cyrilzakka/clinical-trials huggingface dataset:
Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate

PLX115-02 is a phase 1b study to assess how the study drug, PLX5622: 1. affects the body, 2. how the body affects PLX5622 3. the interaction of PLX5622 with Methotrexate and 4. the safety of PLX5622 in rheumatoid arthritis patients taking Methotrexate


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years old with a diagnosis of rheumatoid arthritis by ACR criteria for ≥ 3 months.
* Prior to Day 1, patients must be on oral or subcutaneous methotrexate (≥10 mg/week and ≤ 25 mg/week) for at least 12 weeks (with a stable dose for at least 4 weeks) and folate (≥ 5 mg/week) for at least 6 weeks, and willing to continue on this regimen for the duration of the study.
* Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥ 1.5 X 109/L, Hgb \> 9 g/dL, platelet count ≥ 100 X 109/L, AST/ALT WNL, albumin ≥ 3 g/dL, calculated CrCl\>60 mL/min using Cockcroft-Gault formula).
* Women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of dosing with study drug and must agree to use a double barrier method of birth control from the time of the negative pregnancy test up to 30 days after the last dose of study drug. Women of nonchildbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
* Fertile men must agree to use an acceptable method of birth control while on study drug. Acceptable methods of contraception must include either abstinence from the first dose of study drug through 4 weeks after the last dose of study drug, or use of a condom with instructions to the female partner of child-bearing potential to also be protected as above.
* Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.

Exclusion Criteria:

* Use of biologic response modifiers within the following periods prior to Day 1: 4 weeks for Kineret (anakinra) and Enbrel (etanercept); 12 weeks for Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept), Actemra (tocilizumab), or Cimzia (certolizumab); 12 months for Rituxan (rituximab).
* Use of Arava (leflunomide) within 12 weeks prior to Day 1 or any immunosuppressive agents, including hydroxychloroquine or sulfasalazine, within 4 weeks of Day 1.
* Investigational drug use within 4 weeks of Day 1.
* Positive urine drug screen for drugs of abuse (except for opiates if being used for RA).
* Concomitant use of DMARDs (other than methotrexate), biological response modifiers, or known strong inducers or inhibitors of CYP3A4 (see Appendix 2).
* Uncontrolled intercurrent illness.
* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
* QTc ≥ 450 msec at Screening.
* The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.
Temozolomide for Relapsed Sensitive or Refractory Small Cell Lung Cancer

The purpose of this study is to determine whether treatment with temozolomide will shrink small cell lung cancer tumors. Temozolomide is an oral chemotherapy drug that is currently used to treat brain cancer and melanoma.

As part of this study, we will be doing additional tests that may help us understand how temozolomide works. First, if there is a tumor sample from a biopsy done in the past, it will be analyzed for an abnormal gene that may be present in lung cancer. Before starting temozolomide, a research blood test will be done to look for the same abnormal gene we are looking for in your tumor sample. Also, before starting temozolomide and every time you have a repeat CT scan, a research blood test will be done to analyze the number of tumor cells in your bloodstream.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have pathologically confirmed SCLC at MSKCC that has progressed after one or two chemotherapy regimens.
* At least 3 weeks must have elapsed since last chemotherapy or radiation treatment and initiation of study treatment.
* Karnofsky performance status \> or = to 60%.
* Patients must have measurable disease, this can include brain metastases.
* Patients must have normal organ and marrow function as defined below:
* - leukocytes \> 3,000/mcL
* platelets \> 100,000/mcL
* total bilirubin \< 1.5 mg/dL
* AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal
* Creatinine \< 2.0 mg/dl
* For women of child-bearing potential, negative pregnancy test within 7 days prior to starting temozolomide.
* Men and women of childbearing potential must agree to practice adequate contraception.
* Ability to understand and the willingness to sign a written informed consent document.
* Both men and women of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

* Patients who have not recovered from adverse events of previous therapies.
* Patients receiving other investigational agents.
* Patients with leptomeningeal involvement.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
* Women who are pregnant or breast feeding, due to possible adverse effects on the developing fetus or infant due to study drug.
Prone Breast Irradiation for Pendulous Breasts

We hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose of this study is to compare the 3-D dose distribution in PTV(Planning Target Volume) and normal tissues in prone position versus supine position.

Local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. Adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position.

Based upon literature and our own preliminary experiences, we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart. However, no quantitative data are yet available to test this hypothesis. Therefore, the aim of our study is to compare the 3-D dose distribution in PTV and normal tissues in prone position versus supine position. For treatment in prone-position an in-house developed device, the "mammaboard" was used.

