bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Rucaparib
Intervention description: Rucaparib will be administered daily
Intervention MeSH terms: Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 277.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRPC; PARP inhibitor; PARPi; BRCA; ATM; HRD; TRITON; homologous recombination; DNA repair; DNA defect; DNA anomaly; BARD1; BRIP1; CDK12; CHEK2; FANCA; NBN; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD54L; germline; somatic; mCRPC

Summary:

      The purpose of this study is to determine how patients with metastatic castration-resistant
      prostate cancer, and evidence of a homologous recombination gene deficiency, respond to
      treatment with rucaparib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years old at the time the informed consent form is signed

          -  Have a histologically or cytologically confirmed adenocarcinoma or poorly
             differentiated carcinoma of the prostate

          -  Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL
             (1.73 nM)

          -  Experienced disease progression after having received at least 1 but no more than 2
             prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based
             chemotherapy, for castration-resistant disease

          -  Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other
             homologous recombination deficiency

        Exclusion Criteria:

          -  Active second malignancy, with the exception of curatively treated non-melanoma skin
             cancer, carcinoma in situ, or superficial bladder cancer

          -  Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any
             platinum-based chemotherapy

          -  Symptomatic and/or untreated central nervous system metastases

          -  Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
             in the opinion of the investigator, interfere with absorption of rucaparib
Platelet-Rich Plasma Therapy for Patellar Tendinopathy
Condition: Patellar Tendinitis
MeSH terms: Tendinopathy
Intervention: PRP; Dry Needling; Dry Needling - Sham
Intervention description: Injection of autologous platelet rich plasma (PRP); This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.; This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking description: Subjects and assessors will be blinded to the subject group allocation. Subjects will be identified to study personnel using a unique study number only and results of the imaging studies will be blinded, batched, and evaluated in a randomized manner.
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No

Summary:

      The overall goal of this research is to find an effective treatment for patellar tendinopathy
      (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to
      investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function
      scores) and bio-mechanical (knee strength) measures will be correlated with disease
      modification changes assessed using conventional and novel quantitative magnetic resonance
      imaging (MRI) and ultrasound (US) techniques.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age between 18 and 39 years

          2. Chronic (>3 months) PT

          3. Clinical examination consistent with PT

          4. MRI or US confirmation of PT

          5. Pain score of 3 or greater on a 10-point visual analogue scale

          6. Self-report failure of supervised physical therapy

          7. Self-report failure of at least 2 of the most common treatment options for PT (e.g.
             NSAIDs, relative rest, ice and bracing).

        Exclusion Criteria:

          1. Inability to comply with study follow-up requirements

          2. History of bleeding disorders or other hematologic conditions

          3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal
             tear, ligament injury or reconstruction)

          4. Full or partial patellar tendon tear

          5. Current use of anticoagulation or immunosuppressive therapy

          6. Prior knee trauma requiring medical attention or surgery

          7. Worker's compensation injury

          8. Daily opioid use for pain

          9. Contraindication to MRI.

         10. Systemic diseases such as Diabetes and connective tissue diseases.

         11. Prior PRP or DN procedure.

         12. Women that are pregnant
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery
Condition: Preterm Birth
MeSH terms: Premature Birth
Intervention: Progesterone Cervical Pessary 6.3 g; Progesterone 200 mg vaginal capsules; Progesterone Cervical Pessary 7.7 g
Intervention description: Progesterone Cervical Pessary low dose; Progesterone 200 mg vaginal capsules daily; Progesterone Cervical Pessary high dose
Intervention MeSH terms: Progesterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 271.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preterm birth; Short cervix; Cervical Pessaries; Progesterone

Summary:

      Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized
      progesterone for the prevention of preterm delivery, established through spontaneous birth
      before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the
      pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant
      women at high risk of premature birth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a single pregnancy and a cervical length of 10 mm - 25 mm between 16 and 24
             weeks of gestation, without any previous factors.

          -  Women with a single pregnancy with 10 mm or more cervical length between 16 and 24
             weeks of gestation, and pre-existing risk factors risk factors for preterm birth:

          -  Previous preterm birth before week 35.

          -  Previous rupture of membranes before week 35

        Exclusion Criteria:

          -  Pregnancies with:

               -  Major fetal abnormalities, such as lethal malformations or malformations
                  requiring pre- or post-natal surgery; and fetal death before inclusion into the
                  study.

               -  History of rupture of membranes or prophylactic cerclage before study entry.

          -  Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion
             secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).

