cyrilzakka/clinical-trials huggingface dataset:
Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases

The number of infectious agents associated with risks of malignant hematologic diseases is non-negligible and include both viruses and bacteria.

The various organisms affect cancer risk either directly by transforming susceptible cells, through chronic antigenic stimulation or by hampering immune function in other ways conducive of cancer development.

Suspicion of an infectious cancer origin may arise because of clustering with other conditions (e.g. immune deficiency), specific environments or settings (e.g. geographic locales) or with exposures (e.g. blood transfusions).

In this context, relatively few studies have addressed clustering of diseases among spouses to generate hypotheses about the relative contributions of environmental and genetic factors to the risk of individual cancer types.

As a prelude to such an exercise aiming specifically at malignant hematologic diseases, we will test an algorithm characterising cohabitation patterns in the Danish population to assess the risk of sexually transmitted diseases in analyses of register data.

Such information will also be relevant to current guidelines for blood donor deferral policies. Specifically, because of the so-called precautionary principle all blood donations are extensively tested for infectious agents and transfusion of blood now carries an extremely low risk of transmission of HIV, hepatitis B and C. The residual risk of HIV transmission in Denmark is estimated to 1:10,000,000 transfusions. However, several deferral criteria have existed for years without studies to prove their relevance.

Aim: To compare the incidence of both known and suspected sexually transmitted diseases between different cohabitation patterns in the Danish population.

Perspectives: The study results can be used to leverage changes in deferral rules in the Danish blood banks to accommodate strong wishes from stakeholders to avoid the perceived discrimination of various minorities. The study can thus have important ethical and political consequences.


Eligibility Criteria:
Inclusion Criteria:

* All citizens in Denmark

Exclusion Criteria:

* Institutionalized individuals
V/Q Matching Variations With PEEP in ARDS According to Compliance-based Phenotypes (France)

This study aim to compare the effect of Positive End Expiratory Pressure (PEEP) on ventilation/perfusion mismatch in two phenotypes of patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS), characterized by their respiratory system elastance (Ers). Ventilation/perfusion mismatch will be assessed by Electrical Impedance Tomography (EIT).

Acute Respiratory Distress Syndrome (ARDS) is characterized by hypoxemia caused by inflammatory lung injury. Recent studies showed an important variability in ARDS phenotypes . The recent COVID-19 crisis highlighted the presence of ARDS patients with severe hypoxemia and normal respiratory system compliance, and retrospective series confirmed the existence of this atypical ARDS pattern also in non-COVID etiologies.

The dissociation between mechanics and hypoxemia may be related to a specific diversity in the pattern of ventilation-perfusion matching (V/Q matching) among patients with normal compliance and ARDS. In patients with low compliance, V/Q mismatch may be characterized by right-to-left shunt, secondary to collapse of the gravity-dependent regions; while, in patients with normal compliance, V/Q mismatch may show a redistribution of blood flow to hypo-ventilated lung areas by larger dead space and impaired hypoxic vasoconstriction.

These differences may also influence the response to PEEP in terms of gas exchange and lung protection . It may also explain the failure for high PEEP levels to improve significantly mortality in the global ARDS population (i.e., with patients' selection only based on hypoxemia).

Electrical Impedance Tomography (EIT) is a device allowing to assess ventilation and perfusion distribution. Thus, EIT can be used to evaluate global and regional V/Q matching, and could be used to understand mechanisms of hypoxemia, especially in patients with normal mechanics and ARDS.

The aim of this study is to assess V/Q matching according to these different ARDS phenotypes, and to evaluate the effects of PEEP in each one.

Eligibility Criteria:
Inclusion criteria:

* intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
* undergoing deep sedation
* on controlled mechanical ventilation
* between 24 hours and 5 days after intubation.

Exclusion criteria:

* age \<18 years old; pregnancy
* patient undergoing legal protection
* contra-indications to EIT (e. g. severe chest trauma or wounds)
* pneumothorax; patient undergoing ECMO
* patient with BMI ≥35 kg/m2
* hemodynamic instability with MAP \<60 mmHg despite vasopressors.
Dose Escalation of OXi4503 as Single Agent and Combination With Cytarabine w/Subsequent Ph 2 Cohorts for AML and MDS

Phase 1 will investigate maximum tolerated dose of OXi4503 as a single agent and in combination with intermediate-dose cytarabine in subjects with relapsed/refractory AML or MDS.

Phase 2 will investigate overall response rate of OXi4503 in combination with intermediate-dose cytarabine in 1) subjects with MDS after failure of 1 prior hypomethylating agent (Arm A) and 2) subjects with relapsed and refractory AML after treatment failure of up to 1 prior chemotherapy regimen (Arm B).

Phase 1 dose escalation component will assess the safety, PK/PD, and preliminary efficacy of OXi4503 as a single agent in subjects with relapsed/refractory AML and MDS, and the safety and PK/PD of the combination of OXi4503 with intermediate-dose cytarabine in subjects with AML/MDS.

Phase 2 will assess the preliminary efficacy of the OXi4503+cytarabine combination in 2 cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Provide informed consent
2. ≥ 18 years of age
3. Phase 1 (dose escalation) subjects must have either:

   * AML that has failed to achieve complete remission or morphologic complete remission or
   * MDS - Marrow blasts must be \> 5% and disease failed at least 1 prior hypomethylating agent
4. Phase 2 (expansion) subjects must have either MDS or relapsed/refractory AML
5. Eastern Cooperative Oncology Group performance status 0, 1, or 2
6. Total bilirubin ≤ 2
7. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times upper limit of normal (ULN)
8. Serum creatinine \< 2.5 times ULN
9. Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%
10. Women of child-bearing potential
11. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods

Exclusion Criteria:

1. Acute promyelocytic leukemia
2. Absolute peripheral blood myeloblast count greater than 20,000/mm3
3. Uncontrolled hypertension
4. History of congenital long QT syndrome or torsades de pointes
5. Pathologic bradycardia or heart block
6. Prolonged baseline QTc
7. Hiistory of ventricular arrhythmia
8. Myocardial infarction and/or new ST elevation
9. Any history of hemorrhagic stroke
10. Symptomatic congestive heart failure
11. Major hemorrhagic event within 28 days
12. Suggestive central nervous system involvement with leukemia
13. Any open wound
14. Pregnant and nursing subjects are excluded
15. Treatment with any anticancer therapy
16. Treatment with colchicine is excluded.
17. Psychiatric disorders that would interfere with consent
Increasing Walking Following Cardiac Rehabilitation

The purpose of the project was to test the widely endorsed assumption that pedometers produce or encourage more physical activity participation in the form of walking. The investigators hypothesized that pedometers would not increase the amount of walking cardiac patients participated in after their cardiac rehabilitation program compared to patients without pedometers.

As evidenced by the media attention given to pedometers and recent physical activity promotional efforts focused on pedometers, people seem to think that owning a pedometer will influence activity levels.

However, an examination of a few social cognitive theories produces no theoretical rationale that would support any sustained positive influence of pedometers in the absence of some other conditional factor, such as a behavioural goal or a social support system. We believe that once people determine how many steps their usual routes and daily activity typically amounts to, that the pedometer will no longer be used. We based our contentions on two theories: self efficacy theory (Bandura, 1986;1997) and self-determination theory (Deci \& Ryan, 2000).

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to the Northern Alberta Cardiac Rehabilitation Program
* Patients who are willing to participate
* Are able to read English
* Patients who are able to walk at 2.0 mph based on their exercise stress test results

Exclusion Criteria:

* patients unable to walk or walking contra-indicated
* unwilling
* do not read English
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \>= 6 months
* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* Adequate hematologic and organ function prior to initiation of study treatment

Exclusion Criteria:

* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
* History or active inflammatory bowel disease
* Disease progression within 6 months of receiving any HER2-targeted therapy
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Participants with active HBV infection
* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
* Symptomatic active lung disease, including pneumonitis or interstitial lung disease
* Any history of leptomeningeal disease or carcinomatous meningitis
* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
One-visit Root Canal Treatment Using Chlorhexidine as a Final Irrigant

A hundred asymptomatic molar teeth with periapical lesions were treated in single versus multiple visit root canal treatment. Half of the teeth were randomly assigned to the one-visit (OV) group and received an additional final rinse with 2% CHX before obturation. The other teeth were treated in two visits (TV) with calcium hydroxide dressing. All patients were recalled and investigated clinically and radiographically for 48 months

The aim of the study was to evaluate the radiographic evidence of periapical healing in teeth with apical periodontitis treated in a single visit with an additional final irrigation using 2% chlorhexidine and to compare the results with conventional multiple-visit root canal treatment (RCT) with an intracanal calcium hydroxide dressing as a control group. 100 asymptomatic molar teeth with periapical lesions were treated using engine-driven nickel-titanium (NiTi) instrumentation with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the one-visit (OV) group and received an additional final rinse with 2% chlorhexidine (CHX) before obturation. The other teeth were treated in two visits (TV), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. All patients were recalled and investigated clinically and radiographically for 48 months. Changes in apical bone density indicating radiographic healing were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* with a non-contributory medical history,
* mature molar teeth with periapical lesions,
* diagnosed as asymptomatic apical periodontitis

Exclusion Criteria:

* clinical symptoms, drainage,
* more than 5 mm loss of periodontal attachment,
* previous endodontic treatment,
* non-restorable tooth
Interstitial Pneumonia With Autoimmune Features: Evaluation of Connective Tissue Disease Incidence During Follow-up

Interstitial lung diseases (ILD) represent a frequent complication of connective tissue diseases (CTDs), especially systemic sclerosis, idiopathic inflammatory myopathies and rheumatoid arthritis. ILD can either occur during CTD course or be the first manifestation of CTDs. Therefore screening patients with ILD for CTD is crucial. In some cases, ILD are associated with clinical and/or serological autoimmune features but not classifiable for CTDs. Evolution of these forms to defined CTDs has never been study. Recently, the European Respiratory Society/American Thoracic Society experts proposed a new term, "interstitial pneumonia with autoimmune features" or IPAF, to describe these patients according to updated classification criteria. Aims of this study were to compare CTD occurence during follow-up between IPAF and non-IPAF patients in a idiopathic interstitial pneumonia cohort and to identify risk factors of CTD progression in IPAF patients at diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a new diagnosis of ILD confirmed by two chest-HRCT 3 months apart
* Patients with a minimal follow-up duration of 3 years after ILD diagnosis

Exclusion Criteria:

* Patients with a defined CTD at ILD diagnosis
* Patients with an other ILD etiology identified at diagnosis (i.e. sarcoidosis, hypersensitivity pneumonitis)
Sleep to Prevent Evolving Affecting Disorders

The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.

The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia.

Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete.

A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia

Exclusion Criteria:

* Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients

Neoadjuvant therapy in the treatment of breast cancer is not only a means of breast conserving surgery, but also a sensitive scheme for patients, in order to reduce the treatment grade, low toxicity and high efficiency. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Paclitaxel plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxus (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. In the HER2 positive neoadjuvant therapy population, relatively early and low-risk patients may obtain good curative effect in the treatment of single drug taxane chemotherapy combined with double target therapy.

The project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the HER2 positive breast cancer patients with clinical stage T1c, lymph node negative and receiving Taxanes combined with double target neoadjuvant therapy admitted to the center from January 1, 2019 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. Objective to evaluate the efficacy and safety of Taxanes combined with double target neoadjuvant therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;
2. The clinical stages were T1c, N0, M0;
3. Received treatment in our hospital and had hospitalization records;
4. Has signed and agreed to participate in the PKUPH breast disease cohort study;
5. It is up to the clinician to decide whether to add anthracycline chemotherapy in the adjuvant treatment stage.

Exclusion Criteria:

1. Lack of clinical and pathological data (such as imaging data and pathological data);
2. Patients with metastatic breast cancer or bilateral breast cancer;
3. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
4. Receiving other regimens besides the established neoadjuvant regimens
Smartphone Addiction and Muscular Disorder

Background and aim: The use of smartphones, which has reached the level of addiction causes some physical and psychological health problems. The aim was to examine the musculoskeletal disorders of the neck and upper extremities of mobile phone addiction in a population of young adults.

Methods: The study is a cross sectional research conducted on students of a university in İstanbul between December 2018-October 2020. The level of addiction was assessed with the Smartphone Addiction Scale Short Form (SAS-SF). The posture of participants was evaluated by New York Posture Rating Chart (NYPRC), mostly usage smartphone posture, forward head and myofascial trigger points were questioned according to Simon and Travel criteria. Mann-Whitney U test Pearson's chi-squared test were used for analyzing the data.


Eligibility Criteria:
Inclusion Criteria:

* used smartphones
* volunteered to participate in the study.

Exclusion Criteria:

* having any history of trauma at the neck region within the last six months,
* taking any treatment for trigger points within the last 3 months
* having a history of neck surgery.
Pemetrexed/Cisplatin Versus Gemcitabine/Cisplatin According to Thymidylate Synthase Expression

This study trys to evaluate the predictive role of thymidylate synthase expression for pemetrexed/cisplatin in Non-small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed nonsquamous NSCLC
* Stage IIIb, IV or recurrent NSCLC
* Age ≥ 18years
* ECOG performance status of 0 to 1
* Known TS immunohistochemical analysis data
* At least one measurable lesion by RECIST 1.1
* No previous chemotherapy or therapy with EGFR TKIs for advanced NSCLC
* Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
* At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
* Adequate renal function: estimated creatinine clearance ≥ 50mL/min

Exclusion Criteria:

* Patients whose disease recurred within 6 months after the completion of adjuvant chemotherapy.
* Patients with post-obstructive pneumonia or uncontrolled serious infection
Osteoporosis in Primary Hyperparathyroidism

Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (\>12 months after last menstrual period) with primary hyperparathyroidism and with osteoporosis on Dual Energy Xray Absorptiometry (DXA) (according to International Society for Clinical Densitometry (ISCD) - criteria) and/or osteoporotic fracture of the vertebra or hip

Exclusion Criteria:

* The patient is not able to give informed consent
* other classic complications of primary hyperparathyroidism (e.g. kidney stones, renal insufficiency)
* serum albumin-corrected calcium level \> 2.85 mmol/L (except when the patient is reluctant to undergo surgical treatment)
* osteoporosis treatment less than a year ago, less than two years ago in the case of oral bisphosphonate, less than three years ago in the case of parenteral bisphosphonate
* bilateral hip endoprosthesis
* additional causes for secondary osteoporosis (other than vitamin D deficiency) and pathological laboratory findings that are incompatible with the Summary of Product Characteristics (SmPC) of both medicines
* cancer, except if in stable remission of more than 5 years