cyrilzakka/clinical-trials huggingface dataset:
Juntos: A Pilot Test of a Dating Violence Intervention for Latine Families

In this trial, we will be pilot-testing a family-based dating violence prevention program for Latine caregivers and adolescents. Participants will be randomized 1:1 to receive a community-based 6 week intervention or to a wait-list control where they will receive a resource guide.


Eligibility Criteria:
Inclusion Criteria:

Adolescents

1. Between the ages of 12-16
2. Identify as Hispanic or Latino/a/x/e
3. Speaks Spanish or English
4. Lives within 50 miles of Pittsburgh, Pennsylvania
5. Has a participating parent or caregiver\* in the study

Adults

1. Over the age of 18
2. Identifies as Hispanic or Latino/a/x/e
3. Speaks Spanish
4. Lives within 50 miles of Pittsburgh, Pennsylvania
5. Is a caregiver of a participating adolescent in the study
6. Was born outside of the United States

Exclusion Criteria:

* Does not meet inclusion criteria
* Unable to consent
Europe-Japan Diagnostic Study for EGFR Testing

This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older in Europe and aged 20 years and older in Japan
* Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
* Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
* Provision of diagnostic cancer tissue or cytology sample upon inclusion
* Provision of a routine blood sample

Exclusion Criteria:

* Evidence of severe or uncontrolled systemic disease
* Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
* Pregnancy or breast-feeding
A Personal Nutrition Advisor to Assist Remote Dietary Counselling for Weight Loss and Maintenance

The purpose of the study is to assess the usability of the PNA and satisfaction with the treatment within the framework of usual care remote nutritional counselling for GLP-1-supported weight management and collect pilot data on its potential to support weight loss.

The global prevalence of obesity and overweight is increasing and persistently drives global mortality and morbidity.As overweight and obesity are the result of an imbalance between energy intake and energy use, achieving a negative energy balance build the foundation for weight loss. Whilst dietary modification as a standalone procedure often fail in achieving or maintaining weight loss, the recent advent of supportive Glucagon-like Peptide-1 (GLP-1) based pharmacotherapies have greatly changed the landscape.Dietary counselling help people on GLP-1 based treatment reaching their individual weight goals and continued reimbursement of medication costs. However, nutritional advice provided by dietitians is often generic, not sufficiently aligned to individual weight loss trajectories.

The "Personal Nutrition Advisor" (PNA) is a decision support tool which is built upon an interpretable weight prediction model based on the energy balance equation (energy intake is a function of recorded dietary intake and a latent part dependent on observed weight changes, whereas energy expenditure is a function of weight and physical activity). Food, weight- and activity records captured using a smartphone application represent input data to the model. Output of the model is the predicted body weight trajectory alongside with personalized recommendations to reach a pre-defined target weight.

Integrating the PNA into a remote dietary counselling programme, in which certified dietitians deliver nutritional and lifestyle coaching via an application, has the potential to improve treatment satisfaction and efficacy. Therefore, the purpose of the study assess the usability of the PNA and satisfaction with the treatment within the framework of usual care remote nutritional counselling for GLP-1-supported weight management and collect pilot data on its potential to support weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Receiving GLP-1-based pharmacotherapy in combination with remote nutritional counselling
* Achieved weight loss of ≥5 (for baseline BMI 28-35 kg/m2) or ≥7% (for baseline BMI≥35kg/m2) after 4 months of GLP-1 based therapy (1st milestone)

Exclusion Criteria:

* Inability to give written informed consent
* Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
* Self-reported pregnancy, planed pregnancy within next 3 months or breast-feeding
* Concomitant participation in another trial that interferes with the normal conduct of the study and interpretation of the study results
* Not proficient in German
The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion

Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1 are increased in response to acipimox. The hypothesis is that G protein coupled receptors on enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.

In a controlled, open, randomized experiment, eight healthy, overweight men will be studied on an intervention day, where they receive acipimox, and on a control day. The study day includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a biopsy from adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* Adult men
* Healthy
* BMI 25-35

Exclusion Criteria:

* Known DM2
* Receiving hypolipidemic drugs
Hearing Aid Transmitter Performance Study - SRF-366

Sonova Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).

In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss)
* Good written and spoken English language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Willingness to wear Receiver in Canal hearing aids
* Informed Consent as documented by signature
* Normal cognitive abilities

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Sydney (AUS)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Known psychological problems
AED 3 Post-Approval Study

Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Suspected out-of-hospital cardiac arrest
* Use of ZOLL AED 3 public-access defibrillator (running software v.1.03.602 or newer (US) or v. 6.03.006 or newer(OUS)) with Uni-padz III
* Unconsciousness
* Absence of breathing
* Absence of pulse and other signs of circulation

Exclusion Criteria:

* Pre-existing Do Not Attempt Resuscitation (DNAR) orders
* No evidence of cardiac arrest
Contrast Nephropathy Prevention With N-Acetylcysteine in Acute Myocardial Infarction

Patients with acute myocardial infarction undergoing primary angioplasty are at high risk for renal injury due to the toxic effect of contrast agents. Patients developing renal dysfunction after primary angioplasty have worse outcome. To investigate the role of the antioxidant N-acetylcysteine (NAC) in preventing renal injury in angioplasty, we randomized 352 consecutive patients undergoing primary angioplasty into three groups: the first group received NAC at standard dose (NAC group, 600 mg i.v. bolus before primary angioplasty, followed by oral 600 mg twice daily for the following 48 hours; n=115), the second group received NAC at double dose (DD-NAC group; 1,200 mg i.v. bolus and oral 1,200 mg twice daily for 48 hours; n=118), and the last group received placebo (controls; n=119).


Eligibility Criteria:
Inclusion Criteria:Consecutive patients admitted to the Coronary Care Unit for ST-segment elevation acute myocardial infarction undergoing primary angioplasty. Patients were included if they presented within 12 hours (18 hours for acute myocardial infarction complicated by cardiogenic shock) from the onset of symptoms. -

Exclusion Criteria:Patients in chronic peritoneal or hemodialytic treatment and those with known allergy to N-acetylcysteine.

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Orthokeratology for High Myopia (OHM) Study

This project aims to investigate/examine high myopic subjects on full correction ortho-k (using Topaz ortho-k lenses for high myopia) compared to subjects undergoing partial reduction ortho-k and their relationship with myopia and myopic progression.

For many years, commercially-available ortho-k lenses aim to reduce low - moderate myopia. Attempts to use these lenses for reduction of high myopia have been shown to give rise to complications such as corneal staining and lens decentration. Thus, practitioners may choose a more conservative way for high myopic children, that is, offering partial reduction ortho-k. Partial reduction ortho-k is target for 4.00-5.00D reduction and the residual refractive errors will be corrected with single vision spectacles to allow good visual acuity in the daytime. Partial reduction ortho-k has been shown to slow axial elongation in high myopic children, however, the main disadvantage is that the children have to wear spectacles in the daytime to correct residual refraction.

Euclid has recently designed a new lens, Euclid's Topaz, for high myopic children. It is currently commercially available to correct myopia for up to 10 D. However, evidence of its effectiveness for visual correction and slowing AL growth is lacking. While numerous studies have shown that orthokeratology is an effective clinical treatment to slow axial eye growth in children, the exact mechanism underlying this reduction in myopia progression associated with orthokeratology remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Myopia: at least 5.00D in one eye or in both eyes
* Astigmatism: ≤1.50D; with-the-rule astigmatism (axes 180 ± 30) ≤1.25D; astigmatism of other axes ≤0.50D in both eyes
* Anisometropia: not be more than 1.00D in the former and not more than 2.00D in the latter.
* Best-corrected Monocular Snellen visual acuity 6/7.5 or better

Exclusion Criteria:

* Strabismus at distance or near
* Previous experience in contact lens wear or myopia control treatment (e.g. refractive therapy or progressive spectacles)
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
* Previous history of ocular surgery, trauma, or chronic ocular disease
* Concurrent use of medications that may affect tear quality or contact lens wear
* Systemic or ocular conditions that may affect tear quality or contact lens wear (e.g allergy and concurrent medication) or that may affect refractive development (e.g Down syndrome, ptosis)
* Poor compliance to tests (e.g poor fixation in noncontact tonometry or intolerance of lens wear)
* Not willing to comply with the allocated treatment, use and care of lenses and follow-up schedule
A Study of BBI608 in Adult Patients With Advanced, Refractory Hematologic Malignancies

This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.


Eligibility Criteria:
Major Inclusion Criteria:

1. Signed written informed consent must be obtained and documented according to the International Conference on Harmonisation (ICH) and be in accordance with local regulatory requirements
2. A histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options
3. ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase
5. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after their last dose
6. Females of childbearing potential must have a negative serum pregnancy test
7. Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN). Patients whose disease involves the liver and who have laboratory values of AST ≤ 3.5 ULN, AST ≤ 3.5 ULN, and albumin ≥ 35g/L may be enrolled if agreed upon by the Principal Investigator and Medical Monitor for the Sponsor
8. Total bilirubin \< 1.5 x ULN, except for cases in which elevation of total bilirubin is due to elevated levels of unconjugated bilirubin consistent with a diagnosis of Gilbert's Syndrome
9. Life expectancy ≥ 3 months
A New Non-invasive Method to Assess and Measure Palatal Masticatory Mucosa Using Dynamic Navigation System

Periodontal plastic surgery is widely used to improve the esthetic and functional demands of patients. The palatal masticatory mucosa is the main donor area. A lot of methods to evaluate the thickness of palatal soft tissue were used. However, the methods published before were invasive or non-reproducible. Therefore, the aim of this study was to investigate the accuracy of the novel invasive method to evaluate the thickness of palatal masticatory mucosa thickness.

