cyrilzakka/clinical-trials huggingface dataset:
Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery

The background for the study is that many bariatric surgery patients struggle with their oral health after bariatric surgery. This is probably related to both physiological changes and changes in eating and drinking patterns. In addition, many have reduced oral health even before surgery, and a significant proportion also have dental treatment anxiety, which also affects their ability to seek dental treatment. In sum, this is probably a patient group that may be at risk of oral pathology.

Participants in the study will be randomly allocated to different patient education programmes. The three interventions are:

1. customised information on a website
2. education delivered by a clinician
3. distribution of free samples relevant to dental hygiene

The outcomes recorded are level of knowledge, drinking patterns, self-perceived oral health, and oral hygiene routines.

Both caries and periodontitis are more prevalent among people with obesity. At the same time, we know that bariatric surgery is associated with poorer oral health expressed by caries, enamel erosion and short-term increased inflammation in the gums. Although we do not yet have evidence to determine causality, we suspect that oral health in bariatric surgery patients is further impaired by both systemic effects (hyposalivation, altered oral microbiome, reflux and vomiting) and by altered eating and drinking patterns after surgery (acid exposure with subsequent demineralisation of tooth enamel).

The patient's own diet and oral hygiene can be an opportunity to prevent or slow down such oral problems, but requires personal effort and must be a special focus in patient education.

Patient education is one of the hospital's statutory duties, but the quality of patient education is rarely systematically investigated. This project investigates the effect of three alternative educational interventions on patients' drinking habits, oral hygiene routines, knowledge level and oral health. The three interventions are a website with adapted patient information, group-based education given by healthcare professionals, and distribution of relevant product samples to maintain oral hygiene. Patients are randomised between the different educational interventions.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for bariatric surgery at a Norwegian hospital

Exclusion Criteria:

* Insufficient language skills
* Lack of consent competency
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation.

Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe Alopecia Areata.

Part A is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center Proof-of-Concept (POC) study in adult subjects with severe Alopecia Areata (AA). Bempikibart (ADX-914) or matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24 weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo. All participants in Part A have completed participation.

Part B is a multicenter, open-label study comprised of a screening period of up to 4 weeks, a treatment period of 36 weeks, and a follow-up period of 16 weeks, for a total study duration of up to 56 weeks.

Open Label Extension Cohort is a multicenter, open-label extension to assess the long-term efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe AA who experienced hair regrowth as participants in Part A of the study. Participants enrolled in the Open Label Extension Cohort will receive bempikibart (ADX-914) for a duration of 6 months followed by a 16-week follow-up period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent.
2. Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score.

Key Exclusion Criteria:

1. History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
2. History (lifetime) or presence of hair transplants.
3. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
4. Use of systemic, topical, or device-based therapy for AA.
5. History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.
Detection of Anaerobes in Different Clinicalsamples

Early detection of anaerobic bacteria to avoid its serious comlications

Infections caused by anaerobic bacteria are common and may be serious and life-threatening.Obligately anaerobic bacteria do not grow on solid media in room air (0.04% carbon dioxide and 21% oxygen); facultatively anaerobic bacteria can grow in the presence or absence of air. Microaerophilic bacteria do not grow at all aerobically or grow poorly, but grow better under 10% carbon dioxide or anaerobically. Anaerobic bacteria can be divided into strict anaerobes that can not grow in the presence of more than 0.5% oxygen and moderate anaerobic bacteria that are able of growing between 2 and 8% oxygen. Anaerobic bacteria usually do not possess catalase, but some can generate superoxide dismutase which protects them from oxygen.

Anaerobes are the predominant components of the bacterial flora of normal human skin and mucous membranes, and are therefore a common cause of bacterial infections of endogenous origin. Infections due to anaerobic bacteria can evolve all body systems and sites . The predominant ones include: abdominal, pelvic, respiratory, and skin and soft tissues infections. Because of their fastidious nature, they are difficult to isolate from infectious sites and are often overlooked. Failure to direct therapy against these organisms often leads to clinical failures. Their isolation requires appropriate methods of collection, transportation, and cultivation of specimens. Treatment of anaerobic bacterial infection is complicated by the slow growth of these organisms, which makes diagnosis in the laboratory possible only after several days, by their often polymicrobial nature and by the growing resistance of anaerobic bacteria to antimicrobial agent.

