cyrilzakka/clinical-trials huggingface dataset:
Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are:

1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals.
2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.

Either Pioglitazone or Placebo Pioglitazone will be administered during this study in this Type 2 Diabetic population with Heart Failure to examine if there are any beneficial effects on diastolic and systolic function.

Myocardial blood flow (MBF) is measured using a PET scan, then participants will be randomized to pioglitazone or a placebo to examine the effects of the study drug on the effects on the systolic and diastolic function of the heart. In addition, myocardial insulin sensitivity change will be measured as well as myocardial fat content. The ratio of ATP: PCr will also be measured.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 30-70 years
4. Body Mass Index (BMI) of 27.5-40kg/m²
5. HbA1c of 6.5 to 10%
6. Blood pressure of less than or equal to 145/65mmHg
7. eGFR greater than 45 ml/min/1.73m²
8. Subject must have HFpEF (EF \> 50% by ECHO screening)
9. NYHA class II-III heart failure
10. Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
11. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional \[4 weeks\] after the end of study participation.
12. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

1. Subjects with history of osteoporosis or proliferative diabetic retinopathy
2. Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
3. Patients with symptomatic coronary artery disease.
4. Subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication).
5. Subjects treated with a GLP-1 RA or thiazolidinedione.
6. Subjects treated with a SGLT2i
7. Pregnancy or lactation
8. Known allergic reactions to components of the study interventions.
9. Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.

It will be a randomized control trial at Services Hospital Lahore through convenience sampling technique which will be allocated through simple random sampling through sealed opaque enveloped in to Group A and Group B . Group A: patients will be treated with basic breathing technique whereas Group B: will be treated by will be breathing technique along with diaphragm and abdominal training. The study will be completed within 6 months after synopsis approval from ethical Committee of RCRS \& AHS . Data will be entered and analyzed by SPSS version 25. After assessing the normality of data , it will be decided either parametric or non-parametric test will be use within a group or between two groups.

Chronic Obstructive Pulmonary Disease (COPD) is a set of diseases that cause airflow obstruction, breathing difficulties, wheezing and chest tightness. Risk factors are smoking and non-tobacco-smoking, the use of biomass fuel and open fires for domestic purposes in poorly ventilated households. Physiotherapy is an important component of multidisciplinary therapies. Airway clearing, pulmonary rehabilitation, inspiratory muscle training, and non-invasive ventilation is the prior treatment .The aim of this study will be to find the effects of diaphragm and abdominal muscle training on pulmonary function testing and dyspnea among COPD patients .

It will be a randomized control trial at Services Hospital Lahore through convenience sampling technique which will be allocated through simple random sampling through sealed opaque enveloped in to Group A and Group B . Group A: patients will be treated with basic breathing technique whereas Group B: will be treated by will be breathing technique along with diaphragm and abdominal training. The study will be completed within 6 months after synopsis approval from ethical Committee of RCRS \& AHS . Data will be entered and analyzed by SPSS version 25. After assessing the normality of data , it will be decided either parametric or non-parametric test will be use within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age group of 35-60 years
* Moderate COPD patients.
* Cognitive
* no previous surgery
* clinically stable COPD patients with reduced inspiratory muscle strength \[Pi and persistent activity-related dyspnea

Exclusion Criteria:

* Acute attack
* Severe copd
* Inability to perform physiological testing
* active cardiovascular comorbidity (i.e., severe heart failure with reduced left ventricular ejection fraction, cardiomyopathy, recent acute myocardial infarction, cardiac arrhythmias, or stroke),
* Unstable
* Red Flags Like: Fever, Night Sweats, Malaise
Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers

This study will compare the performance of three combination metered dose inhalation devices and the variability of mometasone and formoterol doses delivered to the lungs in a healthy volunteer population


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female subjects age 18 to 65 years of age (included)
* In good health as confirmed by past medical history
* Female subjects must be either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
* Body mass index (BMI) within the range of 18.5 to 32 kg/m2 and weigh at least 50 kg
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* Understand and sign the written informed consent

Exclusion Criteria:

* Smokers (use of tobacco products in the previous 1 year with a pack year history of no greater than 10 pack years).
* Female subjects who are pregnant, or lactating
* Treatment with any oral or intravenous corticosteroids within 1 month of the first study treatment.
* Patients with a current respiratory tract infection or one within 1 month prior to screening.
* Patients with a history of malignancy, myocardial infarction, untoward reactions to sympathomimetic amines or inhaled medicine.

