cyrilzakka/clinical-trials huggingface dataset:
Utility of Presepsin in Distinguishing Between Sepsis and SIRS

This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).


Eligibility Criteria:
Sepsis/SIRS Patients

Inclusion Criteria:

* Male or female aged ≥ 21 years
* Appropriate clinical data to enable classification into sepsis or SIRS
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation

Exclusion Criteria:

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Control

Inclusion Criteria:

* Male or female aged ≥ 21 years
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative

Exclusion Criteria:

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

End Stage Renal Disease

Inclusion Criteria:

* Male or female aged ≥ 21 years
* Documented diagnosis of end stage renal disease currently undergoing dialysis
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative

Exclusion Criteria:

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%
Efficacy of the CO-OP Approach With Brazilian Children With Developmental Coordination Disorder

Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. To date, there are a number of interventions to improve performance of these children on activities they want or need to. In Brazil, there is little research on the efficacy of such approaches. Our main objective was to start a set of studies to examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals.

Background. Children with Developmental Coordination Disorder (DCD) have difficulties performing daily activities which reflects negatively on participation, impacting their lives. Objectives. To examine the effects of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP Approach) protocol on occupational performance and satisfaction of Brazilian children who have DCD; to examine whether children were able to transfer strategies and skills learned during CO-OP to untrained goals. Methods. A pre-post group comparison design with eight boys aged 6-10 years old. Children participated in 12 CO-OP sessions with their parents twice a week, with an extra session added to the protocol for parents´ orientation. The Canadian Occupational Performance Measure and the Performance Quality Rating Scale were used as outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* poor motor performance measured by a motor performance test (cut off score below the 15th percentile).
* poor performance on academic and daily living activities measured by the Developmental Coordination Disorder Questionnaire answered by the parents.
* attending regular education with no evidence of marked school delay (over a year).
* cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Third Edition (WISC-III).

Exclusion Criteria:

* signs of neurological or neuromuscular disorder.
* presence of intellectual disability.
Impact of Race/Ethnicity on Platelet Function

The effects of race/ethnicity on platelet function and response to antiplatelet agents will be assessed using healthy participants and coronary heart disease patients from at least 5 racial/ethnic groups.

The effects of race/ethnicity on platelet function and response to antiplatelet agents will be assessed using 125 healthy subjects, 250 coronary heart disease patients treated with aspirin, and 250 coronary heart disease patients treated with aspirin and a P2Y12 receptor antagonist, clopidogrel or prasugrel. A minimum of 25 healthy people, 50 people taking only aspirin, and 50 people taking aspirin and clopidogrel/prasugrel will be recruited for at least 5 racial/ethnic groups.

Eligibility Criteria:
Inclusion Criteria: Each subject must fulfill the following criteria in order to be included in the study.

* The subject must be capable of understanding the nature of the study and executing an informed consent document.
* The subject must be aged 19 years or older.
* For healthy subjects, the subject must deny taking any medications that affect platelet function for at least 7 days before blood collection.
* For diseased patients, subjects with documented CAD are eligible to participate if they have been treated with antiplatelet therapy of aspirin (81 to 325 mg/day) with and without clopidogrel (75 mg/day) or another P2Y12 antagonist for at least one month.

Exclusion Criteria: For healthy volunteers, subjects who fulfill one or more of the following criteria will be excluded from the study.

* taking medications for chronic cardiovascular diseases.
* illnesses requiring hospitalization or surgery within the last three months.
* history of drug or alcohol abuse.
* history of recent anemia or thrombocytopenia.
* history of excessive bleeding or thrombosis.
* pregnancy.

For coronary heart disease subjects, subjects who fulfill one or more of the following criteria will be excluded from the study.

* illnesses requiring hospitalization or surgery within the last one month.
* history of drug or alcohol abuse.
* history of recent anemia or thrombocytopenia.
* pregnancy.
* recent bleeding diathesis
* malignancy
* renal insufficiency
* liver dysfunction
* treatment with warfarin or glycoprotein (GP) IIb/IIIa antagonists during the preceding 14 days
Effectiveness of Zinc Supplementation With Topical Retinoids in Acne Vulgaris Patients

The study was 8 weeks, randomized, double-blind, placebo-controlled trial to assess the effect of zinc sulphate on symptoms of mild and moderate acne vulgaris in 122 patients. Participants was assessed at baseline, and 8 weeks. Subjects was randomized to receive either 20 mg elemental zinc daily or 20 mg placebo tablet daily for 8 weeks. The primary outcome was the measure of the GAGS score and the secondary measure includes serum zinc level and evaluate adverse effects.

