cyrilzakka/clinical-trials huggingface dataset:
A Study of Two Different Formulations of LY3502970 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation
* Participants who have a hemoglobin level of at least 11.4 grams per deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants
* Participants with a body weight of at least 45 kilograms (kg) and body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Participants who have any abnormality in the 12-lead electrocardiogram (ECG) at screening
* Participants who have an abnormal blood pressure, pulse rate, or both, which are deemed to be clinically significant by the investigator, at screening
* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
* Participants who have used or intend to use over-the-counter or prescription medication including herbal medications or traditional medications within 14 days prior to dosing
* Participants who show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies, or both. A negative test within 6 months of screening would not need to be repeated.
* Participants who show evidence of hepatitis C and/or positive hepatitis C antibody, or both. A negative test within 6 months of screening would not need to be repeated.
* Participants who show evidence of hepatitis B, positive hepatitis B surface antigen, and/or positive hepatitis B core antibody, or all. A negative test within 6 months of screening would not need to be repeated.
Protocol for Evaluation Effectiveness Monitoring Neurophysiological Per-operative in Surgery Traumatic Acetabular

Pelvic fractures in which integrate the acetabulum fractures represent a risk of traumatic injury to the sciatic nerve trunk by stretching or section (1): Judet and Letournel reported a complication rate of around 6% (1). Fractures of the acetabulum strictly speaking are also providers of neurological complications with rates, significant, have recently been precisely detailed by a cohort study published by Lehmann et al. (2): In a series of 2073 patients, the authors reported an overall complication rate of neurological related to the initial trauma of the order of 4%. In this series, 1395 patients were operated with a rate of iatrogenic neurological complications of 2 to 3%. Regarding the first routes (and therefore the types of fractures), the Kocher-Langenbeck path is the path that leads to the greatest number of neurological complications: 3 to 4% in this series (2). However, this cohort study does not specify what truncal achievement it is. Obviously violations posterior acetabular are preferentially providers of sciatic injury while violations prior acetabular are more providers of obturator or femoral lesions. But this is not always the case. Moreover, this study does not specify the type or severity of neurological involvement.

Methodology Design: This is an interventional study in routine care, prospective, single-center.

Main objective / secondary:

Primary objective :

To evaluate the sensitivity of the neurophysiological monitoring combining two specific new procedures to detect intraoperative complications on the sciatic trunk (by measuring potential with somatosensory storied collection of P15 and electromyographic recording with the potential of sciatic nerve in the popliteal fossa).

secondary objectives

Frequency of neurophysiological changes on the interventions of the acetabulum.

An anomaly being retained as:

* Interval prolongation N8-P15\> 10%
* And / or decrease in the amplitude ratio P15 / N22\> 50%
* And / or elongation of the latency of nerve potential\> 10% of the value-operative Opré
* And / or reducing the amplitude of the nerve potential\> 50% Correlation between the impact of changes neurophysiological intraoperative and
* The occurrence of postoperative neurological deficit:

  * motor deficit
  * and / or sensory deficit
  * territory of the sciatic trunk

Correlation between the incidence of intraoperative neurophysiological modifications and:

* The type of surgery
* The type of fracture

Eligibility Criteria:
Inclusion Criteria:

* Patients sent to the Hospital Group Service Paris Saint Joseph for surgical treatment of fractures of the acetabulum.
* Anterior and posterior surgical first Routes
* Major Patient
* Age \<60 years

Exclusion Criteria:

* Known diabetes treated
* Previous history of spine surgery
* Sick antecedent the peripheral or central nervous system known
Couple-Based Mindfulness Intervention for Metastatic Colorectal Cancer

The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners.

The overall objective of this study is to develop a novel couple-based mindfulness intervention aimed at reducing distress in patients with metastatic colorectal cancer (mCRC) and their partners. The intervention is named "MIND-Together" (Mindfully Navigating Distress Together). MIND-Together will be the first mindfulness-based intervention designed to reduce mCRC couples' distress by targeting their unique psychosocial needs. The intervention is projected to be a 4-session intervention delivered by a trained therapist to individual couples facing mCRC (i.e., a patient and his/her intimate partner) via video-conference (e.g., Zoom).