Subjects with a current or history of a clinically significant cardiac arrhythmia.

* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* Significant illness within the two weeks prior to dosing.
* A past medical history of clinically significant ECG abnormalities.
* History of fainting, known hypersensitivity to the study drug or drugs similar to the study drug. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, immunocompromise, including a positive HIV (ELISA and Western blot) test result, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations.

Other protocol-defined inclusion/exclusion criteria may apply
OPC-1085EL in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects

It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.

The trial includes 2 period:

1. Screening period: 4 weeks. For subjects entering the screening period, 0.005% latanoprost will be administered for 4 consecutive weeks, one drop for each eye, once per day.
2. Evaluation period: 8 weeks. Subjects who are eligible are randomly assigned to the OPC-1085EL group or 0.005% latanoprost group at a ratio of 1:1, one drop for each eye, once per day.

Eligibility Criteria:
Inclusion Criteria:

1. Gender: Unlimited
2. Hospitalization status: Outpatients
3. Age: 20-80 years old
4. Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension.

   \[At the end of the screening period\]
5. IOP: After 4 weeks treatment with 0.005% latanoprost, the unilateral eye with a pre-dose IOP from 18 mmHg to \<30 mmHg, and IOP \<30 mmHg in the contralateral eye.

Exclusion Criteria:

1. Subjects with a best-corrected visual acuity ≤ 0.2.
2. Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma.
3. Subjects who cannot stop using contact lenses during the trial.
4. Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
5. Subjects who are allergic to any ingredients in carteolol or latanoprost.
Enteric Neural Precursor Cells (ENPC) in the Human Gut

The study aim is to acquire human tissues to (a) understand the structure and organization of the human Enteric Nervous System; (b) perform a molecular transcriptomic profile of individual cells residing in the human gut; (c) study the turnover rates of individual cell types by Fluorescence-activated cell sorting-aided C14 dating of cells; and finally (d) culture the human gut-derived cells characterize the human adult enteric neural stem cell and study its potential for Neuro-glial differentiation. This study will advance our knowledge of the the cellular and molecular correlates of changes in the Enteric Nervous System that are associated with disorders of motility.

(i) To study the structure and organization of the human Enteric Nervous System by tissue clarification, immunofluorescence, and 2-photon and light-sheet microscopy.

(ii) To find out the molecular signature that defines various gastrointestinal cells that include the neurons, glia, precursor cells within the Enteric Nervous System and cells associated with the Enteric Nervous System, such as Interstitial Cell of Cajal and macrophages in the human whole gut surgical resection and full thickness endoscopic resection-derived tissues using single cell RNA sequencing and analyses.

(iii) To isolate these cells and study their proliferative and neurogenic potential in vitro and on transplantation into the gut tissue of immunodeficient mice.

(iv) To time stamp and determine the age of Enteric Nervous System cells in adults and determine whether different enteric disease states alter the cycling times of these cells.

(v) To use gut specimens derived from surgical resections and full thickness endoscopic resection-derived tissues for

1. Generating ex vivo preps to study and understand the electrophysiological properties of the gut wall and
2. Generating cultured ex vivo preps to understand the interaction between enteric extracellular matrix and cells of the Enteric Nervous System.

Eligibility Criteria:
Inclusion Criteria:

* English speaking patients in the age range 18 - 100.
* Patients suffering from Irritable Bowel Syndrome, Inflammatory Bowel Disease, Diabetes, Gastroparesis, will be included.
* Patients suffering from Collagen disorders such as Alport Syndrome, Ehlers-Danlos Syndrome, Goodpasture Syndrome.
* Patients suffering from plexiform neurofibromas.
* Patients with bariatric surgery.
* Patients with appendicitis.
* Patients with scleroderma.

Exclusion Criteria:

* Patients suffering from HIV, Hepatitis C, and other infectious diseases that require the handling of tissues in a Bio-safety level 3 environment.
* Patients suffering from infectious enteric disorders.
* Patients without any Gastrointestinal disorders (i.e. healthy volunteers).
Neutrophil Function During Therapy With Protease Inhibitors in Chronic Hepatitis C

The aim of this study is to characterize neutrophil function in patients undergoing chronic hepatitis C triple therapy with protease inhibitors in comparison to dual therapy with peginterferon and ribavirin and with interferon free treatment regimen to thereby elucidate the possible mechanisms of protease-inhibitor associated infections.

