cyrilzakka/clinical-trials huggingface dataset:
Granulocyte Transfusion Study

To evaluate granulocyte transfusion therapy with respect to its prophylactic and therapeutic effectiveness to prevent and aid recovery from infection. The study trials were conducted simultaneously.

BACKGROUND:

Infection remains a major cause of death in patients receiving chemotherapy for malignant diseases. One approach to the problem of septicemia and high mortality in these patients was the therapeutic use of granulocyte transfusions. Improvements in collection techniques, employing continuous flow centrifugation, permitted the collection of granulocytes from a single, normal donor in sufficient numbers to study their application in the treatment of infections in granulocytopenic patients. Studies had demonstrated the efficacy of granulocyte transfusions as an adjunct in the therapy of septicemia due to gram negative microorganisms associated with granulocytopenia.

The aims of the study were to determine (1) whether infections could be prevented in patients who received granulocytes prophylactically and (2) whether recovery from infection was aided in patients who received granulocytes therapeutically. Both trials utilized controls who received no granulocytes.

Four contracts were awarded in September 1976. The protocol designed to evaluate the efficacy of prophylactic granulocyte transfusions was completed at the close of 1977. The protocol for the therapeutic trial was completed in April 1978. Approximately 90 patients were randomized in the prophylactic trial and 51 in the therapeutic trial. The Recruitment and Intervention Phase ended in February 1980. The trial has concluded.

DESIGN NARRATIVE:

Prophylactic Trial and Therapeutic Trial: randomized, non-blind, sequential. Eligible patients were randomized to daily granulocyte transfusions or no granulocyte transfusions.

The study completion date listed in this record was inferred from the first publication listed in the Citations section of this study record.

Eligibility Criteria:
Prophylactic Trial: males and females, 12 years or older, who were in the first induction phase of chemotherapy for acute leukemia, who had severe neutropenia, and who did not have documented infection.

Therapeutic Trial: males and females, any
Drug-Drug Interaction Study in Healthy Adult Volunteers

The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of K-877 in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.

This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older at the time of the procedure.
* Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging.
* Pulmonary nodule ≤2 cm in largest diameter.
* Subject able to understand and adhere to study requirements and provide informed consent.

Exclusion Criteria:

* Planned lymph node staging performed before nodule biopsy.
* Nodule is a pure ground glass opacity.
* Plan to biopsy multiple nodules.
Use of a Supplemental Radiofrequency Detection System Subsequent to Manual Counting of Vaginal Textiles Following Vaginal Birth

The purpose of this study is to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth).

This study proposes to evaluate the FDA-approved Radio Frequency Surgical Detection System (RFDS) as a non-radiological means to ease the process of detecting retained sponges and reconciling sponge counts in the labor and delivery room (following vaginal birth). It would not replace any of the current standard-of-care safety mechanisms already in place at the study site to prevent retained sponges. All safeguards remain enforced: counting, visual inspection, and x-rays if indicated by standard protocol. The system being studied involves the surgeon scanning the subject's vaginal area using a spherical device placed 1cm above the symphysis pubis. This static scan will serve to detect any retained cotton textiles within the vaginal cavity after birth. This Verisphere, a reusable device, is encased in a sterile sheath during use. It does not come into direct contact with the subject's vagina, but hovers above the pelvic/vaginal region. If any radio-frequency tagged sponges remain inside the subject, a signal alerts the surgical team to remove them. The visible console displays a confirmation code once the scan is complete. This confirmation code is kept as part of the medical record once absence of retained textiles is confirmed. Once the provider is assured there is no retained item, the same device may be used to scan trash receptacles to locate a missing textile if the pre- and post-delivery sponge/gauze count remains incongruent. This alleviates the need for the assistant personnel to manually "dig" through soiled materials for sponge localization.

Eligibility Criteria:
Inclusion Criteria:

* Adults only, 18 years or older
* Admitted as inpatients to labor and delivery; patients must be in anticipation of vaginal delivery

Exclusion Criteria:

* Urgent or emergent admissions under the influence of preoperative medication, drugs or alcohol.
* Age less than 18 years,
* The patient does not understand English well enough to adequately understand the study.
* Hesitancy of the patient to participate or family reluctance based on the study doctor's opinion.
Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction

Our aim in this study is to examine the functional and clinical results of patients who have undergone MPFL reconstruction at least 2 years after the operation. The presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Undergone unilateral medial patellofemoral ligament (MPFL) reconstruction
* At least 2 years after the operation

Exclusion Criteria:

* Patellar instability
* Knee ligament injury
* Meniscus injury
* Knee osteoarthritis
* Ankle ligament injury
* Ankle osteoarthritis
* Any neurological disease
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes

This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes.

This study is not recruiting patients in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of genital herpes
* Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months

Exclusion Criteria:

* - Currently taking suppressive herpes antiviral therapy
* Females who are pregnant, breast feeding or planning to become pregnant during study
* History of allergy to famciclovir or similar products (e.g. aciclovir, valaciclovir)

Other protocol-defined exclusion criteria may apply.
Visual Performance of Multifocal Intraocular Lenses

To evaluate the clinical outcomes with an extended range of vision (ERV) IOL based on achromatic diffractive technology.

This was a prospective comparative study including 60 eyes undergoing cataract surgery with implantation of the ERV Tecnis Symfony IOL (Abbott Medical Optics, Inc.) (ERV group: 60 eyes of 30 patients). Visual, refractive, contrast sensitivity, defocus curve, ocular optical quality (Optical Quality Analysis System; iTrace), and visual function questionair（NEI-VFQ 25） outcomes were evaluated during a 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* visually significant cataract
* age of 20 years or older
* preoperative corneal astigmatism of 1.50 diopters (D) or lower.

Exclusion Criteria:

* previous ocular surgery
* active ocular pathology
* amblyopia
* systemic or ocular medication that could affect vision
* subclinical or clinical corneal ectatic disease
* pupil abnormalities
* intraoperative complication leading to capsular or zonular abnormalities
Accent Cardiac MRI Study

The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.

Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.

Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.

Eligibility Criteria:
Inclusion Criteria

* Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker
* Will receive a new dual chamber pacemaker and leads
* Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan
* Be able to provide informed consent for study participation
* Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
* Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
* Age≥18 years
* Subjects must be able to undergo pectoral implantation

Exclusion Criteria

* Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment
* Permanent Atrial Fibrillation/Flutter
* Are medically indicated for an MRI scan at the time of enrollment
* Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc
* Have a non-MRI compatible device or material implanted
* Have a lead extender or adaptor
* Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are allergic to dexamethasone sodium phosphate(DSP)
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 12 months due to any condition
* Subjects with exclusion criteria required by local law (e.g. age)
* Are unable to comply with the follow up schedule
Impact of a Resource-based Life Review Intervention on Advanced Cancer Patients

The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial is conducted. The study takes place in the oncology department of the University Hospitals of Geneva at 3 outpatient units.

The main objective of the present study is to evaluate the effects of the Revie ⊕ intervention on the self-esteem of patients diagnosed with an advanced cancer. The secondary objectives are to evaluate the effects of the Revie ⊕ intervention on spiritual well-being, personal development, life satisfaction, and the perception of the interaction with the nurses. A pragmatic, two-arm parallel-group, waitlist randomized controlled trial (WLRCT) is conducted in which participants are randomized into (i) intervention, or (ii) waitlist control groups. The intervention group (IG) receives the Revie ⊕ intervention early on and the control group (CG) the same intervention but later on (i.e., after eight weeks).This monocentric study takes place in the oncology department of the University Hospitals of Geneva (HUG) at two outpatient units (planned n=102; 51 per group).

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years with and advanced cancer,
* whose general health status is adequate for participation in the study based on a clinical assessment by the nurse / doctor; and
* who consent to participate in the study.

Exclusion Criteria:

* documented cognitive impairment that compromises capacity for discernment,
* command of French is insufficient for reading, writing, or conversing.
Genetic Information Assistant in Telegenetics

The goal of this clinical trial is to learn about different ways cancer genetic screening can be provided to rural communities in participants at high risk for certain cancers. The main question it aims to answer is:

• Does receiving pre-genetic test education with a chat bot or genetic counselor affect if the participant decides to get genetic testing?

Participants will:

* have a pre-test genetic counselling session with a genetic counselor or the GIA chatbot
* answer questions about their cancer genetic knowledge and how they are doing
* provide a saliva sample for genetic testing to test for cancer gene mutations
* have their genetic testing results provided to them.
* have the option to share their genetic testing results with family members

Researchers will compare how many participants who had pre-genetic counseling with the chatbot received genetic testing to how many participants who had pre-genetic counseling with a genetic counselor received genetic testing.

High risk patients will be randomized to standard of care telegenetics with a UVA Genetic Counselor (GC) for pre-test counseling or to the novel interventional arm of pre-test counseling via Genetic Information Assistant (GIA). Participants in the study will receive their link for a telegenetics appointment or GIA link based on randomization and patients will complete pre-test genetic counseling via their assigned treatment arm. Participants will not be masked to their trial arm assignment. In the telegenetics arm, patients will be offered a video visit scheduled through Epic zoom or a phone visit in our cancer genetics clinic per standard of care. Patients randomized to the GIA arm will receive a personalized link based on their family history. At the completion of counseling, participants will be offered genetic testing. If they agree, they will be mailed a saliva kit via Invitae Genetics for panel based genetic testing via The Invitae Common Hereditary Cancers panel to analyze 47 genes associated with cancers of the breast, ovary, uterus, and gastrointestinal system, which includes the stomach, colon, rectum, small bowel, and pancreas.

