cyrilzakka/clinical-trials huggingface dataset:
5p15/ 9q22/ 15q22 Hyperdiploidy and Their Significance in Multiple Myeloma Patients

Our study aims to detect 5p15/ 9q22/ 15q22 hyperdiploidy and thier significance in Multiple Myeloma patients

Multiple myeloma is a malignancy of terminally differentiated B cells(immunoglobulin-producing long lived plasma cells ).Its a Bone Marrow based,multifocal plasma cell neoplasm,Multiple myeloma (MM) is the second most common hematologic malignancy.It is mostly observed in older adults with a median age of 66 to 70 years .The exact etiology of multiple myeloma is unknown. However, frequent alterationsand translocations in the promoter genes, especially chromosome 14, are commonly found in multiple myeloma and likely play a role in disease development.In addition, other oncogenes such as NRAS, KRAS, and BRAF may participate in plasma cell proliferation In the majority of patients,malignant proliferation of plasma cells causes the M protein (abnormal IgG, IgM, or IgA or rarely IgE or IgD) in serum and/or urine. Typical symptoms are hypercalcemia, renal failure, anaemia, or destructive bone lesions ("CRAB") The definition of HD in MM has varied across studies; one study defined HD as numerous chromosomal trisomies and low prevalence of IgH translocations and another as a chromosome count of 48-65, with a gain of at least two odd chromosome, Multiple myeloma can be distinguished into two major subgroups based on the genetic abnormalities that all patients harbor; hyperdiploid MM (≥47 and \<75 chromosomes; H-MM) and non-hyperdiploid MM (NH-MM).1 NH-MM is further divided into three subgroups: hypodiploid (≤44 chromosomes), pseudodiploid (45-46 chromosomes) and near tetraploid (\>75 chromosomes), H-MM has been defined by multiple chromosomal gains, preferentially of the odd chromosomes 3, 5, 7, 9, 11, 15, 19 and 21.Hyperdiploidy is usually associated with a favourable prognosis.

cytogenetic mutations in MM divided into two classes: primary and secondary. primary mutations that occur during the monoclonal gammopathy of undetermined significance (MGUS) stage, a noncancerous condition that affects plasma cells.The primary mutations typically affect the immunoglobulin genes,the most common trusted Source primary mutation is hyperdiploidy,which causes three chromosomes to develop instead of two, it can be observed in around half of the patients and is considered as a favorable prognostic factor, Secondary mutations occur later in the disease or during its progression.Secondary mutations can also be monosomic, where the mutation causes one member of a chromosome pair to be missing

Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed Multiple Myeloma Patients -

Exclusion Criteria:

Patient of Multiple Myeloma who received treatment

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Comparing HILT, Steroid Injection, and Manual Therapy for Frozen Shoulder

This study compares three common treatments for frozen shoulder when added to a standard exercise program: High-Intensity Laser Therapy (HILT), a corticosteroid (steroid) injection into the shoulder joint, and hands-on manual therapy by a physical therapist. A fourth group will receive only the standard exercise program. The goal is to see which combination works best to reduce shoulder pain and improve shoulder function over 6 months. The main outcomes are changes in pain (VAS scale) and shoulder disability (SPADI questionnaire) at 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

Age between 40 and 70 years, inclusive. Clinical diagnosis of primary (idiopathic) frozen shoulder, defined by shoulder pain and ≥50% restriction in passive external rotation compared to the contralateral (unaffected) shoulder.

Symptom duration between 3 and 9 months. Average shoulder pain intensity ≥ 4 on a 10-cm Visual Analogue Scale (VAS) over the past week.

Normal or age-appropriate radiographic findings of the glenohumeral joint (ruling out significant arthritis, fractures, calcific tendinitis).

Willingness and ability to attend scheduled treatment/assessment sessions. Ability to understand study procedures and provide written informed consent.

Exclusion Criteria:

Secondary frozen shoulder (e.g., post-traumatic, post-surgical, related to systemic disease like diabetes - clarify if diabetes is excluded or just secondary FS from diabetes).

Clinical or imaging evidence of significant rotator cuff tear requiring specific management.

Radiographic evidence of moderate to severe glenohumeral osteoarthritis (e.g., Kellgren-Lawrence grade ≥ 3).

Previous surgery on the index shoulder. Significant neurological disorders affecting shoulder or upper extremity function (e.g., cervical radiculopathy, stroke).

Received a corticosteroid injection in the index shoulder within the past 3 months.

Known contraindications to corticosteroid injections (e.g., uncontrolled diabetes, allergy, local infection).

Known contraindications to High-Intensity Laser Therapy (e.g., active malignancy in the treatment area, photosensitivity, pacemaker over treatment area).

Current participation in another interventional clinical trial for shoulder pain.
Non Motoric Reactions in Vojta Reflex Locomotion

Monitoring of non-motor manifestations of reflex locomotion according to Professor Vojta in laboratory conditions on healthy woman probands.

The accompanying non-local manifestations during a maximum of 20 minutes of pressure stimulation of the zones defined by the concept of Professor Vojta will be observed. We will also examine the possible correlation between the magnitude of the response to Vojta Reflex Locomotion (VRL) and the degree of stress and anxiety on the part of the study participants. Approximately 20-30 participants will take part in the research. Manual stimulation of defined zones will be performed by an experienced physiotherapist who has successfully completed a course in the Vojta method. A Trigno Wireless EMG System Delsys device will be used to measure electrical muscle activity. Kistler force plates and a pliance-x® sensing system pedobarography device will be used to measure changes in standing. The SP-10 Pocket Spirometer Gima and wireless ECG will be used to measure changes in breathing and circulation. In addition, the DASS-42 and POMS questionnaires will be used. The aim of the study is to clarify whether during manual pressure stimulation of the zones defined by the above concept there is a change in electrical muscle activity, specific activity of the autonomic nervous system and whether there is a different partial pressure distribution in standing after the stimulation. Last but not least, the aim of the study is also to determine a possible correlation between the response rate to VRL and the level of stress and anxiety on the part of the study participants. All probands will be familiarized with the experimental measurement procedure and will sign an informed consent form prior to the start of the experiment. Measurements will be taken in the kinesiology laboratory of Physiotherapy department.

Eligibility Criteria:
Inclusion Criteria:

These will be healthy adult women. The expected number of participants is 20-30. To participate in the study, participants must agree to participate voluntarily.

Exclusion Criteria:

Contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. Persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing.
Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation

The objective of this study is to investigate the efficacy and safety of the humanized anti-human IL-6 receptor monoclonal antibody tocilizumab (TCZ) either in monotherapy or in combination therapy with methotrexate (MTX) in patients with an inadequate response to treatment with MTX.

Furthermore, in patients who have been able to achieve control of disease activity via the above therapy, we investigate the possibility of stopping TCZ and verify safety when TCZ is restarted after disease recurrence.

In this study, we aim to prospectively and randomly evaluate efficacy for changes in clinical remission and joint destruction in RA patients in treatment with TCZ monotherapy(SWITCH) and in combination therapy with MTX(ADD-ON), and also to investigate the best therapeutic approach to achieve discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RA in accordance with the 1987 classification criteria of ACR
* Aged 20 to 75 years inclusive at enrolment (within 2 weeks before starting treatment with the investigational drug)
* Treated with MTX at ≥6 mg/week for at least 8 weeks immediately before enrolment
* Rheumatoid arthritis of duration ≤10 years
* DAS28-ESR ≥3.2 (within 2 weeks before starting treatment with the investigational drug)
* Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent

Major exclusion criteria:

* Patients who were Steinbrocker Class IV.
* Patients who received leflunomide within 12 weeks, DMARDs other than MTX within 8 weeks , or tacrolimus within 4 weeks before the 1st TCZ infusion.
* Patients who previously received biologic DMARDs including TCZ.
Location Specific Differences in Intestinal Brake Activation

The appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.


Eligibility Criteria:
Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Based on medical history and previous examination, no gastrointestinal complaints can be defined.
* Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
* BMI between 18 and 25 kg/m2)
* Weight stable over at least the last 6 months (≤5% weight change)

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
* Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
* Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 alcoholic consumptions per week)
* Smoking
* Blood donation within 3 months before the study period
* Self-admitted HIV-positive state
* Weight \<60kg
* Evidence of casein or sucrose hypersensitivity
* Participation in any other study in which radiation was used, within 12 months before the study period
Safety Study of Plasma Treatment System to Treat Back Acne

The purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne.


Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant, non-nursing females age 18-40 years old.
2. Presence of clinically-evident back acne.
3. Minimum of 20 non-inflammatory lesions (open and closed comedones)
4. Minimum of 30 total lesions (sum of inflammatory and non-inflammatory)
5. Subject must have measurable sebum production.
6. Subjects must be in generally good health.
7. Must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

1. Any nodulo-cystic lesions at Baseline
2. Pregnancy or breast feeding
3. Use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study
4. Intake of any oral retinoids within four months prior to study start and throughout the duration of the study
5. Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
6. Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
7. Use of an experimental drug or device within 30 days prior to study start;
8. Intake of hormonal therapy within 3 months prior to study start
9. Use of topical products on the back containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
10. Concomitant use of mega-doses of certain vitamins, such as vitamin D (\>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
11. Procedures on the skin of the back such as chemical or laser peel, microdermabrasion, photodynamic therapy) within the past 2 weeks or during the study.
12. History or evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
13. Any significant medical conditions that could confound the interpretation of the study results.
14. History of/or current skin cancer cancer
15. Use of tanning booths, sun lamps within the past 2 weeks or during the study
16. Any metallic implants or prostheses in the vicinity of the treatment site (such as shoulders, back, spine, pacemakers, etc.).
17. Any known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
18. History of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
19. History of or is currently immunocompromised.
Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using \[18F\]-labeled substance P antagonist receptor quantifier, may be effective in finding disease in patients with pancreatic cancer.

