cyrilzakka/clinical-trials huggingface dataset:
Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR

A two-parallel, evaluator-blind, single-center, randomized controlled trial was designed to assess the effectiveness of a home-based mobile guided exercise-based cardiac rehabilitation among patients undergoing Transcatheter Aortic Valve Replacement.

The purpose of our study was to investigate the effect of home-based mobile-guided exercise-based cardiac rehabilitation on the improvement of exercise capacity among patients undergoing transcatheter aortic valve replacement. 90 subjects will be recruited and followed up for a six-minute walk distance, short physical performance battery, exercise adherence, quality of life, frailty, nutritional status, sleep status, readmission rate, and all-cause mortality et al. The subjects will be invited to participate in on-site visits at 1, 3, and 6 months. Patients in the interventional group will receive a home-based mobile-guided exercise-based cardiac rehabilitation for 3 months. The home-based mobile-guided exercise-based cardiac rehabilitation is a multi-component intervention strategy including the preparation for discharge, family support, motivational interviews, health education, telephone follow-up, wearable devices, APP, et al. While the patients in the control group will receive routine care. For example, the preparation for discharge of the control group does not include the guidance of mobile-guided exercise-based cardiac rehabilitation, family support, and motivational interviews. After discharge, nurses will conduct telephone follow-ups once a month for the control group. Baseline data and outcomes will be collected in a Case Report Form.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years and ≤ 89 years old;
* Patients scheduled to be discharged after TAVR;
* Those who have the ability to read and write, and have normal speech and communication skills;
* Patients and their families are willing to participate in this study;
* Patients or family members have the ability to use mobile and an app.

Exclusion Criteria:

* Serious complications occur before discharge (such as major bleeding, stroke, valve detachment, moderate or above perivalve leakage, coronary artery occlusion, etc.) ;
* Patients who are unable to participate in postoperative exercise rehabilitation due to limb dysfunction;
* Being in palliative care or treatment;
* Those with other Contraindication to exercise-based cardiac rehabilitation (such as resting ECG changes indicating significant ischemia, acute myocardial infarction or other acute cardiac events, unstable angina, uncontrolled arrhythmia, heart failure decompensation, etc.);
* Currently participating in other rehabilitation projects.
The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis.

Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study.

Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P\<0.05) was considered significant.

Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.

Eligibility Criteria:
Inclusion Criteria:

24 patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected

Exclusion Criteria:

1. systemic disease
2. pregnancy or breastfeeding
3. allergy drug used
4. smoking
5. medication 6. not willing to consent to participate in the study

7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment
Dosage Effects of Folic Acid on Blood Folates of Honduran Women

CDC staff at the National Center on Birth Defects and Developmental Disabilities have been working closely with a Honduras-based organization, Project Healthy Children (PNS) and the Ministry of Health, on a folic acid supplementation study among female maquila workers. Participants are divided into two groups. One group receives a 1.0 milligram pill daily while the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess serum blood folate levels measured at baseline, midpoint, and endpoint of the study. Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily in raising blood folate levels.


Eligibility Criteria:
Inclusion Criteria:

minimum employment in factory 6 mths

-

Exclusion Criteria:

* pregnant
* currently consuming folic acid
* prior birth-defect affected pregnancy
* chronic disease
* currently taking folic acid antagonist
Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner

This research aims to create a tool for detection of mental health disorders in adolescents with chronic pain. The first part is testing a screening questionnaire and comparing in with existing questionnaires. The second part involves two focus group with the adolescents aimed at recording their perception of the questionnaire.

First part : creation of a screening tool. After detailed interviews with chronic pain experts and bibliographic research, a screening tool for mental disorders in chronically painful adolescents has been designed for use by the general practitioner. This tool is composed of 10 questions, making up a score of 10 points. The tool will be compared to two screening tools used in different clinical contexts, the HAD scale and the RPPS scale, in order to determine a positivity threshold. There is only one center participating in the research, the Centre de la Douleur et de la migraine de l'hôpital Trousseau (Trousseau Hospital Pain Center). Parents' consent is required for participation. For this assessment, the adolescents (between 10 and 18 years old) that see a doctor at the Centre de la douleur, will be asked to fill up the questionnaires in the waiting room. The filling of the questionnaire takes a few minutes. At the end of the appointment, the doctor will read the questionnaire to check that all elements have been addressed during the appointment.

Second part : focus group on the questionnaire: 5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.

The data will help designing a guidebook for the clinician explaining the main points in screening for mental disorders in chronic pain adolescent patients.

A validation study for the screening tool will be eventually carried out after the completion of this preliminary study.

Eligibility Criteria:
Inclusion Criteria:

* patient from 10 to 18 years old
* chronic pain (existing for more than 3 months or longer than tissue repair time)
* first consultation in the service
* Collection of the written consent of the holders of parental authority and agreement of the adolescent
* Adolescents able to understand the questionnaire and the purpose of the study
* Affiliation to a social security scheme or beneficiary

Exclusion Criteria:

Exclusion Criteria :

* Decompensated physical or psychological pathology requiring urgent medical treatment
* Heavy psychological pathology preventing the adolescent's understanding of the study
* Patient benefiting from State Medical Aid
An 8-Week Refractory Chronic Cough Study (MK-7264-021)

This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.


Eligibility Criteria:
Inclusion Criteria:

* Women and Men between 18 and 80 years of age inclusive
* Have refractory chronic cough
* Women of child-bearing potential must use 2 forms of acceptable birth control
* Have provided written informed consent.
* Are willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

* Current smoker
* Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) \< 60%
* History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
* History of opioid use within 1 week of the Baseline Visit
* Body mass index (BMI) \<18 kg/m2 or ≥ 40 kg/m2
* History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with \<3 excised basal cell carcinomas)
* Screening systolic blood pressure (SBP) \>160 mm Hg or a diastolic blood pressure (DBP) \>90 mm Hg
* Significantly abnormal laboratory tests at Screening
* Clinically significant abnormal electrocardiogram (ECG)
* Pregnant or Breastfeeding
* Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial
Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care

In critical care, hemodynamic instability often requires volume expansion to restore tissue perfusion, increasing fluid balance and TBW, factors associated with higher mortality. Excess fluid leads to organ dysfunction due to venous congestion, making fluid removal crucial. When diuretics fail, RRT, typically through continuous renal replacement therapy (CRRT), is recommended. However, prescribing the correct level of UF is challenging; insufficient UF can worsen edema, while excessive UF risks hemodynamic instability. This pilot, single-center, prospective, interventional, randomized, controlled, open-label study includes two parallel groups: a standard group with UF prescribed by the physician based on clinical and hemodynamic status and an experimental group with UF guided by the extracellular to total body water (ECW/TBWat) ratio measured by BIA. The aim is to determine if ECW/TBW-guided UF improves fluid and TBW reduction over a 72-hour RRT period.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* The patient was hospitalized in the intensive care unit of Amiens-Picardie University Hospital.
* Patient with an increase in fluid balance (TBW \> 5%)
* Patient receiving continuous veno-venous hemofiltration (CVVH) on a PrismaFlexR or PrisMaxR machine, initiated due to oliguria, potassium level \> 6.5 mmol/L, urea level \> 25 mmol/L, or creatinine \> 300 µmol/L and severe metabolic acidosis (pH \< 7.2).
* Hemodynamically stable patient with a mean arterial pressure (MAP) \> 65 mmHg for more than 4 hours with norepinephrine.
* Signed consent to participate in the study by the patient or, if unconscious, their legal representative/next of kin.

Exclusion Criteria:

* Invalid BIA measurements
* Internal device powered by an electrical current (pacemaker, implantable cardioverter-defibrillator, neurostimulator)
* Cardiac arrhythmia (atrial fibrillation, atrial flutter) present at the inclusion
* Chronic dialysis patient
* Moribund patient
* The patient is on extracorporeal mechanical support
* Hemorrhagic shock
* Pregnant woman
* Patient under guardianship or conservators.
Triaging Patients With Musculoskeletal Disorders Directly to Physiotherapists at Primary Health Care Clinics.

The purpose of this study is to determine whether initial triaging to physiotherapists of patients with musculoskeletal disorders who seek health care from primary care clinics affects the patients health and/or health care utilization differently than initial consultation with a general practitioner.


Eligibility Criteria:
Inclusion Criteria:

* seeking primary care clinic for musculoskeletal disorder
* age 16-67 years
* speaks enough Swedish or English to understand the patient information and complete the questionnaires
* triage nurse judges it suitable to triage participant to physiotherapist

Exclusion Criteria:

* has received treatment at the clinic by physician or physiotherapist during the preceding month for the same problem
* seeking for chronic musculoskeletal disorder with unchanged symptoms the latest 3 months and for which the patient has already tried physiotherapy
* seeking for help with medical aids other than crutches
* is in need of home care
* has been included in the study earlier
Effect of Massage Therapy on Muscle Fatigue

The main objective of the current proposal is to investigate the clinical and physiological changes triggered by massage therapy in a group of individuals with chronic low back pain experiencing muscular fatigue.

The investigators believe these objectives are in line with the "2014 Massage Therapy Research Fund research priorities", since the results produced by these investigations will generate knowledge with regard to the short term clinical efficacy of massage therapy and will provide critical information related to the physiological mechanisms underlying massage therapy clinical effects. Most importantly, the combined assessment of clinical and physiological outcomes will also yield key information to identify specific biological components of the massage therapy intervention. Determining the presence of a biological mechanism is, as for any treatment, considered one of the necessary criteria to declare a causal relationship between a specific intervention and its associated clinical effects. The investigators strongly believe that the proposed research will contribute to the identification of specific mechanisms that will complement the emerging clinical evidence supporting massage therapy in the treatment of chronic low back pain.

The proposed research project will involve researchers and future practitioners of massage therapy. In conjunction with a high quality research environment, it is the goal of the investigators to create an educational environment for undergraduate and graduate students that will foster interdisciplinary collaboration in order to ensure a diversified; high quality training of young researchers and clinician scientists working in the field of manual therapies.


Eligibility Criteria:
Inclusion Criteria:

* Non specific low back pain

Exclusion Criteria:

* Low back pain of specific origin including but not limited to:

herniated disk fractures spondylolisthesis

* inflammatory rheumatic disease
* infectious disease
* neuromuscular disease
* vascular disease
* connective tissue disease
* severe disabling pain
* neurologic signs and symptoms
* pregnancy
U Shaped Toothbrush in Removing Plaque in Children

The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.

Children accepted in the study will be randomly divided into two groups:

The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)

This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:

Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.

Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.

Eligibility Criteria:
Inclusion Criteria:

Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.

Exclusion Criteria:

Children with limited ability to communicate. Children with motor disabilities.
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for RBD as determined by screening PSG's
* steady bed partner for completion of RBD questionnaire

Exclusion Criteria:

* Hepatic impairment
* RBD associated with narcolepsy
* use of fluvoxamine, rifampin, fluconazole or ketoconazole
* current alcohol or drug abuse
Study of Time to Pregnancy in Normal Fertility

The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.

Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these "fertile" days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving.

All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age.

All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle.

The primary outcome is time to pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* couple with prior pregnancy within the past 8 years

Exclusion Criteria:

* any history that suggests subfertility
* any history that suggests a medical contraindication for pregnancy
Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
* Subject's SARA score at 10\~20 points.
* Ages between 20\~70 years.
* Signed informed consent from the patient and/or guardian.

Exclusion Criteria:

* Subjects enrolled in any other cell therapy studies within the past 30 days.
* Pregnancy test positive.
* Subjects deemed to be not suitable for the study by the investigator.
Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty

In this prospective study we investigated the impact of an improved postoperative microcirculation and its effect of surgical side infections after breast reduction.

Many studies identifying risk factors for surgical side infections (SSI) after breast surgery included a large percentage of breast conserving therapies and risk factors for patients undergoing more extensive procedures like breast reduction (BR) are underrepresented and risk factors for more extensive breast surgeries might not be identified. Our approach to decrease SSI after BR was the application of an i.v. isotonic crystalloid solution, 6% hydroxyethylstaerke (HES) as a diminished peripheral blood flow and impaired vasculogenesis are characteristics of poorly healing wounds. HES causes a medium- to long-term increase in blood volume, blood flow and improved blood oxygen transport. Blood flow and tissue oxygenation are parts of regulating the healing process by utilizing molecular oxygen as a terminal oxidant. This antioxidant capacity can influence the wound healing process positively, as a characteristic feature of the inflammatory phase is the oxidative burst. HES additionally decreases haematocrite, blood viscosity and aggregation of erythrocytes positively influencing the complex components regulating wound healing. These characteristics and the increase in blood circulation might influence the postoperative healing and regeneration process.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were at least 18 years of age, scheduled for breast reduction, guaranteed follow-up of 30 days.

Exclusion Criteria:

* Patients were excluded if they had a history of coagulopathy or history of antiplatelet agent use within 10 days of surgery
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)

Exclusion Criteria:

* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
* Patients with serious renal or hepatic disease
* Patients who are the excessive alcohol addicts
* Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception