cyrilzakka/clinical-trials huggingface dataset:
A Study of RO5045337 in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed soft tissue sarcoma
* Evaluable disease according to RECIST version 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Eligible for doxorubicin therapy
* Acute toxicities from prior anti-tumor therapy, surgery or radiotherapy must have resolved to NCI-CTCAE Grade \</= 1 prior to start of study
* Adequate bone marrow, hepatic and renal function
* Patients with stable CNS metastases are eligible

Exclusion Criteria:

* Previous treatment with limiting doses of doxorubicin
* Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy or other ailment \</= 28 days from Day 1 dosing on study treatment
* History of seizure disorders or unstable CNS metastases
* Severe and/or uncontrolled medical conditions or other conditions that could affect the participation in the study
* Pregnant or breastfeeding women
* HIV positive patients who are currently receiving combination anti-retroviral therapy
* Patients with known coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
* Patients receiving oral or parenteral anti-coagulants/anti-platelet agents
Testing a Personalize Medication Log for Patients With Lymphoma

The purpose of this study is to see if using the MedLog is helpful to patients. Since the investigators do not yet know if this MedLog is helpful, some patients will receive it and some will receive our standard of care. The investigators want to know whether providing patients with this additional information is helpful and if having this additional information about their treatment schedule has an effect on their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lymphoma
* No prior treatment for lymphoma
* Scheduled to receive CHOP14 +/- Rituximab, CEOP 21, CHOPE or EPOCH +/- Rituximab
* Age 18 or older
* Able to speak and read English

Exclusion Criteria:

* Documented major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Multicenter Dispensing Study of Biofinity Lenses in Extended Range

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.


Eligibility Criteria:
Inclusion Criteria:

* Has had an oculo-visual examination in the last two years
* Is at least 18 years of age and has full legal capacity to volunteer
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their habitual vision correction
* Currently wears soft contact lenses
* They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
* Has clear corneas and no active ocular disease
* Demonstrates an acceptable fit with the study lenses.

Exclusion Criteria:

* Has any systemic disease affecting ocular health
* Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
* Have any active ocular disease and/or infection that would contraindicate contact lens wear.
* Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
* Has worn gas permeable contact lenses within the last month.
* Is aphakic
* Has undergone corneal refractive surgery.
* Is participating in any other type of clinical research study
* Female who is currently pregnant or is breast-feeding.
Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement

Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent

Exclusion Criteria:

* Atrial fibrillation
* Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)
High Carbohydrate vs. High Fat Diets in the Treatment of Obesity (JBR 0512)

The purpose of this study is to compare the ability of low calorie high carbohydrate and low calorie high fat/protein diets to decrease abdominal fat in overweight and obese subjects. The investigators will also test the effects of these diets on secondary outcomes including body composition, fluid and electrolyte balance, lipids and lipoproteins, blood pressure, arterial compliance, glucose and insulin metabolism, bone turnover, and measures of satiety.

Participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks.

Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. The first 2 weeks consist of a weight stabilization period, during which subjects will be required to consume an average American diet. This is followed by the 6 week weight loss period where subjects will be randomized to either a low calorie high carbohydrate or a low calorie high fat/protein diet. On both diets there will be a 50% calorie deficit compared to the weight stabilization period. This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. Appropriate adjustments will be made to keep the subject's weight stable.

During the entire inpatient study, subjects will consume one multivitamin per day (Centrum, always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited access to zero calorie liquids (water/diet soda) will be available and will be encouraged to maintain one's usual activity level.

Females of reproductive age, need to make sure that they do not become pregnant during the inpatient study. Urine will be tested for pregnancy once during the stabilization and weight maintenance phases of the study.

Eligibility Criteria:
Inclusion Criteria:

* Man or a woman with a body mass index (BMI) of 30 to 34.9
* Man with a BMI of 25 to 29.9 with a waist circumference \> 102cm (40in)
* Woman with a BMI of 25 to 29.9 with a waist circumference \> 88cm (35in)

Exclusion Criteria:

* High Blood Pressure
* High Cholesterol
* Diabetes
* HIV positive
* Syphilis
* Hepatitis B/C positive
Mass Balance Study of KBP-5074 in Healthy Male Subjects

This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Males, of any race, between 18 and 55 years of age, inclusive, at screening.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening.
3. In good health, determined by no clinically significant findings from medical history, physical examination (assessed only at check-in), 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in as assessed by the investigator (or designee).
4. History of a minimum of 1 bowel movement per day.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, or other disorder, as determined by the investigator (or designee).
2. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
3. Positive urine drug screen, including cotinine, at screening; positive alcohol test result or positive urine drug screen, including cotinine, at check-in.
4. Use of any drugs or substances known to be strong or moderate inhibitors or inducers of cytochrome P450 (CYP)3A4 or P-glycoprotein substrates within 30 days prior to study drug administration. Medications will be reviewed by the medical monitor to determine acceptability for the study.
Anti-Mullerian Hormone - At My Home

The AMH\^2 (Anti-Mullerian Hormone - At My Home) study is a head-to-head-to-head validation study aiming to evaluate the concordance of AMH levels found in blood collected via three different routes: collected at-home using the TAP II device, drawn through standard venipuncture techniques, and collected with the ADx card, another at-home collection device widely available on the market for commercial use.

Today, information regarding fertility potential is challenging to obtain for healthy women; clinically meaningful in-clinic testing is limited by physician availability and patient willingness to undergo testing in-clinic. Meanwhile, at-home hormonal bloodwork relies on the use of an ADx card, and is not widely accepted as clinically reliable by the medical community. The Sponsor is developing a comprehensive home fertility assessment to enable couples to proactively estimate and manage their fertility and family building options. Accurate and reliable at-home AMH testing is necessary to reach this goal.

This study aims to validate the clinical excellence and medical accuracy of blood drawn via the TAP II device relative to a standard in-clinic venipuncture draw and other options available on the market to support emerging telemedicine care models. In doing so, the Sponsor may receive CLIA validation for the TAP II in AMH testing and commercialize a Lab Developed Test.

Eligibility Criteria:
Study Participants

Inclusion Criteria:

* Women between the ages of 20 and 39, inclusive (two age brackets above)
* Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent
* Women who are in driving distance from Boston

Exclusion Criteria:

* Turtle Health employees
* Women who do not speak English natively or fluently
* Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
* Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to wait 2 cycles
* Women who are currently pregnant or may be pregnant
* Women who have known blood hypo- or hypercoagulability disorders or known blood clotting issues
* Any woman the PI believes is not capable of giving independent, informed consent
Ozone Therapy in the Prevention of COVID-19 Infection

Coronavirus has already infected 4,673,809 people and killed 312,646 people worldwide, and no specific treatment or a vaccine against it has yet proven to be effective. Ozone therapy has become o promising tool for both prevention and treatment of COVID-19 infection by various possible mechanisms. The oxidative stress created by ozone in the body to stimulate the peripheral phagocytic cells, activate the antioxidant system, and restore the immune system is thought to be effective for the prevention of COVID-19 infection.

In recent years, ozone therapy has become a popular alternative method for chronic pain management of various diseases such as fibromyalgia, knee osteoarthritis, and rheumatic diseases. As a result of this, there were many individuals who had received ozone therapy before the outbreak of COVID-19. This study aimed to investigate the preventive effect of ozone therapy against COVID-19 infection in these individuals.

The inclusion criteria were determined to be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020). Individuals who received ozone therapy locally or fewer than ten sessions, who did not want to participate were excluded.

The major autohemotherapy procedure to all the participants was applied as follows: 100mL of blood was drawn by a vacuum from the antecubital vein into a sterile glass bottle in which 12 mL of 3.13% sodium citrate solution as an anticoagulant (MediPac®, Germany). A corresponding volume (100mL) of gas with an ozone concentration of 10-20 µg/mL was immediately added and continuously mixed by a gentle rotating movement to avoid foaming to the blood in the bottle. Ozone was produced by a Blue-S medical ozone generator (Turkozone®, Turkey). Reinfusion was accomplished in about 15-20 minutes, and the whole procedure was carried out in approximately 30 minutes and was repeated two or three times a week.

Eligibility Criteria:
Inclusion Criteria:

* To be completed at least ten sessions of ozone therapy applied by the method of major autohemotherapy in the last six months from the time the first COVID-19 case of Turkey reported (Mar 11, 2020)

Exclusion Criteria:

* To received ozone therapy locally or fewer than ten sessions
* not want to participate
Weekly Docetaxel and CMF in the Adjuvant Treatment of Elderly Women With High-Risk Breast Cancer

This trial will evaluate the effectiveness of standard adjuvant treatment with CMF chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens. This CMF regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer; however, the patient population in this trial has tolerated more intensive CMF regimens poorly in other trials.

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

* Docetaxel
* Cyclophosphamide + Methotrexate + 5-fluorouracil

This is not a blinded study so both the patient and the investigator will know which treatment has been assigned.

Chemotherapy will be followed by breast and/or regional radiotherapy in appropriate patients, and by hormone therapy with tamoxifen for 5 years in patients who are estrogen-receptor positive. Patients who are considered poor candidates to receive tamoxifen may receive hormonal therapy with anastrazole.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Female patients with adenocarcinoma of the breast confirmed by biopsy
* Age 65 or older
* Under age 65 must have significant medical illness, or general frailty
* Adequate bone marrow, liver or kidney function
* Normal heart function
* Less than 84 days from mastectomy/lumpectomy or axillary dissection
* Signed consent obtained prior to initiation of any study procedures

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Received neo-adjuvant therapy
* Primary tumor is locally advanced at diagnosis
* Received prior chemotherapy within five years
* Received previous radiation therapy within 5 years
* Peripheral neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.

