cyrilzakka/clinical-trials huggingface dataset:
Safety & Efficacy of Nuberol Forte® in Pain Management

The global prevalence of Musculoskeletal disorders (MSD) ranges from 14% to as high as 42%. In addition WHO also estimates that 40% of people over the age of 60 years suffer from MSD and about 80% of the people have had low back pain at some point in their life. In Pakistan, to estimate the prevalence of MSD, there is no data available based on the local population. Locally, studies were conducted on the specific subject pools mainly considering the work related musculoskeletal disorders and backache. However, no real data is available for the symptomatic management of painful musculoskeletal disorders in multiple settings to calculate more generalizable results. So this study is planned and if we found good results then it will help physicians to prescribe the above said medicine to all such cases.

The management of musculoskeletal pain is complex therefore plethora of treatment options are available include non-pharmacological treatments , complementary therapies, and pharmacological interventions. In order to provide optimal care to patients with musculoskeletal pain and ensure the efficient use of healthcare resources, a comprehensive overview of the available evidence for the most effective treatment options for musculoskeletal pain presentations is essential. In this context, an observational study is planned on the efficacy and safety of analgesic combination (i.e Nuberol Forte®). Nuberol Forte® is a combination of muscle relaxant (Orphanedrine) and an analgesic/antipyretic (Paracetamol/Acetaminophen). There are clear indications that the combination of Orphenadrine with Paracetamol may give increased antinociceptive activity and duration of action over and above the use of Orphenadrine or Paracetamol alone.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a clinical history of painful musculoskeletal disorder from last 1 year
* Patient aged ≥18 and ≤70 years inclusive of either sex
* Patient with ability to understand and sign written informed consent form.

Exclusion Criteria:

* Known hypersensitivity to Nuberol Forte product, the metabolites, or formulation excipients.
* Patients with Glaucoma, prostatic hypertrophy or obstruction at the bladder neck, myasthenia gravis, oesophageal spasm and pyloric or duodenal obstruction.
* Treated with Nuberol Forte to evaluate safety as per approved prescribing information for Nuberol Forte in Pakistan.
* Pregnant (assesed on LMP) or breast feeding women (assessed on interview).
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid

A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid.

The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.


Eligibility Criteria:
Inclusion Criteria:

* Wish to increase hearing
* Moral commitment to use the device
* Ability to understand the study
* Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz)
* Patient 60 years of age and older,
* No previous hearing aid

Exclusion Criteria:

* Inability to use the device
* Previous use of a hearing aid
* local intolerance
Multicenter Analysis of Different Approaches in Segmentectomies in Early-stage Lung Cancer

The study is a retrospective, observational and multicentric study. The study describes robotic segmentectomies performed in four referred centers, with the aim to assess the perioperative compilications of robotic segmentectomies compared to video-assisted thoracoscopic surgery (VATS) and open approach.

Minimally invasive techniques have been gradually replacing open approach in the treatment of lung cancer. Video-assisted thoracoscopic surgery (VATS) was the first procedure to be developed in the thoracic field and is the most widespread. It has been associated with decreased postoperative pain, shorter recovery, decreased inflammatory response and improved tolerance to chemotherapy.

What is limiting video-assisted thoracoscopic surgery (VATS) spread is the steep learning curve, difficulties and discomfort to operate, suboptimal view and rigid instrumentation. These problems have been partially overcome by the Robotic technique (RATS).

This study aims to compare the perioperative complications of robotic segmentectomies to VATS and open approaches.

In addition, The secondary aim of the study is to analyze the duration of surgery, mediastinal and hilar lymph nodes dissection, rate of conversion of robotic approach compared to VATS, overall survival and disease free survival in the three different approaches.

The study is retrospective, observational and multicentric. The four centers involved are: IRCCS San Raffaele Hospital, IRCCS European Institute of Oncology - IEO, IRCCS Humanitas Research Hospital - ICH and the department of General Thoracic Surgery, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

The population includes: all patients that underwent segmentectomies from the 1st January 2010 to the 31st of December 2023 treated with robotic segmentectomy and VATS or open segmentectomy, reaching a total of 472 cases of which 50 from our hospital.

