cyrilzakka/clinical-trials huggingface dataset:
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Men or women the age of majority in their country
* Has pathologically documented breast cancer that:

  1. is unresectable or metastatic
  2. has HER2 positive expression confirmed per protocol
* Has an adequate tumor sample
* Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Has protocol-defined adequate cardiac, renal and hepatic function
* Agrees to follow protocol-defined method(s) of contraception

Exclusion Criteria:

* Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
* Has a corrected QT interval (QTc) prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females
* Has a medical history of clinically significant lung disease
* Is suspected to have certain other protocol-defined diseases based on imaging at screening period
* Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

  1. safety or well-being of the participant or offspring
  2. safety of study staff
  3. analysis of results
Education Program for Burn Patients

The purpose of this study is to assess the effect of an educative program including telephone follow-up for burn patients regarding the impact of this intervention on the health status and return to work at six months after hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* adult burned patients (18 years or older), male and female
* patients burned for the first time who needed hospitalization at the Burns Unit
* in cognitive conditions to participate (being able to tell one's address, day of the week and age or birth date)
* in physical conditions to accomplish self-care.

Exclusion Criteria:

* participants burned due to suicide or with previous psychiatric diagnoses or cognitive and psychological difficulties that do not allow them to answer the instrument questions and take care of themselves.
Invictus Medical, Medical Cranial Support Device (CSD) is a Device Safety Study in Infants at Risk of Head Ulcers.

While using the device as a cushion, the passive distribution of pressure over bony skull prominences of infants will protect against formation of pressure ulcers.

This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU. Specifically, this study will:

* Collect safety information at specified time points (baseline, 15 minutes, 1 hour, 3 hours, and 6 hours) utilizing a widely used dermal assessment tool, health assessments (temperature, pulse, respiration rate), excessive scalp sweating/moisture accumulation, and adverse events, as reflected in the Table 1.0, Time and Events Table.

Additional safety assessments will be performed following the final removal of the CSD from the infants head. Refer to Table 1.0 Time and Events Table and section 6.1.

* Assess the HCP's impression of likely safety and effectiveness (Function Assessments) of the CSD based on experience working with infants in the NICU, Evaluate/Rate the form and fit, and evaluate/rate the ease of application of the product.
* Collect additional feedback (if any) on HCP's impressions of device design and usability based on experience working as a HCP in the NICU

Eligibility Criteria:
Inclusion Criteria:

1. Have a parent(s) or guardian(s) who has provided written informed consent for the patient to participate in the study.
2. Be \> 30.0 weeks gestational age at time of enrollment into the study
3. Be in medically stable condition within the NICU
4. Be able to breathe adequately on room air without support
5. Be deemed suitable (i.e., in no acute distress) for participating in the study for approximately six (6) hours, in the investigator's opinion
6. Upon visual inspection have intact skin without breaks and/or lacerations of the scalp or adjacent areas where the CSD will fit

Exclusion Criteria:

1. The use of any additional respiratory support (i.e., intubation, using CPAP, etc.) is required,
2. The patient has any genetic dermatological conditions
3. The patient's head size is not appropriate for the device \< 28 centimeters or \>34.3 centimeters (\< 11 or \> 13.5 inches)
4. Patient has significant medical condition(s) (e.g., encephalocele, IVH, Shunt, etc.) that makes participating in the study not in the patient's best interest
Apomorphine Effects on Experimental Pain

The aims of this study were to assess the effects of the dopamine agonist apomorphine on experimental pain models in healthy subjects and to explore the possible association between these effects and a common polymorphism within the dopamine transporter gene.

Healthy volunteers (n=105) participated in this randomized double-blind, placebo-controlled, cross-over trial. Heat pain threshold and intensity, cold pain threshold, and the response to tonic cold pain (latency, intensity, and tolerance) were evaluated before and for up to 120 min after the administration of 1.5 mg apomorphine/placebo. A polymorphism (DAT-1) within the dopamine transporter gene (SLC6A3) was investigated.

Eligibility Criteria:
Inclusion Criteria:

- healthy and free from chronic pain of any type did not use any medications other than oral contraceptives were able to understand the purpose and instructions of the study.

Exclusion Criteria:

- any type of medical or painful condition use of medications or recreational drugs pregnancy.
Phase 2 Study of TMX-049 in Subjects With Type 2 Diabetes and Albuminuria

The primary objective of this study is to assess the effect of 2 dose levels of TMX-049 on urinary albumin excretion in subjects with Type 2 diabetes and albuminuria (a urinary albumin-to-creatinine ratio (UACR) 200 to 3000 mg/g and an estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2). Effects of each TMX-049 dose on UACR will be assessed in terms of ratios using log-transformed UACR at Baseline and after a 12-week period of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with ≥1 glucose-lowering medication for at least 12 months
* UACR 200 to 3000 mg/g
* eGFR ≥30 ml/min/1.73m2
* Treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB), but not both

Exclusion Criteria:

* History of Type 1 diabetes
* Women who are breast feeding
* Treatment with any uric acid-lowering therapy within previous 2 weeks
* History of intolerance to any XO (xanthine oxidase) inhibitor
* History of a gout flare requiring pharmacologic treatment
* History or presence of tophaceous gout
* History of immunosuppressant treatment for any known or suspected renal disorder
* History of a non-diabetic form of renal disease
* Glycosylated hemoglobin (HbA1c) \>11%
* sUA \<4.0 mg/dL or \>10.0 mg/dL
* Positive urinary pregnancy test
* Dialysis for acute renal failure within previous 6 months
* Renal allograft in place or a scheduled kidney transplant within the next 22 weeks
* Congenital or acquired solitary kidney
Quality and Behavior of Pelvic Floor in Runner Women

The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race.

Introduction: Women are more likely to suffer injuries in the Pelvic Floor (PF) and Urinary Incontinence (UI) because of their anatomical characteristics. Their participation in the sports field has been more active recently. There are studies that correlate the race with presenting weakness of the SP muscles and Stress Urinary Incontinence (SUI), so the race is considers as a risk factor for these affectations. However, there are few studies of real-time measurements during running. Some runners may even present SUI during daily activities (ADL). The UI is not only a physical problem but also affects the social, emotional, psychological, sexual and professional level and may even lower their self-esteem or renounce the physical activity.

Objectives: The purpose of this study is to perform measurements of different variables in real time while running and in their ADL. The main objective is to analyze the relationship between the PF muscles and the other variables along the different tasks of daily life and during the race. The secondary objectives are to differentiate these neuromuscular, physiological and biomechanical responses of PF and abdominal girdle (AG) according to the type of stroke, duration, intensity and distance. And compare results between both group (interventional group and no interventional group).

Material and method: Randomized clinical trial will be performed with 59 female runners aged 25-44 years. The sample will be divided into two groups randomly. The study will be carried out health center called "Tiro de Pichón" in Málaga.

Eligibility Criteria:
Inclusion Criteria:

* Healthy woman between 25 and 44 years old.
* Women not pregnant.
* Women who run at least 10 km / week.
* In case of having children, it has to be 12 months after childbirth, having had the first postpartum menstruation and having left breastfeeding.

Exclusion Criteria:

* Women Pregnant or suspected of it.
* Postpartum less than one year.
* Having the period during the exploration for the classification in groups or during the day of the measurements.
* Present operation in the urogenital region as well as any visceral or spinal operation.
* Urinary tract and/or vaginal infections.
* Vaginal lesions; anorectal lesions or bleeding.
* Women with gynecological bleeding; urethral obstruction; fistulas; malformations (ectopic ureter, etc); genital prolapse.
* Women with pain in Pelvic Floor or lower limbs or back.
* Pain during the race.
* Allergy to silver, nickel and/or latex.
The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy

Purpose This cardiac dysfunction in patients with Duchenne muscular dystrophy is associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). The purpose of this study is to investigate whether the administration of Carvedilol can suppress the minor cardiac damage and prevent deterioration of cardiac function.

The life span in patients with Duchenne muscular dystrophy has been extending due to the development of artificial respiratory devices. According to that, the ratio of cardiac dysfunction as a cause of death has been increasing. This cardiac dysfunction was associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). Furthermore, and the detection rate of cTnI plasma as revealed to be correlated with the deterioration speed of LV dysfunction assessed by serial echocardiography measurements. Accordingly, if this minor cardiac damage is suppressed, it is postulated that the progression of cardiac dysfunction can be stopped. In the cases with ventricular arrhythmia and tachycardia, we found plasma cTnI became undetectable after administration of beta-blocker. Accordingly, we investigate whether administration of beta-blocker, carvedilol can persistently suppress the minor cardiac damage and lead to suppress the deterioration of LV function. Note that his study preventive study for preserved to moderate LV dysfunction and is not intended to the beta-blocker treatment for severe LV dysfunction. Because we assume that the mechanism of elevation of cTnI is different; spontaneous in preserved to mild LV dysfunction in patients but LV wall stress in severe LV dysfunction in patients with Duchenne muscular dystrophy.