To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus
* Normal lung function

Exclusion Criteria:

* Smokers
Pragmatic Weight Loss Intervention During Menopause

The investigators are using a community-based participatory research (CBPR) model to develop a lifestyle intervention targeting weight loss that is specifically tailored to women in perimenopause.

This is a participatory research study which will enroll women (n of up to 56) with experience of menopause to help identify preferred strategies (modalities) for weight loss, which will combine calorie (dietary) restriction and exercise tactics.

Aim 1: Explore attitudes and perceptions about weight gain during the menopause transition, and identify weight loss strategies from the patient (peer) perspective.

- The investigators will apply these learnings: 1) to understand barriers for weight management during menopause; 2) to establish strategies to guide retention; 3) to finalize the intervention structure, including feedback on the frequency and duration of the study visits; and 4) to gather feedback on menopause-specific education resources set to be provided throughout the intervention.

Aim 2: Engage the Community Advisory Board (CAB) of the Louisiana Clinical and Translational Center (LA CaTS) to understand scalability and community-based implementation of an intervention tailored for women in perimenopause.

- The investigators will then utilize the Louisiana Clinical \& Translational Science Center (LA CaTS) Community Advisory Board (CAB) to help us tailor a lifestyle intervention in perimenopausal women with emphasis on scalability and community-based implementation using learnings obtained from the focus groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 to 60 years
* Currently experiencing (or have experienced) the one of the following menopause-related traits:
* Vasomotor symptoms including hot flashes and/or night sweats
* Irregular menstrual cycle
* African-American (Black) or Caucasian (White) race
* Self-report having a desire to lose (or maintain) weight during menopause
* Willing to be recorded during the focus group for transcription purposes

Exclusion Criteria:

* Are pre-menopausal
* Non-English speaking
The Effect of Kinesio Taping Applications on Pain, Neck Awareness and Functionality in Neck Pain

It is important to clarify neck awareness, functional status and pain severity in people with chronic neck pain. Since neck pain, which has become a big problem among the public, cannot be treated definitively, it was aimed to examine the effect of kinesio taping technique on individuals with neck pain. The purpose of the research; To examine the positive and negative effects of kinesio taping applied in addition to traditional treatment on pain, functional status and neck awareness in patients with neck pain. The aim of this study by the researchers is to gain a new perspective on the treatments applied to individuals with neck pain.

Neck pain is a common complaint that can occur for different reasons and is common among the public. The most common musculoskeletal system pathology after low back pain is neck pain. Neck pain symptoms often do not provide a permanent solution. Chronic neck pain is a sensory and emotional experience that affects an individual's quality of life, behavior and professional life. In addition, psychosocial status is also affected due to problems such as health expenses, work attendance problems, and work efficiency. Early diagnosis and identification of risk factors are of great importance to prevent neck pain from turning into a chronic problem. 40-70% of the society complains of neck pain at least once in their lives. About ¼ of these are chronic neck pain. Today, many occupational and personal risk factors for neck pain have been identified. The purpose of the research; The aim of this study is to examine the positive and negative effects of kinesio tape application in addition to traditional treatment on pain, functional status and neck awareness in patients with neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Agreed to participate in the study and signed the informed consent form,
* Having complained of neck pain for at least 3 months,
* Must be 18 years or older.

Exclusion Criteria:

* Pregnancy
* Loss of function due to neurological or systemic disease,
* Having previously undergone cervical region and spine surgery,
* Having received physiotherapy in the neck and back area in the last 6 months,
* Being on another treatment during the study,
* Having a history of trauma affecting the spine.
Study of the Vascularity of Uterine Septum Using Three Dimensional Power Doppler Ultrasound

This study aims to assess the relation between the vascularity of uterine septum and obstetric performance with Transvaginal 3D Power Doppler Ultrasound

Research hypothesis:

In women with uterine septum vascularity of the septum may affect obstetric performance.

Research question:

In women with uterine septum does vascularity of the septum affect obstetric outcome?

Eligibility Criteria:
Inclusion Criteria:

* Patients with septate uterus diagnosed by office hysteroscopy

Exclusion Criteria:

* Women with previous uterine scar.
* Women with suspected or confirmed pregnancy.
* Women with active pelvic infection or old one.
* Women with abnormal uterine bleeding.
* Fibroids, adenomyosis or ovarian swelling.
A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to their current DMARD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe active RA of ≥6 months duration
* DAS28 \>3.2
* Inadequate response to a stable dose of non-biologic DMARD for ≥2 months
* Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* History of or current inflammatory joint disease other than RA
* Previous treatment with alkylating agents or total lymphoid irradiation
* Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline
* Previous treatment with any cell-depleting therapies
* American College of Rheumatology (ACR) Functional Class IV