Eligibility Criteria:
Inclusion Criteria:

* Pre or post-operative diagnosis of NSCLC surgically treated with pulmonary segmentectomy from 1st January 2010 to the 31st to December 2023.
* Age \> then 18 years at the moment of surgery

Exclusion Criteria:

* Age \< then 18 years at the moment of surgery
* diagnosis other than NSCLC
Intermittent Oral Tube in Alzheimer's Patients

This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
* presence of no contraindication for enteral nutrition.
* with dysphagia verified by Imaging materials.
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
* Minimum Mental State Examination ranging from 10-26

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
* complicated with other intracranial lesions, such as stroke.
* abnormal structure of swallowing-related organ and tissue.
Pain Score and Opioid Consumption of Index and Previous Cesarean Delivery

Postoperative pain after cesarean delivery is common and affects on both mothers and children.

The goals of this retrospective observational study aim to predict pain score and opioid consumption of index cesarean delivery from pain score and opioid consumption of previous cesarean delivery.

The authors will review the medical records of recruited participants for demographic data as well as pain scores and opioid consumption of index cesarean delivery and previous cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had at least 2 cesarean deliveries
* Patients received spinal anesthesia and intrathecal morphine for cesarean delivery
* Patients received postoperative pain control as per standard protocol

Exclusion Criteria:

* Patients with chronic pain prior to cesarean delivery
* Unable to give pain score
* Receiving general anesthesia for cesarean delivery
* Receiving postoperative pain control beyond the standard protocol
* Patients with multiple pregnancy, placenta abruption, placenta accrete, postpartum hemorrhage
* Patients with psychotic disorder
Value of Cortactin Expression in Invasive and Non-invasive Urinary Bladder Urothelial Carcinoma in Egyptian Population

Urothelial carcinoma is the ninth most common malignant neoplasm worldwide. nearly in all human tumors, actin filaments are involved in lamellopodia or cellular extensions. Cortactin is involved in fixing the actin assembly to enhance cellular penetration. Assessment of Cortactin expression in invasive and non-invasive urothelial carcinoma and recording any significant different expressions may have benefits in developing more effective anticancer chemotherapeutic agents.

Bladder carcinoma is the 9th most prevalent cancer worldwide. Mostcases are diagnosed in men. Bladder carcinoma is categorized into three disticly different categories; non- muscle invasive, muscle invasive and metastatic bladder carcinoma. Vast majority of all bladder carcinomas are diagnosed as urothelial carcinoma (UC). Squamous cell carcinoma (SCC), adenocarcinoma and other rare types represent the remaining 10%. In Egypt, bladder carcinoma is ranked as the most prevalent cancer . The most important etiological causes for such disease in Egypt are festation by S. haematopium and Cigarette smoking. Cortactin is a 63-65 kDa protein, encoded by a gene located on 11q13. Cortactin activates and binds to Arp2/3 and stabilizes the branched Actin networks. Invadopodia are Actin-rich cellular protrusions, associated with enhanced proteolytic activities in the invasive regions of carcinomas. it is also incorporated in invadopodia, Cortactin expression is enhanced once or rapidly following secretions of transmembrane metalloproteinase, MT1-MMP. Extracellular matrix (ECM) proteolytic cleavage develops soon after secretion of MT1-MMP and Cortactin. increased secretion of Cortactin was studied in a lot of malignant tumors, including melanoma, mammary, pancreatic duct, hepatocellular and colorectal adenocarcinomas.

Eligibility Criteria:
Inclusion Criteria:

* patients with primary urinary bladder carcinoma.

Exclusion Criteria:

* patients received chemotherapeutic agents.
Safety Study of ECO Conversion System For Red Blood Cells.

The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. Additional samples of blood will be drawn for testing and evaluation.

This study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of A-ECO cells. All participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create A-ECO cells (test group); or 2) washed with saline (control group). The test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer subjects who have no clinically apparent cardiovascular, renal, pulmonary, endocrinological, autoimmune or neurological disorders
* Blood Group A
* Available for follow up periodically at varying intervals for twelve weeks
* Have a clinical presumption of a stable blood volume
* Between 18 and 65 years of age
* Able to provide informed consent
* Practicing contraception, other than oral or systemically delivered contraceptives, while participating in the study (subjects of potential reproductive age).

