cyrilzakka/clinical-trials huggingface dataset:
Satisfaction of Limited English-Proficient Patients With Phone Interpretation Services Compared to In-Person Interpreters: A Randomized Controlled Trial

The aim of the study is to determine if In-person interpreters increases patient satisfaction of URGYN office visits compared to the use of phone interpreter services for Limited English Proficient (LEP) patients

This study is a randomized controlled trial. Patients presenting to the UMass Memorial UROGYN clinic will be screened for eligibility using the inclusion and exclusion criteria. LEP patients will be identified as patients that initiate conversation in a non-English language and are only able to communicate adequately regarding their medical problem in a non-English language.

After patients have been seen for their scheduled office visit, they will be invited to participate in the study. Once the patient has agreed to participate in the study the participant will be randomized. Study assignment will be revealed using sequentially numbered sealed opaque envelopes. Randomization will be performed using software and a block randomization scheme to yield a 50% chance of having an in-person interpreter.

Those assigned to the control group will receive phone translation services and the experimental group will have in person interpreters.

At the subsequent visit, demographic information will be collected and patients will then receive interpretation services from the phone or an in-person interpreter.

Eligibility Criteria:
Inclusion Criteria:

* LEP speaking Spanish and Portuguese female patients presenting to the U Mass UROGYN clinic with or without Ad-hoc interpreters
* Spanish and Portuguese speaking female patients with LEP presenting to the U Mass UROGYN clinic for an office visit of any type

Exclusion Criteria:

* Unable to provide consent
* Under 18 years of age
* Pregnant women
* Prisoners
* LEP subjects who decline interpreter services
* Non -Spanish or Non - Portuguese speaking subjects
* Patients with cognitive impairment
* Visually or hearing impaired patients
* Patients not requiring a follow up appointment
Hemostatic Disorders on Intensive Care Patients.

1. To assess the incidence of hemostatic disorders among ICU patients.
2. To establish a relationship between supportive treatment and survival in patients with coagulopathy in ICU.
3. To provide solutions that can help in reduction of the incidence of hemostatic disorders in ICU patients.

Hemostasis is the physiological process that stops bleeding at the site of an injury while maintaining normal blood flow elsewhere in the circulation. Blood loss is stopped by formation of a hemostatic plug. The endothelium in blood vessels maintains an anticoagulant surface that serves to maintain blood in its fluid state, but if the blood vessel is damaged components of the subendothelial matrix are exposed to the blood. Several of these components activate the two main processes of hemostasis to initiate formation of a blood clot, composed primarily of platelets and fibrin.

Many critically ill patients develop hemostatic abnormalities, ranging from isolated thrombocytopenia to complex defects, such as DIC. Coagulation abnormalities are commonly found in critically ill patients. Prompt and proper identification of the underlying cause of these coagulation abnormalities is required, since each coagulation disorder necessitates very different therapeutic management strategies.

Management of coagulopathy The key basic management principle of all coagulopathies is that the decision to transfuse blood products should not be based on the results of coagulation tests alone, rather an individualized approach is warranted. It is imperative to synthesizes all the available clinical data and treat the underlying cause.

In summary, hemostatic disorders are very common in the critically ill. Blood product support is frequently required, but there is only a very limited evidence-base to support its use. In many cases, no specific product support is required and the key management step is the treatment of the condition underlying the coagulopathy .

Eligibility Criteria:
Inclusion Criteria:

* Intensive care unit patients,aged more than 18 years .
* Any Acquired bleeding disorders (platelet disorders; thrombocytopenia, acquired thrombocythemia and thrombocytosis, acquired coagulation defect, Thrombophilia ) Diagnosed in Critical care unit in Assiut university in one year time frame

Exclusion Criteria:

* Patient less than 18 years.
* Patients with Inherited platelet defects ( Amegakaryoctye aplasia and Bernard Soulir syndrome)
* Patients with Inherited coagulation defects (e.g.hemophilia , Von Willebrand disease and any inherited coagulation defect.
Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

Good quality of postoperative analgesia would lead to attenuate or prevent the adverse effects on the common functions of the immune system. We compared the effect of epidural analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines following malignant urological surgery.

