cyrilzakka/clinical-trials huggingface dataset:
Communicating Objective Risk for Personalized Decision Making About Mammography

The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. Two presentation formats will be tested and compared.

This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.

After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.

After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.

In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.

Eligibility Criteria:
Inclusion Criteria:

* Adult women between the ages of 35 and 49 will be invited to participate in this study.

Exclusion Criteria:

* Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma

This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record.


Eligibility Criteria:
Inclusion Criteria:

Cohorts A and B:

* Initiated dabrafenib and trametinib combination therapy (D+T) according to approved label between 01 May 2020 and 31 July 2022
* Was ≥18 years old of age at the initiation of D+T
* Had at least one tumor assessment after initiation of D+T
* Written informed consent if requested by the study site

Cohort A Only • Confirmed BRAF V600 mutation positive mucosal melanoma that was unresectable or metastatic

Cohort B Only

• Confirmed BRAF V600 mutation positive non-mucosal melanoma (cutaneous and acral melanoma) that was unresectable or metastatic

Exclusion Criteria:

None specified
Nicotine Vapor Specific Sensory Measurement

This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.

PRIMARY OBJECTIVE:

I. Study that flavors might be related to the phenomenon of 'indirect' toxicity.

OUTLINE: Participants are randomized to 1 of 2 conditions.

CONDITION I: Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).

CONDITION II: Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).

Eligibility Criteria:
Inclusion Criteria:

* Current daily vapers of products containing nicotine
* No concurrent use of other tobacco products
* Self reported general good health
* No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
* No self-reported taste or smell deficits
* Not pregnant or lactating
* No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
* Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
* Access to video-conference or telephone
* Ability to store test products in a secure location away from children

Exclusion Criteria:

* Not current daily vapers
* Concurrent use of other tobacco products
* Self-reported fair or poor general health
* Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
* Self-reported taste or smell deficits
* Pregnant or lactating
* Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
* Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
* No access to video-conference or telephone
* Unable to store test products in a secure location away from children
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Adults unable to consent
* Adults unable to legally purchase tobacco products in New York (NY) state (18-20)
Correlation Between Idiopathic Parkinson's Disease and Diabetes Mellitus

Correlation between Idiopathic Parkinson's disease and diabetes mellitus in Egyptian Elderly Patients

1. Record RBDSQ ("Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire) total score difference between Group 1 and Group 2 .
2. Oral glucose tolerance test will be performed and compared between Group 3 and Group 4.
3. Association between glucose level and motor complication of L-dopa among Idiopathic Parkinson's patients using Unified Parkinson's Disease Rating Scale (UDPRS).

Eligibility Criteria:
Inclusion Criteria:

1. Diabetic Patients
2. Idiopathic Parkinsonism

Exclusion Criteria:

1. Secondary Parkinsonism due to stroke, trauma and encephalitis.
2. Drug induced Parkinsonism.
Cervical Cancer Prevention for Black Adults

The goal of this study is to develop and pilot test an intervention, entitled Health is Wealth: A Cervical Health Program, designed to promote screening and reduce perceived barriers to Cervical Cancer (CC) screening.

Aim 1: Examine general awareness and cultural factors (fatalism, religiosity/spirituality, temporal orientation, medical mistrust, and acculturation) related to cancer control and prevention among African Americans (AA) and Sub Saharan African (SAI) Immigrants.

Aim 2: Examine the socioecological barriers and facilitators to CC screening and self-sampling to inform tailoring of an evidenced based cervical health program to promote CC screening.

Aim 3: Assess feasibility, acceptability, and preliminary efficacy in a pilot test of the Health is Wealth: A Cervical Health Program among 30 AA and 30 SAI women using quasi-experimental design.

This study will take place in 2 phases.

In phase 1, the investigators will conduct a cross-sectional survey with 150 Black men and women to examine factors impacting cervical cancer screening. Also, as part of phase 1, Aim 2 employs focus groups and a quantitative Health Belief Model checklist with 30 participants to guide development of a tailored intervention. In phase 2, Aim 3 will assess feasibility, acceptability, and preliminary efficacy of the Health is Wealth: A Cervical Health Program intervention among 30 African American and 30 Sub-Saharan African immigrant women.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Black woman (African American or Sub-Saharan African Immigrant)
* No pap smear within the last three years or no pap smear/HPV co-test within past five years
* Able to speak and write in English
* Reside in Kentucky

Exclusion Criteria:

* Do not self-identify as Black woman (African American or Sub-Saharan African Immigrant)
* History of hysterectomy
* History of cervical cancer
* Being pregnant
* Unable to speak and write in English
* Do not reside in Kentucky
Meditoxin® Treatment in Patients With Cervical Dystonia

To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 20 to less than 75 years
* Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score \>=20 and TWSTRS-Severity score \>=10

Exclusion Criteria:

* Subjects with pure anterocollis
* Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)
* A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product
* Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study
Oral T7 Oral Testosterone in Man

The purpose of this study is to test how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

We will be using three drugs: The first, acyline, temporarily turns off the body's production of testosterone for about two weeks. Subjects will receive acyline as shots three times over a six-week drug administration period. During the time when the body's production of testosterone is turned off, we will give testosterone either by itself or with a medication called finasteride by mouth twice daily for one week to see how much is absorbed and present in the bloodstream after administration. Subjects will go through three one-week study drug exposure periods. During two of the three one-week study drug administration periods subjects will also take a second medication, finasteride, by mouth twice daily. On the last day of each one-week drug administration period, subjects will be admitted to the University of Washington General Clinical Research Center overnight for monitoring of your blood testosterone levels. There will be 3 overnight visits for this study. This study will allow us to determine the absorption of testosterone taken by mouth, and the relative impact of two different doses of oral finasteride on testosterone absorption.

Eligibility Criteria:
Inclusion Criteria:

* Males between 18 and 50 years of age
* In good health based on normal screening evaluation (consisting of a medical history, physical exam normal serum chemistry, hematology, and baseline hormone levels.
* Must agree to not participate in another research drug study
* Must agree to not donate blood
* Must be willing to comply with the study protocol and procedures

Exclusion Criteria:

* Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
* A known history of alcohol or drug abuse
* Participation in a long-term male contraceptive study within the past month
* History of bleeding disorders or current use of anti-coagulants
* History of sleep apnea
* History of major psychiatric disorder
* Body mass index \> 37
* Infertility
* Hematocrit \> 55 or \< 30
* PSA \>4
Investigation of Pain and Anxiety During Electrodiagnostic Examination Using Self-selected Music

The investigators hypothesized that self-selected music played during electrodiagnosis is effective in relieving the discomfort caused by the procedures.


Eligibility Criteria:
Inclusion Criteria:

Investigators recruited volunteer patient participants from patients referred to the electrodiagnosis laboratory of Department of Physical Medicine and Rehabilitation in a medical center using convenient sampling.

The inclusion criterion is:

* adult patient with working diagnosis of possible neurological disorder and
* is referred for both nerve conduction study and needle electromyography

Exclusion Criteria:

The exclusion criteria are:

* conscious disturbances,
* cognitive impairment, or
* language dysfunction.
Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC

To evaluate the safety and efficacy of cisplatin plus intensity-modulated radiotherapy (IMRT) based on FDG-PET/CT after induction chemotherapy (IC) for locally advanced head and neck squamous cell carcinoma.

Current guidelines define that pre-IC target volumes must be used for radiotherapy (RT) planning. This prospective, phase II trial assessed the results of patients with locally advanced squamous cell carcinoma of head and neck treatment with IC following by chemoradiotherapy (CRT), using post-IC PET/CT images for IMRT planning.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years or over;
* Histologically confirmed locally advanced (stage III and IV) head and neck squamous cell carcinoma (HNSCC);
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
* Signed written informed consent approved by the Lithuanian Bioethics Committee (LBEC);

Exclusion Criteria:

* Positive serum pregnancy test in women of childbearing potential or breastfeeding;
* Presence of distant metastasis;
* Second primary tumor;
* History of other malignancy within the last 5 years;
* Recurrent head and neck cancer;
* Serious uncontrolled concomitant disease that would contraindicate the use of any drugs use in this study as chemotherapy or radiotherapy; ;
* Inadequate organ function, evidenced by the following laboratory results:

  1. Absolute neutrophil count \<1,500 cells/mm3;
  2. Platelet count \<100,000 cells/mm3;
  3. Hemoglobin \<9 g/dL;
  4. Total bilirubin greater than the upper limit of normal (ULN);
  5. AST (SGOT) or ALT (SGPT) \>1,5 x ULN;
  6. Alkaline phosphatase levels \>2,5 x the ULN;
  7. Serum creatinine \>2,0 mg/dl or 177 umol/l.
Study to Evaluate the Efficacy of SDP-4 in Subjects With Dry Eye Disease (DED) (SDP-4-CS202)

SDP-4-CS202 is a Phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel group study designed to evaluate the ocular efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over an 8-week treatment period. Once concentration (1%) of SDP-4 ophthalmic solution will be given in a parallel group to vehicle via topical ocular instillation BID.


Eligibility Criteria:
Inclusion Criteria:

* Have DED in both eyes, as supported by a subject-reported history of daily symptoms of dryeye for ≥ 6 months prior to Visit 1/Screening requiring the use of artificial tears.
* Total score ≥ 40 and ≤ 70 on the SANDE questionnaire at Visits 1 and 2.
* Tear break-up time (TBUT) of ≤ 6 seconds in both eyes at Visits 1 and 2.
* Anesthetized Schirmer's test tear volume ≥ 3 mm and \<10 mm in both eyes (only at Visit 1).
* Best-corrected visual acuity (BCVA) of +0.7 logMAR or better in each eye as assessed by logMAR chart at Visits 1 and 2.

