cyrilzakka/clinical-trials huggingface dataset:
Zevalin® First Line in Follicular Lymphoma

This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). For patients with complete clinical remission but persistent molecular disease subsequent to 90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to eradicate minimal residual disease.

Only patients requiring treatment (B-symptoms, lymphoma progression \> 50% within an observation period of 6 months or less, organ compression by lymphoma or bulky disease as defined by lesions above 5 cm on one axis) may enter the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 50 years old
* Follicular lymphoma grade I, II, or IIIa according to REAL/WHO classification
* Ann Arbor stage III, or IV, or stage II with disseminated abdominal disease requiring extensive abdominal irradiation
* No prior chemotherapy, immunotherapy, or irradiation. Furthermore, when receiving therapy as part of this "Zevalin® first line in follicular lymphoma" trial and up to six months after therapy has ended, patients may not participate in another clinical trial. If patients receive consolidation therapy with Rituximab, the six months period is counted from the end of the consolidation therapy.
* Lymphoma cells positive for CD20
* Measurable disease (two perpendicular diameters by either physical or radiological examination)
* WHO/ECOG performance status 0 - 2
* Written informed consent

Exclusion Criteria:

* Bone marrow involvement only
* Bone marrow infiltration \> 25%
* Leukocytopenia \< 2.500 /µl
* Thrombocytopenia \< 100.000 /µl
* Bulk lesions \> 10 cm
* CNS lymphoma manifestation
* Circulating tumor cells \> 500 /µl
* Extensive pleural effusion/ascites (\> 1000 ml as estimated by ultrasound/CT)
* Severe concomitant diseases (e.g. congestive heart failure, myocardial infarction within 6 months of study, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease, liver disease)
* Abnormal liver function: transaminases or total bilirubin \> 2 x upper limit of normal (ULN) (unless caused by the lymphoma)
* Abnormal renal function: serum creatinine \> 2 x upper limit of normal (unless caused by the lymphoma)
* Previous malignancy other than non-melanoma skin cancer
* Pregnant or breast feeding female patients (negative pregnancy test required for women of fertile age), no effective contraception
* HIV positivity
* Known hypersensitivity to foreign proteins, murine antibodies, presence of human anti-murine antibodies (HAMA) reactivity
* Severe psychiatric illness
Identification of Null Allelic Variant of CYP2C8 In A Korean Population

The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.

Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8\*11 using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was conducted in 7 healthy subjects with CYP2C8\*1/\*1 and 2 with CY2C8\*1/\*11.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Medical problems in taking probe drug
Effect of Attention Deficit Hyperactivity Disorder Knowledge Improvement Program on Male Primary School Teachers

The study aims to assess the impact of implementing ADHD knowledge improvement program on male primary school teachers' knowledge regarding ADHD in Abha City, Saudi Arabia.

Primary school teachers play an essential role in early detection and proper treatment of school children suffering attention deficit hyperactivity disorder (ADHD). There are indications that teachers may not have enough knowledge about this disorder. Training programs can help to improve the knowledge of teachers about ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Male teachers in governmental and private primary schools in Abha City, Saudi Arabia.

Exclusion Criteria:

* Those who have a similar training program before.
* Those who are not directly involved in the teaching process.
Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

The objective of this study was to determine the bioequivalence among three commercial tablet formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in combination with artesunate.

Pharmacokinetic parameters were determined for mefloquine in whole blood from Peruvian subjects with uncomplicated falciparum malaria administered Mephaquin®, Mefloquine-AC Farma, and Lariam®. The Mefloquine-AC Farma arm comprised 13 patients while the reference (Lariam) and Mephaquin arms consisted of 12 patients. Although Cmax was significantly less (p=0.04) in the Mephaquin arm (AUC0-t = 2500 ng/ml/day) relative to the reference (AUC0-t = 2820 ng/ml/day) arm, there were no significant differences in the AUC∞, tmax, and t1/2 for Mefloquine-AC Farma or Mephaquin relative to the reference. Except for the Cmax of the Mefloquine-AC Farma, the 90% confidence intervals for all parameters of both treatments were outside the specified FDA range of 80-125%. Therefore both formulations were not considered bioequivalent to the reference.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for enrolling patients included; male or non-pregnant female ≥ 18 years of age, infection with P. falciparum alone, with a parasite density between 250 and 50,000 asexual parasites/mm3 as determined by microscopic examination of a thick blood smear, informed consent from patient, and a willingness to be hospitalized for the first 24 hours after therapy is initiated and to return for follow-up visits through day 56.

Exclusion Criteria:

* Patients exhibiting evidence of severe malaria or with a history of an underlying chronic disease or illness that could interfere with the absorption of MQ, a history of hypersensitivity to MQ, or a history of neuropsychiatric illness or cardiac conduction problems were excluded.
Correlation Between Serum Anti-Müllerian Hormone & Müllerian Ducts Anomalies in Infertility

Anti-Müllerian hormone (AMH), also known as Müllerian inhibiting substance, is a dimeric glycoprotein that belongs to the transforming growth factor-beta family. It is involved in the regression of the Müllerian ducts during male fetal development. In the female, AMH is solely produced by the granulosa cells of preantral and small antral follicles, and regulates ovarian activity and follicular steroidogenesis

Following approval of the internal review board of Egyptian IVF-ET center, a retrospective analysis will be undertaken where a detailed review of the patients files who underwent intracytoplasmic sperm injection (ICSI) trials starting January 2010 till January 2015 will be done.

Patients with diagnosed mullerian anomalies will have their name , age ,duration of infertility, serum FSH, LH ,\& AMH levels recorded. The method of diagnosis (HSG, 3D/ultrasonography, hysteroscopy, or laparoscopy) will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* women with diagnosed mullerian anomlies whether clinically or through imaging

Exclusion Criteria:

* previous ovarian surgery
* ovarian drilling
* polycystic ovarian syndrome (PCOs).
Treximet ™ Pharmacy Budget Impact Model Database Validation Study

The purpose of this retrospective claims database study was to compare the change in migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects initiating treatment with other orally available triptans. The study was used to validate the migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact Model.

The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis. The database contains 30% of prescription claims filled in the United States (US), approximately 160 million patient lives. The data has broad representative coverage at both the geographic and payment levels.


Eligibility Criteria:
Inclusion Criteria:

* At least one prescription claim for either Treximet ™ or orally administered triptan
* at least 18 years of age at index Rx date
* at least one prescription claim for any medication in the pre- and post-index period (proxy for continuous enrollment)

Exclusion Criteria:

* Subjects receiving nasal sumatriptan at any time
* Subjects over 65 years of age
The Influence of Testosterone on Experimental Pain Perception

This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).


Eligibility Criteria:
Inclusion Criteria:

* Healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study.

Exclusion Criteria:

* The following criteria will exclude a participant from the study:
* Anyone that has a tree nut allergy.
* Women that are pregnant or may feel that they may be pregnant or breast-feeding.
* Anyone taking supplements that may influence their testosterone level.
* Anyone taking any kind of steroid that may increase their testosterone level.
* Anyone that smokes tobacco or uses smokeless tobacco.
* Anyone that reports any condition associated with nerve damage.
* Anyone that is using hormonal contraceptive.
* Anyone who was sick or unwell at the time of screening.
* Each participant completed a Testosterone Pre-Screen form. This form asked each participant individually whether they are taking any drugs or have any conditions that might be exacerbated by testosterone. This form was completed before they signed the consent form and each time they arrived in the lab for an experimental session.
Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer

Rationale: In patients with medullary thyroid cancer (MTC), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. The currently most used tracer in clinical practice, F-18 labelled fluorodeoxyglucose (18F-FDG), does not accurately detect MTC tumors with an indolent growth rate. A new, complimentary tracer is warranted to detect different subtypes.

Objective: The primary objective is to assess the feasibility of using the F-18 labelled prostate specific membrane antigen (18F-PSMA) PET/CT for (re)staging patients with medullary thyroid cancer. The secondary objective is to compare the ability to detect MTC with the 18F-PSMA PET/CT to that of the 18F-FDG PET/CT.

Study design: Prospective, single-centre, feasibility study.

Study population: Patients (18 years of age or older) with biochemically and cytological/histological confirmed MTC, for whom the indication of an 18F-FDG PET/CT for tumor staging has already been determined on clinical grounds.

Main study parameters/endpoints: The primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18F-PSMA PET to detect MTC lesions in patients with cytologically/histologically confirmed disease. Secondarily, the performance of the 18F-PSMA PET will be compared to the 18F-FDG PET/CT.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histological or cytological proven MTC
* Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA)
* Clinical indication for an 18F-FDG PET/CT
* Able to follow instructions to participate in the study
* Able to give informed consent

Exclusion Criteria:

* Patients with prostate cancer or renal cell carcinoma
* Pregnant patients
* Recent neck surgery (\<3 months ago)
Percutaneous Cholangiopancreatoscopy Registry

The Percutaneous Cholangiopancreatoscopy (PCPS) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the United States. In the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. The prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (IR) for a procedure or clinic visit.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults
* 18 years of age and older
* Patients undergoing clinically indicated percutaneous cholangiopancreatoscopy procedure at the Johns Hopkins Hospital or one of the registry sites.
* Willing and able to understand and sign a written informed consent document for the prospective component of the study.

Exclusion Criteria:

* Pregnant women
* Children (\< 18 years of age)
Fabrication of a Definitive Cad/Cam Titanium Abutment Prior to Guided Surgery: a Pilot Study.

The study will involve placing a dental implant through a guided surgery protocol developed using 3D CT technology. Because the implant position is planned digitally using the CT data from the patient, this allows investigation of an abutment that supports the implant crown and soft tissues to be fabricated prior to implant placement. In doing so, this makes the protocol for patient care simpler and faster. In fabricating the the abutment prior to surgery, the investigators will design the abutments at different heights below the gumline to see an optimal margin height for fabrication of the abutment prior to surgery. The study hypothesis is that more often the abutment margin placed just slightly below (.5mm) the gumline will be visible about half of the time while the abutment margin placed further under the gumline (1.5mm) will be visible only about 10% of the time. The optimal outcome is that at delivery and follow-up, the abutment margin will not show intraorally.


Eligibility Criteria:
Inclusion Criteria:

* partially edentulous with single edentulous space
* edentulous site where previous tooth has been extracted for at least two months
* minimum of 20 teeth present
* able to tolerate dental implant surgical and restorative procedures
* consent to participate in clinical trial

Exclusion Criteria:

* asa class 3+
* present drug use
* is pregnant or plans to become pregnant
* patients in need of lateral window sinus graft
* patients in need of grafting prior to implant placement
* patients in need of extensive grafting at time of implant placement
* tooth is present or extracted within the last 2 months
* history of IV bisphosphonate use or oral bisphosphonate use contraindicating dental implant therapy
* untreated caries or periodontal disease
* severe bruxism
* smoker within past 6 months
* unlikely to be able to comply with study procedures according to investigators
* known allergy to any materials used in dental implant surgery
Pilot Study of IVUS Imaging During Endovascular Interventions of Failing Hemodialysis Access Grafts

This pilot study will provide data to aid in the planning of a follow-up multi-center randomized, controlled trial (RCT). As such, the sample size for this pilot is not driven by formal statistical hypothesis testing. Rather, the sample size of 100 patients (50 per arm) was derived in consultation with the study PI and Co-PI who are experts in vascular surgery, and in particular, the field of hemodialysis access interventions. The results of this pilot study will provide the data that is necessary for generation of specific hypotheses that can then be formally tested in the follow-up RCT


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be \> 18 and \< 85 years of age
2. Patient or legally authorized representative must be willing to participate and able to understand, read, and sign the informed consent document before the planned procedure
3. Eligible for de-clot procedure or evaluation of slow flow for a failing hemodialysis graft that previously provided access for at least 1 successful hemodialysis session

Exclusion Criteria:

1. Patient or legally authorized representative cannot or will not provide written informed consent
2. Known metal allergy precluding endovascular stent implantation
3. Known reaction or sensitivity to iodinated contrast that cannot be pretreated
4. Patients who are pregnant or lactating
5. Patients with scheduled kidney transplant within the next 6 months
6. Patients scheduled to switch to peritoneal dialysis within the next 6 months
7. Patients with life expectancy of less than 6 months
8. Participation in any other clinical research study that would interfere with the patient's participation in this study
9. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.

Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures.

Eligibility Criteria:
Inclusion Criteria:

* varus knee deformity
* unicompartmental arthrosis

Exclusion Criteria:

* patellar arthrosis
* lateral arthrosis
* inflammatory diseases
* bone healing impair drugs or diseases
Diabetes Self-Management & Support LIVE

The purpose of this study is to determine whether participation in virtual environment which incorporates real-time diabetes self management and support (DSMT/S) is associated with positive changes in behavior and metabolic outcomes as compared to traditional web-based DSMT/S.


Eligibility Criteria:
Inclusion Criteria:

* Live in close proximity to Duke University Medical Center (DUMC) or NYU Endocrinology Clinic, or Faculty Practice and Bellevue Medical Center to facilitate follow-up research appointments
* Diagnosis of Type 2 Diabetes (T2D)
* \>= 21 years old
* able to read and understand English
* access to a computer with broad band internet connection in a private location
* reachable by telephone
* no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (e.g.
* Are able to travel to a clinical lab for blood work

Exclusion Criteria:

-
Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy

This trial studies the quality of holographic mm-wave imaging in patients undergoing radiation therapy. Holographic mm-wave imaging is a common type of imaging used in airport body scanners that may be helpful in improving the efficiency and positioning of radiation oncology patients and their overall experience.

PRIMARY OBJECTIVES:

I. To obtain patient images in a clinical setting and assess their quality.

SECONDARY OBJECTIVES:

I. To assess the registration agreement through a voxel-voxel distance-to-agreement metric.

OUTLINE:

Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial computed tomography (CT) simulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to receive either an optical or CBCT imaging scan as part of their treatment management.
* The study will be open to English and Spanish speaking participants.

Exclusion Criteria:

* Patients that are not scheduled for fluoroscopic or optical imaging as part of the normal course of radiotherapy.
Transversus Abdominis Plane Block and Inguinal Hernia Repair

This prospective, randomized, double blinded, placebo-controlled study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane block with ropivacaine 0,75 %, in patients undergoing unilateral inguinal hernia repair with a mesh under general anaesthesia, and how the efficiency of early postoperative analgesia achieved correlates with the risk of developing a chronic pain state, a not uncommon condition after this type of surgery.


Eligibility Criteria:
Inclusion Criteria:

ASA I-III patients undergoing inguinal hernia repair with a mesh

age between 18 and 75 years old

ability to read and write greek

-

Exclusion Criteria:

* Inability to consent to the study
* BMI \>40kg/m2
* Skin infection at the puncture site
* Contraindication to mono-amide local anaesthetics, paracetamol, NSAID's (parecoxib)
* Preoperative use of opioids or NSAID's for chronic pain conditions
MTPr With Shockwave on Pain & Function of SHS in Stroke

Background: shoulder-hand syndrome is considered a significant reason for the reduction of upper limb functions after stroke. Purpose: To investigate the influence of Myofascial Trigger Points (MTrPs) release and shockwave therapy on pain and functions of the upper extremity in stroke patients with diabetic neuropathy.

Methods: two equal groups of thirty stroke patients, divided into, study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program.

Eligibility Criteria:
Inclusion Criteria:

* stroke from 4:8 months
* age ranging from 45:60 years
* All the patients were identified with SHS as diagnosed by the Diagnostic criteria for SHS post-stroke 18 and were in stage I of syndrome evolution

Exclusion Criteria:

* any other causes of shoulder pain in the hemiplegic side of the body
* a cognitive impairment
* structured joint deformity in the painful shoulder or hand
* other musculoskeletal disorders of UE.
Labor Protocol Study

The goal of this study is to see if there is a better way to induce labor.

This is quasi-experimental prospective cohort study with historical control to examine the efficacy of a new labor induction bundle. The prospective cohort will consist of all eligible nulliparous and multiparous patients admitted for induction; the historical control group will consist of all eligible nulliparous and multiparous patients admitted for induction between August 2019 and February 2020. Patients who are part of the prospective cohort who do not consent to the labor bundle due to personal or physician preferences will be included in secondary analyses as a contemporary control group, however the sample size of this group will not be determined in advance.

Objective: To assess if implementation of an evidence-based labor induction bundle will increase the rate of vaginal delivery within 24 hours.

Hypothesis: Implementation of a labor induction bundle would result in a 30% increase in the rate of vaginal delivery within 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy
2. Cephalic presentation
3. Gestational age 36 weeks 6 days- 42 weeks 0 days at initiation of induction of labor
4. Age 18 and over

Exclusion Criteria:

1. Preterm (less than 36 weeks 6 days) at initiation of induction of labor
2. Non-cephalic presentation
3. Major fetal anomalies or intrauterine fetal death
4. Bishop score more than 6 at initiation of induction of labor
5. Any contraindication to any agents in the induction protocol (i.e. prior cesarean delivery or myomectomy, three or more contractions per ten minute period averaged over 30 minutes at the initiation of induction of labor, low lying placenta).
6. Any contraindication to vaginal delivery
7. Latex allergic