cyrilzakka/clinical-trials huggingface dataset:
US-Guided ESPB Versus TPVB on Acute and Chronic Pain After VATS

Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB) and erector spinae plane block (ESPB), which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and randomized controlled prospective studies with ESPB are increasing. In this study, it is planned to compare the effects of US-guided TPVB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Patients with bleeding disorders
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

Compression therapy is widely used in the treatment of chronic venous leg ulcers (VLUs). The clinical performance of a compression system depends on the apply pressure and the stiffness.

The static stiffness index (SSI) is defined by the difference in interface pressure measured when the subject is standing (working pressure) and the interface pressure measured when the subject is in the lying position (resting pressure).

Eligibility Criteria:
Inclusion Criteria:

* Subject with a body mass index of less than 30 (BMI = kg / m²),
* Subject presenting a healthy skin on both legs without any sign of dermatological lesion,
* Subject presenting a venous doppler of the lower limbs without detectable anomaly
* Subject with a ankle brachial pressure index (ABPI) greater than 0.9 and less than 1.3 for each of the lower limbs,
* Subject accepting to wear a compressive system on both legs for a period of three days.

Exclusion Criteria:

* Subject with chronic venous insufficiency whose stage is greater than or equal to 2 (CEAP classification of chronic venous diseases)
* Subject with type I or II diabetes
* Subject with lipoedema and / or dismorphic leg
* Subject presenting ankle ankylosis
Effects of RF Microneedle on Photoaging Skin

Melasma relapse is almost common after discontinuation of conventional treatment. Recent studies have suggested that photoaging dermis is main pathomechanism of melasma emphasizing stromal targeting therapy. Therefore, we investigated maintenance effect of microneedle radiofrequency (RF) for melasma treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult more than 19 years old
* Melasma clinically diagnosed by three dermatologists

Exclusion Criteria:

* Aesthetic medical procedures in three months prior to the study
* Use of topical depigmenting agents in three months prior to the study
* Pregnant or lactating
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

The aim is to evaluate the impact of visual projection of images of relatives or loved ones in patients undergoing cardiac surgery in the immediate postoperative period, and its influence on the incidence and development of postoperative delirium.

A randomized, double-blind clinical trial was designed in the immediate postoperative period of adult patients undergoing cardiac surgery. CONSORT guidelines were followed.

A control group and an intervention group were established. In the intervention group, the patients underwent a visual projection, while the usual unit treatment was carried out with the control group. Sociodemographic, anthropometric, anesthetic, and surgical variables were also recorded. The postoperative delirium assessment scale used was the "Confusion Assessment Method for the Intensive Care Unit scale" (CAM-ICU).

The projection of visual material could reduce the incidence of postoperative delirium in patients undergoing cardiac surgery, although it cannot be established that it is effective as a treatment once the pathology is already established.

The results obtained suggest that the visual projection of images is an effective and economical tool to address an increasingly incidental problem due to the aging of the population.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing heart surgery (aortic valve replacement, mitral valve replacement and/or coronary bypass) in the immediate postoperative period during their stay in the cardiac resuscitation unit.
* Over 18 years of age

Exclusion Criteria:

* Not being sedated for at least 24 hours.
* Leven of consciousness.
* Spanish speaker.
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk

Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when individuals visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location.

The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("TRAC-ER") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.

For this study, the investigators will enhance an existing mHealth intervention (TRAC) to reduce alcohol use among young adults at risk for HIV by combining the intervention with an app which delivers EMI messages in real-time. Upon enrollment, participants will be randomized into one of 3 arms: TRAC-ER (EMI messaging, TRAC intervention, and smartphone-based alcohol monitoring), TRAC (TRAC intervention and smartphone-based alcohol monitoring), or a comparison group (smartphone-based alcohol monitoring only).

Participants will be recruited from Kentucky and Connecticut through community-based recruitment and health clinics.

Preliminary data used for this study were collected from a study (PI: Lauckner, K01AA02530) testing the TRAC intervention with people living with HIV/AIDS, which has shown promising preliminary results, with high feasibility, acceptability, and encouraging preliminary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* is between the ages of 18-35 at the start of the study
* owns a smartphone
* has not been diagnosed with HIV
* screens positively for at-risk alcohol use (score of 4 or higher on the AUDIT-C, OR report engaging in binge drinking at least once over the past 12 months).
* meets criteria for pre-exposure prophylaxis (PrEP) OR is identified as being at high risk for HIV (i.e., reports history of using PrEP/PEP, reports unprotected sex, etc.)

