cyrilzakka/clinical-trials huggingface dataset:
A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. Pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed. Patients will be treated in a single session with 75 Gy maximal dose covering a 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Treatment will be delivered using the CyberKnife Robotic Radiosurgery System with the patient in the supine position. An aquaplast head mask will be used to ensure adequate immobilization during therapy. The target volume shall be the 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Patients will receive subcutaneous injection of amifostine (500 mg) or placebo 30 minutes +/- 30 minutes prior to SRS. Facial pain will be assessed using the Visual Analog Scale and Short-form McGill Pain Questionnaire. Following SRS, patients will be followed at 1, 3, 6, and 9 months ±7 days. Facial numbness will be assessed using the Barrow Neurologic Institute (BNI) Facial Numbness Score. Patient reported BNI facial numbness scoring and complete cranial nerve exam by a physician will be performed pre-treatment and at follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are:

* Intolerant of or refractory to medical management; AND
* Not candidates for or refusing a surgical micro-vascular decompression.

Exclusion Criteria:

* Patients who present with pre-existing BNI grade III or IV facial numbness.
* Patients who have previously been treated with MVD.
* Patients who have previously had an ablative treatment, including prior SRS.
* Pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent will be excluded.
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

* To demonstrate lot consistency of the Fluzone ID manufacturing process.
* To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

* To describe the safety profile of subjects who receive of Fluzone ID.

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Eligibility Criteria:
Inclusion Criteria :

* Aged 18 to 64 years on the day of vaccination.
* Informed consent form signed and dated.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.

Exclusion Criteria :

* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
* For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
* Breast-feeding woman.
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
* Receipt of any vaccination in the 4 weeks preceding the trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
* Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
* Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
* Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for \>=5 years).
* Personal or family history of Guillain-Barré Syndrome.
Pathways Relating Amnestic MCI to a Mild Traumatic Brain Injury History

This study will probe if the biological changes in amnestic mild cognitive impairment (aMCI) are related to a history of mild traumatic brain injury (mTBI) using high definition transcranial direct current stimulation (HD-tDCS) and blood-derived biomarker tools. Participants who Do as well as those who Do Not have a history of mTBI will be enrolled in the study.

Ten study visits will be completed by each participant. The initial visit will include a blood draw and a baseline memory evaluation. Afterwards, participants will be randomized to begin with one of 3 conditions of HD-tDCS. The three conditions are sham-control, active stimulation to frontal region, and active stimulation to left temporal region. All participants will be expected to completed each HD-tDCS condition, which will be counterbalanced and separated by 14 days. Active HD-tDCS will be applied at 2 mA for 30 minutes over 3 consecutive daily sessions while sham stimulation will be applied for the same duration and timespan. All subjects will complete memory assessments again immediately following each HD-tDCS condition for a total of four test sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Active diagnosis of amnestic mild cognitive impairment
2. Presence of an mTBI history for the mTBI+ group; absence of an mTBI history for a control sample
3. Female and male subjects
4. All races/ethnicities
5. Age 55 years and older
6. Fluent in English

Exclusion Criteria:

1. Mild traumatic brain injury within past year
2. Lifetime history of moderate or severe brain injury
3. Lifetime major neurologic syndromes (e.g., stroke, epilepsy, brain tumor)
4. Lifetime major cardiovascular conditions (e.g., heart attack, heart failure)
5. Current substance use disorder
6. Current major psychiatric disorders (e.g., major depressive disorder, bipolar disorder)
7. Current vision or hearing impairment that interferes with testing
8. Any electronic and or metallic implants in the skull or brain
9. Current medication use known to alter HD-tDCS reactivity
Influence of Screen Sizes on Responses to Visual Analog Scales of Stress

Visual analog scales (VAS) are one of the most common tools used in questionnaires. VAS are validated for pain and stress for example on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100). Nowadays, most VAS are used on questionnaires on internet. However, the influence of screen sizes on responses to visual analog scales were never studied.

Visual analog scales (VAS) are one of the most common tools used in questionnaires. VAS are validated for pain and stress for example on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100). Nowadays, most VAS are used on questionnaires on internet. However, the influence of screen sizes on responses to visual analog scales were never studied.

Primary objective is to study the influence of screen sizes on response responses to visual analog scales.

