cyrilzakka/clinical-trials huggingface dataset:
n3 PUFA and Muscle-disuse Atrophy in Young Women

This study will examine the influence of n3 PUFA supplementation on the rate of muscle atrophy in women undergoing 2 weeks of unilateral limb immobilization. Assessments in skeletal muscle strength and skeletal muscle volume will also me made before, after and in recovery from immobilization.

Biological aging is associated with the loss of skeletal muscle mass and strength resulting in compromised metabolic function and mobility. Throughout life, individuals will also experience periods of reduced physical activity/muscle disuse that independently lower muscle mass and strength accelerating the aging process. The losses in muscle mass with aging and disuse are underpinned by feeding-induced declines in rates of muscle protein synthesis. Thus, strategies to enhance muscle protein synthesis could have clinical implications for those who wish to maintain metabolic health and function during times of muscle disuse.

Supplementation with n3 PUFA-enriched fish oil has been shown to potentiate rates of muscle protein synthesis in response to simulated feeding in both younger and older adults. Fish oil supplementation also has been efficacious in enhancing skeletal muscle strength during a period of resistance exercise training. However, no study has examined the impact of fish oil supplementation to enhance muscle protein synthesis and offset declines in muscle mass/strength during a period of immobilization.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18-30 years

Exclusion Criteria:

* Take any analgesic or anti-inflammatory drugs(s), prescription or non-prescription, chronically will be excluded
* A history of neuromuscular problems or muscle and/or bone wasting diseases
* Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
* Use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)
* Fish allergy
Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens

Exclusion Criteria:

* Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments.
* Use of any concomitant medication that could affect the patient's study treatment response or assessment results.
* Any clinically relevant concomitant disease as judged by the investigator.
* Pregnancy or female planning to become pregnant during the study.
A Study of RO4917838 With Rosuvastatin in Healthy Volunteers

This single centre, open-label study will investigate the effect of RO4917838 on the pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers. Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of Rosuvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, 18 to 65 years of age
* A body mass index (BMI) between 18 to 30 kg/m2

Exclusion Criteria:

* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis (Gilbert's Syndrome is allowed)
* Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
A Study Of PGN-EDO51 In Participants With Duchenne Muscular Dystrophy Amenable To Exon 51-Skipping Treatment

The study consists of 3 periods: A Screening Period (up to 45 days), a Multiple Ascending Dose (MAD) Period (16 weeks), and a Long-Term Extension (LTE) Period (108 weeks).

The primary purpose of the MAD period is to evaluate the safety and tolerability of multiple ascending intravenous (IV) doses of PGN-EDO51 administered to participants with Duchenne Muscular Dystrophy (DMD). The primary purpose of the LTE period is to evaluate the long-term safety and tolerability of PGN-EDO51 in participants who have completed the MAD period.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of DMD able to be corrected by skipping Exon 51
* Body weight at least 18kg at Screening
* Performance of Upper Limb (PUL) 2.0 entry score of at least 4 at Screening (assessing upper limb function in ambulant and non-ambulant individuals with DMD)

Exclusion Criteria:

* Known history or presence of any clinically significant conditions that may interfere with study safety assessments
* Treatment with any gene replacement therapy for the treatment of DMD at any time
* Current or recent systemic infection within 2 weeks prior to Screening or infection requiring IV antibiotics within 4 weeks prior to Screening
* Recent surgery requiring anesthesia within 3 months prior to Screening or expected surgery requiring general anesthesia during the study
A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers

Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male between 19 and 45
* BW is above 50kg and BMI is between 18.5 and 30.0
* Subject who agreed and signed on informed consent form prior to the study participation

Exclusion Criteria:

* Presence or history of clinically significant disease
* Treatment history of any drug which might affect IP within 10days
* History of other study drugs within 12weeks
GLP-1 Mediating DPP-4 Inhibition in Type 2 Diabetes

To determine the extent to which the effects of treatment with LAF237 100 mg QD on glucagon secretion are mediated by Glucagon-like-peptide 1 (GLP-1) in type 2 diabetic patients and healthy subjects.

