cyrilzakka/clinical-trials huggingface dataset:
The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain.

This study try to find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain.

There were reports of no association with anesthesia in the area of anesthesia to the high pain control requirement in the postoperative recovery room, 24 hours of high pain medication, use of inhalation agent, and a high dosage of remifentanil. However, an anesthesia-related study was either a retrospective study or anesthetic was injected with more than a clinical dose in order to make the difference following methods.

In this study, bispectral index is used to maintain anesthesia depth. In addition, the commercially available noninvasive pain depth equipment (Surgical Pleth Index) is used to assess the nociception-antinociception balance. Displays the automatically calculated values of SPI=100-(0.3\*heartbeat interval + 0.7\*photoplethysmographic pulse wave ampule) using a waveform with peripheral oxygen saturation. Through this process, patients want to objectify the amount of anesthetic agent used during surgery. And all patients are inserted the laryngeal mask airway.

This study would try find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

The investigators hypothesize that patients who suffered severe acute postoperative pain, regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy pain.

Eligibility Criteria:
Inclusion Criteria:

-undergoing breast conserving surgery + sentinel lymph node dissection

Exclusion Criteria:

* cardiac arrythmia
* allergic history for drugs
* renal failure (Cr\> 1.5 mg/dl)
* performing axillary lymph node dissection or Total mastectomy
* difficult airway and failed to place laryngeal mask airway properly
An Adequate Cost Effective Follow Up Protocol For Bone & Soft Tissue Sarcomas - A Prospective Randomized Trial

The purpose of this study is to evaluate the impact on overall survival of an intensive follow-up protocol (as practiced today at TMH) against a more cost effective follow-up protocol in patients operated for extremity sarcoma.

Follow up studies are performed for a variety of reasons. The detection of a recurrence of the index lesion is the foundation of surveillance. Detection of other medical conditions is a secondary benefit. Psychologically, follow up testing can serve as a source of reassurance. Whether an increased frequency of follow up and the use of various expensive imaging modalities for screening and early detection of recurrence actually results in improving overall survival of patients with extremity sarcomas is a question that remains as yet unanswered. Currently followed post -operative surveillance regimes are empirical and vary widely from centre to centre. Allocation of limited health funding should be guided by evidence based recommendations rather than empirical beliefs. An ideal surveillance regime should meet the criteria of easy implementation, accuracy and cost effectiveness.

In a vast country like India where patients often travel thousands of kilometers in their search for quality medical care the frequency of routine follow up visits is as important as studying the role of expensive screening modalities while drawing up guidelines for cost effective follow up strategies.

This study, a prospective randomized controlled trial, attempts to outline guidelines regarding the role of follow up vis a vis frequency and the use of various imaging modalities for early detection of recurrence in improving overall survival of patients with extremity sarcomas.

Eligibility Criteria:
Inclusion Criteria:

1. Patients operated for primary or recurrent extremity bone \& soft tissue sarcomas.(both limb salvage and amputations)
2. Non Metastatic at presentation.
3. Patients reliable for follow-up.

Exclusion Criteria:

1. Non-extremity sarcomas.
2. Metastatic at presentation
3. Patients unreliable for follow up.
Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate

During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient hospitalized in an intensive care unit
* Patient with acute renal failure defined by a KDIGO stage ≥ 1 and suspected non-obstructive
* Patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and/or cardiovascular SOFA ≥ 1 and/or lactatemia \> 2mmol/L)
* Indication for Extra Renal Replacement Therapy with IHD.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Known chronic renal insufficiency of any stage
* Cardio-renal and hepato renal syndrome
* Unstable hemodynamic state: refractory shock
* Patient included in another interventional study likely to modify the hemodynamic state
* Patient deprived of liberty
* Patient under guardianship or curatorship
* Patient not affiliated to a social security system
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Adult Type 1 or 2 diabetic patients that present with foot ulcers.
* Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
* Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
* Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
* All ulcer durations will be eligible
* Patients currently receiving NPWT for a diabetic foot ulcer
* Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.

Exclusion Criteria:

* Active foot infections
* Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
* Patients who are pregnant
* Allergies to any material contained within the NPWT or bioscaffold
* Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
Enhanced Housing Placement Assistance

Randomized controlled trial of housing placement assistance for homeless persons with HIV

Approximately 800 persons living with HIV/AIDS (PLWHA) reside in HIV emergency single-room-occupancy (SRO) hotels in New York City and do not have the ability to secure permanent housing on their own. The study evaluated a pilot program which fast-tracked PLWHA from HIV emergency SRO hotels into permanent housing. The Enhanced Housing Placement Assistance (EHPA) program had three components: 1) active recruitment of emergency SRO hotel residents with high need for housing; 2) assistance in the rapid (fast-track) acquisition of permanent housing; and 3) participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability. Participants were randomly assigned to either 1) EHPA or 2) usual care, which included standard connections to services and housing programs offered by the New York City HIV/AIDS Services Administration (HASA), Housing Opportunities for Persons With AIDS (HOPWA), or Ryan White services, and were followed over twelve months using a questionnaire developed with significant input from the target population of PLWHA residing in emergency SRO hotels.

Eligibility Criteria:
Inclusion Criteria:

* Person living with HIV in New York City
* Residing in an New York City HASA single-adult single-room-occupancy (SRO) hotel

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete survey in English or Spanish
Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy

Objective of the study: to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy.

A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves clinical and hemodynamic results in patients scheduled to septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal myectomy. If patients were suitable for both surgical techniques, they were randomized to septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons were experienced at least 50 related procedures.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent (either from the patient or a substitute decision-maker)
* Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy

Exclusion Criteria:

* indications for mitral valve replacement
* Patient failure at any stage of the study
Human Papillomavirus in Young People Epidemiological Research 4

Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years.

The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program.

Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 21 to 25 years old in 2023-2024
* Same-sex attracted
* Residing in Australia since 2013

Exclusion Criteria:

* Unable to complete all study requirements in English
An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia

This multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center observational clinical study. The main purpose is to evaluate the safety. And the second purpose is to evaluate the efficacy of atypical antipsychotics. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. This study belongs to IV period post-marketing drugs research. Planned sample size is 3000 cases.

Visits occurs at 0,4,8,13,26,52,78,104,130 and 156 weeks. The main indexes include physical examination, vital signs, abdominal circumference , laboratory tests (blood cell analysis/ blood biochemical tests / prolactin (PRL) / thyroxine, etc.), adverse events, 12-lead electrocardiogram( ECG), extrapyramidal syndrome(EPS )assessment, sexual function evaluation, medication and other subjective feelings. The second indexes include scales of Positive and Negative Syndrome Scale(PANSS)，Clinical Global Impression-severity of Illness Scale(CGI-S), Calgary Depression Scale for Schizophrenia(CDSS),Personal and Social Performance Scale(PSP), the MOS 36一item Short Form Health Survey(SF-36), relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.


Eligibility Criteria:
Inclusion Criteria:

1. An in-patient or out-patient (male or female) and aged ≥18 years
2. A diagnosis of schizophrenia,DSM-IV(Diagnostic and Statistical Manual Diploma in Social Medicine-IV)
3. Subjects must have the ability to effectively communicate with investigator,complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures.
4. Patients are taking or will take atypical antipsychotics which include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine

Exclusion Criteria:

1. Participation in other clinical studies.
2. Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
POPQ Versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair During Vaginal Reconstruction

The objective of the Preoperative Pelvic Organ Prolapse Quantification (POPQ) versus Simulated Apical Support as a Guideline for Anterior or Posterior Repair at the Time of Transvaginal Apical Suspension (PREPARE) trial is to compare surgical outcomes of POPQ-based surgery with simulated apical support-based surgery for anterior or posterior vaginal wall prolapse at the time of transvaginal apical suspension.

The PREPARE trial is a prospective, randomized trial conducted with the aim to determine non-inferiority of the primary outcome between POPQ-based surgery and simulated apical support-based surgery for anterior or posterior vaginal wall prolapse. Participants will undergo transvaginal surgery for prolapse, including the assigned procedure for anterior or posterior vaginal prolapse under general or spinal anesthesia. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive transvaginal vault suspension, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension with both delayed absorbable and permanent sutures, according to the preference of surgeon. Incontinence surgery will also be performed for women with documented urodynamic stress incontinence.

A standardized protocol for enrollment, treatment and data collection will be employed by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, it is our intent that when feasible and ethical, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks and 6, 12, and 24 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* POPQ stage 2-4 prolapse
* Descent of vaginal apex or cervix at least ½ way into vaginal canal (i.e. POPQ point C ≥ -TVL/2)
* Correction of either anterior or posterior vaginal wall prolapse under simulated apical support (i.e. from stage 2 or greater to stage 0 or 1)
* Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)
* Vaginal reconstructive surgery is planned, including a vaginal apical suspension procedure

Exclusion Criteria:

* Large pelvic mass
* Previous prolapse surgery
* Known malignancy
* Two or more inpatient hospitalizations for medical comorbidities in the previous year
* Subject wishes to retain her uterus
* Subject is unable and unwilling to participate in
Acute Myocardial Infarction by Penetrating Cardiac Trauma

Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their damage in the cardiac injury repair. The investigators objectives are to know the PAMI incidence, make an approximation to PAMI pathophysiology, and propose management strategies.


Eligibility Criteria:
Inclusion Criteria:

* Heart stab Injury

Exclusion Criteria:

* Previous cardiac injuries, coronary artery disease with previous diagnostic, previous coronary angiography (for any indication)
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine

The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection.

This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.

A reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (HAART). This is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy.

The majority of the viruses in the latent reservoir use CCR5 receptor during entry.

More recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. The treatment of acute infection may set the stage for subsequent attempts at eradication. To achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed.

In contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. In addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets.

Maraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in HIV-1 infected patients with a recent HIV-1 infection.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected adults (\>=18 years old).
2. No previous antiretroviral therapy for more than 2 weeks.
3. HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months.
4. CCR5-tropism confirmed at screening.
5. Voluntary written informed consent.

Exclusion Criteria:

1. Pregnancy or fertile women willing to be pregnant.
2. Active substance abuse or major psychiatric disease.
3. Presence of NRTI mutations in the screening genotype.
The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study

Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost.

The fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed pulmonary TB and extrapulmonary TB patients
2. No previous anti-TB drugs treatment
3. Age more than 18years old

Exclusion Criteria:

1. Expected life \< 6months
2. Baseline AST and ALT \> 3 fold upper limit of normal (ULN) or total bilirubin\>2mg/dl
3. Age less than 18years old
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (OCA). All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria were considered for this study.


Eligibility Criteria:
Key Inclusion Criteria:

1. Definite or probable PBC diagnosis
2. Inadequate response or intolerance to UDCA
3. Age ≥18 years at the index date
4. Continuous enrollment and evaluable data for at least 12 months before the index date (inclusive)

Key Exclusion Criteria:

1. History or presence of other concomitant liver diseases
2. History of non-skin malignancy or melanoma
3. History of HIV
4. Medical conditions that may cause non-hepatic increases in ALP
5. Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
6. History of liver transplant
7. Evidence of fenofibrate, or bezafibrate use
8. History or presence of hepatic decompensating events