cyrilzakka/clinical-trials huggingface dataset:
Pain After Endoscopic Submucosal Dissection

Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after ESD.

A prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014. All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) either before or after ESD.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing ESD for gastric neoplasms

Exclusion Criteria:

* (1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders
Comparison of Two Hydroxy-apatite Coated Hip Stems

In this study, the investigators propose to randomize 80 subjects to receive either the Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and follow these patients for a period of 2 years post-surgery. The investigators aim to determine if the Avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.

This is a multi-center, randomized controlled trial of patients undergoing primary total hip arthroplasty. This study will be focused on enrollment at a single site with possible expansion to additional centers should patient enrollment occur at a slower than expected rate. Decision to expand the study to additional centers will be mutually agreed upon by both the clinical site and the study sponsor.

Patients will be randomized to two study groups:

1. Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup;
2. DePuy-Synthes Corail cementless, HA-coated, non-collared femoral hip stem with matching Pinnacle cup Patient allocation to the study groups will occur following a randomized 4-block design.

Eligibility Criteria:
Inclusion Criteria

* Symptomatic osteoarthritis of the hip undergoing primary total hip arthroplasty
* Between the ages of 18 and 79 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria

* Requires specialty implant (e.g., suspected metal allergy, coxa vera implant)
* Avascular necrosis
* Unresolved infection of the hip
* Hip fracture
* Hip dysplasia
* At risk for loss to follow-up
* Prior surgery to the ipsilateral hip
* Severe proximal femoral deformity preventing the use of standard proximal press-fit femoral components
* Medical condition precluding major surgery
* Current or pending patient incarceration
Pharmacological Treatment of Rett Syndrome With Statins

This is a phase 2 , open label, dose escalating study of Lovastatin in Rett syndrome.

Excess neuronal cholesterol plays a role in the pathophysiology of Rett syndrome(RTT) and the investigators hypothesise that inhibition of cholesterol synthesis in the CNS will reduce neuronal cholesterol and lead to improvement in Rett syndrome related symptoms.

Goal: To determine the optimal dosing regiment of Lovastatin for patients with RTT and to identify the most appropriate primary outcome measure for the subsequent Phase 3 study.

Phase 2, dose escalation study.

Primary outcome: Gait speed Secondary outcomes: respiratory function, cognition, EEG (encephalopathy), Rett syndrome severity scale, neurodevelopmental assessment (QOL)

20 ambulatory female patients with genetically confirmed.

Eligibility Criteria:
Inclusion Criteria:

* Females patients,
* Genetically confirmed RTT,
* Ambulatory.

Exclusion Criteria:

* Presence of co morbid non-Rett related disease,
* History of adverse reaction/hypersensitivity to statins,
* Levels of aspartate-amino trans-ferase (AST), alanine-amino transferase (ALT) or creatine kinase (CK) triple the normal values,
* Active liver disease,
* Concomitant use of strong CYP3A4 inhibitors,
* Condition predis-posing to renal failure secondary to rhabdomyolysis (scoliosis surgery within 6 months),
* Oral contraceptives use.
A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

Four hypotheses will be tested in this study:

1. The intervention group performs better in child, parent and transactions outcomes than the control group throughout the follow-up period.
2. The intervention group shows greater changes in early neurophysiological brain functions and transactions within the family that lead to better neurodevelopmental outcomes than the control group.
3. Certain polymorphisms of the dopamine-related genes are associated with the neurodevelopmental outcomes in VLBW preterm infants.
4. Very low birth weight preterm infants carrying more genetic plasticity in the dopamine-related genes may benefit more from the interventions than those carrying less genetic plasticity.

A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.

Eligibility Criteria:
Inclusion Criteria:

* birth body weight \< 1500 grams
* gestational age \< 37 weeks
* parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi

Exclusion Criteria:

* severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC)
* congenital or chromosome abnormality
* mother \< 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol, and drug)

Terminated Criteria:

* diagnosis of brain injury (e.g., PVL, stage IV ROP or greater)
* severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge
* hospital discharge beyond 44 weeks' post-menstrual age.
Gyn Onc Prehab Study

Patients will be randomized to a unimodal or trimodal prehabilitation program prior to surgery for known or suspected gynecologic cancer.