Eligibility Criteria:
Patient Inclusion Criteria:

* Provision to sign and date the consent form.
* Stated willingness to comply with all study procedures and be available for the duration of the study.
* Be aged \> 18 years.
* Fluent in English language
* Be a person (i.e., patient) diagnosed with metastatic colorectal cancer (mCRC), a partner (e.g., spouse) of someone diagnosed with mCRC, or a clinician who treats patients diagnosed with mCRC.

Additional patient participant inclusion criteria:

* Has a current diagnosis of metastatic (Stage IV, recurrent) colorectal cancer
* Has an ECOG status \<2 or otherwise deemed appropriate for study participation by a clinician
* Is in a committed relationship with a romantic partner for \>6 months
* Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
* Indicates a score \>0 on the Distress Thermometer

Additional partner participant inclusion criteria:

* Has been in a committed relationship \>6 months with a patient who meets the above eligibility criteria
* Has access to computer/internet through with video-conferencing (phone, laptop, tablet, desktop computer)
* Indicates a score \>0 on the Distress Thermometer

Additional clinician participant inclusion criteria:

∙Is a physician or advanced practice clinician (e.g., oncologist, nurse practitioner, physician assistant, psychologist, mental health provider, etc.)

Exclusion Criteria:

∙Has a serious mental illness (e.g., psychotic disorder), cognitive impairment (e.g., dementia), or medical condition (e.g., significant impaired sight/hearing) that would compromise participation
The Role of Genetic Factors in the Development of Epilepsy in the Kazakh Population

This is a GWAS study that aims to identify possible candidate genes associate to epilepsy by exploring single nucleotide polymorphism (SNP) in a group of epilepsy, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with epilepsy

A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies

Eligibility Criteria:
Inclusion Criteria:

* Children with seizures, confirmed by EEG and no morphological damage to the brain, confirmed by MRI of the brain;
* The age of the patients is from 0 to 5 years;
* Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs;
* Children are parents or legal guardians who have given written informed consent.

Exclusion Criteria:

* Children over 5 years old;
* Children whose parents, according to the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
* Children with seizures with brain damage that cause epilepsy;
* Children of a non-Kazakh ethnic group.
Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume

The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Subject aged between 35 and 65.
2. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level

Exclusion Criteria:

1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
3. Those who has thin skin in the mid-facial area
4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics

\<Extension Study\>

Inclusion Criteria:

1. Participated in the pivotal study and completed the end of study visit
2. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study

Exclusion Criteria

1. Those who have following procedual history between completion of the pivotal study and entry of extension study

   - facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting
2. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment
Effectiveness of Local Food Solutions for the Prevention of Acute Malnutrition in Tigray, Northern Ethiopia (ELOFSAM)

The lack of diversified and enriched complementary foods is one of the key causes of the high burden of acute malnutrition among 6-23 months old children in Ethiopia. Thus, a new innovative way of diversifying and enriching complementary foods is essential in communities where vulnerable populations are likely to have nutrient gaps in their typical diets and multiple micronutrient deficiencies. The purpose of this project is to investigate the acceptability and effectiveness of locally produced cereal based foods (LP-CBFs) and small quantity lipid based nutrient supplements (SQ-LNS) as preventive interventions to effectively reduce the burden of acute malnutrition among 6-23 months old children in the post conflict settings of Tigray, Northern Ethiopia.


Eligibility Criteria:
Inclusion Criteria:

* All 6-23 months old children

Exclusion Criteria:

* 6-23 months old children with severe acute malnutrition.
Group Versus Individual Contraceptive Counseling for Resettled African Refugee Women

To evaluate the feasibility and effectiveness of group contraceptive counseling on family planning knowledge acquisition, service satisfaction, method uptake and continuation among a group of resettled African refugee women.

Thousands of women refugees arrive in the United States each year, yet there is very little known about reproductive health and family planning needs of these women after resettlement.

This randomized controlled pilot study, in a population of resettled African refugee women, will evaluate differences between group and individual contraceptive counseling on the decision to use contraception, satisfaction with counseling method, and modern family planning knowledge.

Participants will arrive to clinic during an assigned "intervention day." An intake and exit survey will be performed before and after their counseling session. Demographics, attitudes towards contraception, and knowledge regarding contraceptive methods will be assessed via questionnaire. Participants will be randomized to either group or individual contraceptive counseling. After each session, participants will have the option to privately choose a reversible method of contraception free of charge.

Telephone survey follow-up with participants will occur every three months for one year. Follow-up surveys will include questions regarding method continuation, method satisfaction and and modern contraceptive knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Resettled refugee
* Ability to speak and comprehend conversational Swahili, French or Lingala
* Interest in contraceptive counseling
* Willing to adhere to study protocols including randomization and follow-up
* Cellular phone access

Exclusion Criteria:

* Male
Optimization of Keverprazan-amoxicilli Dual Therapy for Helicobacter Pylori

The purpose of this study was to evaluate the efficacy and safety of keverprazan with different doses of amoxicillin for Helicobacter Pylori.

This study is a prospective, single-center, open-label, randomized, parallel-controlled trial. A total of 268 H. pylori positive patients needed to be recruited and were randomized into 2 groups in 1:1 ratio, Group A was the control group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. Group B was the experimental group and subjects were required to take keverprazan 20mg,bid and amoxicillin 1.0g,tid for 14 days. All the above regimens were used for eradication of H. pylori. During the 14-day eradication treatment, all subjects were instructed and asked to record their adverse drug reactions and compliance. On days 7 and 14 of treatment, researchers followed up with patients via WeChat or phone to determine adverse reactions and compliance, and observed and recorded whether subjects experienced any adverse reactions such as nausea, diarrhea, dizziness, bitter taste in the mouth, rash, and constipation. Subjects were seen again 4 weeks after the end of treatment to check for H. pylori eradication by 13C-UBT or 14C-UBT. Patients were encouraged, but not required, to undergo tongue and fecal flora testing before and after H. pylori eradication to determine the short-term effects of different doses of amoxicillin in combination with keverprazan for 14 days on the patient's tongue and intestinal flora.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Helicobacter pylori positivity through 13C-UBT or 14C-UBT
2. Patients who have not received eradication treatment for Helicobacter pylori in the past, or who have failed eradication in the early stage but have not received eradication treatment within six months
3. Voluntarily participate in this experiment and sign an informed consent form

Exclusion Criteria:

1. Allergies to research drugs (such as those allergic to penicillin, amoxicillin, keverprazan)
2. Patients with peptic ulcer
3. Patients who have received Helicobacter pylori eradication treatment within six months
4. Use antibiotics or bismuth medication 4 weeks before starting the study；use P-CAB or PPI 2 weeks before starting the study
5. Using corticosteroids, non steroidal anti-inflammatory drugs, or anticoagulants
6. Those who are using atazanavir, nelfinavir, rilpivirine, itraconazole, tyrosine kinase inhibitors (imatinib, gefitinib, etc.), digoxin, and methyl digoxin
7. History of esophageal or gastric surgery
8. Pregnant or lactating women
9. Suffering from serious concomitant diseases such as liver disease, cardiovascular disease, lung disease, or kidney disease
10. Excessive drinking
11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant neoplastic diseases
Effects of Barley Based Food Products on Metabolism and Gut Microflora

The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.

100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women between 50-79 years and
* BMI between 19-28.

Exclusion Criteria:

* fasting blood glucose concentrations \> 6,1 mmol/L,
* known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
* furthermore, the subjects should be non-smokers and
* consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
* antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.
High-Resolution Ultrasound Imaging of the Retina and Choroid for Detection on Age Related Macular Degeneration

The macula is the site of central vision within the retina. The retina is oxygenated by the underlying choroid. These tissues are less than 1 mm thick in total. While optical techniques can reveal much about the structure of the retina, ultrasound allows imaging of the choroid and deeper tissues. This study will investigate use of high frequency (20 MHz) ultrasound for imaging of the retina and choroid in patients with age-related macular degeneration, a prime cause of blindness. The investigation will involve use of novel post-processing methodologies to achieve maximum resolution of the fine tissue structures involved in this disease.

Age-related macular degeneration (AMD), a condition affecting over 40% of individuals 70 years or age or more, causes progressive loss of central vision. Photocoagulation has long been used to slow the progress of AMD, but new vision-preserving methods are currently under investigation. Because destroyed photoreceptors are permanently lost, early management is essential for preservation of vision. The aim of this project will be to study AMD using a suite of new high-resolution ultrasound imaging techniques that have been developed. Specifically, high-resolution ultrasound will be used to generate images of the retina and choroid, including perfusion measurements using slow-flow methods developed by our research group. Ultrasound studies will be performed in conjunction with optical coherence tomography (OCT) imaging in a series of patients and age-matched control subjects with the aim of determining if choroidal thickness and/or perfusion might be used as an early indicator of AMD and thus aid in patient management.

We will study 20 subjects diagnosed with AMD. We will attempt to have an approximately equal number of subjects with wet and dry forms of AMD. A control group consisting of 20 non-AMD age-matched subjects will also be recruited. Ultrasound scan sequences will consist of B-mode images of the macula and surrounding tissues.

Eligibility Criteria:
Inclusion Criteria:

Age related macular degeneration age matched control

Exclusion Criteria:

none
Evaluation of the Quality of Life After a Multidisciplinary Auditory Rehabilitation Program

In 2008, the Handicap-Santé survey counted 10 million people with hearing difficulties in France, i.e. 16% of the national population. For 5.4 million of these people, the hearing limitations considered to be moderate to total, are likely to have repercussions on their daily life.

In 2010, 600,000 people with hearing loss wore hearing aids, including 360,000 with very severe to total limitations who were unable to follow a conversation with others.

Hearing loss can impact hearing skills (comprehension in noisy environments or with multiple speakers) and be a source of cognitive decline. It can also limit the quality of exchanges, communication and information taking.

Several studies have shown that hearing loss can also have a negative effect on quality of life, psychological well-being, personal fulfillment, social relationships and can lead to social isolation, depression and/or anxiety.

Currently, the treatment of people with hearing loss is often limited to hearing aids from a hearing aid specialist. Hearing rehabilitation and lip-reading training with a speech therapist may be offered at a later stage. However, many people who have been fitted with a hearing aid describe a decrease in their quality of life despite the fitting.

Current treatment seems to deal mainly with auditory-cognitive problems. To date, no multidisciplinary rehabilitation services seem to be offered in France to take into account the other consequences of this condition: anxiety, depression, and limitations in social participation.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age ≥ 18 years
* Patients with acquired hearing loss (mild, moderate, severe or profound)
* Patients with hearing aids
* Patients participating in a complete rehabilitation program
* Patients who master the French language

Exclusion Criteria:

* Patients with proven cognitive impairment
* Implanted patients
* Patients under guardianship or curatorship
* Patients deprived of liberty
* Patients under court protection
* Interruption of the rehabilitation program before a minimum of 6 half-days of HDJ
* Patients objecting to the use of their data for this research
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects

This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age
2. Continuous non-smoker
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.
4. Women of non-childbearing potential only
5. Able to understand and sign a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems
2. History or presence of clinically significant medical or psychiatric condition or disease
3. History or presence : Familial hyperlipidemia, Diabetes, Bleeding disorder(s), including relevant familial history, Thromboembolic disease, Bleeding in the gastrointestinal tract or CNS, Hepatobillary disease, Gilbert's syndrome
4. History or presence of alcohol or drug abuse.
5. Has liver function test(s) including ALT, AST, GGT, and/or ALP or total bilirubin that are \> ULN at screening or check-in.
6. Positive urine drug or alcohol results.