cyrilzakka/clinical-trials huggingface dataset:
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis

The purpose of this study is to observe the clinical manifestation, Lab findings including chest CT scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.

Presentation of patient with suspected vasculitis

1. Established diagnosis Clinical findings Laboratory workup Tissue biopsy Angiogram where appropriate
2. Evaluating respiratory system Chest HRCT Pulmonary function test Bronchoscopy exam(BALF, TBB) Lung biopsy(needle biopsy, VAST)
3. screening underlying damage to other system Paranasal sinus, vision \& audition Nervous system Kidney Gastrointestinal tract Heart \& vessel Skin Hematology Muscle, bone \& joint
4. Treatment
5. Prognosis

Evaluation

1. Study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months.
2. Disease activity was measured on the basis of the BVAS/WG and the physician's global assessment.
3. Damage related to disease or treatment was scored according to the Vasculitis Damage Index (scores for this index range from 0 to 64, with higher scores in- dicating more severe damage).
4. Health related quality of life was scored with the use of the Med- ical Outcomes Study 36-Item Short-Form Health Survey (SF-36).Scores on this scale range from 0 to 100, with higher scores indicating better health.
5. Serial serum samples were tested for proteinase 3-ANCA and myeloperoxidase-ANCA by means of a direct enzyme-linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Aged from 18-75 years with informed consent
* Patients with ANCA-vasculitis

  1. Wegener's granulomatosis, microscopic polyangiitis or CSS
  2. positive serum assays for proteinase 3-ANCA or myeloperoxidase-ANCA
  3. manifestations of activity disease, and Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease)

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential
* Secondary vasculitis, cancer,infective disease or drug induced vasculitis
Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg

The proposed project will provide data concerning dating and sexual interactions that occur on Fort Bragg, North Carolina, in addition to piloting a sexual assault prevention program through the use of social norms and bystander intervention concepts. The investigators will be able to use data and feedback gained from this research to help reduce rates of sexual assault in the military by providing a sexual assault prevention program tailored to at risk male Soldiers that can be disseminated across military posts.

Research has shown that one beneficial preliminary step to sexual assault prevention is the examination of a population's social norms pertaining to sex, dating, and alcohol- use. Studies show that the social norms surrounding these behaviors can be risk factors that increase the likelihood that certain high-risk men will perpetrate sexual assault.

Among college-age men, research on social norms has been used to inform the development of a sexual assault prevention program that positively impacts high-risk men. A hallmark of this approach is its exploration of the climate of a given population with regard to sex, dating and alcohol-use, and its use of data gathered to inform the development of a sexual assault program. Researchers have yet to study the effectiveness of this approach in the U.S. Army.

It has been well documented that sexual assault in the Army carries a significant threat to the readiness of the force. As such, the Army continues to make strong and laudable efforts to reduce sexual assault. However, there remains a need to better understand how young at-risk men behave in the social situations where sexual assault can occur and what they subjectively believe about these behaviors in order to effectively reduce perpetration.

In order to fill this gap, the investigators propose to implement a sexual assault prevention program by using social norms and bystander approach concepts via surveys, interviews and group workshops. The data and feedback from this research have the potential to produce insight that could help leaders and the investigators more effectively promote health in male Soldiers' dating and sexual relationships.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Active-duty Soldier (Active-duty Army, Activated Reservist or National Guardsmen) at Fort Bragg, NC
* Between the ages of 18 and 26; usage of "18-26" means at least 18 years of age but less than 27 years of age
* Reported having engaged in oral, vaginal, or anal sex within previous 4 months
* Able to speak and comprehend English sufficiently to complete the study procedures
* Indicate at risk-drinking via an AUDIT-C score \>4

Exclusion Criteria:

* Screen positive for alcohol withdrawal on the ASWC (score of \> 23)
* Report or indicate suicidal or homicidal ideation
NTRK 1,2,3 Rearrangements in Patients With Solid Tumors

This study aims to evaluate the incidence of NTRK rearrangements in patients with solid tumors in Italy. Additionally, the study seeks to define the correlation between IHC and FISH testing and to simplify the assessment of NTRK rearrangements in patients with solid tumors.

Neurotrophic tropomyosin-related kinases (NTRKs, or the commonly used alias TRKs) constitute a receptor tyrosine kinase family of neurotrophin receptors involved in neuronal development, including the growth and function of neuronal synapses and memory development.

