cyrilzakka/clinical-trials huggingface dataset:
Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women

To evaluate for the effect of corticosteroid epidural injections on bone mineral density in postmenopausal women. Candidates for the study: Post menopausal women between the ages of 55 and 80. No history of bone disease. No thyroid/parathyroid disorder. not used injected or oral steroids in the last year. No recent smoking.

The purpose is to identify any significant change in bone mineral density with the use of epidural steroid injections. This may implicate the need for patient counseling regarding this possible side effect and the possible use of preventive measures to avoid this adverse effect.

Glucocorticoids reduce bone formation and increase bone loss via a variety of mechanisms. This effect has been shown to be dose-dependent. Doses as low as 10mg of Prednisone, has been shown to lower bone density over periods as short as 20 weeks, an effect which may be prevented with use of Calcium and Vitamin D. Inhaled Tramcinilone has also been shown to lead to dose-related loss of bone at the hip in premenopausal women. Clinic visits will be arranged for recruited patients at baseline and then at 3 and 6 months after the ESI and at any time for new-onset or severe back pain. During the initial visit, consent will be obtained, patient will be given details on the study design and rationale, severity and characteristics of back pain. Epidural corticosteroid injection (ESI) has been shown to decrease pain, speed return of function, and improve neurological signs in patients presenting with low back pain.

Eligibility Criteria:
Inclusion Criteria:

Patients with low back pain and have consented to ESI. Age 55 and 5 years postmenopausal Caucasian women.

Exclusion Criteria:

1. any women who doesn't meet the inclusion criteria
2. Women with history of a disease affection bone turnover
3. Women taking any drugs known to influence bone metabolism
4. Women who had smoked within the preceding year
5. Women with abnormal serum thyrotropin concentration, or high parathyroid hormone concentratons.
6. Women who had received more than two short courses (lasting 2 weeks or less) of oral or parenteral glucocorticoids in the preceding year or any oral or pareneteral or local (intraarticular, paraspinal,...) or inhaled glucocorticoids in the preceding year
7. Women diagnosed with osteoporosis (T score\<=2.5) on baseline DXA or had history of osteoportic fracture.
8. Pregnant women
9. Severe scoliosis -
Photoacoustic Imaging of the Ovary

The purpose of this study is to develop technology to image the ovaries in order to better evaluate ovarian disease and to study how these experimental imaging techniques might work together or separately to improve our ability to detect ovarian cancer.

Epithelial ovarian cancer causes the highest mortality of any of the gynecologic cancers although it is the second most common gynecologic malignancy. Ovarian cancer is not usually detected earlier than Stage III or IV because it is usually asymptomatic; yet survival is high with early stage disease. In addition, women with a pelvic mass noted on ultrasound that undergo oophorectomy have only a 1-3% risk of malignancy and thus 97-99% will be overtreated because of our inability to reliably differentiate benign from malignant masses with ultrasound. BRCA1 testing and family history will identify certain high-risk individuals who have a higher risk of malignancy and need a modality that will be more reliable in detecting early cancers to provide more accurate surveillance.We are developing a new transvaginal imaging device optimized for ovarian cancer detection, diagnosis and validated from ex vivo and in vivo clinical studies. This automated system may provide an early diagnostic tool for ovarian cancer in the future.

Eligibility Criteria:
Inclusion Criteria:

* All patients, twenty one years or older, referred to the University of Connecticut for conditions necessitating oophorectomy.
* Patients cannot be pregnant or wish to become pregnant.
* Willingness to participate in the study.

Exclusion Criteria:

* All Subjects who fail to meet the inclusion criteria are ineligible for the study.
Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL

The purpose of this study is to determine the optimal dosing scheme for the combination of ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma (MCL).

This is a multi-center, study which will be open at up to 4 clinical sites. The purpose of this study is to determine the optimal dosing scheme for the combination of ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma (MCL). The main criterion for eligibility is MCL with measurable disease which is relapsed or refractory to at least 1 chemotherapy-containing regimen and has not been previously treated with ibrutinib.