Eligibility Criteria:
Inclusion Criteria:

* At high risk for having a genetic pathogenic variant as assessed by a GC or physician according to the NCCN guidelines
* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 18 and over.
* Subjects must have a smartphone with access to cellular and/or internet service or a computer with internet service.
* Subjects must have technological competency/proficiency to use their Smartphone and/or computer in conjunction with the communication aid GIA.

Exclusion Criteria:

* Cannot communicate in English or Spanish.
* Subjects must not have completed panel-based cancer genetic testing in the past.
Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers

To evaluate how the drug dextran sulfate (DS) is absorbed by the stomach and intestines when taken by mouth. To evaluate its effect on blood coagulation.

DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.

DS has been reported to have anti-HIV activity. However, it is not known how much of the drug is absorbed into the bloodstream and can be used by the body when DS is taken by mouth.

On 2nd day of hospitalization, each volunteer receives an oral dose of DS. Over the next 24 hours, 15 blood samples are obtained (from 15 separate needle sticks). On 4th day, each volunteer is given an injection of DS into vein. 18 blood samples are obtained. Blood is withdrawn before the infusion, at the end of the infusion, and 30 and 60 minutes after the infusion. All urine is collected.

Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Volunteers with any of the following are excluded:

* Disorders of coagulation or disorders of plasma lipids.
* Allergy to dextran sulfate, other sulfates, other dextrans.

Concurrent Medication:

Excluded:

* Volunteers who anticipate need for medication during study.

Volunteers with any of the following are excluded:

* Disorders of coagulation or disorders of plasma lipids.
* Allergy to dextran sulfate, other sulfates, other dextrans.

Prior Medication:

Excluded within 2 weeks of study entry:

* Any medication.

Risk Behavior:

Excluded:

* Ingestion of alcohol within 48 hours prior to study.
* History of recent drug or alcohol abuse.
* Disorders of coagulation or disorders of plasma lipids.
* Allergy to dextran sulfate, other sulfates, other dextrans.

Volunteers selected are:

* In good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory.
* Consenting volunteers.
* Available for 6 days of continuous hospitalization.
Rationale and Design of Diabetes Management With Curcumin and Saffron (DMCS): a Randomised, Three Blind -Blind, Placebo-controlled Study

## Study Hypotheses Summary:

\*\*Primary Hypothesis:\*\* Women with diabetes mellitus receiving the intervention will exhibit significantly lower levels of sugar indicators (FBS, HA1c, 2HPP) and lipid indicators (LDL, HDL, TG) compared to the placebo group.

\*\*Secondary Hypotheses:\*\*

1. \*\*Psychological Outcomes:\*\* The intervention group will show significant reductions in stress, anxiety, and depression compared to the placebo group.
2. \*\*Sexual Health Outcomes:\*\* The intervention group will experience improvements in sexual performance, marital satisfaction, and quality of sexual life compared to the placebo group.
3. \*\*Diabetes Management Outcomes:\*\* The intervention group will demonstrate improvements in clinical symptoms of diabetes and anthropometric index compared to the placebo group.
4. \*\*Medication Adherence:\*\* The intervention will be well-received by women with diabetes mellitus of reproductive age, leading to improved medication adherence.

The study is a four-arm trial testing the effectiveness of curcumin, saffron, and a combination of both compared to a placebo in women with diabetes. The trial will measure glucose and lipid levels, medication side effects, adherence to treatment, and various other health indicators at different time points. Participants will be recruited from a specialty diabetes clinic in Yazd province, Iran, with specific eligibility criteria including age, diabetes diagnosis, and exclusion criteria such as allergies and certain medication use. The diagnostic criteria for diabetes mellitus are outlined by the American Diabetes Association.

Eligibility Criteria:
Inclusion Criteria:

* being married, having type 2 diabetes(according to American Diabetes Association provides guidelines) that had been diagnosed and treated for at least one year, not being dependent on insulin, being between the ages of 18-45 and having a body mass index between 18.5 and 30. Additionally, Absence of menorrhagia on the basis of the PBLAC chart

Exclusion Criteria:

* Participants who are allergic to turmeric or saffron plant essence will be excluded from the study. Additionally, women who do not regularly use supplements or take drugs for at least 7 consecutive days per month were excluded. Anticoagulant use, pregnancy, and breastfeeding will be also exclusion criteria. Finally, participants who had taken multivitamins or supplements affecting metabolism in the last three months will be not included in the study. Exclusion criteria for the study will include changes in diet and physical activity, experiencing a stressful event during the intervention (as reported by the research unit), and the use of drugs that affect sexual performance (as reported by the research unit)