cyrilzakka/clinical-trials huggingface dataset:
Integrin α6-targeted SPECT Imaging of Breast Cancer

A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.

Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.

Eligibility Criteria:
Inclusion criteria:

* Healthy volunteers.
* Body mass index (BMI) at 19 to 25 \[Body mass index = body weight (kg)/ height squared (m2)\];
* Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance;
* Informed written consents were obtained from all 9 subjects before the procedure.
* Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information.

Exclution Criteria:

• The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.
Treatment for Borderline Personality Disorder

This study will expose patients to either a Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) to determine the more effective therapy for treating borderline personality disorder.

Participants are randomly assigned to receive either Systems Training for Emotional Predictability and Problem Solving (STEPPS) or treatment as usual (TAU) for 20 weeks. STEPPS is a new cognitive behavioral treatment which involves skills training for emotion management and lifestyle behaviors as well as education for the affected individual's family members, friends, and professional caregivers. Participants are assessed at baseline and Weeks 4, 8, 12, 16, and 20. Interviews of patient's health care providers and family members and self-rating scales are used to assess patients. Follow-up assessments are made 1, 3, 6, 9, and 12 months after study completion. Participants must live within a reasonable driving distance of Iowa City, IA.

Eligibility Criteria:
Inclusion Criteria:

* Borderline Personality Disorder
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.

The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs. Anticipated enrollment is 530 live births.

Eligibility Criteria:
Inclusion Criteria:

* Woman ≥ 18 and ≤ 50 years of age at time of conception
* Diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception)

Cohort 1

* Exposure to relugolix combination therapy at any time during pregnancy

Cohort 2

* No exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy)

Exclusion Criteria:

* Exposure to known teratogens during pregnancy
* \< 6 months of continuous healthcare coverage immediately prior to date of conception
A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy.

This study intends to study the safety and tolerance of the combination of pyruvate, creatine, and niacinamide over 6 months in patients with PSP.

There are no effective symptomatic or biologic treatments for progressive supranuclear palsy (PSP), a relatively rare neurodegenerative disease that presents late in life with relentless progressive postural balance disturbances, non-levodopa responsive parkinsonism, supranuclear vertical gaze palsy, pseudobulbar palsy, and frontal behavioral and dysexecutive symptoms. In light of currently proposed etiopathogenic mechanisms in PSP and based on successful experiments inhibiting cellular neurotoxicity, it is hypothesized that preservation of brain energy homeostasis may allow endogenous neuroprotective mechanisms to reverse or impede free radical injury or other neurotoxic events leading to neurodegeneration in this disease. An emerging literature has described the neuroprotective effects of pyruvate, (as a neuronal energy fuel and free radical scavenger); niacinamide, (which boosts cofactor NAD), and creatine, (which buffers and selectively parcels cellular energy utilization) in various animal models of brain injury or degeneration.

Ajay Verma et al. have further demonstrated a synergistic neuroprotective effect of these three nutrients in various neural injury models. We thus propose using these nutrients as a novel and safe neuroprotective approach for treating PSP patients. This randomized, double-blind, placebo, control pilot study will test the safety and tolerance of this nutrient combination over 6 months in patients with PSP, and will measure their transport across the blood brain barrier. In addition to clinical and neuropsychological outcome measures, brain creatine will also be evaluated using magnetic resonance spectroscopy before and after therapy

Eligibility Criteria:
Inclusion Criteria:

* All subjects must meet the clinically definite or probable NINDS-SPSP PSP diagnostic research criteria that includes the presence of postural instability at disease onset, as well as supranuclear vertical ophthalmoparesis.
* All subjects must be able to tolerate oral feedings and be ambulatory
* All subjects or their caregivers must be able to read and understand the consent

Exclusion Criteria:

* Any contraindications to the use of pyruvate, creatine, and niacinamide
* the presence of a medical condition that can reasonably be expected to subject the patient to unwarranted risk or require frequent changes in medication.
* Pregnancy, nursing, or lack of effective contraception, if still at child-bearing age.
* History of prior sever traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury, which will interfere with outcome evaluation, in the opinion of the local principal investigator
* Subject unable to discontinue prohibited medication, which includes antiparkinsonian medications with potential neuroprotective effects such as amantadine, deprenyl, and vitamin E supplements \> 400 IU per day.
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.

