cyrilzakka/clinical-trials huggingface dataset:
VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 18 years or older
* Diagnosis of B-cell lymphoma (CD20+) of

  * follicular lymphoma (grades 1, 2, and 3) or
  * marginal zone lymphoma (extranodal, nodal, and splenic)
* Documented relapse or progression following prior anti-neoplastic treatment.
* At least 1 measurable lymph node mass that is \>1.5 cm.
* No active CNS lymphoma
* Voluntary consent

Exclusion Criteria:

* Previous treatment with VELCADE
* Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
* Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
* Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug.
* Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug.
* Radiation therapy within 3 weeks before the first dose of study drug.
* Major surgery within 2 weeks before the first dose of study drug.
* Peripheral neuropathy or neuropathic pain
* History of allergic reaction attributable to compounds containing boron or mannitol
* Known anaphylaxis or hypersensitivity to any component of rituximab
* Diagnosed or treated for a selected malignancies other than NHL within 5 years.
* Active systemic infection requiring treatment
* Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
* Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
* Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).

Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).

Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old
* GHD of childhood onset
* completed growth
* IGF-1 \<=2SDS
* rhGH treatment naive
* hGH levels below cut-off

Exclusion Criteria:

* History of malignancy or intracranial tumors
* ECG abnormality
* ICH
* hepatic dysfunction
* renal impairment
* major medical conditions
* inadequate T4
* positive for HBV, HCV, or HIV
* alcohol or drug abuse
Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer.

PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.

OBJECTIVES:

* To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with unresectable stage IIIB or IV non-small cell lung cancer.
* To compare symptom control in these patients.
* To compare geriatric assessment outcomes, as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale, in these patients.
* To compare the effects of the PCI vs standard care on resource use.
* To identify subgroups of patients who benefit most from the PCI in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12.

OUTLINE: Patients are assigned to 1 of 2 groups.

Group I (usual care): Patients receive standard care.

Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising sessions, focused on physical, psychological, social, and spiritual well-being, once weekly in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9, 13, 17, and 21.

Eligibility Criteria:
Criteria:

* Diagnosis of stage IIIb-IV unresectable NSCLC
* Undergoing treatment with chemotherapy, radiation, or combined modalities
* Living within a 50 mile radius of the City of Hope
* No previous cancer within the past 5 years
LUng CAncer focuS - Long-term Monitoring of Bronchogenic Carcinoma Patients (LUCAS)

Long-term non-interventional monitoring of diagnostics and treatment patterns in newly diagnosed patients in selected pneumology centers in Czech republic.

Diagnosis, treatment and care of patients with bronchogenic carcinoma (BCA) is, as with most other oncological diseases, a complex multidisciplinary process. Due to the lack of information on the speed and success of the initial diagnosis, the use of the necessary laboratory techniques, and the individual therapeutic steps leading to cure or medical failure, the Czech Pneumological and Phtizeology Society (CPPS) decided to carry out long-term non-interventional monitoring of newly diagnosed patients.

This monitoring is non-interventional, so the usual diagnostic and therapeutic procedures will be used according to the decision of the physician. All patients with bronchogenic carcinoma diagnosed from June 1, 2018 will be enrolled with up to 60 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

- clinical diagnosis of lung cancer (C34 in MKN classification)

Exclusion Criteria:
Synergy Lens Outcomes Evaluation

This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years and older.
2. Gender: Males and Females.
3. Uneventful bilateral lens extraction
4. Bilateral implantation of Synergy IOLs (toric and non-toric) by 5 anterior segment surgeons at Center For Sight (DWS, WJL, JWK, WLS, and JOD) and 1 surgeon at Carolina Eyecare Physicians (KDS) through the months of June to December 2021.
5. Willing and able to provide written informed consent for participation in the study.
6. Willing and able to comply with scheduled visit and study examination procedures.
7. At least 3 months postoperative from second eye IOL implantation.
8. Postoperative best corrected visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Established ocular pathology, including: glaucoma (except glaucoma suspects), uveitis, and clinically-significant retinal pathology affecting the macula (with visual acuity worse than 20/32) and/or any other ocular findings that may, in the opinion of the investigator, affect vision.
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
5. Clinically significant corneal dystrophy.
6. Irregular astigmatism.
7. History of chronic intraocular inflammation.
8. Previous intraocular surgery.
9. Previous keratoplasty
10. Previous refractive surgery.
11. Severe dry eye
12. Pupil abnormalities
13. Any clinically significant, serious or severe medical or psychiatric condition that may interfere with the interpretation of study results.
14. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
15. Best-corrected distance visual acuity worse than 20/32 in each eye.
16. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
17. Abnormal iris
18. Patients who had a complication during cataract surgery, which could include ruptured zonules, torn capsule, or vitrectomy.
Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)

