cyrilzakka/clinical-trials huggingface dataset:
Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality

This study was planned to examine the effect of progressive relaxation exercises applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality.

It is thought that relaxation exercises reduce respiratory distress and improve sleep quality in lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18-65
* Ability to communicate adequately
* Absence of psychiatric problems
* Those who are determined by the physician that they do not have a physical disability in exercising
* Volunteering to participate in the research
* Individuals who have the ability to use technological tools
* Patients with at least 3 cures

Exclusion Criteria:

* Individuals with phones that do not have voice recording capabilities
* Individuals with phones that do not have the ability to install Whatsapp
Peppermint Oil for Urinary Retention

A randomized controlled study will be conducted, with two arms. Postpartum women experiencing urinary retention will be randomized into one of the two following arms:

* Arm 1: Subjects will be exposed to vapor of peppermint oil
* Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.

The purpose of the study is to determine if the use of peppermint oil among postpartum women experiencing urinary retention will increase spontaneous urination and decrease the need for catheterization. A randomized controlled study will be conducted, with two arms. Subjects will be randomized into one of the two following arms:

* Arm 1: Subjects will be exposed to vapor of peppermint oil
* Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 1. 18 years old or older 2. English speaking 3. Admitted to Bethesda North Mom Baby Unit 4. Postpartum 5. Experiencing urinary retention - defined as meeting at least one of the following criteria:

  * More than 6 hours after delivery or foley catheter removal without being able to spontaneously void
  * Symptomatic urinary retention without being able to spontaneously void
  * Change in fundal height or position without being able to spontaneously void 6. Bladder scan showing bladder containing 400mL or more urine

Exclusion Criteria:

1. Allergy to peppermint
2. Asthma
3. Active herpes lesions
4. Seizure disorder
5. Not able to void in toilet (ex: requiring use of bed pan to void)
Development and Validation of a Preoperative Frailty Index Using Health Administrative Data

The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.

The investigators will create a frailty index using health administrative data available for older people having surgery. The index will be based on the Canadian Study of Health and Aging Frailty Index and standard recommendations for creation of frailty indices.

Once derived the index will be tested to measure its association with outcomes, as well as its discrimination. Various representations of the frailty index will be tested (primary-as a continuous measure; secondary as a binary, categorical and fractional polynomial variable). Performance in subgroups will also be evaluated,

Eligibility Criteria:
Inclusion Criteria:

* Having elective or emergency noncardiac surgery

Exclusion Criteria:

* no provincial health insurance number
MELODY Registry Follow-Up Study

Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe / OUS


Eligibility Criteria:
Inclusion Criteria:

* previous inclusion in the MELODY Registry

Exclusion Criteria:

* none
Complementary And Alternative Medicine During The COVID-19 Pandemic

Complementary and alternative medicine is frequently used in the treatment of several groups of diseases.

This study aimed to explore the attitudes of adults living in Turkey toward complementary and alternative medicine in the period of the COVID-19 pandemic and identify whether Turkish adults used it during the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* agree to participate in the study
* not to be a communication problem

Exclusion Criteria:

* be a communication problem
Cognitive Biases Modification Treatment for Social Anxiety

Adults with Social Phobia will be randomly assigned to either an attention bias modification treatment, interpretation bias modification treatment, both, or a placebo control condition not designed to change cognitive bias patterns.

Outcome measures will be social anxiety symptoms and severity as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews based on DSM-IV criteria.

The investigators expect to find significant reduction in social anxiety symptoms in the Treatment groups relative to the placebo control group. The investigators want to find out the relative efficacy of attention and interpretation oriented treatments and the combination of the two.


Eligibility Criteria:
Inclusion Criteria:

People suffering from social anxiety

Exclusion Criteria:

Pharmacological or Psychological treatment
The Effectiveness of Recombinant Coagulation Factor IX With Recombinant Albumin (rIX-FP) in Severe Hemophilia B Patients

The pivotal clinical data support prolonged dosing intervals of up to 14 days for routine prophylaxis in hemophilia B patients. The majority of adult and pediatric patients using Idelvion for routine prophylaxis had a median annualized spontaneous bleeding rate (AsBR) of 0.00. The majority (99%) of bleeding episodes were managed successfully with one or two infusions, and 94% of bleeds were controlled with only one infusion regardless of the cause or location.

The rationale for this study is to collect the effectiveness and safety data of severe hemophilia B patients treated with Idelvion following institutional standard of care. It is the aim of this study to extend the results of the clinical trial program to a broader hemophilia B population, and to compare with current alternative factor IX treatments in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with age ≥ 20 years old
* Endogenous FIX activity ≤1 IU/dL,
* At least 50 exposure days (EDs) with FIX products,
* No detectable inhibitor to FIX or inhibitor history,
* Had a minimum of 2 nontrauma-induced bleeding episodes (any type or location) treated in the 6 months preceding study entry,
* The patient or patient's parents or legal authorized representative, as applicable, are capable to understand the study objectives and procedure, and sign the written consent,
* Accept that the supply of Idelvion might be stopped once the study is completed,
* Able to complete a diary during 12 months or 50 EDs, whichever comes first.

Exclusion Criteria:

* Currently participating in an interventional clinical trial,
* Known hypersensitivity to any FIX product or hamster protein,
* Known inhibitor to FIX or inhibitor history,
* With other comorbidities which are not suitable for this study, at investigator's discretion,
* Not able to compliant with the prophylactic treatment,
* Lacking previous treatment and bleeding records.
Supporting Laypeople Addressing Prehospital Hemorrhage Study

It is unknown if bystanders equipped with point-of-care (POC) instruction are as effective as bystanders with in-person training for bleeding control. Therefore, POC instructional interventions were developed during this study in response to the scalability challenges associated with in-person training to measure the comparative effectiveness and skill retention of POC instructions vs in-person training using a randomized clinical trial design.

Road traffic injuries (RTIs) are the largest contributor to the global trauma burden, which disproportionately affects low- and middle-income countries (LMICs). With a lack of robust emergency medical services (EMS), there has been increasing reliance on layperson bystanders to respond to RTIs in LMICs, called lay first responders (LFRs). In prospective studies of LFR activity across three sub-Saharan African countries comprising 2,039 total patient encounters, LFRs most frequently provided hemorrhage control in 61% of patient encounters. Rapid hemorrhage control for compressible extremity hemorrhage by bystander LFRs has the potential to mitigate exsanguination, reducing mortality secondary to RTIs. Rapid hemorrhage control also has applicability to high-income country settings like the United States that sustain high rates of penetrating trauma due to gun violence. Rapid hemorrhage control using tourniquets for compressible extremity hemorrhage in patients not yet in shock is strongly associated with saved lives demonstrated in battlefield studies, decreasing preventable deaths by more than 50%. Bystanders may be trained in-person or point-of-care (POC) instruction may be provided, as exists with automated external defibrillators. However, it is unknown if bystanders equipped with POC instruction are as effective as bystanders with in-person training for tourniquet application. Therefore, the investigators developed POC instructional interventions in response to the scalability challenges associated with in-person training to measure comparative effectiveness and skill retention using a randomized controlled trial design.

Eligibility Criteria:
Inclusion Criteria:

* Understand spoken and written English

Exclusion Criteria:

* None
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Are at least 18 years of age or legal age of consent in the jurisdiction in which the study is taking place, whichever is older.
* Have HbA1c at screening

  * ≥7.0% and ≤10.5% if background diabetes medication does not include a sulfonylurea, or
  * ≥7.5% and ≤10.5% if background diabetes medication includes a sulfonylurea.
* Are on stable treatment of at least 1 and no more than 3 oral antihyperglycemic drugs for at least 90 days before screening. Antihyperglycemic drugs may include metformin, SGLT-2 inhibitors, and/or sulfonylureas
* Have increased risk for cardiovascular (CV) events due to:

  * Coronary heart disease
  * Peripheral arterial disease, presumed to be of atherosclerotic origin
  * Cerebrovascular disease, presumed to be of atherosclerotic origin
  * Chronic kidney disease (CKD)
  * Congestive heart failure (CHF) New York Heart Association (NYHA) functional classification II to III
* Are of stable weight (± 5%) for at least 90 days prior to screening
* Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to screening
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (e.g. laster photocoagulation or intravitreal injections of anty-VEGF inhibitors
* Have a known clinically significant gastric emptying abnormality
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) or aspartate aminotransferase (AST) enzyme level ≥5.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory
* Have had any of the following within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization for congestive heart failure
* Have an eGFR \<15 mL/min/1.73 m2 as determined at screening
* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* Have been taking any other diabetes medicines other than metformin, SGLT-2 inhibitors, and/or sulfonylureas during the last 90 days
* Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening
Incidence and Outcome of Acute Diverticulitis in Finland

The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.

Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.

Eligibility Criteria:
Inclusion Criteria:

* all patients with acute diverticulitis (K57) in Finland and in two hospitals

Exclusion Criteria:

* other reasons for acute or chronic abdominal pain
Next Generation Sequencing in Intrahepatic Cholangiocarcinoma

The aim of the present study is to perform a comprehensive molecular characterization of intrahepatic cholangiocarcinoma (ICC) in patients exposed to well-known or putative risk factors (such as asbestos) for this malignancy, in order to identify possible "molecular signatures" associated to such different risk factors.

Exposure to distinct risk factors of the enrolled ICC patients will be assessed by modified ReNaM questionnaire. Molecular characterization of ICC tissue samples will be carried out by RNAseq. Briefly, after surgical resection tissue samples will be immediately suspended in RNAlater. RNAseq analysis will be performed on the Illumina HiScanSQ platform. Any possible mutations identified by RNAseq will be validated by Sanger sequencing. Putative identified fusion transcripts will be confirmed by RT-PCR, using specific primers pairs located on the sequences from the exons of the two putative fusion genes. Variations in gene expression will be validated by the real-time PCR. The bioinformatic analysis will be made by using CentOS5 Server. For evaluation of asbestos fibers in tumor tissues, samples embedded in paraffin will be incinerated and then analyzed in a scanning electron microscope and by EDS spectroscopy.

Eligibility Criteria:
Inclusion Criteria:

* patients having a confirmed diagnosis of ICC resected;
* patients who have signed the informed consent;
* patients (males or females) who are at least 18 years old.

Exclusion Criteria:

* patients who have been treated with any medical treatment (chemotherapy or experimental standard) or with radiotherapy during the last 5 years.
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers

Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.


Eligibility Criteria:
Inclusion criteria:

* Japanese healthy male
* 20 to 40 years of age
* body mass index (BMI) between 17.6 and 26.4 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)

Exclusion criteria:

1. Any clinical relevance findings of the medical examination as follows

   1. Blood pressure (systolic blood pressure is lower than 110 mmHg and diastolic blood pressure is lower than 60 mmHg at the screening in either a supine or a sitting position),
   2. pulse rate,
   3. electrocardiogram \[ECG\]
   4. laboratory test parameters) of clinical relevance
2. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of orthostatic hypotension, fainting spells or blackouts
5. Chronic or acute infections
Collecting Information From Patients Enrolled in the Breast Specialized Program of Research Excellence

RATIONALE: Collecting and storing information from patients with cancer to study in the future may help doctors learn more about cancer.

PURPOSE: This study is collecting information from patients enrolled in the Breast Specialized Program of Research Excellence.

OBJECTIVES:

* Provide a database for administrative and biostatistical support for the Breast Specialized Program of Research Excellence.

OUTLINE: Data is collected from patients for future research studies.

PROJECTED ACCRUAL: A total of 535 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography

Pulmonary complications after cardiac surgeries are common. It is one of the most crucial concerns of cardiac surgeons and anesthesiologists. These adverse events may vary from a mild respiratory dysfunction to acute respiratory distress syndrome (ARDS). One of the most public reasons of these complications is atelectasis that would result in hypoxia and pneumonia. Any of these adverse events rises the prevalence of morbidity and mortality. The chief inducing causes for atelectasis are CPB and dropped blood perfusion and ventilation of the lungs. The ventilation arrest is related with a high frequency of retained bronchial sections, local atelectasis, decrease in arterial O2 concentrations as a effect of surge in arteriovenous shunt, declined lung compliance, pulmonary edema and hence increased risk of nosocomial infections.

