cyrilzakka/clinical-trials huggingface dataset:
BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.

The aim of this study is to document an optimized pharmacologic treatment for patients with Takotsubo Syndrome. There is currently no published documentation in a large number of patients. The study is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
3. Written informed consent obtained

Exclusion Criteria:

1. Previous randomization in the trial
2. Any concomitant condition resulting in a life expectancy of less than one month
3. Previously diagnosed left ventricular ejection fraction \<50%
4. Known cardiomyopathy (except previous Takotsubo syndrome)
5. Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
6. Heart transplant or left ventricular assist device recipient
7. Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
8. Systolic blood pressure \<80 mm Hg at screening
9. Estimated glomerular filtration rate \<30 mL/min/1.73m2
10. Current dialysis
11. Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
12. Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to the trial protocol

    Specific exclusion criteria for Randomization 1
13. Any contra-indication for treatment with adenosine or dipyridamole (including AV-block II and III, sick-sinus syndrome in subjects who don´t have a functioning pacemaker, unstable angina, ongoing treatment with dipyridamole)
14. Severe asthma (defined as asthma requiring medium or high-dose inhaled corticosteroids combined with other long-acting medications) and severe Chronic Obstructive Pulmonary Disease (COPD), (defined as FEV-1 ˂ 50 %)
15. Ongoing treatment with dipyridamole
16. Declined participation in study 1

Specific exclusion criteria for Randomization 2

1. Any contra-indication for anticoagulant treatment.
2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy
3. Declined participation in study 2
Routine Nasobiliary Insertion During ERCP in High Risk Patients.

110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy admitted to departement of surgery of Minia university hospital for ERCP then laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP after CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. Tans-nasobiliary Intraoperative cholangiography was done and methylene blue injected at the end of the procedure to detected any leak in NB group

110 patients with common bile duct (CBD) stones and had one or more anther preoperative predictors for high risk for difficult cholecystectomy as , age \> 65 , male sex, obesity, acute cholecystitis, previous upper abdominal surgery, and certain ultrasonographic findings i.e. distended gall bladder (GB), thickened GB wall, pericholecystic fluid collection and impacted stone etc. these patients admitted to department of surgery of Minia university hospital for ERCP followed with laparoscopic cholecystectomy (LC). the patient divided into 2 equal group. in group 1, nasobiliary (NB) catheter was inserted during ERCP to settle high up in the intrahepatic biliary tree after complete CBD clearance. In group 2, only CBD clearance was done. In all patients LC was done within the same week of ERCP. sequential, multiple, step after step, tans-nasobiliary Intraoperative cholangiography was done during every step in cholecystectomy especially during dissection of calot's triangle and just before clipping of supposed cystic duct (CD) to make sure that the structure supposed to be CD was not the CBD. after the end of procedure methylene blue is injected from the the NB to detected any leak and if present

Eligibility Criteria:
Inclusion Criteria:

* patients with GB stone complicated with CBD stones
* accept to share in the study
* the presence of one or more preoperative predictors for high risk for difficult cholecystectomy
* patient fit for LC

Exclusion Criteria:

* patients\< 18 and \>80
* unfit for surgery
* didn't accept to share in the study
Ethnic Differences and the Ischemia/Bleeding Risk of DAPT Duration

this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* patients enrolled in previous RCTs related to the duration of dural antiplatelet agent therapy
The Turkish Version of the Medial Tibial Stress Syndrome Score

The medial tibial stress syndrome (MTSS) score was originally developed in Dutch to assess severity of disease relative to patient-reported outcome, particularly patients with MTSS. The purpose of this study was to translate and cross-culturally adapt the MTSS score into Turkish and investigate its psychometric properties.

The medial tibial stress syndrome (MTSS) score was originally developed in Dutch to assess severity of disease relative to patient-reported outcome, particularly people with MTSS. The purpose of this study was to translate and cross-culturally adapt the MTSS score into Turkish and investigate its psychometric properties. Fourty-eight individuals with MTSS will include. Within a 7-day period after the first assessment, the participants completed the Turkish version of the MTSS score to evaluate test-retest reliability.

Cronbach's alpha (α) was used to assess internal consistency. Construct validity was examined total score of PCS domain of SF-36-Tr with MTSS-Tr total score in the first visit. Concurrent validity was examined by evaluating the relationship between pain level and Detmer's classification with MTSS score in the first visit. The pain level of the patient assessed with visual analog scale (VAS) score.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with MTSS by a sports medicine physician
* Patients aged between 18 and 75 years
* Patients whose native language is Turkish
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Having tibia fracture history,
* Patients with suspected stress fracture or chronic compartment syndrome,
* Pregnant and breastfeeding women
Analysis of Novel Positioning Sensor-assisted Postoperative Position Correction and Effective Prone Time Recorded in Patients With Different Prone Times After Macular Hole Surgery

Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is \>400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older；
* Patients diagnosed with IMH;
* Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery;
* Agreed to the study protocol.

Exclusion Criteria:

* Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm;
* Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology;
* Previous history of internal eye surgery in the operated eye;
* Patients with local or systemic other diseases significantly affecting visual function;
* Those who cannot maintain face-down position after surgery due to systemic factors, etc.
Studying the Effects of Phentermine on Eating Behavior

The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.

This study aims to explore whether short-term measures of eating behavior can be related to later, longer-term weight loss. In a double-blind, randomized fashion, participants will be asked to take study medication for three weeks: one week of phentermine and two weeks of placebo. At the end of the first and third weeks, participants will be asked to participate in a range of eating behavior studies. Following this three-week, double-blind phase, participants will be offered 6 months of open treatment for weight loss.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 30-40kg/m2
* Stable weight (+5 lbs) for a minimum of 3 months
* Systolic Blood Pressure \<140mm Hg
* Diastolic Blood Pressure \<90 mm Hg
* Pulse \<95 beats per minute
* English language proficiency

Exclusion Criteria:

* Previous unsuccessful trial of phentermine
* Prior adverse reaction to phentermine
* On any antidepressant medications,especially monoamine oxidase inhibitors(MAOI)
* History of neurological disorder (e.g. dementia)
* History of moderate or severe head injury
* Current or past history of coronary artery disease
* Current or past history of stroke or transient ischemic attack
* Current or past history of heart arrhythmias
* Current of past history of congestive heart failure
* Current or past history of peripheral artery disease
* Current or past history of liver disease
* Current or past history of kidney disease
* Uncontrolled diabetes mellitus (type I or II)
* Narrow-angle glaucoma
* Hypo- or hyper-thyroidism not adequately treated
* On medications (prescribed or OTC) known to affect appetite (e.g. diet pills), weight, or metabolism
* Current or past history (within the past 12 months) of major depression
* Current or past history (past 12 months) of alcohol or drug abuse or dependence
* Current or past history (lifetime) of amphetamine abuse or dependence
* Known history of learning disorder or developmental disability
* Current or past Attention Deficit Hyperactivity Disorder (ADHD)
* Pregnancy, planning to become pregnant, or lactation within the previous 6 months
* Waist circumference greater than 188cm
* Indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo
* Significant claustrophobia
* Current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)
Effect of CCRT on Respiratory Performance and Functional Capacity in Esophagus Cancer Patients

The purposes of this study are to investigate in patients with newly diagnosed esophageal cancer: 1)changes in pulmonary and respiratory muscle function, functional capacity and quality of life during and after RT or CCRT treatment; 2)the correlations between these changes; and 3)the impacts of these changes on the postoperative pulmonary complications following esophagectomy.

Background and Purpose: Incidence rates of esophageal cancer vary internationally with the higher rate found in Eastern Asia. Preoperative concurrent chemoradiation therapy (CCRT) for resectable esophageal cancer has been shown to improve overall survival in meta-analyses. Preoperative pulmonary function and functional capacity are known predictive factors for the development of postoperative pulmonary complications in patient undergoing major cancer surgery. Little is known concerning the impacts of preoperative CCRT on pulmonary function and functional capacity in patients with esophageal cancer. The aim of this study is to examine changes of respiratory performance and functional exercise capacity during RT or CCRT, the relations between these changes, and the impacts of these changes on the postoperative outcomes in patients with esophageal cancer.

Method: Patients with newly diagnosed esophageal cancer without metastasis will be recruited from the Far Eastern Memorial Hospital. Demographic data will be obtained from the chart. Respiratory muscle strength will be measured by maximal inspiratory and expiratory pressure. Spirometric variables will be tested by force expiratory volume in one second and forced vital capacity. Dyspnea will be measured using modified Borg scale. Functional exercise capacity will be measured by six minute walk distance. Quality of life will be measured using EORTC QOL-C30 and QOL-OES18 instruments. All the measurements will be repeated weekly during the concurrent therapy period. Repeated measure ANOVA will be used for analyzing difference among various time points. Spearman correlation coefficient will be used to test relationship between multiple variables. For patients who are receiving esophagectomy after CCRT or RT, pulmonary complications and total length of hospital stay will be documented.

Clinical relevance: The results of this study will help to better understand the indications for chest physiotherapy (e.g., respiratory muscle weakness, reduced functional capacity, and their related sequels)

Eligibility Criteria:
Inclusion Criteria:

* primary esophagus cancer
* planning to receive radiation therapy

Exclusion Criteria:

* MMSE \< 24
* A clinical diagnosis affecting respiratory muscle function and functional activity performance
* Unstable angina or acute myocardial infarction prior 1 month of assessment
Effect of Gutamine Administration in the Innate Immune System Response in ICU Patients.

Glutamine is the most abundant nonessential amino acid in the human body. Besides its role as a constituent of proteins and its importance in amino acid transamination, glutamine may modulate immune cells.

The innate immune system is the first line of host defence against pathogens and in most cases sufficient to eliminate invading microbes. Mammalian Toll-like receptors (TLR) comprise a family of germ line-encoded trans-membrane receptors which activation leads to the induction of inflammatory responses, phagocytosis but also to the development of antigen specific adapative immunity.

It has been postulated though not formally proven yet that glutamine beneficial effect could be due to a positive effect on the innate immune system. Given the importance of TLRs and TLRs-dependent signalling in host defence against infections we hypothesized that glutamine may increase the expression and/or functionality of TLRs which in turn may have beneficial effects to clear infections.

Objective: To evaluate whether glutamine supplementation alters the expression and functionality of TLR2 and TLR4 in circulating monocytes of trauma patients admitted to the ICU. Specifically the next variables were measured:

* Expression of TLR2 and TLR4 in peripheral blood monocytes was determined by flow cytometry
* To study the functionality of TLR2 and TLR4, monocytes were stimulated with TLR specific agonists and cytokines were measured in cell culture supernatants. We determined the concentration of IL-1β, IL-6, TNFα and IL-10 in cell culture supernatants using a bead array ELISA.
* To determine the phagocytic capability of monocytes, live Escherichia coli expressing green fluorescent protein was added to 100 μL of whole blood collected in K2-anticoagulation medium tubes. Bacteria were added at a ratio of 100 bacteria per monocyte. The analyses were carried out in an Epics XL flow cytometer.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years (inclusive).
* Moderate to severe trauma, as defined by an Injury Severity Score (ISS) \> 12 points were included in the study
* Traumatic patients who required total parenteral nutrition

Exclusion Criteria:

* Patients who were under 17 and over 76 years of age,
* Patients whose life expectancy was less than 5 days
* Patientes allergic to glutamine.
* Patients with any basic pathology included any serious immune system condition (diabetes, HIV, lupus, etc.) or who, in their long-term treatment prior to admission to ICU, received corticoids or any other immunosuppressant medication.
* Pregnant women.
Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate

Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and the hip by DXA. Each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy procedure will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 5 years postmenopausal
* Subjects treated with any combination alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for 3-5 years. Or subjects treated with any combination of alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for greater than 5 years.

Exclusion Criteria:

* Presence of metabolic bone disease other than PMO
* Use of any medication other than alendronate or risedronate within with in the past 6 months likely to interfere with skeletal homeostasis.

Uncontrolled hyperthyroidism. Previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin.

* Alcohol or drug abuse, current or within the past 5 years.
* Allergy to tetracycline, Novocain, or Versed.
* Hip anatomy not conducive to transiliac bone biopsy or DXA scan.
* Previous bilateral transiliac bone biopsies.
Influence of Corticoids on Renal Function in Cardiac Surgery

Hypothesis: Corticoid treatment in cardiac surgery works renal protective.

Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.


Eligibility Criteria:
Inclusion Criteria:

* age between 20-80 year
* patients scheduled for elective cardiac surgery.
* preoperative creatinine levels of \< 2mg/dl
* no corticoid treatment

Exclusion Criteria:

* non-elective surgery
* patiënts with renal dysfunction: creatinine \> 2mg/dl
* patiënts treated with corticoids
Communication Skills Training and Competency Assessment for Pulmonary and Critical Care Medicine Fellows

Study to determine if pulmonary/critical care fellows will demonstrate increased competency in the behavioral skills necessary to facilitate family meetings focused on discussions of goals of care in the ICU from pre- to post-communication skills training.

The investigators hypothesize that pulmonary/critical care fellows will demonstrate increased competency in the behavioral skills necessary to facilitate family meetings focused on discussions of goals of care in the ICU from pre- to post-communication skills training.

Eligibility Criteria:
Inclusion Criteria:

* First- and second-year pulmonary/critical care fellows
Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea

The purpose of this study is to determine whether Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel are effective and safe in the treatment of papulopustular rosacea.

Currently, there is no known cure for rosacea. The most effective treatment is systemic antibiotics, particularly of the tetracycline family. Topical treatments include metronidazole, antibacterials such as erythromycin and clindamycin, sulfacetamide and benzoyl peroxide. Isotretinoin (Accutane) is also used.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age and older.
2. Clinical diagnosis of papulopustular facial rosacea.
3. A minimum of 4 but not more than 50 facial inflammatory lesions (papules plus pustules).
4. Willing and able to understand and sign informed consent.
5. Able to complete study and comply with study procedures.

Exclusion Criteria:

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
2. History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis, bloody diarrhea) or similar symptoms.
3. Use of topical rosacea treatments in the past 2 weeks.
4. Use of systemic antibiotics in the past 4 weeks.
5. Use of systemic retinoids within the past 3 months.
6. Use of laser or light based rosacea treatments within the past 2 months.
7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids as these may impact assessments.
8. Current drug or alcohol abuse.
9. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or acne vulgaris.
10. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
11. Subjects who are pregnant or planning a pregnancy.
12. Use of any investigational therapy within the past 4 weeks.
13. Known hypersensitivity or previous allergic reaction to clindamycin or retinoids
A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASE

The purpose of this study is to assess the ability of CJH1 to increase the sensitivity of dopamine receptors and thereby reduce symptoms of Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient's with Parkinson's disease

Exclusion Criteria:

* Contraindications to study medication
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque

To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypercholesteremia
* The indication of coronary angiography, coronary angioscopy and intravascular ultrasound are expected

Exclusion Criteria:

* Patients who has current administration of Lipitor or history of discontinued administration of Lipitor
* Acute cardiac infarction