Exclusion Criteria:

* do not speak English
* are actively detoxifying from substances and need medical supervision
* a score of 20 or greater on the Alcohol Use Disorders Identification Test
Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth.

The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial.

The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).


Eligibility Criteria:
Inclusion Criteria:

* The study will include all women delivering at one of the maternity units involved in for the duration of the study.

Exclusion Criteria:

* Women delivering in the "washout" period in each unit.
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study

The study investigates long-term immunity and safety of IC51 (IXIARO®, JESPECT®) in a pediatric population vaccinated in the parent study IC51-322.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received two vaccinations in study IC51 322. (2) Subjects who were enrolled as part of the immunogenicity subgroup of study IC51-322.
* Male or female healthy subjects aged ≥ 9 months to \< 21 years at the time of enrolment into this study.
* Written informed consent by the subject, the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.

Exclusion Criteria:

* History of or clinical manifestation of any Flavivirus disease during study IC51-322.
* Vaccination against JE virus (JEV) (except with IC51) at any time prior or planned during this study.
* Participation in another study with an investigational product during study IC51-322 or IC51-324.
* History of or development of any immunodeficiency including post-organtransplantation after inclusion into study IC51-322.
* History of or development of an autoimmune disease during study IC51-322.
* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during study IC51-322 up to first visit of study IC51-324. (For corticosteroids this means prednisone or equivalent at \>= 0.05 mg/kg/day. Topical or inhaled steroids are allowed).
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Illicit drug use and/or a history of drug or alcohol addiction and/or current drug or alcohol addiction.
* Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
* Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
Serum FGF-23 and Vitamin D Deficiency

We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23 concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of vitamin D deficient patients with healthy subjects and patients with genetically-determined hypophosphatemic rickets.

Study group was composed of vitamin D deficient females (n =18, mean age 29.1±9.9 yrs), vitamin D sufficient healthy females (control group; n = 19, mean age 28.5±5.2 yrs) and patients with genetically-determined hypophosphatemic rickets (n=13, mean age 26.5±15.1 yrs). Groups were compared for serum FGF-23, 1,25 dihydroxy vitamin D3, calcium, phosphate, bone turnover markers, intact parathyroid hormone and urinary excretion of calcium and phosphate. Vitamin D deficient group was re-evaluated after a standard treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Serum 25OHD Vitamin \<30 ng/mL for group 1
* Serum 25OHD Vitamin \>30 ng/mL for control group

Exclusion Criteria:

* Receiving medication(s) affecting bone metabolism
* History of gastrointestinal disease and malabsorption
* History of renal and liver disease
Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

Participants as part of this research study will receive Proton radiation over 6 weeks with oral chemotherapy (capecitabine) only taken on radiation days.

In addition, If surgery is an option, then surgical resection will be performed at least 8 weeks after treatment with radiation and chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven unresectable adenocarcinoma of the pancreas.
* Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
* A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
* Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
* Required pretreatment laboratory parameters:

  * Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
  * Platelet count ≥ 100,000/mm3
  * Bilirubin \< 2 mg/dl
  * ALT/SGPT \< 3x upper limit of normal
  * Creatinine \< 3 mg/dl

Exclusion Criteria:

* Evidence of distant metastasis.
* Prior surgical resection.
* Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
* Active or untreated infection,
* Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
* Previous Radiation to the abdomen.
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults


Eligibility Criteria:
Inclusion Criteria:

1. Males or females 18 to 60 years of age
2. Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional
3. Subject is willing and able to comply with all the protocol requirements.

Exclusion Criteria:

1. Primary and/or comorbid psychiatric diagnosis other than ADHD
2. Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug;
3. Has used any investigational drug within 30 days of the screening visit;
Sickle Cell Trait in Football Players

This study will look at the five different types of sickle cell and their relation to self-reported ill health to determine whether or not one or two of the sickle cell haplotypes are correlated with worse health outcomes. Participants can do complete the study in under half an hour in the privacy of their own home.

