cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Versus Palpation for Epidural Catheterization

The study will assess the benefit of using spinal ultrasound before epidural catheter insertion compared to the conventional palpation technique in women undergoing cesarean section.

The study will compare the ultrasound-assisted and the conventional palpation techniques for epidural catheterization as a component of combined spinal-epidural anesthesia for cesarean section.

Participants will be randomly assigned into 2 equal groups. In the ultrasound group: Preprocedure lumbar spinal ultrasound will be performed before epidural catheterization. In the palpation group: Conventional technique of landmark palpation will be used.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I or II.
* Full term parturients scheduled for elective cesarean delivery under combined spinal-epidural anesthesia.

Exclusion Criteria:

* Body mass index ≥ 35 kg/m2.
* Patients having any contraindication to neuraxial anesthesia (Refusal of the procedure, Coagulopathy, Uncorrected hypovolemia, Increased intracranial pressure, Local skin infection).
* Marked spinal deformity or previous spinal surgery.
* Unpalpable anatomical landmarks.
* Emergent situations.
Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients

Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
2. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of guselkumab
The Effect of Two Different Modes of Anaesthesia Mainantance on Postoperative Delirium

In this study, the cognitive status of the patients in the preoperative period was taken into consideration and the development of delirium after the surgery was investigated. There is no harm to the patient.

The patients were preoperatively assessed for American Society of Anesthesiologists (ASA) risk by an anesthetist and age, sex and comorbidities were recorded. The Mini-cog test was applied as a cognitive screening test by the anesthesiologist in the preoperative period and the test score was recorded. Three-word memory test, clock drawing, and visual function test was performed to evaluate the patient's cognitive functions. In this test, patients were asked to memorize three words such as umbrella, sunshine, and chair at the beginning of the test.

Eligibility Criteria:
Inclusion Criteria:

* There was a correlation between the incidence of delirium after the age of 60(10).

Exclusion Criteria:

* Patients' age\&lt; 60 years,
* Patients undergoing emergency cholecystectomy or did not have preoperative Mini-Cog assessment,
* With a history of cerebrovaskuler insult that was thought to have an effect on postoperative delirium ,
* Patients with difficulty in cooperation ,
* Patients with hemodynamic instability(arterial blood pressure above 160/90 mmHg and below 90/60 mmHg and patients with pulse rate below 50/min and above 100/min) ,
* Patients with previously diagnosed dementia, and those who had surgical procedures lasting more than 2 hours were excluded from the study.
Smartphone-Based Use of Phonocardiography Technique for Estimating Heart Rate and Heart Rate Variability: Performance Study

This study aims to investigate the use of heart sound recordings, or phonocardiograms, recorded with smartphones' built-in microphones and accessory microphones to estimate heart rate (HR) and heart rate variability (HRV). HR refers to the number of heart beats per minute, while HRV refers to the variation in the intervals between heart beats.

Participants will have their heart sounds (phonocardiograms) recorded before and after exercise, and electrocardiogram (ECG) and photoplethysmogram (PPG) data recorded before, during, and after exercise to induce a wide range of HR.

Researchers will match the phonocardiograms, ECG, and PPG data to create a database for use in future training and testing of algorithms (including artificial intelligence (AI)).


Eligibility Criteria:
Inclusion Criteria:

* With no tattoos on their body where a smartwatch will be placed

Exclusion Criteria:

* Not ready to undertake physical activity as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) derived from the Canadian Society for Exercise Physiology
* Implanted active medical devices in the torso, such as pacemakers and defibrillators
* Failure to collect baseline heart sound time series from ECG or both smartphone and auscultation pin before exercise
Impact of Misoprostol on Blood Loss In Myomectomy Operations

The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.

A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.

The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal patients aged between 35 to 50 years old.
* Five or less symptomatic uterine myomas .
* Maximum diameter of the largest myoma is 6 cm .
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* History of previous surgery.
* Allergy to Misoprostol.
* Hypertension.
* Cardiac and Pulmonary diseases.
* Patients who have bleeding disorders.
* Anemia (Hb \< 10g %).
* Chronic endocrine or metabolic diseases such as Diabetes.
* Obesity (body mass index \> 30 kg/m2).
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Healing Efficacy of Isobutyl Cyanoacrylate High Viscous Solution in Treatment of Traumatic Ulcer in Children

30 children with traumatic oral ulcer that will be divided into equal three groups. Group A (Isobutyl cyanoacrylate) includes children will be treated with isobutyl cyanoacrylate high viscous solution only once during the treatment episode, group B (control positive) includes children will be treated chlorohexidine gel (0.2%) twice daily and group C (control negative) includes children will be treated with normal saline five times per day. Clinical follow up will be done by assessment of pain perception, photographs of the ulcer will be recorded by using digital camera and measurement of ulcer size in the 1st ,5th and 9th days after treatment

Thirty children will be randomly and equally allocated into three groups, by throwing a dice (1\&4 for group A, 2\&5 for group B and 3\&6 for group C). 10 for each group as follows: -

* Group A (Isobutyl cyanoacrylate): 10 children will be treated with isobutyl cyanoacrylate high viscous solution will be applied on the ulcer site.
* Group B (control positive): 10 children will be treated with chlorhexidine (0.2%) gel twice daily for 9 days.
* Group C (control negative): 10 children will be treated with normal saline will be applied on the ulcer site 5 times per day.

  * Children will be examined before treatment to assess pain by using Children's International Mucositis Evaluation Scale (ChIMES) and measure ulcer size by periodontal probe. Then apply different treatments of each group
  * All patients in both groups will be instructed to avoid eating or drinking for at least half an hour after oral administration of the oral gel.
  * All patients can be given oral analgesics (paracetamol) if needed to decrease pain severity.
  * The size of the ulcers, change in pain severity will be assessed on the 1st, 5th and 9th days after using isobutyl cyanoacrylate high viscous solution and chlorhexidine (0.2%) gel.

Assessment of pain will be performed using Children's International Mucositis Evaluation Scale (ChIMES) will be used for pain assessment

1. Photographs of the ulcers will be recorded with a digital camera at 1st, 5th and 9th days.
2. Measurement of ulcer size by using a periodontal probe

Eligibility Criteria:
Inclusion Criteria:

Apparently healthy cooperative children free from any systemic diseases that may predispose oral ulceration.

Development of pain/ulceration in the oral mucosa, surrounded by light red areola less than 1 cm. diameter.

Child with good oral hygiene. Parents willing to participate in the study and have a good likelihood of recall availability

Exclusion Criteria:

Taking of drugs that may influence the pattern of oral ulceration Oral ulcerations with unknown etiology that are not traumatic in nature. Allergic or who have suffered adverse reactions to isobutyl cyanoacrylate gel or chlorhexidine gel
HD-tDCS as a Treatment for Chronic Tinnitus

Transcranial Direct Current Stimulation (tDCS) aims to induce cortical plasticity by modulating the activity of brain structures. The broad stimulation pattern, which is one of the main limitations of tDCS, can be overcome with the recently developed technique called High-Definition tDCS (HD-TDCS). The objective of the current study is to investigate the effect of HD-tDCS on tinnitus in a large patient cohort.


Eligibility Criteria:
Inclusion Criteria:

* chronic, subjective, non-pulsatile tinnitus
* met the criteria for HD-tDCS safety

Exclusion Criteria:

* a middle ear pathology
* another tinnitus treatment ongoing
Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

This study had two parts, a Core Part and an Extension Part. The Core Part of the study was a randomized, multicenter, double-blind, placebo-controlled parallel-group study in patients with secondary progressive multiple sclerosis (SPMS). Eligible patients were randomized (2:1) to receive either siponimod or placebo. The duration of the Core Part of the study was variable for each patient, given that this was an event-driven study and terminated when a pre-defined number of confirmed disability progression (CDP) events had occurred irrespective of duration of individual patient participation. Patients who had 6-month CDP during the Treatment Epoch of the Core Part were provided with options that included starting treatment with open label siponimod as rescue medication.

Patients who were eligible to enter the Extension Part received open label siponimod.

Eligibility Criteria:
Inclusion Criteria:

* Prior history of relapsing remitting MS
* SPMS defined as progressive increase of disability over at least 6 months
* EDSS score of 3.0 to 6.5
* No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

* Women of child bearing potential must use reliable forms of contraception.
* Diagnosis of Macular edema during screening period
* Any medically unstable condition determined by investigator.
* Unable to undergo MRI scans
* Hypersensitivity to any study drugs or drugs of similar class
RRx-001 in Second Line Treatment of Advanced Cholangiocarcinoma Prior to Readministration of First-Line Therapy

The purpose of this study is to see if the investigational drug, RRx-001, an epigenetic agent, which turns on a number of beneficial genes that the tumor has silenced, can resensitize the tumor(s), in other words make it/them re-respond to gemcitabine and cisplatin, which, hopefully, will translate to a longer lifespan. The name of the open-label study, which means that patients will know what treatments they are receiving, is EPIC, a hybrid or combination of EPIgenetic for the mechanism of action of RRx-001 and Cholangiocarcinoma.

The study treatment is divided into two stages. During the first stage, patients will receive RRx-001, which is administered intravenously weekly, for a fixed time period of six weeks. At that time the second stage starts in which cisplatin and gemcitabine are reintroduced for as long as the tumors respond to them to determine whether resensitization has occurred.

The primary objective of this clinical trial is to evaluate the progression-free survival (PFS) of patients at 9 weeks after the reintroduction of gemcitabine and cisplatin.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/cholangiocarcinoma
* Must have locally advanced or distant metastatic disease that is not surgically curable
* Failed first-line chemotherapy
* Age ≥ 18 years
* Life expectancy of at least 12 weeks (3 months)
* Performance status 0 or 1
* Adequate liver, kidney, and bone marrow function

Exclusion Criteria:

* Symptomatic metastatic brain or meningeal tumors
* Investigational compound within 4 weeks of enrollment
* History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
* Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation
* Pregnant or nursing
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
* Albumin \<2.8
* Uncontrolled or clinically relevant ascites
* Absolute contraindication for MRI imaging such as intracorporeal metal or pacemaker
A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP

A phase 2 study to assess tolerability, safety, pharmacokinetics and effect of AZP2006 at different doses versus placebo on cerebrospinal fluid biomarkers in 36 patients with progressive supranuclear palsy. The patient study duration is 29 weeks including a washout period.

This is a randomized, double blind, placebo controlled, parallel group study comparing 2 doses of AZP2006 (60 mg Once daily \[QD\] during the 12-week treatment period or 80 mg for 10 days followed by 50 mg QD) with placebo in 36 men and women aged ≥40 years and ≤80 years and diagnosed with probable or possible PSP according to Movement Disorder Society PSP (MDS-PSP) criteria.

Patients were assessed for eligibility at baseline. Eligible patients were randomized on

Day -1 in a 1:1:1 ratio into one of the following 3 study intervention groups based on a randomization scheme with blocks stratified by center using an interactive web response system (IWRS):

1. 60 mg AZP2006/day during the 12-week treatment period;
2. 80 mg AZP2006/day for 10 days followed by 50 mg AZP2006/day;
3. Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with probable or possible PSP
* Patients must be stable with their medication for at least 30 days prior to the inclusion visit.

Exclusion Criteria:

* Any history of clinically significant head trauma or cerebrovascular disease or recent history of substance abuse or alcohol abuse and deemed to be clinically significant by the Investigator.
* History of deep brain stimulator (DBS) surgery other than sham surgery for DBS clinical study.
Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients

Coronary artery disease is the first cause of death related to atherothrombosis.

Coronary artery disease is the first cause of death related to atherothrombosis. There is a close correlation between the extension of coronary artery disease and the severity of atherosclerotic lesions in extra coronary arterial beds. In addition, these symptomatic extracoronary lesions dramatically decrease the survival of these patients. However, scant data are available regarding the prevalence of extracoronary asymptomatic lesions. Conversely, the annual absolute risk of these lesions remains unknown. Consequently, whether a systematic identification of these extracoronary asymptomatic lesions is relevant remains to be established. The Primary Objective and Primary Endpoint of the AMERICA study is to demonstrate the superiority of an active detection and management of the extension of atherothrombosis in high Risk coronary patients (active strategy) in comparison with standard of care for coronary atherosclerosis (conservative strategy).

Eligibility Criteria:
Inclusion criteria:

1. Three vessel disease recently identified recently (\<6 month)
2. Accrue coronary syndromes in patients\>75 years old (\<1 month)

Exclusion criteria:

1. Absence of significant coronary lesions
2. Other causes of rise in the troponin level
3. Patient\<18 years old
4. Pregnant women
5. Patient without affiliation to National Social Security
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

A randomized, double-blind, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naïve, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject has never received antiviral treatment for hepatitis C infection
* No evidence of liver cirrhosis

Exclusion Criteria:

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Abnormal laboratory tests
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
* Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
* Adequate organ function defined by blood test.

Exclusion Criteria:

* History of another primary cancer in the last 3 years.
* Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
* History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.