Design:

This two center study employs a double blind, placebo controlled, cross-over study in patients with type 2 diabetes (T2D) and healthy volunteers with comparable age, gender and BMI distribution. Subjects (40 patients and 40 healthy volunteers, referred to as subjects in remaining part of the document) will be randomized to 100 mg LAF 237 QD or placebo for two 10-day treatment periods in a cross-over design. Thirty two (32) efficacy evaluable patients are required to complete the study.

Each subjects will participate in an approximate 14-day screening period, a 2-week wash-out period from metformin, a 1-day baseline period and a 10-day treatment period followed by a 2-4 week wash-out period and a second treatment period. An end of study evaluation will be conducted following the completion of the second treatment period or in the event of early withdrawal or termination of the patient.

At screening, subjects meeting inclusion/exclusion criteria will begin a weight maintenance diet containing 50% carbohydrates, 30% protein and 20% fat. Patients will receive guidance on dietary maintenance at screening and will stay on this diet from screening to the end of study evaluation. Following the screening visit, enrolled patients will start a 2 week drug wash-out period where oral hypoglycemic medication will be discontinued.

During the drug wash-out period, all patients will monitor their glucose levels two times a day (prior to breakfast and dinner) using a glucometer. Additionally, at one week intervals, patients will perform a seven point blood glucose test, where glucose measurements will be made prior to and two hours after each meal, and prior to bed. Weekly telephone calls will be made to each patient, where the results of these glucose tests will be recorded. Patients will be discontinued from the study during the wash-out period if fasting glucose levels exceed 200 mg/dl on any two consecutive measurements.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with either diet/exercise or metformin
* HbA1c 6.5 - 9.0 %
* Fasting plasma glucose 6.0 - 11.0 mmol/l
* Body-mass-index 20.0 - 35.0 kg/m²
* Healthy controls were required to have a normal oral glucose tolerance test (75g) and no first-degree relatives with type 2 diabetes nor a personal history of gestational diabetes

Exclusion Criteria:

* Significant heart, kidney (serum creatinine ≤ 123 µmol/l in woman and ≤ 132 µmol/l in men), liver (transaminases \< 2fold upper limit of normal) and gastrointestinal disease
Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis

Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some patients experience anaphylaxis is association with exercise, a disorder called exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially those with hypotension during the anaphylactic episodes, have been shown to have abnormal, clonal populations of a certain cell type, mast cells, in the bone marrow. This has been described in at least one patient with exercise-induced anaphylaxis. The investigators would like review the findings in a group of patients with exercise-induced anaphylaxis who have undergone evaluation for the presence of abnormal, clonal mast cells.


Eligibility Criteria:
Inclusion Criteria:

* Anaphylaxis in association with exercise on at least two occasions
* During anaphylactic reaction, the subject must have experienced one or more of the following: flushing, hypotension, lack of urticaria

Exclusion Criteria:

* Pregnancy
Pre-operative Versus Post-operative Vaginal Cleansing With Chlorhexidine Solution in Prevention Post-Cesarean Section Infection

Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done to compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities. Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine.

Background: Maternal infectious morbidity is a common complication of cesarean delivery, especially in a poor recourse setting like ours. This study was done in a tertiary hospital in Abakaliki, Ebonyi State, Southeast Nigeria over a period of 5 months. The State is inhabited mainly by rural farmers and petty traders. Literacy is low and poverty is common with poor maternal health indices.

Aim: To compare the effectiveness of preoperative vaginal cleansing with immediate postoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean infectious morbidities.

Method: Randomized trial involving 120 consented women who had elective or emergency cesarean sections at term, 60 in each group. Group 1 had preoperative while group 2 had postoperative vaginal cleansing with 1% chlorhexidine. Research Randomizer software was used to generate 120 numbers. Sixty numbers were randomly generated from a pool of 120 numbers and were assigned to group 1 while the remaining 60 numbers were automatically assigned to group 2. Both groups received antibiotics and anterior abdominal wall scrubbing. There were monitored for symptoms and signs of endometritis, wound infection and pyrexia till discharge.

Eligibility Criteria:
Inclusion Criteria:

* Those that gave consent
* Term pregnancy

Exclusion Criteria:

* Refusal of consent
* Antepartum hemorrhage
* Cord prolapse
* Fetal distress
* Anemia in pregnancy
* Presence of fever and chorioamnionitis
Orthotic Use for Chronic Low Back Pain

The purpose of this research study is to determine the change in perceived levels of pain and dysfunction in 50 patients with chronic low back pain, following the use of custom-made shoe orthotics for a three month period. The hypothesis of this study is that custom orthotic intervention will improve the patients' low back pain and dysfunction symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females must be at least 18 years old.
2. Subjects must be symptomatic with current pain between T12 and the Sacroiliac joints with or without radiating pain.
3. Symptoms must have been present for at least three months.

Exclusion Criteria:

1. Use of custom-made shoe orthotics in the past year
2. Brain disorders (i.e.: dementia or Alzheimer's Disease) that would lead to difficulty in questionnaire completion.
3. Active conservative care (such as physical therapy or chiropractic care) for the low back received in the last six months (excluding the use of oral medications or daily at-home exercises for general well-being). We do not want to over-treat the patient or have any cross-over effects within this study from previous treatment.
4. Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study.
5. Current or future litigation for low back pain.
6. Chronic pain other then low back pain such as fibromyalgia
7. Low back surgery in last six months.
8. Other conditions that may affect the outcomes of this study or exclude patients from participation in the study, including contraindications to orthotic use.
9. Peripheral neuropathy due to disorders such as diabetes.
10. Low back or leg pain that is not reproducible.
Metabonomics Study of Chronic Gastritis and Gastric Carcinoma

The pathogenetic mechanisms of chronic gastritis and gastric carcinoma are different. Whether metabonomics play a role in the development of chronic gastritis and gastric cancer is still a question. So the investigators want to clarify this question by this subject.

This project was an untargeted metabolomics study using liquid chromatography coupled with mass spectrometry (LC-MS) in patients with chronic gastritis and gastric carcinoma. The experimental procedures mainly include sample collection, metabolite extraction, LC-MS/MS detection, data analysis, etc.The goal of this study is to identify and (relatively) quantify as many metabolites in biological systems as possible, so as to reveal the overall metabolite information to the maximum extent. Metabolomics aims to investigate the changes of metabolites in gastric tissues in patients with chronic gastritis and gastric carcinoma, and to study the biological processes in which these metabolites participate by screening the different metabolites in the different groups, and to reveal the mechanism of life activities in which they involved in.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic superficial gastritis and chronic atrophic gastritis
* Patients with gastric carcinoma

Exclusion Criteria:

* Patients with history of surgery
* Patients with severe heart disease,lung disease or kidney disease.
A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing

The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (\>=) 24 kilogram per square meter (kg/m\^2). The aim of this study is to find out how safe the study medicine is and how it behaves in your body. Participants will either get NNC0487-0111 or placebo. Which treatment participants will get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 60 days.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m\^2)(both inclusive), with a body weight greater than or equal to (\>=) 65.0 kilogram (kg), at screening.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening
* Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
* Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 Nanograms per millilitre (ng/mL) (30 nanometer\[nM\]) at screening
* Parathyroid hormone (PTH) outside normal range at screening
* Total calcium outside normal range at screening
* Amylase greater than or equal to (\>=) 2 times upper limit of normal at screening
* Lipase greater than or equal to (\>=) 2 times upper limit of normal at screening
* Calcitonin greater than or equal to (\>=) 50 picograms per milliliter (pg/mL) at screening
Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer

The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head \& neck cancer.

To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head \& neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head \& neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with lung cancer or head \& neck cancer (International Classification of Diseases 10: C76, C34)
* Patients who undergo front-line treatment
* Age 18 years or older
* Benefiting from a Social Security scheme
* Written information about the study provided to the patient before any procedure specific to the study
* Patients who had at least one episode of smoking within the past 30 days before diagnosis

Exclusion Criteria:

* History of another lung or head \& neck cancer \< 5 years (Note: The presence of a second tumour location, discovered at the same time as the lung or head and neck cancer, does not constitute a non-inclusion criterion)
* History of another cancer (except for curatively treated cervical cancer in situ and non-melanoma skin cancer) \< 3 years
* Mesothelioma, thymic malignancies, and cancer of the upper oesophagus
* Inability to complete the study for psychosocial reasons (inability to schedule interview (homeless), no access to phone, psychological disorder leading to inability to answer phone interview, do not speak French and no easy access to translator from surroundings)
* Patient under guardianship
* Patient refusal
Abuse Potential Study of PF-00345439

This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to non-dependent, recreational opioid users.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years who are recreational opioid users and are NOT dependent on opioids.

Exclusion Criteria:

* Evidence or history of clinically significant medical conditions.
* Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine).
* Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
* Has a positive urine drug screen (UDS) excluding tetrahydrocannabinol (THC).
* Has a positive alcohol breath test.
* Has any history of a condition in which an opioid is contraindicated.
* History of sleep apnea in the past 5 years that has not been resolved or corrected.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results .
* Positive test for Hepatitis B, Hepatitis C, or HIV.
* Allergy or history of hypersensitivity to naloxone HCl, oxycodone HCl, other opioids, and/or lactose.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
Memory Training in Aneurysmal Subarachnoid Hemorrhage Patients

The study aim is to determine if periodic online cognitive exercises (Lumosity) improve memory function in ruptured cerebral aneurysm patients with disabling baseline memory deficits within the first 24 months after rupture. Half of the subjects will be randomized to use Lumosity-designed online cognitive exercises and half will serve as an active control group performing online crossword puzzles.

In this prospective randomized, control clinical trial subjects have a self-reported disabling memory deficit within the first two years of their ruptured cerebral aneurysm. Subjects will be recruited in the neurosurgery clinic setting, via email and phone screen, through social media and phone screen, or during a monthly support group for the patient population in question.

During the screening interview the inclusion and exclusion criteria are assessed and informed consent is obtained if needed.

Those who qualify for the study will undergo a baseline assessment involving Checklist for cognitive and emotional consequences following stroke (CLCE-24), Working memory questionnaire, Activity of Daily living Questionnaire, and a Lumosity Administered assessment.

After baseline assessments randomization will occur stratified according to duration since SAH \<12 or \>12 months, to either a treatment group, which will include online access to structure-oriented activities (Lumosity), or an active control group(online crossword puzzles).

Subjects in the intervention group will undergo twenty training sessions over 10 weeks involving cognitive games selected from Lumocity. Games will be customized using an automated algorithm supplied by Lumosity, to determine performance in the various targeted skills, which include: task switching, logical reasoning, quantitative reasoning, response inhibition, numerical calculation, working memory, face-name recall, selective attention, spatial recall, spatial orientations, planning, and divided attention. The recommended duration of interaction is 2 hours per week for 10 weeks.

The control group uses a computerized crossword puzzle. the puzzle is offered in three different puzzle sizes, levels of complexity, and font sizes. these puzzles do not provide progressive challenge to the user by either increased speed, visual field size, number of distractors, or degree of difficulty of target stimulus differentiation.

Eligibility Criteria:
Inclusion Criteria:

* Ruptured cerebral aneurysm-confirmed by study personnel within past year
* Age 18 and older
* Those with a modified Rankin 0 or 1
* Baseline memory problem affecting daily life
* Home computer or tablet with internet access

Exclusion Criteria:

* Unable to read or speak English