the main meals (four times a day, maximum 1 h duration each, interval between meals 2-3 h). Immediately after the meals, before replacing the appliance in the mouth, the subjects were advised to perform oral hygiene using a soft end-rounded toothbrush (Colgate® 360º Sensitive Pro-Relief TM) and dentifrice (non-fluoridated from IceFresh, Bauru, SP, Brazil or fluoridated dentifrice from Crest Procter \& Gamble, Cincinnati, OH, USA) according to the phase and dental floss (Sanifill, São Paulo, Brazil).

The remineralising treatment with dentifrices was done ex vivo, 1 min twice a day (after the first and last oral hygiene of the day) using slurry of the dentifrice (1:3 water, 1 drop of solution/specimen). Thereafter, the appliance was replaced in the mouth and the subjects were advised to rinse with 10 ml of water for 5 s and to expectorate. In respect to Professional/Home-care phase, the varnish (Duraphat, Colgate, SP, Brazil) was applied before the in situ study for 6h and then removed.

The enamel remineralization was quantified using transverse microradiography (% mineral recovery and lesion depth, TMR), surface and cross-sectional hardness. The data were submitted to statistical analysis (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

* a stimulated physiological salivary flow rate of \>1 ml.min-1
* a non-stimulated physiological salivary flow rate of \>0.25 ml.min-1
* good oral health (i.e. no cavities or significant gingivitis/periodontitis)

Exclusion Criteria:

* systemic illness
* pregnancy or breastfeeding
* use of fixed or removable orthodontic appliances
* use of fluoride mouthrinse or professional fluoride application in the last 2 months.
mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder

The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the current standard of care, however PPW struggling with OUD may underestimate or misjudge its benefits. At the same time, emerging findings signal that mobile health (mHealth) technologies have the potential to support healthier behaviors among individuals with OUD. In this project, we will test the utility of a theoretically-based digital therapeutics tool (uMAT-R) to encourage MAT adherence and treatment retention while considering the unique needs of PPW. In Aim #1, we will conduct four focus groups with PPW with OUD (target users) on the intervention components of uMAT-R, gathering feedback on theory-driven components that are candidates for inclusion in the tool and eliciting suggestions for additional intervention components. In Aim #2, the tool will be beta-tested for technical/navigational issues among 20 participants. In Aim #3, we will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD (n=60). This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R (n=40) versus a control group (n=20 who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved MAT attitudes, norms, and perceived control. Recruitment for all Aims will occur at a clinic in St. Louis, Missouri that provides perinatal medication-assisted treatment (MAT) and high-risk maternity care to PPW struggling with OUD. Clinically meaningful effect size and attrition estimates will aid in the planning of a larger RCT in which we will test uMAT-R on a larger scale and expand our recruitment to other clinics across Missouri and other states.

This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant or up to 1 year postpartum
2. Receiving treatment at CARE
3. Adult (≥18 years of age)
4. U.S. resident
5. Currently on MAT
6. Fluent in English
7. women with opioid use disorder (OUD)

   Exclusion Criteria:
8. Currently incarcerated
9. Patients with acute suicidality or psychotic disorders as assessed by CARE providers
Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy

The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.

This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.

Facial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software.

Eligibility Criteria:
Inclusion Criteria:

1. Bell's Palsy with acute onset of 1-3 weeks.
2. Unilateral loss of facial weakness.
3. Patients with intact taste sensation.
4. Bell's Palsy of House Brackmann grade 3 and 4.
5. Idiopathic Bell's Palsy.

Exclusion Criteria:

1. History of facial palsy recurrence.
2. Stroke associated Bells palsy.
3. History of pregnancy
4. Subjects with any disability, fracture, or tumor.
5. History of facial surgery.
6. Subject having skin allergy on face.
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems.

The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks).

During the study, participants will visit their study clinic several times.

Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period.

An approximate total of eligible 207 participants will be randomized to one of the three treatment groups -

1. TAK-279 Dose 1
2. TAK-279 Dose 2
3. Placebo

The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days. In South Korea, the age requirement for adult participants is ≥19 years of age.
2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES.
3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC.
4. Participants must meet the contraception recommendations.

Exclusion Criteria:

1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD).
2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study.
3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma.
4. Participants who have failed 3 or more classes of advanced therapies.
PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery

Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients who, at the time of surgery, were ≥ 18 years of age and who had undergone an index laparoscopic gynecologic surgery at least 2 years prior to the start of the study.
* Patients in whom ADEPT® was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions following laparoscopic surgery.

Exclusion Criteria:

* Patients who had frank infection in the abdominopelvic cavity at the time of the surgery.
* Patients who were pregnant or nursing at the time of the surgery.
BIA Guided-fluid Management in Postinjury Open Abdomen

Fluid overload (FO), resulting from high volume fluid therapy, is frequent and contributes to excessive visceral edema, delayed fascial closure, and adverse outcomes among postinjury open abdomen (OA) patients. Bioelectrical impedance analysis (BIA) is a promising tool in monitoring fluid status and FO. Thus, we sought to investigate the efficacy of BIA-directed resuscitation among postinjury OA patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult trauma patients admitted to SICU with OA after emergent abbreviated laparotomy were considered eligible.

