cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or above at the time of screening
* Diagnosis of SLE
* Active disease at screening

Exclusion Criteria:

* Presence of active moderate to severe glomerulonephritis
* Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
* Lack of peripheral venous access
* Pregnancy or breast feeding mothers
* History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin
* Known severe chronic pulmonary disease
* Evidence of significant or uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would impair patient participation
* Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled) at any time in the 52 weeks prior to screening
* Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
* Known active infection of any kind (but excluding fungal infection of nail beds or oral thrush which has resolved before Day 1) within 30 days prior to Day 1. In addition, any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1
* History of serious recurrent or chronic infection
* History of cancer (except basal cell carcinoma of the skin that has been excised and cured)
* History of alcohol or drug abuse in the 52 weeks prior to screening
* Major surgery in the 4 weeks prior to screening excluding diagnostic surgery
* Previous treatment with CAMPATH-1H
* Previous treatment with a BAFF directed treatment in the 12 months prior to screening
* Previous treatment with a B-cell targeted therapy other than one directed at BAFF
* Treatment with any investigational agent, other than those above, in the 28 days prior to screening or five half-lives of the investigational drug (whichever is longer)
* Receipt of any live vaccine in the 6 weeks prior to Day 1
* Intolerance or contraindication to oral or i.v. corticosteroids
* Treatment with a second immunosuppressive or immunomodulatory drug in the 8 weeks prior to Day 1
* Prednisone dose of ≥ 0.7 mg/kg/day (or equivalent) for \> 7 of the previous 30 days prior to screening
* Treatment with cyclophosphamide or a calcineurin inhibitor in the 12 weeks prior to screening
* Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test
Gene Mutation in Samples From Young Patients With Pleuropulmonary Blastoma Syndrome at Risk for Developing Cancer

RATIONALE: The identification of gene mutations in young patients with pleuropulmonary blastoma syndrome may allow doctors to better understand the genetic processes involved in the development of some types of cancer, and may also help doctors identify patients who are at risk for cancer.

PURPOSE: This research study studies gene mutations in samples from young patients with pleuropulmonary blastoma syndrome at risk for developing cancer.

OBJECTIVES:

* To determine if DICER1 mutations contribute to tumor pathogenesis in cystic nephromas and cystic partially differentiated nephroblastomas outside of families with pleuropulmonary blastoma (PPB) syndrome.

OUTLINE: Archived DNA samples are analyzed for DICER1 mutation by qPCR and directly sequenced using BigDye Terminator chemistry. Results are then compared against the single nucleotide polymorphism (SNP) database.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of pleuropulmonary blastoma syndrome
* Normal tissue samples, if available
* Parental and sibling DNA samples, if available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis

Macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of diabetic gastroparesis. Currently, there are no non-invasive ways to study macrophage activation in humans. The researchers are trying to determine the utility of 11C-ER176 based PET-CT scanning to determine pro-inflammatory macrophage activation in gastric wall of patients with diabetic gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 70 years of age.
* Ability to provide informed consent.
* Type I or II diabetes mellitus.
* Gastroparesis defined by gastric retention of Tc-99m \> 60 % at 2 hrs and/or \> 10% at 4 hours on scintigraphy.
* Average Gastroparesis Cardinal Symptom Index (GCSI) ≥ 3 indicating moderate-severe symptoms.

Exclusion Criteria:

* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Using anti-coagulants, anti-inflammatory medications (NSAIDs, corticosteroids, etc.) or immunosuppressive therapies within the 4 weeks prior.
* Opioid use within the last 4 weeks of gastric emptying scintigraphy.
* Prior gastric surgery.
* History of IBD, celiac disease, eosinophilic gastroenteritis, microscopic colitis.

Healthy Subjects Exclusion criteria

* no clinical history of diabetes or any GI symptoms
* no inflammatory disorders of the GI tract
* no use of anti-inflammatory or immunosuppressive therapies
The Effects of Amino Acid Supplement During Acute Inflammation.

The purpose of the study is to investigate the metabolic effects during acute inflammation with and without the nutritional supplement of amino acids.

E. Coli Endotoxin (LPS, lipopolysaccharide) is used to initiate an inflammatory response.

The study is an interventional randomized placebo study including 8 healthy male subjects. Each subject participates 3 times (different days) and are given one of following interventions:

* Placebo (NaCl)
* Endotoxin, US standard reference E.Coli + Placebo (NaCl)
* Endotoxin, US standard reference E.Coli + Amino acids (intravenously)

It is our hypothesis that the nutritional intervention during acute inflammation plays an important role in lipid and protein metabolism.


Eligibility Criteria:
Inclusion Criteria:

* male gender
* 20\<BMI\<30
* Age \> 25 years old
* Written consent before starting the study

Exclusion Criteria:

* Allergy for soya products ore egg
* Diabetes
* Epilepsy
* Infection
* Immune defects
* Heart disease
* Dysregulated hypertension
* Participating in other trials using radioactive tracers or x-rays the last year.
Latin America Cardiac Resynchronization Therapy Study

The Latin America CRT Study is a prospective, multicenter, interventional post-market release study conducted in Latin America. The geography includes Puerto Rico and the Caribbean, Mexico and Central America, and South America.

The purpose of this study is to provide local evidence regarding Cardiac Resynchronization Therapy (CRT), in both pacing and defibrillation devices across Latin America. The primary objective will focus on changes in left ventricular heart size and function measurements in subjects receiving CRT therapy. The following additional parameters will also be collected:

* Data on referral patterns in Latin America;
* Data on device implant (including delivery system, device information, and lead information);
* Clinical data on subject outcomes and changes (improved, unchanged, or worsened) in heart failure status as assessed by heart failure (HF) hospitalizations, New York Heart Association (NYHA) class, mortality, and Quality of Life (QOL) measured by the Patient Global Assessment;

Eligibility Criteria:
Inclusion Criteria: Implant of new CRT-D or CRT-P device (first-time implant), ACC/AHA/HRS/ESC guidelines for implant, NYHA Class II, III or IV, QRS duration \>120 ms, LVEF \< 35%, Receiving optimal medical/drug therapy, Able to give written informed consent, Are \> 21 years of age, Must be able to return for follow-up visits as required, Are not pregnant or do not plan to get pregnant within the next 6 months, Have no physical limitations to perform Echo studies

Exclusion Criteria: Previous or existing CRT system implanted, Unwilling or unable to comply with specified follow-up schedule, Enrolled or intending to participate in another device study during the course of this study that requires specific treatment or device programming, Medical condition that may limit life expectancy to \< 6 months
Combination of Henagliflozin and Continuous Subcutaneous Insulin Infusion in T2DM

The Multi-center, randomized, controlled clinical trial investigate the efficacy and safety of Henagliflozin combined with continuous subcutaneous insulin infusion in newly diagnosed type 2 diabetes

The therapeutic mechanisms of Sglt2i and continuous subcutaneous insulin infusion (CSII) are complementary. We hypothesized that for newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia, combination treatment with Henagliflozin and CSII could achieve glycaemic control in a shorter time, shorten the duration of hospitalization and reduce the total insulin dosage. We also hope to investigate the safety of sglt2i in combination with CSII in T2DM based on continuous glucose monitoring system.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as type 2 diabetes mellitus, diagnosis time ≤ 2 years
2. Age between 20 and 70 years
3. Continuous use of any hypoglycemic drug ≤ 7 days within 6 months
4. 9% ≤ HbA1c ≤ 14% or fasting blood glucose ≥ 11.1 mmol/L
5. Body mass index (BMI) of between 20 and 32 kg/m2
6. Be able to understand the contents and methods of this study and sign the informed consent form voluntarily

Exclusion Criteria:

1. Diabetic ketosis or ketoacidosis, diabetic hypertonic state, diabetic lactic acidosis and other acute diabetic complications or serious chronic diabetic complications
2. Urinary tract infection or/and genital infection with clinical significance, or repeated urinary tract infection or/and genital infection history
3. Serious trauma or acute infection occurred within 4 weeks that may affect blood glucose control
4. People with negligent compensatory heart failure (NYHA grade III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, serious arrhythmia, cardiac surgery or vascular reconstruction within 6 months
5. Serious blood system disease (such as aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or erythrocyte instability (such as malaria, hemolytic anemia)
6. Severe chronic gastrointestinal diseases, or those who have received treatment that may affect drug absorption (such as gastrointestinal surgery)
7. Uncontrolled hyperthyroidism
8. Those who have mental or nervous system diseases and are unwilling to communicate or cannot fully understand and cooperate
9. Pregnant or lactating women
10. ALT\>3.0x ULN and/or AST\>3.0x ULN and/or Tbil\>2.0x ULN Blood ketone body\>ULN eGFR\<30ml/min/1.73 m2 Blood creatine kinase\>3.0x ULN
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.

Eligibility Criteria:
Inclusion Criteria:

* Germline BRCA 1/2 Mutation Positive
* Women and men at least 18 years of age or older.
* Histologically confirmed invasive adenocarcinoma of the breast
* HER2 negative breast cancer as defined by ASCO-CAP criteria
* Tumor greater than or equal toT1, N0-3
* No evidence of distant metastasis
* Adequate bone marrow, hepatic, and renal function
* ECOG performance status 0 or 1

Exclusion Criteria:

* Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.
* Evidence of distant metastasis apparent prior to randomization
* Patients with inflammatory breast carcinoma
* Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.
* Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
* Prior treatment with a PARP inhibitor in any disease setting
* Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
* Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol
* Major surgery within 14 days prior to study entry
* Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.
* Active clinically significant infection
* Clinically significant bleeding diathesis or coagulopathy
* Non healing wound, ulcer or bone fracture
* Known hypersensitivity to any of the components of talazoparib
* Patients with myelodysplastic syndrome/acute myeloid leukemia
* Patients with uncontrolled seizures.
* Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment
Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy

To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).

The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. Probing depth (PD),gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of GagP
* presence of ≥20 teeth
* \<35 years of age
* periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - agree to participate in the study and sign a written consent.

Exclusion Criteria:

* pregnant or lactating
* suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
* received antimicrobials in the previous 6 months
* taking long-term anti-inflammatory drugs
* received a course of periodontal treatment within the last 12 months
* smoked
Preoperative Education

The investigators will evaluate the effect of preoperative education on postoperative opioid.

The investigators propose a randomized trial to be performed at the Cleveland Clinic. Patients will be assigned to: 1) an educational video focused on postoperative analgesia modalities, opioids, and realistic pain expectations (analgesic education); or, 2) an educational video focused on other aspects of the perioperative experience.

Eligibility Criteria:
Inclusion Criteria:

* Modified informed consent
* Adults ≥18 years
* American Society of Anaesthesiologists physical status 1-4
* Scheduled for hip arthroplasty, laparoscopy assisted colorectal surgery
* Personal visit the PACE clinic
* Anticipated overnight postoperative hospitalization
* Reasonable English fluency

Exclusion Criteria:

* Opioid use for more than 30 consecutive days within three preoperative months, at a daily dose of 15 mg or more of morphine or equivalent
* Regional block or epidural analgesia
Oxytocin and Pain Sensitivity and Threshold

Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain. In addition,oxytocin have an important roles in sexual reproduction , in particular during and after childbirth. It facilitates birth, maternal bonding, and, breastfeeding. Nasal oxytocin has been commonly used to improve breastfeeding in lactating women. A review of safety , side effects and subjective reaction to intranasal oxytocin in human research in 1529 subjects did not review any differences from placebo. The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.4 Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain.

The main objective of the current investigation was to evaluate the effect of intranasal oxytocin on pain sensitivity and threshold in human volunteers. We hypothesized that intranasal oxytocin, in human volunteers ,would decrease sensitivity and and increase pain threshold compared to intranasal saline .

Significance: Intranasal oxytocin may become a viable treatment for acute and chronic pain in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females volunteers
* English speaking
* Age \<20 and \> 35

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy to preservatives
* Mental disease
* Chronic pain
* Current use of analgesics
* Anxiety or depression Drop Out: volunteer request
Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section

The aim of the study is to assess the impact of soft tissue mobilization on the scar in patients after cesarean section. An additional aim is to assess the relationship between the initial stiffness and elasticity of the scar and the age of the patients, the number of cesarean sections performed, as well as the time that has passed since the last cesarean section. Two physiotherapeutic interventions will be performed in the form of mobilization of the soft tissues (myofascial release techniques) of the lower abdominal area and the cesarean section scar, two weeks apart. The researchers will perform an assessment before and after each therapeutic session, as well as 2 weeks after the last therapy (follow-up). The level of satisfaction with life (Satisfaction with Life Scale (SWLS)) as well as the area of the cesarean section scar (Vancouver Scar Scale (VSS), scar assessment according to the Mustoe classification) will be analyzed. Researchers will also assess the sequence of abdominal muscle contractions during activation of the pelvic floor muscles (ultrasound examination) and quantify the state of soft tissue tension using the MyotonPro measuring device.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18-45,
* undergone at least 1 cesarean section in a period of not less than 6 months,
* not using physiotherapy for a cesarean section scar

Exclusion Criteria:

* women under 18 and over 45,
* pregnant women,
* presence of abdominal mesh,
* condition after abdominoplasty; nephrectomy; hysterectomy; cystectomy,
* uterine fibroids,
* stoma,
* occurrence of neurological symptoms (exclusion based on a functional test including the following elements: trunk flexion test in a sitting position (Slump test), Babinski test and clonic reflex test, tension tests for the sciatic nerve (passive straight leg raise test) and bowstring test and femoral nerve test (in lying on the front and on the side), examination of knee and ankle reflexes, as well as assessment of superficial sensation and strength of indicator muscles in the innervation of the lumbar-sacral spine),
* positive result of pain provocation tests: axial compression of the spine and maximum compression of the intervertebral foramen in the lumbosacral spine area,
* presence of contraindications to myofascial release therapy (active cancer, deep vein thrombosis, aneurysms, infectious diseases, viral and bacterial infections, acute inflammation and fever),
* women who underwent CC surgery in less than 6 months,
* previous surgical treatment and spine injury,
* vertical scar after cesarean section,
* use of physiotherapy treatments in the last six months,
* additionally the following comorbid conditions: cancer, diabetes, osteoporosis, diseases of the digestive system, circulatory system, rheumatic, mental and gynecological diseases, pregnancy