cyrilzakka/clinical-trials huggingface dataset:
On-pump Versus Off-pump Coronary Artery Bypass Grafting , Short Term Outcomes , Sohag Experience

Coronary artery disease (CAD) and its sequlae, such as myocardial infarction, arrhythmia and heart failure, are among the leading causes of death around the world . the durable role of coronary artery bypass grafting (CABG) in the treatment of CAD has long been shown.

Coronary artery bypass grafting (CABG) is a commonly performed surgical procedure for patients with coronary artery disease (CAD), CABG can be performed using either the on-pump or off-pump technique, each with its own advantages and limitations.

On-pump CABG involves the use of CPB which as agold standard for surgical coronary revascularization has led toexcellent results in mortality and complications. On-pump CABG allows the surgeon to temporarily stop the heart and provide perfusion and oxygenation to the body. This technique provides a bloodless and motionless operative field, allowing for precise graft anastomosis. However, the use of CPB is associated with deleterious effects as systemic inflammatory response, hemodilution, and organ dysfunction as dysrhythmia and neurocognitive problems. These factors may adversely affect patients lives specially those with impaired EF, who already have compromised cardiovascular function.

Another technique for CABG is on-pump beating heart CABG (ONBH-CABG) surgery that is relatively novel hybrid approach to coronary artery grafting which aims to stabilize hemodynamic parameters during the operative period. This has specific benefits such as reduced preload alongside the afterload which decreases the oxygen demand of the myocardial tissue


Eligibility Criteria:
Inclusion Criteria:

* fair and impaired EF

Exclusion Criteria:

* malignancy
* COPD
* renal failure on dialysis
Retrieval Practice for Word Learning for Deaf and Hard of Hearing Children

This study is designed to advance the promising yet underutilized research on retrieval practice by evaluating the effectiveness and efficiency of two key retrieval practice features (feedback and spacing). The study uses four single case adapted alternating treatments studies, each with four 5- to 8-year-old children who are deaf and hard of hearing to evaluate the effects of feedback and spacing on the efficiency of word learning and retention.

The proposed research addresses a long-standing and important challenge of improving language skills of children who are deaf and hard of hearing, a historically under researched group. The study aims to leverage retrieval practice - an empirically validated intervention approach - for improving how efficiently children who are deaf and hard of hearing learn and retain new words. To advance the promising yet underutilized research on retrieval practice, the study completes the next logical step of evaluating the effectiveness and efficiency of two key retrieval practice features: feedback and spacing. Feedback is predicted to result in more efficient learning because it focuses attention on unmastered material, prevents the illusion of success, and reduces repeated errors. Spacing trials are predicted to result in more efficient learning than massed trials because they require more effort with fewer cues provided. The study will accomplish these aims through four single case adapted alternating treatments design studies with sixteen 5- to 8- year-old children who are deaf and hard of hearing. Study innovations include the critical evaluation of retention and use of a multi-session intervention context. The knowledge gained will guide language intervention for children who are deaf and hard of hearing.

Eligibility Criteria:
Inclusion Criteria:

* At least minimal prelingual hearing loss
* Standard scores of at least 70 for receptive and expressive vocabulary skills
* English is only spoken language

Exclusion Criteria:

* Below average nonverbal cognition
* Uncorrected vision impairment
* Evidence of severe motor impairment
Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic or unresectable pancreatic cancer
* No prior chemotherapy except radiation-sensitizing doses of 5-FU
* No radiotherapy less than 4 weeks prior to the start of the study

Exclusion Criteria:

* Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
* Moderate to severe renal impairment
* Uncontrolled diabetes
* Inability to swallow tablets
Exploring Stress and Coping Behaviors of the Major Carer Whose Children With Prader-Willi Syndrome

Ask the 4 carers of children with Prader-willi syndrome to disclose their experiences and difficulties for searching better management and intervention


Eligibility Criteria:
Inclusion Criteria:

* a person who care and live with children with Prader-Willi syndrome

Exclusion Criteria:

* siblings or less-contact family
* teachers
The Longitudinal Impact of SES and the CNDS on Recovery From SUD

The goal of this study is to provide a scientific understanding of the impact of socioeconomic status (SES) on the recovery trajectory (psychosocial functioning, relapse/remission status, and neurocognitive mechanisms).

The study will characterize the effect of SES (subjective and objective indicators) on long-term trajectories of recovery and neurocognitive functioning. By using an accelerated longitudinal design, the investigators will examine the association between baseline SES, changes in CNDS, and changes in psychosocial functioning (e.g., quality of life) and relapse. Moreover, the investigators will use computational modeling to capture underlying changes in components of CNDS functioning related to SES and SUD recovery.

