cyrilzakka/clinical-trials huggingface dataset:
Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia

Labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta.

In the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve roots.

In this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II parturients
* Pregnant patients in active labor
* active labor with cervical dilation \< 5cm
* 37-42 weeks of gestational age
* Pregnant women between the ages of 18 and 45

Exclusion Criteria:

* Patients who do not want to participate voluntarily in the study
* Pregnant women outside the age range of 18 - 45
* Pregnants other than Nullipar
* Patients with allergic reactions to anesthesia and analgesia drugs to be used
* Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
* Gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.)
* Substance abuse history
* Chronic pain history
* Psychiatric problems and communication difficulties
* BMI\> 35 kg / m2
* Failure in neuraxial interventions
Fycompa in Catamenial Epilepsy

The purpose of the proposed investigation is to carry out a pilot study of add-on perampanel (Fycompa) in women with perimenstural (C1) catamenial epilepsy. Perampanel, a noncompetitive AMPA receptor antagonist, is uniquely positioned to decrease progesterone receptor mediated excitotoxicity. This mechanism of action would allow a novel use of perampanel as an effective treatment of C1 catamenial epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosis of focal onset seizures (FOS) i. Established by clinical history and an EEG ii. Patients with a normal EEG may be included if they met other diagnostic criteria based on clinical history
* Presumably ovulatory women based on menstrual cycles of 21-35 days from beginning of menstrual flow to the beginning of the next menses
* ≥18-50 years old
* ≥2 unprovoked seizures per month despite drug trials with ≥1 first-line anti-epileptic drugs (AED)
* Seizures must show a C1 catamenial pattern in 2 of 3 documented cycles i. C1 pattern will be defined as a two-fold increase in average daily seizure frequency during the menstrual phase, as compared to the follicular and luteal phases of the ovulation cycle, in 2 of 3 documented cycles. The menstrual phase will be defined as days -3 to +3 of the menstrual cycle (where onset of menstruation is defined as day 1) (Herzog et al, 1997). Of note, in the NIH Progesterone Trial, the level of catameniality was 1.69 based on Herzog et al. (1997) criteria though this trial will use a level of 2 to include women only with high levels of perimenstrual catamenial exacerbation.
* Willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria:

* Progressive neurologic or systemic disorder
* Use of systemic hormonal contraception during 3 months prior to enrollment (however, subjects with a progestin-releasing IUD who still have monthly periods may be enrolled)

  a. Women on system hormonal contraception will be excluded as these women are not ovulatory
* Subject is pregnant or breastfeeding
* Active suicidal or homicidal ideation
* Comatose individuals.
Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

We are testing to see if Galantamine, a learning enhancing medication, will help methadone maintained cocaine abusers with their learning and memory specific to CBT using an innovative CBT computer program.

We are proposing a randomized double blind clinical trial of galantamine and our innovative computer-assisted version of CBT, alone and in combination, to improve treatment outcome and cognitive functioning among cocaine users. The proposed study will be the first to evaluate a cognitive enhancing medication as a means of enhancing the effects of an extremely promising empirically validated behavioral therapy for addiction, and hence bridge cognitive neuroscience and behavioral therapies development.

The aim is to conduct a 12 week randomized placebo controlled trial, using a 2x2 factorial model, that will evaluate the efficacy of adding computer assisted training in CBT ("CBT4CBT") and galantamine to standard treatment for 160 cocaine abusing or dependent methadone-maintained individuals. Participants will be randomized to (1) standard treatment (TAU) plus placebo, (2) TAU plus galantamine, (3) TAU plus CBT4CBT plus placebo, or (4) TAU plus CBT4CBT plus galantamine.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages of 18 and 50
* Enrolled in RNP methadone program and stable on methadone for at least 3 weeks
* Current cocaine abuse or dependence according to DSM-IV criteria
* No current medical problems and normal ECG
* If female, not currently pregnant or breast feeding and using reliable birth control
* Fluent in English and have at least a 6th grade reading level
* Can commit to 12 weeks of treatment and are willing to be randomized

Exclusion Criteria:

* Current major psychiatric illness including mood, psychotic or anxiety disorder
* History of major medical illnesses including asthma, chronic obstructive lung disease, gastrointestinal ulcer, hepatic or renal impairment, cardiac rhythm disturbances
* Use of medications including beta blockers and NASAIDs
* Known allergy to Galantamine
Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel

African Americans with coronary artery disease who have been prescribed clopidogrel (also known as Plavix), an antiplatelet drug will be enrolled. The purpose of this study is to help identify why African Americans are at an increased risk of having a major heart attack or stroke after a common procedure to open up blocked arteries with stents. The knowledge to be gained from this study includes:

1. A better understanding of the metabolism of the antiplatelet drug, clopidogrel, and abnormal platelet function in African Americans; this understanding may provide a basis for potential future therapy
2. A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Sex: Male and Female
3. Race: Self-identified as African American
4. History of percutaneous coronary intervention in the past 12 months
5. Currently taking aspirin and clopidogrel for at least one month and up to one year
6. English speaking

Exclusion Criteria:

1. Use of nonsteroidal anti-inflammatory drugs
2. Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test
Predictive Value of PRECISE DAPT Score in STEMI Patients After Primary PCI

To investigate the predictive value of PRECISE DAPT score in relation to coronary slow flow \& other short term major adverse cardiovascular events (MACE) post PPCI .

Coronary artery disease (CAD) is the leading cause of death around the world and more than 4 million people die every year due to CAD in Europe.\[1\] The incidence of ST elevation myocardial infarction (STEMI) appears to be declining; however, it is still an important issue in cardiovascular medicine.\[2\] Initial risk assessment is important for STEMI to estimate adverse cardiovascular outcomes. Previous studies demonstrated that increased age, advanced Killip class, heart rate, arterial hypotension, increased serum creatinine, white blood cell counts, and hemoglobin levels were predictors of in-hospital and early mortality in patients with STEMI treated with primary percutaneous coronary intervention (PPCI).\[3,4 \]Therefore, risk scores including the aforementioned parameters were developed to estimate mortality in patients with STEMI.

No-reflow is still a challenging major issue in the management of the patients with STEMI undergoing primary PCI. It is defined as inadequate myocardial perfusionthrough a given segment of the coronary circulation without angiographic evidence of mechanical vessel obstructionas \[5\] Angiographic no-reflow defined as less than Thrombolysis In Myocardial Infarction (TIMI) 3 flow \[6\] and angiographic success was defined as TIMI Grade 3 Flow .

PRECISE-DAPT score includes age, creatinine clearance, white blood cell counts, hemoglobin levels, and prior spontaneous bleeding \[7\]. All these factors have a close relationship with coronary artery disease (CAD) and complications \[8-10\]. Therefore, in this study, we aimed to evaluate the association of admission PRECISE-DAPT score with the development of slow flow \& bleeding \& othershort term cardiovascular complications that develop in patients with STEMI treated with primary PCI.

Eligibility Criteria:
Inclusion Criteria:1.Subjects diagnosed as STEMI accordind to fourth universal definition with age range from 18 to 75 years underwent PPCI at cardiology hospital assiut university hospital.\[11\].

2..Patients elegable for PPCI with STEMI within 12 h of symptom onset, provided it can be performed expeditiously (i.e. 120 min from STEMI diagnosis)\[12\]

-

Exclusion Criteria:1-late presentation with STEMI more than 12 hr \& door to ballon more than 120 min including rescue PCI .

2- cardiogenic shock 3-Patients known to have autoimmune disease (e.g vasculitis ) 4- platelate count less than 100000 IU . 5- prothrombin concentration less than 60% 6- Patients taking triple anti thrombotics .

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Cetuximab + Gemox in Biliary Tract Cancer

The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.

Primary Objective(s) The primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) as first line treatment in patients with advanced or metastatic biliary tract cancer.

Secondary Objectives

The secondary objectives of this study are as follows:

* toxicity
* secondary resection rate
* progression-free survival (PFS)
* overall survival (OS)

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)
* age ≥ 18 years
* ECOG performance status ≤ 2
* bidimensionally measurable disease per RECIST criteria
* no prior chemotherapy or targeted therapy for advanced disease
* adequate bone marrow reserve (neutrophil count \> 1500 /µL, platelet count \> 100,000 /µL)
* adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
* adequate hepatic function (serum bilirubin \<2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
* written informed consent

Exclusion Criteria:

* prior palliative treatment
* resectable disease
* brain metastases
* serious or uncontrolled concurrent medical illness
* pregnancy or nursing
* history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
* peripheral neuropathy (grade \> 1)
Effect OF Nitrous Oxide On Acute Pain and Opioid Consumption, and Chronic Pain After Hysterectomy

The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups.

The study is prospective and double blind. In the clinic, patients undergoing hysterectomy that meet the criteria for inclusion into the study and agreed to participate in the study will be randomized into two groups. In the first group of patients will receive Nitrous Oxide and In the second group of patients will receive oxygen during the general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old at time of the first procedure
* Female
* American Society of Anesthesiologists physical status I or II
* Hysterectomy undergoing the general anesthesia

Exclusion Criteria:

* Neuropathic disease
* Chronic opioid users
* Contraindication for Nitrous Oxide receive
* Consent will not be obtained patient
* Psychiatric disorders
* Current or recent drug abuse (within past 6 months).
Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and prompt implementation of the etiological treatment. The bacterial infections are the most common and are associated with high morbidity and mortality. Diagnosis is based on the detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis, gram + and gram - are circulating and often present in small amounts; they can be detected by sensitive and specific tools following a pretreatment of the blood sample (innovative technology Bacti-DIAG).

The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams) in the patient's care including diagnosis and treatment.

All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS) sepsis suspects will be included: in addition to the samples taken for routine care of the patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas under the ROC curves for the detection of gram + and gram will be calculated and associated detection limits will be determined to meet the objectives of the study.

It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and analyze biometric and biological data based on the subsequent evolution of the patients. The care of patients will be blinded to the results of the new biomarker Bacti-DIAG


Eligibility Criteria:
Inclusion Criteria:

* Age\> = 18 years
* Patient hospitalized in ICU with a diagnosis of SIRS:
* Temperatures above 38 ° C or below 36 ° C

At least one other criterion from:

* Heart rate\> 90 bpm
* Respiratory rate above 20 breaths / min or PaCO2 \<32 mmHg
* Leukocytosis greater than or less than 4000/mm3 12000/m3

  * Patient admitted in intensive care for less than 12 hours
  * Patient does not preclude its participation in the study.

Exclusion Criteria:

* No affiliation to a social security scheme (beneficiary or assignee)
A Study to Evaluate Virtual Reality As Adjunct to Anesthesia During Orthopedic Surgery

The purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (VR ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. This will serve as a preliminary study for future trials to compare outcomes between VR and standard of care vs standard of care only.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty).
* Subject willing to participate and able to provide informed consent.

Exclusion Criteria:

* Age \< 18 years old.
* History of motion sickness or blindness.
* Unable to consent due to cognitive difficulty.
* Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software.

Sensitivity to flashing light or motion.

* Recent stroke.
* Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).
Frequency and Predictors of Recurrent SBP in Cirrhotic Patients in Al Rajhi University Hospital

* Assess the frequency of recurrent SBP in ascitic cirrhotic patients.
* Determine the predictive factors of recurrence after the first episode of SBP in ascitic cirrhotic patients

Spontaneous bacterial peritonitis (SBP) is a common complication in cirrhotic patients. The prevalence of SBP in hospitalized patients and the mortality rate were reported to be 10%-30% and 30%-50%, respectively.

SBP has been considered a life-threatening infection that requires a prompt diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Any cirrhotic patient above the age of 18 years old of both sexes, having a first episode of SBP will be included in our study.

  1. The diagnosis of cirrhosis was based on clinical manifestation (ascites, splenomegaly, lower limb edema and/or esophageal varices by upper gastrointestinal endoscopy), laboratory findings and radiological (abdominal ultrasonography), or liver histology.
  2. The diagnosis of SBP was based on a neutrophil cell count of 250 cell or more per mm3 with or without culture positivity of ascitic fluid, in the absence of hemorrhagic ascites and secondary peritonitis.

Exclusion Criteria:

* Any patient with one or more of the following criteria will be excluded:

  1. Patients with bacterial ascites defined by a positive culture of ascitic fluid associated with a neutrophil cell count less than 250 cell per mm3 in the ascitic fluid.
  2. Patients presenting with empyema or bacterial peritonitis secondary to an intra-abdominal organ perforation or surgical operation
Coagulopathy and SIRS During ECC in Intensive Care

This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and circulatory support devices under intensive care conditions.

The complex interplay between the various factors contributing to the ECC-related coagulopathy and inflammation in intensive care settings is only poorly understood so far. Furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which anticoagulants may be employed to decrease complications associated with specific ECC systems. Therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy varies between different ECC systems and intensive care units.

A better understanding of the mechanisms of the activation and interaction of platelets and leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight starting-points to increase the safety and efficacy of ECC in intensive care medicine. The investigation of these phenomena in different ECC systems under clinical conditions is therefore the goal of this study.

In order to achieve the study goal, we will investigate cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different ECC systems under intensive care conditions.

Eligibility Criteria:
Inclusion Criteria:

Need for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases

Exclusion Criteria:

1. History of previously diagnosed hereditary coagulation and/or platelet disorders
2. Refusal to receive blood transfusion
3. Participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization
4. Diagnosis of hepatitis B, hepatitis C, and HIV
5. Age \> 85 years
Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Type 1 Diabetes Mellitus

We hypothesize that ingested human recombinant interferon-alpha (hrIFN-a) will prolong the "honeymoon" period and enhance B cell survival in type 1 diabetes in a phase II randomized, placebo-controlled, double-blind clinical trial. We have demonstrated that ingested IFN-a prevents type 1 diabetes in the NOD mouse, prolongs the "honeymoon" period in newly diagnosed type 1 diabetics, and delays murine islet allograft rejection. The natural history of type 1 diabetes is unique for a phase frequently referred as the "honeymoon," a period in which the insulin need becomes minimal and glycemic control improves. The B cell (the insulin producing cell) partially recovers. However, as with all honeymoons, they end and the patient becomes completely insulin-deficient. The general consensus of the international diabetes community is to test potential preventive therapies for type 1 diabetes in newly diagnosed patients. Prolongation of the honeymoon as the reversal of the disease is considered a positive result.

In this phase II randomized, double-blind, parallel-design clinical trial we will determine whether ingested (oral) human recombinant IFN-a will prolong the "honeymoon" period and increase counterregulatory anti-inflammatory cytokine(s).

We will determine the safety and efficacy of 30,000 units ingested hrIFN-a vs placebo in eighty patients with newly diagnosed type 1 diabetes in a phase II trial for one year. Primary outcome measures will be a 30% increase in C-peptide levels released after Sustacal stimulation at 3, 6, 9, and 12 months after entry. Secondary outcome will be decreasing titers of islet cell antibodies (ICA). If successful, a larger and longer phase III trial of prevention of type 1 diabetes in high risk patients will be undertaken. We will also determine if ingested hrIFN-a increases IL-4, IL-10 or IFN-a production in peripheral blood mononuclear cells (PMNC) from patients with recent onset type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 1 diabetes (within one month of diagnosis).
* IDDM patients: Prepubescent, adolescent, or early adult patients.

Exclusion Criteria:

* Patients below the age of 3 or over 25.
* Patients will not be eligible if they are on immunosuppressive or immunostimulatory medications such as azathioprine, oral nicotinamide, superoxide dismutase-desferroxamine, vitamin E, aminoguanidine, oral insulin or other experimental therapies at any time.
* Patients with a history of alcoholism, renal, cardiac, or pulmonary disease or in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol, or participation in the treatment and evaluation program
* Patients who are pregnant or nursing, or those who are not willing to practice an acceptable birth control method
* Patients with abnormal pre-treatment values on WBC or who are receiving potentially hepatotoxic medications