Twelve periodontally healthy patients who will have CBCT on maxilla for implant surgery will be recruited in this study. Each patient will be measured at 15 points of palatal masticatory mucosa over canine to the second molar area, it will be done by a dynamic navigation system (test group) and periodontal probe piercing (control group). The data will be analyzed to evaluate the accuracy of dynamic navigation in the measurement of palatal masticatory mucosa thickness.


Eligibility Criteria:
Inclusion criteria:

1. Above 20 years old
2. The patient need dental implant surgery in maxilla
3. The patient have at least complete canine to second molar at one side
4. Periodontaliy healthy patients
5. The patient could sign for the consent form.

Exclusion criteria:

1. patients can not receive dental implant surgery
2. fuzzy palatal alveolar bone line
3. all maxillary posterior teeth with metal crowns
4. all posterior teeth are missing at one side over maxilla
5. all maxillary posterior teeth with hyper-mobility
6. Pregnancy
Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers

This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Korean 19-45 years
* Body weight:55-90kg, BMI:18.0-27.0

Exclusion Criteria:

* Present condition or history of any clinically significant disease
* Clinical evidence or history of GI disease or history of GI surgery
* History of hypersensitivities, including drug allergies
* AST (SGOT) or ALT (SGPT) \> 1.5 times the upper normal limit
* Systolic blood pressure : \<100 mmHg or \>160 mmHg
* Diastolic blood pressure : \<60 mmHg or \>100 mmHg
* Drug abuse within 2 months, or a positive reaction to an abusive drug or cotinine
* Taken any ETC or herbal supplement within 2 weeks or any OTC or vitamin supplement within 1 week
* Participation in and administration of IP of another clinical trial within 2 months
* Donation of whole blood within 2 months, or blood components within 1 month, or receipt of blood transfusion within 1 month
* Consumption of more than 21 units of alcohol/week or inability to abstain from drinking during the study period
* Smoking within 3 months
* Taking caffeine- or grapefruit-containing products within 3 days
* Plan to be pregnant, or not to use an appropriate method of contraception
Implementation of Cognitive Stimulation Therapy

This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL
* has a SLUMS score greater than 10.

Exclusion Criteria:

* unable to hold a meaningful conversation,
* unable to hear well enough to participate in a small group discussion
* severe visual impairment that precludes ability to see most pictures
* unable to remain in a group setting for 45 minutes
Analgesia of Erector Spinae Plane Block Versus Quadratus Lumborum Block

Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia.

The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and dexamethasone will be used for both techniques.

Erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of stress (cortisol and CRP), primary hemodynamics, time to first rescue analgesic request, the total amount of rescue analgesic consumption and postoperative nausea and vomiting are the parameters of comparison between both techniques.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II
* Body mass index from 18.5 to 35 Kg/m2

Exclusion Criteria:

* Body mass index more than 35 Kg/m2.
* Severe or uncompensated cardiovascular disease.
* Severe renal disease.
* Severe hepatic disease.
* Severe endocrinal disease.
* Pregnancy.
* Postpartum.
* Lactating females
* Allergy to one of the agents used.
* Refusal to participate in the study.
Assessment of Robotic Assistance on Gait Parameters Among Healthy Subjects and Brain Damaged Patients

The main objective of this study is to quantitatively assess the robotic assistance given by an exoskeleton on patients gait parameters. Patients will be asked to walk with- and without the exoskeleton on a treadmill. During the study, the biomechanical and the energy consumption will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis due to stroke
* Min 18 years
* Time since stroke \> 15 days
* Ability to understand instructions
* Ability to do gait analysis on the treadmill

Exclusion Criteria:

- Contraindication for the use of the robot Atalante
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches

Cranial electrotherapy stimulation (CES) may be a safe adjunct to medical treatment for pain relief in migraine patients. However, despite the number of CES studies done, many have been open label, single blinded, or have utilized a small group of patients.

This study will evaluate the efficacy of the Fisher Wallace Cranial Stimulator in persons with chronic migraine who have not achieved satisfactory pain control on their current medications.

Eligibility Criteria:
Inclusion Criteria:

* Subjects satisfying the IHS (International Headache Society) criteria for migraine
* Subjects have not achieved satisfactory pain control on their current medication
* Ability to maintain a daily headache diary
* Stable medication use related to migraine for at least 4 weeks prior to enrollment in the study

Exclusion Criteria:

* Previous exposure to or experience with cranial electrotherapy stimulation (CES)
* Contraindications to Fisher Wallace stimulator, such as cardiac pacemakers or implantable defibrillators, known or suspected heart disease, or pregnancy
* Seizure disorders