Acne vulgaris (AV) is the eighth most prevalent disease worldwide. Acne is a self-limiting condition, it may cause significant psychological and social problems, depression, disfigurement, and scarring that can persist for a lifetime. Multiple factors contribute to acne pathogenesis including increased sebum production, aberrant keratinization of the pilosebaceous duct, bacteria such as Propionibacterium acnes, hormonal influences, the skin microbiome, and chronic inflammation. Relapse rates in patients with acne after treatment with standard of care vary between 10% and 60%. Recent trials attempted to assess the effect of zinc in reducing the severity of symptoms of acne vulgaris patients. This study evaluates whether there is any role of zinc in reducing acne symptoms between those who did and did not receive zinc in an 8 weeks period. This includes 122 acne vulgaris patients who were recruited from Dermatology and Venereology OPD of BSMMU. Participants took either 20 mg elemental zinc daily in the form of zinc sulphate tablet or 20 mg placebo tablet daily for 8 weeks. Initially, baseline serum zinc level was measured and repeated again after 8 weeks of intervention. A baseline acne symptoms survey was done by GAGS score and also repeated at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed mild and moderate AV patients diagnosed by a dermatologist at the outpatient Department of Dermatology and Venereology,
* Age: 11-35 years,
* Gender: Both male and female

Exclusion Criteria:

* Pregnancy and lactation,
* History of oral contraceptive pills, zinc, and iron intake,
* Suffering from any cosmetic induced acne
Adjunctive Vaginal Progesterone in Management of Preterm Labor

This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy with gestational age 24-33 weeks 6 days
* preterm labor
* received treatment with tocolysis and corticosteroids

Exclusion Criteria:

* conditions that need immediate delivery such as fetal distress, chorioamnionitis
* have medical complications such as heart disease, seizure
* fetal anomalies
* cervical dilatation more than 5 cm
* allergy to progesterone
* contraindication to progesterone
* contraindication to tocolytic use
Comparing Bowen Therapy With Ice to Medical Massage for Acute Ankle Sprain

Foot pain is particularly prevalent among older adults, affecting approximately 20% to 37% of men and women aged 45 years and older living in the community. Ankle pain is somewhat less common. This study evaluates the combined impact of cryotherapy (ice application) with Bowen therapy versus traditional medical massage in alleviating symptoms. A total of 41 patients, aged 32-75 years participated and were divided into two treatment groups: one receiving medical massage and ice, and the other Bowen therapy and ice, with three sessions over 15 days. Pain and functionality were measured using the VAS pain scale and Roland-Morris questionnaire. Findings revealed improvements in both groups, with the Bowen therapy group achieving greater pain reduction and functional improvement, suggesting potential advantages of Bowen therapy combined with cryotherapy for managing symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 32 to 75 years.
* Diagnosed with ankle sprain by a qualified healthcare professional (physiatrist or orthopedist).
* Able to provide informed consent.
* Willing to comply with the study protocol and attend all scheduled therapy sessions.

Exclusion Criteria:

* Presence of serious spinal pathologies (e.g., cancer, osteoporosis, trauma, or fracture).
* History of significant neurological disorders or conditions affecting mobility.
* Pregnancy or breastfeeding.
* Previous surgical interventions on the spine or significant other surgeries within the last six months.
* Current use of medications that affect pain perception (e.g., opioids).
* Participation in other therapeutic interventions for low back pain during the study period.
Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes

Patients with type 1 diabetes trained in multiple daily insulin injection were treated with two diffferent kinds of long acting insulin preparations. The two insulin preparations were glargine and ultralente insulin. Patients were randomized to receive one of the two insulin preparations for the first 4 months followed by the second preparation for a further four months. Short acting insulin used was the same during both periods. We found that glargine insulin was better than ultralente insulin in our study.

Multiple daily insulin injection (MDI) programs are commonly accompanied by considerable glycemic variation and hypoglycemia. In order to determine whether use of insulin glargine as a basal insulin would result in comparable HbA1c with less glycemic variation and hypoglycemia than ultralente insulin, 22 individuals with type 1 diabetes, experienced with MDI, and a HbA1c of \<7.8 % were randomized, to receive either glargine or ultralente as the basal insulin for 4-months. Aspart insulin was used as the prandial. Physicians providing insulin dose adjustment advice were masked to the type of basal insulin. Treatment with glargine resulted in lower mean HbA1c, less nocturnal variability , and less hypoglycemia primarily due to less daytime hypoglycemia (p=0.002). On the other hand, serious hypoglycemia and average glucose concentration measured with continuous glucose monitoring system (CGMS) did not differ. We conclude that, while use of either ultralente or glargine as a basal insulin can result in excellent glycemic control, treatment with glargine is associated with slightly but significantly lower HbA1C, with less nocturnal glycemic variability and less hypoglycemia.

Eligibility Criteria:
Type 1 diabetes, HbA1c \< 7.8%, who have had prior instruction in a complex insulin program, and presently using a MDI insulin program with basal insulin preparations of Glargine or Ultralente and Humalog as the short acting insulin, should be free of hepatorenal abnormalities and hypoglycemia unawareness; non-pregnant, and should be able to perform frequent self monitoring of blood glucose (SMBG) and accept the use of continuous glucose monitoring system (CGMS). They should also possess the skill and understanding of insulin dose adjustments and supplementation.
Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.

Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.

In our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.

Hypothesis: New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.

Eligibility Criteria:
Inclusion Criteria:

All preterm Infants born with less than 32wGA admitted in our NICU.

Exclusion Criteria:

Congenital malformations and Known Chromosomal disorders,
A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients

Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.

The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged 18 years or older
* mild to moderate hypertension (systolic blood pressure \> 139 mmHg or diastolic blood pressure \> 89 mmHg)

Exclusion Criteria:

* secondary form of arterial hypertension
* severe hypertension (systolic blood pressure \> 179 mmHg or diastolic blood pressure \> 109 mmHg)
* pregnant or lactating women
The Effect of Addition of Metformin to SGLT2 In Diabetic Patients With Heart Failure With Preserved Ejection Fraction

a prospective open-label, randomized controlled study to evaluate the efficacy of the addition of metformin to SGLT2 in diabetic patient with preserved ejection fraction

Regardless of the benefits noted with SGLT2is, metformin is recommended as first-line therapy for glycemic control in individuals with T2DM and HF, including HFpEF, with estimated glomerular filtration rates (eGFRs) ≥30 mL/min/1.73 m2. This is based on the demonstrated experience with long-term use; its safety, low cost, and low side effect profile; as well as observational (not clinical trial) data suggesting a 20% relative risk reduction in mortality in individuals with HF, including HFpEF.

Nevertheless, it is worth mentioning that Metformin is a common anti-diabetic drug with both systemic and cardioprotective benefits in addition to its hypoglycaemic effect. At the cellular level metformin activates adenosine monophosphate-activated protein kinase (AMPK) an important regulator of several metabolic pathways resulting in enhanced glucose utilisation, reduction of protein synthesis and improvement of mitochondrial function. Furthermore, metformin has been shown to reduce collagen accumulation and potentially reduce LV hypertrophy and improve diastolic function in the diabetic myocardium. The cardio protection afforded by metformin treatment seems to result from interference with TGF-beta signaling pathway and activation of the AMP-kinase signaling cascade. A recent systematic review and meta regression analysis have shown that metformin treatment was associated with a reduction in mortality in patients with HFpEF. In addition, treatment with metformin of non-diabetic metabolic syndrome patients with diastolic dysfunction, on top of lifestyle counseling, was associated with improved diastolic function.

Nevertheless, a recent met analysis showed that initial SGLT2 inhibitor/metformin combination therapy has glycaemic and weight benefits compared with either agent alone and appears relatively safe. High dose SGLT2 inhibitor/metformin combination therapy appears to have modest weight, but no glycaemic benefits compared with the low dose combination therapy.

based on that we our aim is to evaluate the efficacy of the addition of metformin to SGLT2 in diabetic patient with preserved ejection fraction

Eligibility Criteria:
Inclusion Criteria:

Age of 40 years to 74 years. HFpEF (≥ 50%) Written informed consent of the subject to participate in the study. New York Heart Association functional class I-IV. Diabetic patients SGL-2 naive. Newly diagnosed heart failure of preserved ejection fraction

Exclusion Criteria:

Patients with heart failure with reduced ejection fraction (\< 40%) Age less than 40 and more than 74 GFR \< 30 mL/min A1c \> 9 Known allergy to metformin End- stage liver disease Cancer Pregnancy or lactation
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion Criteria:

* A cosmetic or therapeutic procedure:

  * within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  * anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
* Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

  * of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  * anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
* Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
* Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
* Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
* Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
* Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
* Females of childbearing potential
The Safety, Acceptability and Efficacy of Alena

The present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the Alena CBT programme as a treatment for social anxiety disorder.

This is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. Participants are randomly allocated to receive access to the Alena CBT programme or to a wait list control group, in a 1:1 ratio. The programme consists of CBT-based therapy for social anxiety based on the Clark and Wells model.

Eligibility Criteria:
Inclusion Criteria:

* female
* aged between 18 and 35 years old (inclusive)
* located in the UK
* fluent in English
* comfortable taking part in a study that included deception (due to the nature of the cognitive assessments)
* had an iPhone and daily access to an internet connection
* scored over 30 on the Social Phobia Inventory (SPIN; indicating at least moderate social anxiety).

Exclusion Criteria:

* currently undergoing any mental health therapy
* changed the usual mental health medication or dosage within the past eight weeks
* scored eight or above on the Alcohol Use Disorders Identification Test for consumption (AUDIT-C; indicating higher risk of alcohol dependence)
* scored two or above on the adapted drug questions (indicating higher risk of drug dependence)
* had previously participated in scientific studies or user research undertaken by Alena