Chronic hepatitis C infection (CHC) is a major health problem, potentially leading to liver related mortality via complications of liver cirrhosis or hepatocellular carcinoma, and affects more than 185 million persons worldwide. Antiviral therapy evolved during the past 25 years from standard interferon, the combination with ribavirin and pegylated interferon (P/R) to the addition of protease inhibitors and is currently on the edge to an interferon-free era with the first such substances being approved in 2014. However, current standard therapy for CHC genotype 1 patients without cirrhosis consists of ribavirin and pegylated interferon (P/R) in combination with boceprevir (BOC) or telaprevir (TPV), which are direct acting antivirals and represent the first-generation protease inhibitors.

Triple therapy for CHC has been reported to be associated with a quantitative and qualitative increase in treatment-related (serious) adverse events compared to the former standard therapy without protease-inhibitors. Moreover, reports of serious infectious complications during triple therapy - especially in patients with acquired immune deficiencies like liver cirrhosis - that lead to considerable morbidity and mortality, have accumulated recently. The mechanisms of this increased susceptibility to infections remain unclear. However, BOC is known to inhibit neutrophil elastase activity.

Aims of this study were therefore to analyse infections that occurred in CHC outpatients during therapy in the study centre, to prospectively characterize neutrophil function in patients undergoing CHC triple therapy in comparison to dual therapy with peginterferon and ribavirin and to thereby elucidate the possible mechanisms of protease-inhibitor associated infections.

Eligibility Criteria:
Inclusion Criteria:

* chronic hepatitis C
* planned antiviral therapy

Exclusion Criteria:

* immunosuppressive medication
* active infection at baseline
* treatment with antibiotics within the last two weeks
Mos-FED (Mosaicism in Focal Epilepsy Cortical Dysplasia Tissue)

Focal cortical dysplasia (FCD) is a malformation of brain development, the most common cause of drug-resistant epilepsy and often caused by mutations in mammalian target of rapamycin (mTOR) pathway genes. Patients with FCD develop drug-resistant seizures. This study will look at FCD tissue removed during epilepsy surgery and aims to detect mutations in mTOR pathway genes in brain cells. Secondly, the investigators will establish if evidence of mutations found in brain cells can also be detected as circulating free DNA (cfDNA) in blood. By looking at which genes are made into proteins in individual cells found in epilepsy surgical tissue (single cell expression profiling),the investigators will attempt to identify new genetic targets in FCD.

The main outcome will be finding new causes of epilepsy with FCD and the development of new diagnostic and screening tools.

Primary Objectives:

1. To identify if somatic mosaicism for mTOR is present in resected tissue from patients with FCDIIA/B, and can be detected in DNA from patient's serum as circulating free DNA (cfDNA) or from nasal epithelial cells collected non-invasively by olfactory mucosal brush swab.
2. To establish if single cell expression profiling from resected fresh frozen tissue reveals novel FCD causing pathways and single cell RNA sequencing increases the yield of mTOR pathway variant detection.
3. To determine if phosphorylated upstream and downstream mTOR pathway components can be characterised by immunohistochemistry and Western blot as novel biomarkers of mTOR activation in human FCDII tissue.

Secondary Objectives:

To engage with patients, representatives and charitable organisations to assess feasibility and develop plan to set up a future trial of mTOR inhibitor treatment.

Eligibility Criteria:
Epilepsy in Focal Cortical Dysplasia Type IIA/B

Key Inclusion Criteria:

1. Adult and Paediatric Patients (male and female)
2. A histologically proven diagnosis of FCDIIA/B or a suspected diagnosis of FCDIIA/B (on MRI/EEG and PET grounds) awaiting resective Epilepsy surgery.
3. Able to attend appointment/hospital and undergo sampling of serum and nasal swab
4. Informed Consent Available

   Key Exclusion Criteria:
5. Any acute or chronic conditions that could limit the ability of the patient to participate in the study.
6. Refusal to give informed consent.
Ranibizumab 0.5 mg for Diabetic Macular Edema With Initial Intensive Treatment in the Real World Clinical Setting in Korea (Rising K)

This study was a multicenter, non-interventional, retrospective chart review of patients with DME who received ranibizumab 0.5 mg as initial intensive treatment in real-world clinical setting in Korea.

