cyrilzakka/clinical-trials huggingface dataset:
Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia

The purpose of this study is to determine whether or not bedtime snacks are necessary to prevent overnight low blood glucose reactions (nocturnal hypoglycemia) in adults with type 1 diabetes who are using intensive insulin therapies, either multiple injections of insulin or insulin pump.

We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well adjusted and delivered, especially by use of insulin pump which is considered the "gold standard" for overnight blood glucose control.

Nocturnal hypoglycemia is a significant side effect of insulin replacement therapy and can lead to many problems including coma and death in the most extreme cases and deterioration of glycemic control. Strategies to prevent nocturnal hypoglycemia include development of newer insulins and delivery systems and the use of specific bedtime snack compositions. Detection of nocturnal hypoglycemia, as it occurs in everyday life, has been a problem since most episodes go unnoticed and therefore untreated leading to a very dangerous situation. With the recent availability of technology which allows for continuous glucose monitoring , it has been made possible to detect nocturnal hypoglycemia as it occurs in daily life. As well, this technology allows for the possibility of better titration of therapy.

Therefore, the goal of our study was to use continuous glucose monitoring technology as a tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia as it occurs in daily life. Specifically, we sought to compare the use of insulin pump therapy with no bedtime snacks and using a new type of insulin called an analogue(lispro) versus multiple daily injections of insulin, using the same type of insulin analogue, and with and without bedtime snacks. Therefore, we compared 3 groups: 1) insulin pump with no bedtime snacks; 2) multiple injections with bedtime snacks and 3) multiple injections with no bedtime snacks. The groups were primarily compared for the occurrence and frequency of nocturnal hypoglycemia. Other comparisons included: long term glycemic control (A1c), weight and body composition and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adults with type 1 diabetes for more than 3 years duration and on intensive insulin therapy using multiple daily injections of insulin (MDI) for at least 1 year prior to study.

Exclusion Criteria:

* Pregnant women or intending to become pregnant in next year,
* Significant hepatic or renal disease,
* Active cancer,
* Abuse of alcohol or drugs.
Identification of Cardiovascular Risk Factors Linked to Renal Failure Progression

The aim of this study is to appreciate the influence of renal failure progression on vasculopathy (coronary calcifications and left ventricular hypertrophy) and cardiovascular risk factors.

The aim of this study is to appreciate the relationship between:

* extension of coronary calcifications and chronic renal failure progression
* extension of coronary calcifications and levels of osteoprotegerin (bone disease marker)
* cardiovascular risk factors and coronary calcifications
* cardiovascular risk factors and existence of cardiovascular diseases

Eligibility Criteria:
Inclusion Criteria:

* Patient who has signed the written consent form
* Patient aged \> 18 and \< 90 years
* Chronic renal failure defined by glomerular filtration rate (GFR)

  * group 1: GFR \>90 mL/min with urinary biological abnormalities and GFR comprised between 90 and 60 mL/min
  * group 2: GFR comprised between 60 and 30 mL/min
  * group 3: GFR \<30 mL/min but without dialysis therapy

Exclusion Criteria:

* Chronic renal failure patient requiring dialysis therapy
National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children

The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the use of prescription drugs, medical and hospital services and vital statistics between BC participants who experience adverse drug reactions and those who do not.

Study hypothesis: Genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.

CPNDS will identify ADR predictive markers by comparing DNA and plasma samples from patients that suffer ADRs with samples from control populations that are stratified by medication type and age. The GATC will obtain its clinical material for ADR patients mainly, from hospital-based active surveillance network across Canada's major hospitals.

1. CPNDS will examine known SNPs in candidate genes related to the ADR (i.e. drug metabolism genes, drug transporter genes, drug target genes, and other disease-specific genes or genes related to the physiological pathway of the ADR.) 2. CPNDS will discover novel ADR predictive SNPs and mutations by sequencing DNA samples from our patient cohorts. CPNDS will also genotype and sequence DNA samples from populations of controls that received the same drugs, but did not suffer ADRs; and a second population of control patients who represent a random sample of the population of known ethnic backgrounds.

Novel ADR predictive SNPs and mutations will be functionally validated by pharmacokinetic approaches applied to time course analysis of drug concentrations for each specific genotype. Pharmacokinetic studies will also be used to determine the drug concentration in patients to characterize possible mechanisms of the ADR, translating into rational approaches to the choice of candidate genes to be examined in the genomic analyses.

The cost-effectiveness of an ADR screening program for the prevention of ADRs in children and adults will be calculated in detailed health-economic studies.

Eligibility Criteria:
Inclusion Criteria:

* Children under 19 years who have taken drugs.
* Biological parents of children who have had an ADR.
* Patients/parents who speak and understand English (except in Quebec).
* Adults (for validation of findings in children)
Pilot Study on Breathing Exercises and Pulmonary Function in Children With Cerebral Palsy: A Randomized Trial

This pilot study is a randomized controlled trial aimed at investigating the efficacy of protocolized conductive breathing exercises combined with regular air ventilation, in addition to standard care, on various aspects of health in school-aged children with cerebral palsy (CP). The primary objectives of the study include assessing the effects on pulmonary functions, quality of life (QoL), depression anxiety and stress (DAS) levels, eating-drinking ability (EDACS), and severity of drooling in this population.

The study compares two groups of participants: one group undergoes protocolized conductive breathing exercises three times per day for five minutes, five days a week, while the other group receives only standard rehabilitation care. Evaluations include spirometry parameters ( forced vital capacity \[FVC\] forced expiratory volume in the first second \[FEV1\], FEV1/FVC ratio and peak expiratory flow \[PEF\]. Assessments are conducted at the beginning and end of the eight weeks intervention period, with additional evaluations after a 2.5-month washout period.

The conductive breathing exercises, developed by Dr. András Pető, the founder of the conductive education system, consist of techniques such as diaphragmatic breathing, deep breathing, and playful forced expiration.

Respiratory well-being is crucial, particularly in pediatric CP patients, as compromised pulmonary functions can significantly impact overall health. Despite this, there is currently a lack of established protocols and research regarding the efficacy of conductive breathing exercises in this specific population. Therefore, the this study seeks to address this gap by determining whether a structured regimen of conductive breathing exercises, when added to standard care, can lead to measurable improvements in respiratory health and QoL among school-aged children with CP.


Eligibility Criteria:
Eligibility Criteria:

Inclusion Criteria:

* Children with cerebral palsy (GMFCS I-V)
* School-Aged 12-22 years, of both genders
* Teens and adolescents attending continuous standard care
* Capable of understanding and following commands given by the therapist
* Children who do not require respiratory support

Exclusion Criteria:

* Children who have received recent surgical procedures or botulinum toxin injections
* Children who are unable to perform spirometry
Exercise-snacks at Work: Impact on Cardiometabolic Parameters

The main objective is to measure the effects of intense brief exercise program in the workplace of administrative staff on the cardio-metabolic health

Backgrounds: Very short (\< 1 minute) and intense exercises, entitled "exercise-snacks", have been reported to be effective 1) in improving physical fitness over 6 weeks and 2) in improving vascular function and lowering blood glucose levels over one day. These studies were all carried out in the laboratory. The question therefore arises as to whether these acute vascular and metabolic benefits, as well as those on physical fitness, are sustainable over time following a chronic "exercise-snacks" program applicable in the professional environment to sedentary, overweight people.

Aims of this project is therefore to measure the effects of an "exercise-snacks" type physical activity program in the workplace of administrative staff on the cardio-metabolic health and sedentary behaviour of staff.

Eligibility Criteria:
Inclusion Criteria:

* administrative staff,
* age between 30 and 60,
* body mass index ≥25kg/m²,
* sedentary time ≥7h/day,
* minimum 3 working days on site,
* no known cardiovascular or metabolic pathology, social security affiliation or benefit,
* ability and willingness to give free, written and informed consent.

Exclusion Criteria:

* pregnant or breast-feeding women,
* anti-hypertensive treatment, beta-blockers and anti-diabetics,
* known contraindications to physical activity (articular, cardiac or other),
* exercise-induced asthma,
* lack of motivation of subjects posing problems of compliance and adherence to the exercise program,
* participation in a study in the preceding 3 months, ongoing participation in a clinical trial.
Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment

Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance.


Eligibility Criteria:
Inclusion Criteria:

* consecutive consented patients (\> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the Midwestern University, Multidisciplinary Clinic;
* patients in possession of an email address and Internet connection.

Exclusion Criteria:

* patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis),
* untreated dental caries.
COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients

Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) .

Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.

This is a prospective multicenter interventional observational study will be conducted in 4 major tertiary hospitals (Al-Sabah, Farwaniya , Mubarak Al-Kabeer and Jahra) in Kuwait .

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years old ( those who are younger are involved after case based discussion)
2. Confirmed laboratory diagnosis with SARS-CoV-2 ,and admission diagnosis of SARS-CoV-2.
3. Patients with moderate or severe COVID-19 (moderate COVID-19 disease defined as the presence of any signs of pneumonia (fever, cough, dyspnoea fast breathing) including SpO2 \>90 on room air , but no signs of severe pneumonia (severe pneumonia have the above plus one of the following: respiratory rates \>30 breaths/minutes or SpO2\<90% on room air), or admission to intensive care unit (ICU) for respiratory support (i.e.high flow nasal cannula, non-invasive mechanical ventilation and intubation).

Exclusion Criteria:

1. -Contraindication to transfusion (volume overload, history of anaphylaxis to blood products).
2. - Patients presenting with acute severe multiorgan failure, hemodynamic instability.

3- Severe disseminated coagulopathy (DIC), septic shock and those with expected survival of less than 48 hours.
The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women

Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18-40 year
* History of recurrent urinary tract infections (two or more episodes in the past year).
* Singleton pregnancy.

Exclusion Criteria:

* Multiple gestations.
* History of preterm labor.
* Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
* Use of antibiotics or probiotics within the past month.
Clinical Triage and Treatment of Atypical Glandular Cells (AGC) Detected in Screening

The risk of cervical cancer after diagnosis with atypical glandular cells (AGC) detected by screening is elevated for 15 years after discovery. The current recommendation is that when AGC is detected during screening, referel is made to a gynecologist for colposcopy with biopsy within 3 months after the index test. Repeated tests should be done after one year and after two years and if these are negative, the woman can return to routine screening.

Given the increased risk of cancer associated with AGC a new evaluation of the optimal follow-up and treatment of AGC, which is detected during screening, is carried out. In this randomized study, women with AGC will be randomized to routine treatment according to current guidelines or to conization. The aim of the study is to determine which of the two treatments is most effective.

Evidence from a nationwide cohort study demonstrated that the risk of cervical cancer following a diagnosis of AGC detected in screening was elevated for 15 years, particularly the risk of adenocarcinoma. Furthermore, the study suggested that compared to high-grade squamous intraepithelial lesion (HSIL) management, the management of AGC has been suboptimal in Sweden (Wang et al., BMJ 2016). A study conducted in the greater metropolitan region of Stockholm showed that the PPV for high grade lesions was 60% for Human Papillomavirus (HPV) positive AGC detected in screening (Norman et al., BMJ Open, 2017).

The new guidelines for cervical cancer prevention were adopted in January of 2017 nationally and in December 2017 in county of Stockholm and outline a clinical management strategy for AGC. The recommendation is that AGC detected in screening, regardless of HPV status, should be referred to a gynecologist for colposcopy with biopsy within 3 months of the index test. For women over the age of 40, an ultrasound and endometrial biopsy is also recommended. Repeat tests should be done at one year and two years, if these are negative then the woman can return to routine screening.

The elevated risk for high grade lesions and cancer associated with AGC, coupled with the reality that cervical cancer incidence has increased in Sweden, begs a new evaluation of the optimal clinical management and treatment of AGC detected in screening. Women will be randomized to routine management according to the new guidelines or to an alternative management.

Eligibility Criteria:
Inclusion Criteria:

* give informed consent
* Women diagnosed with AGC (atypical glandular cells, M69720) and HPV 16/18 positive, detected in cervical screening.

Exclusion Criteria:

* Do not give informed consent
* HPV negative or none-HPV16/18 positive
Determine the Efficacy of Closed Suction Drain After Hydrocelectomy. (END Trial)

There is no clear consensus regarding the benefits of putting a closed suction drain after eversion of the sac in a hydrocele of the tunica vaginalis testis. Our study will find out the benefits if at all of a closed suction drain in hydrocele surgery. The potential complications expected after hydrocelectomy surgery are bleeding, infection, redness, and pain. There is no such trial to date to determine the benefits of putting a closed suction drain after hydrocelectomy surgery.

Study objectives:

1. Primary:

   To compare the postoperative complication rates of hematoma, skin edema and surgical site infection after hydrocelectomy, between patients with or without a closed suction drain (CSD).
2. Secondary:

To compare postoperative pain (testalgia) between the two groups of patients.

Study setting: All patients over 18 years of age attending the outpatient department of General Surgery at AIIMS, Bhubaneswar with the diagnosis of idiopathic hydrocele and planned for elective surgery.

Total Sample Size = 60 (30 in each arm)

Eligibility Criteria:
Inclusion Criteria:

- All patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery.

Exclusion Criteria:

* Patient not giving consent to participate
* Patients with ASA (American Society of Anaesthesiology) grade 3 \& 4
* Patients with congenital or secondary hydrocele
* Patients with recurrent disease, pyocele or filarial scrotum
Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Type 2 Diabetes diagnosis
* Plan to fast during Ramadan
* Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1
* Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
* Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
* Inability to comply with the study procedures or medications.

"Other protocol-defined inclusion/exclusion criteria may apply"
Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.

Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)

Patients are invited to participate in a research study of Kuvan® (sapropterin dihydrochloride). We hope to learn whether treatment with Kuvan® is safe and effective in improving the ability of the stomach to relax after eating and improving the symptoms of diabetic gastroparesis. Women are selected as a possible participant in this study because they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).

Eligibility Criteria:
Inclusion Criteria:Inclusion Criteria

Patients with moderate to severe symptoms of diabetic gastroparesis will be studied (GCSI \>21). Patients should not have post-surgical gastroparesis or dyspeptic symptoms with normal gastric emptying. In order to qualify for inclusion in the trial, patients must satisfy the following inclusion criteria:

1. Diagnosis of diabetes mellitus \> 5 years requiring medical therapy
2. Female gender
3. Ages 18-65 years
4. Documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment)
5. Symptoms of gastroparesis for at least 6 months with Gastroparesis Cardinal Symptom Index (GCSI) score \> 21 indicating moderate to severe symptoms
6. Recent negative upper endoscopy or upper GI series within 2 years of enrollment (no evidence of mechanical obstruction or peptic ulcer disease)

Exclusion Criteria:Exclusion Criteria

Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in the study:

1. Diabetes diagnosed \< 5 years prior to the study
2. Male gender
3. Normal gastric emptying
4. Gastroparesis from post-surgical etiologies
5. Another active disorder, which could explain symptoms in the opinion of the investigator
6. Pregnancy
7. History of significant cardiac arrhythmias and/or prolonged QTc
8. Daily use of narcotic analgesics for abdominal pain
9. Contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae.
10. Underlying seizure disorder
11. Known history of cardiac ischemia
12. Recent clinically significant gastrointestinal bleeding
13. Patients taking Levodopa
14. Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
15. Failure to give informed consent
16. Surgery for placement of a gastric stimulator within the past 6 months (patients \> 6 months post-op with persistent symptoms and delayed gastric emptying are eligible).
17. A normal upper endoscopy not performed within 2 year of study entry.
18. Patients taking phosphodiesterase inhibitors such as sildenafil, vardenafil, tadalafil
19. Patients with renal impairment (i.e. Creatinine \> 2.5 mg/dL)
20. Patients with hepatic dysfunction (i.e. ALT and AST values \> 2.5x ULN and T. bilirubin \> 1.5x ULN)
21. Patients with uncontrolled diabetes, such as HbA1c \> 10 mg/dl at screening/baseline will be excluded.