NTRK1/2/3 gene fusions have emerged as new targets for cancer therapy as they can be successfully inhibited by targeted kinase inhibitors. Several compounds targeting TRKs are currently being explored in clinical trials and, notably, one of these compounds, larotrectinib (VITRAKVI®), has received accelerated approval by the United States Food and Drug Administration (FDA) for adult and paediatric solid tumours with a NTRK fusion without known resistance mutations. In addition, entrectinib has received breakthrough designation status by the United States FDA for the treatment of cancers types harbouring NTRK fusions. Hence, there is an active interest in clinical oncology for NTRK fusions, which has prompted an urgent need to define the routine diagnostic test to identify gene fusions as a companion diagnostic method to support clinical decision in this context. Irrespective of the method adopted for NTRK detection, high activity of anti-NTRK agents and therefore the necessity to guarantee these agents to all NTRK+ patients, strongly supports a NTRK screening program for patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of any solid cancer
* Availability of tumor tissue for biomarker analyses (at least 5 slides, 4 micron)
* Signed informed consent form

Exclusion Criteria:

* No tumor tissue available
Efficacy of Intravenous Iron Administration in Hemodialysis Patients

The purpose of this study is to determine whether the frequency of intravenous iron administration has an effect on anemia correction and oxidative stress formation in hemodialysis patients.

In patients who are on chronic hemodialysis (HD), anemia is a major complication and is associated with poor clinical outcomes. Consequently, management of anemia by recombinant erythropoietin is reported consistently to improve outcome measures in HD patients. Because iron is essential for hemoglobin formation, as is erythropoietin, most patients routinely receive iron intravenously (IVIR) for anemia correction. Although IVIR has been shown to improve both survival and quality of life of HD patients, it has been suggested that IVIR may enhance the generation of hydroxyl radicals in the body through the inflammation process and the Fenton reaction. Previously we demonstrated that that serum albumin is highly oxidized in HD patients and that IVIR on these patients significantly increased the oxidation status of albumin.

In 2004, the committee on the guidelines of the Japanese Society for Dialysis Therapy (JSDT) published the original Japanese "Guidelines for Renal Anemia in Chronic Hemodialysis Patients". In the JSDT guidelines 2004, the committee recommended two IVIR schedules for iron deficient patients; 1) administer 40 mg of IV iron at the end of dialysis session 3 times a week for 4 weeks (total 520 mg of iron), 2) administer 40 mg of IV iron at the end of dialysis session once a week for 3 months (total 520 mg of iron). Both administration schedules are effective for the correction of iron deficiency and consequently for the amelioration of anemia. However, the effect of IVIR frequency (three times a week vs. once a week) on the oxidative stress formation has not been investigated before.

Comparison: the two IVIR schedules recommended by the JSDT guideline 2004 will be compared by measuring both hemoglobin and oxidized albumin in chronic HD patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic renal failure
* Clinical diagnosis of iron deficiency anemia
* Must be on regular hemodialysis

Exclusion Criteria:

* Allergic to intravenous iron administration
A Study to Evaluate the Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD)

The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 compared with placebo in participants with HD.

Participants will first be randomized to Part A or Part B or Parts D or E in a 1:1 randomization ratio, depending on their Huntington's disease Integrated Staging System (HD-ISS) staging criteria and then to active treatment (PTC518 5 mg in Parts A and D and 10 mg in Parts B and E) or matching placebo within each part in a 2:1 ratio of active treatment to placebo. A Drug Safety Monitoring Board (DSMB) Charter will undertake an unblinded review of safety data from the 5 and 10 mg dosing groups and provide a recommendation on when Parts C and F (with a 20 mg active treatment arm) can be initiated. At that time, participants will be randomized to any study Part that is currently open for enrollment, and then to either active treatment or placebo (in a 2:1 ratio) within that Part.

Eligibility Criteria:
Key Inclusion Criteria:

* Genetically confirmed HD diagnosis with a cytosine-adenine-guanine (CAG) repeat length from 40 to 50, inclusive

Eligibility for HD-ISS Stage 2 Group (Parts A, B, and C):

* A Unified Huntington's Disease Rating Scale (UHDRS)-Independence Scale (IS) score of 100
* A UHDRS Total Functional Capacity (TFC) score of 13
* A score between 0.18 and 4.93 inclusive on the normed version of the HD prognostic index (PINHD)

Eligibility for HD-ISS Mild Stage 3 Group (Parts D, E, and F):

* A UHDRS Total Functional Capacity (TFC) score of 11 or 12, or a UHDRS TFC score of 13 with an UHDRS IS score of \<100

Key Exclusion Criteria:

* Receipt of an experimental agent within 90 days or 5 half-lives prior to Screening or anytime over the duration of this study, ribonucleic acid (RNA)- or deoxyribonucleic acid (DNA)-targeted HD-specific investigational agents such as antisense oligonucleotides, cell transplantation, or any other experimental brain surgery
* Any history of gene therapy exposure for the treatment of HD
* Participation in an investigational study or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc) within 90 days prior to Screening or anytime over the duration of this study
* Any medical history of brain or spinal disease that would interfere with the lumbar puncture process safety assessments
* Any medical history or condition that would interfere with the ability to complete the protocol-specified assessments (for example, implanted shunt, conditions precluding magnetic resonance imaging \[MRI\] scans)
* Pregnancy, planning on becoming pregnant during the course of the study or within 6 months of end of treatment, or currently breastfeeding

Note: Other inclusion and exclusion criteria may apply.
Genetic Study of Brain Tumors in Young Children

RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.

PURPOSE: Genetic study to understand how genes may be involved in the development of brain tumors in young children.

OBJECTIVES:

* Determine the frequency and type of deletions and mutations of the INI1 gene in infants with embryonal central nervous system tumors.
* Compare the gene expression profiles in infants with atypical teratoid/rhabdoid tumors vs medulloblastoma or primitive neuroectodermal tumor.

OUTLINE: This is a multicenter study.

Tumor samples are analyzed by fluorescence in situ hybridization (FISH) for deletions of INI1 gene in chromosome band 22q11.2. Tumors without demonstration of deletions of INI1 gene by FISH are examined by polymerase chain reaction (PCR)-based microsatellite analysis for loss of heterozygosity using markers that map to 22q11.2.

DNA from tumor tissue is analyzed for mutations in the exons of the INI1 gene. Isolated matched normal DNA may be analyzed for identification of germline mutations. Parental DNA may be analyzed to identify inherited germline mutations of the INI1 gene.

The patient's physician may receive the results of the genetic testing. The results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 25 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary intracranial central nervous system tumor

  * Medulloblastoma
  * Primitive neuroectodermal tumor
  * Atypical teratoid/rhabdoid tumor
  * Choroid plexus carcinoma
* Potential enrollment on PBTC-001 therapeutic protocol

PATIENT CHARACTERISTICS:

Age:

* Under 3

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior steroids allowed

Radiotherapy:

* No prior radiotherapy

Surgery:

* Not specified

Other:

* No concurrent investigational agents
The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide

In this study, we will evaluate the incidence of hepatitis B virus reactivation within the first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive.

This is a prospective, multicenter, interventional, single arm, evaluating the incidence of hepatitis B virus (HBV) reactivation within the first 6 months treatment period in HBsAg positive patients treated for DLBCL/Chronic Lymphoid Leukemia with Rituximab, standard chemotherapy, and TAF.

Approximate duration of the recruitment period based on the number of patients available The duration of the recruitment period has been estimated at 12 months.

Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy. Then patients will be also observed for further12 months

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent according to ICH/EU/GCP and national local laws.
* Male/non-pregnant/non-lactating female subjects \>18 years old with newly diagnosed DLBCL/Chronic Lymphoid Leukemia who are going to receive treatment with rituximab in combination with chemotherapy.
* HBsAg positivity, serum HBV-DNA negative or positive (\<2000/IU), and normal liver function, including alanine aminotransferase(ALT), aspartate aminotransferase(AST) and bilirubin. (inactive carriers).
* No previous treatment with antiviral drugs for HBV infection.
* Patients with satisfactory renal function.

Exclusion Criteria:

* Hepatic insufficiency for any reason
* History of other liver diseases such as hepatitis C, D, autoimmune hepatitis, primary biliary cirrhosis, Wilsons' disease
* Positive viral markers, such as IgM antibody to hepatitis A virus, hepatitis C virus, IgG antibody to hepatitis D virus, IgM antibody to hepatitis E virus, or antibody to HIV
* Pregnant or breastfeeding women
* Other major systemic diseases, such as active infection, significant cardiac disease, neurological deficit or psychiatric disorder, that the investigators consider being a significant risk
* Patients with moderate or severe renal failure.
* Intolerance to any of the components of the therapeutic regimen. Treatment with any investigational medicinal product (unapproved) in the last 30 days.
* Any other disorder that, in the investigator's opinion, makes the patient ineligible for recruitment or that could interfere in his/her participation or in the conclusion of the study.
Long-term Recurrence Rates of Atrial Fibrillation Following New-onset Atrial Fibrillation During ICU Admission

The Primary Objective of the study is to establish the One-year recurrence rates of atrial fibrillation (AF) following new-onset atrial fibrillation during intensive care unit (ICU) admission.

The Secondary Objective is a composite of death from cardiovascular causes, stroke (either ischemic or hemorrhagic), or hospitalization with worsening of heart failure or recurrent AF.

The prevalence and recurrence rates of AF will be divided into sub-groups based on primary ICU admission diagnosis.

All-cause mortality.

Patients will be screened for atrial fibrillation during hospitalization in the intensive care unit and will be followed until discharge. Once discharged home or to a rehabilitation center, they will be invited to a routine follow-up clinic at RMC cardiology institute 4-6 weeks after hospital discharge. During the clinic visit, patients will be recruited to the study follow-up plan.

The follow-up plan will consist of 3 clinical visits at 4-6 weeks, 6-months and 1 -year after discharge.

The follow-up program will include a comprehensive screening for symptomatic and asymptomatic atrial fibrillation events as following:

Patients will be provided with a home cellular-digital 12-lead ECG transmitter. They will be instructed to conduct routine weekly transmission in order to record asymptomatic events as well as to transmit at any time they suspect an event/feel symptoms (palpitations). Home routine testing will be initiated and guided by a telephone call from a medical monitoring center. A blinded, independent, on-call medical professional team will analyze the received ECG.

A 48-hour Holter ECG will be performed at 6 months and 12 months after ICU discharge

Clinical visits will include 12 leads ECG, physical examination, vital signs, symptoms evaluation for suspected AF events, questioning for hospital admissions, or any other documented AF event. Patients will be asked to perform echocardiography as part of their clinical evaluation. For both the study and control group, documented AF events will be managed according to physician discretion based on clinical practice and guidelines.

Long-term follow-up- 3 years- data regarding recurrent events of AF, hospitalization due to thromboembolic events, and mortality will be evaluated by telephone call or by matching patient identification numbers with the Israeli National Population Register.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU over 24 hours
* Diagnosed with new-onset atrial fibrillation
* The patient survived the index hospitalization and was discharged home/ to a rehabilitation center.

Exclusion Criteria:

• Previously documented atrial fibrillation
The Stork OTC: Collection, Placement & Delivery

This is a clinical study designed to validate the usability and safety of the over-the-counter (OTC) device by obtaining feedback in a home use environment regarding ease of use of The Stork™ Conception System and the instructions for use. In addition to usability, results for safety, including vaginal

Female participants will undergo a baseline pelvic examination. Participating couples will be given The Stork™ Conception System (OTC), including Instructions for Use, the questionnaire and two ziplock bags. The device will be used in accordance with the instructions for use. Participants will use the Conceptacle as a collection condom during sexual intercourse. Participants will remove the Cervical Cap from the Sheath of the Conceptacle and discard the Sheath. Participants will then load the Cervical Cap into the Applicator for insertion, placement and deployment of the device. Participants will wash the applicator with soap and water and place it in the double zip lock bags. During the time the cervical cap is inserted, normal activity will be recommended with the exception of having intercourse. The female participants will leave the conception cap inserted for a period of time between 4 and 12 hours, return to the investigator's office for examination, remove the Cervical Cap, and undergo a follow up pelvic examination. Participants will be asked to complete the study and the questionnaire within 3 days of receiving the study packet. As a result, this study could take up to 4 days to complete per enrolled couple.

Eligibility Criteria:
Inclusion Criteria:

* Literacy must be in English (able to understand Informed Consent)
* In general good health
* Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active (as a couple)
* 18 - 50 years of age
* REALM-SF Test Results demonstrate 6th grade literacy or above
* Past experience with using condoms
* Trying to conceive or using a non-vaginal birth control with which they do not normally use a condom.
* Signed Informed Consent

Exclusion Criteria:

* Vaginal prolapsed (female)
* Hysterectomy (female)
* Erectile Dysfunction (male)
* Colposcopy with biopsy surgery within the last three (3) months (female)
* Treatment for dysplasia surgery within the last three (3) months (female)
* Vaginal/cervical surgery within the last three (3) months (female)
* Current Pregnancy (female)
* Unable to read and understand English
Carpal Tunnel Release Effects on Median Nerve Perfusion

This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging to view the perfusion to the nerve.

The study will involve patients undergoing carpal tunnel release surgery at our institution, with no change in the actual procedure performed. Using the SPY Scope, we will measure blood flow prior to the carpal tunnel release, and again measure once carpal tunnel release has been performed, in order to compare the values. This may add roughly 15 minutes to the total procedure time, however, no steps in the actual operation will be altered or affected in any way.

Eligibility Criteria:
Inclusion Criteria:

* carpal tunnel syndrome
* 18 years or older

Exclusion Criteria:

* pregnant
* less than 18 years of age
* allergy to iodide or iodinated contrast agents