cyrilzakka/clinical-trials huggingface dataset:
Breast Cancer in Pregnancy Register Study

Women who were diagnosed with breast cancer during their pregnancy may be registered in this trial.

Data is collected on the foetal outcome 4 weeks after delivery, maternal outcome of pregnancy as well as the breast cancer therapy applied (treatment, response to chemotherapy, type of surgery), diagnostic procedures applied (palpation, US, mammogram) and the outcome of mother and child after 5 years of therapy.

Breast cancer is the most common cancer malignancy in women of childbearing age after the age of 25 years. Since the incidence of breast cancer under the age of 40 is increasing, and women tend to delay pregnancy into later reproductive years, the coincidence of pregnancy and breast cancer is increasing. About 1 in 1,000 pregnancies is complicated by breast cancer. Nevertheless, little is known about the right therapy for the mother and the unborn child. We are therefore carrying out a trial, collecting prospective and retrospective data about pregnant women, with histological confirmed breast cancer. Data on the biology of the tumour and placenta tissues is also collected. The anonymous data is collected in a database.

Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Women with histologically confirmed breast cancer during pregnancy
* Cohort 2: Patients ≤ 40 years with histological confirmed breast cancer who are not pregnant (patients who have been pregnant recently can also be collected into this cohort)
* Informed consent for data collection (for prospective participants) and biomaterial collection. For retrospective participants an informed consent is not required as long as the data are anonymously captured

Exclusion Criteria:

* Cohort 1: Diagnosis of breast cancer outside the period of pregnancy
* Cohort 2: Age at diagnosis of breast cancer \> 40 years
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions

To compare the relative bioavailability of Kali and Ortho-McNeil's

To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg

Eligibility Criteria:
Inclusion Criteria:

* Healthy Males and females between 18 and 45 years of age inclusive
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.

Exclusion Criteria:

* Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
* Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
* Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
* Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
* This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
* Tobacco use(\>5 cigarettes per day)in the 3 months prior to study dosing.
* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
* Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
* Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
* females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
High-Dose Methotrexate in Treating Young Patients With Residual Ependymoma

RATIONALE: Drugs used in chemotherapy, such as methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well high-dose methotrexate works in treating young patients with residual ependymoma.

OBJECTIVES:

Primary

* Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.

Secondary

* Assess the reasons why primary surgery was complete/incomplete in these patients.
* Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.

OUTLINE: This is a multicenter, open-label study.

Patients receive high-dose methotrexate IV continuously over 24 hours on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Patients then proceed to further chemotherapy on protocol UKCCSG-CNS-9204.

After completion of study treatment, patients are followed periodically for 9 years.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ependymoma, including the following histologic variants:

  * Cellular
  * Papillary
  * Clear-cell
  * Tanycytic
  * Anaplastic (malignant) ependymoma
* The following diagnoses are excluded:

  * Myxopapillary ependymoma
  * Subependymomas
  * Ependymoblastomas
  * Primitive neuroectodermal tumors (PNETs)
  * Other neuroepithelial tumors
  * Choroid plexus tumors
  * Germ cell tumors
* Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary

  * Has undergone surgical resection within the past 3 weeks

PATIENT CHARACTERISTICS:

* At least 3 months to under 3 years of age
* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Able to tolerate chemotherapy
* No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from prior surgery
* No previous chemotherapy
* Previous steroids allowed
* No previous radiotherapy
Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction

The overall objective is the histological and radiological assessment of bony consolidation of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.

Clinical correlation with the histological and radiological results using the SF36 questionnaire.

\* Study design: Monocentric, prospective, randomised study. Patients who need revision anterior cruciate ligament reconstruction and show a tunnel enlargement of \>10mm will have a first operation filling the tibial/femoral tunnel either with bone graft substitute (Actifuse) or autologous spongiosa.

5 - 6 months after this first operation a CT will be performed to assess the bony consolidation of the former tibial/femoral tunnel. An MRI will be performed to assess vitality of the bone substitute.

An osseous biopsy will be taken from the tibial/femoral tunnel at the revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting.

Clinical evaluation will be performed 6 weeks, 3 months and 6 months postoperative. At 6 months postoperative additional radiological evaluation and clinical assessment using the SF36 questionnaire will be performed.

* Treatment: Either autologous spongiosa or Actifuse (MIS applicator) will be administered by the investigator as a bone graft substitute for tunnel enlargement in patients undergoing revision anterior cruciate ligament reconstruction.
* Duration of Participation: The participation of each subject will be approximately 12 months.

