cyrilzakka/clinical-trials huggingface dataset:
TMP-Visitas al Hogar

Treinta Millones de Palabras- Visitas al Hogar (TMP) is designed to intervene upon mothers' knowledge, beliefs, and behavior, which in turn influences their interaction with their children, impacting children's development. The investigators will measure change in mothers' knowledge, beliefs, and behavior during and after intervention, and measure impacts on children's development across major developmental domains. Specifically, the investigators will measure mothers'

1. Knowledge of child language development and the role of parents in that development
2. Beliefs about the malleability of intelligence and their role in shaping their children's intelligence
3. Interaction with their child, specifically their linguistic input and responsiveness to their child's communication

Concurrently, the investigators will measure children's

1. Emergent oral language development, in both Spanish and English
2. Social-emotional development
3. Math and spatial reasoning skill development


Eligibility Criteria:
Inclusion Criteria:

* participants (i.e. parents and their children) who live at or below 200% of the federal poverty line,
* female caregivers with a child between the ages of 24-30 months old,
* participants whose preferred home language is Spanish,
* education level is less than or equal to a bachelor's degree.

Exclusion Criteria:

* participants (i.e. parents and their children) who live over 200% of the federal poverty line,
* parents under the age of 18,
* non-female primary care giver
* children younger than 24 months old or older than 30 months old (at start of study),
* parents who do not have legal custody of their child,
* parents whose child does not live with them,
* parents who are not with their child at least two full days per week,
* parents who are unable to commit to the intervention requirements,
* foster parents,
* children with significant cognitive or physical impairments, (specifically Autism Spectrum Disorder, Epilepsy, Cerebral Palsy, hearing impairment, Down Syndrome and blindness),
* parents who have earned or are currently working toward a graduate or professional degree (e.g. M.A., M.S., M.B.A), and
* parents whose preferred home language is not Spanish.
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures

The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization.

We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 or older
* Good general health, based on the opinion of the investigator
* Voluntarily requesting permanent sterilization
* Negative pregnancy test
* Agree to premedication with ibuprofen and ativan
* English speaking, or other language if an interpreter is available to be present at all points of the study procedure.
* Willing and able to sign an informed consent
* Willing to comply with the terms of the study

Exclusion Criteria:

* Significant physical or mental health condition, based on the opinion of the investigator.
* Positive pregnancy test
* Request for IV/IM sedation prior to the start of the procedure
* Refusal of ibuprofen, ativan, or paracervical block
* Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate
* History of toxic reaction to local anesthetics
* Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)
* Weight less than 100 pounds. \[Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)\].
* Current participation in another research study which would interfere with the conduct of this study.
To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period

An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.


Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.

Exclusion Criteria:

1. Subject with clinical diagnosis of non-AGA
2. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
3. Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
5. Subject has clinically significantly abnormal laboratory tests at Screening
6. Known hypersensitivity to any of the IMP ingredients
7. Any other conditions in the investigator's opinion that prevent the subject from participating
Shoes on Balance, Muscular Endurance and Functional Skills

In daily life, stiletto heeled shoes which are popularly preferred by women have different heel heights. This study aims to investigate the effects of these differences on balance, muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done barefoot, 10 cm, and 4cm shoes.

The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg Standing for static balance, heel raising and squat-up test for muscular endurance of plantar flexor and quadriceps muscles, ascending stairs for functional skills.

Measuring distance will be used for Functional reach test and timing will be used for single leg standing test. Timing and repetition number will be used for muscular endurance tests. Timing will be used to climb up 10 stairs with and without heel contact.

Eligibility Criteria:
Inclusion Criteria:

* the shoe number will be 37
* women who do not regularly wear high heeled shoes
* women who are familiar with stiletto heeled shoes

Exclusion Criteria:

* any pain which prevents to participate in tests
* women with cardiovascular disease, metabolic disease, blood pressure disorders, diabetes diseases, neuromuscular diseases.
The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients

The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation


Eligibility Criteria:
Inclusion Criteria:

* Eligible for and scheduled to receive radiation therapy on Radiation Therapy Oncology Group (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial). (NCT02603341)
* Ability to understand and the willingness to sign a study-specific written informed consent document

Exclusion Criteria:

* There are no exclusion criteria.
Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing

The study aims to investigate whether cell-based non-invasive prenatal testing (cbNIPT) can be used as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for monogenic disorders (PGT-M).