Eligibility Criteria:
Inclusion Criteria:

Male patients with Duchenne muscular dystrophy are required to meet the following criteria:

1. Aged ８ to 45 years
2. Positive plasma cardiac troponin I (0.06ng/mL) at least 4 blood measurement in every 3 month.
3. Left ventricular ejection fraction \>30% by echocardiography assessment
4. Written informed consent

Exclusion Criteria:

Patients with the following conditions will be excluded from the study:

1. Left ventricular ejection fraction \<30%
2. No plasma cTnI elevation
3. beta-blocker is already administered without measurement of plasma cTnI
4. Contraindication against treatment with β blockers
5. Any other serious disease that could potentially complicate the management and follow-up protocols
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.


Eligibility Criteria:
Inclusion criteria:

* Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:

  1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
  2. liver biopsy consistent with chronic HCV infection.
* HCV infection of genotype 1 confirmed by genotypic testing at screening
* Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
* Plasma HCV RNA = 100,000 IU/mL at screening

Exclusion criteria:

* Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
* Human immunodeficiency virus (HIV) co-infection
* Decompensated liver disease, or history of decompensated liver disease
* Body weight \< 40 or \> 125 kg at screening
* Hemoglobin \<12.0g/dL for women and \<13.0g/dL for men at screening
* White blood cell count \<3000 cells/mm3 at screening
* Absolute neutrophil count \< 1,500 cells/mm3 at screening
* Platelet count \< 90,000 /mm3 at screening
* Serum creatinine \> 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening
Fractional Laser and Ultrasound for Striae Distensae

This was a prospective randomized controlled study comparing the efficacy of micro-focused ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus 1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch marks).

Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.

The primary outcome measure by two dermatologists blindly compared the two areas of striae distensae on each side from live subjects using a questionnaire and quartile rating scale on the final follow-up visit.

This study was a pilot study designed to determine the feasibility of these procedures.

The secondary outcomes were qualitative measurements of the mean striae width in the treatment area before(week0) and after treatment(week10) and subject satisfaction was determined by a satisfaction questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old male and female subjects with striae distensae on both thighs or both sides of the abdomen.
* Subjects are in good health.
* Subjects are willing, have the ability to understand and provide informed consent, and are able to communicate with the investigator.
* Subjects should be within a 20 lb range of their starting weight during in the study period.

Exclusion Criteria:

* Pregnant or lactating
* Subjects who are unable to understand the protocol or give informed consent.
* Subjects currently under treatment with corticosteroids for any medical problems or subjects who discontinued treatment less than 2 months prior to consent.
* Subjects who have had medical e.g usage of oral or topical retinoids, laser or surgical treatment for striae distensae within the last year.
* Subjects who have active skin disease or skin infection in the treatment area.
* Subjects who are allergic to lidocaine or prilocaine.
* Subjects who have a history of abnormal scarring.
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

In this study the treatment group will include all patients receiving MILD, and the control group will include all patients receiving IPD for the treatment of LSS during the enrollment period. Reoperation and harms data will be studied for the MILD and IPD procedures for a 24-month follow-up period after the index procedure using Medicare claims data. This study is exempt from IRB oversight (Department of Health and Human Services regulations 45 CFR 46) and does not require prior enrollment nor patient consent. The inclusion of the study's NCT number on MILD Medicare claims is required and results in enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Medicare beneficiaries receiving MILD or interspinous process decompression
* Diagnosis of LSS with NC

Exclusion Criteria:

* Patients that have received a laminectomy, laminotomy, fusion, interspinous process decompression, or MILD in the lumbar region during the 12 months prior to the index date
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.

Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification
* Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy
* Negative post-chemotherapy (or interim) PET scan
* Absolute neutrophil count greater than 1500 and platelet count greater than 40,000
* Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

* The patient is compliant on combination anti-retroviral therapy (CART)
* The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion Criteria:

* Any contraindications to irradiation
* Primary CNS lymphoma
* HIV/AIDS
3D Craniofacial Cephalometric Analysis

Development of three-dimensional craniofacial cephalometric analysis for virtual planning in orthognathic surgery.

Cone beam computed tomography is taken for diagnosis independently from this study. Investigators are using this medical imaging for performing the 3D cephalometric analysis. Investigators apply a set of well described landmarks of three-dimensional reconstruction of the skull from patients suffering from diverse craniofacial malformations. Then a set of specific measurements is taken from the patient and provide insights how to modify the anatomy of the patient to improve the skull's architecture and symmetry

Eligibility Criteria:
Inclusion Criteria:

* maxillomandibular dysmorphoses,
* facial asymmetry,
* craniofacial syndromes

Exclusion Criteria:

* patients with orthodontic treatment only
* growing patients
Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis \>75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* planned TAVI implantation
* Age ≥ 60
* Intelligence quotient \> 80
* Sufficient knowledge of German
* Normal or corrected vision and hearing

Exclusion Criteria:

* Serious neurological or psychiatric diseases that make participation in the trial procedure impossible
* Oncological disease with a life expectancy \< 12 months
* pregnancy