Secondary objectives are to assess:

* the variability of responses depending on screen sizes within a week
* the influence of perception of work and addiction to work on the variability depending on screen sizes
* relationships with biomarkers of stress : salivary DHEAS, heart rate variability and skin conductance

An open questionnaire will be created by the Clinical Research Direction. The questionnaire will be opened by the examinator who will fulfill the anonymized identification of participants and the type of screens. In a dedicated room at the LaPSCo, the participants will answer the same VAS on four different sizes/types of screens (24-inch screen, laptop, tablet, smartphone) and on paper. Saliva will be collected after answering questionnaires. Heart rate variability and skin conductance will be measured with the use of a wrist watch during 15 minutes, from the entrance in the room to the completion of questionnaires.

The participant will undergo the same examination within a week (15 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Adult persons

Exclusion Criteria:

* Refusal to participate in the study
* Unable to answer basic questions (difficulties understanding, cognitive disorders...)
Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma

CD20, the protein which is expressed on the surface of all mature B cells, is active in many B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL), the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases. This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP chemotherapy regimen compared with CHOP chemotherapy alone.

Rituximab, a chimeric anti-CD20 monoclonal antibody, has been proved valuable treatment for CD20-positive DLBCL. The combination of rituximab with CHOP has been shown to increase both survival and response rate, in comparison to CHOP alone. CMAB304(Retuxira), a biosimilar of rituximab, was developed by Shanghai CP Guojian Pharmaceutical Co.,Ltd. Previous Phase I study showed that CMAB304 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 250 to 500 mg/m2. In this study, efficacy and safety of CMAB304 were evaluated in DLBCL patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 70 year, male or female
2. Previously untreated
3. DLBCL patients with CD20-positive
4. Lymphoma lesions can be Measured and evaluated; Spiral CT or MR evaluation of the lesion must be ≥ 1cm; Measured by clinical examination or others must be ≥ 2cm
5. Normal blood test, adequate liver and renal function;
6. ECOG score 0\~2
7. Life expectancy of greater than 3 months
8. No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
9. Signed ICF

Exclusion Criteria:

1. DLBCL transformed from other low-grade NHL types
2. Primary central nervous system lymphoma, or primary gastrointestinal DLBCL
3. History of foreign protein allergies
4. Abnormal liver and/or renal function
5. Suspected or diagnosed central nervous system violation
6. Serious infection or organic diseases
7. Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months
8. Breastfeeding or pregnant
9. Leukemia crisis or bone marrow metastases
Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma

Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in 60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel therapy in advanced cases survival is still short, approximately 12 month.

Pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced pretreated STS.

Functional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either for pre- / post- treatment evaluation or follow up.

Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources.

The aim of the study is to investigate the contribution of FDG PET/CT to assessment of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment

Exclusion Criteria:

* Other treatment
* FDG negative tumor
Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects

The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).
2. Male or female aged 18-55（adult healthy volunteers).
3. Body mass index (BMI) between 19 and 28 kg/m2.
4. Normal Electrocardiogram (ECG).

Exclusion Criteria:

1. History of persistent tachyarrhythmia and syncope.
2. A history of stomach or bowel surgery or excision.
3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
4. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.
Body Impedance Analysis to Detect ICUAW

The aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the Medical Research Council (MRC) score. An MRC score ≤ 48 is defined as a diagnosis of ICU acquired weakness. The correlation of the values detected by BIA and their transfer to an MRC Score ≤ 48 will be investigated.

The knowledge gained will be used for early detection of ICUAW in order to reduce the consequences of the same.

Intensive Care Unit Acquired Weakness (ICUAW) describes the clinically diagnosed manifestation of neuromuscular organ dysfunction. It develops in approximately 40% of all ICU patients, which corresponds to at least 1.2 million patients annually in Germany. All these patients face a wide spectrum of sequelae and increased mortality up to 5 years after ICU discharge. A characteristic pathophysiological phenomenon is early severe muscle atrophy, which is as high as 17% in the first days after ICU admission.

ICUAW is currently diagnosed by the MRC score, which is assessed by the sum of manual muscle strength test results in 12 muscle groups (sum score). Manual muscle testing (MMT) is not possible during the early phase in critical illness in most patients due to coma, delirium, and/or injury. In addition, there is a possible discrepancy by different observers. As a result, early detection of ICUAW may be inadequate in most patients and unreliable during critical illness.

Measurement by BIA is reproducible, so differences in measurement can be attributed to changes in clinical condition. Body impedance analysis thus demonstrates a means of objective measurement.

Thus, the study aims to counteract the long-term consequences of ICUAW through early detection of ICUAW by allowing countermeasures to be taken earlier.

Eligibility Criteria:
Inclusion Criteria:

- Patients aged ≥ 18 years with ventilatory support within 36 hours from ICU admission.

Exclusion Criteria:

* With a language barrier
* Patients with pacemaker or other electronic implant
* Expected death or discontinuation of life-sustaining measures.
* Not walking independently before hospitalization (gait aids allowed)
* Allergy to electrode gel
* BIA or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages
Female Patient Preferences Regarding Physician Gender

This is a cross sectional survey study to describe female patient preferences when choosing their OB/GYN and other providers.

The American College of Obstetricians and Gynecologists (ACOG) published that as of 2009, 79.7% of the Obstetrics and Gynecology residents were female. Given the striking decline in male providers selecting OB/GYN in more recent years, it is critical to characterize patient preferences in the current environment.

Nevertheless, it is not clear that females have strong preferences regarding gender. We hope to better understand the influence of bias on physician gender in present day.

The purpose of this study is to describe female population preference based on physician gender and specialty.

The study will be conducted on an online platform distributed across the United States by the aid of SurveyMonkey® .

Eligibility Criteria:
Exclusion Criteria:

* Unwillingness to participate in the study
* Lack of access to the internet
* Non-English speaking
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)

The purpose of the study is to find out if administration of danazol with plasma exchange and corticosteroids will reduce the number of plasma exchanges required to control Thrombotic Thrombocytopenic Purpura (TTP).

Danazol is a synthetic steroid hormone structurally resembling a group of natural hormones (androgens)found in the body. Danazol has immune modifying activity and is effective in treatment of blood disorders with low platelet counts such as idiopathic thrombocytopenic purpura (however FDA has not yet approved danazol for this disorder). A study of danazol in conjunction with plasma exchange for thrombotic thrombocytopenic purpura showed that danazol decreased the number of plasma exchanges required by approximately 80% and reduced the time needed to control the disease. It's not clear how danazol works in TTP. It is not approved by the FDA for the treatment of TTP.

Eligibility Criteria:
Inclusion Criteria:

* TTP with platelets less than 100,000 and microangiopathic hemolytic anemia
* Age greater than 18 and less than 60
* LDH \> 2x upper limit of normal
* PT and PTT normal
* Patients must give signed informed consent
* Pre-menopausal woman must have negative pregnancy test.
* TTP not related to underlying cancer, treatment of cancer or transplantation.
* TTP not associated with drugs.

Exclusion Criteria:

* LFTs AST/ALT \> 2x upper limit of normal
* Hepatitis B and Hepatitis C infection.
* HIV with active opportunistic infections
* Acute or chronic Disseminated Intravascular Coagulation (DIC), defined as D-dimer 8ug/ml and fibrinogen\<100 mg/dl
* TTP related to drugs, malignancy and transplantation.
* Pregnancy
* Concurrent other investigational drug use during this study.
* Porphyria.
Pilot Study of BAO-G Technique in TAAA Endovascular Repair

Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of thoracoabdominal aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to evaluate the safety and efficacy of BAO-G in thoracoabdominal aortic aneurysm endovascular repair.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with TAAA, confirmed by aortic CTA.
2. TAAA diameter ≥ 6cm, or symptomatic TAAA with diameter ≥ 4cm.
3. Informed consent signed.

Exclusion Criteria:

1. were pregnant.
2. had a history of previous endovascular or open repair.
3. had other contraindications of endovascular treatment.
4. Uncontrolled autoimmune disease.
Project SHINE (Sleep Health INitiative for Equity): Culturally Informing a Sleep Extension Intervention for African American Adults

The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial.

The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention.

There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2.


Eligibility Criteria:
Inclusion Criteria:

Phase 1:

* Not meeting Physical Activity Guidelines
* age range: 21 to 75 years
* body mass index: ≥25.0 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American

Phase 2:

* Not meeting Physical Activity Guidelines
* age range: 21 to 75 years
* body mass index: ≥25.0 kg/m2
* average self-reported habitual sleep duration of ≤6 hours
* self-identify as Black or African American

Exclusion Criteria:

Phase 1:

* Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
* pregnant or less than 4 months postpartum
* infant living in household less than 1 year old

Phase 2:

* Self-reported organ-related disorder (COPD, cardiac arrhythmia, gastro-esophageal disorder)
* pregnant or less than 4 months postpartum
* infant living in household less than 1 year old