cyrilzakka/clinical-trials huggingface dataset:
Fetal Outcomes Among Pregnant Emergency General Surgery Patients

Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. Even less is known about the role of non-operative management of general surgical disease in the pregnant population. However, fetal outcome is not compromised by emergency general surgery condition interventions.

Approximately 1 in 500 pregnant women require non-obstetric surgery. Surgical care for the pregnant woman raises concern for complications adversely affecting pregnancy outcomes. The most common reason for surgery is acute appendicitis followed by gallbladder disease. Despite the common incidence of non-obstetric surgery among pregnant women, little is known regarding fetal outcome and the impact of laparoscopic interventions versus traditional open procedures. Even less is known about the role of non-operative management of general surgical disease in the pregnant population. However, fetal outcome is not compromised by emergency general surgery condition interventions. The primary objective of this study is to establish best practices for management of pregnant patients requiring emergency non-obstetric general surgery.

This is a prospective multi-center observational study of pregnant women and their fetus/neonate (birth to 30 days) with acute general non-obstetric surgical diseases, including those undergoing operative and non-operative management. Data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. The patients will be managed per institutional standard of care. Data collection will occur in the following format:

* Initiated upon admission for general surgery until discharge for that admission
* Upon the birth of the child
* Post-delivery of the child, through that admission until discharged, for a maximum of 30 days post- delivery All of the data will be collected from the medical record, as long as the subject's providers utilize EPIC. Otherwise, an approved member of the research team may need to contact the patient via telephone to obtain access to their non-EPIC record.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 or older with non-obstetric acute general surgical disease (Acute appendicitis, Acute cholecystitis, Acute biliary pancreatitis, Bowel obstruction, Acute diverticulitis

Exclusion Criteria:

* Trauma patients
Fluid Management After Surgery in the Post-Anesthetic Care Unit (PACU)

The objective of the present study is to describe the current practice of postoperative fluid management in the Post Anesthesia Care Unit (PACU) of the Shaare Zedek Medical Center, Jerusalem, Israel.

The aim of this study is to follow and present the current practice of fluid administration in the PACUof Shaare Zedek Medical Center for an extended period of time as a first step towards establishing guidelines for postoperative fluid management.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yrs
* elective surgery
* ASA I-III

Exclusion Criteria:

* massive intraoperative blood loss
* non elective surgery
* pregnant women
* stay in the PACU \< 15 minutes
The Relationship Between Body Composition and Physical Fitness in Young Male Basketball Players

In this study, it is aimed to investigate the relationship between body composition, aerobic capacity, trunk muscle endurance and muscle strength in young male basketball players.

The study will take place at a local basketball academy. Young male athletes between the ages of 10-24 and enrolled in a basketball academy will be included in the study. Participants who have been involved in basketball for less than a year, and those who have injuries that prevent participation in the study will be excluded.

Individual development differences in young people can have an impact on physical fitness components such as aerobic capacity, trunk muscle endurance and muscle strength required for basketball. At the same time, differences in these components can have effects on each other.

There is a complex relationship between anthropometric changes during growth and physical fitness because many differences can occur during the physiological development of players. In this context, differences in growth rate and development in young basketball players are complex factors that affect game performance and player success. Characteristics such as body height, body weight, skeletal muscle ratio and body fat are among the basic anthropometric components of a basketball player, and these components are considered to be important indicators of a player's game performance.

Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Being between the ages of 10-24

Exclusion Criteria:

* Athlete's own or family refusal to participate in the study
* Interested in basketball for less than a year
* Having an injury that would prevent participation in the study
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)

Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.

Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.

Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.

Eligibility Criteria:
Inclusion Criteria:

* 12- to 15-month-old males and females with no active liver disease
* A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

Exclusion Criteria:

* Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
* Any immune deficiency
* History of allergy to any of the vaccine components
* History of any seizure disorder
Mobilization With Movement Versus Mulligan Knee Taping Technique on Patellofemoral Pain Syndrome.

This study intends to determine the effects of MWM verses Mulligan knee taping on patellofemoral pain syndrome.

This is a single blinded randomized controlled trial, will be conducted at Pakistan railway general hospital Rawalpindi. Both MWM and Mulligan knee taping Techniques are used in patients with patellofemoral pain syndrome. Sample size of 34 individuals was calculated through Open Epi tool version 3 with 95 % confidence interval (CI), and power 80%. 34 individuals were screened out on the basis of inclusion and exclusion criteria. Individuals of this selected population were randomly allocated as 17 individuals in MWM (straight leg raise with traction and tibial gliding) group and 17 individuals Mulligan knee taping group by sealed envelope method. And after this Both groups will receive conventional therapy.