The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Good oral hygiene
* Patient aging 20-40 y
* Patients with proximal deep carious lesion
* International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
* Normal response to a vitality test.

Exclusion Criteria:

* poor general health
* poor oral hygiene
* Teeth would need direct pulp capping
* Teeth act as abutment for fixed or removable prosthesis.
* patients with excessive parafunctional habits
* Patient potentially unable to be compliant to recall visits
Study of Nivolumab for Advanced Cancers in India

This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization

Exclusion Criteria:

* Participants with untreated, symptomatic central nervous system (CNS) metastases
* Participants with carcinomatous meningitis
* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Other active malignancy requiring concurrent intervention

Other protocol defined inclusion/exclusion criteria could apply
MRI-based 3D Hip Labrum and Cartilage Morphology in Patients With Hip Deformities Compared to Asymptomatic Volunteers

In this study, the investigators seek to describe the normal 3D hip joint morphology in asymptomatic volunteers and compare it to various hip joint deformities. Asymptomatic volunteers will be asked to undergo a non-contrast MRI of the hip at 3 Tesla, utilizing a high-resolution morphologic 3D sequence (3D T2 DESS) that enables the segmentation of labrum and cartilage. 3D morphological parameters of the asymptomatic group will subsequently be compared with the 3D morphological parameters of patients with hip deformities, which were collected as part of a previous retrospective study.

Hip deformities can cause hip pain and early onset osteoarthritis in young individuals.

Correcting these deformities typically involves planning with X-rays and MRI images, which offer a limited view of the hip joint's 3D structure. A comprehensive 3D analysis of hip structures, including cartilage, and labrum, would enhance diagnosis and surgery planning. However, 3D hip morphology hasn't been adequately described for distinguishing deformities.

The aim of this study is to describe normal 3D hip joint morphology in healthy participants and compare it to various hip joint deformities (Dysplasia, acetabular protrusion, retroversion, deep hip, and cam deformity).

Asymptomatic volunteers will undergo a non-contrast MRI of the hip at 3 Tesla using high-resolution morphologic 3D sequence (3D T2 DESS), which allows segmentation of labrum and cartilage.

The 3D morphological parameters of the asymptomatic group will then be compared with those of patients with hip deformities, data sourced from a retrospective study that included 100 patients from the outpatient clinic. These patients underwent direct MR arthrography at 3 Tesla in accordance with the institutional routine protocol at the Department of Diagnostic, Interventional, and Pediatric Radiology at Inselspital.

Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years.
* Signed an informed consent form.
* History free of significant hip pain, with no history of juvenile hip disease, traumatic injuries, inflammatory conditions, or tumors affecting the hip.
* Normal clinical examination of the hip.

Exclusion Criteria:

Individuals who are not considered suitable for MRI (Magnetic Resonance Imaging) for the following reasons:

* Potential pregnancy
* Presence of metal fragments in the eye or elsewhere in the body
* Presence of implants and metallic foreign bodies, such as a pacemaker, heart valve, cerebrospinal fluid shunt, insulin pump, nerve stimulator, or cochlear implant
* Claustrophobia
Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.


Eligibility Criteria:
Inclusion Criteria:

1. 22-80 years of age
2. Subjects have GERD with hiatal hernia \< 5 cm (defined as maximum ,axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery) and Hill grade III or IV
3. Pathologic reflux while off PPI based on Lyon criteria by either of the following:

   3.1. Conclusive evidence for pathologic reflux defined as acid exposure time (AET) \> 6% (worst day) or LA grade C or D esophagitis.

   3.2. Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B.
4. Commitment to long-term study
5. Ability to give consent individually or by a legally authorized representative

Exclusion Criteria:

1. Hiatal hernia \> 5 cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at time of surgery)
2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
3. Pregnancy (in females) at time of procedure
4. Previous anti-reflux procedure
5. Subjects requiring mesh treatment at time of procedure
6. At the discretion of the site PI for subject safety
7. BMI \> 35 at time of surgery.
8. Prior gastric surgery that may affect ability to perform either procedure or affect normal gastric function (e.g. gastrectomy, gastric bypass, sleeve gastrectomy, pyloroplasty.
9. Severe gastroparesis
Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises Patient With Hemophilia

Hemophilia is a bleeding disorder caused by a deficiency of clotting factors in the blood. Muscle and joint bleeding are frequently observed in patients with hemophilia. Lower extremity bleeding can adversely affect balance, gait, and proprioception. The goal of this study; To compare the effectiveness of closed kinetic chain exercises and proprioceptive exercises on balance, proprioception and gait parameters in adolescent and young hemophilic individuals with lower extremity joint involvement.

The main question it aims to answer is:

Are the effects of closed kinetic chain exercises and proprioceptive exercises different on balance and walking in hemophilic individuals?


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Hemophilia A and Hemophilia B
* Having a blood factor level below 5%,
* Between 13-25 years old
* History of bleeding to the lower extremity and target joint
* Total lower extremity Hemophilia joint health score ≥3
* Using prophylaxis

Exclusion Criteria:

* Having undergone lower extremity surgery in the last 6 months
* Having a Body Mass Index over 30 kg/m2
* Have an inhibitor
* Using a walking aid
Effects of Deepure(Pu-erh Tea Extract) on Glycemic Control

This is a randomized, controlled, cross-over study on the effects of consumption of Deepure puerh tea extract (PTE) on glucose tolerance and metabolic markers.

The study will involve consuming three different doses: 1 gram, 1.5 grams, and 2 grams, and will be given in warm water, with a bland meal. The effects on glucose and insulin after consumption will be evaluated.The subjects will be randomly assigned to one of four groups with different sequences.

Eligibility Criteria:
Inclusion Criteria:

* Men and women;
* Aged 18-70 years;
* BMI between 20-30;
* Fasting blood glucose at screening between 71-125 mg/dL. both inclusive.

Exclusion Criteria:

* Taking dietary supplements judged to interfere with the effects of Deepure on glucose metabolism (for example: cinnamon extract; chromium picolinate; mulberry extract; bitter melon extract, green tea extracts, black tea extracts, pu-erh tea);
* Participation in other clinical trials, involving an investigational product or lifestyle change, during the last month;
* Participation in another research study during this trial, involving an investigational product or lifestyle change; Taking prescription medication known to affect glucose metabolism;
* Taking over-the-counter medication known to affect glucose metabolism;
* Drinking 3 or more cups of tea daily;
* Unwilling to abstain from drinking tea for 24 hours before clinic visits; (if a person drinks tea within 24 hours of a clinic visit, the person's visit will be re-scheduled);
* Consuming 2 or more drinks of alcohol per day;
* Unwilling to abstain from drinking alcohol for 10 hours before clinic visits;
* Diagnosed with diabetes Type I; Taking medication for diabetes Type II;
* Diagnosed with the thyroid disorder Hashimoto's disease;
* Past major surgery to your stomach or intestines (minor surgery not a problem such as hernia repair, appendix removal, gallbladder removal);
* Currently taking cholesterol-lowering medication (for example: statins);
* Currently taking coumadin;
* Major trauma within the past 6 months;
* Major surgery within the past 6 months;
* Severe chronic infectious disease (such as HIV, chronic hepatitis);
* Active depression;
* Self-reported eating disorders;
* History of drug abuse during past two years;
* Currently going through intense stressful events or life changes;
* Women of child-bearing potential: Pregnant, breast-feeding, or trying to become pregnant;
* Women of child-bearing potential: Not using effective contraception;
* Food allergies or sensitivities to tea.
Thermal Micro-cautery for Painful Knee Osteoarthritis

To trial a traditional pain management technique from Ayurveda in a modern way - the technique involves micro - cautery to painful areas in knee osteoarthritis for patients on a waiting list for knee replacement. The Investigators will include a waiting list control series.

The Research and Ethics Committee at Tallaght University Hospital approved the recruitment of patient into the study by invitation. Patients who accepted the invitation were enrolled into the intervention group and patients who declined the invitation were enrolled into the control group and both groups were followed up for 8 week period. Agnikarma is a traditional surgical technique (thermal cautery) described in ancient surgical manuscripts for the treatment of severe persistent pain.

It applies intense heat to points of maximum pain agreed with the patient pre procedure. The heat is applied by a metal rod (Shalaka) heated in an open naked flame. The rod is applied to the skin at the agreed pain point in an even manner and generates a micro second degree burn. A traditional herbal cream is then applied which cools the application as reported by the patient. It is usual to allow skin healing to occur before the application of further heat (1-2 weeks). The pain points can move within a painful area and the technique best works with precise application to the current pain point. So before each application the precise points are agreed with the patient in advance by demarcating the painful area with a pen and searching for the points of maximum tenderness within that field.

The purpose of this study was simply to define if indeed this technique delivers pain relief as observed in practice. The investigators chose one group to study - painful knee arthritis. In this condition patients often wait many years for the definitive procedure and run some risks with current pain relief treatment. As these patients were not the normal attendees at a pain clinic the investigators decided in advance to limit the study to 4 applications over a 4- 8 week period, the latter to allow for different speeds at which the skin might heal. The investigators recruited both our interventional group and waiting list control group from the same orthopedic waiting list.

Eligibility Criteria:
Inclusion Criteria:

* awaiting knee replacement surgery on an orthopaedic waiting list

Exclusion Criteria:

* none
Risk Stratification and Benefits With Cardiac Resynchronization Therapy (CRT)

This is an observational study to learn which patients benefit from CRT therapy and to track the clinical changes that help identify the risk-level of CRT patients.

The purpose of the study is two-fold. First, to determine if an algorithm can be developed based on pre-implant clinical variables to predict response to CRT-D therapy. Second, the study aims to determine in patients implanted with CRT-D if the combined use of cTnT and BNP can further predict and risk-stratify HF improvement and all-cause mortality. Additionally, novel biochemical markers defining cardiac mortality in high risk patients detected by plasma proteomic analysis in the CRT-D patients will be evaluated.

This study represents a combination of previous CRT studies that evaluated these variables independently. Data from this study will be pooled with data from previous studies to build a more complete picture of CRT therapy.

Eligibility Criteria:
Inclusion Criteria:

* Meets current clinical indications for CRT-D therapy
* Patient is 18 years old or older
* Ability to independently comprehend and complete all QOL questionnaires
* Patient has the ability to perform the 6-minute Hall Walk Test (6-MHW) with the only limiting factor being fatigue or shortness-of-breath
* Ability to provide informed consent for a study and be willing and able to comply with the prescribed follow-up

Exclusion Criteria:

* Inability to successfully implant an intravascular lead and CRT-D device. (i.e. exclude epicardial leads) within 30 days of initial procedure.
* Myocardial infarction in the last 3 weeks
* Unstable angina in the last 3 weeks
* Status 1 classification for cardiac transplantation
* Currently participating in a clinical trial that includes an active treatment arm
* Life expectancy of less than 12 months.
* Recent (within 1 week) administration of Nesiritide™ or inotropes
* Patients in whom revascularization is expected
* Patient is pregnant
Collect Flow and Ultrasound Images of Coronary Bypass Grafts

This is a post-market observational, non-interventional, multicenter clinical investigation with the purpose of harvesting high quality data from regular cardiac bypass surgery (CABG).


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years
* Scheduled for CABG
* Understand the nature of the procedure and willingness to comply with the CIP
* Provide written informed consent

Exclusion Criteria:

* Patient younger than 18 years
* Any condition that the investigator believes should exclude participation