cyrilzakka/clinical-trials huggingface dataset:
Shock Trial: Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock.

To test if early revascularization, primarily with angioplasty (PTCA) or bypass surgery (CABG), reduced all-cause in-hospital mortality from cardiogenic shock compared to conventional treatment, including thrombolysis.

BACKGROUND:

Approximately 7.5 percent of all acute myocardial infarctions which are diagnosed in an emergency room or in-hospital lead to cardiogenic shock and an in-hospital death rate of 70 to 80 percent, usually within one to two days of diagnosis of cardiogenic shock. The high death rate has not changed in the last two decades. Non-random clinical series and animal studies suggest that rapid revascularization following cardiogenic shock complicating acute myocardial infarction may substantially improve survival. However, the apparent benefit reported in the non-random clinic studies could have resulted partly from a selection bias towards patients with a better prognosis.

DESIGN NARRATIVE:

Randomized, multicenter, Phase III, controlled clinical trial. Patients with shock due to left ventricular failure complicating myocardial infarction were randomly assigned to emergency revascularization or initial medical stabilization. Revascularization was accomplished by either coronary-artery bypass grafting or angioplasty. A total of 152 patients were randomized to early revascularization and 150 patients to conventional therapy consisting of thrombolytics and a possible late attempt at revascularization. Intraaortic balloon counterpulsation was performed in 86 percent of the patients in both groups. The primary endpoint was mortality from all causes at 30 days. Secondary endpoints included all-cause mortality at six months and assessment of the quality of life in survivors after discharge.

All patients with a clinically suspected diagnosis of cardiogenic shock complicating myocardial infarction formed a registry, with limited information collected on in-hospital procedures, medications, length of stay and vital status at discharge.

The study has been extended through June, 2005 for patient follow-up and data analyses. Long-term survival rates (6 to 11 years post-MI) will be estimated and the quality of life of survivors of acute MI complicated by cardiogenic shock will be studied. Extended trial data analyses will be conducted: a) To determine the early echocardiographic parameters which are associated with one year survival in cardiogenic shock patients, and to assess the interaction of these parameters with early revascularization; b) To examine differences in disease course and patient outcome as a function of age, gender, national practice, and changes in serial hemodynamic measurements, as well as to better characterize the related conditions and complications of cardiogenic shock.

Eligibility Criteria:
Men and women with myocardial infarction and cardiogenic shock.
A Randomized, Double Dummy, Placebo-controlled Pilot Study to Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood and Anxiety

This study aims to evaluate the efficacy and safety of Leonurus cardiaca extract in reducing anxiety symptoms in adults with Generalized Anxiety Disorder (GAD). Sixty drug-free participants aged 20-50 years with a diagnosis of GAD will be randomly assigned to receive either Leonurus cardiaca extract or placebo for 30 days. The primary outcome is the reduction in anxiety symptoms assessed by the SCAG scale. Secondary outcomes include changes in quality of life (SF-12), perceived stress (PSQ), anxiety severity (HAM-A), and anthropometric measures. Safety will be assessed through liver, kidney, and thyroid function tests. Assessments will be conducted at baseline, day 14, and day 30.


Eligibility Criteria:
Inclusion Criteria:

* Female participants aged 18 to 50 years
* Diagnosis of Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD) according to DSM-5 criteria
* Regular menstrual cycles (25-35 days) in the past 6 months
* Presence of PMS symptoms for at least 6 months, confirmed through prospective symptom diary
* No hormonal treatment in the previous 3 months
* Written informed consent obtained

Exclusion Criteria:

* Postmenopausal women, or those who are pregnant or breastfeeding
* Use of hormonal contraceptives in the last 3 months
* Current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder)
* Known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes)
* Use of medications that could affect mood or the menstrual cycle (e.g., SSRIs, anxiolytics, antipsychotics)
* Severe hepatic or renal impairment
* Any other serious or unstable medical condition that, in the investigator's judgment, could interfere with study participation
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention

The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma formation after harvesting LD flap.

NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to reduce seroma formation

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-60 years Underwent breast reconstruction with LD Flap

Exclusion Criteria:

* Locally advanced cancer
Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)

This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.

Eligibility Criteria:
Key Inclusion Criteria:

Informed consent

Clinical diagnosis of moderate to severe VVC

Negative pregnancy test

Vaginal pH less than 4.5

Key Exclusion Criteria:

Has an intolerance or hypersensitivity to any amphotericin B (AMB) product, or to azole antifungal drugs

Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy

Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months

Has another cause of vulvovaginitis

Has other urogenital infection(s) that would potentially alter their response to disease

Has another vaginal or vulvar condition that would confound the interpretation of clinical response

Has significant laboratory abnormality at screening

Has any known azole-resistant Candida infection;

Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk
New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Our project aims to find new biomarkers in MRI at three levels: cerebral, medullary and muscular. These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression of the disease. This study will use advanced Magnetic Resonance Imaging (MRI) techniques High field (3T) and very high field (7T) MRI. Results from neurological and electrophysiological tests will be compared to the MRI. Subjects will be recruited from ALS center of Marseille, France. MRI will be done on ALS patients at baseline, at 3 month and at 6 month intervals.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be adults with a diagnosis of ALS.
* Healthy controls will also be recruited and will be age- and gender-matched to patients.
* Patients able to undergo a brain MRI for approximately an hour.

Exclusion Criteria:

* Subjects with other psychiatric or CNS or PNS diseases.
* Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign body, or significant claustrophobia that could affect the ability to have an MRI scan.
Patient Experience of Interventional Pain Management. Qualitative Study

There are quite a few qualitative studies done to find out patients experience of chronic pain. There are no studies on what the patients feel and what thoughts and feelings arise in the patients that are exposed to interventional pain management. This study aims to illuminate how it is to live through an interventional pain management program.

A qualitative interview is performed with patients that have passed through an interventional pain management program. The transcribed interviews are analyzed with qualitative content analysis according to Graneheim and Lundman in order to illuminate the experience, feelings and thoughts arisen among the patients.

Eligibility Criteria:
Inclusion Criteria:

Patients passed through an interventional pain management program

Exclusion Criteria:

Purposeful sampling will be applied
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
* Subjects must understand and consent to be in the study.
* American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria:

* Subjects who have any systemic disease at all.
* Subjects who do not understand the study and the risks.
* Smokers.
* Subjects who are pregnant.
* Subjects having either signs or history of peripheral ischemia.
* Others deemed ineligible by the clinical staff.
Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity

The purpose of this study is to assess the association between the "point-of-care" (POC) measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and postoperative delirium in elderly patients undergoing cardiac surgery.

Furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of ChE activity.

Cardiac surgery in elderly patients is associated with serious complications, like increased morbidity, mortality and postoperative delirium with further hazardous consequences. The incidence of postoperative delirium in elderly is reported with a range from 36.6% - 54.9%. The pathophysiology of delirium is complex and the interaction of the cholinergic system and inflammation reaction is a relevant precipitant factor. It was suggested that there is a strong association between the perioperative plasma ChE activity and the inflammatory response in patients developing delirium. Patients showed a significant reduction of the total ChE activity after orthopaedic surgery, with significant lower pre- and postoperative values of AChE and BuChE and increased inflammatory response in patients developing postoperative delirium. It remains unclear if these results are applicable to other patient populations and which factors have influenced the low preoperative ChE levels. In patients suffering from a cardiac disease, a reduced total ChE respectively BuChE activity was significantly associated with mortality and long-term major adverse cardiovascular events. The investigators hypothesize that the ChE activity in peripheral blood can be used as a potential biomarker, to early detect patients at high risk for postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* ≥ 65 years of age
* Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB
* Both genders