Each subject will undergo revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting. A biopsy will be taken at this operation. A clinical and radiological follow up is planned for further 6 months.

\* Subjects: Male and female patients ≥ 18 years. Approximately 40 patients who undergo revision anterior cruciate ligament reconstruction will be included in the study.

Inclusion criteria: Patients in need of revision anterior cruciate ligament reconstruction Exclusion criteria: Infection, wound healing complications

Eligibility Criteria:
Inclusion Criteria:

* Patients in need of revision anterior cruciate ligament reconstruction

Exclusion Criteria:

* Infection, wound healing complications
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)

The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

Study IPI-549-02 is a multi-national, prospective, randomized, active-control Phase II trial to evaluate the efficacy and safety of IPI 549 administered in combination with nivolumab compared to nivolumab monotherapy.

The study will enroll approximately 160 checkpoint-naïve, advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Patients will be randomized 2:1 to receive intravenous (IV) nivolumab 480 mg every 4 weeks (Q4W) in combination with oral (PO) IPI 549 40 mg once daily (QD) or IV nivolumab 480 mg Q4W in combination with placebo PO QD.

Eligible patients who have confirmed progression of disease during treatment with nivolumab monotherapy may crossover to the combination treatment arm.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
* Measurable disease by CT or MRI as defined by RECIST v1.1
* Disease progression or recurrence after treatment:
* i) With at least 1 platinum-based chemotherapy regimen for the treatment of metastatic (Stage IV) or locally advanced unresectable disease; or
* ii) With disease recurrence within 1 year of completing a platinum-based neoadjuvant or adjuvant therapy
* Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
* Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Blood sample must be provided for mMDSC levels for randomization into the study

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Any serious or uncontrolled medical disorder that may interfere with study treatment/interpretation
* Prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been apparently cured
* Active, known, or suspected autoimmune disease
* A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
* Prior therapy with anti-tumor vaccines, any T cell co-stimulation or checkpoint pathways, or IPI-549
* Prior surgery or gastrointestinal dysfunction that may affect drug absorption
* Past medical history of interstitial lung disease
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
* Positive test for hepatitis B, C or HIV
* Dependent on continuous supplemental oxygen
Community-Led Action Research in Oncology: Improving Symptom Management

This study will be conducted at La Liga Contra el Cancer in San Pedro Sula, Honduras. The overall objective of this project is to improve symptom management for patients undergoing chemotherapy in Honduras. The first step in this line of research is a "proof of concept" feasibility study in which the investigators will demonstrate their ability to train nurses to administer a non-pharmacological, telephone-delivered, symptom management program for chemotherapy patients.

The investigators will use the team's previous experience delivering a standardized, non-pharmacological palliative care intervention by telephone to inform a "proof of concept" feasibility study in Honduras. They will train nurses at La Liga Contra el Cancer in San Pedro Sula to conduct the telephone sessions and monitor their fidelity to treatment as they enroll a minimum They will then evaluate the feasibility, acceptability, and potential effectiveness of the program.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are over the age of 18 and are beginning a chemotherapy regimen to treat any solid or hematological cancer will be eligible for the study.

Exclusion Criteria:

* Patients who do not start planned chemotherapy.
Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index With the Clinical Evaluation

The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit.

The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable and continuously monitored by a physiological control (reserve control)not yet discovered.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve is decreased reversibly with aerobic activity and may reach an exhaustion threshold in which the assumed reserve control induces a reversible fatigue and dyspnea which dissolve once the activity decreased.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit (composed of blood pressure, heart rate, respiratory rate, central venous pressure or its estimation, weight, height and gender.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit (cross sectional comparison).

Eligibility Criteria:
Inclusion Criteria:

* adult informed consent

Exclusion Criteria:

* an emergency case
A Study of Domestic Automated Peritoneal Dialysis Machine

This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.

Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Eligibility Criteria:
Inclusion criteria:

1. The duration of PD is more than 1 month.
2. The age is range from 18 to 80 years old.
3. The patient can be treated with regular PD in home.
4. The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
5. The patient can be visited regularly.
6. The patient must be freely given informed consent

Exclusion criteria:

1. Peritonitis was happened within 1 month
2. The KT/V\<1.7
3. Infections in the exit or tunnel
4. With tumors.
5. With low transport of peritoneum.
6. With mental and behavior disorders.
7. With acute renal failure
8. Hemodialysis meanwhile
9. With heart failure( NYHA III-IV ) or cardio- cerebrovascular events
10. Attending other clinical trails
11. Refused to give informed consent Exit criteria

（1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.
Non-invasive Current Stimulation for Restoration of Vision

The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters to uncover mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.