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, real time bedside imaging modality, which provide the assessment of regional gas volume and lung ventilation. EIT has been experienced in quite a lot of animal and clinical applications including optimization of mechanical ventilator strategies and recognition of respiratory adverse events. Besides, EIT has been used to recognize ideal PEEP by detection of homogenous ventilation in non-dependent and dependent lung regions. Homogeneous ventilation is key for inhibition of ventilator-induced lung injury.

The aim of this study is to use four different ventilatory strategies 【Group R : IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) ； Group RP, Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O ；Group RI : Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1) ；Group RPI: Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)】 to compare the beneficial in decreasing the incidence of post-operative pulmonary dysfunction after cardiac surgery including of the data of EIT, GAS , Lactate , PFR：PaO2/FiO2 ratio , cardiac index (CI) , BMI..etc . EIT were measured at two perioperative timepoints 1. after intubation at the onset of anesthesia with mechanical ventilation with 7ml/ kg (Predicted body weight) 2. at the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-80 year-old
* Adult patients receiving elective cardiac surgery with hypothermic CPB

Exclusion Criteria:

* Patients were excluded if they had complicating comorbidities, such as chronic hepatic or renal insufficiency, acute cardiopulmonary failure requiring mechanical ventilation, intra-aortic balloon pump, or extracorporeal membrane oxygenation
Prediction of Sphenoid Septation in MRI Compared With CT and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery

To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.

The current research project addresses the question whether MRI alone is sufficient for preoperative planning and computer-assisted surgery (CAS) during standard trans-sphenoidal pituitary surgery and if situations can be identified, where additional CT yields more information for the surgeon.

A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.

50 patients operated the University hospital of Basel \[USB\] (Centre A) are consecutively included into the prospective part of the study. MRI is used to assess the standardized variables, confirmed by CT. Additionally, for the 50 prospectively collected patients, neuroimaging results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

Between 20-50 patients operated at the University of Malaya Medical Centre \[UMMC\] and Specialist Centre \[UMSC\] (Centre B)will be included retro- and prospectively . MRI is used to assess the standardized variables and the results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

Eligibility Criteria:
Inclusion Criteria:

* lndicated trans-nasal trans-sphenoidal surgery for an anterior skull base tumour with preoperative baseline MRI (Centre A and B) and baseline CT (Centre A).

Exclusion Criteria:

* Previous trans-sphenoidal surgery
* Patients without CT, MRI or intraoperative endoscopic video
Safety and Efficacy of RM-004 Cells for Hemoglobin H-Constant Spring Disease

The purpose of this study is to evaluate the safety and efficacy of RM-004 for Hemoglobin H-Constant Spring disease.

This is a non-randomized, one-arm, open label study to evaluate the safety and efficacy of RM-004 for autologous hematopoietic stem cell transplantation (HSCT) for the treatment of Hemoglobin H-Constant Spring disease. Five subjects aged from 12 to 35 years will be recruited in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily sign informed consent by themselves or their legal guardians and complete the study procedures, follow-up examination and treatment.
2. At the time of screening, subjects should be aged from 12 to 35 years old, regardless of gender.
3. History of at least 100 mL/kilograms (kg)/year of packed red blood cells (pRBC) transfusions in the prior 2 years before screening.
4. Subjects diagnosed with Hemoglobin H-Constant Spring disease (--/ααCS) with HBA2 c.427T\>C mutation.

Exclusion Criteria:

1. Subject who has an available HLA-matched/well-matched HSCT donor for allogeneic hematopoietic stem cell transplantation (HSCT).
2. Prior HSCT or gene therapy.
3. History of severe hemorrhagic disease.
4. Clinically significant active bacterial, viral, fungal or parasitic infections per investigator's judgement at the time of screening.