cyrilzakka/clinical-trials huggingface dataset:
Closed-loop Control of Glucose Levels (Artificial Pancreas) for 60 Hours in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.

The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of old.
* Clinical diagnosis of type 1 diabetes for at least one year.
* The subject will have been on insulin pump therapy for at least 3 months.
* HbA1c ≤ 12%.

Exclusion Criteria:

* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
* Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* History of pheochromocytoma or insulinoma (glucagon could induce an hormonal response of these tumors)
* Beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses)
* Chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose)
* Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
* Anticholinergic drug (risk of interaction)
* Pregnancy.
* Severe hypoglycemic episode within two weeks of screening.
* Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
* Known or suspected allergy to the trial products or meal contents (gluten free menus will be available).
* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator (e.g. need for major revision of carbohydrate counting).
* Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
* Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, not willing to change pump parameters, etc).
* Treatments that could interfere with glucagon
Effect of Nigella Sativa in Atorvastatin Treated Hyperlipidaemia

This study will be 8 weeks randomized, double-blind, placebo-controlled trail to assess the effect of Nigella Sativa in 84 Hyperlipidaemic patients. Participants will be assessed at baseline and after 8 weeks of intervention. Subjects will be randomized to receive either Nigella Sativa 500 mg capsule daily or placebo capsule identical to Nigella Sativa twice daily for 8 weeks. Evaluation of lipid profile, SGPT, S.Creatinine will be before and after 8 weeks of intervention. Nigella Sativa related adverse events will be identified. Study outcome will establish safety and efficacy of Nigella Sativa in atorvastatin treated hyperlipidaemic patients

Hyperlipidemia is one of the most important risk factors to cause atherosclerosis that ultimately triggers cardiovascular complications like myocardial infarction, ischemic stroke, peripheral vascular disease etc. These are considered as the leading cause of mortality and morbidity worldwide. Nigella sativa has both lipid lowering and anti-oxidant potentials. In this regard Nigella Sativa can be given with standard therapy to regulate blood lipids.

Aim of this study: This proposed study is therefore an effort to find out the safety and efficacy of Nigella Sativa in patient with hyperlipidemia.This study will be a single center study, utilizing a randomized, double-blind, placebo controlled trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of cardiology, BSMMU from the day of approval by the Institutional Review Board to June, 2024. The study will involve a total of Eighty four (84) patients attended in the outpatient department of cardiology, BSMMU, diagnosed as hyperlipidemia, with 42 of them receiving standard treatment along with a twice daily dose of 500mg of Nigella Sativa capsule for 8 weeks. The remaining 42 patients will undergo standard treatment along with a placebo over the same duration. The data collected will be analyzed through descriptive statistical techniques, offering a comprehensive summary of the results. In this study we will assess various sociodemographic characteristics of all the participants, including like age, sex, body mass index (BMI).In addition to these factors we will also evaluate their lipid profile, serum glutamic pyruvic transaminase (SGPT), serum creatinine level at baseline and after 8 weeks of interventions. Addition of Nigella Sativa with the conventional treatment of Statin could potentially reduce blood lipids in patients with hyperlipidemia.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed hyperlipidaemic patient.
2. Both male and female
3. Hyperlipidemic patients suffering from ischemic heart disease, diabetes mellitus, hypertension
4. Diagnostic criteria for dyslipidemic patients

   1. Total cholesterol 200mg/dl
   2. LDL-C 140mg/dl
   3. Triglyceride 150mg/dl
   4. HDL \<40mg/dl

Exclusion Criteria:

1. Patients with renal impairment
2. Patients with active liver disease
3. Patients having history of hypersensitivity on any member of statins
4. Pregnant woman.
5. lactating mother
Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

This trial is a randomized controlled study aiming to investigate the effect of an 8-week internet-based intervention focused on acceptance and compassion or a wait-list control group. Primary treatments outcomes are Chronic Pain Acceptance Questionnaire (CPAQ), Self-Compassion Scale (SCS) and Pain Disability index (PDI). Secondary outcomes were Montgomery Åsberg Depression Rating Scale (MADRS-S), Anxiety sensitivity index (ASI), Quality of Life Inventory (QOLI), Multidimensional Pain Inventory (MPI) and Perseverative Thinking Questionnaire (PTQ). A six month follow-up was conducted. Findings showed significantly greater levels of acceptance (CPAQ), self-compassion (SCS) and reduction in activity limitation (PDI) measured with the primary outcomes for the treatment group after the intervention with effect sizes raging from small to moderate and these results were maintained at six-month follow-up.

