cyrilzakka/clinical-trials huggingface dataset:
A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).

Eligibility Criteria:
INCLUSION CRITERIA

1. Females ≥18 years of age at the time of informed consent.
2. Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.

   * Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.
   * Subjects with carcinosarcomas (even if there is a serous component) are not eligible.
3. Measurable disease per RECIST Guideline Version 1.1
4. Required prior therapy for endometrial cancer:

   1. Treatment with a platinum-based chemotherapy regimen.
   2. Treatment with a PD-(L)1 inhibitor
   3. Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
5. Adequate hematologic and organ function

EXCLUSION CRITERIA

1. Any of the following treatment interventions within the specified time frame prior to C1D1:

   1. Major surgery within 28 days
   2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
   3. Radiation therapy within 21 days;
   4. Autologous or allogeneic stem cell transplant within 3 months.
   5. Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter).
2. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
3. A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

PRIMARY: To determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated Mycobacterium avium Complex (MAC) infection in HIV-infected patients. To determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population.

SECONDARY: To determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. To determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. To compare survival and outcomes of primary endpoints in the treatment arms.

Patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for MAC prophylaxis. Patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. Patients are followed for 1 to 2 years.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Preventive therapy with isoniazid for M. tuberculosis.
* Maintenance therapy for CMV retinitis.

Patients must have:

* HIV infection or history of an AIDS-defining condition by CDC criteria.
* One documented CD4 count \< 100 cells/mm3 within 12 months prior to study entry.
* NO active MAC disease, MAC bacteremia, or active mycobacterial infection (tuberculous or nontuberculous).
* NO acute opportunistic infection.
* Life expectancy of more than 6 months.
* Consent of parent or guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

ALL PATIENTS -

* Unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of MAC and fungal infections have not been excluded.
* Serious hypersensitivity reactions to macrolides or rifampin.
* Unable to tolerate oral medications. FOR FLUCONAZOLE RANDOMIZATION -
* Serious hypersensitivity reaction to fluconazole.
* Active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, Candida esophagitis, thrush, vaginal candidiasis).
* Positive baseline urine cryptococcal culture.

Concurrent Medication:

Excluded for fluconazole randomization:

* Maintenance therapy for deep fungal infections.
* Chronic therapy with ketoconazole or fluconazole.
DECAMP 1 PLUS: Prediction of Lung Cancer Using Noninvasive Biomarkers

DECAMP 1 PLUS aims to improve the efficiency of the diagnostic evaluation of patients with indeterminate pulmonary nodules (8-25 mm). Molecular biomarkers for lung cancer diagnosis measured in minimally invasive and non-invasive biospecimens may be able to distinguish between malignant or benign indeterminate pulmonary nodules in high-risk smokers. Ultimately, this study aims to validate molecular as well as clinical and imaging biomarkers of lung cancer in individuals with indeterminate lung nodules.

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that previously initiated the DECAMP-1 and DECAMP-2 studies for lung cancer early detection. Now, with the support of Johnson and Johnson, 3 Veterans Administration Hospitals (VAH), 3 Military Treatment Facilities (MTF) and 12 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores, we are expanding our work in lung cancer early detection.

Eligibility Criteria:
Inclusion Criteria:

* Radiologic diagnosis of solid indeterminate pulmonary nodule (0.8 to 2.5 cm) identified in the past 3 months OR semi-solid (mixed density) nodule with solid component of at least 0.6 cm identified in the past 12 months; must be of appropriate size at enrollment.
* CT scan completed within 3 months prior to enrollment
* Able to tolerate all biospecimen collection as required by protocol
* Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for approximately three years from enrollment
* Able to complete the Patient Lung History questionnaire with study staff

Arm 1 - Screening

* Age 55-77 years old
* Current and former smokers with 30 pack-years or more(and quit less than 15 years ago)

Arm 2 - Incidental

* Age \> 45 years old
* Current and former smokers with 10 pack-years or more(and quit less than 15 years ago)

Exclusion Criteria:

* History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any other non-lung cancer within 5 years (not including non-melanoma skin cancer)
* Symptoms of lung cancer (unexplained weight loss 10 lbs or more in 3 months, recent hemoptysis)
* Diagnosis of pure ground glass opacities for the target lesion on chest CT within the last 12 months (i.e., mixed features on the target lesion and pure ground glass opacity on non-target lesions are acceptable as mentioned above)
Phase 2 Study of Oral K201 for Prevention of AF Recurrence

To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration \>3 days and \<6 months).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic AF (sustained \>3 days and \<6 months) and clinically indicated for cardioversion;
* Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
* Hemodynamically stable (90 mmHg \< systolic blood pressure \< 190 mmHg)at screening and on Day 1;

Exclusion Criteria:

* Known prolonged QT syndrome or QTc interval of \>0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
* QRS \>0.130 sec;
* Previous episodes of second- or third-degree atrioventricular block;
* Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
* Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
* Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
* NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
* Known concurrent temporary secondary causes of AF;
* Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
* Received treatment with other drugs known to prolong the QT interval within 5 half-lives.
Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer

The overall objective of this study is to ultimately develop an improved standard of cancer care by facilitating new cancer research, clinical trials, new technology, new informatics solutions, and "personalized medicine" for the University of New Mexico Comprehensive Cancer Center (UNMCCC) and the Oncology Research Information Exchange Network (ORIEN) Consortium of academic medical centers, community hospital systems, and other health care providers. To bring new translational research to the community, the ORIEN consortium has initiated the ORIEN Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of patients with cancer or at risk of having cancer. This is not a treatment trial. It is a study designed to create a centralized data and tissue repository.

Through this protocol, UNMCCC and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, the investigators require the permission of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and/or other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older.
* Has a diagnosis of cancer or is suspected of having cancer.
* Able to understand and sign the Informed Consent form directly.
* Pregnant women are permitted to be enrolled.

Exclusion Criteria:

* Prisoners
Integral Remediation for Major Depression ("Rehabilitación Integral Para la Depresión Mayor", RIDEM)

Available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (MDD). More recent studies have described that functional disability and the indirect costs of MDD (e.g., sick leaves at work, decreased productivity, ...) are related to persistent cognitive deficits. Some programs of cognitive rehabilitation and cognitive training (developed for other pathologies) have been tested, but the results are inconsistent.

There is an imperative need to develop a specific comprehensive rehabilitation program for MDD that includes the benefits of traditional functional remediation (FR) and computerized cognitive training (CCT) programs adjusted for each patient's cognitive deficit.

Objectives: To develop the Integral Rehabilitation Program (FR + CCT) and to demonstrate its efficacy in cognitive and functional remission (i.e. global remission) of patients with MDD in clinical remission.

Methodology: The project will consist of two stages:

1. - Development and adaptation of the Integral Rehabilitation program for MD, based on the program developed for bipolar disorder, and including a computerized cognitive training adjusted to the neuropsychological profile of each patient;
2. - A clinical trial, randomized, blind evaluator, with three intervention arms: INTEGRAL REHABILITATION (FR + CCT); PSYCHOEDUCATION + online games; and TREATMENT AS USUAL.

Sample size will be a total of 90 patients with MDD in remission (full or partial).

Eligibility Criteria:
Inclusion Criteria:

* 18 and 60 years (males and females)
* diagnosis of Major Depression (criteria Diagnostic and Statistical Manual 5th edition, DSM-5) in Remission or Partial Remission phase (scores below 14 in the Hamilton Depression Rating Scale-17 items (HDRS-17))
* Cognitive Symptoms (-1.5SD (standar deviation) in objective as subjective tests),
* PDQ \> 20
* FAST\> 17

Exclusion Criteria:

* Intelligence Quotient (IQ) \< 85
* Any medical condition that may affect cognition
* Presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months)
* Electroconvulsive therapy (ECT) in the previous year
* Other psychological intervention in the 6 months prior to the study.
Post Infarction Exercise Effects on Myocardial Function Assessed by 2D Strain Ultrasound

The main goal of our project is to study and describe the effect of exercise training on systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial infarction.

Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise training will be improved compared to baseline values as well as compared to values in a no-training group. Should this hypothesis prove true, it would help explain the improvements in functional capacity observed during the post-infarction period and after exercise training.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 4 months of follow-up
* The patient had a first myocardial infarction episode (within the past 3 months) requiring medical treatment or revascularisation (e.g. balloon angioplasty) or aortocoronary bypass

Exclusion Criteria:

* The patient is simultaneously participating in (or has participated in the past 3 months) another interventional study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection or under guardianship
* It is impossible to correctly inform the patient or the patient refuses to sign the consent
* The patient is pregnant, parturient, or breastfeeding
* Contra indication for exercise training
* Valve prosthesis
* Severe valvular disease
* Pacemaker
* Heart transplant
* Non sinus rhythm
Economic Evaluation of Heart Failure Management in Colombian Clinics

Cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management.


Eligibility Criteria:
Inclusion Criteria:

* Asthma moderate to severe.
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
* A body weight of ≥60 kg male and ≥50 kg female

Exclusion Criteria:

* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
* Clinically relevant abnormal medical history, physical findings or laboratory values
A Comparative Study of the Air-Q ILA and the ILMA for Ventilation and Intubation

The objective of this study is to determine if the glottic view obtained with the air-Q Intubating Laryngeal Airway (air-Q ILA, Cookgas LLC®, Mercury Medical®, Clearwater, FL, USA) is better than that obtained with the traditionally used intubating laryngeal mask airway (LMA FastrachTM or ILMA, LMA North America Inc., San Diego, CA). The study will also compare effectiveness of ventilation.


Eligibility Criteria:
Inclusion Criteria:

* healthy ASA class I and II patients scheduled for elective surgery under general anesthesia requiring the use of the LMA

Exclusion Criteria:

* history of acid reflux,
* a BMI ≥ 40kg.m-2,
* require endotracheal intubation,
* have predictors of difficult intubation,
* not candidates for insertion of an ILMA or LMA, including a mouth opening of less than 2.5 cm,
* cannot consent to the study
Star Homes Project 2

Malaria, pneumonia and diarrhoea causes a lot of illness in children in Tanzania and the study want to find better ways of protecting people against these diseases and want to find out if the type of house design can affect the general health of children living in the house.

The study hypothesis is that healthy houses will reduce the incidence of malaria, respiratory diseases and diarrhoeal diseases in children compared with traditional houses. And healthy houses are also likely to reduce the incidence of all-cause morbidity incidence, disease severity, improve growth and well-being. The primary endpoints will be assessed in children under 13 years of age through weekly household visits for three years. All homes will have access to basic vector control, such as insecticide treated nets (ITNs). Access to early diagnosis and appropriate malaria treatment will be assured. Approximately 2,750 Tanzanians living in 550 houses in Mtwara region, of which 110 are new design houses (Star Homes) and the remaining 440 traditional African houses will be participating in this study. 330 children living in the novel design houses and 1320 children in traditional homes will be followed for three years for the assessment of malaria, respiratory tract infections and diarrhoea. Mosquito density will be assessed from all 550 houses where tent/light trap will be used for mosquito catch at night in all study houses. Acceptance of the novel designed houses will be assessed using mixed methods. Acceptability surveys will be conducted with 550 household heads concurrently with in-depth interviews with 30 purposively selected heads of the households in the intervention arm. Ten focus group discussions will be conducted each comprising 10 heads of households making it to be 100 heads of households.

Funder: Hanako Foundation, Singapore

Eligibility Criteria:
Inclusion Criteria

Main study

* Children, aged under 13 years old, male or female
* Residing in a study village for at least 3 years
* Parents/guardian is willing and able to give written informed consent for the child to participate in the baseline and end-of study evaluation and the surveillance for malaria, respiratory tract infection and diarrhoeal disease.
* Additionally, children 10, 11, and 12 years of age provide assent to participate.

Ancillary studies

* Head of a household or other family member of a household that is taking part in the main study
* 18 years and above
* Consent to take part in the main study
* Residing and live in the village for 3 years or more
* Live in the intervention or comparison houses or a trusted community member (community leaders, medical officer and community health worker)

Exclusion criteria

Main study

* Any participant who refuses, or in the case of children whose parents/guardian refuses, to participate in the study.
* Any child who is between 10 and 12 years who refuses to provide assent
* If the family plans for moving to other village during the study period
* Parents/guardians have mental health problems

Ancillary studies

* Under 18 years
* Not provide consent
* Not living in the study village for 3 years or more
Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients

The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.

Sleep apnea is more prevalent in end stage renal disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea in the general population, the prognostic impact of sleep apnea in the end stage renal disease population has not yet been investigated.

The purpose of this trial is to investigate the hypothesis that moderate to severe sleep apnea increase the risk of major cardiovascular events in patients with end stage renal disease.

The severity of sleep apnea is measured at inclusion and the patients are followed during 3 years to assess the cardiovascular end-points. The result of the sleep study is communicated to the treating physician and the decision whether to treat or not sleep apnea is left to the treating physician, independently of the study protocol. The comparison will include three groups: patients without sleep apnea, untreated patients with moderate to severe sleep apnea and treated patients with sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease on renal replacement therapy
* age ≥ 18 years

Exclusion Criteria:

* unstable congestive heart failure
* active psychiatric disease
Analysis of Percutaneous Ablations for Cancer Treatment

This is a study involving patients with cancer who are referred by their treating physician for percutaneous locoregional therapies.

Patient's clinical and radiology findings, pathology findings, survival, treatment responses, and complications after their locoregional therapy will be studied.

The efficacy of the percutaneous and transarterial treatments for solid tumors will be studied. Prospective study on patients who receive percutaneous locoregional therapies, including radiofrequency ablation (RFA), cryoablation, microwave ablation, IRE and chemical ablation for treatment of cancer will be performed.

Preoperative clinic chart, procedure note, postoperative chart, pre- and post-operative CT, MRI or Ultrasound, angiographic findings, biopsy results and pathologic findings, will be reviewed. Patient survival, treatment responses, complications after the therapy will be collected from clinic visits and clinical encounters.

Patient overall performance status before and after procedures will be assessed using the Quality of Life questionnaire (SF-36™ Health Survey).

Eligibility Criteria:
Inclusion Criteria:

* 18yrs of age
* Cancer diagnosis
* Candidate for Locoregional therapy
* Willingness to sign informed consent

Exclusion Criteria:

* Unable to sign informed consent
* Patients not eligible for locoregional therapies