Study groups: 60 patients were included in the study randomly allocated into two groups of 30 patients. Rectus sheath group (RSB): Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia. Control group: the patients did not receive any intervention after anaesthesia induction.

Eligibility Criteria:
Inclusion Criteria:

Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia.

Exclusion criteria:

Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.
Cold Water and Decision-Making

The behavioral within-subject cross-over design study "CoVa" aims to investigate the effect of a short-term full-body cold-water immersion vs. warm-water immersion control on value-based choice, psychological well-being, and peripheral physiology.

This randomized within-subject cross-over design behavioral study in cognitive neuroscience will employ an acute peripheral physiological intervention, i.e., a 10-minute full-body cold-water (10-16°C) immersion vs. a control condition (10 min @ 30- 36°C water) on two visits separated by approx. 30 days.

Forty eligible female and male participants will be subject to a head-out full-body cold-water immersion or a warm-water condition (control) on two visits. Participants will perform resting-state and task-based non-invasive electrophysiological recordings of the heart, pulse, respiration, skin conductance, and pupil, will undergo thermographic imaging, pre- and post-immersion blood sampling (4 time points), engage in two computer-based decision-making tasks (reinforcement learning task, risk decision-making task), a brief food choice task, and receive a battery of psychometric questionnaires. The visits are separated by approximately 30 days and do not differ in their timeline except for the primary intervention, i.e., cold vs warm-water immersion, and the medical screening on visit 1.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years of age
* Consent to participate
* Fluency in German
* Physically and mentally healthy
* BMI 18-30 kg/m2
* Normal day-night rhythm

Exclusion Criteria:

* Raynaud syndrome
* Cold urticaria
* High resting heart rate (\>160 beats per minute)
* Acute infection
* Diagnosed current or former illnesses of

  * Brain and mind
  * Heart and blood circulation
  * Gastrointestinal system
  * Endocrine system
  * Other serious past or present medical conditions
* Wearing of medical devices (e.g., pacemaker)
* Fear of blood, needles, or phlebotomy
* Allergies to plasters, gels, and other medical equipment
* Allergies to commercially available liquid meals (e.g., shakes, yfood Labs GmbH)
* Recurrent intake of medication which affect metabolism
* Regular nicotine consumption (e.g., vaping, cigarettes)
* Excessive alcohol consumption (\>14 servings/week)
* Recent illegal drug consumption (within 2 weeks prior)
* Strong mental or physical stress
* Excessive exercise (\>2 h high-intensity exercise/day)
* Pregnancy or breastfeeding
* Inability to wear skin-exposing swimwear, e.g., for religious reasons
* Affinity for winter swimming, cryotherapy, breathwork (\>3 times/year)
Effect of a Socio-educational Intervention on Sexual Health in Young University Students

The sexual health is considered as a state of physical, mental and social well-being in relation to sexuality that requires a positive and respectful approach to sexuality, as well as the possibility of having pleasant and safe sexual experiences, free from all coercion, discrimination and violence. However, lack of family planning, having unprotected sex, unwanted pregnancies, abortions, Sexually Transmitted Infections, lack of acceptance of sexual identity, sexism, having multiple sexual partners and having sex under the influence of alcohol and drugs are some of the main elements that alter the well-being of people's sexual health, especially in the young population. In this sense, different organizations have pointed out the importance of promoting in young people strategies related to providing an adequate level of knowledge in sexual health from a perspective of the exercise of sexual rights to reduce alterations in risky sexual practices and it has been identified that the school environment can be the ideal space for a health services approach to this age group to strengthen their well-being and ensure their development during adulthood. However, the sexual health interventions traditionally implemented by the health services are usually aimed mainly at transmitting knowledge about the benefits of condom use, sexually transmitted diseases and unwanted pregnancies and violence, excluding other elements that make up the sexual health and making use of conventional educational strategies through print media or short educational sessions, which causes little interaction between health personnel and users that consolidates the purpose of the interventions. That said, the implementation of a socio-educational intervention in sexual health that promotes sexual rights, positive attitudes towards sexuality and the prevention of risky sexual behaviors articulated in a model of a life project that motivates them to achieve the ideal stage of life for starting a family in a healthy way through family planning, can promote the strengthening not only of their sexual health but also their well-being for their future development as adults.


