cyrilzakka/clinical-trials huggingface dataset:
A Study of SGN-40 in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma

This is an open-label, multicenter Phase Ib study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one prior rituximab-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of histologically confirmed CD20-positive, follicular NHL or marginal zone NHL
* At least one previous treatment with rituxan monotherapy or a rituximab-containing regimen
* Measurable disease
* Either fresh or archived tumor specimen must be available for central confirmation of diagnosis and correlative studies
* Life expectancy of \> 3 months
* For patients of reproductive potential, use of a reliable means of contraception

Exclusion Criteria:

* Chemotherapy or radiotherapy within 28 days of Day 1
* Prior treatment with a monoclonal antibody directed against CD40
* Radioimmunotherapy or immunotherapy with a monoclonal antibody other than rituximab within 3 months of Day 1
* Prior treatment with an investigational drug within 28 days of Day 1
* Prior allogeneic bone marrow transplant
* Prior autologous hematopoietic stem cell transplant within 12 weeks of Day 1
* Concurrent systemic corticosteroid therapy
* Prior anaphylactoid or other serious reaction to rituximab that resulted in hospitalization or discontinuation of therapy, or both
* Evidence of clinically detectable ascites on Day 1
* Other invasive malignancies within 3 years prior to Day 1 except for adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, or other cancer of which the patient has been disease-free for at least 3 years
* History or evidence on physical examination of CNS disease
* Active infection requiring parenteral antibiotics within 14 days of Day 1
* Major surgical procedure (excluding lymph node biopsy) or significant traumatic injury within 28 days prior to Day 1
* Pregnancy (positive pregnancy test) or lactation
* Serious, nonhealing wound, ulcer, or bone fracture
* Clinically significant cardiovascular disease, congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day 1. Grade II or greater peripheral vascular disease at study entry.
* Known human immunodeficiency virus (HIV) infection
* Known serious medical conditions, including cirrhosis, hepatitis C infection, and chronic obstructive or chronic restrictive pulmonary disease
Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter

The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group.


Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI \>30 before 20 weeks gestational age)
* Singleton pregnancy
* Vertex presentation
* Bishop Score \<6
* Intact membranes
* Gestational age 37+0 to 42+0
* Normal fetal heart tracing on admission for ripening

Exclusion Criteria:

* Induction of labour for intrauterine fetal demise
* Intrauterine growth restriction
* Suspected abruption at the start of induction
* Any contraindication for a vaginal delivery
Patient-reported Outcome Measures in Patient Underwent Total Hip and Knee Arthroplasty

Registry of Galeazzi Orthopedic Institute: provides for the regular and systematic collection of all data (clinical and some PROMs) obtained from patients undergoing hip and knee arthroplasty to which questionnaires are proposed investigating the specific functional sphere of the joints undergoing surgery (Knee injuryOsteoarthritisOutcomeScore (KOOS-PS) and Hip injuryOsteoarthritisOutcomeScore (HOOS-PS) but also the sphere of general health (ShortForm health survey-12 (SF-12) and VisualAnalogueScale (VAS)) , in addition, of course, to the satisfaction rate.


Eligibility Criteria:
Inclusion Criteria:

* male and female
* age more than 18
* patient underwent hip or knee arthroplasty

Exclusion Criteria:

* age less than 18
* comorbidity that can results in the difficulty to come back for the follow up
Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery

Obesity surgery has become commonplace nowadays. This type of surgery is in full swing and although it is mostly beneficial for the health of the patient (reduction of cardiovascular risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however associated with risks. There are several short and long term complications, excluding the ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections, dysphagia, risks of endobrachyoesophagus, etc...

The gastroœsophageal reflux remains by far the most common post-op complaint within patients. Patients can experience symptoms as far as 3 years after the surgery. Medical treatment alone can in most cases lighten the symptoms. However, in some cases, this treatment fails and another type of surgery (bypass) must be undertaken, which is psychologically traumatic for the patient.