Prehabilitation generally refers to the act of an intervention prior to a known potentially debilitating event. Usually taking the form of physical therapy prior to surgery, prehabilitation programs have demonstrated success in colorectal, urological, and surgical oncology cases. Patients with a gynecologic oncology diagnosis face an arduous course. Their treatment generally involves a major surgery and is often followed by chemotherapy, radiation, or both.The patient population is generally older in life as the average age for an endometrial or ovarian cancer diagnosis is 63. These patients may already have a lower performance status at baseline deeming their treatment course exponentially more difficult to endure. Women with gynecologic cancer suffer significant mental duress often living in fear of the high rates of recurrence from some of these malignancies suggesting they may benefit from psychologic support and counseling through their treatment.

Given the proven success in other surgical disciplines, we believe that instituting prehabilitation programs should be standard of care. Patients will be randomized to a trimodal approach (physical therapy, nutritional counseling, cognitive behavioral therapy) versus a unimodal intervention (physical therapy) for a formal prehabilitation program. Our primary outcome will be functional return to baseline following surgery with secondary outcomes including items such as quality of life assessments, patient satisfaction, and compliance.

Eligibility Criteria:
Inclusion Criteria:

* Patient who will be undergoing a planned surgery for known or presumed gynecologic cancer diagnosis.

Exclusion Criteria:

* Non-English speaking patients
* Surgeries done for palliative intent
* Poor performance status or other inability to participate in physical therapy
European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms

The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.

Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.

Secondary objectives of the study are:

* To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction;
* To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Prostate volume ≥ 30 mL;
* Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
* Consent to participate;

Exclusion Criteria:

* Absence of consent;
* Subsequent withdrawal of consent;
* Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
* Documented bladder impaired contractility
* Urethral stenosis
* Previous prostate surgery
Effect of Hearing Aid Versus Cochlear Implant on Hearing and Speech Recognition in Children

This study examines the comparative effects of hearing aids and cochlear implants on hearing and speech recognition in children with hearing loss.

This research adopts a quantitative approach to compare the outcomes of children using hearing aids versus cochlear implants. Data will be collected through audiological evaluations, including aided audiometry and speech recognition tests conducted in an audiology clinic. Descriptive and inferential statistical analyses will be used to determine differences between the groups.

The study aims to provide evidence-based guidance for audiologists, educators, and caregivers regarding optimal device selection and management. By identifying the strengths and limitations of each intervention, the findings will contribute to improved rehabilitation strategies, ultimately enhancing auditory and speech outcomes in children with hearing loss. This research holds significance for advancing clinical practices in pediatric audiology.

Eligibility Criteria:
Inclusion Criteria:

* Children with 6-18 years of age
* Bilateral hearing aid users with Moderate to Severe degree Sensorineural hearing loss.
* Unilateral Cochlear Implant users with Severe to Profound degree Sensorineural hearing loss and no amplification to other ear.
* Consistent use of hearing aid or cochlear implant for more than 1 year.
* Known or presumed early onset of hearing loss before 3 years of age
* Urdu as primary language of education
* Enrolled in rehabilitation program (school or pre-school for hearing impaired children) focused on oral communication.

Exclusion Criteria:

* Children below 6 years or above 18 years
* Children with less than 1 year of consistent use of hearing aids or cochlear implant
* Children with cognitive, neurological or developmental disorders."
Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC), decreasing the incidence of primary graft dysfunction and primary failure. The degree of dysfunction will be monitored by the method of LIMON, metabonomics techniques and according to the latest published validation Liver Transplantation (16 943-949 2010), total billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days. Liver dysfunction is considered, the presence of a transaminase value\> 2000 IU / L 1-7 postoperative day or BT\> 10 mg / dl or INR\> 1.6, both only in the 7th postoperative day (Olthoff et al Liver Transplantation 16,943 -949 2010).

The reason of this study is to evaluate the efficacy of the use of n-acetylcysteine in liver transplant, by administering it in the perfusion liquid, at the time of extraction of the liver of the donor to improve the damage caused by ischemia / reperfusion. The dose is 400 mg in the portal perfusion liquid.

The study included all considered valid and perfused livers. Patients are randomized to contain no drug or n-acetylcysteine by randomization. Then analyzed using blood tests and in the receiver and daily during the first seven days post-transplant hepatic dysfunction parameters, in order to objectify if liver function improves after administration of the antioxidant (n-acetylcysteine ). Safety assessments were performed with intraoperative monitoring anesthetic depth, postoperative parameters of liver and kidney function and graft pathologic examination after perfusion.

Eligibility Criteria:
Inclusion Criteria:

* All grafts perfused by extraction for liver transplantation.