Assesment will be done at baseline, 2nd week and after 6 weeks Data will be analyzed on SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:• Anterior knee Pain durations lasting longer than two months,

* Pain scoring three or more according to Numeric pain Rating scale (NPRS) during at least two activities
* Age between 20 and 45 years
* Both Genders

Exclusion Criteria:

* • Past history of total knee artthroplasty

  * Intra articular steroid injection
  * Rheumatoid Arthritis
  * Use of Assistive devices e.g. canes, walkers and braces
  * Knee injury
Prognosis in Adult Patients with Congenital Heart Disease

This is a mono-center observational ambispective study in which adult patients with congenital heart disease evaluated at our institution will be enrolled.

The primary endopoint is to assess the clinical and echocardiographic predictors of adverse events during follow-up (death, arrhythmias, cardiac hospitalization).

The secondary endpoints are: 1) evaluation of the incidence of the singular components of the primary endpoint; 2) evaluation of the prognostic impact of acquired lesions, including valve disease not present at birth; 3) need for surgical/percutaneous interventions during follow up.

Participants will be evaluated in the context of scheduled follow-up visits in our Outpatient ACHD Clinic. No interventions/drug administration will be performed other than those required by standard clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients evaluated in our ACHD Outpatient Clinic between January 2014 and December 2026
* Age ≥ 18 years

Exclusion Criteria:

* Patients without congenital heart disease confirmed during the first evaluation
* Impossibility to retrieve information about the first clinical evaluation in our clinic from our electonic datasets
* Follow up shorter than one-year
* Refused consent to participate to the study.
X-Ray Verified Accuracy of the proGAV Verification Instrument

This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with proGAV Requiring adjustment Implant must be palpable under the skin

Exclusion Criteria:

* Unwilling to consent Implanted within 7 days of inclusion visit
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer

This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

* Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
* Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.

Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.

* Men or women ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Adequate hematologic, hepatic, renal and coagulation function
* Amylase and lipase ≤ 2.0 x ULN
* Adequately controlled type 1 or 2 diabetic subjects

Exclusion Criteria:

* Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
* Known central nervous system metastases
* Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
* Adjuvant chemotherapy or chemoradiotherapy
Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach

Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach

ASA physical status 1, 2 and 3 patients scheduled to undergo elective surgery of total hip arthroplasty under spinal anesthesia.

The investigators would like to study the impact of supra-inguinal fascia iliaca block on postoperative pain management after total hip arthroplasty by posterior surgical approach. The principal investigator perform this block with ultrasound technique. The investigators also want to observe if this loco-regional new approach to fascia iliaca block could have influence on opioid side effects, postoperative nausea and vomiting, length of hospitalisation and first mobilisation side effects.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients scheduled to undergo elective surgery of total hip arthroplasty by posterior surgical aboard

Exclusion Criteria:

* Patient refusal
* Allergy to used medications or local infection.
* Pregnancy
* Obesity with body mass index \> 35
* History of chronic pain or fibromyalgia
* Drug (opioids) addiction
* Treatment with corticosteroids for more than 6 months
* Severe kidney or liver diseases
* Mental disorders or serious neurological diseases
A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan

This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 months
* P. vivax or P. falciparum mono-infection or P. vivax / P. falciparum mixed infection
* Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
* Able to tolerate oral medication
* Able and willing to comply with the study protocol for the duration of the study
* Informed consent from the patient or from a parent or guardian in the case of children

Exclusion Criteria:

* Bodyweight ≤5kg
* Presence of general danger signs in children aged under 5 years or signs of severe malaria in any patient according to the definitions of WHO
* Presence of severe malnutrition
* Acute anaemia \<8g/dL
* Regular medication, which may interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s)
* A positive pregnancy test or lactating.
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.


Eligibility Criteria:
Inclusion Criteria:

* Infant \<1 year suffering from cholestasis

Exclusion Criteria:

* Rejection or inability for parent to give their informed consent
Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers

This clinical trial develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis.

PRIMARY OBJECTIVES:

I. Systematically and culturally adapt a mindfulness-based intervention to improve psychological wellbeing in Latino patients with advanced cancer and their family caregivers.

II. Evaluate the feasibility of the adapted mindfulness-based intervention and overall study procedures in Latino patient-family caregiver dyads.

SECONDARY OBJECTIVE:

I. Determine the effects of the adapted mindfulness-based intervention on the secondary outcomes of patient and caregiver psychological distress, quality of life (QOL), and patient cancer symptoms, compared to a waitlist control.

