cyrilzakka/clinical-trials huggingface dataset:
Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

This study will determine the recommend dose of palbociclib in combination with letrozole and another medication, Ado-trastuzumab emtansine (T-DM1). Additionally, researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer.

The study will include a safety lead-in with escalating dosing of palbociclib to determine the recommended phase II dose (RP2D) of palbociclib in this combination and an expanded phase II of palbociclib at the RP2D in combination with letrozole and Ado- trastuzumab Emtansine (T-DM1).

The starting dose of palbociclib will be 75 milligrams (mg) by mouth (PO) daily for each 21 day cycle. If 0 of 3 patients at the 75mg dose level experience a dose limiting toxicity (DLT), the next 3 patients will be enrolled at the next higher dosing cohort of 100mg PO daily for each 21 day cycle. If 0 of 3 patients at the 100mg dose level experience a DLT, the next 3 patients will be enrolled at the next higher dosing cohort of 125mg PO daily for each 21 day cycle. If 0 of 3 patients at the 125mg dose level experience a DLT, 125mg PO daily of palbociclib will be the phase II recommended dose used in the phase II expanded cohort. Patients receiving the phase II recommended dose in phase I will be enrolled in phase II of the study.

During safety lead-in and expanded phase II, Letrozole 2.5mg PO will be administered daily for each 21 day cycle and T-DM1 3.6 milligrams per kilograms intravenously (IV) will be administered on Day 1 of each 21 day cycle.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of Estrogen Receptor (ER) positive and HER2 (human epidermal growth factor receptor 2) positive metastatic breast cancer based on local laboratory results.
* Prior treatment with a taxane (including paclitaxel, docetaxel and/or nanoparticle protein-bound paclitaxel).
* Prior treatment with trastuzumab with or without pertuzumab.
* Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
* Eastern Cooperative Oncology Group Performance Status of 0-2
* Adequate organ and marrow function
* Women must be post-menopausal
* Must be able to swallow pills

Exclusion Criteria:

* Current or anticipated use of other investigational agents
* Prior therapy with a cyclin-dependent kinase 4/6 inhibitor
* Subject has received chemotherapy or radiotherapy within 14 days prior to Cycle 1, Day 1 of the study or has not recovered from adverse events due to agents administered more than 14 days earlier
* Subject has leptomeningeal disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in study
* Subject has other illness or disease that the investigator believes will interfere with study requirements.
Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure.

Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women (primary or secondary)
* Age between 18 and 40 years.

Exclusion Criteria:

* age\<18 years and˃ 40 years.
* pelvic inflammatory disease.
* .Active uterine bleeding
A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia

The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

Eligibility Criteria:
Key Inclusion Criteria:

* Male of age 18-50 years
* Clinical Diagnosis of Androgenetic Alopecia
* Written informed consent

Key Exclusion Criteria:

* Other types of Alopecia or other diseases that can cause hair loss
* Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
* Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
* Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose
Non-drug Treatment Study in Parkinson's Disease Patients and Healthy Volunteers to Collect Biological Samples in Order to Assess ex Vivo the Activity of Candidate Therapies and Develop Novel Analytical Methods for Biomarkers

This is a non-drug study in patients with Parkinson's Disease (PD) and healthy volunteers to process and analyze their blood and optional cerebrospinal fluid (CSF) samples ex vivo, or outside of their body, to further develop researchers knowledge on LRRK2 biomarkers. Participants were enrolled either in Cohort A or in Cohort B. A blood sample was collected in each participant within a maximum of two study visits within 14 days, and an option to complete both visits on the same day.

This study will allow researchers to assess the potency of investigational LRRK2 inhibitors, outside of participant bodies. It will enroll Parkinson's disease patients (LRRK2 G2019S symptomatic carriers and idiopathic) and healthy volunteers meeting eligibility criteria. The study will consist of a maximum of two study visits, a selection visit to check eligibility criteria, and a sample collection visit. The two visits can take place on the same day or can occur within 14 days of each other. Participants will be assigned to Cohort A or Cohort B, each include a blood sample collection, and an optional cerebrospinal fluid (CSF) collection in Cohort A. No investigational product, study drug, will be administered to study participants.

Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential (WOCBP) must have a negative pregnancy test
* Parkinson's disease (PD) patients must be at least 40 years old
* Healthy volunteers must be at least 30 years old
* PD patients must have a PD diagnosis, according to the 2015 Movement Disorder Society criteria, with bradykinesia, and at least one of the following: muscular rigidity, or resting tremor with no other suspected cause of Parkinsonism
* The LRRK2 G2019S symptomatic carrier PD patients must have a documented G2019S mutation on the leucine-rich repeat kinase 2 gene (LRRK2)

Exclusion Criteria:

* Pregnant or lactating women
* Have participated in an investigational drug trial within 30 days
* Are SARS-CoV-2, COVID-19, positive within 15 days prior to blood sample collection
* Have another active disease that the investigator believes could interfere with study results
Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of anterior cruciate ligament reconstruction: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring anterior cruciate ligament reconstruction will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.

Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia

Primary endpoints is reduction in pain as measured by Visual Analogue Scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.

Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.

Eligibility Criteria:
Eligibility Criteria:

Inclusion Criteria:

* All adult patients over age 18 and scheduled for a primary or revision anterior cruciate ligament reconstruction

Exclusion Criteria:

* Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact anterior cruciate ligament reconstruction
The Efficacy and Safety of R-EPOCH and R-CHOP Regimen for Patients With AIDS Associated CD20+ Diffuse Large B Lymphoma

1. Compare the efficacy of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma; 2. Compare the safety of R-EPOCH and R-CHOP regimen for patients with AIDS associated CD20+ diffuse large B lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. male or female aged 18-60 years old;
2. Confirmed as AIDS patients and treated with HAART;
3. Confirmed as CD20+ diffuse large B lymphoma;
4. Serum test; negative for HBV, HCV and syphilis;
5. Hematology: Absolute neutrophil count greater than or equal to 1000/mm(3); Platelet count greater than or equal to 50,000/mm(3); Hemoglobin greater than 8.0 g/dl; Lymphocyte count less than or equal to 4,000/mm(3);
6. Chemistry: Serum ALT/AST less or equal to 5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl;
7. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram;
8. Negative pregnancy test for female;
9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment;
10. To be able to understand and sign the Informed Consent Document with legal force.

Exclusion Criteria:

1. With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system;
2. Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells;
3. Women with pregnant or breastfeeding;
4. Any form of primary immunodeficiency;
5. Concurrent Systemic steroid therapy;
6. History of severe immediate hypersensitivity reaction to any of the agents used in this study;
7. History of allogeneic stem cell transplantation.
Umbrella Study for Single Patient Treatments in Oncology

The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments.

The UNIQUE umbrella protocol is an overarching framework to study precision medicine in patients with precise molecular data, who have exhausted all established treatment options and who are not eligible for any of the ongoing trials. There is no additional visit or procedure required to participate in this study. Participants who have received/who may receive the following treatments may join the study and will be assigned to a study cohort (group):

* Group 1 - Health Canada approved/marketed drug(s) used on or off-label as Standard of Care (SOC)
* Group 2 - Drugs accessed from Special Access Program (SAP)
* Group 3 - Non-marketed investigational agents

Under the UNIQUE framework, data from participants will be evaluated. The following data will be collected:

* Demographic data (for example: sex, race, month and year of birth)
* Medical history
* Cancer characteristics including biomarkers
* Treatment history
* response to treatment

Eligibility Criteria:
Inclusion Criteria \& Exclusion Criteria:

Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease".

The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed.

The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied

The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women
* Aromatase inhibitor as the last hormonal treatment
* Breast adenocarcinoma with positive hormone receptor
* Measurable disease as per RECIST definition

Exclusion Criteria:

* ECOG performance status (PS) \> 2
* Prior exposure to fulvestrant or to an anti IGF-1R compound
* No evidence of hormonosensitivity
* HER 2-neu positive tumor
* More than one prior regimen of chemotherapy for metastatic disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose.

Primary Objective:

- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

Secondary/Observational Objectives:

* To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
* To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.
* To describe the safety profile following vaccine administration.


Eligibility Criteria:
Inclusion Criteria :

* Healthy, as determined by medical history and physical examination.
* Aged 4 to 6 (\< 7) years at the time of study vaccination on Day 0.
* Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
* Signed and dated informed assent form from the subject if required by the IRB.
* Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
* Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).

Exclusion Criteria :

* Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the original trial period.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the past 3 months.
* Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
* History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
* Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.
Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor

According to the latest national cancer statistics released by the National Cancer Center in February 2022, intracranial tumors account for about 60%-70% of the more than 3.5 million cancer patients, and the morbidity and mortality remain high. Intracranial malignant tumors have become a problem that needs to be solved urgently because of their early recurrence, rapid progression, and short survival, and intracranial malignant tumors include high-grade gliomas, metastases, lymphomas, etc.

Glioblastoma (GB) is the most common primary malignancy in the adult central nervous system, accounting for about 57% of all gliomas and 48% of all primary weighted nervous system malignancies. At present, the standard treatment for glioblastoma is mainly surgical treatment, supplemented by postoperative concurrent chemoradiotherapy and adjuvant chemotherapy, but the prognosis of patients is still poor, with a one-year survival rate of 40.6%, a five-year survival rate of only 5.6%, and an average survival time of 12-15 months.

For patients diagnosed with intracranial malignancies (including high-grade glioma, metastases, lymphoma, etc.), multimodal image-guided microsurgery combined with postoperative chemoradiotherapy recommended by the guidelines, and intraoperative radiotherapy with tumor bed radiation therapy to achieve targeted and precise tumor treatment, thereby improving the prognosis of patients (including progression-free survival and median overall survival, etc.)


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old, non-pregnant or lactating women
* KPS ≥60
* MRI and CT of the brain with contrast should be considered for diagnosis of high-grade glioma or other malignant brain tumors
* No other underlying diseases that affect survival time, follow-up or quality of life, and no other serious organic lesions
* Not receive radiotherapy, chemotherapy and other treatment methods for intracranial lesions in the past;
* Tumor located supratentorium, and the position should ensure that the tumor resection volume is more than 90%;
* The required dose of standard radiotherapy exceeds normal tissue tolerance
* No related contraindications such as intraoperative radiotherapy and craniotomy.

Exclusion Criteria:

* Refuse to undergo craniotomy or radiation therapy;
* The postoperative paraffin pathological results were not high-grade gliomas or other cranial malignant tumors;
* Refuse to participate in the clinical trial after informed consent without the above exclusion criteria.
Occipital Nerve Stimulation for the Treatment of Chronic Migraine Headache.

Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache greater than 15 days per month.

Method: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responsers were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.

The therapy under investigation involves a Medtronic neurostimulation device which delivers electrical impulses via insulated lead wires placed under the skin near the occipital nerves at the base of the head.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Migraine Headache by International Headache Society (IHS) criteria
* compliance with daily questionnaire
* headache that has not responded to at least two classes of headache medications
* stable headache medication regimen

Exclusion Criteria:

* previous surgical procedures to disrupt the nerves of the neck relating to the headache
* subjects who may require MRI or Diathermy