The purpose of this study was to explore if a psychological treatment fusing ACT and CFT principles and therapeutic techniques could improve outcome in chronic pain patients with high levels of self-criticism in comparison to a wait-list control group. The treatment was delivered via the internet, guided by trained professional. Internet delivered cognitive behavior therapy (CBT) and ACT treatments have shown similar efficacy as compared to face-to-face treatments in a variety of problem areas and across a large range of outcomes. Participants were recruited from a clinical setting. The treatment program consisted of eight sections and was based on a manual based on ACT developed for chronic pain (Buhrman et al., 2013) and a CFT-manual for chronic pain.

Following a screening interview participants deemed eligible were asked to complete an assessment battery online. All correspondence concerning treatment was held through a web portal including the online questionnaires and a secure e-mail service. The system handled security issues with two factor authentication. The participants logged in with electronic identification which is a secure service used by banks and in clinical settings.

Measures were obtained pre- and post- intervention and administered via the internet. A sixth month follow-up of the treatment group was administered. Mediation measures were also obtained.

Eligibility Criteria:
Inclusion Criteria:

* have experienced pain for more than three months,
* have been medically investigated (within the past year)
* be at least 18 years of age
* have regular access to a computer and the internet
* reported self-criticism measured with the Self-Compassion Scale.

Exclusion Criteria:

* planned surgery
* ongoing medical investigation that could impede participation in the study,
* suffering from acute physical or psychological conditions,
* very severe symptoms of depression (i.e., defined as a score of \>2 on item 9 on MADRS-S and information from telephone screening)
* ongoing psychological treatment,
* not being fluent with the Swedish language since all the material would be in Swedish.
Real-Life Evidence on Stroke Prevention in SPAF

To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window
* Diagnosis of NVAF on start date of study or anytime during 365 days before this date
* Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date)
* Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window.

Exclusion Criteria:

* Patients with valvular AF
* Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date
* Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period
* Prescriptions of \< 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort
Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients

This purpose of this study is to investigate the efficacy and tolerability of pregabalin in treating idiopathic RLS patients for up to 12 months.


Eligibility Criteria:
Inclusion Criteria:

* idiopathic RLS with the presence of all four clinical manifestations of RLS
* RLS symptoms occur predominantly in the evening
* RLS history at least 6 months
* IRLS =\> 15 at the beginning and the end of placebo run-in
* Have =\>15 nights with RLS symptoms in the month prior to screening

Exclusion Criteria:

* Any secondary RLS
* Current augmentation due to RLS treatment
* Placebo responders identified during the placebo run-in
The Efficacy of Adjunctive Use of Ondansetron in Patients With Sepsis and Septic Shock

Sepsis is a systemic inflammatory response that has deleterious effects and considered the leading cause of death in critically ill patients 1 . One of the hallmarks of severe sepsis is the progressive, injurious inflammatory response to infection, mediated by the excessive release of inflammatory mediators and consequently, associated with multiple organs damage 2 . Various studies have demonstrated that adverse outcomes in sepsis patients are closely related to the development of myocardial dysfunction 3 . The mortality of sepsis combined with cardiac functional insufficiency has increased significantly to 70%-90% 4 . Therefore, targeting cardiac insufficiency and heart injury may represent a novel treatment strategy. Several reports documented critical involvement of serotonin 5-hydroxytryptamine in the pathogenesis of sepsis. The aim of the current study is to evaluate the efficacy of ondansetron adjuvant use in patients with sepsis and septic shock.