PURPOSE: This phase I trial is studying how well a PET scan using \[18F\]-labeled substance P antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.

OBJECTIVES:

* Determine whether \[18F\]-labeled substance P antagonist receptor quantifier positron emission tomography can identify pancreatic cancer evident on multiphase CT scan.

OUTLINE: Patients undergo multiphase CT scan of the chest, abdomen, and pelvis. No more than 15 days later, patients receive \[18F\]-labeled substance P antagonist receptor quantifier IV and undergo positron emission tomography over 6 hours.

Blood is collected periodically to measure the metabolism of the radiotracer by high performance liquid chromatography with radioactive detectors.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

  * Primary or metastatic disease
* At least one site of measurable disease
* Enrolled in an NCI protocol (either a treatment or screening protocol) such as NCI-05-C-0044 or NCI-05-C-0141

PATIENT CHARACTERISTICS:

Inclusion criteria:

* ECOG performance status 0-2
* WBC ≥ 1,200/mm³
* Creatinine \< 2.0 mg/dL
* Negative pregnancy test
* Fertile patients must agree to use effective contraception
* Not pregnant or nursing

Exclusion criteria:

* Allergy to IV contrast
* Claustrophobia that would preclude completion of a scan or unable to lie on one's back for positron emission tomography scan

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* More than 4 weeks since prior abdominal surgery

Exclusion criteria:

* Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits
* Aprepitant within 72 hours of \[18F\]-labeled substance P antagonist receptor quantifier positron emission tomography
Hold Parameters on Likely Cardiovascular Depressant Medications

This pilot study is being pursued to observe whether certain medications are given to patients within a timeframe where their being given could play a part in a critical event in the management of the patient.

There are general rules about when it would be appropriate for these types of medications not to be given. However, it is not current standard practice for the criteria to be put in place without the expressed wishes of the ordering physician or their agent.

Research Question:

Can the administration of cardio-depressant medications be documented as a significant risk factor for hypotensive or bradycardic events?


Eligibility Criteria:
Inclusion Criteria:

* Serial evaluation of the first 50 documented events of Code Blue or call to Rapid Response Team involving hypotension, bradycardia or asystole in the adult inpatient population events beginning January 1, 2006.
Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas

Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a small growth called an adenoma in the parathyroid glands) is an increasingly significant medical and public health condition.

Surgery is the only effective management for primary hyperparathyroidism. However; it is sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of tumors.

SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing the tumor. This, however, is a challenge because the parathyroid glands usually are located close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the parathyroid but not in the thyroid.

A more sensitive and specific radiotracer/tracking agent would markedly improve the investigators ability to identify parathyroid tumors preoperatively, and thus offer more patients a minimally invasive parathyroidectomy.

anti-3-\[18F\]FACBC is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments, anti-3-\[18F\]FACBC has shown uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.

The primary aim of this study is to determine if anti-3-\[18F\]FACBC PET-CT demonstrates uptake within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will undergo PET-CT using anti-3-\[18F\]FACBC in addition to the standard 99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery routinely, the investigators will then compare findings at surgery to those of the anti-3-\[18F\]FACBC PET-CT to determine if this radiotracer is worthy of further study in a more comprehensive experiment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older.
2. Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery .
3. Ability to lie still for PET scanning
4. Patients must be able to provide written informed consent

Exclusion Criteria:

1. Age less than 18.
2. Inability to lie still for PET scanning.
3. Cannot provide written informed consent.
4. History of secondary hyperparathyroidism.
5. Positive serum or urine pregnancy test within 24 hours of imaging
Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ranging between 18.5 kg/m2 and 30 kg/m2.
* Screening serum urate level is ≤ 7.0 mg/dL.

Exclusion Criteria:

* Asian subject who has a positive test for the HLA-B\*5801 allele.
* History or current diagnosis of kidney stones.
* Estimated creatinine clearance, as determined at Screening, of ≤ 80 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
* Undergone major surgery within 3 months prior to Screening.
* Donated blood within 4 weeks prior to Day 1 or experienced an event (other than blood donation) of significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 4 weeks prior to Day 1.
* Inadequate venous access or unsuitable veins for repeated venipuncture.
* Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.
Muscle Parameters and Pathological Response in Breast Cancer Patients

The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

In patients with operable breast cancer (BC) receiving neoadjuvant chemotherapy (NAC), the pathological response rate was found to be related to body composition. The success of complete pathologic response (pCR) is a known prognostic factor in BC patients treated with NAC. The investigators aimed to accurately measure muscle mass and predict pCR to NAC and its effect on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy.

Exclusion Criteria:

* Patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.
A Phase 2 Study Of PF-00232798 In HIV Positive Patients

To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years inclusive.
* Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay.

Exclusion Criteria:

* Patients who have received any experimental drug within the past four months (prior to the first dosing day of the study) or who have previously received another CCR5 antagonist.
* Patients with evidence of decompensated liver disease.