cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males

The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 35 years
* Weight between 50 and 80 kg
* Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
* Judged as eligible as a study object following the screening test by the investigator
* Volunteers to participate in the study, who are capable of giving written informed consent

Exclusion Criteria:

* Known hypersensitivity to drugs
* History of drug or alcohol abuse
* Received other investigational drug within 4 months of the trial drug administration
* Had \> 400 mL of whole blood drawn within 3 months of the trial drug administration
* Had \> 400 mL of blood components drawn within 1 month of the trial drug administration
* Used any drug within 10 days of the trial drug administration
* Engaged in strenuous exercise within 5 days of the trial drug administration
* Consumed alcohol within 3 days of the trial drug administration
* Judged as ineligible for the study participation by the investigator for a reason other than above
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder

The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* A primary diagnosis of Major Depressive Disorder, single or recurrent episode, without psychotic features.
* Depressive symptoms for at least 30 days before the screening visit.
* Outpatient men and women at least 18 years of age.

Exclusion Criteria:

* Significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent.
* Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.
* Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder; b) current (within 12 months before baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder; c) presence (within 12 months before baseline) of a clinically important personality disorder as assessed during the psychiatric assessments.
McKenzie Retraction and Bruegger's Exercises Effects on Forward Head Posture

The aim of the study is to compare effects of McKenzie Retraction exercises and Bruegger's exercise on neck pain, ROM, craniovertebral angle and functional performance on forward head posture among young adults.

There are many advantages of technology such as improving work productivity and efficacy; however, using technology for an extended period of time can place a substantial amount of load on the neck musculature leading to musculoskeletal disorder. The most related cause of neck pain is muscle weakness leading to forward head posture due to static abnormal posture used while using electronic devices.

The aim of the study is to compare effects of McKenzie Retraction exercises and Bruegger's exercise on neck pain, ROM, craniovertebral angle and functional performance on forward head posture among young adults. A randomized clinical trial will be conducted at Sadiq Hospital, Sargodha. Non-probability convenience sampling will be used, and 36 subjects, age 15-30 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive hot pack for 10-15 minutes, as common treatment. Group A will be treated with McKenzie Retraction Exercises and Group B will be treated with Bruegger's Exercise.5 sessions per week and total20sessions for 4 weeks. The outcome measures will be conducted through NPRS, NDI, photogrammetry and goniometry before and after 4 weeks. Data will be analyzed using SPSS software version 26.

Eligibility Criteria:
Inclusion Criteria:

* Both Male and Female age between 15-30 years.
* Craniovertebral angle \< 50.
* Electronic gadgets \>6 hours a day.
* Neck pain from the previous 3 months.
* NPRS \>3.
* NDI \> 10.

Exclusion Criteria:

* Neck surgery or trauma.
* Torticollis.
* Subjects with diagnosed cases of discogenic disease.
* Subjects with migraine problem.
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome.

Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients

Data to be collected from a retrospective chart review will include:

* Patient demographics
* Medical history
* Pre and post treatment clinical assessments and laboratory results
* Radiologic findings (if available)
* Adverse events

Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.

Eligibility Criteria:
Inclusion Criteria:

* Pediatrics (age≤21 years) at time Korlym initiation
* Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
* Received at least one dose of Korlym
* Availability of pre-treatment (baseline) and follow-up data

Exclusion Criteria:

* None
RCT of Pain Perception With Fast and Slow Tenaculum Application

This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.

In order to detect a 15 mm difference on the VAS with two-sided 5% alpha and 80% power and a standard deviation of 33 mm (based on prior studies), a total of 71 subjects per group are required. We aim to recruit 75 subjects per arm in order to account for possible drop out.

Eligibility Criteria:
Inclusion Criteria:

1. plans for IUD insertion or endometrial biopsy;
2. 18 to 49 years of age;
3. not taken analgesics or anxiolytics in the previous 24 hours;
4. the ability and are willing to give informed consent.