Eligibility Criteria:
Inclusion criteria;

* Young college students aged 18 to 24.
* Que reported having an active sex life.
* Who attended the family planning counseling services of the School Clinic.
* Who agreed to participate in the study by signing informed consent.

Exclusion criteria;

* Young people who reported going to private family planning services.
* They were in the gestation stage.
Perioperative Temperature Management

The investigators aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

Hypothermia, defined as a core temperature below 36 degrees celsius, is commonly seen in patients undergoing surgery. Intraoperative hypothermia is related to postoperative patient discomfort, impaired wound healing, increased blood loss, anxiety and disturbances in glucose and insulin levels. Prewarming of patients prior to surgery may result in maintenance of intraoperative temperature and reduce postoperative complications. We therefore aim to investigate the effects of prewarming of patients undergoing elective orthopedic surgery on intraoperative temperature control and blood loss and postoperative patient discomfort and glucose and insulin levels.

Objective of the study:

Does preoperative heating of patients undergoing elective orthopedic surgery reduce the incidence of intraoperative hypothermia and postoperative comfort and modulate postoperative glucose and insulin blood levels?

Study design:

Multi-center, prospective, randomized clinical trial.

Study population:

Patients undergoing an elective orthopedic hip- or knee replacement

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective orthopedic knee- or hip replacement
* Participation based on informed consent
* \> 18 years old and \< 85 years old

Exclusion Criteria:

* BMI 18.5 \> x \< 40
* Pregnancy
* Non elective trauma patients
* Infectious or febrile patients (\> 37.5oC)
* Diabetes Mellitus
* Combined surgery
* Anemia (Hb \< 4.0 mmol/l)
Efficacy and Safety of Memantine in Moderate to Severe Alzheimer's Disease

The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type.

Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to severe Alzheimer's Disease (AD) have demonstrated memantine's efficacy and safety by showing positive treatment effects on cognitive, global and functional decline.

This 24-week randomised, double-blind, placebo-controlled, multicentre study examines the effect of memantine 20 mg, administered once daily, on cognitive and behavioural symptoms in outpatients diagnosed with moderate to severe AD and significant psychopathology.

Eligibility Criteria:
Inclusion Criteria:

Outpatients who:

* had a primary diagnosis of probable Alzheimer's Disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) criteria, and with Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revised (DSM IV TR) criteria for dementia of the Alzheimer's type
* had moderate to severe dementia, defined as a Mini Mental State Examination (MMSE) total score \>=5 and \<=15 at screening. Before substantial protocol amendment SA04 (dated 7 October 2004) was implemented, the MMSE total score range at screening was \>=8 and \<=18. Substantial protocol amendment SA07 (dated 4 September 2009) allowed patients who had previously had an MMSE score of 16 or 17 to be re-screened \>6 months after their initial screening and, if there was documented evidence of cognitive decline, to be enrolled in the study
* had a Neuropsychiatric Inventory (NPI) total score \>=13 and an NPI agitation/aggression subitem score \>=1 at screening and baseline
* did not have vascular dementia or a modified Hachinski Ischaemia Scale score \>4 at screening

Exclusion Criteria:

* Evidence of clinically significant active disease, evidence of other neurological disorders, and previous treatment with memantine
PPI Supplementation to Fight ECtopIc Calcification in PXE

