cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye

The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have provided written informed consent
* Have dry eye in both eyes

Exclusion Criteria:

* Use of contact lenses
* Have an uncontrolled systemic disease
* Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
* Women who is pregnant, nursing or planning a pregnancy
Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM

The study has the following primary aims: (1) to test whether participants assigned to CNU (a 7-session, manualized intervention entitled "Connect 'n Unite") engage in lower HIV/STI behavioral risk compared to participants assigned to WP (a wellness promotion attention control condition); (2) to test whether participants assigned to CNU have lower cumulative incidence of STIs-chlamydia and gonorrhea-confirmed via biological assay compared to participants assigned to WP; and (3) to test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.

This study addresses the overrepresentation of the African American/Black community among those living with HIV/AIDS in the U.S. as well as men who have sex with men (MSM), the transmission category that accounts for the majority of HIV infections. In the absence of a vaccine or cure for HIV infection, behavioral risk reduction represents the best public health tool for prevention of HIV transmission. The proposed randomized clinical trial will rigorously test an innovative, couples-based intervention targeting the intersection of stimulant use and sexual risk behavior among racial/ethnic and sexual minorities, with the ultimate goal providing an evidence-based intervention that can be delivered in drug treatment and other service settings to reduce the spread of HIV among stimulant-using, African American/Black MSM.

Eligibility Criteria:
Inclusion Criteria:

* Male
* At least 18 years old
* Report having a "primary/main male partner" operationalized as a male with whom he has had an ongoing sexual relationship over the prior 6 months and has an emotional bond with more than any person
* Self-identify as African American and/or Black, or identify having a main partner who self-identifies in this manner
* Report using a illicit use of psychostimulant and/or psychoactive drugs in the past 90 days (or has a main male partner who meets this criterion)
* Report having unprotected anal sex with a man who is a non-main partner in the past 90 days (or has a main male partner who meets this criterion)
* Identify each other as their main partner

Exclusion Criteria:

* Either partner reports the occurrence of ≥1 incident of severe intimate partner violence (IPV) within the relationship in the past year as assessed using the Revised Conflict Tactics Scales
* Either partner has a language or cognitive impairment that prevents comprehension of study procedures as assessed during informed consent
* Either partner reports being currently involved (i.e., has not completed the final follow-up assessment) in an HIV prevention research study
Evaluation of Parturients With Anxiety

The primary objective of this study is to examine the effects of cognitive bias modification for interpretation (CBM-I) on prenatal anxiety in parturients. Half of the participants will receive CBM-I assignments, while the other half will receive placebo assignments.

Maternal prenatal anxiety has been shown to have implications on neonatal behavior and early childhood behavioral and emotional wellbeing. Recent studies found that adults using computer-assisted feedback-learning paradigms, referred to as Cognitive Bias Modification for Interpretation (CBM-I), experienced significant reductions in levels of social anxiety, trait anxiety, and depression. Our goal is to identify patients with prenatal anxiety and evaluate the effects of CBM-I on symptoms of prenatal anxiety and patient satisfaction with the labor and delivery experience.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Women before 36-week gestation
* At least high school level education

Exclusion Criteria:

* They refuse
* Have impaired decision-making capacity
* Are blind or extremely visually impaired (excluding use of glasses)
* Cannot understand or read English
* Diagnosed with psychiatric disorder other than anxiety
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)

The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects with histological confirmation of RCC
* Advanced or metastatic disease
* Measurable disease as defined by RECIST 1.1 criteria
* Karnofsky Performance Status (KPS) ≥80%
* Available tumor tissue (archival or recent acquisition)
* Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have received any prior systemic therapy for RCC with the following exceptions:

  1. One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred ≥ 6 months after the last dose of the adjuvant or neoadjuvant therapy
  2. Only prior cytokine based treatment for metastatic RCC \[eg, interferon-alpha (IFN-alpha) or interleukin 2 (IL-2)\] as prior therapy is allowed

Exclusion Criteria:

