cyrilzakka/clinical-trials huggingface dataset:
A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

This is a Phase Ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (TNBC) (Part 2) to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part 2)


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* A life expectancy of at least 3 months
* Have disease that is measurable as according to RECIST v1.1
* Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
* For Part 1, have a histologically confirmed diagnosis of ovarian or endometrial cancer, and have received at least one line of prior therapy for metastatic disease
* For Part 2 ONLY, have disease that can be safely biopsied
* For Part 2 ONLY, have a deleterious germline or somatic breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation or tumors that are wild-type BRCA but show high levels of loss of heterozygosity (LOH) (tBRCAwt/LOHhigh) signature
* For Part 2 Cohort 1 (ovarian cancer), high-grade serous or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (PPC)
* For Part 2 Cohort 1, have received at least one and no more than two lines of prior platinum-containing therapy and progressed after the most recent platinum therapy in a platinum-sensitive timeframe
* For Part 2 ONLY, Cohort 1, have a CA125 measurement that is greater than 2 times the upper limit of normal (ULN)
* For Part 2 Cohort 2 (TNBC), metastatic, histologically confirmed estrogen receptor (ER)-negative, progesterone receptor-negative, and HER2-negative adenocarcinoma of the breast per local laboratory assessment
* For Part 2 Cohort 2, radiologic/objective evidence of recurrence or disease progression after one line of chemotherapy for TNBC in the metastatic setting
* Have adequate organ function

Exclusion Criteria:

* History of prior malignancy except a) curatively treated non-melanoma skin cancer, b) solid tumor treated curatively more than 3 years ago without evidence of recurrence, c) For Cohort 1 (ovarian cancer): breast cancer with no evidence of disease or inactive for at least 3 years, and d) synchronous endometrial cancer (Stage 1A) with ovarian cancer
* Treatment with chemotherapy, radiation, hormones (except corticosteroids and megestrol acetate), or other anticancer therapies less than or equal to (\<=) 14 days prior to first dose of study treatment
* Preexisting duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib
* Symptomatic and/or untreated central nervous system metastases
* Prior treatment with any poly adenosine diphosphate-ribose polymerase (PARP) inhibitor
Tomosynthesis in the Oslo Breast Cancer Screening Program

The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.

Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Women 50 to 69 years who have signed the informed consent

Exclusion Criteria:

* Women with pacemaker, implants, and severely disabled
Antiremodeling Effect Of Aldosterone Receptors Blockade With Canrenone In Mild Chronic Heart Failure. AREA IN-CHF Study

The RALES study has shown that spironolactone reduces the risk of morbidity and mortality both from progressive heart failure and sudden death, in patients with NYHA III or IV heart failure. This favourable effect was clearly independent from a diuretic effect. Antialdosterone drugs may be effective because they opposes the effects of aldosterone on sodium retention, loss of magnesium and potassium, sympathetic activation, baroreceptor function and vascular compliance. Antialdosterone treatment may also antagonize the effect of aldosterone in promoting cardiac fibrosis. In a RALES substudy baseline serum PIIINP, a marker of cardiac fibrosis synthesis showed an independent negative correlation with survival and CHF hospitalizations in the placebo group. Therefore it seems interesting to evaluate the effect of an Aldosterone receptor blocker on progression of left ventricular dysfunction in patients with mild heart failure assuming standard therapy.

The protocol is sponsored by and independent organization and partially supported by Therabel

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of congestive heart failure in NYHA class II
* Left ventricular ejection fraction \<= 45% measured within 6 months from enrolment
* Stable standard heart failure therapy (if patients are on beta blocker drugs, treatment must have been started at least three months before enrolment)
* Informed consent (obtained prior of any study procedures)

Exclusion Criteria:

* Age \<18 and \>80
* Serum creatinine level \> 2.5 mg per deciliter
* Serum potassium level \> 5.0 mmol per liter
* Valvular heart disease amenable to surgical treatment
* Congenital heart disease
* Unstable angina and/or acute myocardial infarction and/or coronary revascularization procedure within three months before enrolment
* Intravenous therapy with inotropic drugs within three months before enrolment
* History of resuscitated ventricular fibrillation or tachycardia, unless these occurred within 24 hours of an acute myocardial infarction or the subject has an implanted an automatic cardioverter defibrillator
* Chronic active hepatitis or cirrhosis
* Malignant neoplasm or any life threatening non cardiac disease
* History of hypersensitivity to study drug
* Pregnancy or lactating or childbearing age women who are not protected by an accepted method of contraception
* History of drug or alcohol abuse
* Legal incapacity and/or other circumstances rending the patient unable to understand the nature, scope and possible consequences of the study.
* Evidence of uncooperative attitude
* Any condition other than heart failure that does not permit an optimal participation to the trial
* Participation to other RCTs during the last 3 months
* Treatment with: Lithium salts, Potassium sparing diuretics, oral positive inotropic drugs or any investigational drug
Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab

This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe plaque psoriasis
* Loss of satisfactory response to adalimumab
* Currently receiving or recently discontinued treatment with adalimumab

Exclusion Criteria:

* Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
* Serious medical conditions
Local Wound Anesthesia in Spine Surgery

Prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between NaCl, Ropivacain, Levobupivacaine combined with Tramadol

Subcutaneous local wound injections with NaCl, Ropivacain or Levobupivacaine combined with Tramadol will be performed in a randomized, double-blinded manner at the end of spine surgery. Pain control, dosage of analgesics used, analgesics reduction compared to preoperative, wound healing problems and clinical outcome socres will be assessed up to 6 weeks after surgery

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Age ≥ 18 years
* Elective spine surgery with any technique
* At least 6 weeks of scheduled follow-up from hospitalization

Exclusion Criteria:

* Documented decline for data inclusion
* Allergy to any of the drugs used
* \<50kg total body weight
* Vertebro- or Kyphoplasty
* Pregnancy and breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC

To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity.

Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.

Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.

This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (\> 72 hours) administration is not advised without dose supervision.

Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories:

* AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol.
* Patients who qualify for AZT under the labeling:
* (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and \< 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or \> 15 lbs or \> 10 percent of total body weight within the previous 3 months) and \< 200 T4 cells and one or more of the following symptoms:
* (1) fever \> 100 degrees F without infectious cause of \> 3 weeks duration; (2) clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites, cryptosporidia, and Mycobacterium avium-intracellulare.

Note:

* Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4 lymphocyte count, does not constitute an indication for AZT treatment under the labeling.

Exclusion Criteria

Co-existing Condition:

* Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded.

Concurrent Medication: Excluded:

* Acetaminophen.
Young Adults with Violent Behavior During Early Psychosis

This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.

The investigators will conduct an open pilot trial of a behavioral intervention to reduce violent behavior within the OnTrackNY network. The focus of this open pilot is to explore the acceptability and feasibility of the intervention. The study will enroll early intervention service (EIS) clinician - EIS participant dyads. The planned sample size is 3-4 EIS clinicians and 10-16 EIS participants (up to n=16 dyads). This real-world open pilot will provide feedback to help tailor the intervention to the OnTrackNY setting.

Eligibility Criteria:
Inclusion Criteria for EIS participants:

* Ages 16 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (International Classification of Disease Clinical Modification (ICD-10-CM) Diagnosis Code F20.x)
* Receive First Episode Psychosis (FEP) treatment in one of OnTrackNY clinics/sites with an eligible EIS clinicians
* Willing to participate in research interviews after each study visit during the study period

Exclusion Criteria:

* Unable to provide informed consent
* Not fluent (speaking, reading, writing) in English
The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA"

The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiologic and morphometric features (chemical, electrophysiologic and ultrasound biomarkers) that reflect the intensity of pain and/or foretell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.

The investigators include patients aged 18-80 years with acute (less than 1-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor, etc) in the background, already had CT or MRI scan during routine workup, and who have given written consent to participate in the study. Exclusion criteria are pregnancy, hypersensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor, etc) in the background of pain. The patients will be given 3 times daily 150 mg tolperisone or placebo in addition to standard therapy in a randomized double-blind design. Treatment will last for 14 days and a final follow-up is performed at 21 days. Clinical condition and biomarkers will be tested before treatment and at 14 days. Patients fill in a diary on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers.

Exclusion Criteria:

* pain, inflammation,
Asprosin in Breast Cancer

To evaluate the clinical utility of Asprosin measurement in breast cancer patients in comparison with healthy controls and patients with benign breast lesions.

To compare between Asprosin and the routine markers (CEA, CA15-3) as biomarkers for breast cancer diagnosis


Eligibility Criteria:
Inclusion Criteria:

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Females aged (40 ± 20 years) who did not receive any chemotherapy or surgical treatment and they will be divided as follow:

Group 1: healthy controls from healthy volunteers. Group 2: patients with benign breast lesions. Group 3: breast cancer patients.

Exclusion Criteria:

* 1- Female patients with any other type of malignant or benign tumors. 2- Past history of chemotherapy or surgical treatment of cancer.
Endothelial Dysfunction, Biomarkers, and Lung Function -Ancillary to MESA

The purpose of MESA-Lung is to assess the role of endothelial dysfunction and genetic susceptibility in subclinical COPD.

Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the United States, and morbidity and mortality from COPD continue to rise. Despite the magnitude of the problem, therapeutic options are limited - particularly in comparison to cardiovascular disease. Smoking cessation is essential to the treatment and prevention of COPD. However, although smoking is the principal cause of COPD, only a minority of smokers develops symptomatic COPD and many former smokers develop COPD years to decades after they have stopped smoking. The only other medical intervention proven to reduce mortality from COPD is supplemental oxygen therapy. There is therefore an urgent need for newer understandings of the pathophysiology of COPD that might lead to the development of better therapies for COPD.

MESA-Lung is ancillary of the ongoing Multi-Ethnic Study of Atherosclerosis (MESA). MESA-lung will utilize the various existing measures of endothelial function that have been already been collected in MESA (flow-mediated dilatation \[FMD\] and related biomarkers and gene polymorphisms) to test the hypotheses that the endothelial dysfunction occurs in the clinical COPD.

Eligibility Criteria:
Inclusion Criteria:

* A random sample of MESA participants active at Exam 3 and/or 4.

Exclusion Criteria:

* MESA participants without MESA Exam 3 or 4 measurements.
* MESA participants without FMD measurements in Exam 1.
* MESA participants who have not consented to genetic testing.
Plethysmography Opto-electronic and Asthma

Objective: To assess the influence of nebulization with bronchodilators carried by the heliox coupled to PEP in the distribution of compartimental lung volumes in asmathic adults and to correlate with pulmonary function data. Methods: A controlled randomized trial involving 27 patients divided into four groups: heliox + PEP, oxygen + PEP, heliox and oxygen. After the initial evaluation, it was placing 89 reflective markers attached to the surface of the trunk and images acquired by optoelectronic plethysmography (OEP) of six cameras. Three slow vital capacity maneuvers and quiet breathing regarded as phase control. After the control phase, all patients underwent nebulization with a distribution noninvasive system, semi-closed using 10 drops of Fenoterol Bromide and 20 drops of Ipratropium.


Eligibility Criteria:
Inclusion Criteria:

* The study included individuals diagnosed with moderate to severe asthma with forced expiratory volume in one second (FEV1) \<60% or FEV1 \<60% - 80% predicted;
* showing reversibility of bronchial obstruction after administration of bronchodilators at least 10% in FEV1.

Exclusion Criteria:

* unable to understand or perform the spirometric maneuver;
* with a history of smoking;
* pulmonary comorbidities as chronic obstructive pulmonary disease (COPD);
* bronchiectasis and tuberculosis sequel;
* hemodynamic instability defined as heart rate (HR) greater than 150 bpm or systolic blood pressure below 90 mmHg or greater than 150mmHg;
* pregnancy and any contraindication to the use of PEEP;
* such as increased work of breathing (acute asthma);
* active hemoptysis;
* acute sinusitis;
* pneumothorax;
* untreated; surgery or facial trauma;
* oral or injury;
* epistaxis;
* nausea and esophageal surgery.
Orange Almond Potato Cookies Supplementation

The goal of this clinical trial is to assess the effect of potato almond orange cookie supplementation on the nutritional status of stunted under-five children.

The main questions aimed to answer are:

* Can cookie supplementation improve the weight of stunted under-five children?
* Can cookie supplementation improve the weight for age z score of stunted under-five children?

Participants divided in the two groups i.e.:

* Treatment group received 50 g potato almond orange cookie each day during 4 weeks.
* Control group received 50 g potato orange cookie each day during 4 weeks.
* Mothers of both groups given balanced nutrition education for stunted under-five children twice at the second and third week of study.

Treatment group received 50 g potato almond orange cookie each day during 4 weeks.

Control group received 50 g potato orange cookie each day during 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age in the range of 12-59 months
* Male and female
* Lived in Sawangan Lama, Depok, and Depok Jaya neighborhoods of Depok City (three urban villages with a large stunting prevalence)
* Had a Height-for-Age Z-score (HAZ) index of \< -2 SD
* Were not suffering from chronic or infectious diseases.

Exclusion Criteria:

* Suffered from chronic or infectious diseases
Remote Ischemic Conditioning to Reduce Burn Wound Progression

Burned skin areas, which were initially vital, can be irreversibly damaged by wound progression. The aim of the present study is to evaluate the feasibility of ischemic conditioning to reduce secondary wound progression.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the study information and the consent to sign

  * Thermal injury (burn / scalding) with a clinical evaluated depth of at least 2a (superficial partial)
  * At least one of the following sites must not have skin lesions

    : Upper arm right and left
  * hospital admission within 6 hours after trauma has taken place

Exclusion Criteria:

* Participation in another experimental study

  * Pregnancy (women are subjected to a pregnancy test (urine)
  * Contraindication for the use of the tourniquet, for example Lymph drainage disorders after axillary lymphadenectomy or Irradiation of the axilla
  * Non-compliant patients who are, e.g. Intubated
  * Pure 3rd degree burns (full thickness) or charring
  * Thermal injuries older than 6 hours
Open Label Immunotherapy of Myoma

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.

Eligibility Criteria:
Inclusion Criteria:

diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -

Exclusion Criteria:

other gynecological diseases not related to myoma hysterectomy

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