Exclusion Criteria:

* (a) age less than 18 years; (b) pregnancy; (c) lactation; (d) limb amputations; (e) mental disorders; (f) diabetes mellitus; (g) pre-existing blood disorders; (h) pre-existing abdominal fistulas; (i) pre-existing terminal illness; (j) liver dysfunction (Child-Pugh class C); (k) New York Heart Association (NYHA) class IV; (l) chronic renal failure requiring dialysis; (m) therapy with an extra-corporeal membrane oxygenator (ECMO); (n) enrolled in an ongoing, interventional RCT; (o) received prior fluids for resuscitation during their ICU stay; (p) expected to die within 1 hour of ICU admission for devastating injuries; (q) activated opt-out process for BGFM trial.
Prolonged Exposure Versus Treatment as Usual in Chronic Posttraumatic Stress Disorder Combat and Terror Related Patients

Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic Posttraumatic Stress Disorder (PTSD)


Eligibility Criteria:
Inclusion Criteria:

* PTSD

Exclusion Criteria:

* Psychotic symptoms
* Dissociation
* Drug or Alcohol dependence
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.


Eligibility Criteria:
Inclusion Criteria:

* no clinical and radiographic evidence of pulp pathology,
* no clinical and radiographic symptoms,
* no history of spontaneous pain and tenderness,
* no percussion, swelling or sinus tracts and pathologic mobility.

Exclusion Criteria:

* any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
* furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
* without permanent successor
Ethics Communication in Groups Among Healthcare Professionals (The Ethics-com Study).

Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to improve the ethical climate and prevent moral distress. Our research group has developed the "one to five-step method" for interprofessional ethical communication in groups. The overall aim of this project: is to implement and evaluate a method for organized interprofessional communication about ethical issues in healthcare.

Ethically difficult situations are a part of the everyday clinical practice for health care professionals and concerns difficult judgements, prioritization and crucial decisions. Being unable or prevented to act according to one's moral conviction for what is good and right care may increase the risk for health care professionals to experience moral distress. Moral distress has been described as a condition with frustration, guilt, anger and as one reason for health care professionals to leave the profession. Ethics communication in groups has been showed to work as support for health care professionals in ethically difficult situations and further work as a tool to improve the ethical climate and prevent moral distress. Our research group has developed the "one to five-step method" for interprofessional ethical communication in groups. The method is a stepwise support for facilitating ethics communication in clinical practice when the situations occurs. The overall aim of this project: is to implement and evaluate a method for organized interprofessional communication about ethical issues in healthcare.

Significance: The study can generate knowledge about ethics communication in groups in line with the " one to five step method", reduce moral distress, create improved ethical climate for healthcare professionals and in turn open up prerequisites for good care.

Eligibility Criteria:
Inclusion Criteria:

* healthcare professionals working at included wards

Exclusion Criteria:

-
The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement

The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction.

To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic, additionally find the effect of vitamin D deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time, pain experienced by the patient during OTM and rate of orthodontically induce apical root resorption.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranged from 18 to 30 years, from both sex.
2. Healthy general medical condition, healthy periodontal condition.
3. Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm).
4. Normal shape and structure of maxillary canine, with no history of filling or root canal treatment and normal shape and structure of maxillary first molar.

Exclusion Criteria:

1. Pregnant women.
2. Patient with renal or liver disease.
3. Patient taking corticosteroid or anticonvulsant drugs.
4. Patient with thyroid or parathyroid problems.
Rehabilitation of Patient With Acute Isolated PCL Rupture

The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000)

The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000) to indicate whether one rehabilitation alternative is preferable in terms of less knee joint laxity and improve knee function. Participants considered included in the study if he or she agrees to participate in the study by signing the informed consent. Inclusion criteria will be whether the patient has an acute isolated PCL injury. Exclusion is additional injuries of ligaments, cartilage and meniscus of the knee. Randomization to groups is done continuously.

Eligibility Criteria:
Inclusion Criteria:

* Acute isolated PCL injury : 0- 3 weeks ( maximum 21 days) from the initial injury
* Isolated PCL rupture (grade I, II and III)
* Patient age should be between 16-60 years ( with closed epiphyseal plate )
* Understood and accepted written consent

Exclusion Criteria:

* Injury to the ACL or other ligaments in the knee
* Extensive injury to the cartilage or meniscus , requiring repairs
* Unfit to understand or to sign consent
* History of alcohol or drug abuse in the past three years
* Current serious illness or injury that makes rehabilitation difficult.
Hydrotherapy Intervention in Elderly With Knee Osteoarthritis

Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands on pain and functional disability in old people with knee osteoarthritis.

The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that a hydrotherapy treatment during 8 weeks would benefit patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* confirmed clinical diagnosis of knee osteoarthritis

Exclusion Criteria:

* total knee arthroplasty
* inability to co-operate or follow instructions.
* a major neurological disorder
A Prospective Virtual Study to Evaluate the Longevity of IgG Antibodies in Individuals Exposed to COVID-19

The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.

This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Willing to provide informed consent prior to participation.
* Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
* Cohort 2 (Arm 2) - Received the COVID-19 vaccine

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy
Ningbo Schizophrenia Cohort

In recent years, the prevalence of schizophrenia in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-onset, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with schizophrenia.

Currently, NSC has accumulated data on more than 30,000 patients with schizophrenia and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of schizophrenia (F20)

Exclusion Criteria:

* None.