OUTLINE: Patients and their partners are randomized to 1 of 32 groups.

GROUP I: Patients and their partners participate in mindfulness program together over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.

GROUP II: Patients and their partners participate in mindfulness program separately over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.

GROUP III: Patients and their partners participate in mindfulness program either separately or together, depending on participants' preferences, as in Group I beginning 12 weeks after starting the study and completing the third study visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a stage III-IV solid tumor
* On active treatment
* Self-identify as Hispanic/Latino
* ECOG (Eastern Cooperative Oncology Group) performance status of =\< 2
* Willing to participate in the study with a family caregiver (e.g., spouse, adult child) with whom they currently reside and who consents to participate

Exclusion Criteria:

* At least 18 years old
* Able to speak English or Spanish
* Have access to the internet
* Able to provide informed consent
Influence of Cognitive Function Software Therapy on the Improvement of Manual Skills in Multiple Sclerosis Patients

Multiple Sclerosis (MS) is a chronic demyelinating disease of the central nervous system leading to the impairment of motor, visual and cognitive functions. A standardized rehabilitation of cognitive functions can be provided by a systematized treatment program devised to improve neurological patients' quality of life. The degree of difficulty of the computerized tasks was adapted to a patient's predispositions and modified once a desirable improvement in the practiced skill has reached.

The aim of the study was to assess the influence of cognitive therapy by means of the cognitive software on manual dexterity in patients with multiple sclerosis. We also attempted to establish whether factors like age, sex and Expanded Disability Status Scale (EDSS) scores contribute to the outcomes of that therapy. All patients enrolled will have a documented history of MS disease prior to study enrollment. The EDSS scores varied between 1.5-4 (mean score 2.1). The Nine Hole Peg Test (NHPT), administered to all of the patients, was used to evaluate the subjects' manual dexterity. Having been administered the NHPT test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. After completing each task the patient would move on to a higher level of difficulty. Failure meant having to redo that particular task. One training session lasted 20 min., after which the patient could take a break.

Having completed the training each patient was administered the NHPT test again in view of assessing the efficiency of their upper limb. Due to progressive deterioration of health and other factors only 10 patients managed to complete the training.


Eligibility Criteria:
Inclusion criteria:

MS clinically diagnosed based on McDonald's criteria of 2011 The EDSS between 1.5-4; relapsing-remitting form MS;

exclusio criteria Mental disorders, alcoholism, severe vision disorders including diplopia coinciding upper limb therapy

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IC14 Antibodies to Treat Individuals With Acute Lung Injury

This is a phase II, randomized, double-blind, placebo-controlled, safety and efficacy study of a recombinant chimeric monoclonal antibody against CD14 (IC14) in hospitalized patients with acute lung injury (ALI).

BACKGROUND:

This study will use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing CD14, to block CD14 medicated cellular activation in patients with sepsis-induced ALI. Research results of antibody interaction with CD14 suggest that CD14 has a central role in the recognition of bacterial products and the induction of innate immune responses. Although beneficial, when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful. This study will implement strategies to block CD14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response, mechanical ventilation days, multiple organ failure, and severity of organ dysfunction in patients with sepsis-induced ALI.

DESIGN NARRATIVE:

The primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at Days 2 and 3, and Days 6 to 8.

The key secondary outcomes of this study will be: 1) Worst Murray Lung Injury Score (measured at Days 1 through 7, and Day 28); 2) Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28); 3) Infections-nosocomial and/or surgical site infections (measured at Day 28); 4) Ventilator-free days (measured at Day 28); and 5) Mortality (measured at Day 28).

Eligibility Criteria:
Inclusion Criteria:

* Presence of ALI, defined as the following:

  1. Acute onset (less than 28 days from study entry)
  2. PaO2/FiO2 of less than 300
  3. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
  4. Requirement for positive pressure ventilation via endotracheal tube
  5. No clinical evidence of left atrial hypertension
* Clinical indication for antimicrobial therapy at the time of randomization
* Anticipated duration of mechanical ventilation greater than 48 hours

Exclusion Criteria:

* Treatment with a drug or device within 30 days prior to study entry that has not received regulatory approval at the time of study entry
* Does not meet safety criteria for bronchoscopic alveolar lavage either at baseline or is anticipated to be too high a risk for lavage on Day 1 of the study
* Intubation for cardiopulmonary arrest
* Intubation for status asthmaticus, pulmonary embolus, or myocardia infarction
* Anticipated survival less than 48 hours from intubation
* Anticipated survival less than 28 days due to pre-existing medical condition