Pseudoxanthoma elasticum (PXE) is a rare inherited metabolic disorder (OMIM 264800, frequency 1/25000) characterized by progressive ectopic calcification of connective tissues. PXE mainly affects the skin (inesthetic papules and plaques in the skin folds), the retina (central blindness), the vasculature (peripheral arterial occlusive disease and stroke) and the renal system (renal lithiasis) in adulthood. Although rarely, early lethal forms have been reported. This chronic and highly disabling condition results from a loss of function of the gene encoding for the ABCC6 membrane transporter primarily expressed in the hepatocytes and renal tubular cells. Recently, it has been reported that PXE was characterized by a 50-60% decrease in the plasma level of inorganic pyrophosphate (PPi), a major physiological anti-calcifying factor. PXE is an incurable disease which therapeutic options are limited to symptomatic treatments to stem the devastating effect of the ectopic calcifications. Recently, encouraging proof of concept studies with animals PXE models and healthy volunteers have shown that, contrary to what was initially reported and thought, the oral administration of PPi salts are able to increase PPi plasma levels, opening up new therapeutic perspectives in PXE. Therefore, we propose to perform the first Phase II randomized controlled trial (RCT) to evaluate the safety and efficacy of a daily and oral administration of PPi salts against placebo in PXE patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients (\>18 years and \<65 years), men and women, presenting a clinically and biologically authenticated PXE (genotype + phenotype) according to the international diagnostic criteria (26).
* Efficient contraceptive method in woman of childbearing age at inclusion and during the overall study
* Patient affiliated to a social security insurance
* Signed informed consent
* Patient without acute complication linked or not to the pathology at the time of the study

NON-INCLUSION CRITERIA

* Renal insufficiency (i.e. defined by a renal clearance \<30ml / min / 1.73 m²)
* Patients with osteomalacia
* Patients with chronic diarrhea (\> 1 month)
* Pregnancy, lactating or fertile women who may wish to become pregnant within three years.
* Any other medical condition that may be considered in the opinion of the Principal Investigator.
* Use of bisphosphonate during last 5 years.
* Hypocalcemia (calcium \<2.20 mmol/L and ionized calcium \<1.15 mmol/L) \*.
* Vitamin D deficiency \<35 nmol/L \*
* Enrollment in another inteventional clinical trial which could interfere with the present study
* patients (\>18 years) protected by law

  * After correcting the hypocalcemia and/or vitamin D deficiency, a participant is again suitable for participation in the trial, as long as the participant meets the inclusion criteria.
A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients

The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.

This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for 7 days.

After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Eligibility Criteria:
Inclusion Criteria:

* H. pylori-positive at screening
* Complain of gastric discomfort symptom

Exclusion Criteria:

* Having received prior therapy for eradication of H. pylori
* Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days
Compuflo® vs Conventional Training With an Epidural Simulator

Epidural block is one of the most difficult skills that can be mastered by trainees probably due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in real-time at the orifice of a needle and it has been successfully used in clinical practice to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may help trainees to identify the ligamentum flavum using a realistic Epidural Simulator

The investigators enrolled 60 trainees who have never performed an epidural block. After having had a standardized learning module on epidural anatomy and technique, each trainee practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5 attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an increase of resistance due to the penetration of the needle in the LF. The correct position of the needle was verified by an expert instructor. The number of attempts was noted. The power analysis required a sample size of 60 observations to set 80% test power and a 95% significance. Unpaired T-test was used to evaluate the differences in the number of epidural attempts. A logistic regression model was used to correlate the "success at the first attempt ratio" and the technique used.

Eligibility Criteria:
Inclusion Criteria:

First year trainees in anesthesia who never have performed an epidural block

Exclusion Criteria:

-
Life-2023-02 Esophagogastric Variceal Bleeding

Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding

Participants with acute esophagogastric variceal bleeding in 5 days and under stable status will be included in this study. All the patients will take CTP test to confirm the blood flow status of the portal vein before endoscopic treatment. After that they will be randomly divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5 days; B. no growth inhibitor will be applied after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* acute esophagogastric bleeding with hepatic cirhosis;
* stable status (no active bleeding)

Exclusion Criteria:

* endoscopic test limitation;
* previous acute esophagogastric bleeding treatment history;
* ICU;
* pregnant;
* Immunity disabled;