Eligibility Criteria:
Inclusion Criteria:

* Achieved pregnancy following preimplantation genetic testing

Exclusion Criteria:

* None
Vietnam Era Twin (VET) Registry

To conduct a baseline survey on cardiovascular, respiratory, and other major systemic disease and risk factors in members of the Vietnam Era Twin Registry.

BACKGROUND:

The Vietnam Veteran Twin Registry, maintained by the NAS-NRC, was created with funding from the Veterans Administration. Department of Defense records were searched for subjects born between 1939-1957 and having the same last name and date of birth. Follow-up of induction records determined if the subjects were twins.

The registry supplemented the older World War II Veterans Twin Registry supported by the National Heart, Lung, and Blood Institute. The new registry provided an opportunity to create a resource with Black and Hispanic twins as well as whites. The new registry also included data on greater educational, socioeconomic, and lifestyle diversity than was available in the World War II Veterans Twin Registry.

DESIGN NARRATIVE:

During the first year a mailed questionnaire was designed which provided baseline data on family history, body size, morbidity, psychosocial characteristics, smoking, alcohol consumption, diet, physical activity, and drug use. The baseline data were used for analysis of cardiovascular, pulmonary, and blood diseases, and for follow-up. From the original survey, the Veterans Administration provided magnetic tape data on zygosity, smoking, alcohol consumption, heart, lung, and blood diseases, discharge rank, education, occupation, and family income. The questionnaire was completed by almost 8,900 individuals including over 3,000 twin pairs.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
No eligibility criteria
Efficacy of 308-nm Excimer Laser for Primary Localized Cutaneous Amyloidosis Treatment in Asians

Efficacy of 308-nm excimer laser for primary localized cutaneous amyloidosis treatment in Asians, pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Patients, aged \>18 years old with lichen amyloidosis diagnosed by using clinical presentation and pathologic features

Exclusion Criteria:

* Those with cutaneous amyloidosis associated systemic diseases
* Pregnancy or lactating woman
* Those who are allergic to urea, olive oil
* Those who are photosensitive to ultraviolet radiation
* Those who had been previously treated with medications/ radiation/ laser within 3 months for systemic and 1 month for topical therapy
Treatment of Metastatic Melanoma with Lenvatinib + Anti-PD1

The hypothesis is that treatment with Lenvatinib + Pembrolizumab is less effective in real life than in clinical trials. In fact, an objective response rate \&lt; 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic melanoma (stage III non operable or stage IV according to American Joint Committee on Cancer staging rules) refractory to immunotherapy (≥ 2nd treatment line after minimum a failure of immunotherapy)

Exclusion Criteria:

* Uveal melanoma
Advanced Therapeutics in Rheumatoid Arthritis (RA)

This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).

Conventional therapies for Rheumatoid Arthritis (RA) treatment include nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) selective inhibitors, corticosteroids and disease modifying anti-rheumatic drugs (DMARDs). These therapies are often partially effective.

For those patients, where conventional therapies have failed to alleviate their symptoms, Tumour Necrosis Factor (TNFis) is often prescribed to treat the pain and inflammation associated with RA. The main problem with TNFi and other advanced therapies in RA is retention. At least ¼ of patients stop treatment within a year and another ⅕ to ¼ in the second year, mostly due to secondary loss of efficacy.

Another advanced therapy, the Janus kinase inhibitor (JAK) has demonstrated similar efficacy to TNFi treatment in RA. This trial will determine if using a different class of treatment (small molecule, oral drug, JAK kinase inhibitor) will have a better retention than a TNFi (using the most commonly prescribed TNFi for RA in Canada).

