cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Auricular Acupuncture in Depression During the Covid 19 Pandemic

Participants with moderate depressive symptoms measured by PHQ-9 will be randomized to receive auricular acupuncture. The triple blinded procedure will be conducted in 12 sessions (6 weeks). The primary outcome is the response to the treatment 3 months after inclusion.

Depression, often under-diagnosed and under-treated, is the leading cause of disability worldwide and contributes significantly to the global burden of diseases, with university students being a major risk group. There is a growing demand for non-pharmacological treatments for depression. In this sense, auricular acupuncture is considered a simple, low cost technique, well accepted by patients. The Unified Health System (Sistema Único de Saúde -SUS) incorporated this practice in 2006, but there is a lack of studies evaluating its efficacy and safety. The main objective of this study is to evaluate the efficacy of auricular acupuncture to reduce depressive symptoms in comparison with usual care and non-specific auricular acupuncture. This is a randomized clinical trial, blinded to the evaluator, participant and statistician. The study sample will be composed of 280 university students, divided equally into two groups: Experimental group - GE (auricular acupuncture) and Control group - GC (non-specific auricular acupuncture). The GE and GC participants will be submitted to 12 sessions of auricular acupuncture, 2 times a week. The primary outcome of the study will be the proportion of participants who present improvement of 50% or more in their symptoms, evaluated by the PHQ-9, three months after inclusion. The secondary outcomes will be: improvement of 50% or more in their symptoms, after six months; quality of life (SF-36), change in the use of antidepressant medication, events and adverse effects, levels of Brain-derived neurotrophic factor (BDNF), Interleukin 1β, Interleukin-6 and TNF-α in blood plasma. The data will be analyzed aiming at treating according to the principles of CONSORT.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years old
* PHQ-9 score between 10 and 19 (moderate depression)
* Availability for sessions

Exclusion Criteria:

Use complementary and integrative practices at the last 3 months; Suicidal risk evaluated by question number 9 in the PHQ-9 Severe depression score in the PHQ-9 Prior use of auricular acupuncture Pregnancy Menopause Tape and metal allergy
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age

The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)


Eligibility Criteria:
Inclusion Criteria:

* Birth length below -2 SD
* Height at start below - 2 Sd

Exclusion Criteria:

* Any endocrine or chronic disease
* Any known syndrome with short stature
Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography

The primary objective of this study is to determine the diagnostic efficiency and accuracy of using the StentOptimizer. The ability of StentOptimizer to influence post deployment treatment strategy will be assessed and compared to the IVUS system. In addition, the correlation of diameter measurements between the StentOptimizer, IVUS and 2D QCA will be assessed. The StentOptimizer software, IVUS and 2D QCA were all part of the clinical procedure outside the study. The analysis of post deployment treatment decisions and diameter measurements using those modalities retrospectively make this an observational study.

Stent under-expansion is defined as the minimum stent area by itself or compared with a predefined reference. It plays a role in the pathogenesis of adverse events following stent deployment. Stent under-expansion has been a consistent finding in IVUS reports of acute or subacute BMS or DES thrombosis.

Post intervention imaging can determine whether there is adequate stent expansion. Currently the only available tool for evaluation of properness of stent deployment is intravascular ultrasound (IVUS). IVUS procedure is invasive, labor intensified, associated with radiation and contrast media use, and is not free of complications. In many medical centers, IVUS is not used routinely because of lack of knowledge and expertise in reading it, and it's relatively high price.

The StentOptimizer is an angiography based software tool aimed to enhance visualization of deployed stents and to provide the physician with quantitative data regarding stent dimensions. The StentOptimizer is part of an image acquisition and processing software system (IC-Pro), designed as an add-on to conventional X-ray angiography systems.

An enhanced stent image is produced using the radiopaque markers of the delivery balloon from several frames (minimum 20). The result is a still image of the stent with enhanced edges and the region of interest around it

Eligibility Criteria:
Inclusion Criteria:

1. Percutaneous coronary intervention indicated clinically.
2. IVUS used as part of the standard procedure.
3. Subject must be \>=40 yrs.
4. Subject must provide written informed consent.

Exclusion Criteria:

1. Low image quality as determined by the investigator.
2. Subject is pregnant or nursing.
3. Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
The Effects of Game-Based Exercises on Upper Extremity

The aim of this research is to investigate the impact of game-based exercises on upper extremity muscle strength, sensory perception, and functionality in adult individuals. The focus lies in measuring and assessing the effects of these exercises on this particular group. The goal is to determine the potential benefits of game-based exercises concerning upper extremity muscle strength, sensory perception, and overall functionality in adults.

This study focuses on exploring how game-based exercises affect upper extremity muscle strength, sensory perception, and functionality in adults. It addresses the potential impact of these exercises on physical activity levels, sensory development, and body awareness. The research highlights the significance of physical engagement, particularly in digitally inactive environments, emphasizing the need for supportive physical activity interventions. Additionally, it delves into the intricate hand movements and functions related to grasping activities, emphasizing the importance of sensory perceptions in these processes. Ultimately, the study aims to understand the correlation between game-based exercises and various facets of upper extremity functionality in adults.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria comprise participants aged between 18 and 25 years, having good overall health with no significant upper extremity issues.
* Participants should demonstrate active use of both hands.
* Preference is given to individuals who have not previously engaged in regular upper extremity-focused exercises or do not have a habit of regular exercise.
* Voluntary participation in the study and willingness to comply with program requirements are necessary.

Exclusion Criteria:

* Encompass individuals with significant upper extremity disorders or a history of serious - hand, arm, or shoulder injuries,
* Those with sensory impairments,
* Individuals whose health conditions deem them unsuitable for participation in the exercise program,
* Individuals outside the specified age range,
* Participants who have previously engaged in upper extremity-focused exercise or similar studies
Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients

To evaluate the efficacy and safety of glumetinib combined with osimertinib as the first-line treatment for locally advanced or metastatic NSCLC.

In the Phase II stage, eligible subjects who have passed screening will be randomly assigned in a 1:1:1 ratio into the Group 1, Group 2, and Group 3 to receive study treatment:

In the Phase III stage, eligible subjects who have passed screening will be randomly assigned in a 1:1 ratio into the test group and the control group to receive the study treatments, and the RP3D obtained from Phase II will be used as the dose of glumetinib for the test group.

Randomization stratification factors include: c-MET status (≥2+, ≥75% and 3+, \<50% vs 3+, ≥50% or FISH positive), and EGFR-sensitive mutation type (19Del vs L858R).

In both the Phase II and Phase III stages, each treatment cycle is every 3 weeks, with continuous treatment until progressive disease (PD) confirmed by the investigator, intolerable toxicity, withdrawal of informed consent by the subject, loss to follow-up, death, or other criteria for terminating treatment as specified in the protocol, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* 1. Able to understand and voluntarily sign the written informed consent form (ICF); 2. Male or female subjects aged 18 to 75 years (inclusive). 3. Patients with NSCLC who have unresectable locally advanced or metastatic disease; 4. At least one measurable lesion, as defined by RECIST 1.1 criteria; 5. ECOG performance status of 0 or 1; 6. Expected survival ≥ 3 months; 7. Adequate function of major organs and bone marrow; 8. Women or man of childbearing potential must use highly effective contraception.

Exclusion Criteria:

1. Prior treatment with an EGFR inhibitor or MET inhibitor;
2. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
3. Patients who have taken strong inducers or inhibitors of CYP3A4 within 2 weeks prior to the first dose of the study drug, or who cannot discontinue the use of strong CYP3A4 inducers and inhibitors during the study;
4. Patients with a history of autoimmune diseases, a history of immunodeficiency, including positive for HIV, or other acquired or congenital immunodeficiency diseases, or a history of organ transplant;
5. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
6. Severe or uncontrolled cardiovascular disorder requiring treatment;
7. Refractory nausea, vomiting, chronic gastrointestinal disease, inability to swallow drugs orally;
8. Women who are pregnant or breastfeeding;
Essential Oils Following IUD Insertion

This study will measure the effects of topical application of sweet marjoram essential oil + grapeseed oil with massage on uterine cramping/pain post-IUD insertion/placement.

The intention is to conduct a pilot study that could give a first look at the data to determine whether this line of research is worth pursuing with more time, effort, and resources. The results of this pilot study will provide adequate data (e.g., variance estimates) needed for obtaining reasonably reliable sample size estimates if larger studies are warranted in the future.

Patients will be consented and randomized to one of three methods by a member of the study team on the day of their IUD insertion. Several variables of interest will be collected via the electronic medical record and via questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of IUD insertion
* English speaking
* Subject has signed study-specific consent form
* Subject has taken clinic recommended NSAID at least 30 minutes prior to IUD insertion

Exclusion Criteria:

* Subject is in post-partum period
* Known allergies to sweet marjoram essential oil or grapeseed oil
* Broken or irritated skin on lower abdomen
* Diagnosis of IBS/IBD
Equivalence of a Human-Powered Nebulizer to an Electric Nebulizer

This is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in San Salvador, El Salvador.

The study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). Subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. Improvement in peak expiratory flow will be the primary endpoint. Blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from Mild or Moderate Asthma symptoms
* Increased respiratory rate, but not over 30 breaths per minute
* Reduced peak expiratory flow rate, but not less than 60% of normal
* Oxygen saturation levels reduced but greater than 90%

Exclusion Criteria:

* Any other respiratory condition that would interfere with nebulizer treatment
* If any other medication is being taken at the time
* Pregnant women or women who may think they might be pregnant
* Never taken salbutamol before
Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium


Eligibility Criteria:
Inclusion Criteria:

* symptomatic adenomyosis
* irregular menstrual bleeding and dysmenorrhea .

Exclusion Criteria:

* asymptomatic patients -
* non-lactating patient
* not desire for pregnancy
* no hormonal treatment more than 6 month even contraception e.g IUD
* no focal lesion of uterus (malignancy ,fibroid or adenxal mass )
RWD Patients With Pulmonary Arterial Hypertension Treated With IP Prostacyclin Receptor Agonists

This is an observational, ambrispective study of patients in real world clinical practice, who has pulmonary arterial hypertension in whom a prostacyclin IP receptor agonist (Selexipag) is initiated between 2017 and 2021.

The aim of this study answer the following questions:

* Changes in the mortality risk profile of these patients after treatment administration.
* Baseline characteristics of patients initiating Selexipag.
* Parameters used for risk stratification prior to treatment escalation.
* Events during follow-up.

No comparison group available


Eligibility Criteria:
Inclusion Criteria:

* They agree to participate in the study by signing an informed consent form

Exclusion Criteria:

* Decline to participate in the study
* Patients living 6 months or less in the reference health area
* Patients with active malignant tumors
Elranatamab Expanded Access Protocol in Adults With Relapsed/Refractory Multiple Myeloma

Elranatamab is a bispecific antibody: binding of elranatamab to CD3- expressing T-cell and BCMA- expressing multiple myeloma cells causes targeted T-cell mediated cytotoxicity.

This expanded access protocol will provide access to elranatamab until it becomes commercially accessible to patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 antibody and have no access to other comparable/alternative therapy and for whom elranatamab could be a possible treatment option.

Study C1071017 is a single-arm, open-label study in patient with relapsed /refractory multiple myeloma.

Each patient will receive study intervention until disease progression, unacceptable toxicity, withdrawal of consent, study termination or until elranatamab becomes commercially accessible.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of MM as defined according to IMWG criteria .
* Patients who are ineligible for participation in any ongoing clinical trial of elranatamab, including lack of access due to geographical limitations, and who have exhausted all other treatment options or experience lack of access to commercially available therapies due to geographical, financial or socioeconomic limitations.
* Measurable disease at screening based on IMWG criteria as defined by at least 1 of the following:
* Serum M-protein ≥0.5 g/dL (≥5 g/L)
* Urinary M-protein excretion ≥200 mg/24 hours
* Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
* Refractory to at least one IMiD, one PI, and one anti-CD38 antibody.
* Relapsed/refractory to last anti-MM regimen.
* ECOG performance status 0-1.
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
* Not pregnant, willing to use contraception

Exclusion Criteria:

* Smoldering MM; plasma cell leukemia; POEMS syndrome; Waldenström's macroglobulinemia; amyloidosis; stem cell transplant within 12 weeks prior to enrollment or active GVHD
* Previous treatment with BCMA directed therapy;
* Active HBV, HCV, SARS- CoV-2, HIV or any active, uncontrolled bacterial, fungal, or viral infection.

Active infections must be resolved at least 14 days prior to enrollment.

* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ or Stage 0/1 with minimal risk of recurrence per treating physician.
* Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
The iTAP Study for Veterans

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

More than half of returning Veterans who screen positive for hazardous drinking report clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments in executive functioning, negative emotionality, and craving. The proposed project aims to examine improvements in insomnia as a mechanism for improvement in alcohol use among heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and research diagnostic criteria will participate in a randomized pilot trial. Participants will be randomly assigned to receive personalized normative alcohol feedback in the context of one of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n = 22). Outcomes will be assessed at the end of the active intervention period (6 weeks), mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity/frequency, alcohol-related consequences, executive functioning, negative affect, emotion regulation, craving for alcohol, and use of alcohol as a sleep aid.

Eligibility Criteria:
Inclusion criteria:

* Veteran deployed for military service after September 11, 2001
* 1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days
* DSM-5 and research diagnostic criteria for Insomnia Disorder

Exclusion Criteria:

* Inability to provide informed consent
* Cognitive impairment
* Contraindications for CBT-I (mania or seizure disorder)
* Untreated sleep disorder requiring more than behavioral treatment for insomnia
* Engagement in overnight shift work at baseline
* Care of a child under 1 year of age
* Severe or untreated psychiatric disorder that requires immediate clinical attention
* Current behavioral treatment for insomnia or alcohol use
* Initiation of sleep medication in the past 6 weeks
Effect of High Rebound Mattress Toppers on Sleep and Sleep-Related Symptoms

The purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms.

The study will compare effects of use of high rebound mattress toppers versus use of low rebound mattress toppers on sleep and sleep related symptoms and core body temperature during diagnostic sleep studies.


Eligibility Criteria:
Inclusion Criteria:

* Adults Age 18-65 who are scheduled for a diagnostic sleep study at the Stanford Sleep Clinic for sleep disorders (including but not limited to, insomnia, Sleep Apnea or other sleep disorder symptoms).

Exclusion Criteria:

* Individuals with a history of having difficulty swallowing food or large capsules. We will not be able to enroll individuals with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (IBD), peptic ulcer disease, Crohn's disease, ulcerative colitis, previous gastrointestinal surgery.
* Individuals who are pregnant.
* Individuals who are unable to provide informed consent (i.e. decisionally impaired).
The Safety of Intravenous Lacosamide

To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.

Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
* Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
* Patients may be male or female.
* Patients must be 4 years of age or older, and less than age 35 years.
* Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.

Exclusion Criteria:

* Patients will be excluded from entry into the study if any of the following are true:
* Patient has previously participated in any other intravenous Lacosamide study.
* Patient has status epilepticus within the last 3 months.
* Patient has a history of drug allergy to Lacosamide.
* Patient is pregnant.
* Patient has taken experimental drug within last 30 days.
* Patient with significant hepatic or renal disease.
An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Advanced Renal Cell Carcinoma
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
* Must have at least 1 lesion with measurable disease

Exclusion Criteria:

* Subjects with active central nervous system metastases
* Subjects who received prior therapy with checkpoint inhibitor
* Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply