cyrilzakka/clinical-trials huggingface dataset:
Treatment of Depression After Coronary Bypass Surgery

This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.

Depression is a very common problem for people who have had CABG surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Cognitive behavior therapy (CBT) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (SSM) interventions have also been shown to improve depressive symptoms. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery.

Participants will be screened for depression within 1 year after CABG surgery. Those who have depression will return for additional testing 1 week later. Eligible participants will be randomized to receive CBT, SSM, or usual care (UC), with no restrictions on nonstudy antidepressants, for 12 weeks. Patients will be monitored for worsening depression referred for additional care if needed. Depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of CBT or SSM).

Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months
* Meets DSM-IV criteria for major or minor depressive episode

Exclusion Criteria:

* Severe cognitive impairment
* Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia)
* Severely debilitating or life-threatening illness other than coronary disease
Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

* The investigators evaluated the role of allopurinol in prevention of post-ERCP pancreatitis.
* 100 Egyptian patients who were candidates for ERCP were included and divided into two groups. Group 1 (study group) included 50 patients who received two doses of allopurinol 300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50 patients who did not receive allopurinol prophylaxis.

A diagnosis of procedure-related pancreatitis was based on an increased serum amylase level greater than three times the upper normal limits, associated with abdominal pain requiring analgesics and persisting for at least 24 hours after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were going to be subjected to ERCP due to different causes

Exclusion Criteria:

* Patients with clinically evident acute pancreatitis or hyperamylesemia (≥150 IU/L) before the procedure.
* Current or recent use of allopurinol (within the last 48 hours).
* Hypersensitivity to allopurinol or hydro-soluble contrast solutions.
* Current use of drugs with a known interaction with allopurinol, including cyclophosphamide, chlorpropamide, azathioprine, mercaptopurines, or probenecid.
* NSAIDS intake within a week prior to assessment.
* Previous endoscopic or surgical sphincterotomy.
* Those with severe co-morbid conditions.
* Female patients with a known or suspected pregnancy and/or lactation.
Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects

It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus. Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will accumulate, because of an improved balance between supply and demand of lipids.

The major research objective is to examine if acute exercise results in a more pronounced increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in endurance-trained subjects when compared to sedentary subjects.

The investigators hypothesize that the increase in acetylcarnitine levels will be lower in trained subjects when compared to sedentary subjects, due to a better balance between lipid supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine concentrations will be restored faster in these trained subjects, because of a tighter regulation of influx of fatty acids.

To test this hypothesis the investigators want to compare the acetylcarnitine response to exercise in a group of sedentary subjects and a group of endurance trained subjects. This response will be measured for 30 minutes after exercise with the use of 1H-MRS.


Eligibility Criteria:
Inclusion Criteria:

* Normal weight (BMI 18-25 kg/m2)
* Healthy
* Stable dietary habits
* No use of medication
* VO2-max for trained subjects above 50 mL/min/kg
* VO2-max for untrained subjects below 40 mL/min/kg

Exclusion Criteria:

* Any medical condition requiring treatment and/or medication use OR diminishing exercise tolerance
* Alcohol consumption of more than 20 g per day (± 2 units)
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Participation in another biomedical study within 1 month prior to the screening visit
* Contraindications for MRI scan:

  * Central nervous system aneurysm clips
  * Implanted neural stimulator
  * Implanted cardiac pacemaker of defibrillator
  * Cochlear implant
  * Iron- containing corpora aliena in the eye or brain
  * Hearing aids and artificial (heart) valves which is contraindicated for MRS
* Subjects, who do not want to be informed about unexpected medical findings cannot participate in the study.
Study of Ambrisentan in Participants With Pulmonary Hypertension

The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.


Eligibility Criteria:
Key Inclusion Criteria:

* Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants participating in countries where ambrisentan is commercially available may be eligible if they do not qualify for treatment per the current prescribing information of that country.

Key Exclusion Criteria:

* Participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study

To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females


Eligibility Criteria:
Inclusion Criteria:

* Healthy Normal Subjects
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC

The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.

This is a single-arm, exploratory clinical study. Eligible patients were treated with Trilaciclib before the first cycle of chemotherapy, and their peripheral blood samples were tested on days 3,7,14,21±1 after chemotherapy. At the same time, the incidence of FN, the use of antibiotics, the safety, the number of patients who delayed the second cycle of treatment, the number of patients who reduced the dose of chemotherapy, the number of patients who reduced the dose of chemotherapy due to neutropenia, and the number of patients who discontinued chemotherapy were observed.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old (including 18 years old)，regardless of gender；
* ECOG-PS score of 0-1,；
* expected survival≥12 weeks；
* There was no tumor deterioration in the 2 weeks prior to study drug treatment.
* Advanced non-small cell lung cancer without systemic chemotherapy.
* At least one tumor lesion with a maximum diameter ≥10 mm (short diameter ≥15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose.
* Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment.
* Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment.
* All subjects voluntarily participated and signed the informed consent form in person.

Exclusion Criteria:

* Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV);
* stroke or cardio-cerebrovascular event within 6 months before enrollment;
* QTcF interval \> 480msec at screening or \> 500msec for patients with implanted ventricular pacemakers;
* Previous hematopoietic stem cell or bone marrow transplantation;
* Allergy to the study drug or its components;
* Others considered by the investigator to be unsuitable for this study.
Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors

Comparative study to determine whether several fertility monitoring products - the DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are substantially equivalent in performance, and secondarily to determine the appropriateness of labeling information for the DuoFertility monitor.

The investigators plan to recruit 30 women who are currently trying to conceive, and ask them to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the study the women will be asked to fill in online questionnaires to assess the usability of the monitors. As the spouse is often a critical partner in the purchase decision and compliance, the investigators will also ask the spouse to complete similar online questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation
* Females aged 18 to 44 years
* Have a body mass index (BMI) above 19 and below 29
* Regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months
* Minimum menstrual cycle 24 days
* Maximum menstrual cycle 33 days
* Female participants willing to use the 3 fertility monitors for at least 3 cycles.
* Willing to fill in regular questionnaires and study diaries

Exclusion Criteria:

* Women aged younger than 18 years, or older than 44 years
* Have a BMI less than 18 or greater than 29
* Any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases
* Polycystic ovary disease
* Endometriosis or other pelvic pathology (including proven tubal disease)
* Taking steroids, including oral contraceptives or anti inflammatory drugs
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators

The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

The primary objective of this study was to compare the performance (i.e., patient self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator (patient's current ventilator). For the User Needs Assessment, the primary objective of the study was to validate the V60 to user needs. All patients were volunteers from the Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study utilized a randomized 2-period cross-over study design to compare the V60 System to the patients' existing conventional noninvasive ventilator in different ventilation modes.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 85 years
* Weight \> 20 kg (44 lbs)
* Respiratory failure or respiratory insufficiency
* Ability to cooperate with the investigators

Exclusion Criteria:

* An endotracheal tube or tracheostomy in place
* Hemodynamic instability
* Prolonged apnea
* Inability to maintain the airway
* A recent history of cardiac and or respiratory arrest
* Acute hemorrhage
* Multiple organ system failure
* Undrained pneumothorax
* High risk for aspiration
* Metastatic or terminal cancer
* Do-not-resuscitate orders
* Inability to clear respiratory secretions
* Inability to fit a mask
* Facial surgery, trauma, or deformity
* Upper gastrointestinal or airway surgery
* Pregnancy
* Refractory delirium
* Inability or unwillingness to provide Informed Consent
* PaO2 \< 50 mmHg
Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision

The purpose of this study is to measure the behavioral effects of learning information about male circumcision and HIV risk on sexual behavior and the demand for male circumcision.


Eligibility Criteria:
Inclusion Criteria:

* The study will involve men between the ages of 25 and 40

Exclusion Criteria:

* None
Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Adults With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma

This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with FL, MZL, CLL, or SLL.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FL, MZL, SLL, or CLL (meeting International Workshop on CLL \[IWCLL\] Criteria, 2008) as documented by medical records and with histology based on criteria established by the World Health Organization

  * FL Grades 1, 2, or 3a
  * SLL with absolute lymphocyte count of \< 5 x 10\^9/L at initial diagnosis
  * MZL (splenic, nodal, or extra-nodal)
* Prior treatment for FL or CLL/SLL with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available
* Presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy
* All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study therapy (with the exception of alopecia \[Grade 1 or 2 permitted\], or bone marrow parameters \[any of Grade 1, 2, or 3 permitted)
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Able to provide written informed consent

Exclusion Criteria:

* History of lymphoid malignancy other than FL, MZL, SLL, or CLL
* History of myelodysplastic syndrome
* History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* History of prior therapy with any inhibitor of serine/threonine kinase (AKT), Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3-kinase (PI3K), or spleen tyrosine kinase (SYK)
* Ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy
A Study of VERVE-101 in Patients with Familial Hypercholesterolemia and Cardiovascular Disease

VT-1001 is an open-label, phase 1b, single-ascending dose study that will evaluate the safety of VERVE-101 administered to patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), and uncontrolled hypercholesterolemia. VERVE-101 uses base-editing technology designed to disrupt the expression of the PCSK9 gene in the liver and lower circulating PCSK9 and LDL-C in patients with established ASCVD due to HeFH. This study is designed to determine the safety and pharmacodynamic profile of VERVE-101 in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female participants 18 up to 75 years at time of signing of informed consent
* Female participants not of child-bearing potential
* Diagnosis of HeFH
* Established ASCVD

Exclusion Criteria:

* Active or history of chronic liver disease
* Current treatment with PCSK9 monoclonal antibody therapy
* Current or past treatment with inclisiran
* Clinically significant or abnormal laboratory values as defined by the protocol
Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma

The purpose of this study is to better understand the natural history of oropharyngeal carcinoma (OPC), with or without an association with the human papilloma virus (HPV). For this study, the investigators plan to collect blood from OPC patients prior to treatment and at six subsequent time points.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with oropharyngeal carcinoma or patients with cancer of the unknown primary that is HPV associated, or possibly deemed to be originating from the oropharynx.

Exclusion Criteria:

* Not willing to sign consent
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy

For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy was based on platinum. However, if they were refractory to platinum-based chemotherapy, there were no other more effective medications or treatment. The marketing of anti-PD-1 antibody has provided an opportunity of curative management. This single arm, open, phase II trial would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients achieved complete or partial remission, or at least total 6 patients achieved complete or partial remission or stable disease, the same regimen would be given for rest patients. The primary end is overall response rate (ORR). The second ends include progression-free survival, overall survival, disease control rate, remission duration, and adverse events. A molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic tissues.


Eligibility Criteria:
Inclusion Criteria:

* Female of 18-75 years old
* Eastern Cooperative Oncology Group score 0-1
* Pathological confirmed of uterine cervical adenocarcinoma, squamous carcinoma, or adenosquamous carcinoma, with stage IA1 (with lymph-vascular space invasion) to IVB, which had accepted radical treatment for the purpose of cure
* Having accepted at least one regimen of platinum-based chemotherapy after the diagnosis of recurrent or persistent advanced cervical cancer, and having an interval of at least 4 weeks since fulfilling the last treatment regimen
* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
* Anticipative survival period of 3 months or more
* Lab testing within reference ranges
* With appropriate contraception
* Provided consents of participating the trial

Exclusion Criteria:

* With brain metastasis
* With addiction to psychiatric medications or with mental disorders
* With following history and/or complications: autoimmune disease; systematic utilization of corticosteroids (with equivalent of prednison of \> 10 mg/day) or other immunosuppressors within 14 days; utilization of antitumor vaccine or other immunostimulation treatment with 3 months; exposure to PD-1 antibody, or PD-L1 antibody, or PD-L2 antibody, or cytotoxic T lymphocyte-associated antigen-4 antibody; history of other malignancies; pulmonary tuberculosis; interstitial pneumonia or related history; active hepatitis; positive testing of human immunodeficiency
* With adverse effects more than Common Terminology Criteria for Adverse Events grade 1 (except for alopecia), which caused by previous anti-tumor treatment
* With infective disease which need systematic treatment within 14 days
* With severe open trauma, fracture or major surgery with past 4 weeks
* With potential allergy or intolerance to study regimens
* Not eligible for the study judged by researchers
Study of Biomarkers in Tissue Samples From Patients With Breast Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tissue samples from patients with breast cancer.

OBJECTIVES:

* Identify by mass spectroscopy and site-specific mutagenesis the post-translational modifications of estrogen-related receptor alpha (ERRα1) that are responsible for ERRα1 function as a constitutive activator rather than a down-modulator of transcription of estrogen response element-regulated genes in tumors of patients with breast cancer.
* Produce a panel of monoclonal antibodies to ERRα1 by standard hybridoma methods that can be used to distinguish between the activator and repressor forms of this receptor in these patients.
* Validate the utility for immunohistochemistry (IHC) assays of some of the ERRα-specific sera by performing IHC and quantitative real-time PCR on some primary breast carcinomas.
* Correlate the results of IHC studies on archival paraffin sections of primary breast tumors using monoclonal antibodies to ERRα1, ERRα1 status, currently assayed biomarkers, and course of treatment with patient outcomes.

OUTLINE: Breast tumor tissue samples are obtained from a tissue bank in the form of frozen tumors and paraffin-embedded sections on microarray blocks. Monoclonal antibodies (MOABs) to ERRα1 are produced using antigens in these tissue samples and immunohistochemical studies are performed using the MOABs. Cytogenetic studies are performed on DNA purified from these tissue samples.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Tumor tissue available
* The following clinical information must be known:

  * ErbB2 status
  * Nodal status
  * Percent S phase
* Hormone receptor status:

  * Estrogen receptor and progesterone receptor status known

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified