cyrilzakka/clinical-trials huggingface dataset:
Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation

The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.

The side effects are modest, since PARP inhibitors affect cancer cells to a much larger extent than normal cells. The effect of this PARP-inhibiting treatment is evident although the greatest effect is seen in patients with mutations in BRCA genes. The reason for this is that BRCA deficient cancer cells are unable to repair both DNA double strand and single strand breaks and undergo apoptosis to a large extent.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
2. Patients with known germline BRCA1/2 mutations
3. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
4. Platinum resistance or partially platinum sensitive disease (Relapsed within six months of prior first line/later lines of platinum-based therapy or relapsed within six to twelve months of prior first line/later lines of platinum-based therapy)
5. Age ≥ 18 years.
6. Performance status 0-2.
7. Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria
8. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):

   WBC ≥ 3.0 x 10\^9/l or neutrophils (ANC) ≥ 1.5 x 10\^9/l Platelet count ≥ 100 x 10\^9/l Hemoglobin ≥ 9.7 g/dl (6 mmol/L) Serum bilirubin ≤ 1.5 x ULN Serum transaminases ≤ 2.5 x ULN Serum creatinine ≤ 1.5 x ULN
9. Written informed consent.
10. Tissue available for BRCAness analysis.

Exclusion Criteria:

1. Previous treatment with a PARP inhibitor.
2. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
3. Patients who have received (or are planning to receive) treatment with any other investigational regimen, or who have participated in another clinical trial within 28 days prior to entering this trial.
4. Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
5. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
6. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse.

   Curatively treated prior breast cancer is allowed if no relapse is suspected at time of inclusion.
7. CNS metastasis.
8. History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease).
9. Allergy to the ingredients of the study medication.
Fraction Dose Escalation of Split-course Hypofractionated Concurrent Chemoradiotherapy Following Induction Chemo-immunotherapy in Unresectable Locally Advanced Esophageal Squamous Carcinoma: a Phase I Study.

This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.

This Phase I study is to determine the maximum tolerated fraction dose (MTD) for split-course hypo-CCRT following induction chemo-immunotherapy in LA-ESCC patients, to clarify the dosimetric advantage of split-course hypo-CCRT, and to investigate the treatment-related toxicities and quality of life of the new regimen.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed ESCC
* II-IVB stages (IVB stage only with metastatic celiac or supraclavicular lymph nodes) based on the TNM staging system proposed by the International Union Against Cancer (UICC 2002)
* Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
* Charlson Comorbidity Index score≤4
* oral medication can be administered despite esophageal obstruction
* adequate hematological, renal and hepatic functions

Exclusion Criteria:

* contraindication for radiotherapy or chemotherapy
* prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ
* distant metastasis, except for celiac or supraclavicular lymph nodes metastases
COVIDIG (COVID-19 Hyper-ImmunoGlobulin)

The objective of this study is to evaluate the efficacy and safety of 5131A for hospitalized patients of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* The COVID-19 patient who diagnosed by PCR within 3 days prior to randomized And who is hospitalized with COVID-19 related symptoms
* The subject who has symptoms of COVID-19 within 7 days
* The subject with pneumonia confirmed by imaging diagnosis related to COVID-19 OR a 70-year-old or older OR 60-year-old or older with underlying disease (diabetes or hypertension or obesity or smoker)
* Willing and able to provide written informed consent prior to performing study procedures

Exclusion Criteria:

* asymptomatic patient
* The subject who requiring mechanical ventilation or ECMO
* The subject who are underlying oxygen therapy before affected by COVID-19
* The subject who have received antiviral drugs for other disease within 4 weeks
* History of allergy to IVIG or plasma products
* The subject who received IVIG or convalescent plasma from a person who recovered from COVID-19
* IgA deficiency
* Cretinine \> 2 X ULN
* The subject with a history of thrombosis or high risk of thromboembolism
* The subject with reduced heart function \[NYHA (New York Heart Association) Functional Class III or IV\]; or cerebral cardiovascular disorder or a patient with the medical history (ischemic disease, cardiovascular disease, cerebrovascular disorder, blood vessel disorder, etc.)
Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers

The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation.

Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radio-graphic examination and primary impression for diagnostic cast construction.

Visit 2: Teeth preparation, secondary impression,temporary restoration and teeth sensitivity evaluation using United States Public Health Service criteria.

Visit 3: Placement and permanent cementation of the final restoration

Visit 4: marginal adaptation measurement by electron microscope using impression replica.

Eligibility Criteria:
Inclusion Criteria:

* From 18-40 years old, be able to read and sign the informed consent document.
* Be physically and psychologically able to tolerate conventional restorative Procedures.
* Have no active periodontal or pulpal diseases, have teeth with good restorations.
* Patients with teeth problems indicated for laminate veneer (e.g:discoloration, fracture not involve more than 50% enamel loss, mild malposition.
* Be willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth.
* Patient with fractured teeth of more than 50% enamel loss.
* Patients with poor oral hygiene and motivation.
* Pregnant women.
* Patient with post and core endodontically treated teeth.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for restoration
Kidney Cancer Observational Protocol

The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

A databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form.

Each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. At each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. Yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. The data collected will be handled following the most strict GCPs and privacy norms. The main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Kidney cancer diagnosis
* Indication to cancer removal through surgery
* Ability to read and sign the informed consent

Exclusion Criteria:

* Age \< 18 years
* Absence of kidney cancer
* Inability to read and sign the informed consent
Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer

This phase I trial studies a sexual health counseling intervention during radiation therapy in improving quality of life for women with gynecologic cancer. Women with gynecologic cancer often suffer long-term complications from treatment that can affect their physical and psychological well-being. An early sexual health counseling intervention prior to and after radiation may improve symptoms management and reduce the physical and psychological effects of treatment.

PRIMARY OBJECTIVE:

I. To determine the feasibility of a sexual health counseling intervention before and after pelvic radiation for women with gynecologic cancers.

SECONDARY OBJECTIVE:

I. To preliminarily evaluate the efficacy of a sexual health counseling intervention on patient reported outcomes in quality of life, sexual function, and genitourinary symptoms.

OUTLINE:

Patients receive sexual health counseling prior to starting and at the completion of radiation.

After completion of study, patients are followed up at 1 and 6 months after radiation.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with endometrial, cervical, vaginal, or vulvar cancer receiving adjuvant external beam radiation or definitive external beam radiation and brachytherapy will be eligible for the study
* Those receiving concurrent chemotherapy will be eligible
* Any prior gynecologic surgery is permitted

Exclusion Criteria:

* Patients with metastatic or recurrent disease and patients receiving brachytherapy alone
Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy

The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.

The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Primary open angle glaucoma or pseudoexfoliation glaucoma
* medically uncontrollable intraocular pressure or intolerance of topical therapy
* negative urine/serum pregnancy test of women in childbearing age
* signed and dated informed consent

Exclusion Criteria:

* previous incisional glaucoma procedure on affected eye
* pregnancy, nursing period
* Patients in military service, training periods and civil service
* Participation in another clinical trail
* pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects

This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.

This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day),
* BMI ≥27 and ≤45 kg/m2
* HbA1c ≥7.0% and ≤10.5% at screening

Exclusion Criteria:

* Type 1 diabetes mellitus
* Previous treatment with incretin mimetic drugs
* Have used insulin for diabetic control for more than 6 consecutive days within the prior year
* Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months
* Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (\>2 x ULN).
Immune Mechanisms of Rejection in Human Lung Allografts

The investigators have obtained compelling evidence that the development of anti-human leukocyte antigen (anti-HLA) antibodies against mismatched donor antigens significantly correlates with the development of bronchiolitis obliterans (BOS). Further, these anti-HLA antibodies are developed at least 15 months prior to any clinical evidence of BOS. This lag period between the development of anti-HLA antibodies and the onset of BOS gives us an opportunity to intervene to delay and/or prevent the development of BOS.


Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipient.

Exclusion Criteria:

* Pregnant women,
* Prisoners, AND
* Anyone who is unable or unwilling to consent to this study.
Learning to Resist the Urge: Inhibition Training in Abstinent Patients With Alcohol Use Disorders

The study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder.

Therapeutic interventions to treat alcohol use disorders (AUD) still need to be improved. A novel alcohol-specific inhibition-training seems to be a promising new intervention. In this study, recently abstinent patients with AUD attending an inpatient treatment program will be randomly assigned to one of two alcohol-specific inhibition-training groups (varying in Go/NoGo-ratio) or to a control condition. Besides the effects on drinking behavior, inhibition and implicit attitudes, the investigators expect the training to influence neurophysiological reactivity to alcohol related stimuli. A subgroup of patients will therefore additionally undergo EEG recording so that the neurophysiological effects of the training can be assessed and related to clinical outcome. Furthermore, since training effects rely on learning processes, the influence of endogenous cortisol level (a consolidation-enhancer which peaks in the morning) on training outcome will be examined by the variation of daytime of the training. All patients' inhibitory control and implicit associations towards alcohol will be measured before and after training. The training effects will be examined on proximal outcome variables (e.g. implicit associations, inhibitory control, abstinence related self-efficacy, craving) and on distal outcome variables at 3-, 6- and 12- months follow-up (e.g. percent abstinent days (primary outcome)).

Eligibility Criteria:
Inclusion Criteria:

* Abstinent patients with an alcohol use disorder in the 12-week inpatient program of the Clinic Südhang or the Forel Clinic,
* Abstained from alcohol for at least 4 weeks (in relation to timepoint when training will start),
* Informed Consent as documented by signature.

Exclusion Criteria:

* Other main psychiatric diagnosis than alcohol use disorder (comorbidity is allowed if the alcohol use disorder is to be considered the main diagnosis),
* other severe substance use disorder (except nicotine), even as secondary diagnosis
* Neurocognitive problems (e.g. Korsakoff syndrome),
* Current medical conditions excluding participation (e.g. acute infectious disease),
* Inability to read and understand the participant's information,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach

Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

Treatment with a therapeutic dose of any low molecular weight heparin (LMWH) or unfractioned heparin (UFH) or fondaparinux is allowed only within the 36 hours immediately preceding randomization. Randomization is performed as soon as the diagnosis of PE (and DVT if concomitant suspected symptomatic DVT) is confirmed.

Allocation to treatment is done centrally by Interactive Voice Response System (IVRS) and stratified by (1) center, (2) intended treatment duration, ie, 3 months or 6 months. At randomization, the planned duration of treatment (3 or 6 months) is prespecified by the Investigator and determined on the assessment of risk of VTE recurrence. Participants are randomized to either idrabiotaparinux + placebo of warfarin, or warfarin + placebo of idrabiotaparinux, with an initial treatment of at least 5 days with enoxaparin in both treatment groups.

Participants in the 3-month stratum have an additional 13-week observational period after cessation of study treatment. Participants in the 6-month stratum have a 13-week up to 26-week observational period.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis

Exclusion Criteria:

* End stage renal failure, hepatic failure, uncontrolled hypertension;
* Active bleeding or high risk for bleeding;
* Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion.
* Breastfeeding.
* Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins;
* hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin;
* Indication of prolonged anticoagulation therapy for other reason than PE;
* Life expectancy \< 6 months;
Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement

The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines \[≥150 min/week of MVPA\]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.

All participants will receive a 6-month, fully automated online behavioral exercise program (Energize! Exercise Program). This program is designed to increase moderate-intensity physical activity among individuals who engage in little to no physical activity at baseline. Over the course of the program, participants are given a physical activity goal which starts at 75 minutes per week and gradually progresses to 200 minutes per week. Participants are instructed to view a 10-15-minute video lesson weekly, during months 1-3, and monthly during months 4-6. These lessons teach behavioral principles for increasing exercise and maintaining physical activity long-term. Participants are also asked to complete an 'Apply Your Knowledge' activity after watching each video lesson. These activities are designed to help the participant engage more with the lesson content, with a particular emphasis on applying the content to their lives. Within this program, participants are also asked to plan and report their exercise each week, and automated feedback is provided based upon their weekly physical activity reports.

In addition to receiving the Energize! Exercise Program, participants will be randomly assigned to receive 0-4 supplemental intervention components (phone coaching, progress reports to providers, 'Hear From Others' videos, and individualized feedback) which are each described in more detail below.

Eligibility Criteria:
Inclusion Criteria:

* had a knee replacement (including primary, staged or independent bilateral, or revision) at least 12 months ago
* have a computer, tablet, or smartphone with active internet access
* self-report engaging in less than 60 minutes/week of moderate-intensity physical activity
* be English-speaking and able to read consent and study materials written in English
* be willing to complete the 4 remote assessments, including physical activity monitoring
* be willing to be randomized to receive 0-4 supplemental intervention components.

Exclusion Criteria:

* any contraindications to physical activity (e.g., chest pain)
* have a scheduled surgery within the next 12 months (e.g., hip or knee replacement)
* have a mobility limiting comorbidity unrelated to knee replacement
* live outside of the continental U.S
* do not currently have a physician or orthopedic surgeon whom they see regularly
* are currently participating in physical therapy (for knee)
* are participating in a structured weight loss or physical activity program
* unable to provide proof of knee replacement surgery
* have a BMI \>40kg/m2
* score \>30 on PROMIS cognitive function
MANI Real-life Perspective Observatory

The purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.

To represent real-world mild moderate Italian asthmatics, all adults with diagnosed asthma by specialist, according GINA (Global Initiative for Asthma) document, attending respiratory or allergy clinic for a scheduled visit are eligible for study enrollment. If inclusion/exclusion criteria are satisfied, a written consent to participate in the study will be obtained and an informative leaflet for the patient and his/her general practitioners will be delivered.

Subjects follow up will be scheduled according with GINA document and center plan (6 or 12 months follow up visit).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Asthma diagnosis according GINA 2020 algorithm (Annex 1)
* Patients enrolled in other previous or ongoing observational studies

Exclusion Criteria:

* Severe asthma patients according International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. \[Chung KF et al. European Respiratory Journal Feb 2014, 43 (2) 343-373; DOI: 10.1183/09031936.00202013 (Annex 2)\]
* Subjects are excluded from this cohort if they exhibit interstitial lung diseases, pulmonary neoplasms, current lung infections, immunological disorders leading to the use of immunosuppressants or continuous treatment with oral steroids.