* Active central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation
* History of cerebrovascular accident including transient ischemic attack within the past 12 months
* History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months
* Chronic systemic steroids (\>10 mg/day Prednisone equivalents) or any other immunosuppressive agents
* White blood cell (WBC) \<2,000/mm3
* Neutrophiles \<1,500/mm3
* Platelets \<100,000/mm3
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x upper limit of normal (ULN)
* Total Bilirubin \>1.5x ULN (except subjects with Gilbert syndrome, total bilirubin \<3.0 mg/dL)
* Cardiac ejection fraction \<LLN (lower limit of normal)
* Serum creatinine \>1.5x ULN or creatinine clearance \<40 mL/min (Cockroft-Gault formula)

Exclusion Criteria for Arm S and Arm P only:

* For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and required permanent discontinuation due to toxicity or required dose reduction or delay during the first 12 weeks of therapy due to toxicity, or received both prior Sunitinib and Pazopanib
* Poorly controlled hypertension
* Active bleeding or bleeding susceptibility
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI

comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.

In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection

All patients are informed that they are going to receive topical anaesthetic agent before the IVI.

pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.

Eligibility Criteria:
Inclusion Criteria:

* All patients between 30 to 70 years

Exclusion Criteria:

* uncooperative patients
Measurement and Analysis of Gas Composition in Digestive Tract

The purpose of this study is to detect the concentration of various gases，including hydrogen, methane, hydrogen sulfide, nitric oxide in different parts of the digestive tract by a safe and direct method, and to establish a human digestive tract gas profiles. Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 70 years.
* Patients undergoing endoscopic examination

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
* Patients have history of gastrointestinal surgery
* Patients who failed to complete the endoscopic examination due to various reasons
* Patients Boston score of Bowel preparation≤ 6 points
* Patients who have medication history of probiotics, antibiotics, PPIs and prokinetic drugs in the last 4 weeks
* Patients who combined with thyroid disease and other diseases that affect gastrointestinal motility
* Patients who combined with other risk factors such as mental illness, alcoholism, and drug abuse
* Patients who unable or unwilling to provide informed consent
Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins

The study is designed to learn more about the causes of rheumatoid arthritis (RA). People who get RA have elevated protein markers called autoantibodies in their blood years before initial symptoms of arthritis. The goal of this study is to learn more about how autoantibodies in RA might be related to inflammation in the lungs.

The Specific Aims of This Study Are As Follows:

1. Identify whether sputum anti-CCP predicts incident RA
2. Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
3. Determine the role of sputum macrophage phagocytosis in NET clearance \<br\> The knowledge gained from this study will improve the overall understanding of the development of RA. It is anticipated that these findings will improve the field's understanding of how best to screen for RA risk and target RA prevention. This study could support future lung-targeted prevention strategies for RA that could avoid the administration of systemic toxic therapies. Such potential prevention interventions could be implemented in subjects at risk for RA in order to prevent the irreversible joint damage that can occur in the later stages of clinically-apparent RA.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 100 years;
* At-Risk for RA, RA diagnosed, and Healthy Control subjects will be included in the study until recruitment goals are met for each group.

At-Risk:

1. No evidence of inflammatory arthritis on clinical examination AND
2. At elevated risk for RA based on familial or serologic risk

   * Familial risk includes having a first degree relatives (FDRs) with RA
   * Serologic risk includes asymptomatic serum ACPA positivity

Healthy Controls :

1. No history of RA
2. No FDRs with RA
3. No systemic use of immunosuppressants for autoimmune disease

RA Diagnosis:

1. Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR
2. Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)

Exclusion Criteria:

1. Currently pregnant or planning to become pregnant during the sample collection period of the study
2. Exacerbation of underlying obstructive lung disease within the past 1 month
3. Known FEV1 \<1 liter
4. Oxygen requirement \>2 liters at rest
5. Participants with health acuity or behavioral health concerns leaving them unable to participate in the current research

Note: If a subject temporarily does not meet inclusion criteria but is interested in participating, he/she may participate once inclusion criteria have been met.

If interested, please take a few minutes to complete the screening questionnaire for this study opportunity. You may open the survey in your web browser by clicking the link below:

https://is.gd/SPAROscreen

If the link above does not work, try copying the link below into your web browser:

https://redcap.ucdenver.edu/surveys/?s=3WM8WH3WKK
Study of Tomotherapy in Patients With Benign Brain Tumour

Although malignant brain tumors are the most common type of primary brain tumor, there are a number of other benign brain tumors that exist. Many difficulties exist with treating these tumors that have led to controversies in the best treatment. A common issue among these brain tumors is the risk of long term side effects from treatment. What limits the use of curative radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the amount of radiation to the normal structures in the brain. A new method of delivering radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will be used in this study. It has the ability to deliver a high dose of radiation to the tumor while minimizing the amount of radiation to normal brain structures. This study will use this method of radiation therapy to deliver radiation and see if the long term side effects from radiation therapy can be reduced.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed newly diagnosed base of skull benign tumour
* Karnofsky Performance Status (KPS) equal to or greater than 70

Exclusion Criteria:

* Brain metastases or recurrent tumour
* Prior radiotherapy (RT) to head or neck
* No prior chemotherapy or radiosensitizer
Epidemiology of Diabetes Interventions and Complications (EDIC)

The Diabetes Control and Complications Trial (DCCT,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM) over a mean follow-up of 6.5 years. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. The level of glycemia was the primary determinant of complications. We also described the adverse effects of intensive therapy; assessed its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. After the primary DCCT results were reported in 1993, intensive therapy aiming for a HbA1c \<7% was adopted world-wide as standard-of-care for T1DM.

The Epidemiology of Diabetes Interventions and Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort. Micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for \~15 years despite the convergence of HbA1c levels in the two groups during EDIC, a novel concept termed metabolic memory. Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality.

The overarching goals for the current cycle (2022-2027) are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. With increasing longevity, the increased adiposity that has affected patients with T1DM, including EDIC participants, has potential adverse consequences. Thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. The results will guide treatment priorities as T1DM patients age.


Eligibility Criteria:
Participants originally enrolled in the Diabetes Control and Complications Trial (DCCT) (N01-DK-6-2204-A).
Protein Supplements to Cyclists

To investigate the effect of marine peptide combined with dietary protein on the capacity to recover after exhaustive endurance cycling as measured by exercise capacity and blood glucose homeostasis.

The current study uses cyclists as test subjects since they represent a physical demanding sport requiring both high endurance capacity and muscle strength. In the recovery phase following exhaustive physical activity there is a need both for rebuilding the muscle energy stores, for muscle repair and for compensatory muscle cell development. Therefore, marine peptide combined with dietary protein will be given in order to examine the capacity to recover after exhaustive endurance cycling.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed Consent
* The subject is a man between 40-50 years
* The subject has a body mass index (BMI) between 19-29
* Willing to comply with all study procedures and be available for the length of the study
* In good general health as judged by the physician at the screening visit

Exclusion Criteria:

* The subject has had surgery or trauma with significant blood loss or has donated blood within the last 3 months prior to the screening visit
* Diabetes type 1 or 2, or persistent high blood sugar levels
* The subject has tested positive for human immunodeficiency virus (HIV)
* Hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
* The subject has taken any investigational drugs within 1 month prior to screening
* Treated with antibiotics within 3 months prior to screening (oral, parenteral or rectal), but not spray or ointment
* Treated with steroids within 1 month prior to screening (including oral treatment)
* Treated with medication that effects the intestinal function such as, H2- protonpump inhibitors, diuretics, antiemetics, antidepressants, antacids,
Genomics in Michigan Impacting Observation or Radiation

To determine the impact of Decipher test results on adjuvant treatment decisions of high-risk post-RP patients with undetectable post-op prostate specific antigen (PSA) compared to clinical factors alone.

This prospective, randomized trial will compare the receipt of adjuvant therapy for high-risk radical prostatectomy (RP) patients who undergo Decipher testing to those who do not. 350 subjects from within the statewide Michigan Urological Surgery Improvement Collaborative (MUSIC) will be randomized to either a Genomic Classifier (Decipher) or Usual-Care-Based (UC) strategy for a period of three months. If enrolled during the Genomic Classifier period, both subjects and their treating physician will be provided Decipher results and CAPRA-S scores. In the UC periods, CAPRA-S scores but not Decipher results will be provided.

The enrollment goal, initially and throughout the study, was to enroll 350 evaluable patients. During the study, the target accrual goal was raised to 550 patients to allow more flexibility among sites to achieve the enrollment goal of 350 evaluable patients.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients who have undergone radical prostatectomy
* PSA \< 0.1 ng/ml at enrollment
* At least one of the following:

  * pT3 (seminal vesicle invasion or extraprostatic extension), or
  * Positive surgical margins
* Radical prostatectomy within one year of enrollment

Exclusion Criteria:

* Individuals who have any of the following will not be eligible to participate:

  * Have regional or distant metastatic disease
  * Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
  * Node positive
Multi-Centre European Photopatch Test Study

It is known that people can develop an allergic skin reaction to a substance which is placed on the skin and then subjected to sunlight. This process is called Photocontact allergic dermatitis. It is known that people can develop Photocontact allergic dermatitis to sunscreen chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).

The purpose of this study is to determine the frequency of Photocontact allergic dermatitis to 19 sunscreen filters and 5 topical NSAIDs in 1,000 European patients who present to a dermatologist with a sun-exposed site dermatitis.

Each participant will have the 24 test agents plus one control of petrolatum applied to the skin of the back for 24 or 48 hours. After removal of the substances, the area of skin will be exposed to a precise amount of ultraviolet-A light. The area is then assessed 24, 48 and 72 hours later to see if a photocontact allergic reaction has occured. This method is known as photopatch testing.

The study will run for one year, during which time it is planned to recruit 1,000 patients.

Specific Intervention Names:

* Butyl-methoxy-dibenzoylmethane
* Homosalate
* Methylbenzylidene camphor
* Benzophenone-3
* Octyl methoxycinnamate
* Phenylbenzimidazol sulfonic acid
* Benzophenone 4
* Drometrizole trisiloxane
* Octocrylene
* Octyl salicylate
* Octyl triazone
* Isoamyl-p-methoxycinnamate
* Terephtalidene dicamphor sulphonic acid (Mexoryl SX)
* Tinosorb S
* Tinosorb M
* Univul A+
* Neoheliopan AP
* Uvasorb HEB
* Parsol SLX
* Ketoprofen 1%
* Etofenamate 2%
* Piroxicam 1%
* Diclofenac 5%
* Ibuprofen 5 %

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older.
* Have sufficient cognitive capacity to give written informed consent.
* Have an eruption on photo-exposed sites, which is to be further classified using one (or more) of the categories below:
* Known photosensitivity disease
* History of sunscreen reaction
* Sun exposed site dermatitis during summer months
* Any sun exposed site dermatitis problem

Exclusion Criteria:

* Male or female aged 17 years or younger
* Have had potent topical steroid applied to the photopatch test site on the back in the previous 5 days. (This potentially suppresses reactions which would otherwise have been visible)
* Have skin disease on the back which is too active to allow testing. (This obscures the sites of testing by making differentiation between a positive result and other skin disease difficult)
* Be prescribed systemic immunosuppressant medication (e.g. prednisolone, methotrexate, azathioprine, ciclosporin) (This potentially suppresses reactions which would otherwise have been visible)
* Be taking any photoactive medicine (for example thiazides, sulphonamide derivatives, amiodarone, fluoroquinolones, chlorpromazine, NSAIDs, quinine). (This is a relative exclusion. Many centres may wish to go ahead despite such medication).