cyrilzakka/clinical-trials huggingface dataset:
BUILD 3: Bosentan Use in Interstitial Lung Disease

BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female aged 18 years or older (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception.)
* Proven diagnosis of IPF according to American Thoracic Society / European Respiratory Society (ATS-ERS) statement, of \<3 years, with surgical lung biopsy (SLB)

Exclusion Criteria:

* Interstitial lung disease due to conditions other than IPF.
* Presence of extensive honeycombing (HC) on baseline high-resolution computed tomography (HRCT) scan.
* Severe concomitant illness limiting life expectancy (\<1 year).
* Severe restrictive lung disease.
* Obstructive lung disease.
* Diffusing capacity of the lung for carbon monoxide \<30% predicted.
* Residual volume \> or = 120% predicted.
* Documented sustained improvement of patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
* Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
* Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements.
* Chronic heart failure with New York Heart Association (NYHA) class III/IV or known left ventricular ejection fraction \<25%.
* Alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) \> 1.5 times the upper limit of the normal ranges.
* Moderate to severe hepatic impairment.
* Serum creatinine \> or = 2.5 mg/dl or chronic dialysis.
* Hemoglobin concentration \<75% the lower limit of the normal ranges.
* Systolic blood pressure \<85 mmHg.
* Pregnancy or breast-feeding.
* Current drug or alcohol dependence.
* Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of randomization):oral corticosteroids (\>20 mg/day of prednisone or equivalent), immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of N-acetylcysteine (prescribed for IPF).
* Oral anticoagulants other than those indicated for a venous or arterial thrombotic disease.
* Treatment with glibenclamide (glyburide) and calcineurin inhibitors (cyclosporine A, tacrolimus) up to 1 week prior to randomization.
* Treatment with an endothelin receptor antagonist up to 3 months prior to randomization.
* Participation in the BUILD 1 trial.
* Treatment with another investigational drug up to 3 months prior to randomization or planned treatment.
* Known hypersensitivity to bosentan or any of the excipients.
INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring

Background

INTELLiVENT-ASV, an automated closed-loop mode of mechanical ventilation, available on Hamilton ventilators for clinical use, uses mainstream end-tidal CO2 (etCO2) monitoring to adjust minute ventilation. However, sensors for mainstream etCO2 monitoring are expensive and fragile. The less expensive and more robust sensors for sidestream etCO2 monitoring could serve as a good alternative to sensors for mainstream etCO2 monitoring.

Objective of the study

The objective of this randomized noninferiority trial is to determine whether INTELLiVENT- ASV with sidestream capnography is noninferior to INTELLiVENT-ASV with mainstream capnography with regard to the percentage of breaths in a broadly accepted predefined 'optimal' zone of ventilation.

Hypothesis

The investigators hypothesize that INTELLiVENT-ASV with sidestream capnography is noninferior to INTELLiVENT-ASV with mainstream capnography with respect to the percentage of breaths a patient spends within the 'optimal' zone of ventilation.

Study design

INTELLiSTREAM is a randomized noninferiority study.

Study population

The study population consists of consecutive elective cardiac surgery patients who are expected to need at least 2 hours of postoperative ventilation in the ICU of Amsterdam Medical University Centers, location 'AMC'.

Intervention

Shortly after arrival at the ICU, patients will be randomized to receive either ventilation with INTELLiVENT-ASV with mainstream capnography or sidestream capnography.

Primary outcome of the study

The primary study endpoint is the percentage of breaths a patient spends inside the 'optimal' zone of ventilation, as defined before (i.e. tidal volume \< 10 ml/kg PBW, maximum airway pressure \< 30cm H2O, etCO2 between 30-46 mmHg and pulse oximetry between 93-98%).

Secondary outcomes

The percentage of time spent in other ventilation zones, as defined in the protocol. Time to spontaneous breathing, duration of weaning, loss of etCO2 signal, duration of postoperative ventilation and ventilator parameters as well as results of clinically indicated arterial blood gas analysis.

Nature and extent of burden and risks associated with participation, benefit and group relatedness Hamilton ventilators can use mainstream and sidestream etCO2 sensors. INTELLiVENT-ASV is a safe mode of ventilation, also in patients who receive postoperative ventilation. Furthermore, as all patients are sedated as part of standard care during postoperative ventilation, the burden for the patient is minimal


Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective cardiac surgery in the Amsterdam University Medical Centers, location 'AMC'
* Planned admission to the ICU for postoperative ventilation
* Expected to need postoperative ventilation for at least 2 hours

Exclusion Criteria:

* Age under 18 years
* Patients previously included in the current clinical trial
* Patients participation in other interventional clinical trials that could influence ventilator settings and ventilation parameters
* Patients with suspected or confirmed pregnancy
* Moribund patients
Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Study

Small cell lung cancer (SCLC) is one of the most aggressive lung cancer subtypes, accounting for approximately 15-20% of total lung cancer cases. Although SCLC is relatively sensitive to chemotherapy, it is highly susceptible to recurrence. The advent of immunotherapy has revolutionized the clinical practice of oncology, and the newly released results of the ASTRUM-005 study have led to the incorporation of Serplulimab into the first-line treatment of extensive-stage SCLC. Although immunotherapy in combination with chemotherapy is currently the most promising regimen, due to the limited understanding of genetic alterations and the marked genetic heterogeneity of SCLC, treatment responsiveness varies greatly. Thus, there is an urgent need to find molecular biomarkers that can effectively predict prognosis and further suggest the effectiveness of this new treatment mode.

Minimal residual disease (MRD) refers to the presence of tumor cells disseminated from the primary lesion to distant organs in patients who lack any clinical or radiological signs of metastasis or residual tumor cells left behind after local therapy that eventually lead to local recurrence. These years, the development of real-time, high-sensitivity liquid biopsy assays have enabled the identification of MRD in individual patients with cancer. Multiple studies have demonstrated that detection of MRD dynamics following definitive therapy for solid cancers is strongly prognostic and has extremely high positive predictive value for risk of recurrence and treatment efficacy.

The aim of this study was to explore the predictive value of MRD dynamics on disease prognosis before and after the first-line treatment of Serplulimab in combination with chemotherapy for extensive-stage SCLC.


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.
* Have previously untreated and confirmed by histological and imaging examinations as extensive small cell lung cancer
* Adequate organ function and expected survival time ≥ 12 weeks;
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Key Exclusion Criteria:

* Presence of mixed carcinoma component on histology.
* Patients with other active malignancies within 5 years prior to enrollment.
* Known active autoimmune diseases.
* Currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose.
* Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
* Presence of other uncontrolled serious medical conditions.
Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma

This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.

Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.

Eligibility Criteria:
Inclusion Criteria:

* first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
* pretreatment with systemic therapy
* 18-65 years of age
* Performance status:ECOG 0-2
* Granulocyte count \>1.5/µm3, Platelet count \>100/µm3
* Creatinine -Clearance ≥ 1 ml/sec
* GPT/GOT ≤ 1.5 x normal (except tumour related)
* Bilirubine \< 22 µmol/l
* no participation in another study 3 month before and during this study
* informed consent

Exclusion Criteria:

* Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
* CNS- involvement by lymphoma
* respiratory Partial- or global insufficiency
* cardiac insufficiency (NYHA-Stage 3-4, EF \< 30 %)
* severe neurological or psychiatric disease
* pregnancy
* HIV positivity ,active virus hepatitis, bacterial infection
* No follow up procedures ensured
Oxytocin in Spectrum Autism Disorders

Observe effects of oxytocin on individuals with autism spectrum disorder

To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is a randomized, double-blind, placebo-controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:Diagnosis of ASD by DSMV

* CARS\> 30
* age between 3 and 16 years
* stable (3 months with medication maintained or without medication)

Exclusion Criteria:- pregnant women, infants and

* participation in another research project of pharmacological or behavioral intervention in progress
* Use of pituitary hormones, cortisol, androgens and estrogens.
* heart problems: recent AMI, heart failure.
* respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.
71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women

An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A\>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies.

Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* hirsute women with polycystic ovary syndrome

Exclusion Criteria:

* Use of any drugs known to interfere with hormone levels for at least 3 months before the study
* Women with type 2 diabetes, homa index \> 3.8, liver or renal disease or thyroid dysfunction
* Other hyperandrogenic disorders than PCOS
PRISM: Patient Experiences With PET Imaging in Prostate Cancer

The purpose of this study is to examine patient experiences, health-related quality of life, and decision-making associated with PET imaging for prostate cancer. In particular, Prostate Specific Membrane Antigen (PSMA) PET, a new and more sensitive form of imaging that can help identify metastatic cancer earlier and more reliably.

The primary objective is to measure health related quality of life among patients with prostate cancer who are undergoing prostate specific membrane positron emission tomography (PSMA-PET) imaging. This will be assessed in four domains: cancer related anxiety, decisional conflict, health related quality of life (physical functioning) and health preferences.

The secondary objective is to conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging.

Study Design Investigators will conduct a longitudinal explanatory sequential mixed methods study consisting of two phases. In the first phase, serial quantitative psychological (anxiety, uncertainty) and HRQoL survey data from patients undergoing PET imaging in routine clinical care will be collected. In the second phase, a subset of patients from phase 1 who have completed initial surveys will be recruited and conduct longitudinal in-depth qualitative interviews to better explore patient experiences and perspectives on PET imaging.

Patient clinical and sociodemographic data will be collected through automated extraction from the medical record (EPIC) into the REDcap database through collaboration with JDAT. For fields that are not populated via automated methods we will manually enter information via abstraction of the patient's medical record (EPIC).

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of prostate cancer
* Scheduled for their FIRST PSMA PET scan for prostate cancer
* English-speaking
* Willing and able to complete 4 surveys electronically or on paper at 3 timepoints (within 1 month after PET scan, 3-6 months, 12 months)
* Able to use mobile device (smartphone or tablet) or computer with web access to complete study surveys or able to complete paper surveys

Exclusion Criteria:

* Lack of access to a mobile device (smartphone or tablet) or computer with web access or unable to receive surveys by mail.
* Unable to give consent and be enrolled
* PET scan is being conducted within a clinical trial
Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma

To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD): expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis.

To determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 10 mg per day) to the standard treatment with cisplatin and pemetrexed.

To determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib.

Serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically diagnosed malignant mesothelioma
* age \> 18 years
* Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy)
* Measurable or evaluable disease is not required
* Ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course
* No previous chemotherapy
* Radiotherapy is allowed when this is given for palliation, the interval is \> 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field.
* WHO performance status =\< 2
* Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:

Hematology:

* ANC=\>1.5 x 109/L,
* Platelets=\>150 x 109/L,
* Hemoglobin =\> 6,0 mmol/l

Chemistry:

* total serum bilirubin \< UNL;
* AST and ALT= \< 2.5xUNL,
* AP \< 5xUNL (unless bone metastases are present in the absence or any liver disease)
* Serum creatinine =\< 2xUNL

Exclusion Criteria:

* Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency
* Previous successful pleurodesis
* Uncontrolled hypertension
* Symptomatic peripheral neuropathy =\> grade 2 according to NCIC CTC,version 3.0
* Presence of symptomatic CNS metastases
* Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition
* Concomitant administration to any other experimental drugs under investigation
* Impaired renal function
Prophylactic Fenestration of the Peritoneum in Kidney Transplantation

A single centre open randomised parallel-group study to evaluate whether prophylactic fenestration of the peritoneum at the time of renal transplantation prevents lymphocele formation.

Adult (\>18 years old) recipients of renal transplants from deceased donors were eligible for inclusion. From March 2007 to May 2009 130 patients were included. The patients were randomized either to peroperative peritoneal fenestration, or to serve as controls. Block-randomization was conducted in groups of 10, drawn from envelopes containing five notes from each group. Patients who previously had undergone extensive abdominal surgery, or were included in other studies were excluded.


Eligibility Criteria:
Inclusion Criteria:

* Adult recipients of kidney transplants from deceased donors

Exclusion Criteria:

* Former extensive abdominal surgery
* Participation in other studies
Evaluation of Play and Care Together (PACT) Implementation

This study aims to evaluate the effectiveness of PACT intervention in improving resilience, life skills, and psychosocial skills among children and peer supporters. The evaluation will be carried out in the Public Schools of Karachi, Sindh, Pakistan.

Right to Play is a non-governmental organization that offers play-based life skills education in public schools of Pakistan. This project aim to improve psychosocial wellbeing, resilience and social and emotional life skills of students enrolled in secondary schools of Lyari in Karachi South, Sindh, Pakistan through "Play and Act Together (PACT)" curriculum. The Aga Khan University will evaluate effectiveness of their intervention that will be offered in public schools of Karachi. Data will be collected from grade 6 students(children) and grade 7 or 8 peer supporters at baseline, midline and endline of the study. Moreover, throughout PACT intervention, fidelity monitoring would be ensured randomly for 3 sessions out of 10 through a checklist to evaluate accuracy of PACT intervention delivered. Furthermore, feasibility checklist would be filled by each participant at the end of the study to analyze the satisfaction, feasibility of PACT intervention and important learnings from PACT curriculum. After the intervention, focus group discussion will took place to learn about the experiences of children, peer supporters and adult coaches who received PACT intervention.

Eligibility Criteria:
Inclusion Criteria:

* Have not participated in previous Right to Play activities
* Voluntarily agree to participate in this program in 2022-23
* More than 30 students in grades 6 enrolled
* A safe playing area (either indoors or outdoors)
* Only Boy or Only girl school
* Sindh Literacy and Education Department direct administration
* Children of grade 6 age 12-15 years
* Children who give assent to participate
* Parents who give consent to participate their children

Exclusion Criteria:

* Schools who does not give consent to participate
* Children who do not give assent
* Parents who do not give consent
Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects

Investigation of pharmacodynamics (inhibition of oxidosqualene cyclase, MES as marker), effect on routine lipid profile parameters, safety and preliminary pharmacokinetics


Eligibility Criteria:
Inclusion Criteria:

* Healthy male caucasian subjects as determined by results of screening
* Written informed consent in accordance with good clinical practice (GCP) and local legislation given
* Age ≥ 18 and ≤ 65 years
* Broca ≥ - 20 % and ≤ + 30 %
* Cholesterol level ≥ 5.4 mmol/l

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 100 ml (≤ 4 weeks prior to administration or during the trial)
* Excessive physical activities (≤ 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
* Abnormal findings at eye lens examination
Incidental Cancer in Gallbladder Surgical Specimens Focus on Elderly Patients

Causes such as long-term stones and polyp are thought to play a role in the etiology of gallbladder cancer. The routine histopathological examination provides the detection of incidental gallbladder cancers. It should be remembered that acute or chronic cholecystitis accompanied by the thicked wall and a prolonged history of gallstones may be the cause of malignancy, especially in elderly patients.

The investigators aimed to incidental gallbladder cancer and compare other pathology results with elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* acute cholecystectomy
* elective cholecystectomy

Exclusion Criteria:

* lack of data
* incidental cholecystectomy,
* cholecystectomy secondary to trauma
* cholecystectomy secondary to malignancy