cyrilzakka/clinical-trials huggingface dataset:
Bortezomib (Velcade) in Waldenstrom's Macroglobulinemia

The purpose of this study is to evaluate how tumors in patients with Waldenstrom's macroglobulinemia respond to treatment with bortezomib (Velcade) and to see what effects (good and bad) it has on the cancer.

* Patients will receive bortezomib intravenously twice weekly for 2 weeks on days 1,4,8 and 11 of each cycle. A 10-day rest period (days 12-21) will follow the 2 weeks of treatment. The treatment cycle is repeated up to eight times depending upon the disease response and if the patient is tolerating the drugs.
* The following procedures will be conducted as part of the treatment monitoring: DAY 1 VISIT (of each treatment cycle): evaluation of disease-related symptoms, vital signs and weight and blood tests. DAY 4 VISIT (of each treatment cycle): vital signs and blood work. DAY 8 VISIT (of each treatment cycle): vital signs and blood work. DAY 11 VISIT(of each treatment cycle): vital signs, blood work, and possible CT Scan.
* Treatment will be discontinued if any of the following occur: Disease gets worse, severe side-effects or the patient requires other anti-cancer therapy.
* At the end of the treatment (30 days after the last dose of study drug) the patient will have a physical exam, vital signs, evaluation of disease-related symptoms, blood work and CT scan for tumor measurements.
* Long term follow-up consists of every 3 month clinical visits until disease progression or up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia who have failed one first line therapy
* Measurable disease, defined as presence of immunoglobulin M (Ig M) paraprotein with a minimum IgM level of \>2 times ULN
* Karnofsky performance status of \>60
* Life expectancy of \> 3 months
* Baseline platelet count \>50,000,000,000/L and ANC of 750,000,000/L
* AST and ALT \< 3 x ULN
* Total bilirubin \< 2 x ULN
* Calculated or measured creatinine clearance \> 30mL/minute
* Serum sodium \> 130 mmol/L

Exclusion Criteria:

* Greater than or equal to Grade 2 peripheral neuropathy
* Hypersensitivity to bortezomib, boron or mannitol
* Prior therapy with Velcade
* Pregnant or lactating women
Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?

This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.

Hypotheses:

1. Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
2. Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
3. The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months.
2. Age 8 years to less than 45 years old.
3. Subject understands the study protocol and agree to comply with it.
4. Subject is on insulin pump or injection-based basal-bolus therapy
5. Subject comprehends written English.
6. For females, subject not intending to become pregnant during the study.
7. Informed Consent Form signed by the subject
8. No history of altered skin integrity, poor wound healing, adhesive allergy, or previous infection from sensor wear.
9. Hemoglobin A1C ≤10%

Exclusion Criteria:

1. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
2. The presence of any of the following diseases:

   a. Current use of systemic corticosteroids (within the last week) b. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol i. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Current or past use of a continuous glucose sensor is not an exclusion criterion.
5. Active skin condition that would affect sensor placement
6. Use of acetaminophen or Vitamin C supplement within the last 7 days
7. Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
8. Pregnancy A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.

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"Cancersensor" Chemotherapy

Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed metastatic colorectal cancer;
* 0 to 3 prior chemotherapy lines;
* Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Estimated life expectancy exceeding 3 months;
* At least one measurable metastatic lesion (RECIST criteria);
* Performance Status (WHO) of 0 to 2;
* Good haematological, hepatic and renal functions.

Exclusion Criteria:

* More than 2 surgical resections of metastases from colorectal cancer;
* Poor performance status (\>2);
* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.
Outcomes of Bilateral Temporomandibular Joint Arthroscopy and the Role of a Second Intervention - Timings and Results

Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.

Temporomandibular joint (TMJ) arthroscopy has been used successfully for intra-articular disorders. It was first introduced by Onishi at 1975, as a pioneering technique to treat painful joints and has been associated with a reduction in the number of open joints surgeries. This minimally invasive technique allows observation of the TMJ upper compartment tissues, and sometimes the lower compartment. Moreover, this intervention allows joint lysis and lavage (level 1 arthroscopy) and intra-articular surgical procedures (level 2-3 arthroscopy).

