cyrilzakka/clinical-trials huggingface dataset:
Pelvic Congestion Syndrome and Endometriosis

The pelvic congestion syndrome (PCS) is a complex and multifactorial condition associated with inflammatory and hormonal etiophatogenesis similar to the endometriosis.

Furthermore, both pathologies share same clinical symptoms as chronic pelvic pain and dyspareunia.

Our hypothesis is that PCS prevalence is higher in patients with endometriosis than in those without clinical or ultrasound signs of endometriosis.

Patients undergoing routine gynecological examinations are included in the study.

Patients are divided into 2 groups:

* Group A: with endometriosis
* Group B: without clinical or ultrasound signs of endometriosis This is an observational, monocentric, prospective, exploratory study. The aim is to assess PCS incidence, associated symptoms and ultrasound characteristics in patients with endometriosis and to compare those findings to those of patients who do not present clinical or ultrasound signs of endometriosis.

The study also evaluates the correlation between:

* Type of pain symptoms (dysmenorrhea, chronic pelvic pain, ovulation pain, dyspareunia, dysuria, dyschezia) and PCS
* Pain severity (assessed according to VAS scale from 0= no pain to 10= unbearable pain) and PCS
* Symptoms and ongoing medical treatments
* History of pelvic surgery and PCS.

Ultrasound parameters of pelvic vascular insufficiency are:

* Ovarian vein diameter \<4mm
* Slow ovarian blood flow (\<3cm/sec)
* Retrograde blood flow
* Dilated arcuate veins communicating with pelvic varices
* The presence of pelvic varices is evaluated qualitatively as normal, moderate and serious

This evaluation includes the study of uterine and ovarian vessels, using different techniques:

* Standard 2D study: it allows to measure vessels diameter
* Vascular doppler study: it allows to evaluate flow direction and blood speed
* 3D color study: it allows a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree.
* Ultrasound images are evaluated independently by two operators.

Eligibility Criteria:
Inclusion Criteria (Group A):

* Obtaining Informed Consent
* Nulliparity
* Clinical or ultrasounds signs of endometriosis

Inclusion Criteria (Group B):

* Obtaining Informed Consent
* Nulliparity

Exclusion Criteria:

* Menopause
* Actual or previous pregnancy
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy

Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by the investigator; and:

  1. if patient is able to give consent: by the study patient
  2. if patient is unable to give consent: by the legal representative or
  3. if an emergency situation is determined: by an independent consultant physician
* Minimum age of 18 years

Study-specific:

* Body weight greater than 40 kg
* Acute Kidney Injury (AKI) with clinical indication for CRRT
* Hypercapnia with indication for ECCO2R:

(paCO2 ≥ 55 mmHg at given best possible protective ventilation parameters: Guiding parameters: tidal volume = 6 ml/kg PBW, PEEP to be adjusted according to the FiO2 1, driving pressure \< 15 cmH2O, max. inspiratory pressure \< 30 cmH2O or TV\<=5 ml/kg when max. inspiratory pressure\< 30 cmH2O cannot be held)

* Vascular access and Shaldon catheter allowing blood flow of 100 ml/min to 500 ml/min
* Arterial line in place, allowing blood sampling
* Estimated life expectancy greater than 3 days

Exclusion Criteria:

* In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required)
* Participation in an interventional clinical study during the preceding 72 hours
* Previous participation in the same study

Study-specific

* Severe ARDS (Berlin definition): PaO2/FiO2 \< 100 mmHg
* Intracerebral haemorrhage
* Intracranial hypertension
* Acute myocardial infarction
* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II), if heparin is used as anticoagulant
* severe liver insufficiency or fulminant hepatic failure
* Uncontrolled bleeding and coagulation disorders, thrombocytopenia \< 75000µL
* Liver cirrhosis CHILD Pugh Classification \> A
* BMI \> 40 kg/m²
* Decision to limit therapeutic interventions
Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI

In this proposed study, Text messages are used to intervene in the NSSI behavior of adolescents, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of adolescents' NSSI behavior is discussed.

In this proposed study, the investigators will evaluate the effect of text message intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110 adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the participants will be randomized to the intervention group (55 cases) or the control group 55 cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety, and hopelessness 3) The use of emotion regulation strategies and coping styles. A semi-structured quantitative interview will be conducted among adolescents from the SMS group to get the attitude and experiences feedback about the text message.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents aged 10-19 years old.
2. Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.
3. The adolescents who have mobile phone, and have the ability to send or receive text messages.
4. Adolescents and guardians agreed to participate and signed the informed consent form

Exclusion Criteria:

1. Adolescents with severe somatic diseases who cannot complete the study.
2. Adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study.
3. The adolescents who do not have a mobile phone.
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)
* Participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
* Prior CNS or leptomeningeal metastases allowed if asymptomatic
* Participants with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
* Measurable disease by RECIST Version 1.1 prior to the administration of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment

Exclusion Criteria:

* Participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal \[GI\] cancer by endoscopic resection or in situ carcinoma of the cervix)
* Participants who have received any previous ALK inhibitor other than crizotinib
* Any GI disorder that may affect absorption of oral medications
Management of Heart Failure in Italian Outpatients Clinics: Observational Study

OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.

Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines.


Eligibility Criteria:
Inclusion Criteria: age \>18 years, post-menopausal, permanent sterile, or childbearing potential on highly effective contraceptive methods women, stable clinical conditions (NYHA class I-III), outpatients setting, capability to understand the study procedures and sign the informed consent form.

Exclusion Criteria: any clinical condition that would have jeopardized patient safety while participating in this study.
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting

Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.


Eligibility Criteria:
Inclusion Criteria:

* Psychosis
* Must be able to use oral antipsychotic drugs

Exclusion Criteria:

* Mania
* Unable to cooperate with the assessments
* Unable to understand Norwegian language
* Candidates for electroconvulsive therapy
* Use of Clozapine at admittance
Addressing Discrimination and Mistrust Among Black Men: Phase III

The purpose of this research study is to test a group program aimed at improving the quality of life of HIV+ Black men who have sex with men. The group will address ways to cope with discrimination and will help men examine mistrust that they may have about healthcare, including doctors and other healthcare providers and HIV medications. The aim is to provide a supportive community for HIV+ Black men.

The aim of the study is to examine whether the pilot intervention can reduce mistrust and improve coping responses to discrimination among HIV positive Black men who have sex with men (MSM). We will conduct a small randomized pilot trial to test the feasibility of evaluation methods. All participants will attend a baseline, a first follow-up visit, and a final follow-up visit (each 3 months apart) at which they will take computer assessments. Participants who are assigned to the intervention will attend 9 weekly intervention sessions after baseline and before the first follow-up. Using a wait-list control design, control group participants from the first two cohorts will be offered the intervention after they complete the final follow-up visit. Control group participants from the third cohort will be offered the intervention after they complete the first final-up visit and before they complete their final follow-up due to timing and budgetary restraints. We will hold three consecutive groups for our small randomized control trial. This means that we will be recruiting continuously; once we finish recruiting for the first group, we will start recruiting for the second group, and so on. Each group has about 12 or 13 intervention and 7-11 control participants.

Eligibility Criteria:
Inclusion Criteria:

* 18 years-old or older
* Biologically male at birth
* Currently self-identifies as male
* Self-identifies as Black or African American (mixed-race individuals will be eligible if they primarily identify as Black or African American)
* HIV-positive
* Reported having sex with men in lifetime
* Able and willing to provide informed consent

Exclusion Criteria:

* Does not meet all of the inclusion criteria (e.g., if they are unable to provide proof of their HIV-positive status)
* Unable to provide informed consent
* Reports or presents evidence of severe mental health problems that require immediate treatment (e.g., psychotic symptoms, active suicidality at time of enrollment) or diagnosed mental disorder that would limit the ability to participate (e.g., dementia)
* Reports or presents evidence of cognitive impairments that limit the ability to comprehend the informed consent or to fully participate in the various parts of the study (assessments, intervention, homework).
Dexmedetomidine and Liver Transplantation

1.1. Background 1.1.1. Perioperative ischaemia/reperfusion (I/R) injury during liver transplantation is strongly associated with early allograft dysfunction, graft loss, and mortality.

1.1.2. Hepatic I/R injury also causes remote damage to other organs including the renal and pulmonary systems.

1.1.3. Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia, has been widely shown in preclinical studies to provide organoprotection by ameliorating the effects of I/R injury in a range of tissues (including the liver). However, prospective clinical evidence of any potential benefits in improving outcomes in liver transplantation is lacking.

1.2. Objectives 1.2.1. To investigate the hypothesis that perioperative treatment with dexmedetomidine reduces the incidence of early allograft dysfunction and primary graft non-function in deceased donor liver transplantation.

1.2.2. The impact of dexmedetomidine on postoperative renal and pulmonary function will also be examined.

1.3. Study Design This is a prospective, single-centre, randomised, parallel-group study.

1.4. Setting Departments of Anesthesiology, Renji Hosptial, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China.

1.5. Patients 200 patients (18-65 years) scheduled to undergo liver transplantation under general anaesthesia.

1.6 Intervention 1.6.1. For the patients in the treatment group, a loading dose of dexmedetomidine will be given after induction of anaesthesia (1μg/kg over 10 min) followed by a continuous infusion (0.5μg/kg /h) until the end of surgery.

1.6.2. For patients in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anaesthesia followed by an equal volume continuous infusion until the end of surgery.

1.6.3. All other supplements, e.g. opioids, sedatives and muscle relaxant, will be identical in the both arms and administered according to routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years
2. Scheduled to undergo allogenic liver transplant(DCD/DBD) surgery under general anaesthesia
3. Patients should meet the UCSF criteria
4. Agree to participate and give written informed consent

Exclusion Criteria:

1. Severe renal dysfunction (undergoing renal replacement therapy before surgery)
2. Severe pulmonary dysfunction (including pneumonia, atelectasis, pleural effusion, acute lung injury or ARDS)
3. Severe circulatory instability (severe coronary artery disease, unstable angina, left ventricular ejection fraction \< 30%, sick sinus syndrome, severe sinus bradycardia \[\< 50 bpm\], second-degree or greater atrioventricular block)
4. Known allergy or intolerance to trial medication
5. Refusal to participate in the study
6. Participation in other clinical trials within 30 days prior to randomisation.
7. Retransplantation
8. Multiple organ transplantation
9. Other reasons that are considered unsuitable for study participation by the responsible surgeon or anaesthetist (reasons must be documented in the case report form \[CRF\])
Role of Vitamin C Infusion in Postoperative Mechanically Ventilated Neonates With Sepsis

This study aims to evaluate the effect of intravenous vitamin C infusion on septic mechanically ventilated full-term neonates who underwent surgical interventions regarding mechanical ventilation parameters, time to wean, and the need for inotropic support.

Neonatal sepsis is a syndrome featuring non-specific signs and symptoms of systemic infection accompanied by bacteremia in the first 28 days of extrauterine life. This condition is a public health problem that still contributes to mortality and morbidity in neonatal intensive care units (NICUs) in high, as well as low- and middle-income countries.

Vitamins are essential micronutrients with key roles in many biological pathways relevant to sepsis. Some of these relevant biological mechanisms include antioxidant and anti-inflammatory effects, protein and hormone synthesis, energy generation, and regulation of gene transcription.

Vitamin C, ascorbic acid, is a water-soluble essential micronutrient commonly found in plants, especially fruits. When absorbed, it dissociates at physiological pH to form ascorbate, the redox state of the vitamin most commonly found in cells. In addition to being a potent antioxidant, vitamin C is a cofactor for enzymes involved in protein and hormone synthesis, metabolic pathways for energy generation, and regulation of gene transcription.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 37 weeks.
* Both sexes.
* Neonates with sepsis are diagnosed both clinically and serologically after any surgical intervention.

Exclusion Criteria:

* Major congenital anomalies and Chromosomal abnormalities.
* neonate \<37weeks gestation.
* Hypoxic Ischemic Encephalopathy (HIE).
* Neuromuscular diseases.
* Intraventricular hemorrhage (IV Hge).
P53 Immunohistochemistry Abnormal Staining in Endometrial Cancer

Objective: Calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types and grading.

Patients and methods:

100 cases of endometrial cancer will be included in the study, recruited from Alexandria university hospital gyne-oncology unit. Surgical staging, histopathological examination and immunohistochemistry of p53 were done to all cases to calculate the incidence of P53 immunohistochemistry abnormal staining in endometrial cancer and to identify its relation with disease stages, pathological types, grading.

Keywords: P53 immunohistochemistry, endometrial cancer, clinicopathological relation.


Eligibility Criteria:
Inclusion Criteria:

* endometrial cancer patients

Exclusion Criteria:

* patients unfit for surgery
Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation

A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the potential of using NGS to guide MRD eradication by blinatumomab.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with B cell precursor acute lymphoblastic leukemia
* Patients who received blinatumomab for consolidation
* Patients who were detected MRD positive by NGS before initiation of blinatumomab treatment

Exclusion Criteria:

* Patients without data of NGS detection after receiving blinatumomab treatment
Intra Artherial Therapies in Treatment of Primary Liver Diseases: an Observational Study

The goal of this observational study is to learn what are the best conditions that will give a positive outcome to men and women that receive a intra arterial therapy (IAT) for primary liver cancer.

Intra arterial therapies are radiologic procedures that block liver cancer blood supply.

The researchers will collect the data of participants located in the Radiology department in "IRCCS Azienda Ospedaliera Universitaria" Hospital in Bologna and will study clinic and radiological traits to understand which is the best case scenario for a optimal treatment response.

This study is non profit, observational, retrospective, prospective and single institution.

The researchers will do a retrospective and prospective data collection and analyze the results. They will examine the radiological images (CT scan and RM) to assess the type and size of the cancer, track how the disease responds to treatments, identify possible complications.

There are no drugs involved and all the intra arterial therapies are performed within the routine clinical-care path.

* For the retrospective phase the researchers will analyze radiological image of the participants that received a intra arterial therapy from the 1st of January 2009. It's expected to enroll around 2000 participants.
* For the prospective phase the researchers will enroll for 5 years eligible participants that will receive a intra arterial therapy. Participants will go through a follow up every three months for the duration of the whole study. It is expected to enroll around 1300 participants.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA) and clinical indication to receive or have already received one of the following treatments:

  * Trans-arterial embolization (TAE),
  * Transarterial chemoembolization (TACE),
  * Transarterial radioembolization (TARE)
  * Drug-eluting beads chemoembolization (DEB-TACE)
* Age over 18
* To give informed consent

Exclusion Criteria:

* shunt of gastro intestinal arteries that cannot be embolized
* metastasis spread outside of the liver
* liver failure