Exclusion Criteria:

* Women that are pregnant
* Persons with documented immune deficiencies
* Persons found to have abnormal platelet function or anti-platelet antibodies as determined by a pre-study screen
* Persons with a history of idiopathic thrombocytopenic purpura
* Persons who are bleeding or undergoing an active hemolytic process
* Persons who have any history of hemorrhagic tendency
* Persons who are taking any drug known to interfere with hemostasis, or who take combinations of drugs that have been reported to cause hemostatic problems or interfere with laboratory coagulation and platelet function testing
* Persons who test positive for von Willebrand's disease
* Persons taking investigational drugs or using an investigational device
* Persons with a family history of a bleeding disorder
* Persons with a history of vasculitis
* Persons with a history of a dermatological disorder that might be confused with bruising in the judgement of the investigator
* Persons with medical conditions which represent a contraindication to any study procedure, in the judgement of the investigator
* Persons with unexplained bruising
* Persons with abnormal laboratory screening tests
COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients

Investigators will evaluate the immunogenicity of a third dose of mRNA-1273 SARS-CoV-2 vaccine among cancer patients receiving the recommended third vaccine dose


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Is a cancer patient enrolled in the Cancer Patient Immune Response to COVID-19 Vaccine study (a basic science study) MCC 21138 or who has completed the two mRNA-1273 vaccine series prior to March 31, 2021.
* Understands, agrees and is able to comply with the study procedures and provides written informed consent.
* Has no known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reactions to the vaccine or its excipients.
* Has not received more or less than 2 doses of mRNA-1273 vaccine

Exclusion Criteria:

* Participants who will not return for the third vaccine dose
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand

Liver cancer, specifically cholangiocarcinoma (CCA), is very common in different areas in Thailand. Many factors make this cancer more common, such as liver fluke infection, older age, eating raw fish, family history of cancer, alcohol intake, taking certain medicines (praziquantel), low intake of fresh vegetable, and low education. In 2015, researchers from Khon Kaen University developed the Community-based Health Education and Communication (CHEC) program to prevent liver cancer caused by liver flukes in communities of the Khon Kaen province, Thailand.

The main aim of this 5-year research study is to enhance the CHEC program to prevent liver cancer, and test if it is effective in improving the knowledge and behaviours of community residents regarding how to prevent liver cancer. This study will take place in Khon Kaen, Thailand. Other aims are to:

1. Increase understanding in the community that make it difficult to prevent liver cancer, as well as community characteristics that can help prevent liver cancer;
2. Incorporate the program we develop in healthcare to prevent liver cancer in Thailand.


Eligibility Criteria:
Inclusion Criteria:

* any individual residing in one of the 16 villages selected in the Khon Kaen province of Thailand, aged 20 and older

Exclusion Criteria:

* any individual 19 years or younger
* any individual not residing in one of the 16 pre-selected villages in the Khon Kaen province of Thailand
Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure

The aim of this study was to compare the indices of rapid shallow breathing, neuromechanical efficiency (NME), and neuroventilatory efficiency (NVE) between patients being successfully extubated and those who failed weaning.

Patients, mechanically ventilated for \> 24 h, were included when they met criteria for their first spontaneous breathing trial (SBT) on continuous positive airway pressure (CPAP) (5-6 cmH2O) for 30 minutes. Patients who did not fulfill the criteria for successful SBT, or required assist, or deceased within 48h post-extubation were considered extubation failure (F). Patients who completed the SBT and remained extubated \> 48 h were considered successfully extubated (S). Before and during the SBT, arterial blood gases, heart, rate, blood pressure, and EAdi, flow, Vt, f, and, airway pressure (Paw) were measured. At 0, 5, 10, 15 and 30 minutes of the SBT, f/Vt, diaphragm electrical activity (EAdi), NME, and NVE were calculated. NME was calculated as Paw/EAdi during inspiratory occlusion. NVE was calculated as Vt/EAdi during unassisted inspirations.Arterial blood gases, heart rate, and blood pressure were measured. The receiver operating characteristic (ROC) curve was calculated to evaluate the predictive performance of each index.

Eligibility Criteria:
Inclusion Criteria:

* We chose a number of eligible patients which were admitted to ICU of the Zhong-Da Hospital and required mechanical ventilation for more than 24 h.