Recent studies updated that TMJ arthroscopy promotes a reduction in pain and inflammatory process and restoring the mandibular function with low morbidity. Moreover, TMJ arthroscopy seems to be also long-term effective for relieving TMJ symptoms. Until now, limited studies are available regarding the clinical evidence of bilateral TMJ arthroscopy for Dimitroulis 2-3. This prospective study investigated the efficacy of TMJ arthroscopy in patients with bilateral disorders, and also the need for a posterior surgery.

Eligibility Criteria:
Inclusion Criteria:

* age \>16 years;
* clinical diagnosis of bilateral intra-articular disorder;
* clinical criteria for bilateral TMJ arthroscopy;
* magnetic resonance imaging (MRI) assessing the intra-articular derangement

Exclusion Criteria:

* The exclusion criteria included any history of previous TMJ surgical intervention or any facial trauma within the last 4 weeks prior the study.
* Severe medical problems or mental illness, and pregnancy were also exclusion criteria
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.

This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.

Eligibility Criteria:
Inclusion Criteria:

1. They are aged between 18 and 40 years.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They have successfully worn contact lenses within six months of starting the study.
5. They can be satisfactorily fitted with the study contact lenses.
6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
8. They own and habitually wear single vision spectacles.
9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
10. They agree not to participate in other clinical research while enrolled on this study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contraindicate contact lens wear.
2. They have a systemic disorder which would normally contraindicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer

Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines.

The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.

These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.

In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.


Eligibility Criteria:
Inclusion Criteria:

* 1. Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status.
* 2. Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
* 3. HR+/HER2-

  1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
  2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
* 4. Female or male patients \> 18 years
* 5. Have received at least one dose of palbociclib
* 6. At least 2 document clinical visits
* 7. Treatment with palbociclib should have started from November 2017 to November 2019
* 8. Data from the clinical records should be available.
* 9. Patients must be able to understand and sign informed consent if alive.

Exclusion Criteria:

* 1. Previous treatment with hormonal therapy, targeted therapy or chemotherapy for metastatic disease. Previous anticancer treatment for early breast cancer are allowed.
* 2. Treatment with palbociclib in clinical trial or compassionate use programs
* 3. HER2 + (IHC 3+ or FISH +) tumors in the most recent or previous biopsies
* 4. HR negative tumors in the most recent biopsy
The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes. There is increasing evidence concerning the potential endocrine disrupting for phthalate exposure during pregnancy. Prenatal exposure phthalates would disrupt the level of sex hormone in pregnant women, which results in preeclampsia. The relationship of prenatal phthalate exposure with maternal and neonatal outcomes in human beings was often sex-specific associations. Because of the potentially harmful influence of prenatal phthalate exposure, steps should be taken to prevent or reduce phthalate exposure during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Term pregnancy with the gestational age of 37-40 weeks

Exclusion Criteria:

* Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)
* Delivery before 37 weeks or after 40 weeks
Microgravity Effects on Co-cultured Vascular Cells Types

The goal of this study is to assess the affect of ground based microgravity on co-cultured vascular cell types. Our goal is to better understand the cross-talk between vascular cell types grown under conditions such as microgravity as is seen in space. In this pilot study, the investigator proposes to assess changes in cell phenotype and function in microgravity as compared to normal gravity.

This study builds upon previously reported space flight data in GenLab, as well as our own published data whereby the investigator evaluate the effect of microgravity on the differentiation and functional potential of circulating stem cells. The goal of this work is to leverage the powerful genetic analyses done in the SPHINX study and look at the consequences these changes have on cell-cell communications essential for vascular homeostasis, for a possible correlation to cardiovascular deconditioning. The application of this work is targeted at possible "cell based" countermeasures to address the negative effects of microgravity on the vasculature.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported healthy individuals
* Willingness to have 50mls of whole blood collected

Exclusion Criteria:

* Unwillingness to have blood used in stem cell research
Identification and Characterization of Novel Non-Coding Variants That Contribute to Genetic Disorders

The goal of this study is to identify and characterize novel non-coding and splicing variants that may contribute to genetic disorders. We will particularly focus on patients with a diagnosed genetic disorder that has inconclusive genetic findings.

To perform this study, we will use patient DNA and RNA that is isolated from blood samples. DNA will be sequenced (targeted capture and/or whole genome DNA sequencing (WGS)) to identify any non-coding single nucleotide variants (SNVs), smaller insertions/deletions (indels), or larger structural variants (SVs). RNA will be sequenced (RNA-seq) to identify genes that are expressed in a differential and/or allele-specific manner, which may indicate a functional non-coding or splicing variant. We will test the function of non-coding variants using high-throughput reporter assays and CRISPR based methodologies.

Eligibility Criteria:
Inclusion criteria:

Subjects will have one or more of the following:

* Patients (probands) diagnosed with a genetic disease
* Patients (probands) with inconclusive genetic results
* Patients (probands) that have identical coding and/or splicing variants, but display highly diverse phenotypes
* Unaffected family members of probands

Exclusion Criteria: There are no exclusion criteria for this study.
Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

The primary purpose of the study is to test the safety of HPV Vaccine in Women


Eligibility Criteria:
Inclusion Criteria:

* Females age 16 to 23 years old
* Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion Criteria:

* History of vaccination with an HPV vaccine
* History of hepatitis B infection
* History of vaccination with hepatitis B vaccine
* History of genital warts or treatment for genital warts
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of carotid stenting experience.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥ 18 years of age.
2. Subject does not have any condition that limits their anticipated survival to less than 3 years.
3. Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
4. Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR-
5. Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram.
6. Subject with all the following target vessel characteristics:

   1. Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
   2. Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.
   3. Absence of excessive vessel tortuosity that would impede delivery of devices.
7. Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.

Exclusion Criteria:

1. Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
2. Subject with Hgb \<10.g/dl or platelet count \< 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) \> 1.5.
3. Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
4. Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
5. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
6. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Repeated Low-Level Red-Light Therapy and Orthokeratology in Fast-progressing Myopia Control

The purpose of this multicenter randomized clinical trial is to evaluate the adjunctive effect of repeated low-level red-light therapy (RLRL) and orthokeratology (ortho-k) on myopia control in ortho-k non-responders who have undergone ortho-k treatment but were still experiencing fast myopia progression.

Myopia constitutes a major threat to personal health globally for its increased prevalence. Moreover, its dose-related association with irreversible blindness complications such as myopic macular degeneration have been demonstrated. It is crucial to look for effective ways to control myopia in children to reduce risk of myopic pathologies in later life.

Orthokeratology (ortho-k) is the first-line optical method in myopia control, resulting in slowing axial elongation by 43-63%. However, results after ortho-k treatment vary among individuals. Methods with more accurate efficacy and wider application to slowing down myopia progression, especially for myopia with limited ortho-k response, are still urgently required.

Repeated low-level red-light (RLRL) therapy is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Our previous clinical study suggested RLRL could effectively retard myopia progression without clinically observable side effects.

The purpose of this study is to evaluate the adjunctive effect of RLRL and ortho-k on myopia control in ortho-k non-responders using a multicenter randomized controlled trial design. Ortho-k non-responders are defined as who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression. The subjects will be randomly assigned to either experimental group (RLRL and ortho-k) or control group (ortho-k). Their axial length will be monitored over one year. Changes in axial length in the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Start to receive ortho-k treatment one year ago.
2. Age at enrolment: 8-13 years.
3. Ortho-k non-responders: those who have continuously undergone ortho-k treatment but were still experiencing fast myopia progression (annual axial elongation equal to or more than 0.5 mm) in the past one year in at least one eye.
4. Before wearing ortho-k lenses, spherical equivalent refractions (SERs) ranging from -1.00 to -5.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D, and best corrected logMAR visual acuity (VA) equal to or better than 0 in both eyes.
5. Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

1. Strabismus and binocular vision abnormalities.
2. Ocular or systemic abnormalities.
3. Prior treatment of myopia control in the past three months, e.g. drugs, progressive addition lenses, bifocal lenses, etc.
4. Other contraindications.