cyrilzakka/clinical-trials huggingface dataset:
Basal-bolus Insulin Therapy Versus Standard Therapy for the Inpatient Management of Type 2 Diabetes: the IDA2 Study

Hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia. Inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia. The investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.

The aim of this study is to investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes.

The design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). Randomization is 1:1.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes for at least 6 months
* Age 18 - 90 years
* Pre-meal plasma glucose in the range 10 - 22,2 mmol/L prior to inclusion
* Expected hospital stay longer than 4 days

Exclusion Criteria:

* Hyperglycemia without known history of type 2 diabetes
* Type 1 diabetes mellitus
* Severely impaired renal function (eGFR ≤ 30 mL/min/1,73 m2)
* Severe hepatic disease
* Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
* Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year)
* Planned treatment during hospital stay with intravenous glucose/ insulin for ≥ 12 hours
* Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding)
* Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (\>40 mg)
* History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years
* Presence of alcohol or drug abuse
* Inability to understand the written information or incapability to provide informed consent
Effectiveness of Tai Chi Exercise Program in Scleroderma Patients

Because of multiple system involvement, patients with Scleroderma have complaints such as fatigue, sleep disturbances, functional limitations, skin deformations, pain, swollen hands and joint pain. The aim of this study is to investigate the effect of Tai Chi exercise program on trunk endurance, balance, sleep, fatigue, anxiety and depression in patients with scleroderma.

In the study, which will be planned as a randomized controlled parallel group, the effects of Tai Chi in SS patients are compared with the home exercise group. Evaluations before and after the treatment will make by a physiotherapist. Training of Tai Chi will supervised by an experienced and certified physiotherapist.

Lateral Bridge Test , Berg Balance Scale, Pittsburg Sleep Quality Index , Fatigue Severity Scale and Fatigue Impact Scale , Hospital Anxiety and Depression Scale will be used evaluation before and after training.

Eligibility Criteria:
Inclusion Criteria:

* have been diagnosed with scleroderma,
* have been sedentary (have not routinely participated in exercise activities during the past 3 months)
* have been using a fixed dose of medication for at least 6 months
* no communication problems
* having stable disease

Exclusion Criteria:

* a diagnosis of pulmonary hypertension
* a history of active infection, cardiac involvement, psychiatric disorder, a history of active myositis, renal failure, metastatic cancer, pregnancy
* Data of the participant whose changes were made during the study are not included in this study and participation is terminated.
Professional Bladder Cancers and the Profession of Painter

This is a retrospective study on bladder cancer in French painters' population. The French agency ANSES collected data from all occupational and environmental diseases center in a specific database called RNV3P. We selected cases of bladder cancer in painters in four centers from 01/01/2010 to 31/12/2019. Those cases were analyzed in terms of occupational exposure, histology and sociodemographics data. Comparison between different histologic types of cancer, workplaces and occupational diseases process will be done.


Eligibility Criteria:
Inclusion Criteria:

* painters
* age\> 18 years
* data from one of the French occupational diseases centers
* approval letter

Exclusion Criteria:

* non-approval letter
* age \< 18 years
Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants

This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.

Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent. Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance cellular immunity by increasing T regulatory cells is unknown. The effect of two different doses of vitamin D; 400 IU and 800 IU will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestational age 28-33 weeks

Exclusion Criteria:

* Necrotizing enterocolitis
* Bowel perforation
* Chromosomal anomalies
* Inborn errors of metabolism
* Major congenital anomalies
German Off Pump Coronary Artery Bypass in Elderly Study

Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old.

Hypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).


Eligibility Criteria:
Inclusion Criteria:

* older or 75 years
* indication for elective bypass operation
* patient has signed written consent before randomization

Exclusion Criteria:

* previous heart surgery
* patient unable to give informed consent
Safety Study of Thermal Stimulation on Upper Extremity Motor Recovery to Stroke

Improving upper extremity movement and function in patients with stroke has been one of the primary goals for patients and rehabilitation professionals. Thermal stimulation (TS) had been first found by a domestic research group to be effective to facilitate sensory and motor recovery in patients with stroke within a month. However, the immediate and long-term effects of TS and the mechanism of brain plasticity in patients with stroke for more than three months (golden recovery stage) remain unknown. Thus, we will design a single-blind randomized controlled trial to investigate the immediate and long-term effects of TS in patients with stroke at subacute and chronic stages.

The study was an assessor-blinded randomized controlled clinical trial. Participants with UE impairment for more than 3 months poststroke were randomly assigned to either the experimental (EXP) group or the control group. All participants received regular conventional rehabilitation programs. The EXP group received an additional UE-TS protocol for 30 minutes a day (3 days/week for 8 weeks); the control group received the same TS protocol over the lower extremity (LE). The Brunnstrom's recovery stage, the Modified Ashworth Scale (MAS), the Stroke Rehabilitation Assessment of Movement (STREAM), the Action Research Arm Test (ARAT), and the Barthel Index (BI) were outcome measures and were administered at baseline, 4 weeks and 8 weeks post inception, and at one-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. first-ever stroke survivors with unilateral hemispheric lesions from a hemorrhagic or nonhemorrhagic stroke;
2. stroke onset more than 3 months and less than 3 years prior to study enrollment;
3. no severe cognitive impairments and able to follow instructions;
4. the ability to sit on a chair for more than 30 minutes independently.

Exclusion Criteria:

1. musculoskeletal or cardiac disorders that could potentially interfere with experimental tests;
2. diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy;
3. speech disorder or global aphasia;
4. participating in any experimental rehabilitation or drug studies;
5. skin injuries, burns, or fresh scars at the sites of stimulation;
6. contraindication of heat or ice application.
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes

The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.

The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

1. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization
2. Age ≥18 years
3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored"

Exclusion Criteria:

There are no specific exclusion criteria for the trial.
Vapocoolant Analgesia for Breast Lymphoscintigraphy

To learn if applying vapocoolant anesthetic spray ("Nüm") on the surface of the intended injection site will reduce the pain/anxiety associated with breast injections.

Primary Objectives:

1. Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy.
2. Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy.

Secondary Objectives:

1. To assess patient pain intensity associated with the performance of breast lymphoscintigraphy.
2. To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient undergoing asubareolar breast lymphoscintigraphy injection will be eligible.
* Age ≥18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Childbearing potential, lactating, pregnant women will be included.

Exclusion Criteria:

* Patients who have allergy or had prior hypersensitivity to either of the vapocoolants including 1,1,1,3,3 Pentafluoropropane and 1,1,1,2-Tetrafluoroethane.
* Patients with uncontrolled intercurrent illness (insulin dependent and non-insulin dependent diabetes)
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Preoperative Use of Montelukast Sodium

Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children.

Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and corticosteroids.

The study will comprise 30 american society of anesthesiology (ASA) I-III patients, aged 4-8 years, undergoing inguinal hernia surgery. Patients will exclude if receiving asthma treatment, if they had upper respiratory tract infection in the last week and if the laryngeal mask airway (LMA) could not be placed at a single attempt.

Patients will be separated into 3 groups as Group E (n=10) with high immunoglobulin E (IgE), Group C (n=10) with normal IgE and Group M (n=10) who were administered with 4mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.

With spontaneous breathing after anaesthesia induction, a classic LMA will be placed. Anaesthesia will be maintained with a mixture of 1.3 minimum alveolar concentration (MAC) sevoflurane 500%2 - N2O. At 5-minute intervals, oxygen saturation (sPO2), End-Tidal carbon dioxide, Heart Rate, tidal volume (VT), respiratory rate (f) and peak airway pressure (PAP) will be monitored and coughing, apnea, laryngospasm , bronchospasm, desaturation and need for steroids will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing inguinal hernia surgery

Exclusion Criteria:

* If receiving asthma treatment,
* If they had URTI in the last week and
* If LMA could not be placed at a single attempt.
Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain

This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years
* Generally healthy
* Able to provide informed consent
* Undertaking regular exercise
* Experiencing post exercise knee pain of at least 3 (on a 0-10 scale) at least 2 times in previous 4 weeks
* Agree not to change current diet and/or exercise frequency or intensity

Exclusion Criteria:

* Serious illness( 1 ) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Unstable illness( 2 ) e.g., diabetes and thyroid gland dysfunction
* Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
* Active smokers, nicotine use, alcohol( 3 ) or drug (prescription or illegal substances) abuse
* Allergic to any of the ingredients in the active or placebo formula
* Pregnant or lactating women
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion

Footnotes

( 1 )A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.

( 2 )An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.

( 3 )Chronic past and/or current alcohol use (\>14 alcohol drinks/week)
Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). In addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.


Eligibility Criteria:
Inclusion Criteria: - Subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198) - Females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study - The subject or legally acceptable representative must give informed consent for participation in the study before any study specific procedures are performed Exclusion Criteria: - Greater than a 7-day duration from the week 24 visit in the previous study to the first dose in this study - Any medical disability or condition (e.g., evidence of clinically significant liver dysfunction, active infection requiring treatment with systemic anti-infective agents) that would interfere with the assessment of safety of the study material or would compromise the ability of the subject to provide adequate informed consent - Concurrent treatment with an investigational agent
Applied The Platelet Rich Fibrin in Chronic Periodontitis

Platelet rich fibrin is a second generation platelet concentration which contains various growth factors. The aim of this study is to evaluate the clinical and biochemical efficacy of PRF in subjects of chronic periodontitis in the operation of conventional periodontal flap.

PRF was developed in 2001 by Choukroun in France, it was the second generation fibrin adhesive, and was used to accelerate the soft and hard tissue healing. Many studies have shown beneficial effects of PRF on osteoconductive filler material in sinus lift operations, treatment of periodontal sulcus defect and treatment of furcation defects. Also PRF contains many growth factors. PRF accelerates periodontal regeneration through the gradually excreted growth factors and contributes to the bone regeneration. In this study, the investigators evaluated the effect of PRF on growth factors and its contribution to periodontal regeneration in subjects with chronic periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CP who had pocket depth ≤ 5 mm and at least two area (grouped as Control and PRF) with horizontal bone loss after Phase I therapy

Exclusion Criteria:

* The subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months
Comparative Effects of Frenkel's and Core Stability Exercises in Children With Cerebral Palsy

The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy.

Cerebral palsy (CP) is a brain injury that manifests as a mobility and posture impairment in infancy or early childhood. Frenkel exercises are series of movements with increasing difficulty that can be performed by ataxic patients in order to regain coordinated, smooth and rhythmic movement. The Core stability Exercises are for the spine, pelvis, and kinetic chain to all balance properly under stress, core stability is necessary. The aim of this study is to determine and compare the effects of Frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. This will be a Randomized Clinical Trial in which 50 participants with cerebral palsy will be included as per sample size calculation through non probability convenience sampling technique. The study will be single blinded. Participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two Groups. Group A will receive Frenkel's exercises and Group B will receive core stability exercises, both groups will receive the treatment for 40 minutes with the routine physical therapy for 20 minutes and short-term rest intervals in between for 3 alternative days per week for 12 weeks. Participants initial screening will be done through Gross Motor Function Classification System (GMFCS). The balance will be assessed through the Pediatric Balance Test (PBS), coordination will be assessed through Finger and Nose Test, Heel Shin Test, Catching and Throwing Tasks.

Eligibility Criteria:
Inclusion Criteria:

* The participants fulfilling the given criteria will be included.
* Age: 6 To 12 Years
* Gender: Both male and female
* Children with ataxic cerebral palsy
* Children having level II and III on Gross Motor Functional Classification System (GMFCS)
* Children able to understand the test instruction, able to sit and stand.
* Children with and without using Botulinum Toxin Injections
* The Pediatric Balance Scale (PBS) of 54.6

Exclusion Criteria:

* Severe Cognitive Dysfunction
* Visual problems
* Vestibular Dysfunction
* Uncontrolled epilepsy
* Severe Orthopedic Condition affecting Lower limbs Mobility
Evaluating an Online Parenting Intervention in a Community-Based Sample of Parents

The goal of this clinical trial is to evaluate the effectiveness of the online modality of the Make the Connection (MTC) program in a community-based sample of parents not at-risk for parenting difficulties. The main questions it aims to answer are:

* Does the MTC online program result in improvements in parent-child bond, parent self-efficacy, parental stress, and parental depression among parents who are not at-risk for parent-child relationship difficulties?
* What are some of the barriers, facilitators, perceived benefits and risks to participating in the MTC online program from the perspective of parents?

Participants will be asked to complete a pre-intervention questionnaire, will be invited to complete the 8-week MTC online program consisting of a weekly 15-minute module, and will lastly be asked to complete a post-intervention questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* parents with children between the ages of 0-3 years old
* parents are primarily responsible for the children

Exclusion Criteria:

* parents are at-risk for parent-child relationship difficulties (i.e., endorse two of the following criteria: being a first-time caregiver, socially isolated, low education, caregiving alone, lack of confidence or self-efficacy, at risk for poor infant sensitivity, or at-risk for depression)