Eligibility Criteria:
Inclusion Criteria:

* Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
* No indication for radiotherapy of regional nodes
* Large, pendulous breasts (bra size D and over)

Exclusion Criteria:

* Regional radiotherapy is indicated
* Unable to lie in prone position
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been diagnosed with initial or relapsed primary minimal-change nephrotic syndrome
* patients whose urine protein-creatinine ratio (UPCR) is more than 3.0

Exclusion Criteria:

* patients whose eGFR is less than 30 ml/min/1.73 m2
* patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil, or rituximab, within two weeks before the study
* patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before the study
* patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or who cannot or do not want to use any contraceptive method
* patients who are hypersensitive to the investigational drug or to macrolide, such as azithromycin, clarithromycin, or roxithromycin
* patients who were treated with a live vaccine within four weeks before the study
* patients whose liver panel laboratory test result is three times the normal range, or acute hepatitis patients whose serum bilirubin has been clinically significantly higher than 3.6 mg/dL for more than 1 month
* patients who have a significant general disease that makes it inappropriate for them to participate in this study as adjudged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure \[classified as more than New York Heart Association {NYHA} class III\], hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal-change nephrotic syndrome, rheumatic arthritis with pneumonia interstitials)
* patients who have genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
* patients to whom another investigational drug was administered within 30 days from the enrollment in the study
* patients who participated in the past phases of this study
OPERA - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Current breast cancer surgery is achieving minimally invasive approach to reduce incision while providing better surgical vision and freedom in mastectomy. Breast reconstruction with free deep inferior epigastric artery perforator (DIEP) flap was considered the gold standard, however, the donor site morbidity remains an endless concern. Here we applied robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).

A retrospective chart review identified 14 patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. The patient demographics and mastectomy and flap characteristics were reviewed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA (American Society of Anesthesiologist) classification 1-2
* Breast skin should be free from cancer involvement, with adequate tumor to skin distance, and the largest preoperative tumor size no more than 5 cm
* The lesion should be located in any of the 4 quadrants away from the nipple, at least 1 cm distance between the lesion and the nipple

Exclusion Criteria:

* Patients with previous pelvis surgeries (except C-section)
PERIodontal Disease, Microbiota and Miscarriage

Cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).The information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from Toulouse University Hospital.

Saliva and subgingival plaque samples, classically carried out in routine dental surgery as part of the health check-up oral, will be used to carry out bacterial assays.

Cross-sectional non-interventional observational pilot study recruiting women whom had repeated miscarriages (= at least 3 miscarriages).The information will be collected during a routine maintenance, complete oral clinical and radiological examination (assessment carious, periodontal, mucosal and functional), which is part of the routine assessment in the service of odontology from Toulouse University Hospital.

As part of the health check-up oral, Will be taken:

* Salivary samples by sputum (1 per patient). The patient will retain her saliva for 1 minute in the mouth and it will be collected in a sterile bottle (approximately 5 ml).
* Samples of subgingival plaque in the periodontal sulcus (assessed during periodontal probing) using sterile paper points (minimum 3 and maximum 10 per patient) inserted for 30 seconds into the periodontal sulcus then put in a tube sterile. The plate collection is done by capillary action on the paper tip, a very small quantity is thus taken.

A collection of the history and disease risk factors will then be carried out. periodontal problems (stress level assessed using the visual analogue scale, history personal and family periodontal diseases, oral hygiene habits, etc.) by a routine care interview, the clinical examination (visual examination and recording of oral and periodontal) and radiological examination.

Eligibility Criteria:
Inclusion Criteria:

* women whom had repeated miscarriages
* at least 6 natural teeth

Exclusion Criteria:

* under antibiotic prebiotic or probiotics treatment one month prior to the study
* with high infection risk (HIV,...)
Evaluation of Effectiveness of Combining High Protein Intake With Early Physical Exercise During Critical Illness

Assessment of Effectiveness of combined high protein intake with early physical exercise by ultrasound measurement of rectus femoris muscle thickness in Intensive Care Unite mechanically ventilated patients.

Muscle wasting and weakness is a frequent finding in critically ill patients and is associated with worse short- and long-term outcomes like delayed liberation from mechanical ventilation, longer Intensive Care Unit and hospital stay, worse physical function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients in age group 18-60 years
* Expected Intensive Care Unit stay \>4days after enrolment (to permit adequate exposure to the proposed intervention)
* Previously healthy, Well-nourished, subjects (nutric score=0)

Exclusion Criteria:

* Renal, liver or heart disease or chronic obstructive pulmonary disease
* Previous immune abnormalities (including treatment with corticosteroids)
* Past history of nutritional problems, chronic use of drugs (as drugs inducing myopathies) or orthopedic problems (such as skeletal fractures or immobilization) in the previous 2 years
* Neuromuscular diseases and patients with amputated lower limbs
* Past or recent history of cancer
* Long term critically ill patients shifted from other hospitals
* Pregnant patients
Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty

This study aims to provide high quality evidence from a double-blinded, randomized controlled trial on the efficacy of perioperative pregabalin in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty. It hence aims to improve on choice of analgesia adjuncts for total knee arthroplasty.