Eligibility Criteria:
Inclusion Criteria:

male or female adult patients, aged 18 years or older with sepsis or septic shock after surgery according to the 2016 third international consensus definitions for sepsis and septic shock

Exclusion Criteria:

diagnosis of septic shock longer than 24 hours ago known or suspected disease with a strong indication or contraindication for the study drugs Pregnant and lactating women.
Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers

The use of PRP has dramatically increased in the fields of orthopedics, spine surgery, reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other fields. In this experimental study, the treatment outcome of autologous PRP was assessed in comparison to conventional therapy among patients with chronic venous leg ulcers.

Venous ulcers are the most common form of leg ulcers which have a significant impact on quality of life and work productivity. In addition, the costs associated with the long-term care of these chronic wounds are substantial. Conventional therapies such as dressings, surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory healing since these treatments are not able to provide necessary growth factors that can modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple, affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly good results. Since it is an autologous method, it is biocompatible and safe. Data from this would help in establishing it as a treatment of choice, thereby leading to a reduction in cost and benefiting the patient both financially and psychologically.

PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet-derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, and transforming growth factor. These growth factors are important in modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis during the healing process.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30-80 years of any gender presented with chronic venous leg ulcers

Exclusion Criteria:

* Patients with history of peripheral arterial disease.
* Patients with history of acute venous thromboembolism.
* Patients with platelet count less than 150000.
* Patients with history of bleeding disorders.
* Patients with history of osteoporosis.
* Patients with history of peripheral neuropathy.
* Pregnant patients assessed by history and confirmed by dating scan.
* Patients with history of congestive cardiac failure, chronic liver disease, asthma, COPD, or stroke.
The Effect of Bristle Brush, Rubber Cup, and Air Polishing on Tooth Surface Roughness of Scaled Teeth

This study investigates the effects of three polishing methods using a bristle brush, rubber cup, and air polishing on the surface roughness of scaled human teeth. The study aims to determine which polishing method is most effective in minimizing roughness and preventing plaque accumulation, thus contributing to improved oral health practices.

Tooth surface roughness influences plaque retention and periodontal health. Polishing after scaling helps smoothen enamel surfaces, reducing bacterial adhesion. While various studies have assessed polishing techniques, there are inconsistencies in findings, particularly regarding air polishing vs. rubber cup polishing. Additionally, most studies focus on bovine teeth or indirect restorative materials rather than extracted human teeth. Using a randomized controlled trial (RCT) design, 56 extracted teeth will be divided into four groups: a control group (no polishing) and three experimental groups subjected to different polishing techniques. Surface roughness will be analyzed using a Scanning Electron Microscope (SEM). This study aims to fill these research gaps and provide region-specific data by determining which polishing method is most effective in minimizing roughness and preventing plaque accumulation, thus contributing to improved oral health practices.

Eligibility Criteria:
Inclusion Criteria:

* Extracted human teeth with intact buccal or lingual surfaces.
* Patients with a history of trauma affecting the oral cavity will be eligible, provided they meet other criteria (e.g., intact buccal or lingual surfaces).
* Male and female patients aged 18 years and above.

Exclusion Criteria:

* Teeth with restorations, caries, fractures, or significant developmental defects (e.g., amelogenesis imperfecta, dentinogenesis imperfecta , fluorosis etc).
* Patients with systemic disease such as diabetes mellitus, cardiovascular disorders or any other condition will be excluded.
* Mentally impaired patient.
* Patients who have undergone scaling and polishing within the last 3 months.
Pharmacokinetics of Oral Hydroxyurea Solution

An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatment period for each participant. The study treatment duration will be for 6 months at the maximum tolerated dose \[MTD\], which is usually reached by 6 months after initiation of treatment. For patients in whom time to MTD is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged from 6 months to 17.99 years of age (i.e. to the day before 18th birthday).
2. Diagnosis of sickle cell anemia (HbSS and HbSβº).
3. Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study.
4. Where applicable, the child should assent to undergo blood sampling for pharmacokinetic and biochemistry purposes and to allow physiological measurements to be made.