Exclusion Criteria:

* Planned deep hypothermic arrest
* Acute / emergency procedures
* Surgery without extracorporeal circulation (ECC)
* Patients with a history of pseudocholinesterase deficiency
* Employees of the respective study centres
* Illiteracy
* Severe communication difficulties and severe vision or hearing problems
* Patients legally unable to give written informed consent
* non-fluency in German language
* Severe psychiatric or neuropsychiatric disorders
* MMSE \< 24 points, short geriatric depression scale (GDS) ≥ 10 points
* Recent (\<6 months) history of alcohol or drug abuse
* The participation in a drug or device trial within the previous 30 days
Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

The self-monitoring of capillary blood glucose is part of the package of interventions in diabetes mellitus and an effective therapeutic strategy for the adequate control of the disease; and the continuing education of people with DM is recognized as one of the goals to delay the complications arising from chronic disease and alleviate the symptoms of hypoglycemia and hyperglycemia.

This study aims to evaluate the effects of educational intervention on self-monitoring of capillary blood glucose in metabolic control, knowledge and attitude in two groups of patients with diabetes mellitus: a group of diabetic patients who participate in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive educational interventions (Intervention Group - G1) and a group of diabetic patients who participle in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive conventional treatment (Control Group - G2). As an educational tool in diabetes will be used Conversation Maps which is considered an interactive program of diabetes education.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 Years and older;
* Diagnosis of type 1 and 2 diabetes mellitus;
* In follow-up in the Self-Monitoring of Capillary Blood Glucose at Home Program;
* Have cognitive conditions that enable participation (minimum ability of users to understand issues of data collection instruments, observation of the researcher and/or of the caregivers).

Exclusion Criteria:

* Patients with gestational DM;
* Patients with DM who are not located;
* Those who die in the proposed period for the research;
* Those who dropout the Self-Monitoring of Capillary Blood Glucose at Home Program;
* Those who report difficulties to participate of the study due to work and those with amaurosis;
* Used Conversation Maps as an educational tool.
Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.

To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :

* Group 1 : 48 eyes primarily treated with gas tamponade
* Group 2 : 11 eyes primarily treated with silicone oil tamponade
* Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
* Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade)
* aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months

Exclusion Criteria:

* diabetic retinopathy
* glaucoma
* non rhegmatogenous retinal detachment
* active uveitis
* pseudoexfoliation syndrome.
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.

This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor. Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.

Gemcitabine is given by vein over 30 minutes on days 1 \& 8 of each 21-day cycle. LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection. Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation. Vitamin B12 is administered approximately every 9 weeks after the first injection. Appropriate antiemetic medication should be given to all patients. Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing. This is given to prevent or lessen the possibility of a rash.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of breast cancer
* measurable disease
* received prior anthracycline and taxane
* life expectancy \> 3 months
* acceptable lab results

Exclusion Criteria:

* \>3 prior regimens
* prior treatment with protocol drugs
* prior (pelvic) radiation
* active CNS metastasis
* inability to take oral vitamins
Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery

The aim of this study is to investigate the early effects of Inspiratory Muscle Training (IMT) applied before and after bariatric surgery on respiratory function, respiratory muscle strength and functional capacity in individuals with type 2 diabetes.

The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65. Individuals will be randomly assigned to the IMT (trained at 30% of maximum inspiratory pressure with an IMT threshold device) and control group. As measurement parameters, a 6-minute walk test for functional capacity, a spirometry test for respiratory function, and a portable device (Cosmed Pony FX Desktop Spirometer, USA) will be used for respiratory muscle strength. Hand grip strength will be measured with a Baseline dynamometer. All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery.