Almost all anaerobic infections originate from the patient's own microflora. Poor blood supply and tissue necrosis lower the oxidation-reduction potential and favor the growth of anaerobes. Any condition that lowers the blood supply to an affected area can predispose to anaerobic infection. Therefore, foreign body, malignancy, surgery, edema, shock, traum and vascular disease may predispose to anaerobic infection. Previous infection with aerobic or facultative organisms also may make the local tissue conditions more favorable for the growth of anaerobic organisms. The human defense mechanisms also may be impaired by anaerobic conditions .

Eligibility Criteria:
Inclusion Criteria:

- Patient with infection organism not yet detected

Exclusion Criteria:

* patients with infection organism is already detected
Endoscopy for Post-operative Fistula

Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years
* Early fistula (\< 30 days)
* Post surgery: Lewis Santy, Akiyama, partial or total gastrectomy
* Indication of endoscopic management: metal stents and/or plastic stents

Exclusion Criteria:

* Pregnancy
* Incapable of decision making and informed consent
* Life expectancy \< 1 month
* General anesthesia contra-indication
* Late fistula (\> 30 days)
* Prior endoscopic treatment
* Wall ischemia
* Duodenum or small bowel fistula
* Post bariatric surgery
Tissue Kallikrein Protect Against Ischemic Stroke

The results of previous studies were used to assess the causal association between TK levels and stroke occurrence at 5 and 12 years of follow-up, respectively.

Analyze the data of a 5-year follow-up on 2115 control individuals from the case-control study of the previous research. We completed the 5-year follow-up on this group in 2016 (whether they had a stroke, whether they are alive, and the cause of death).

Conduct a 12-year follow-up on 6487 community individuals from the previous study (whether they had a stroke within 12 years, whether they are alive, and the cause of death). We collaborated with the hospital platform's computer center to conduct follow-up through AI questionnaire surveys, followed by supplementing AI questionnaire data with telephone questionnaire surveys for those lost to follow-up.

Utilize R language R Studio 4.11 for statistical analysis and plotting. Evaluate the distribution of TK levels in the control group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 5 years.

Evaluate the distribution of TK levels in the community group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 12 years.

Eligibility Criteria:
Inclusion Criteria:

* 1) Control population in the previous stroke case-control study;
* 2) The CHD case-control population in the previous study;
* 3) The population in the community cross-sectional study of the previous study.

Exclusion Criteria:

* Stroke patient
Pediatric Pilot Study: Irrigation and Scrubbing in Facial and Scalp Wounds

Most pediatric lacerations occur indoors and are considerably noncontaminated. Wounds that occur outside of the house where dirt often enters the laceration, irrigation and scrubbing with soap has been proven effective at decreasing post-laceration infections. To date there are no pediatric prospective studies addressing a less aggressive approach to face and scalp wound preparation in pediatrics. We argue that wiping wounds with sterile gauze soaked in sterile saline will not increase infection rates as compared to our current practice. In our emergency departments, the current standard of care for all lacerations is aggressive wound preparation: irrigation and scrubbing. This occurs regardless if the wound is contaminated or not. Research has proven that irrigation and scrubbing is unwarranted in adults with face and scalp lacerations. We want to perform a pilot/feasibility study comparing our two emergency campuses. One campus will serve as the control site, while the other will be the intervention site. In this pilot study, our goal is to demonstrate the feasibility of the intervention and provide data that a less aggressive approach to wound preparation is just as effective as our standard of care. We hope this project leads to further discussion about how we manage noncontaminated lacerations and provides a stepping-stone to a larger, appropriated powered study.


Eligibility Criteria:
Inclusion Criteria:

1. facial and scalp wounds acquired by blunt trauma,
2. wounds incurring within a house or indoor gym,
3. all ages, 1 month to 20 years of age.