This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I) injection in Chinese Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Chinese male or female who has agreed to sign and date the written informed consent form
* Age 18-70 years
* Body mass index (BMI) of 18-30 kg/m\^2
* General good state of health as judged by a qualified physician after completing physical examination
* Fit, co-operative, and able to provide consent

Exclusion Criteria:

* Sensitivity to DaTSCAN™ ioflupane (123I) injection or any of its ingredients
* A history of motor disturbances
* A history of pulmonary, cardiovascular, neurological, renal or hepatic, hormonal or coagulation disorders or hyperthyroidism
* A history of drug, alcohol, or solvent abuse
* The subject has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening
* Radionuclide injection within a minimum of 5 radioactive half-lives prior to screening
* Use of any medication (except paracetamol \[acetaminophen\] or oral contraceptive), including traditional Chinese medicine, within 2 weeks prior to the imaging visit
* Classification as a radiation worker
* Women of child-bearing potential not accepting a highly effective method of birth control (A woman is considered of child-bearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as 12 months with no menses without an alternative medical cause, in International Council on Harmonisation (ICH) M3 (R2); A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner, in ICH M3 (R2).
* Pregnant or lactating women
Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy

After being given informed consent, all participants will undergo the fitting and trial of a specially designed head protection for 6 weeks. Week 1 participants will be assessed and clinical data obtained on participants condition with the head protection fitted during the same session. Participants will return after 3 weeks for review and adjustment and again at the 6 week interval where they will also be given a questionnaire to fill up regarding their use and comfort.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible if they are 21 years or above and have had a DC \>30 days, no wounds, able to understand simple commands and have a primary caregiver

Exclusion Criteria:

* Exclusion criteria are patients with severe cognitive impairment, wounds, \> unilateral DC, no caregiver
Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.


Eligibility Criteria:
Cases (Bladder cancer \[BCa\])

Inclusion Criteria:

* Primary BCa diagnosis at cystoscopy, planned for TURB

Exclusion Criteria:

* No histopathological diagnosis of BCaTa-T4 N0-2 MX-0 after TURB

Controls (No evidence of disease \[NED\])

Inclusion Criteria:

* In follow-up with cystoscopy after treatment Ta-T3 N0-2 M0 BCa or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion
* No history of cancer except urothelial

Exclusion Criteria:

* Positive cytology at inclusion visit
* Intravesical instillation therapy during 6 months prior to inclusion visit
Description of the Ability to Learn How to Handle Inhaler Devices in COPD

Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination:

* long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone),
* long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium).

These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.

The correct use of inhaler devices is an inclusion criterion in COPD clinical trials. In real life, patients may make many errors using their own inhaler device, which may alter the positive effects observed in clinical trials.

The main objective of this study is to describe the handling of inhaler devices (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) in patients with COPD.

All participants will receive each of the three treatments (Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg). Each treatment will be given daily for one week, followed by a 7-day washout period.

On day 1 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 2 video recordings:

* Video recording #1: inhalation (one puff) without any instruction of use,
* Video recording #2: inhalation (one puff) after reading the patient information leaflet.

At the end of the visit, the patient will watch a standardized video demonstrating correct inhaler technique.

On day 7 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 1 video recording of inhaler device use (one puff).

30 days after the last visit, the patient will have a phone contact to collect the adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged more than 40 years,
* Written informed consent,
* Diagnosis of COPD according to international guidelines (GOLD 2012),
* Social security or health insurance,
* Women of childbearing potential with a very effective contraception according to the Haute Autorité de Santé (HAS) recommendations.

Exclusion Criteria:

* Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,
* QT ≥ 450 ms,
* Contraindications to tiotropium: hypersensitivity to tiotropium,
* Contraindications to indacatérol: hypersensitivity to indacatérol,
* Contraindications to salmeterol: hypersensitivity to salmeterol,
* Contraindications to fluticasone: hypersensitivity to fluticasone,
* Contraindications to glycopyrronium: hypersensitivity to glycopyrronium,
* COPD exacerbation within 6 weeks before inclusion,
* Chronic psychiatric disease,
* Medical condition that may affect handling of inhaler devices,
* Subject deprived of his/her liberty,
* Protected adult,
* Subject in exclusion period related to another protocol,
* Pregnant or breastfeeding woman
Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial

Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis. Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage. Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, radiographically proven degenerative joint disease in the hip or knee

Exclusion Criteria:

* recent injection in the hip or knee within the previous 3 months
* history of traumatic osteoarthritis or ligamentous reconstruction
* chronic narcotic use
* history of inflammatory or neuropathic arthropathy
* pregnant and/or nursing women
* allergy or strong reaction to study medications
Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage

Pneumococcus is a major cause of morbidity and mortality. In 2000, a pneumococcal conjugate vaccine (PCV) was licensed for use in children and is now part of the routine childhood vaccine schedule. PCV is known to reduce invasive disease and protect against nasopharyngeal (NP) acquisition of vaccine serotype pneumococci; it also results in an increased risk of nonvaccine serotype carriage. This study proposes to assess the longterm impact of vaccine on NP carriage in a setting where there is intense antibody pressure on the ecology of the pneumococcus. A cross sectional study of pneumococcal NP colonization among American Indian children will be combined with surveillance for invasive disease in the same population. The purpose is to determine the impact of community wide PCV use on NP colonization and the relationship with invasive disease. This longterm safety issue needs to be assessed to fully evaluate the impact of vaccine on NP ecology and invasive disease.

There are four specific aims for this study: (1) to determine the overall and serotype specific prevalence and incidence of pneumococcal carriage among children and adults at high risk for carriage and disease in the era of routine pneumococcal conjugate vaccine (PCV) use compared with those measures in the same population prior to use of PCV vaccine; (2) to characterize the intrafamilial NP transmission of clones among those living with children less than 8 years of age; (3) to determine the immune correlates of protection from serotype specific pneumococcal carriage among individuals immunized and not immunized with PCV; and (4) to determine the relative invasiveness of serotypes of pneumococcus during an era of widespread PCV use and compare this to the relative invasiveness of serotypes prior to routine use of PCV.

Eligibility Criteria:
Inclusion Criteria for the Family to Participate.

1. At least one parent is a member of the Navajo or White Mountain Apache Tribe
2. Family home is on or near the Navajo or Apache reservation
3. At least one child in the household is 8 years of age or younger (minimum age of eligibility: birth)
4. At least one child in the household is fully immunized with Prevnar.
5. At least two people in the household will participate in the study
6. Willingness to participate for a 6-month time period

Exclusion Criteria for the Family to Participate.

1. Family will be moving off reservation during the study period

Inclusion Criteria for Individuals.

1. Living in the household
2. Willing to participate for a 6-month time period

Exclusion Criteria for Individuals.

1. Congenital anomalies of the nasopharynx

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Accelerated Resolution Therapy (ART) for Psychological Trauma

Service members and veterans often experience symptoms of psychological trauma following combat deployments. While efforts are being made in the military and at the Veteran's Affairs to meet the large number of soldiers and veterans experiencing symptoms of psychological trauma, there remains a need to evaluate new treatments, particularly those that are designed to be brief in length.

A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological therapy that is designed for rapid resolution of symptoms of psychological trauma. This approach uses a combination of talking and sets of eye movements guided by the therapist. During therapy, this interactive personal guidance is thought to be helpful in resolving problems (such as bad memories).

The purpose of this study is to:

1. Evaluate how effective ART is in treating symptoms of psychological trauma among non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring Freedom in Iraq and in Afghanistan or other combat conflicts.
2. Learn if there is improvement in symptoms of psychological trauma (such as bad memories, anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).


Eligibility Criteria:
Inclusion Criteria:

* Non-active duty U.S. veteran of any prior deployment(s) with recruitment emphasis on those who previously served in Iraq and/or Afghanistan (OIF and OEF).
* At least 18 years of age.
* Symptoms indicative of psychological trauma. This includes a score of \>40 on the PCL-M Checklist, or in the absence of a score \>40, therapist assessment of symptoms of PTSD, as determined from the Checklist for Accelerated Resolution Therapy (ART) Standard Protocol. Individuals with previous treatment for psychological trauma, yet with residual symptoms, will be eligible.
* Ability to read and speak English to complete survey questions.
* Denial of suicidal ideation or intent, including homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis

Exclusion Criteria:

* Brain injury prohibiting speech, writing, and purposeful actions
* Identified to have current suicidal ideation
* Major psychiatric disorder concomitant to symptoms of psychological trauma
* Currently undergoing substance abuse treatment
* Previous diagnosis of eye movement disorder
* Any medical condition that, in the judgment of the Principal Investigator and/or ART therapist, may place the individual at high risk due to a potential heightened emotional reaction