Eligibility Criteria:
Inclusion Criteria:

* patients with RA who meet criteria for obtaining an advanced therapeutic through usual care
* active RA with 5 or more swollen joints
* seropositive
* presence of erosions
* failure of methotrexate and hydroxychloroquine and sulfasalazine
* failure of Leflunomide

  -\> or equal to 18 years
* able to provide consent
* able to attend usual follow up visits

Exclusion Criteria:

* no contraindication to etanercept or tofacitinib
* active serious infection
* active Tuberculosis
* multiple sclerosis
* current cancer
* lymphoma ever
* previous use of an advanced therapeutic (biologic or JAK kinase inhibitor)
* less than 18 years of age
* unable to provide consent
Nurse,Intramuscular Injection, Hybrid Simulation

The study was conducted as a randomized controlled experimental study in order to determine the effect of hybrid simulation training on gaining the intramuscular injection skills of nursing students. The sample of the study consisted of 126 students (63 study groups, 63 control groups) enrolled in Nursing Principles Course at Pamukkale University Faculty of Health Sciences in 2018-2019 academic year. In the study, the study group performed hybrid simulation (standard patient+Digital half hip model simulator) and the control group performed simulation with low reality simulation method (hip/intramuscular model). Study data were collected using Student Identification Form, Intramuscular Injection Achievement Test, Intramuscular Injection Application Skill Assessment Form, Two Column Writing Reflective Thinking Strategies and Scale of Student Satisfaction and Self-confidence in Learning.

Nursing students need to be proficient in nursing knowledge and skills before entering a health care environment in order to provide safe care to patients. One of the important and difficult to accomplish skills that nursing students must learn is the ability to administer intramuscular injections. In order to avoid complications due to IM injection application, it is necessary to comply with surgical asepsia, to know the method of application correctly and to have psychomotor skills. Therefore, nursing students are expected to graduate with knowledge and skills related to IM injection application during their education. Basic plastic mannequins without advanced technology, mannequins or models with low technological features that present the selected anatomical parts of the human body can also be used in standard patient and hybrid simulation. Hybrid simulation applications contribute to learners ' ability to develop psychomotor skills in a safe and realistic environment, as well as problem solving, critical thinking and decision making. Furthermore, hybrid simulations have become an ethical requirement to improve students ' skills without causing any potential harm to actual patients. In this study, the effectiveness of HS method will be evaluated to gain IM injection skills in nursing students. It will be ensured that the students ' knowledge and skills will be sufficient by increasing their desire to learn about IM injection, where they experience intense fear and anxiety before going to the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Students who have not received IM injection skills training before,
* who have no clinical experience,
* who have accepted to participate in the research

Exclusion Criteria:

* Students who have received IM injection skills training before,
* who have clinical experience,
Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.

This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part will be initiated.

In the Randomized Part approximately 200 patients (100 per arm) will be randomized to receive SPI-1620 plus docetaxel or docetaxel alone.

In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel 75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or intolerable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic NSCLC that has failed one prior platinum-containing chemotherapy
* Measurable disease as per RECIST v. 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* More than one prior chemotherapy regimen for metastatic NSCLC
* Known, uncontrolled central nervous system (CNS) metastases
* Significant circulatory disorders in the past 6 mo.
* Concomitant treatment with phosphodiesterase inhibitors
* Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* diagnosed RA for \>=3 months prior to first administration of study medication;
* inadequate response or intolerance to \>=1 anti-TNF therapies, alone or in combination with methotrexate;
* if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for \>=2 weeks prior to start of study.

Exclusion Criteria:

* other chronic inflammatory diseases;
* use of parental corticosteroids within 4 weeks prior to screening;
* severe heart failure, or severe, uncontrolled cardiac disease.
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?

Cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce "oxidative stress". It is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.


Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3
* Echo LVH

Exclusion Criteria:

* Known heart failure
* Patients already on Allopurinol
* Patients with gout
* Patients with hepatic disease
* Contraindications to MRI, including severe claustrophobia
* Current immunosuppressive therapy, chlorpropamide, theophylline, 6- mercaptopurine
* Malignancy or other life threatening disease
* Pregnancy or lactating women
* Patients unable to provide written consent
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery

Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.


Eligibility Criteria:
Inclusion Criteria:

Pre-screening:

To be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores \>3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores \< 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression).

Screening:

* Adults age ≥60 years
* Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy
* PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 indicating clinically significant depression or anxiety symptoms.

Exclusion Criteria:

* Barrier to communication (Unable to read, speak, and understand English)
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10
* Acutely suicidal
* Considered ineligible per the discretion of the oncologic surgeon or study PI
* Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.
CGM Use in Children With Type 2 Diabetes

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.

The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, diabetes duration \>3 months

Exclusion Criteria:

* Prior use of CGM