Eligibility Criteria:
Inclusion Criteria:

1. be ≥18 yrs old
2. meet lifetime DSM-5 SUD criteria
3. have a Recovery Initiation Date less than 3 years prior to the time of enrollment
4. be able to read independently
5. be free of legal problems that could limit participation
6. reside in the U.S.
7. anticipate continued Internet access (to ensure ongoing contact and data collection)
8. be a registrant of the International Quit and Recovery Registry (IQRR)

Exclusion Criteria:

1. Minors will not be included
2. Prisoners will not be included. If participants become incarcerated during this study, they will not be contacted to complete assessments during their incarceration. If the incarceration ends during the study, they may be contacted to participate in assessments.
3. Adults who are not capable of consenting on their own behalf
Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients

To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.

Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Participants who can give written informed consent and willing to comply with all study-related procedures.
* Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass

Exclusion Criteria:

* Patients undergoing duodenal switch procedures
* Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery
* Patients with chronic opioid use
The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control

The purpose of this study is to determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).

Magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. It has been determined that patients with cardiovascular disease have intracellular magnesium (Mgi) deficiencies. Among the ICD registries in Europe and the United States 64% and 77% of patients also carry the diagnosis of CAD, respectively. Patients with CAD have risk factors that lead to the development and or propagation of atherosclerosis. Paramount among these risk factors are hypertension, dyslipidemia, and diabetes.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* Newly implanted ICD or recent ICD shock (within 6 months)

Exclusion Criteria:

* Inability to swallow
* A non-cardiac disease with a survival prognosis of less than 12 months
* Hypermagnesemia
* Creatinine clearance less than 30mL/min
* Lactic acidosis or systemic acidosis syndrome
* Previous intolerance to magnesium L-lactate
Stepped Care for Posttraumatic Stress Disorder Study

Posttraumatic stress disorder (PTSD) prevalence can be as high as 50% in low income and racially diverse primary care clinics, wherein only 13% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable, less burdensome to systems of care, and highly acceptable to diverse patients and care settings. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).

This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. All participants enrolled will receive access to webSTAIR at baseline ("initial treatment").

Nonresponders at 4 weeks are randomized to either continue webSTAIR or webSTAIR plus community health worker coaching ("stage 1 treatments").

Nonresponders at 8 weeks are re-randomized to clinician-administered treatments, either Brief STAIR or WET ("stage 2 treatments").

Nonresponse is defined as less than a 15-point decrease in PTSD symptom severity, as measured by the PTSD Checklist for DSM-5 (PCL-5).

The objectives of this study are to:

* examine the main effects of stage 1 treatments, stage 2 treatments, and embedded
* adaptive interventions on PTSD symptom severity.
* confirm mechanisms of change established in the extant PTSD literature
* identify patient-level moderators of change in PTSD symptoms severity at 18 weeks

Eligibility Criteria:
Inclusion criteria:

Assessed at pre-screening

* Boston Medical Center primary care patient
* At least 18 years of age
* Access to computer or mobile device
* Able to receive treatments in English or Spanish
* Able to read at 4th grade level

Assessed at baseline

* Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline
* PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline
* Clinically appropriate for outpatient level of care
* Stable on psychotropic medication for \>4 weeks

Exclusion criteria:

Assessed at pre-screening

• Patient is currently engaged in clinician-administered therapy

Assessed at baseline (clinician interview)

* Patient is not clinically appropriate for outpatient level of care.
* Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.
Quality of Life in Head and Neck Patients

Evaluation of health-related quality of life of head and neck cancer patients undergoing immunotherapy

Introduction: The treatment of head and neck neoplasms, as well as the evolution of the disease, can affect a variety of body functions, including breathing, swallowing and speech, with great potential to cause various physical, emotional, and social problems to the patient, leading to considerable impairment of their quality of life. Several instruments were developed to measure this variable. Such evaluation is currently considered fundamental to report therapeutic results, but there is no consensus regarding the instrument to be employed. The University of Washington questionnaire has been the most widely used so far. EORTC (European Organization for Cancer Research and Treatment) recently published a new questionnaire specifically for patients treated for head and neck cancer (EORTC QLQ-H \& N43), already validated in Portuguese for Brazil.

Objectives: The aim of this prospective and multi-institutional study is to evaluate the quality of life of patients with metastatic head and neck cancer undergoing immunotherapy in different regions of Brazil. Other endpoints will also be evaluated such as disease-free survival and overall survival.

Procedures: EORTC QLQ-30 and EORTC QLQ-H \& N43 questionnaires, validated in Portuguese for Brazil, will be applied to all patients with metastatic head and neck neoplasms undergoing immunotherapy at participating institutions. These will be evaluated before the beginning of the treatment and then every 2 months, for an estimated period of 2 years or until death or on demand, in case of symptomatology that justifies it.

Eligibility Criteria:
Inclusion Criteria:

Patients with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck region, whose planned treatment is immunotherapy, will be included. We will consider, separately, patients that had been treated with platinum before (platinum-refractory) and patients that were not submitted to this treatment (platinum naïve).

Primary site: patients with primary pharyngeal tumors (oro or hypopharynx), oral cavity and larynx will be included.

