cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
* Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
* Has history of cancer (malignancy)
* Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
Yoga and Vibration Training for Stress Urinary Incontinence in Women

This study aimed to compare the effects of yoga and Whole Body Vibration Training on pelvic floor muscle strength, severity of urinary symptoms and UI-related quality of life in women with UI.

The intervention period for the study was determined as 6 weeks. It has been decided that yoga practice will be done 3 times a week for 45 minutes, and whole body vibration training will be done for 45-55 minutes. The home exercise group will perform the planned exercise protocol every day for 6 weeks.

The results of the study will be evaluated by statistical analysis as a result of the interventions and evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-60,
* patients with SUI or Mix UI with a predominant SUI component,
* patients who have not received treatment with any physical therapy modality in the last 3 months,
* patients who signed the informed consent form.

Exclusion Criteria:

* Those with neurological diseases that may cause incontinence
* Those with prolapse
* Those using intrauterine devices
* Obesity (BMI \>30)
* Patients with serious systemic diseases that prevent them from exercising (Cardiovascular disease, COPD, CVO and/or cancer)
* Patients with pure urge or mixed UI with a predominant urge component
* Patients with a history of thrombosis
* Patients who engage in high-intensity sports activities for at least half an hour at least twice a week (tennis, aerobic exercise, running, exercises with body weight).
* Patients with neurological or vestibular disease that may cause balance disorders
* Patients with grade 3 or 4 knee and/or hip osteoarthritis
* Patients with a history of knee and/or hip joint replacement surgery
* Patients with kidney or gallbladder stones
* Patients with acute disc herniation or spondylolisthesis
A Phase 2 Extension Study of Study GCS-100-CS-4002

The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.

Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney. GCS-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating patients with CKD.

Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage 3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety events, may be asked to participate in this study to test the safety of prolonged administration of study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
2. Subject was enrolled in and completed the End of Study (Day 85) of GCS-100-CS-4002

Exclusion Criteria:

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002
2. Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≤100 mmHg at screening
3. Subject has clinical laboratory results of:

   1. Hemoglobin: ≤9g/dL
   2. Total bilirubin: \>1.5X the upper limit of normal (ULN)
   3. ALT and/or AST: \>2.5X ULN
4. Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk
5. Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator
Topical L. Reuteri in Children With Atopic Dermatitis

This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product

AD if a very frequent allergic skin disorders in children. Produce a negative significant impact on quality of life and related costs. Recently the changes of skin microbiota had been related with inadequate evolution of atopic dermatitis.

L. reuteri had been identified with some effect to reduce skin inflammation and help to modulate inflammatory pathways on skin. Investigators expect using topical L. reuteri as adjuvant some improvement on skin appearance due to the mode of action previous referenced additionally to some potential changes on microbiome

Eligibility Criteria:
Inclusion Criteria:

* Children age 1 to 8 years old
* Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
* SCORAD Index 15 to 50, inclusive
* Subjects whose parents or legal representative are willing to sign the informed consent
* When the child is 8, he/she must also give consent to participate in the study

Exclusion Criteria:

* Use of phototherapy for atopic dermatitis
* Systemic or topic corticosteroids in tthe 30 days prior to the study
* Immunosuppressive or cytostatic drugs in the 2 months prior to the study
* Use of probiotics in the 2 weeks prior to the study
* Other allergic severe disease (asthma, allergic rhinitis)
* Systemic antibiotics in the four days prior to the study
* Fever (temperature\> 37.5 °C axillary or equivalent)
* Pathologies associated with immunodeficiency or cancer processes
* Dermatological diseases that may hinder the evaluation of atopic dermatitis or require the continued use of topical corticosteroids
* Subjects for whom any of the studies products are contraindicated according to their technical specifications
* Subjects who have participated in research studies with any products in the 3 months prior to the trial
Affect-regulatory Characteristics of Deceptive Placebos

The study tries to identify whether specifically framed expectations, induced with an active placebo nasal-spray, have effects on affective regulation processes and rumination.

Healthy volunteers are informed that a new application method for an antidepressant, specialized on positively influencing the experience of aversive emotional states would be tested. They will randomly be assigned to a no treatment control group (not taking a placebo) or to one of the two treatment groups: Participants will be taking the antidepressant (which is in fact an active placebo) which will either protect them from experiencing intense emotional reactions and rumination (anticipatory group) or help them to regulate emotional states quicker as well as to distance themselves from ruminative thoughts (reactive group). Then, an aversive emotional state is induced by an autobiographical recall of events which made the participants feel inadequate, bashful, and ashamed. Currently experienced shame as well as state rumination are assessed before and after the negative recall task.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* fluent in German language

Exclusion Criteria:

* mental disorders
* allergic to capsaicin
* allergic to sesame oil
* intake of psychopharmacological drugs in the last four weeks
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* students in medicine, pharmacy, or psychology
* completed studies in medicine, pharmacy or psychology
* current pregnancy or lactation
* cardio vascular disease
* kidney disease
* liver disease
PROMISE: PRedictors Of Good outcoMes in Thrombectomy for Large Infarct Core Stroke Evaluation

Identify the factors associated with a favorable clinical outcome in participants with acute ischemic stroke and large core infarcts within 24 hours of onset who are treated with endovascular intervention.

In 2022 and early 2023, three randomized controlled trials-RESCUE-JAPAN LIMIT, SELECT 2, and ANGEL ASPECT-were published in the New England Journal of Medicine. These trials demonstrated the effectiveness and safety of endovascular intervention using clot retrieval devices in participants with acute ischemic stroke and large core infarcts. However, the rate of participants achieving a good recovery remains low, while the mortality and disability rates are very high.

Moreover, in Vietnam, the acute stroke treatment process has not been optimized, and the facilities and equipment for monitoring neurointensive care are not fully equipped. As a result, endovascular intervention using clot retrieval devices in participants with large core infarcts has not been widely implemented in the investigator's country, and the effectiveness and safety of this treatment method have not been clearly evaluated.

Addressing this issue is crucial for improving the quality of life and reducing the mortality and disability rates caused by stroke in this participant group. This study aims to provide new insights into the use of endovascular intervention for treating acute ischemic stroke with a large core infarct volume, thereby supporting clinical decision-making and improving treatment outcomes for participants with acute ischemic stroke and large core infarcts.

We hypothesize that core infarction is not the sole factor for excluding patients from potent thrombectomy therapy. We aim to determine predictors of favorable and unfavorable outcomes following thrombectomy in patients with large core strokes. Secondly, we aim to build a multivariable calculator to predict good or poor outcomes after thrombectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18-year-old
* Patients presenting with acute ischaemic stroke within 24 hours of stroke onset
* Received mechanical thrombectomy within 24 hours of stroke onset
* Imaging criteria include:

  * Large vessel occlusion on CT Angiography or MR Angiography (MRA) including tandem occlusion of the internal carotid artery and middle cerebral artery or internal carotid artery.
  * Core infarct criteria:

    1. ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).
    2. ASPECTS score \>5 and core infarct volume of 50-150 ml on CT perfusion (CTP) or reduced cerebral blood flow (rCBF) \<30% on CTP or apparent diffusion coefficient (ADC) \<620 × 10-6 mm2/s on DWI.

Exclusion Criteria:

* Patients presenting with acute ischaemic stroke \>24 hours of stroke onset
* Intracranial hemorrhage identified by CT or MRI
* Pre-stroke modified Rankin Score (mRS) score of \>2 (indicating previous disability)
* Any terminal illness such that the patient has a life expectancy of less than 1 year.
* Patients with active cancer and undergoing treatment for cancer are excluded,
* Pregnancy
Development of Transdiagnostic Single-session Treatment

The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is:

* Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress?
* Will the transdiagnostic treatment program decrease transdiagnostic risk factors?
* Will the transdiagnostic treatment program decrease the measured risk factors equally?
* Will the transdiagnostic treatment program impact patients with anxiety, depression or stress disorders equally?
* Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on transdiagnostic risk factors?
* Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on anxiety, depression, or stress-symptoms?
* Have the participants been able to generalize the skills taught in the program(qualitative)?
* Within group that were treated with single-session treatment and recieved additional care before follow-up, was there a difference in outcome?

The study investigates the effect of a single-session, 4 hour, transdiagnostic treatment for primary care patientst with depression, anxiety or stress.

The treatment includes, interoceptive exposure, behavioral activation, mindfulness, defusion and psycho-education about emotions.

The study is conducted in a clinical setting in northern sweden and follows up results at 3 weeks and 6 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meet the criteria for anxiety, mood disorder, or stress diagnosis
* Symptoms are mild to moderate in severity

Exclusion Criteria:

* Already in ongoing psychotherapy
* Within a month commenced pharmaceutical treatment that will likely impact mood or psychological functioning and is not deemed to be on a stable dose
* Has a comorbid personality disorder
* Has a risk of suicide deemed other than low
* Has other severe psychological disorders outside the scope of primary care
* Is in a severely stressful social situation deemed incompatible with psychotherapy
NRTI-Sparing Pilot Study

This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra).

Participants will be randomly assigned to receive one of the following drug combinations:

* lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
* Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
* Combivir and lopinavir/ritonavir twice a day.


Eligibility Criteria:
Inclusion Criteria:

* Be HIV-positive
* Be at least18 years of age
* Have viral load above 5 000 copies/ml
* Be likely to comply with the study protocol
* Agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs
* Agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator

Exclusion Criteria:

* Have ever received antiretroviral therapy
* Pregnancy or breastfeeding
* Have abnormal laboratory tests (see investigator)
* Have received an investigational drug within 30 days of study drugs administration
* Be receiving systemic chemotherapy
* Have an acute illness
ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach

RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva.

The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group).

The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS.

The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France.

The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age,
* Patient from one of the 2 study populations:

  * Diagnosis of definite or probable ALS according to El Escorial criteria ("patients ALS" group) ;
  * Control group
* Patient able to carry out a mouth rinse,
* Patient affiliated to the healthcare system,
* Patient has dated and signed the consent form,

Exclusion Criteria:

* Recent (\<1 month) or ongoing bacterial or viral infection,
* Known active oral or digestive mycosis,
* Evolving, symptomatic or obvious oral pathology,
* Known pregnancy,
* Patient participating in another clinical research study,
* Patient deprived of liberty by administrative or judicial decision or under guardianship ;
* Subject refusing to take a saliva sample;
* For the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study;
* For control group: medical history of neurological disease (excluding migraine).
Prevalence of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Multiple Myeloma (MM) Among Unique Populations of Black People

This study is being done to screen for monoclonal gammopathies in people of East African descent. Monoclonal gammopathy is a condition where abnormal proteins are found in the blood, most commonly called monoclonal gammopathy of undetermined significance or MGUS. There is little information on the presence of this condition in people of East African descent. This study is being done to determine how this condition affects this population in order to better treat and/or prevent this condition in the future.

PRIMARY OBJECTIVE:

I. To determine the prevalence of monoclonal gammopathies (MGUS, Smoldering and Multiple Myeloma) in people of East African descent in Minnesota.

OUTLINE: This is an observational study.

Participants undergo medical chart review and blood sample collection, as well as complete a questionnaire on study. Participants who test positive for MGUS are notified, along with their primary care physician, so that the necessary follow up and referral is provided as clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 40 years
* Self-reported east African ancestry (including individuals of mixed east African descent)
* Willing and able to review, understand, and provide consent before starting any study-specific procedures

Exclusion Criteria:

* Pregnant women
Changes in Oxygen Saturation in Two Exercise Modalities

The investigator will proceed to assess changes in oxygenation of muscle tissue, electromyographic activation and strength in healthy subjects. For this, a measurement of all demographic variables on the first day of the study as well as a familiarity with the equipment will be performed. Participants will start the intervention 48 hours later to proceed with the first intervention with one of the exercises in this research (inertial pulley or regular machine). Later on, 48 hours later participants will perform the latest intervention that has not yet done, thus generating a crossover study.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary
* No pain
* Non disease

Exclusion Criteria:

* Exercise experience
Kinetic of Melatonin Subsequent to the Consumption of Melatonin-rich Food Supplements

This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.


Eligibility Criteria:
Inclusion Criteria:

* Male between the ages of 18 and 45,
* In good general health, i.e., free of chronic conditions and not taking medication at the time of inclusion and/or long-term,
* Over 70 kg and with a body mass index between 18.5 and 24.9,
* Able and willing to participate in the research by complying with the procedures of the protocol, in particular concerning the taking of the product under study and the performance of sequential blood tests,
* Having freely signed the consent form after adequate information on the proposed study, in accordance with Good Clinical Practice and after submission of the information leaflet,
* Affiliated to a social security scheme or similar.

Exclusion Criteria:

* Smoker,
* Drug addict,
* Subject with an alcohol consumption of more than 2 glasses per day,
* Taking a drug treatment or melatonin or a product containing melatonin within 48 hours prior to a kinetics visit,
* Known organic or functional abnormality of the urinary tree,
* Any medical condition that would involve a change in melatonin metabolism:

Drug intake: Fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, carbamazepine and rifampicin, analgesics, Liver abnormality known or detected at the screening visit and judged to be clinically significant by the investigator, Known autoimmune disease,

* Subject assessed as "moderately" or "definitely" evening type,
* Known hypertension (\>140/90),
* Diagnosis of migraine by a health professional according to the International Headache Society (IHS) criteria revised in 2004,
* Wuth a sleep disorder,
* Thyroid dysfunction, hyperglycemia or anemia judged to be clinically significant by the investigator,
* Blood donation within one month prior to inclusion,
* A known organic or psychological abnormality (including a history of severe depression) that may bias the results of the study as judged by the investigator,
* Workers with atypical working hours (night work, staggered working hours),
* Known allergy or intolerance to any of the components of the product,
* Psychological or linguistic inability to understand and sign informed consent,
* Participant in another interventional clinical trial or during a period of exclusion from a previous clinical trial,
* Under legal protection (guardianship, curatorship) or deprived of his rights as a result of the administrative or judicial decision,
* Subject who has reached the maximum threshold for compensation for research provided for in the regulations.
A Study in Patients With Advanced Cancers

A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.

This is an open-label, Phase 1/2, first-in-human (FIH), multiple ascending dose and dose-expansion study of BIO-106 administered as monotherapy and in combination with pembrolizumab. Phase 1 will define the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BIO-106 that can be advanced to Phase 2. Phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients histologically or cytologically documented, locally advanced or metastatic solid tumor.
* Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment.
* Measurable disease as determined by RECIST v.1.1 or bone only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key Exclusion Criteria:

* History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody.

Impaired cardiac function or history of clinically significant cardiac disease

* Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Active SARS-CoV-2 infection.
* Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

Other protocol defined inclusion/exclusion criteria may apply.