          -  Unconscious, severely ill or mentally disabled patients, or under 16 years of age.

          -  Patients for whom use of progesterone is contraindicated.

          -  Patients with history of thrombosis.
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
Condition: COVID-19
MeSH terms: COVID-19
Intervention: AT-527; Placebo; AT-527; Placebo
Intervention description: One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) for a total of 5 days; One placebo tablet administered every ~12 hours (twice a day) for a total of 5 days; Two 550 mg tablets of AT-527 administered every ~12 hours (twice a day) for a total of 5 days; Two placebo tablets administered every ~12 hours (twice a day) for a total of 5 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Blinded
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety, tolerability, antiviral activity and
      efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors
      for poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma). Eligible
      subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo
      tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg
      BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard
      of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety
      observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Hospitalized or in a hospital-affiliated confinement facility

          -  SARS-CoV-2 positive

          -  Initial COVID-19 symptom onset within 5 days prior to Screening

          -  SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to
             maintain SpO2 ≥ 93%

          -  Must also have a history of at least one of the following known risk factors for poor
             outcomes: obesity (BMI>30), hypertension, diabetes or asthma.

        Key Exclusion Criteria:

          -  Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 <93% on room air or
             requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood
             pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300

          -  Requires mechanical ventilation

          -  Lobar or segmental consolidation on chest imaging.

          -  Treatment with other drugs thought to possibly have activity against SARS-CoV-2

          -  ALT or AST > 5 x upper limit of normal (ULN)

          -  Female subject is pregnant or breastfeeding

          -  Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day
             14 visit (Part B).
(+) Epicatechin to Treat Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: (+)-Epicatechin
Intervention description: 25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 10 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This 24-week study will test the safety and effectiveness of synthetically produced (+)
      Epicatechin in treating patients who have Friedreich's Ataxia, a neurological disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of Friedreich's Ataxia (FA) by Frataxin genetic testing and/or
             Frataxin enzyme analysis

          -  Between age 10 and 50 years of age, inclusive

          -  Body weight of 25 kilograms or higher

          -  Minimum of one affected organ (cardiac or neurological) system, as evidenced by
             clinical signs/symptoms

          -  Disease duration ≤7 years, based on onset date of FA symptoms

          -  Has no known contraindication to gadolinium contrast such as severe allergy or
             Glomerular Filtration Rate <30 ml/min/m^2.

          -  Has no known contraindication to non-contrast Magnetic Resonance Imaging (MRI)
             evaluation such as pacemaker or magnetically active metal fragments.

          -  Women of childbearing age must:

               -  Have a negative pregnancy human chorionic gonadotropin test prior to receiving
                  study drug.

               -  Agree to use contraception for the duration of the study drug dosing, plus 1
                  month after completion of the study.

        Exclusion Criteria:

          -  Advanced cardiac failure, New York Heart Association (NYHA) Classification Scale-Class
             IV (advanced stage heart failure)

          -  Clinically significant comorbidities that may also lead to cardiomyopathy, for example
             long standing hypertension, familial cardiomyopathy.

          -  Clinically significant comorbidities that would, in the opinion of the investigators,
             compromise the interpretation of test results.

          -  Pregnant, breast-feeding or planning to become pregnant during study timeframe.

          -  Patients with contraindications to regadenoson, i. e. second- or third-degree
             atrioventricular (AV) block or sinus node dysfunction. Has received an investigational
             drug within thirty (30) days of baseline visit.

          -  Thrombocytopenia (<125 x 10^9/Liter) or prolonged Prothrombin Time/Partial
             Thromboplastin Time (PT/PTT) at baseline.

          -  Clinically significant hypotension (systolic blood pressure <90) due to heart failure
             or other conditions.
99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer
Condition: Breast Cancer; Doxorubicin Induced Cardiomyopathy
MeSH terms: Breast Neoplasms; Cardiomyopathies; Cardiotoxicity
Intervention: 99mTc-rhAnnexin V-128
Intervention description: Kit for the preparation of 99mTc-rhAnnexin V-128
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a single center, proof-of-concept (PoC), Phase II study. Patients with
      histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and
      scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or
      docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment
      consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC)
      intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and
      99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits:

        1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1)

        2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2)

        3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3)

        4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were
           conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal
           pro B-type natriuretic peptide [NT-proBNP]) was performed at each visit.
    

Eligibility criteria:

        Inclusion criteria:

          1. Females >= 18 years of age with histologically confirmed early stage (Stage I, II or
             III) HER-2 negative breast cancer and planned for (neo)adjuvant doxorubicin-based
             chemotherapy (AC every 2 or 3 weeks x 4 cycles)

          2. Eastern Cooperative Oncology Group Status (ECOG) ≤ 2

          3. Able and willing to comply with the study procedures

        Exclusion criteria:

          1. Pregnancy or lactation

          2. Moderate or severe valvular stenosis or regurgitation

          3. History of atrial fibrillation or flutter

          4. History of any disease or relevant physical or psychiatric condition which may
             interfere with the study objectives at the investigator judgment

          5. Know hypersensitivity to the investigational product (IP) or any of its components

          6. Prosthetic valve or pacemaker

          7. Claustrophobia or inability to lie still in a supine position

          8. Contraindication(s) to the CMRI procedure

          9. Participation in another clinical trial within 4 weeks before study inclusion, except
             for patients who have participated or who are currently participating in a study
             without any study drug administration

         10. Unwillingness to provide consent
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.
Condition: Colorectal Neoplasms; Melanoma; Prostatic Neoplasms; Renal Cell Carcinoma; Neoplasms; Patients Who Have/Have Had Melanoma and Other Tumors
MeSH terms: Neoplasms; Melanoma; Carcinoma, Renal Cell; Colorectal Neoplasms; Prostatic Neoplasms
Intervention: CP-675,206 (Tremelimumab)
Intervention description: 15 mg/kg IV every 3 months as long as required
Intervention MeSH terms: Tremelimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Melanoma and other tumors

Summary:

      This study is intended to provide access to tremelimumab for patients who have previously
      received tremelimumab in a clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject must have already received tremelimumab in another protocol

          -  Females of childbearing potential must agree to practice a form of effective
             contraception for 12 months following any dose of study drug. The definition of
             effective contraception will be based on the judgement of the investigator.

          -  Subject must be willing and able to provide written informed consent and to comply
             with scheduled visits and other trial procedures

        Exclusion Criteria:

          -  None
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BMS-945429 Placebo; BMS-945429; BMS-945429; BMS-945429; BMS-945429; Methotrexate; Methotrexate; Methotrexate Placebo; Methotrexate; Adalimumab Placebo; Adalimumab
Intervention description: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only; Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only; Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks; Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48; Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks; Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only; Tablets, Oral, 15 mg, Weekly, 48 weeks; Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only; Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only; Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks; Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 418.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effective dose of BMS-945429 in subjects with
      inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid
      Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inadequate response to Methotrexate

          -  Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of
             at least 15 mg and stable dose for 4 weeks prior to randomization

          -  American College of Rheumatology (ACR) global function status class 1-3

          -  Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand
             or wrist

          -  High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

        Exclusion Criteria:

          -  Previously received or currently receiving concomitant biologic therapy
A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer
Condition: Oropharyngeal Cancer
MeSH terms: Papilloma; Oropharyngeal Neoplasms
Intervention: TORS; Adjuvant Radiation Therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: T1-2 N2 M0,; stage IVa SCCA; oropharynx; negative for PNI,; negative surgical margins

Summary:

      To determine 2-year local (primary tumor site) control and toxicity rates in patients
      receiving adjuvant RT post-TORS, omitting the primary tumor bed, in patients with completely
      resected, HPV-positive SCCA of the oropharynx.

      To determine acute and long-term toxicity rates in patients receiving adjuvant RT post-TORS,
      omitting the primary tumor bed, in patients with completely resected, HPV-positive SCCA of
      the oropharynx.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years or older Histologically confirmed diagnosis of squamous cell
             carcinoma of the oropharynx, stage IVa, p16-positive on immunohistochemistry
             Pathologic T1 or T2 disease, resected with negative margins ( 2mm) Pathologic N2a,
             N2b, or N2c disease ECOG Performance Status 0-1

          -  Patients must sign an informed consent document that indicates they are aware of the
             investigational nature of the treatment in this protocol as well as the potential
             risks and benefits - - - Ability to understand and the willingness to provide written
             informed consent

        Exclusion Criteria

          -  Prior radiation therapy to the head and neck Prior chemotherapy within the past 5
             years Presence of T3 or T4 disease Presence of close (2 mm) or positive margins PNI on
             TORS resection of the primary cancer Presence of N0 or N1 disease in neck dissection
             Presence of distant metastatic (M1) disease

          -  Uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure, unstable angina pectoris, connective tissue disease or
             psychiatric illness/social situations that would limit compliance with study
             requirements.