This retrospective study will analyze a cohort of patients who underwent bariatric surgery (mainly sleeve gastrectomy), in order to identify those at risk of developping gastroœsophageal reflux and how this complication can be avoided in pre-op. The study will also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients who had at least 1 year of postoperative follow-up

Exclusion Criteria:

* Patients who did not have postoperative gastroœsophageal reflux
* Patients who stopped their postoperative follow-up
* Patients with unsufficient data collection
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese male and female participants
* No clinical relevant abnormalities
* willing and able to comply with all study procedures
* BMI:17.5-30.5
* Sign informed consent

Exclusion Criteria:

* Any clinical significant illness
* History of alcohol abuse
* Use within 14 days prior the first study dose
* CL\>80ml/min
* Abnormal vital signs, such 12-ECG, blood pressure and pulse rate
* Blood donation within 60days
* History of HIV, HBsAg, HBcAb, HCVAb
* Other medical or psychiatric may inappropriate for the study
Combination Treatment for Posttraumatic Stress Disorder (PTSD) After the World Trade Center (WTC) Attack

This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.

Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.

Eligibility Criteria:
Inclusion Criteria:

* Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks
* Age 18-70
* CAPS score greater than 45
* Willingness to consent
* For women, negative pregnancy test and using adequate birth control

Exclusion Criteria:

* Prominent suicidal ideation
* Current psychotic disorder
* Unstable medical illness
* Women who are pregnant or nursing mothers
* Alcohol or substance use disorder in the past 3 months
* History of seizure disorder
* conditions that contraindicate use of paroxetine
* inability to tolerate a drug free period prior to beginning the study of 4 weeks for MAOIs or fluoxetine and 2 weeks for other psychotropic drugs, except zolpidem for insomnia.
Randomized Controlled Trial of Shunt vs ETV/CPC for PIH in Ugandan Infants

Two treatment options exist for infant patients with hydrocephalus. Most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. In recent years, however, another treatment has developed called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC).This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This study will evaluate patients in more detail to measure brain growth and development.

World over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. Surgery is required to insert a shunt into the brain and the abdomen. In recent years, we have developed another treatment called Endoscopic Third Ventriculostomy (ETV) with Choroid Plexus Cauterization (ETV/CPC). This research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or PIH. This is the most common cause of hydrocephalus in Ugandan babies. This study will evaluate patients in more detail to measure brain growth and development. Children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.

Eligibility Criteria:
Inclusion Criteria:

* Infants less than 180 days (six months) old
* Symptomatic hydrocephalus
* Post-infectious Hydrocephalus based on clinical and CT parameters2
* Must be from the following Ugandan districts: Bugiri, Busia, Iganga, Jinja, Kampala, Kamuli, Kapchorwa, Katakwi, Kumi, Mayuge, Mbale, Mukono, Pallisa, Sironko, Soroti, and Tororo

Exclusion Criteria:

* Any patient with a scalp erosion or infection that would exclude the patient from shunt implantation
* Any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement
* Any patient with absence of any visible cortical mantle on the CT
* Patients must be appropriate candidates for either surgical procedure - shunt placement alone or ETV/CPC
Do Script Concordance Tests Correlate With Family Medicine Standardized Tests and Failing Rotation Grades?

Delayed or poor identification and remediation of clinical reasoning difficulties can lead to clinician underperformance and can ultimately compromise patient care. To date, no research has been done to see if SCTs correlate with current grading standards (ITE, ABFM certification exam score, ACGME milestones, or failing clinical rotation grades) in Family Medicine Residents. If investigators can identify that an SCT correlates with current standardized testing of Family medicine residents, it could be possible to identify struggling learners prior to poor scores on the ITE, ACGME milestones, or clinical rotations. If a learner does poorly on an SCT early in the academic year the learner can begin a remediation plan to improve their deficits before receiving a failing grade, poor ITE or ACGME milestone scores.

This study is a longitudinal observation study. A panel of experts (numbering 15-20) consisting of Family Medicine attendings who have been out of residency greater than 3 years will complete the SCT. They will be provided an Informational Consent. Their willingness to be a panel member is their implied consent to be part of the research study.

The basic idea behind SCT is to compare residents' performance with a group of persons who are representatives of the profession (or the specialty) to which they wish to belong. Therefore, panels are made up of physicians with good overall clinical experience in the field rather than experts from narrow parts of the field. Panel composition also depends on the assessment goal.

This study will determine if a Script Concordance Test (SCT) correlates with Family Medicine In Training Exam (ITE) scores, American Board of Family Medicine (ABFM) certification exam scores, Accreditation Council for Graduate Medical Education (ACGME) medical knowledge and patient care milestones, and failing family medicine inpatient clinical rotation grades.

The SCT will be given to PGY1, 2, and 3 residents each year during the Residents three year residency, in June or July.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

--Family Medicine resident at 99MDG

Exclusion Criteria:

-- N/A
Getting Malaria "Off the Back" of Women and Children in Western Uganda

This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda.

The purpose of the study is to assess the feasibility and tolerability of using insecticide-treated lesus to reduce the incidence of P. falciparum malaria infection among infants.

This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda.

The first phase will consist of a series of focus group sessions with mothers of young children and their male partners to gain further insight into lesu use, to include location of purchase and frequency of washing, as well as exploring initial perceptions of insecticide-treated clothing and inform the protocols for the open-label study.

The second phase will consist of a prospective, open-label study. Twenty-five (25) mothers and their young children will be provided with insecticide-treated lesus and twenty-five (25) controls who will be provided untreated lesus. After an initial visit, bi-weekly follow up, including finger-prick blood collections will continue for a period of twelve (12) weeks.

Collected blood spots will be transported to Epicentre for real-time PCR to identify sub-microscopic parasitemia and to the French Research Institute for Development (https://en.ird.fr) in Marseille, France for quantification of the mosquito salivary antigen (gSG6-P1 peptide). Remaining samples will be stored for future analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adult women (age greater or equal to 18 years) with a healthy child between the ages of 6 months to 18 months from one of four eligible villages

Exclusion Criteria:

* Mother or child with HIV (and thus taking cotrimoxazole prophylaxis)
Testing Gene PilotLX with Latinx Cancer Patients

This is a randomized controlled trial designed to evaluate the efficacy of an electronic health decision support tool called Gene PilotLX to increase informed decision making regarding hereditary risk information from tumor genomic profiling (TGP) test among Latinx cancer patients recruited at four cancer centers.

The use of multi-gene tumor genomic profiling (TGP) to examine a patient's tumor for targetable mutations is a cornerstone of personalized oncology. Providers are required to communicate TGP risks to patients and elicit patient preferences for managing information (i.e., "opt out" or have genetic counseling) because of the possibility of uncovering secondary hereditary cancer risks found on this test. Yet barriers exist to support optimal decision-making. Limited study of genetic links to cancer has been done with Latinx patients making them an important understudied group to target for genetic decision support. Shared cultural values among Latinx individuals such as familismo (family loyalty) and fatalismo (fatedness) may influence how patients approach cancer risk assessment and genetics and language and acculturation barriers, access and affordability, deportation risks, medical mistrust and low genetic knowledge impact decision making. As a result, Latinx patients are less likely to participate in clinical genetic testing. Adding to this vulnerability is the fact that many oncologists may not have a good understanding of how to effectively communicate secondary hereditary risks to Latinx patients. This leaves Latinx patients without the support they need to make good decisions about what they would want to do about secondary results from TGP that is in line with their needs, preferences and values.

eHealth interventions can promote health behavior change when developed with targeted messages, but many fall short if they do not effectively address the core barriers to a health decision. Gene PilotLX was developed using commercial marketing techniques to ensure saliency. Using perceptual mapping and vector message modeling, the investigators have shown in our parent Gene Pilot study that was conducted among AA/Black cancer patients that this approach provides a superior methodology for developing effective, persuasive messages that result in significant behavior and decisional conflict changes.

A fully powered randomized controlled trial will be conducted with 232 Latinx cancer patients at four oncology sites to evaluate the efficacy of Gene PilotLX,an electronic health decision support tool. Participants will be randomized either to intervention arm and watch Gene PilotLX or usual arm and review patient information about TGP presented in a written document (pdf). All participants will complete three assessments: baseline, immediate post intervention, and 1-3-month surveys.

Eligibility Criteria:
Inclusion Criteria:

Self-identified Latinx patients who:

1. diagnosed with solid tumor cancers
2. speak/read English or Spanish;
3. can provide informed consent.

Exclusion Criteria:

Patients with hematologic/liquid cancers (leukemia, lymphoma, multiple myeloma, etc.)
PD-1/PD-L1 Pathway Study on Septic Patients

The investigators want to identify that whether PD-1/PD-L1 pathway will change in human sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced immunosuppression.

First, we will detect PD-L1 expression on PBMC of septic patients and healthy controls.

Second, blockade of PD-1/PD-L1 pathway in vitro and stimulate with some biomolecules and then analyze the PBMC function and apoptosis by flow cytometry.

Then, compare with healthy controls and find the differences.

Eligibility Criteria:
Inclusion Criteria:

* patients who develop sepsis

Exclusion Criteria:

* patients with cirrhosis or renal dysfunction
* patients with dyscrasia
* patients with autoimmunity diseases
* patients with severe cardiac and pulmonary diseases
* patients with hematological diseases
* patients with diabetes mellitus
* patients with malignant tumors
Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts

Advanced sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with lower Sperm DNA fragmentation. Previous studies compared the pre-implantation embryo development parameters of those techniques, but none looked at comparing the PGT-A results or euploidy rates of the blastocysts derived from each sperm selection.

PGT-A cases will be randomized on the day of ICSI to the 2 assigned sperm selection techniques.

Eligibility Criteria:
Inclusion Criteria:

* Case must have PGT-A for all of her blastocysts
* Males diagnosed with abnormal sperm DNA fragmentation index (\> 20%).
* Normo responder (\> 5 mature oocytes)
* Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI

Exclusion Criteria:

* Leukocytospermia
* Presence of varicocele.
* Known genetic abnormality
* Use of sperm or oocyte donors
* Use of gestational carrier
* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study

The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.


Eligibility Criteria:
Inclusion Criteria:

1. Able to (or capable of) provide written, voluntary consent to participate in the clinical investigation
2. Is willing and able to return for all protocol defined clinic visits
3. Subject has a combination of the following implants in the study hip (unless in pre-op cohort):

   1. Pinnacle acetabular shell with or without Gription TM porous coating
   2. M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
   3. Ultamet metal insert
   4. One of the following stems

   i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem
4. Subject has high quality films available for review that were taken within 12 months of the primary surgery of the following views:

   1. Standing AP-Pelvis
   2. Standing AP-Proximal Femur (if this view is not available but the AP-Pelvis shows the entire implant and greater trochanter, that is also acceptable)
   3. Lauenstein Lateral Proximal Femur (Lateral-Femur)

Exclusion Criteria:

1. The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, the medical office staff and/or representatives from FDA
2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
3. The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
4. FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
5. FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip
Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension

The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.


Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed as hypertensive

* Untreated confirmed hypertensive patients (consistent SBP \>140 mm Hg or DBP \>90 mm Hg)
* Uncontrolled hypertensive patients (Consistent SBP \>140 mm Hg or DBP \>90 mm Hg) on one drug therapy.
* Uncontrolled hypertensive patients (Consistent SBP \>140 mm Hg or DBP \>90 mm Hg) on two drug therapy.

Exclusion Criteria:

* Inability to switch from all prior antihypertensive medications safely as required by the protocol.
* Need for drugs other than study drugs at the time of baseline.
* Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
* Patients on four or more antihypertensive drugs at screening.
* Pregnant or nursing (lactating) women.
* Patients with diabetes mellitus
* Patients with heart diseases and any other disease

Other protocol-defined inclusion/exclusion criteria may apply