Exclusion Criteria:

1. Any clinically significant medical condition or abnormality, which, in the opinion of the Investigator, might have compromised the safety of the patient or which might have interfered with the study.
2. Hydroxyurea use within 6 months before enrolment.
3. Renal insufficiency (known creatinine more than twice the upper limit of normal (ULN) for age and \>1.0 mg/dL \[88.4 μmol/L\]).
4. Clinical evidence of hepatic compromise with alanine aminotransferase (ALT) \>3 times the ULN (a temporary swing in ALT did not result in exclusion).
5. Other significant organ system dysfunction based on the site Investigators discretion.
6. Severe active infections: fungal, viral or bacterial (as confirmed by culture), examples included tuberculosis, malaria, active hepatitis, osteomyelitis or any other illness that would have precluded the use of HU in normal clinical practice.
7. Active chronic leg ulcers.
8. Known allergy to oral HU solution or any of the excipients.
9. Positive pregnancy test for females of child-bearing potential (in post-menarcheal females) before initiation of treatment, unless participant was sexually abstinent. Note: True abstinence was considered as being in line with the preferred and usual lifestyle of the participant. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
10. Inadequate contraception measures in sexually active females (post-menarcheal females) and males of child-bearing age (see Section 9.5.1.10.4).
11. Breastfeeding at study initiation.
12. Participation in another clinical trial of an IMP.
13. Known infection with HIV.
A Morphological Study in Volleyball Athletes With Cronic Ankle Instability

The former purpose of this study to investigate the effect of transverse abdominis, lumbar multifidus, vastus lateralis, lateral gastrocnemius, anterior talofibular ligament of morphology on explosive power and balance performance in cronic ankle instability with volleyball players. The latter purpose of this study to determine morphological characteristics volleyball players with and without cronic ankle insatbility of trunk muscle morphology, field tests and the muscle morphology features between the body affected and unaffected sides whose those with chronic ankle instability.This study was designed as a cross-sectional. Twelve volleyball players with chronic ankle instability who meet the criteria determined by the ankle consortium will be included in study group. Twelve asymptomatic volleyball players who have been training at least three days a week for at least one year will be include in the control group. They will consist of 24 volleyball players between 14-35 years of age.Morphological characteristics of anterior talofibular ligament, transverse abdominis, lumbar multifidus, vastus lateralis, lateral gastrocnemius will be evaluated via ultrasound, explosive power with squat jump, counter movement jump and balance performance by Y-Balance Test. Trunk muscle morphology, core stabilization, explosive power, balance performance will have been compered in volleyball players with and without chronic ankle instability. The effects of morphological features on explosive power and balance performance will have been determined. It is anticipated that by determining the parameters that can be affected by instability with volleyball players, it will guide the professionals working in the field, countribute to treatment and preventive treatment programs.


Eligibility Criteria:
Inclusion Criteria:

Inclusion for the CAI group followed the International Ankle Consortium guidelines.

Criteria for inclusion in the control group:

To train for 1 hour at least 3 days a week for at least 1 year, Cumberland Ankle Instability Instrument (CAIT) score of 25 or higher, To have a Tegner activity level of 4 and above, It is not to have a systemic disease

Exclusion Criteria:

The patient will be excluded from the study in the event of the presence of at least one of the following criteria:

Having undergone ankle, knee, hip surgery, Having bilateral ankle instability, Having suffered a known musculoskeletal injury of the hip Having suffered an ankle sprain during the evaluation process

Criteria for exclusion from the study:

Withdraw to any period
A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old (including both ends), male or female;
2. ECOG-PS score: 0 or 1;
3. Expected survival ≥ 12 weeks;
4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
5. Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence;
6. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
7. The main organ function is normal, in line with the program requirements;
8. Consent to contraception.

Exclusion Criteria:

1. Other active malignancies within 5 years or at the same time;
2. Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
3. Subjects with biliary obstruction should be excluded;
4. There is active autoimmune disease or a history of autoimmune disease that may recur;
5. Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
6. Severe infection within 4 weeks prior to initiation of study treatment;
7. Active hepatitis B virus (HBV) infection;
8. Have serious cardiovascular and cerebrovascular diseases.