Sickle cell anemia is a disease which results from the inheritance of two hemoglobin S (Hb S) genes. Sickle-cell anemia individuals are referred to as Hb SS patients, and are known to suffer from a variety of life-threatening symptoms. Paramount in the clinical complications of sickle cell patients is the "sickle-cell crisis". If a crisis is not stopped by prompt medical attention, it may result in death. It is becoming increasingly clear that some sickle cell anemic patients have more benign clinical profiles than do others. The genetic reason for such clinical differences has been well determined: although the mutation that changes the "normal" hemoglobin gene is the same in all patients, the genetic material outside of the gene influences how the gene is expressed. This genetic material is referred to as the beta-globin haplotype. Carriers of the sickle cell gene are referred to as Hb AS individuals. Hb AS carriers usually have a normal life free of the clinical problems associated with the disease suffered by sickle cell patients. However, it is becoming increasingly clear that under strenuous situations, some Hb AS carriers do experience heat illness and other life threatening problems while others do not. The purpose of this project is to determine if there is a genetic reason for why some athlete carriers of the sickle cell trait experience heat illness, while others do not. Although the genetic reason for the different clinical outcomes of sickle cell anemic patients is now well understood (different haplotypes result in different disease courses), the possibility that the same haplotypes might be the reason why some sickle cell carriers have worse clinical profiles has never been explored. In this project we will work with a sickle-cell trait registry of athletes, and we will test the haplotypes of Hb AS athletes who have and who have not had heat illness. Our study is the first to attempt to clarify if there is a genetic reason for this occurrence. Total participation time for the study is thirty minutes or less. Information provided by the participant will be analyzed within one year of participation. Deidentified results will be kept for five years, per the University of South Florida's Institutional Review Board protocol, and will be available upon request to the principal investigator. Participants can do complete the study in under half an hour in the privacy of their own home.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* male
* has previously played or currently plays high school or college football
* carries sickle cell trait

Exclusion Criteria:

* under the age of 18
* female
* does not carry sickle cell trait
* has not played or does not play high school or college football
Stem Cell Translpantation in Multiple Myeloma

The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.

This trial includes a natural (no available HLA-identical sibling donor) control arm. Patients with newly diagnosed multiple myeloma without a sibling are initially treated with conventional chemotherapy followed by conventional single or double autologous transplant (PBSCT). Data from this group is used as part of the control group.

Eligible patients with one or more sibling are offered to participate in the main trial arm. Those who decline are asked to consider taking part in the control group (autograft only).

Patients consenting to participate in the main study first receive the PBSCT, followed by the HLA-matched non-myeloablative allograft (matched for HLA -A, -B, -C, -DRB1).

All study patients receive four to six cycles of VAD (or alternative regimens specified in protocol) before PBSCT as first line treatment. Study entry starts at the time of starting conditioning for autologous transplantation. The search for an identical sibling donor begins as soon as the patient has consented to participate in the study.

The allograft is performed when the patient has restored their marrow function but no earlier than 3 months following PBSCT.

The aim is to demonstrate a difference in outcome (progression free survival, transplant related mortality, relapse rate, and survival).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Stage-II and III multiple myeloma (According to Durie and Salmon classification)
* Age under 70 years
* Life expectancy over 3 months
* Patients must be able to give informed consent

Exclusion Criteria:

* Serious concomitant medical disease which would limit life span or the ability to tolerate chemotherapy
* Severe cardiac failure (ejection fraction \<40%)
* Impairment of renal function at diagnosis is not per se reason for exclusion but patients with severe impaired renal function (GFR \<50 ml/min) after initial VAD (or VAD like) induction treatment are excluded
* Severe impairment of liver function (bilirubin \>2 times upper limit of normal)
* Pregnant or lactating women
* Other major organ system dysfunction (GI, neurological, psychiatric dysfunction) that impairs tolerance of therapy or prolong hematological recovery
Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function

Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function


Eligibility Criteria:
Inclusion Criteria:

* Infants with bilateral cleft lip and palate.
* Centralized pre-maxilla that does not need active appliance.
* Normal inner ear and auditory nerve function.

Exclusion Criteria:

* Infant with unilateral cleft lip and palate or cleft palate only.
* Deviated pre-maxilla that needs active appliance.
* Congenital hearing problems or sensorineural hearing loss/