All patients will be evaluated with the same examinations on the first day before surgery and on the fourth day after surgery before discharge. Individuals in the control group will only apply the hospital routine exercise program in the postoperative period. While individuals in the IMT group will receive only IMT on the first day before surgery, they will also receive the hospital routine exercise program in addition to IMT treatment from the first day to the fourth day after surgery. During the training, the patient will undergo two 20-minute training sessions with a linear pressure resistance device, wearing a nose clip (Threshold® IMT-Health Scan Products, USA) in a sitting position (ATS/ETS, 2002). IMT training load will be adjusted according to the 30-40% pressure determined in the MIP measurement. In the postoperative period, all patients will receive incentive spirometry, breathing exercises and ambulation exercises as part of the hospital routine exercise program.

Eligibility Criteria:
Inclusion Criteria:

• Individuals with type 2 diabetes between the ages of 25 and 65 who applied to the General Surgery Department of Büyük Anadolu Hospital and underwent bariatric surgery

Exclusion Criteria:

* Individuals with a history of emergency surgery,
* Smoking,
* Exercising regularly in the last 6 months,
* Comorbidities with respiratory dysfunction,
* Pulmonary dysfunction,
* Acute COPD exacerbation were excluded from the study.
Survey Study: Financial Impact of Breast Cancer Treatment

A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years
* Willing to sign consent
* Able to read and complete surveys in English

Exclusion Criteria:

* Cancer diagnosis other than breast cancer
* More than 2 years since diagnosis with breast cancer or recurrence
Vertebral Bone Marrow Lesions by DWI and ADC Values

The aim of the work is to assess the utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions.

MRI has a high sensitivity in delineating the pathology, its specificity is low. Osteoporotic and metastatic compression fractures may be mistaken for each other in the acute phase (Wong and Suresh, 2018). Edema in the acute phase of benign fractures may replace normal bone marrow and cause hypointense signal changes in T1-weighted images and hyperintense signal changes in T2-weighted images, at the same time taking contrast material. These changes are also typical for metastasis and cause confusion in diagnosis when only one lesion is present (Mauch et al., 2018).

Diffusion-weighted imaging (DWI) has recently appeared as a new method of screening in characterizing lesions without necessitating contrast material and in evaluating the vertebrae quantitatively (Lee et al., 2019) Diffusion-weighted-imaging (DWI) provides microscopic information from water protons which is not possible using conventional magnetic resonance imaging (MRI) (Partridge et al., 2017). DWI measures the random (Brownian) extra, intra and transcellular motion of water molecules (Ahlawat and Fayad, 2018) Apparent-diffusion-coefficient (ADC) is a quantitative parameter calculated from DWI that combines the effects of capillary perfusion and water diffusion (Wang et al., 2018) In a comparatively small number of surveys, ADC values have been studied in discriminating the infectious lesions from the malign lesions The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions, and to determine the sensitivity and the specificity in differentiating benign and malignant vertebral lesions according to the optimal cutoff ADC value (Dahnert et al., 2017)

Eligibility Criteria:
Inclusion Criteria:

After taking clinical complaint and Orthopedic and neurological examinations, all patients (any age or sex) with suspected bone marrow focal lesions will undergo DWI and ADC map.

Exclusion Criteria:

All patients who contraindicated for MRI study as patients with cardiac pacemaker, any metallic stent, claustrophobia and morbid obesity.
Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture

This is a prospective randomized study conducted on 30 patients with an age spanning between 20 and 55 years. Half of the sample was treated by tension band wiring for closed medial malleolar fractures, and the other half by two cannulated screws. The patients were assessed at (6w-3months and 6months) for clinical and radiological union and evaluated functionally (12 months) using modified Olerund and Molander scoring system.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 20-55 years.
2. Isolated or bimalleolar ankle fractures.
3. Closed fractures.

Exclusion Criteria:

1. Patient with poor bone quality on x ray (radiological osteopenia, thinning of the cortices, loss of trabecular definitions and previous insufficiency fractures)
2. Type D isolated medial malleolus, supination adduction (vertical malleolar) fractures.
3. Comminuted fractures.
4. Skeletally immature patients.