Exclusion Criteria:

* Ocular surface corneal disease other than DED.
* Diagnosis of Sjögren's disease.
* Lid margin disorder other than meibomian gland dysfunction (MGD)
* Presence of any ocular condition (e.g., pterygium) that in the Investigator's opinion could affect study parameters.
* Any previous reconstructive or cosmetic eyelid surgery
* Any previous invasive glaucoma and/or corneal surgery
* Corneal refractive surgery in the 12 months prior to Visit 1/Screening.
* Cataract extraction within 90 days prior to Visit 1/Screening.
* Cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal within 30 days prior to Visit 1/Screening or planned during the study.
* Contact lens wear.
* Use of ophthlamic corticosteroids, NSAIDs, antibiotics, antihistamines, IOP lowering medication, in the 30 days prior to Visit 1/Screening
* Serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne

To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycle with mild degree of post - adolescence acne
* agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively.

Exclusion Criteria:

* Pregnancy or lactation
* Other active rashes on faces.
* Allergic to ketoconazole or other ingredients of preparation.
* Signs of hyperandrogenism
* Taking anti-androgenic medications.
A Prospective Clinical Trial Comparing Serum Mast Cell Tryptase (SMCT) Levels to Arthrofibrosis Rates Among Primary Total Knee Arthroplasty (TKA) Patients

This research is being done to see if the amount of an enzyme in blood (called serum mast cell tryptase) changes before and after surgery. The investigators would like to see if these amounts are related to knee stiffness and pain in subjects that undergo a total knee replacement.

Arthrofibrosis (AF), characterized by pain and limited mobility, affects a notable percentage of patients post-total knee arthroplasty (TKA). Despite various treatment advancements, the condition remains challenging to manage. Prior research has indicated a relationship between elevated serum mast cell tryptase (SMCT) levels and increased fibrosis in animal models, suggesting that SMCT could serve as a biomarker for arthrofibrosis in humans. This study aims to 1) assess pre- and postoperative SMCT levels in TKA patients, 2) evaluate SMCT's association with arthrofibrosis and clinical outcomes, and 3) determine the impact of allergic or inflammatory co-morbidities on SMCT levels.

Eligibility Criteria:
Inclusion Criteria:

* Investigators will include all patients with osteoarthritis who are surgical candidates for primary TKA. Investigators will include all eligible male or female patients between the ages of 20 years to 100 years old. All included study participants must be able to give an informed consent.

Exclusion Criteria:

* Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
* Patients taking mast cell inhibitors and/or degranulation inhibitors for any reason.
* The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
* Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
* Presence of previous prosthetic knee replacement devices (of any type)
* Metastatic disease
* Psychiatric illness
* Drug or alcohol abuse
* Inability to participate in standard postoperative rehabilitation protocol
CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells

The purpose of this study is to collect data on the safety and potential effectiveness of 2nd generation designer T cells delivered into the hepatic circulation in patients with liver metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen, CEA. These modified cells are then given back into the participant so that they can attack and kill tumor cells. The investigators hypothesize that regional delivery of the designer T cells directly into the hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic effect.

T cells have the power to destroy malignant cells under certain conditions, as demonstrated by the rare spontaneous remissions of cancer. However, the endogenous T cell response to cancer fails in the vast majority of patients and the tolerogenic conditions within the liver may pose additional immunologic barriers for those with intrahepatic metastases. The investigators modify patient T cells to kill malignant cells based on their expression of tumor antigens using antibody-defined recognition. The investigators will achieve this by preparing chimeric IgCD28TCR genes in mammalian expression vectors to yield "designer T cells" from normal patient cells. Prior studies in model systems demonstrated that recombinant IgCD28TCR could direct modified T cells to respond to antigen targets with IL2 secretion, cellular proliferation, and cytotoxicity - the hallmarks of an effective, self-sustaining immune response.

The present trial will test the regional infusion of anti-CEA designer T cells, given via the hepatic artery using a percutaneous approach. This is an intra-patient dose escalation trial, where patients will receive three doses over the course of six weeks. Doses are 10\^8, 10\^9 and 10\^10 modified T cells. Patients are monitored for safety and response. Patients are on-study for one month after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of CEA+ adenocarcinoma and liver metastases
* Liver metastases must be CEA-expressing as demonstrated by elevated serum CEA levels (≥10ng/ml) or immunohistochemistry on a biopsy specimen
* Failure on at least one line of standard systemic chemotherapy and have unresectable liver disease
* Measurable liver disease (\> 1.0 cm by CT or MRI)
* Extrahepatic disease is acceptable when limited to the lungs and/or abdominal lymph nodes
* At least 18 years of age
* Able to understand and sign informed consent
* Life expectancy of greater than four months
* Good performance status (PS 0-1)

Exclusion Criteria:

* Pregnancy
* Serious medical conditions including but not limited to liver, cardiopulmonary, and renal disease
* Patients with a history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis
* Concurrent malignancy
* Use of systemic steroids