Scalp is defined as the skin covering the head. The face is the area anterior to the ears, below the chin and extending to the hairline of the forehead. Wounds requiring deep sutures will also be included.

Exclusion Criteria:

1. Patients presenting with wounds that occur outdoors,
2. Wounds greater than 12 hour old,
3. Immunocompromised, malnourished or a diabetic,
4. Intoxicated,
5. Currently on antibiotics,
6. Sickle cell anemia,
7. Collagen vascular disease,
8. Wounds requiring plastic surgery,
9. Wounds from human or animal bites,
10. Wounds not on the face or scalp,
11. Patient's just discharged from the hospital within 72 hours,
12. Wounds with foreign bodies or grossly contaminated,
13. No suture nurses are present or available to suture.
One- Versus Two-Stage Aesthetic Crown Lengthening

This randomized controlled trial was aimed at assessing the efficacy of a two-stage crown lengthening intervention (SCL) for restorative purposes in the aesthetic zone compared with a one-stage crown lengthening procedure (CCL).

Subjects were randomly allocated to receive SCL or CCL. SCL consisted of full thickness flaps followed by bone recontouring and minor gingivectomy 4 months postoperatively, if required. In CCL, osseous recontouring after sub-marginal incisions was performed, followed by flap repositioning. Records were obtained at baseline, 4 months (only in SCL), 6 and 12 months. Primary outcome was the precision in achieving a predetermined gingival margin position. Other outcomes were changes in the gingival margin position and keratinized tissue width (KTW) at 12 months, and patient-reported outcomes (PROMs) using the OHIP-14 tool.

Eligibility Criteria:
Inclusion Criteria:

* older than eighteen years of age;
* more than 20 teeth in the mouth;
* with full mouth plaque and bleeding scores lower than 15%; and
* without probing pocket depth and/or attachment loss \>4 mm

Exclusion Criteria:

* Pregnant women or breastfeeding
* smokers
* treated with antimicrobial and/or anti-inflammatory drugs within two months prior to entering the study
* currently undergoing orthodontic therapy
Feasibility of VMAT and CBCT for Head and Neck Carcinomas

This will be a prospective longitudinal study describing clinical throughput metrics and patient reported quality of life outcome measures for patients undergoing Volumetric modulated arc therapy (VMAT) with and without Cone-beam computed tomography (CBCT) for head and neck carcinoma at the British Columbia Cancer Agency.

1. VMAT for the treatment of patients with HNC will provide opportunities for image-guided radiotherapy using CBCT online correction to reduce systematic and random error.
2. Analysis of patient reported quality of life outcomes during VMAT, with and without CBCT acquisition, will be hypothesis generating.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* undergoing radical radiation therapy for head and neck carcinoma at the BC Cancer Agency

Exclusion Criteria:

* treatment being offered is not for curative intent
* patient has received previous radiation for head and neck cancer
* patient has systemic lupus erythematosis or scleroderma
* patients has other autoimmune connective tissue disorders
Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Previous CDI diagnosis
3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics

Exclusion Criteria:

1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
2. Previous adverse reactions to oral vancomycin
3. Requiring metronidazole during hospitalization
4. Known pregnancy
5. Expected survival \<72 hours
6. Patients receiving antibiotics only for surgical prophylaxis
7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia

72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.

To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.

Eligibility Criteria:
Inclusion Criteria:

\* Clinical diagnosis of hypertensive bradyarhhythmia

Exclusion Criteria:

* With other elementary diseases
* With pregnant
* With receiving other treatment within past half year from the beginning of trial.
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device

The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.

Patients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.


Eligibility Criteria:
Inclusion Criteria:

* elective repair for a primary unilateral inguinal hernia OR
* elective repair for a recurrent unilateral inguinal hernia after non-mesh repair

Exclusion Criteria:
Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee

Osteoarthritis (OA) of the knee constitutes a major public health problem. Treatment options for knee OA range from lifestyle changes to pharmacological management to total knee replacement surgery. As a "preference-sensitive" condition, management of OA of the knee is ideally suited for shared decision making (SDM), taking into consideration benefits, risks, and patients' health status, values, and goals. Patient-reported outcomes (PROs) reflect health status from the patient's perspective. For knee OA, relevant PROs include pain and other symptoms, functional status and limitations, and overall health. Prior research indicates that patients with higher baseline physical function and/or poor baseline mental health do not benefit as much from total knee replacement. Still, due to logistical challenges, costs, and disruptions in workflow, PROs have not yet achieved their full potential in clinical care.