Eligibility Criteria:
Inclusion Criteria:

* HH due to ischemic or hemorrhagic stroke
* age between 18 and 75 years
* lesion age at least 6 months
* stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
* presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
* best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

* known active malignancy
* eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma)
* electric or electronic implants (e.g. heart pacemaker)
* metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts)
* expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes)
* epileptic seizure within the last 10 years
* use of antiepileptic or sedative drugs
The Effect of Aging and Immobilisation on Muscle

The debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been investigated. This is contrasted by the fact that the elderly population more often undergoes periods of immobilization and disuse not only due to joint pain but also due to a higher degree of co morbidity and hospitalisation.The purpose of the present study was to compare the effect of a 2 week period of unilateral immobilisation on the physiological muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation angle in young and old healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy males (age 20-30 yrs)or old healthy males (age 60-80 yrs)

Exclusion Criteria:

* Musculoskeletal disorder
* Diabetes
* Cardiovascular disease
* Neurological diseases; or
* Cognitive disorders
Clinical Investigation Exploring Two Ostomy Product Prototypes

Two ostomy product prototypes (Test product A and B) will be tested in this investigation.

All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.


Eligibility Criteria:
Inclusion Criteria:

1. Has given written informed consent
2. Is at least 18 years of age and has full legal capacity
3. Has had an ileostomy for more than 3 months
4. Has suitable peristomal skin area (assessed by investigator)
5. Is currently using flat SenSura Mio 1-piece or 2-piece
6. Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days
7. Has a stoma size less than 45mm in diameter

Exclusion Criteria:

1. Is currently receiving or have within the past 60 days received radio- and/or chemotherapy (Low doses radio- and/or chemotherapy (Assessed by Principal Investigator) is allowed. for indications other than cancer)
2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g. lotion or spray or systemic steroid (tablet/injection) treatment
3. Is pregnant or breastfeeding
4. Has dermatological problems in the peristomal area (assessed by investigator)
5. Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
6. Has any known allergies towards ingredients in the investigational device
Corneal Endothelial Assessment After Posterior Chamber Phakic Intraocular Lens Implantation

our primary aim of the work to assess the effect of phakic IOL implantation on corneal endothelium. we also used the specular microscope to assess the corneal endothelium


Eligibility Criteria:
Inclusion Criteria:

* Our inclusion criteria include: adults 18-35 years of age, myopia ˃ 6 D , anterior chamber depth (ACD) 2.85 mm or greater , an endothelial cell count of ≥ 2000 cells/mm2 and stable refractive history within 0.5 diopter for 1 year.

Exclusion Criteria:

* anterior chamber depth from endothelium \< 2.85 mm, previous or current systemic or eye disease , surgery or trauma, pregnancy and nursing.
A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy

The primary objective of the study is to examine the efficacy of multiple doses of Nusinersen administered intrathecally in preventing or delaying the need for respiratory intervention or death in infants with genetically diagnosed and presymptomatic spinal muscular atrophy (SMA). Secondary objectives of this study are to examine the effects of Nusinersen in infants with genetically diagnosed and presymptomatic SMA.


Eligibility Criteria:
Key Inclusion Criteria:

* Age ≤ 6 weeks at first dose.
* Genetic documentation of 5q SMA homozygous gene deletion or mutation or compound heterozygous mutation.
* Genetic documentation of 2 or 3 copies of survival motor neuron 2 (SMN2).
* Ulnar compound muscle action potential (CMAP) ≥ 1 mV at Baseline.
* Gestational age of 37 to 42 weeks for singleton births; gestational age of 34 to 42 weeks for twins.
* Meet additional study related criteria.

Key Exclusion Criteria:

* Hypoxemia (oxygen saturation \<96% awake or asleep without any supplemental oxygen or respiratory support).
* Any clinical signs or symptoms at Screening or immediately prior to the first dosing (Day 1) that are, in the opinion of the Investigator, strongly suggestive of SMA.
* Clinically significant abnormalities in hematology or clinical chemistry parameters.
* Treatment with an investigational drug given for the treatment of SMA biological agent, or device. Any history of gene therapy, prior antisense oligonucleotide (ASO) treatment, or cell transplantation.
* Meet additional study related criteria.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.