Exclusion Criteria:

* Patients with cognitive impairment that prevents the proper application of questionnaires
* Brain metastasis
* Autoimmune disease
* Systemic immunosuppressive treatment
* Hepatitis B, C or HIV infection
* Prior immunotherapy
24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms

To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows:

1. Moderate VMS: Sensation of heat with sweating, able to continue activity
2. Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Female, \>40 years of age
2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior
3. Spontaneous amenorrhea for at least 12 consecutive months
4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause
5. Bilateral salpingo-oophorectomy \>6 weeks with or without hysterectomy

Exclusion Criteria:

1. BMI ≥ 40 kg/m²
2. Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
3. History of self-injurious behavior
4. History of clinical diagnosis of depression; or treatment for depression
5. History of clinical diagnosis of borderline personality disorder
6. Use of an investigational study medication within 30 days prior to screening or during the study
7. Concurrent participation in another clinical trial or previous participation in this trial
8. Family of investigational-site staff
Effects of a New Knee Brace for Treatment of the Knee Osteoarthritis

The purpose of this study is to evaluate the immediate effects of a knee brace with a new mechanism on the pain and medial knee loading during gait among medial knee osteoarthritis patients. The effects of this new brace is compared to a stabilizing brace and a typical valgus knee brace. The investigators recruited 24 knee osteoarthritis and they have to wear each of the three braces during three months. A fifteen days wash-out period is given after each three months. Biomechanical evaluation is carried out before and after each three months. This evaluation consisted of three questionnaires (KOOS, WOMAC and Medical Outcome Score Short Form-36 (MOS-SF36)), a motion analysis with an optoelectronic system, then a 6-min walk test. During motion analysis, ten gait trials are executed without brace and ten with the brace.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
* Knee pain \> 31/100 (Western Ontario and McMaster Universities Arthritis Index - WOMAC)
* Moderately active
* Varus knee alignment equal or superior to 2°

Exclusion Criteria:

* Severe knee OA (K-L grade IV)
* Rheumatoid arthritis or other inflammatory arthritis
* Avascular necrosis
* History of periarticular fracture or septic arthritis
* Bone metabolic disease
* Pigmented villonodular synovitis
* Cartilaginous disease
* Neuropathic arthropathy
* Synovial osteochondromatosis
* Total or partial knee arthroplasty
* Flexion contracture of ipsi- or contra-lateral knee greater than 15°
* Hip or ankle joint damage with mobility limitation
* Obesity (BMI ≥ 40)
* Intra-articular corticosteroids injection in the affected knee during the two previous months
* Reduced mobility (Charnley class C)
tACS and tRNS Studies on Brain Control of Swallowing

Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory.

Swallowing problems are life-threatening symptom among patients with brain impairments and elderly people. Until now, there are no studies investigating whether tACS and tRNS can have a beneficial effect on swallowing function in human. Our aim is to examine the effects of different strengths of tACS and tRNS to determine the best approach for brain stimulation that controls swallowing action, before using these techniques in patients with (neurological) swallowing disorders.

Participants: Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history

Exclusion Criteria:

* a history of epilepsy
* cardiac pacemaker
* previous brain surgery
* previous swallowing problems
* risk of potential pregnancy
* metal in the head or eyes
* use of medication that acts on the central nervous system.
Mostafa Maged Maneuveur to Prevent and Control Post-partum Haemorrhage During Normal Vaginal Delivery

PPH is commonly defined as blood loss exceeding 1000 milliliters after vaginal birth or cesarean section.1 PPH is often classified as primary/immediate/early (occurring within 24 hours of birth) or secondary/delayed/late (occurring from more than 24 hours postbirth to up to 12 weeks postpartum)..

Atonic post-partum haemorrhage is one of the most challenging complications of normal delivery process . There are many maneuveurs applied to the atonic uterus for controlling the blood loss and conserving the uterus from hysterectomy process . There are pharmacological and surgical methods to control the bleeding . In this study , Mostafa Maged technique is to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method .

In this study , Mostafa Maged technique to prevent and control post-partum bleeding during vaginal delivery . It is so simple and not-costly method . Mostafa Maged maneuveur has been applied to those all female patients to prevent or control post-partum bleeding in normal delivery . Mostafa Maged technique is applied by :- (Description of the Mostafa Maged technique) :-

1. First , placing the right hand to the posterior fornix of vaginal canal trying to cuddle the lower part of uterus compressing the anterior and posterior walls of the uterus .
2. Second , placing the left hand over the fundus of the uterus and the posterior wall of uterus from the abdominal part of the pregnant mother ( the side of the abdominal skin ) .
3. Third , by the two hands , trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is cuddling the symphysis pubis bone and in this way , getting the anterior and posterior walls of the uterus against each other compressed is achieved and reducing the intra-cavitary space so prevention of the expansion of the uterus is applied .

Eligibility Criteria:
Inclusion Criteria:

* pregnant females Inclusion criteria :-

  1. All pregnant patients
  2. Age is between (18) to (40) years old

Exclusion Criteria:

1. Smokers
2. Morbid obese
3. Medical history of blood diseases and collagen diseases