Musculoskeletal providers at Dell Medical School and UT Health Austin currently collect general and condition-specific PROs from every patient seen in their Musculoskeletal Institute. PROs are collected via an electronic interface and results are pulled into the Athena electronic health record (EHR). Given the promise of combining PRO data with clinical and demographic data, musculoskeletal providers at UT Health Austin have begun utilizing an innovative electronic PRO-based predictive analytic tool at the point of care to guide SDM in patients with knee OA.

This project plans to evaluate the clinical effectiveness and impact of the PRO-guided predictive analytic SDM tool and process in a randomized controlled trial in Austin. Outcomes will include decision quality, as reported by patients; treatment decision (surgical vs. non-surgical); and decisional conflict and regret.

Our project contributes to AHRQ's strategy to use health IT to improve quality and outcomes by evaluating a tool and process for the use of PRO data at the point of care. The model being tested puts patients at the center of their care by enabling them to participate in informed decision making by using their personal health data, preferences, and prognostic models. Knowledge gained will be critical to scaling and spreading use of this PRO-guided SDM tool among patients with knee OA nationally.


Eligibility Criteria:
Inclusion Criteria:

* New patients
* Presumptive diagnosis of knee OA
* Aged 45 to 89
* K-L Joint OA severity grade 3 to 4 (moderate to severe)
* KOOS JR score 0-85
* Able to consent

Exclusion Criteria:

* Prior total knee replacement (TKR)
* Prior consultation with orthopaedic surgeons for TKR
* Prior experience with Joint Insights
* Trauma condition or psoriatic/rheumatoid arthritis
* Non-English or Non-Spanish speakers
* BMI \<20 or \>46
LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)


Eligibility Criteria:
Inclusion Criteria:

* At least 2-year history of Allergic Rhinitis that became symptomatic during the annual grass pollen season.
* A skin test for grass pollens positive:
* Have rhinitis symptoms of such severity that the mean T4SS over the baseline period must be 6.

Exclusion Criteria:

* Have an associated asthma requiring corticosteroid treatment,
* Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids,
Correlation Study Between Mental Behavioral Symptoms in Dementia Patients and Mood Disorders of Caregivers

Traditionally, the more severity of dementia patients, the heavier the burden of the comparators, and in the clinical observation,the dementia patients with rich mental behavior symptoms are more burdened. Therefore, exploring the impact of psychological burden and different subtypes of different dimensions with Behavioral and psychological symptoms (BPSD) will more comprehensive understanding of the factors affecting the burden of caregivers.

The starting point of this project is to analyze the relationship between the types of mental behavior symptoms of dementia patients and the emotional disorders of caregivers. The topic will analyze the correlation of psychological burden of caregivers and different symptom dimensions from the perspective of refinement, helping more effective identifying high-burden mental behavior symptoms in clinically , judging the risk of emotional problems in caregivers, and adopting better humanities or medical care, so that dementia patients can better adapt to care and improve the mental health of caregivers.


Eligibility Criteria:
Inclusion Criteria:

1. Age is greater than 18 years old, gender is not limited
2. Comply with ICD-10 diagnostic criteria, diagnosed with dementia, including Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy body, dementia caused by Parkinson's disease

Exclusion Criteria:

1. senile schizophrenia;
2. senile depression;
3. cognitive impairment caused by endocrine system diseases (such as decreased thyroid and adrenal function);
4. Cognitive impairment or dementia caused by serious diseases such as cardiovascular, lung, liver, kidney, and hematopoietic system;
5. Cognitive impairment or dementia caused by alcohol, drug use, psychotropic drugs; 6）Other physical or chemical factors that cause cognitive impairment or dementia-