This dose finding study will use a continual reassessment method, which accounts for both toxicity and efficacy in combinations of agents, to determine the optimal combination of the approved treatment ibrutinib with the investigational agent ABT-199. This study will accrue patients in two stages. In the initial stage, subjects will be accrued to dosing cohorts of increasing dosages of ABT-199 in combination with ibrutinib. The modeling is initiated once 1 subject experiences a dose limiting toxicity (DLT). During the modeling stage, treatment assignments will be made based on model prediction.

Subjects will remain on treatment until progression or unacceptable toxicity, and will be monitored for safety during the treatment interval. Safety will be evaluated by incidence of adverse events and number of discontinuations due to AEs. Efficacy endpoints include Overall Response Rate (ORR), Complete Response Rate (CRR), minimal residual disease response rate, and survival (PFS and OS). The study will also include exploratory analysis of the gene expression pattern in subjects who progress on treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Mantle Cell Lymphoma and has had at least one chemotherapy.
2. Subjects must have measurable or evaluable disease.
3. ECOG Performance Status of 0-2.
4. Must be referred for treatment with ibrutinib.
5. Must have adequate organ function.

Exclusion Criteria:

1. Subject is pregnant.
2. Prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
3. Known CNS lymphoma.
4. Prior or current treatment with certain medications. Talk to Study Contact for specifics.
5. Subject is at high risk for TLS.
6. Subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
7. Subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
8. Significant history of heart disease.
9. Subject has an active infection.
10. Known active Hepatitis B or Hepatitis C.
11. A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.
Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)

The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.

The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several differences between adults and children with respect to biological characteristics of leukemic cells, tolerance to anticancer drugs, treatment itself, and so on. It has been reported that adolescent ALL patients who were treated according to the pediatric protocol had a significantly better survival than those who were treated according to the adult protocol, indicating that the difference of treatment may be of considerable importance. To test the hypothesis, the Japan Adult Leukemia Study Group (JALSG) has planned a phase 2 study to treat younger ALL patients who are negative for BCR-ABL with the pediatric regimen which was used by the Japan Association of Childhood Leukemia Study. Those who are positive for BCR-ABL can participate in a separate protocol. The regimen is especially characterized by dose-intensified L-asparaginase, high-dose methotrexate, and intensified maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated BCR-ABL-negative ALL
* Age between 15 and 24 years
* Performance status between 0 and 3 (ECOG criteria)
* Adequate functioning of the liver (serum bilirubin level \< 2.0 mg/dL); kidneys (serum creatinine level \< 2.0 mg/dL); and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs).
* Written informed consent to participate in the trial

Exclusion Criteria:

* Uncontrolled active infection
* Another severe and/or life-threatening disease
* Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests
* Another primary malignancy which is clinically active and/or requires medical interventions
* Pregnant and/or lactating women
* Past history of renal failure
A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia requiring dialysis;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before and during screening;
* adequate iron status.

Exclusion Criteria:

* previous epoetin treatment within 8 weeks prior to screening;
* failing renal graft in place;
* bleeding episode necessitating transfusion within 8 weeks prior to screening;
* poorly controlled hypertension;
* previous treatment with Mircera.
Comparison of Root Coverage of Gingival Recessions

The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.

A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated.

Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy.

Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession.

After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be analyzed using descriptive and inferential statistics, with parametric tests, through the software package Social Sciences (SPSS), version 17.0 (free version).

Eligibility Criteria:
Inclusion Criteria:

* Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
* Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
* The teeth with gingival recession should not be restored in their cervical portion;
* Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
* Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.

Exclusion Criteria:

* Orthodontic appliances;
* Fixed or removable prostheses involving the premolar teeth with gingival recession;
* Being a smoker;
* Pregnancy or lactation;
* Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
Dexamethasone Versus Methylprednisolone for the Treatment of Active Inflammatory Bowel Disease

The aim of this therapeutic trial is to compare the response of subjects with active IBD to daily intravenous dexamethasone versus the response to daily intravenous methylprednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Parental informed consent
* Subjects 6 to 19 years of age with confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis or indeterminate colitis), who on admission to the hospital have a PCDAI\>15 or a Clinical-Activity Index for the Evaluation of Patients with Ulcerative Colitis of \>10.
* Infectious causes (viruses, bacteria, parasites) have been ruled out.

Exclusion Criteria:

* Subjects in which the administration of corticosteroids would be contraindicated such as systemic or enteric infections diagnosed by stool analysis including culture, Clostridium Difficile toxin assay, rotavirus or adenovirus 40/41 antigens.
* Subjects with enterostomy or colostomy
* Subjects with one or more of the following conditions: unstable vital signs, acute abdomen, toxic megacolon, intestinal obstruction, intestinal perforation
Comparative PK Study Of THC/CBD Formulations

A phase I, single center crossover study.

The goal of this clinical trial is to learn about self-emulsified THC/CBD powder compared with equivalent dose of THC/CBD oil, orally administerd in healthy volunteers.

The main question it aims to answer is:

•If the pharmacokinetics profile of one dose of THC/CBD Self emulsified (S.E powder) compares to THC/CBD oil (equivalent dose).

The secondary is:

•If the use of THC/CBD S.E powder is tolerable and safe at least as THC/CBD oil.

Participants will receive a single dose of THC/CBD S.E powder followed by a 30-day washout period and then a single dose of THC/CBD oil.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 21-65 years old.
2. Subjects must have a signed study informed consent before any procedure.
3. Subjects must have a cannabis license as detailed at procedure No. 106 of the IMC-GCO , license will be issued and approved by PI at screening visit after signing on informed consent.
4. Female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine pregnancy test at screening, visit 1 and visit 2.

Exclusion Criteria:

1. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to THC/CBD.
2. Has an underlying medical condition that would preclude study participation.
3. Chronic use of medications for underlying medical conditions.
4. Use of any medications within 24 hours prior to treatment visit.
5. Is currently participating in another study of an investigational agent/medical device.
6. Has known psychiatric or substance abuse disorders that would interfere with participating in the study.
7. Patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy).
8. Patients who previously suffered from depression or anxiety.
9. Medical history of high blood pressure, low blood pressure or diabetes.
10. Patients who experience difficulties in performing daily activities.
11. Current cannabis use or positive THC urine test results.
12. Pregnant or lactating female subjects
Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in predicting response to treatment in patients with newly diagnosed stage III or stage IV head and neck cancer treated with carboplatin, paclitaxel, and radiation therapy.

OBJECTIVES:

* Determine if gene expression patterns that correlate with treatment response and survival can be identified using DNA microarrays in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) treated with carboplatin, paclitaxel, and radiotherapy.
* Determine if protein expression patterns that correlate with treatment response and survival in HNSCC can be identified using matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOFMS).
* Determine if the molecular signature of human papilloma virus-16 infection can be determined using DNA microarray and MALDI-TOFMS and correlate with gene and protein expression, treatment response, and survival.

OUTLINE: Tumor tissue samples are analyzed by DNA microarray analysis and validated by quantitative reverse transcription-polymerase chain reaction (PCR). Protein and gene expression patterns are analyzed by laser desorption ionization-time-of-flight mass spectrometry, high performance liquid chromatography, liquid chromatography-tandem mass spectrometry, and PCR. Samples are also analyzed by tissue microarray and immunohistochemistry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed head and neck squamous cell carcinoma

  * Stage III-IV disease
* Scheduled for pan-endoscopy
* Tumor tissue available from patients treated with carboplatin, paclitaxel, and radiotherapy on protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

* Able to speak English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Fecal Microbiota Transplantation for Refractory IgA Nephropathy

IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Previous studies suggested that the disorder of intestinal flora may play an important role in the pathogenesis and prognosis of IgAN. Fecal microbiota transplantation (FMT) have been proved to be effective on rebuilding the intestinal microecological balance. However, there is no evidence for the safety and efficacy of FMT in IgAN. Therefore, investigators perform a prospective cohort study to evaluate the safety and efficacy of FMT in IgAN patients who did not response to the conventional treatment and did not want to aggravate immunosuppressive treatments or IgAN patients who did not response to immunosuppressive treatments.


Eligibility Criteria:
Inclusion Criteria:

* Adult, age: 18-65 years old.
* Pathological diagnosis with IgAN, eGFR：20-120 mL/min/1.73 m2.
* The 24-hour urinary protein was still greater than 1g after 3-6 months of treatment of ACEI/ARB
* Recurrence of IgAN after glucocorticoid and (or)immunosuppressant decrement and the 24-hour urinary protein was greater than 1g.
* Not suitable for the administration of glucocorticoid and (or) immunosuppressive agents because of side effects.
* Women of child-bearing age with negative urine pregnancy test have no pregnancy plan for the next 18 months and take effective contraceptive measures.
* Agree to participate in this clinical trial

Exclusion Criteria:

* Malignant tumors and other diseases with expected survival time \<3 months.
* Severe cardiovascular and cerebrovascular diseases and pulmonary dysfunction.
* Other immune system diseases.
* Diabetes
* Inflammatory bowel disease（IBD）
* Clostridium difficile infection
* Gastrointestinal tumor
* Active gastrointestinal bleeding
* Acute and chronic gastroenteritis
* Have received or are receiving FMT treatment.
* HIV
* Psychosis AND dysgnosia
* Contraindication of colonoscopy and enema
* Alcohol/drug abuse
* Other conditions that the researchers thought were not appropriate for the group.
DELPhI Evaluation of Psychiatric Conditions

DELPhI acquisition and analysis software, a QuantalX Neuroscience development, which is designed to measure, analyze, and display brain electrical activity of human electroencephalogram (EEG), to transcranial magnetic stimulation (TMS), will be used to evaluate different psychiatric conditions.

Psychiatric conditions requiring pharmaceutical treatment include Schizophrenia and other psychotic disorders, Major depressive disorder, Bi-polar disorder, Post Traumatic Stress Disorder, Obsessive Compulsive Disorder and anxiety disorders. To date none of the psychiatric conditions mentioned diagnosis' relies on an imaging or other quantitative technique. Diagnosis and treatment prescription in the psychiatric clinic still relies on subjective reports and physician assessment of symptoms. Trans-cranial magnetic stimulation (TMS) is a noninvasive brain stimulation method that allows to study human cortical function In-vivo. Using TMS for examining human cortical functionality is enhanced by combining TMS with simultaneous registration of electroencephalograph (EEG). EEG provides an opportunity to directly measure the cerebral response to TMS, measuring the cortical TMS Evoked potential (TEP), is used to assess cerebral reactivity across wide areas of neo-cortex. Studies integrating TMS with EEG (TMS-EEG) have shown that TMS produces waves of activity that reverberate throughout the cortex. and that are reproducible and reliable thus providing direct information about cortical excitability and connectivity with excellent time resolution. By evaluating the propagation of evoked activity in different behavioral states and in different tasks, TMS-EEG has been used to causally probe the dynamic effective connectivity of human brain networks.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female patients between the age of 18-80 years old.
2. Patients willing to participate with all of the study procedures and sign informed consent form.
3. A clinical diagnosis of psychiatric condition that requires medication or other intervention (such as brain stimulation or psychological treatment).-study groups.
4. Without any psychiatric medications or with stable treatment regimen for the last 2 months-study groups..

4.5. A normal neurological exam- control group.

Exclusion criteria:

1. Prior known epileptic episode. 2. History of any neurodegenerative disease. 3. Patients with history of other known brain disorder/pathology. 4. Contraindication to MR imaging.

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