Enrolled patients started receiving ranibizumab between 01 December 2019 and 31 October 2020, with records of receiving at least 3 doses in the first 4 months after starting treatment in the data collected until 30 April 2021. Subsequent dosing interval was determined by the treating physician based on the patient's condition. Data were collected for up to 24 weeks (±2 weeks) from the date of first dose of ranibizumab, including best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) results at Week 24. Subjects were identified by review of patient medical records, and those who met the inclusion/exclusion criteria were enrolled.

The primary objective of this study was to evaluate the effectiveness of ranibizumab in patients with DME who received initial intensive treatment by analyzing the mean change in BCVA using data collected during the 24-week follow-up period. Central subfield thickness (CST), intra-retinal fluid (IRF), sub-retinal fluid (SRF), edema improvement, and Diabetic Retinopathy Severity Scale (DRSS) results were also assessed to further analyze the effectiveness of ranibizumab. The total number of ranibizumab doses administered was obtained to determine the pattern of ranibizumab treatment in real-world clinical setting.

All decisions regarding the clinical management and treatment of patients were made by the treating physician according to real-world routine practice, independently of the study. All data collected in this study were extracted from the patient medical records recorded in the process.


Eligibility Criteria:
Inclusion criteria:

* Aged ≥18 years at the start of ranibizumab treatment
* Diagnosed with diabetes mellitus (type 1 or type 2)
* Diagnosed with diabetic macular edema (DME)
* Vision loss due to DME as judged by treating physician
* Medical records of receiving at least 3 doses in 4 months (initial intensive treatment) since the first dose of ranibizumab between 01 December 2019 and 31 October 2020 (data up to 30 April 2021 were collected)
* Records of BCVA and OCT at baseline and Week 24 (±2 weeks) after treatment with ranibizumab

Exclusion criteria:

* Contraindications to ranibizumab according to local label information
* History of systemic or ocular anti-VEGF therapy or loser photocoagulation in the last 90 days before the first dose of ranibizumab
* History of intraocular or periocular corticosteroids in the last 120 days before the first dose of ranibizumab
* History of vitrectomy
Behavioural Intervention for Dysphagia in Acute Stroke

Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".

Stroke compromises swallowing function, causing dysphagia, in one quarter to one half of all patients. Dysphagia is associated with an increased risk of aspiration pneumonia, dehydration and malnutrition. Despite the development and implementation of several strategies of managing dysphagia after stroke, Few have been evaluated by means of randomised controlled trials.

Comparisons: This study aims to compare stroke patients with dysphagia assigned to receive usual swallowing care, prescribed by the attending physician; standardised low intensity intervention comprising swallowing compensation strategies and diet prescription; or standardised high intensity intervention and dietary prescription .

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of stroke within the previous 7 days
* clinical diagnosis of swallowing difficulty

Exclusion Criteria:

* no previous history of swallowing treatment
* no previous history of surgery of the head or neck
Do Aromatase Inhibitors (AIs) Decrease Intestinal Calcium Absorption?

Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?

Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy.

We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 5 years past menopause, defined as date of last menses or bilateral oophorectomy
* Newly diagnosed breast cancer and starting an AI as initial adjuvant therapy

Exclusion Criteria

* Recent, current or planned chemotherapy for breast cancer, as this may have independent effects on intestinal health, calcium homeostasis and bone turnover
* Allergy or intolerance to orange juice, as one isotope is given with orange juice
* Current use of over-the-counter or prescription antacids, as they may influence Ca-Ab
* Intestinal conditions associated with malabsorption or low gastric acid levels including Crohn's disease, ulcerative colitis, pernicious anemia, bacterial overgrowth, celiac sprue, chronic diarrhea or use of antibiotics within the past month
* Known Stage 4 or 5 Chronic Kidney Disease, defined as an estimated GFR \<30 cc/minute
* Use of medications known to interfere with calcium or vitamin D metabolism, including oral steroids or anticonvulsants
* Significant lymphedema precluding adequate intravenous access