Exclusion Criteria:

(1) age \<18 or \>85 years, (2) tracheostomy, (3) treatment abandonment, (4) history of esophageal varices, (5) gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days, (6) coagulation disorders (INR ratio\>1.5 and APTT\>44 s), (7) history of acute central or peripheral nervous system disorder or severe neuromuscular disease, (8) history of leukemia, severe chronic liver or chronic cardiac disease, (9) solid organ transplantation, (10) malignant tumor
Comparison of Reposition Sense in Scoliosis and Healthy Adolescents

The aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference.

Considering the role of proprioception during activities of daily living and exercises, it is important for clinicians and researchers to determine the joint position senses of adolescents with scoliosis and to compare them with their healthy peers in planning appropriate treatment programs. In the light of this information, the aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference. Patients who were diagnosed with Adolescent Idiopathic Scoliosis (AIS) in the Department of Orthopedics and Traumatology of Istanbul University and who were referred to the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Istanbul University-Cerrahpaşa and Biruni University and their healthy peers will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 10 and 19 years
* Having a Cobb angle of 10-40 degrees measured on the anteroposterior radiograph or a healthy spine alignment (Forward Bend Test \< 5⁰ (negative) and Flexicurve Kyphosis Index ≤13)
* No previous conservative approach to scoliosis
* Volunteer to participate in the study

Exclusion Criteria:

* Concomitant mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary history
* Any orthopedic disability or severe pain that would preclude evaluations
* Musculoskeletal injury related to the spine in the last 3 months
* Having had spine surgery
* Presence of tumor in the spine
* Loss of vision and/or hearing/presence of vestibular problems
Ghrelin Effect on Beta Cell Function in Health and Disease

To determine the role of nutrient status on ghrelin regulation of insulin secretion. We hypothesize that ghrelin and glucagon-like peptide-1 (GLP-1)(both are hormones made in the gut,) have differential effects on β-cell function in the fed state. We will compare insulin secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed meal protocol in subjects receiving ghrelin or saline. We will also determine the role of ghrelin-stimulated GLP-1 levels in this process using the GLP-1 receptor (GLP-1R) antagonist Exendin(9-39) (Ex-9).

We plan to study 20 healthy subjects on 4 occasions where they will receive ghrelin, ghrelin+Ex-9, Ex-9 or saline infusion after an overnight fast in a randomized order; Ex-9 will be used to block GLP-1 action. A 240-minute meal tolerance test (MTT) using a dual glucose tracer method will serve as the foundation of each study visit. One tracer, \[6,6-2H2\]glucose will be infused intravenously before and during the test meal to quantify fasting endogenous glucose production (EGP), and glucose disappearance during the meal. A second tracer, \[U-13C\]glucose, will be included in the meal to trace the appearance of oral glucose. The systemic appearance rates of both ingested tracer and total (i.e., ingested and endogenously produced) glucose will be calculated. Using this protocol, we will be able to evaluate a) insulin secretion in response to mixed-meal ingestion, b) glucose appearance and glucose disappearance during meal ingestion, c) the ghrelin effect on these parameters without GLP-1, and d) the effect of GLP-1 in the response based on the effects with and without Ex-9.

This dual-tracer method has been used to assess the ability of an individual to dispose of an oral glucose load, and accurately fractionates the appearance of ingested glucose in plasma (Ra meal), EGP, and peripheral glucose disposal (Rd) in this setting 41-42. The \[6,6-2H2\]glucose and \[U-13C\]glucose are stable-isotope tracers and are different from radioactive-isotope tracers in that they do not emit radiation.

All procedures will be performed at the CTRC at the Cincinnati Children's Hospital Medical Center (CCHMC).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women
2. Ages between 18 and 45 years
3. BMI between 18 and 29 kg/m2

Exclusion Criteria:

1. History or clinical evidence of impaired fasting glucose or diabetes mellitus, myocardial infarction within the past year, history or symptoms of congestive heart failure, uncontrolled hypertension, history or active liver or renal disease (AST or ALT \>2x upper limits of normal, calculated glomerular filtration rate \[GFR\] \<60).
2. History of pituitary or adrenal disorders or neuroendocrine tumor.
3. Anemia defined as hematocrit \<33%.
4. Use of medications that alter glucose metabolism
5. Pregnancy or lactation.
6. Abnormal Electrocardiogram (ECG): evidence of ischemia or arrhythmia.
7. Women who have a positive pregnancy test at any time during the study period.