cyrilzakka/clinical-trials huggingface dataset:
BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.

To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.

To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Age: 19\~45
* Body weight: 55kg or higher(female: 50kg or higher) and BMI 18\~27kg/m2
* SBP 90\~150mmHg, DBP 60-95mmHg
* Fasting glucose 70\~120mg/dL
* Infertility

  1. Surgically infertile
  2. To prevent pregnancy, participants who agreed using 2 or more contraceptive methods. Such as
* Barrier methods: Condom, Diaphragm, Cervical cap (Pessary), Spermicide
* Hormonal methods: Pills, Injection (Depot), Skin patch, Hormonal implant (Implanon), Vaginal ring
* Intrauterine Devices (IUDs): Cooper IUD (Loop), Hormonal IUD (Mirena)
* Natural methods: Basic body temperature, Ovulation period, Coitus interruptus, Abstinent
* People who perfectly understood clinical trial and independently decided to participate in clinical trial.
* People who will be able to collect blood sample during clinical trial period.
* People who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview.

Exclusion Criteria:

* Genetic problems such as galactose intolerance, Lapp lacatase deficiency, glucose-galactose malabsorption
* Clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc.
* People who have gastrointestinal disease or history of surgery which would affect absorption of drug.
* History of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease
A Pilot Study of OurRelationship.dk, a Web-based Self-help-Program for Couples With High Levels of Conflict or Distress

The aim of this study is twofold 1) to conduct a pilot test of methods for a larger scale RCT study evaluating the efficacy of OurRelationship offered to couples with high levels of conflict or distress and at least one child at the address, and 2) to test if the OurRelationship program meets predefined feasibility criteria when implemented in a real-world setting. If study results on these two aims are convincing, a full scale RCT of the intervention will be pursued.

A cost-effective online self-help program for distressed couples could help serve more couples, in particular those with limited access to traditional couple therapy. The OurRelationship program, a web-based, primarily self-help program for couples developed in the US, has previously shown medium to large effects sizes on relationship functioning for a diverse sample of couples and these effects were maintained over 12 months (Doss et al., 2016; 2020). These findings promise a large potential in online self-help for couples, if findings replicate in independent research.

For the pilot, 80 couples experiencing high levels of conflict or distress in their relationship and who had at least one child at the address were recruited through a study website (www.ourelationship.dk) build for the pilot. Couples were randomized to receive either the Danish version of the program including 4 coach calls, or an active control condition receiving two copies of a self-help book and a plan for 4 x 30 min couple conversations. In this pilot, research methods in terms of recruitment, randomization, completion of program, test of measures, and data collection are evaluated.

Eligibility Criteria:
Inclusion Criteria:

To detail the criteria "high level of conflict or distress", one or both of the following criteria must be fulfilled:

1. One or both partners report being victim or perpetrator of at least one act of physical or psychological aggression during the past year OR
2. One partner score at least 1 standard deviation (SD) (indicating severe relationship distress) or both partners 0.5 SD below the Danish population mean on a measure for relationship satisfaction (Couple Satisfaction Index; Funk \& Rogge, 2007).

In addition:

* both partners in the couple have to be 18 or above
* been living together for at least six months
* have at least one child below 18 years living at home
* be able to read and understand Danish
* have access to the Internet, a tablet, computer, or telephone
* willing to refrain from couple therapy (or other couple interventions) within the period of the project.

Exclusion Criteria:

* Plans on divorcing, breaking up or having an ongoing affair
* Moderate to severe levels of suicidal ideation (\>=7 on the Suicidal Behavioral Questionnaire-Revised, Osman et al., 2001)
* Victimization of intimate partner violence resulting in injury or fear within the last three months (using screener items developed by Beach, Whisman, Snyder, \& Heyman, 2013).
* Taking psychotropic drugs.
Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma

This early phase I trial studies the side effects of implanting and removing a microdevice in patients with sarcomas that have spread to other places in the body (metastatic) or have come back (recurrent). Microdevices are rice-sized devices that are implanted into tumor tissue and are loaded with 10 different drugs that are delivered at very small doses, or "microdoses," which may only affect a very small, local area inside the tumor. The purpose of this study is to determine which drugs delivered in the microdevice affect tumor tissue in patients with sarcomas.

PRIMARY OBJECTIVES:

I. Assess the safety of drug delivery microdevice (microdevice) placement and removal in subjects undergoing resection of sarcoma.

II. Determine the technical feasibility of microdevice placement and removal with intact surrounding tissue in subjects undergoing resection of a sarcoma.

SECONDARY OBJECTIVE:

I. Use the intratumoral cellular response to evaluate individual agents and/or drug combinations released from the microdevice reservoirs to assess the relative drug efficacy across all individual agents or drug combinations tested using the microdevice technology.

EXPLORATORY OBJECTIVES:

I. Evaluate the microdevice performance for its capacity to predict Response Evaluation Criteria in Solid Tumors (RECIST) response in the subset of patients that receive systemic chemotherapies as part of their standard-of-care or clinical trial treatments. II. Determine genomic, transcriptomic, and proteomic predictive biomarkers from resected specimens that correlate with local (i.e. microdevice-based) and systemic drug response. III. Determine, at a single-cell level, proteomic traits associated with chemosensitivity versus (vs.) resistance using mathematical notions of network robustness and fragility.

OUTLINE:

Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed. Conditions Conditions: Metastatic Sarcoma Recurrent Sarcoma

Eligibility Criteria:
Inclusion:

* Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care.
* 10 years of age or older
* Documented, signed, dated informed consent to participate in the microdevice study
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2

Exclusion:

* Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection
* Age \< 10 years old
* Women of childbearing potential without a negative pregnancy test; or women who are lactating
* Allergies or prior adverse drug reactions to any of the drugs loaded within the microdevice.
Perceived Effectiveness of the Vaginal Moisturizer Investigational Product Under Normal Conditions of Use.

The present research project aims to evaluate the perceived effectiveness of the product under investigation under normal conditions of use for 28 days, to defend the claims "High hydration power, relief of discomfort and improvement of vaginal tone."

This research project aims to evaluate the perceived efficacy of the product under investigation under normal conditions of use for 28 days, to defend the attributes expected for this product category. The study will be carried out through the application of questionnaires, which will be answered by the participants. The study will be conducted with a Brazilian sample in which 45 research participants will be included.

Eligibility Criteria:
Inclusion Criteria:

1. Age range between 25 and 70 years old.
2. Phototypes: I to IV, according to Fitzpatrick classification;
3. Sex: female
4. Intact skin in the evaluation region.
5. Participants complaining of vaginal dryness;
6. Agree to adhere to the study procedures and requirements: study time, return(s) to the laboratory to perform study procedures, home use of the investigational product, filling out the usage diary, not changing cosmetic habits during the study period .
7. Agree not to carry out dermatological or aesthetic treatments until the end of the study and agree not to use any products from the same category as the investigational product.
8. Signing of the Free and Informed Consent Form (TCLE).

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Skin marks in the experimental area that interfere with the assessment of possible skin reactions.
3. Active dermatoses (local or disseminated) that could interfere with the study results.
4. History of ineffectiveness, allergic reactions, irritation or intense sensation of discomfort to topical products: health products or medications.
5. Expected vaccination during the study or up to 3 weeks before the study;
6. Not taking vitamin A (acid and/or its derivatives orally or topically up to 1 month before the start of the study.)
7. Patients with immunodeficiencies.
8. History of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
9. Use of non-steroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study (or considering depot corticosteroids, the interval should be 1 month before the selection).
10. Aesthetic or dermatological treatment up to 4 weeks before the study.
11. Hormonal treatments not stable in the last 3 months.
12. Hyperpigmentation associated with the use of drugs such as tetracyclines, phenothiazides or amiodarone.
13. Hyperpigmentation associated with photosensitivity.
14. People directly involved in carrying out this study and their families.
15. History of lack of adherence or unwillingness to adhere to the study protocol.
16. Any condition that, in the researcher's opinion, could compromise the study.
17. Be participating in another study in the same region of application.
A Comparison of Two Daily Disposable Contact Lenses.

This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.


Eligibility Criteria:
Inclusion Criteria:

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
* They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
* They have diabetes.
* They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Evaluation of Syncope,Its Diagnosis, Treatment, Outcome and Prognosis

The investigators want to look at how patients admitted after passing out (syncope) or nearly passing out (pre-syncope) do after going home and how many of them remain free of symptoms of syncope or pre-syncope.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age 18 or older) admitted with syncope or near-syncope

Exclusion Criteria:

* Patients who do not speak/read the language of the consent form
* Prisoners
* Patients who are of altered mental status or had head trauma
* Refusal or inability to sign consent
Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction

This study is to evaluate the effectiveness of E\>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress

E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, randomized study assessing the efficacy and safety of E\>EYE in the management of MGD (3 applications on days 0, 15 and 45, with a follow up 1 month later) compared to daily use of a warm compress over a period of 75 days.

The study will monitor the change in symptoms and signs of dry eye at each visit.)

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent and participate in the required study visit
* Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following:

  * OSDI score \>13 and
  * NITBUT \<= 10sec

Exclusion Criteria:

* No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months
* Patients with greater 75% meibomian gland loss
* Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present
* Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours
* Artificial tear usage within 2 hours prior to study testing
* Other invasive ocular diagnostic testing within 2 hours prior to study testing
* Eye makeup present on the eye lid within 10 minutes prior to study testing
Gait Analysis and Gait Training in Patient With Total Hip or Total Knee Replacement

The main objective of the present study is the evaluation of the kinematic parameters of gait and distribution of the load, recorded thruogh a sensorized treadmill, on lower limbs in patients at 1 year from Total Hip Replacement or Total Knee Replacement.

The secondary objective is to evaluate the effects of gait training with biofeedback by means of a sensorized treadmill in patients with asymmetry of the kinematic parameters of the step and of distribution of the load on the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Examination ≥ 24
* 12 months after total hip or total knee replacement

Exclusion Criteria:

* impossibility to perform a walking test
* disabling cardiovascular and osteo-arthro-muscular problems that can impair walking tests
* central or peripheral neurological disorders that compromise the sensory-motor skills of the patient under examination and / or the degree of collaboration
* patients who have not signed informed consent
EFFECTS OF MIOFASCIAL RELEASE AND PERCUTANEOUS MICROELETROLYSIS IN TYPE HEADACHE

A headache is a more common disorder and one that prevails over a lifetime of much of the population. Among the causes are in the stress and spasms of the pericranial musculature, presence of painful sensitivity in the region, decrease of pain threshold, and a presence of trigger points (PGs) that can also cause as headaches. The solutions for health and health, in addition to Percutaneous Microelectrolysis (MEP®), which is used in the application of low intensity galvanic current through the acupuncture needle. Although it is a very common pathology, it is still little studied and a lack of information is a question of solutions such as crisis of care. This work justifies the negative bones of CTT in university students, as this has repercussions on the quality of life, besides proposing a therapeutic approach to reduce the symptomatology. The present study aims to investigate the effects of myofascial release techniques, MEP® and an association of therapies, observing the impact on quality of life and repercussions on academic performance. This is a controlled clinical trial of a convenience-based approach, consisting of universities between the 1st and 10th Physical Therapy course of Estácio Ponta Negra, over 18 years of age, who are not present in the application of the questionnaires, It is necessary to use the medicine of the analgesic type. The volunteers are evaluated through the HIT-6 and SF-36 questionnaires, after a selection of pain evaluation, PGs and algometry. The randomization will consist of 4 groups, after a consultation and an immediate re-evaluation and a second time and a new intervention and re-evaluation. A descriptive and inferential statistics will be performed through the SPSS 20.0 program. The normality of the data is observed by the Kolmogorov-Smirnov (KS) test. For a comparison between groups whose parametric data are applied or anova test with post hoc tukey comingue of significance of 5% (p \<0.05). It is believed that the use of the association of myofascial release techniques and Percutaneous Microelectronics promotes greater benefits in tension headache.


Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old, they will be present at the time of ordering, not being pregnant and not taking analgesic medication at least 24 hours before the intervention.

Exclusion Criteria:

* More than 20% of the questionnaire data are incomplete and if during the research the volunteer presents some discomfort.
HMA+DLI vs DLI Preemptive Therapy Based on MRD for AL Undergoing Allo-HSCT

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy. In this prospective randomized controlled study, the safety and efficacy of hypomethylating agents (HMA) + DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.

Allogeneic hematopoietic cell transplantation (Allo-HSCT) is an effective therapy for acute leukemia, but relapse is the most common problem affecting long-term survivors of allo-HSCT. Therapy options for relapse include stopping immune suppression, re-induction of chemotherapy, donor lymphocyte infusion (DLI) or combination therapy. One method of solving relapse is to intervene before hematologic or pathologic relapse occurs based on minimal residual disease (MRD) . DLI is an effective post-transplantation therapy based on MRD for relapse. Whether combination of hypomethylating agents (HMA) and DLI could improve outcomes remains unclear. In this prospective randomized controlled study, the safety and efficacy of HMA+DLI and DLI preemptive therapy based on minimal residual disease in acute leukemia undergoing allo-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

- A patient age of 14-65 years. AL patients who achieved CR at pre-transplantation undergoing allo-HSCT. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* AL patients who were in NR at pre-transplantation undergoing allo-HSCT. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure). Patients with any conditions not suitable for the trial (investigators' decision).
Informed Consent Formats by Information Preference and Priority

This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.

The goal of this study is to investigate whether the same information can be communicated in different formats of an informed consent document in ways that improve participant understanding and confidence. Participants will review one of several different versions of the same informed consent document, and will be asked to complete a survey after reading the documents. The survey will ask participants their willingness to enroll in the clinical trial discussed in the document and their confidence in their decision. The survey will also test participants recollection of information from the informed consent document. Researchers will look at this data to see if there are ways to improve knowledge about the clinical trial and confidence in decisions without necessarily changing enrollment preferences.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years Old or Older
* Read and agreed to informed consent
* Indicated desire to participate
* Diagnosed with asthma
* US resident

Exclusion Criteria:

* Participants from whom we receive multiple responses will be dropped from analysis (but will be compensated for participation)