Aims:

Whether pregabalin given preoperatively and for one week postoperatively in addition to patient-controlled analgesia (PCA) morphine is effective in reducing morphine requirements, improving pain scores and reducing chronic neuropathic pain when compared with placebo for primary total knee arthroplasty.

Methodology:

A single-centre double-blind randomized controlled trial in patients undergoing primary total knee arthroplasty. All subjects receive PCA morphine, paracetamol 1g every six hours, etoricoxib 120mg once daily postoperatively. Subjects receive either pregabalin 75mg po preoperatively followed by 75mg OM and 25mg ON for two days postoperatively or matching placebo. The primary outcome is cumulative morphine consumption at 72 hr following surgery. Secondary outcome measures included pain scores, knee range of motion and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary total knee arthroplasty

Exclusion Criteria:

* revision or bilateral arthroplasty, significant renal or hepatic impairment, documented allergy or intolerance to NSAIDs, paracetamol, morphine or pregabalin, chronic pain syndrome treated with chronic opioids, obstructive sleep apnea not treated with continuous positive airway pressure, seizures, breastfeeding, inability to use patient-controlled analgesia.
Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision

Local anesthetic will be injected into both angles of the rectus sheath incision in an attempt to block sensory nerves in this area that cause the sensation of pain from lscs wound.


Eligibility Criteria:
Inclusion Criteria:

* patients booked for lscs
* primisection
* singleton pregnancy

Exclusion Criteria:

* emergency cesarean section
* bleeding tendency
* hypersensitivity to local anesthetic
Research Study in Healthy Volunteers of Patients With Fanconi Anemia, Myeloproliferative Disorders, or Myeloma

RATIONALE: Analyzing tissue and blood samples from healthy volunteers or patients with Fanconi anemia, myelodysplasia, myeloproliferative disorders, or myeloma in the laboratory may help doctors learn more about the causes of blood cancers.

PURPOSE: The purpose of this study is to analyze in the laboratory blood and bone marrow cells from healthy volunteers or patients with Fanconi anemia, myeloproliferative disorders, or myeloma.

OBJECTIVES:

* Identify the specific molecular function of the Fanconi anemia (FA) complementing gene products in hematopoietic progenitor cells from patients and normal volunteers.
* Identify functional defects in hematopoietic stromal cells, including macrophages, from patients with FA, and selected blood cancers as well as normal volunteers.

OUTLINE: Peripheral blood mononuclear leukocytes, skin fibroblasts, and marrow fibroblasts are collected for loss-of-function and gain-of-function analysis related to the Fanconi anemia complementing gene.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of one of the following:

    * Fanconi's anemia requiring bone marrow biopsy as part of standard care (adults and children)
    * Myeloproliferative disorder or myeloma (adults)
  * Healthy volunteer, meeting 1 of the following criteria:

    * Over 18 years of age
    * Bone marrow transplant donor (children)

PATIENT CHARACTERISTICS:

* Hemoglobin \> 13 g/dL
* White blood cells (WBC) \> 4,000/mm³
* Platelet count \> 150,000/mm³
* No clinical signs or symptoms of acute or subacute infections (viral, bacterial, or fungal)
* No known blood abnormality (healthy volunteers)
* No allergies to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

* Not specified
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

Peripheral neuropathy (PN) is caused by diabetes, aging, chemotherapy, and over 30 other conditions, and impacts more than 30 million patients in the US alone. Diabetes is the number one cause of peripheral neuropathy, and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy (DPN), a complex set of symptoms including pain, numbness, tingling, and burning. Spinal cord stimulation (SCS) is an approved intervention for the treatment of chronic pain, including DPN. Spinal cord stimulation has had FDA approval for the treatment of painful DPN since 2015. This study is being done to learn more about the diagnosis of DPN and treatment of DPN with SCS.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
* Diagnosis of medically refractory pain secondary to diabetic neuropathy
* Presence of pain for 12 months
* Lower limb pain intensity score ≥4 on a visual analog scale
* DN4 ≥4
* Pass pre-operative neuropsychological assessment (surgical group only)
* Capable of providing informed consent

Exclusion Criteria:

* Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
* Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
* Coagulopathy that cannot be corrected
* Unable to discontinue blood thinning medications
* Hemoglobin A1c level greater than 10
* Presence of systemic infection
* Pregnancy
Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures

The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers:

* Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and
* Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes type 2 according to 1985 WHO criteria
2. Age between 35 and 75 years
3. Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
4. Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
5. Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32)
6. Refraction with a spherical equivalent less than 5 Dp
7. Informed consent

Exclusion Criteria:

1. Cataract or other eye disease that may interfere with fundus examinations
2. Glaucoma
3. Any eye surgery within a period of 6-months
4. Other retinal vascular disease
5. Previous laser therapy
6. Dilatation of the pupil \< 5 mm