Exclusion Criteria:

1. Do not speak English unless interpreter present;
2. Taken any narcotic or opiate medication in the last 24 hours.
3. Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines.
4. Taken any anti-anxiety medication or drug in the last 24 hours.
5. Taken any NSAIDS or Tylenol in the last 12 hours.
Transversus Abdominis Plane Block vs Continuous Infiltration Wound Catheter for Analgesia After Caesarean Section

Analgesia following surgery associates different intra-venous or oral analgesic drugs and sometimes opioids. To reduce opioid consumption, loco-regional anaesthesia might be administered as a complement. In the specific context of caesarean sections, pain control is mandatory to enable the mother to take care of her offspring and shorten their hospital stay. This intervention is mainly performed under neuraxial anaesthesia (spinal or epidural), enabling the injection of morphine in the subdural or epidural space, as part of a multimodal analgesia regimen.

Studies have evaluated continuous wound infiltration catheters (CIC) and ultrasound-guided (UGD) transabdominis plane (TAP) block, and both techniques and both techniques reduce postoperative morphine consumption. Recent studies have compared the two techniques and found conflicting results. Furthermore, they did not consider caesarean section performed under epidural analgesia, with a different neuraxial injection site, neither did they compared pain after postoperative day 2.

Consequently, the aim of this study was to compare resting and standing pain up to postoperative day 3 after caesarean section performed under spinal or epidural anaesthesia and receiving either USG-TAP block or CIC. Baseline hypothesis was that the continuous infiltration provided a better analgesia at day 2.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent,
* Age\>/=18 years,
* Caesarean section under spinal or epidural anaesthesia
* Technique surgical "Cohen Stark méthod".

Exclusion Criteria:

* Patient refusal,
* Patient under guardianship,
* Contraindication to one of the two techniques,
* Cesarean section under general anesthesia
* Allergies to local anesthetics
* Maternal instability
Hepatic Arterial Infusion of Oxaliplatin and Fluorouracil Treatment of Advanced Primary Liver Cancer After TACE

To investigate the therapy effect and security of oxaliplatin and fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer


Eligibility Criteria:
Inclusion Criteria:

1. With written informed consent
2. Age ranged from 18 to 80 years, both men and women
3. Confirmed by pathology or clinical diagnosis of liver cancer
4. Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
5. Never received TACE treatment
6. (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
7. ECOG PS score of ≤2
8. expected survival time ≥12 weeks
9. The test results before 7 days entered the group must meet the following requirements:

Hemoglobin ≥ 90 g / L Absolute neutrophil count (ANC)\> 1,500 / mm3 Platelet count ≥ 80x109 / L Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 times the upper limit of normal (UNL) Total bilirubin \<3UNL Serum creatinine \<1.5 UNL PT or INR, PPT \<1.5 UNL (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the INR stable)

Exclusion Criteria:

1. Specific circumstances of patients not suitable for TACE therapy / chemotherapy
2. Hepatic decompensation, or the presence of hepatic encephalopathy
3. Before entering the study with gastrointestinal bleeding within 30 days
4. Presence of brain metastasis
5. Pregnant or lactating women
6. Active bleeding or sepsis
7. History of heart disease:

   NYHA two or more of congestive heart failure, symptomatic coronary artery disease Need to use β-blockers or digoxin medication other than arrhythmias
8. Despite treatment, still systolic blood pressure\> 150 mmHg or diastolic blood pressure\> 90 mmHg hypertension
9. Not cure severe trauma, acute or incurable ulcer, or three months fracture
10. The researchers believe their poor compliance
11. Exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and the group 3 years ago, it has been cured of cancer
12. HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
13. Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
14. Need drug therapy epilepsy (such as steroids or antiepileptic drugs
15. Chemotherapy contraindications exist
16. Any instability or likely to endanger the patient in this study the safety and compliance of the case
Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.

The objective of this study is to evaluate the effect of multiple doses of BI 207127 combined with faldaprevir on cardiac safety parameters in healthy subjects


Eligibility Criteria:
Inclusion criteria:

* Healthy male and female subjects
* Subjects must be able to understand and comply with study requirements
* Age =18 and =55 years
* BMI range: =18.5 and =29.9 kg/m2

Exclusion criteria:

- any relevant deviation from healthy conditions
Improving Quality of Life in Heart Failure

This research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF).

Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge burden in the United States in terms of morbidity, mortality, and economic cost. Although disease management programs have been developed to curb these costs and address the complexities of HF management, evaluations of these programs have yielded equivocal results.

With this study the Investigators plan to: (1) to determine the feasibility of telephone delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield, retention, patient acceptance, and patient satisfaction; (2) to determine whether telephone-delivered PST is associated with greater improvements in QoL than telephone-delivered Time Management over 8 weeks; and (3) to determine whether telephone-delivered PST is associated with greater reductions in depressive symptoms and/or greater improvements in self-efficacy or objectively assessed daily physical activity than telephone-delivered Time Management over 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* Age \> 21
* Exhibits symptoms of hear failure (NYHA Class II or III)
* Left ventricular ejection fraction (LVEF) \>= 40%
* Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score \< 60

Exclusion Criteria:

* Cannot speak English
* Lack telephone access
* Unwilling to be randomized, or
* Unavailable for the study period
* Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
* Planned (within 6 months) cardiac surgery
* Cognitive impairment indicative of dementia
* Recent (3 months)

  * acute myocardial infarction,
  * cardiac decompensation, or
  * HF-related hospitalization.
* Use intravenous inotropic medication
* Use an assistive circulatory device
* Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)
* Currently receiving mental health counseling;
* A history of:

  * bipolar disorder,
  * psychosis, or
  * substance abuse/dependency
* Severe depressive symptoms or suicidality
The Relationship Between Driving Pressure, Mechanical Power, Oxygenation and Saturation Indices: Retrospective Observational Study

By using Mechanical Power and Driving Pressure instead of Pmean we calculate new oxygen saturation indices like Driving Pressure Oxygen Index (OIDP), Dynamic Power Oxygen Index (OIMPdyn), Total Power Oxygen Index (OIMPtot), Driving Pressure Saturation Index (OSIDP), Dynamic Power Saturation Index (OSIMPdyn) ve Power Saturation Index (OSIMPtot).

New oxygenation and saturation indices are able to predict ICU mortality better than the conventional indexes and rates.


Eligibility Criteria:
Inclusion Criteria:

- Patients with a diagnosis of Covid-19 related Acute Respiratory Syndrome (C-ARDS) which hospitalized in Bakirköy Dr. Sadi Konuk Training and Research Hospital intensive care unit

Exclusion Criteria:

* Patients who did not receive invasive mechanical ventilation support.
* Patients who stayed in the intensive care unit for less than 24 hours.
* Patients with missing data
* Patients who received mechanical ventilation support for less than 24 hours
* Patients with Chronic Obstructive Pulmonary Disease (COPD).
* Patients with congestive heart failure
* Patients who underwent tube thoracostomy due to tension pneumothorax
* Patients who received Extracorporeal Membrane Oxygenation (ECMO) support
Clinical Profile and Out Come of Children With Wilson's Disease

Clinical profile and out come of Children with Wilson's disease :A single tertiary center study

Wilson disease (WD) is an autosomal-recessive disorder of copper metabolism caused by mutations in the ATP7B gene . It presents in childhood, adolescence or adulthood with a wide range of clinical manifestations. The disease prevalence has previously been estimated as 1 in 30,000 , but some recent analyses have suggested a genetic prevalence of 1 in 7,000 . Copper is absorbed from the stomach and duodenum, taken up by the liver, and secreted by the liver into the systemic circulation bound to ceruloplasmin ATP7B transports copper through the trans-Golgi network in hepatocytes before it is incorporated into apoceruloplasmin which is secreted as holoceruloplasmin.

ATP7B is also essential for biliary excretion of copper when cytoplasmic levels are high. Dysfunction of ATP7B therefore leads to accumulation of copper in the liver giving rise to cellular damage and disease, and the release of nonceruloplasmin bound copper into the systemic circulation. Copper also accumulates and is associated with cellular damage and disease in other organs mostly in the brain Typical presentation of WD is in adolescence to early adulthood, but it may occur at any age . Clinical presentation can vary widely in terms of type and severity, but the key features are various degrees of liver disease,

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 1-18 years
* fulfill the criteria for diagnosis of Wilson's disease according to Wilson's score

Exclusion Criteria:

1. persistent neonatal jaundice.
2. Patients presented with Acute and chronic liver disease rather than Wilson's e.g

   1. Autoimmune hepatitis
   2. Hepatitis C virus ,
   3. Hepatitis B virus infection ,(d)Hepatic focal lesions and(e) Metabolic liver disease e.g Gauchier ,glycogen storage disease and Niemman pick .
Effect of Follicle Flushing on Oocyte Fertilization Rate

The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment

This will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing IVF treatment.

Oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from:

Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Group II= egg retrieved in the 1st-2nd flush Group III= egg retrieved in the 3rd-5th flush

development and utilization. Pregnancy rates will be reported as a surrogate outcome.

Eligibility Criteria:
Inclusion Criteria:

* Up to 40 years old
* Both ovaries present
* Triggering final oocyte maturation using hCG or GnRH agonist

Exclusion Criteria:

* Egg donation
* PGD cases
The Psychology of Physical Activity

This study plans to learn more about psychosocial factors that contribute to adopting physical activity. The goal of this study is to improve upon existing theories of behavior change in order to help other people become more physically active.

The purpose of this study is to examine the relationship between personal life meaning and purpose and physical activity maintenance in a group of previously sedentary adults starting new exercise programs. Participants complete questionnaires at baseline, 4 weeks, and 12 weeks after starting an exercise program. Participants are randomly assigned to complete questionnaires about daily meaning, mood, and activity for the first 4 weeks or to complete 8 random questionnaires about daily activities over the first 4 weeks. It is hypothesized that personal life meaning and purpose will be related to greater exercise participation at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 30-89 years old
* Joining or already a member of the Anschutz Health and Wellness Fitness Center
* Able to read and understand English
* Sedentary (\< 60 minutes of moderate-vigorous physical activity a week) for the past 3 months
* Planning to start a new exercise program

Exclusion Criteria:

* Physical contraindications to participate in physical activity (as defined as a positive PAR-Q score)
* Existing diagnosis of cardiovascular disease
* Currently pregnant
Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions

The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to determine whether intracoronary transfer of bone marrow cells will augment left ventricular function recovery of the heart.

Despite early coronary reperfusion, salvage of ischemic myocardium is incomplete and loss of viable myocardium initiates a process of adverse left ventricular (LV) remodeling1, compromising clinical outcome.

Experimental data have suggested that autologous bone marrow-derived or circulating progenitor cells may be beneficial for LV function recovery, but underlying mechanisms are unclear and prominent cardiomyocyte transdifferentiation has only been reported under selected experimental conditions. Early non-randomized clinical investigations indicate feasibility, safety and enhanced functional recovery after autologous human bone marrow-derived stem cell (BMSC) infusion into the infarct-related artery. More recently, a randomized open study demonstrated improvement of LV systolic function but not of LV remodeling following BMSC transfer.

In the absence of trials, in which the control group reproduces the exact conditions of the cell transfer group, including bone marrow aspiration and a placebo intracoronary injection, the true benefit of cell transfer cannot be fully appreciated.

We, therefore, designed a randomized, double-blind, and placebo-controlled exploratory study to investigate the effect of autologous BMSC transfer on LV functional and structural recovery after myocardial infarction. In view of the exploratory nature of the study and to detect potential mechanisms for the biological effect, we also assessed myocardial perfusion and oxidative metabolism using serial 1-\[11C\]acetate positron emission tomography (PET).

Eligibility Criteria:
Inclusion Criteria:

* patients with acute myocardial infarction with cumulative ST-segment elevation \>=6mm, successful epicardial reperfusion after PCI and significant LV dysfunction

Exclusion Criteria:

* patients presenting within 2 hours of symptom onset (no dilution of any treatment effect from aborted infarctions)
* patients with prior coronary artery bypass grafting, pulmonary edema, cardiogenic shock or significant co-morbidities