Exclusion Criteria:

* \< 18 years
* Allergy to NAC
* Grafts considered invalid for liver transplantation after perfusion
* Hepatitis fulminant
* Retransplantation
* Split
* \> 10 hours of cold ischemia
* Patients with asthma
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Patients receive 1 of the following:

1. ABT-378/RTV plus NVP plus 2 NRTIs; or
2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 12 years old.
* Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
* Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
* Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
* Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an active illness.
* Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
* Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
* Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
* Have received treatment with a PI other than their current PI.
* Are receiving chemotherapy for cancer.
* Are pregnant or breast-feeding.
Nonsurgical Periodontal Treatment Combined With Anti-TNF-α in Patients With Rheumatoid Arthritis and Periodontitis

Periodontitis is a multifactorial disease of the periodontium that can lead to destruction of the alveolar bone and supporting connective tissue and subsequent tooth loss. Recent studies have shown that periodontitis is associated with age, smoking habits, genetic predisposition, socioeconomic status, and various systemic diseases such as diabetes mellitus, atherosclerosis, obesity, osteoporosis, and rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory disease of unknown etiology that primarily affects the joints. Periodontitis and RA have similar clinical and pathogenic features. Clinically, both diseases are characterized by local destruction of hard and soft tissues. Their pathogenesis involves the release of cytokines and matrix metalloproteinases (MMPs) from inflammatory cells. Expression of proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) leads to the release of high levels of inflammatory mediators that cause bone destruction and the spread of inflammation. TNF-α is the main regulatory cytokine in both RA and periodontitis. TNF-α inhibitors (anti-TNF-α) reduce the number of inflammatory cells, osteoclast formation and bone loss. In addition, many immunological processes have been identified that are similar to both diseases. Autoreactive T cells, natural killer cells, heat shock proteins, autoantibodies and genetic factors are reported to play an important role in the inflammatory pathway of RA and periodontitis.

Recently, TNF-α blocking agents (anti-TNF-α) have been developed and used for the treatment of RA. Animal and human studies have suggested that anti-TNF-α treatment may reduce the severity of periodontitis.

The aim of this study was to investigate the effect of nonsurgical periodontal treatment combined with anti-TNF-α on alveolar bone loss and oxidative stress in individuals with RA and periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Having a confirmed diagnosis of Rheumatoid Arthritis (RA),
* Having a diagnosis of Stage III-IV periodontitis,
* Having at least 20 teeth,

Exclusion Criteria:

* Having used antibiotics for the 3 months before the study,
* Being pregnant and lactating,
* Having received periodontal treatment in the last 6 months,
* Being diabetic.
* Smoking.
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is \<200.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age
* hepatitis C, genotype 1 or 4, of over 6 months duration
* treatment-naïve
* negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

* pregnant or breast feeding females or male partners of pregnant females
* previous interferon or ribavirin based therapy or investigational anti-HCV agent
* systemic antiviral therapy with established or perceived activity against HCV \</=3 months prior to first dose of study drug
* hepatitis A or B, or HIV infection
* history or evidence of medical condition associated with chronic liver disease other than HCV
Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)

The investigators are evaluating the role of senescent cells in uterine fibroids.

Uterine fibroids are prevalent tumors of uterus characterized by excessive fibrotic tissues. Using new cutting-edge computational methods, the investigators have found that small groups of senescent cells in fibroids work in concert with immune cells to produce soluble factors in fibroid tissues to create a feed-forward loop leading to fibrosis. This project seeks to unravel key cell-cell communication networks involving senescent and immune cells in fibroids to develop new treatments for uterine fibroids.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be women above the age of ≥18 - ≤55 years.
* Women with suspected uterine fibroids.
* Subject must be or have been sexually active or have had a previous vaginal exam that used a speculum.
* Subject must be able to understand, read and speak English or Spanish and subsequently, be able to understand what she is consenting to in terms of procedures and use/disclosure of protected health information.

Exclusion Criteria:

* Unwilling to sign the consent form or complete questionnaire.
* Pregnancy.
* Cancer of the uterus
Evaluation of the Use of Resources and Costs

Evaluation of the use of resources and costs with O-arm in deep brain stimulation (DBS) surgeries and complex back surgeries

To measure the use of health resources in application A (with DBS) and in application B (vertebral fusions), in patients in the intervention group with O-arm and in the control group (usual care without O-arm) with the cost in each phase (pre-surgical, surgical, post-surgical and follow-up at 6 months (RAQUIS) and at 12 months (DBS))

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years.
* Signed informed consent.
* Patients with indication for DBS surgery for movement disorders, epilepsy and obsessive-compulsive disorder, or for cervical, dorsal or lumbar fusion surgery levels 1,2 and 3 in a degenerative disease

Exclusion Criteria:

* Patients who have had pediatric instrumented surgery.
* Patients in which the pedicle screws are inserted for neoplasia or other disease.