cyrilzakka/clinical-trials huggingface dataset:
Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.

Muscle dysfunction is a major problem for patients with end-stage renal disease (ESRD). Specifically, these patients experience approximately three-fold greater muscle fatigue of the lower extremities during intermittent submaximal contractions than healthy control subjects. Thus, a treatment that could ameliorate muscle fatigue in this population has the potential to increase endurance during activities of daily living and improve quality of life. Dialysis patients have been shown to have high levels of various markers of oxidative stress, and oxidative stress has been associated with excessive muscle fatigue in other patient populations, but this link has not been established in the ESRD population.

Comparisons: The amount of muscle fatigue during intermittent submaximal quadriceps exercise between dialysis patients and controls will be compared. In addition, the degree of exercise-induced increase in markers of oxidative stress in muscle and in plasma will be compared between dialysis patients and controls and between dialysis patients who have received N-acetylcysteine for 6 days and those who have received placebo capsules.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* undergoing hemodialysis for 3 months or more or healthy control without kidney disease

Exclusion Criteria:

* inability to give informed consent
* diagnosis of diabetes mellitus
* musculoskeletal contraindication to exercise
* infection requiring intravenous antibiotics within 2 months
* hospitalization within 2 months
* ingestion of antioxidant supplements within one month
* requirement for systemic anticoagulation
* estimated GFR \<60 ml/min/1.73 m2 for healthy controls
The HOME Study (HPN With OMEGA-3)

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.


Eligibility Criteria:
Inclusion:

* Signed informed consent available
* Male or female patients ≥ 18 years of age
* Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months
* Patients receiving ≥ 3.0 g lipids/kg body weight per week

Exclusion:

* Persistent high total bilirubin values in medical history of last 6 months (\> 40µmol/l)
* Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
* Patients with history of cancer and anti-cancer treatment within the last 2 years
* Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients
* Patients treated in the past or currently with Teduglutide
* Contraindications to investigational products (if available from medical records) including:

  * Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or 11.4 mmol/l)
  * Severe coagulopathy
  * Intrahepatic cholestasis
  * Severe hepatic insufficiency
  * Severe renal insufficiency in absence of renal replacement therapy
  * Acute thromboembolic events
  * Fat embolism
  * Aggravating haemorrhagic diatheses
  * Metabolic acidosis
* General contraindications to parenteral nutrition (if available from medical records) including:

  * Unstable circulatory status with vital threat (states of collapse and shock)
  * Acute phase of cardiac infarction or stroke
  * Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin)
  * Inadequate cellular oxygen supply
  * Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and hypotonic dehydration)
  * Acute pulmonary edema
  * Decompensated cardiac insufficiency
* Positive test for HIV, Hepatitis B or C (from medical history)
* Known or suspected drug or alcohol abuse
* Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
* Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
* Any medical condition that in the opinion of the investigator might put the subject at risk or interfere with patients participation For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not post-menopausal)
* Women of childbearing potential tested positive on standard pregnancy test (urine dipstick)
* Lactation
* Women of childbearing potential who do not agree to apply adequate contraception
* Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent
mHealth Behavior Study

The goal of this clinical trial is to learn if a brief task completed on a smartphone can reduce alcohol use and risky sexual behavior among women between the ages of 18 and 25 who have a history of experiencing sexual assault or an unwanted sexual experience. The main questions it aims to answer are:

* Does the smartphone task change approach biases for alcohol and condom-related images?
* Does the smartphone task reduce alcohol use and risky sexual behavior?

Researchers will compare the smartphone task to a sham control to see if the smartphone task changes biases and behavior.

Participants will:

* Complete a baseline assessment battery of questionnaires
* Complete either the intervention smartphone task or the sham smartphone task on four consecutive days.
* Complete a follow-up assessment one week after finishing the four tasks
* Complete a three-month follow-up


Eligibility Criteria:
Inclusion Criteria:

* Adult women who report lifetime experience sexual assault,
* Consume alcohol at least moderately (e.g., at least seven drinks per week; NIAAA, 2015),
* Have engaged in sexual intercourse with a casual, non-committed male partner without a condom at least three times during the three months prior to data collection.

Exclusion Criteria:

* Active homicidal or suicidal ideation;
* History of or current psychotic disorders as the study protocol may be therapeutically insufficient;
* Previously identified as having a Pervasive Developmental Disability.
Mental Health Engagement Network (MHEN)

Patients with mood disorder or psychotic disorder will be given handheld devices with personal health records to educate, monitor and deliver customizable healthcare tools based on their personal needs. The use of technology has great potential to deliver care more effectively and efficiently. No actual information is on the handheld device - it is accessed from a secure site behind hospital firewalls.


Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with mood disorder or psychotic disorder for a minimum one year
* Able to make informed consent to participate in the study
* Able to understand and speak English to the degree necessary to participate in interviews/focus groups

Exclusion Criteria:

* Younger than 18 or older than 80
Cognitive Rehabilitation and FES for Hand Functionality in Persons With Cervical Spinal Cord Injury

16 persons affected by Cervical-SCI were recruited for the study and randomly assigned to the Control Group (CG) or to the Experimental Group (EG). Persons of the CG (n = 8) executed 20 sessions of FES for the rehabilitation of hand functions (grasp or pinch), participants of the EG (n = 8) performed 20 sessions of FES and CBA in addition. The primary assessment was a modified version of Bimanual Activity Test (10 tasks); also, SCIM-II and measurement of grasping strength only in participants submitted to grasp rehabilitation were evaluated.

Each participant followed twenty sessions of hand rehabilitation, three times per week. Each treatment, for both CG and EG, lasted about forty minutes.

The FES devices chosen for this research stimulated "grasp" or "pinch" function: the NESS H200 (NESS Ltd., Ra'anana, Israel) was used if patient needed to improve the grasp functions, otherwise the Microstim (Microstim, Medel, Hamburg, Germany) was used to increase pinch functions. In order to provide FES, the five electrodes of NESS H200 were first humidified with warm water and then inserted in the right size place of the rigid splint worn by the patient, while Microstim was used with four standard electrodes, two for each muscle treated. In both case the stimulation was triggered by the therapist clicking a button (Table 1).

The participants of CG received only FES to improve their manipulating skills without the interaction with objects, but only with the muscle contraction induced by the devices.

The participants of EG executed FES and CBA treatment which means that during the stimulation they manipulated different tools. In particular, for the first ten sessions the participants were invited to manipulate specific objects: squares, rectangles and pyramids of different sizes; touch on plastic test tubes coated with materials of different consistency; these two exercises were performed both with open and closed eyes. Finally, for the last ten sessions the participants were asked to execute specific tasks, depending on person's life before the lesion.

Eligibility Criteria:
Inclusion Criteria:

* C-SCI with neurological level between C2-T1;
* reduced ability of hand functions;
* excitable muscles and FES tolerability.

Exclusion Criteria:

* any trauma or surgery to the target hand or upper limb within the last 12 months,
* amputation of any digits on the target hand,
* severe spasticity in the target hand or upper limb preventing use of the instruments,
* experienced autonomic dysreflexia or hypotension in response to FES,
* any contraindication to FES such as: cardiac pacemaker, epilepsy, forearm fracture, pregnancy, skin lesions, cancer or tumor, intracranial metal implants
Humidified Culture and Live Birth After ICSI

Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing a first or second ICSI attempts
* Primary or secondary infertility with a BMI of \< 31 kg/m2
* Duration of infertility of ≥ 18 months and normal baseline ultrasonography
* 18 to 40 years of age
* Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors
* Tubal factors

Exclusion Criteria:

* Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia
* Thin endometrium
* Uterine anomaly and adhesion
* Adenomyosis
* Submucous myoma
* Endometriosis
* Severe medical condition
Study of Blood Flow in Heart Muscle

Blood flows to areas of the heart providing oxygen and fuel to the pumping muscle. Occasionally the arteries providing the fuel can become blocked. This occurs in coronary artery disease.

Magnetic resonance imaging (MRI) can be used to evaluate the blood flow to different areas of the heart muscle. In this study magnetic resonance imaging will be compared to other diagnostic tests (radionucleotide perfusion studies) capable of measuring blood flow to heart muscle.

In this pilot study, magnetic resonance imaging (MRI) of myocardial enhancement during first passage of intravenously injected gadolinium contrast will be used to evaluate regional myocardial perfusion in patients with known or suspected coronary artery disease and hypertrophic cardiomyopathy. The MRI results will be compared with conventional radionuclide perfusion studies (ex. dipyridamole thallium). A clinically defined normal group will also be studied without radionuclide correlation.

Eligibility Criteria:
INCLUSION CRITERIA:

Ages 18 to 80.

Either sex.

Capable of giving informed consent.

Group 1: Outpatients with known or suspected coronary artery disease with clinical indication for radionuclide perfusion imaging.

Group 2: Patients with non-obstructive hypertrophic cardiomyopathy with clinical indication for radionuclide perfusion imaging.

Group 3: Normal volunteers.

Positive stress thallium or stress sestamibi (i.e., exercise, adenosine, dobutamine or dypiridamole) at the NIH.

EXCLUSION CRITERIA:

Pregnancy.

Unstable angina.

Uncontrolled hypertension (SBP greater than 185, DBP greater than 105).

Recent myocardial infarction (less than 5 days).

2nd or 3rd degree heart block by ECG.

Asthma, emphysema, renal failure, acute medical illness (fever, pneumonia, etc.) or anemia (hct less than 30).

Cardiac pacemaker or implantable defibrillator, aneurysm clip, neural stimulator, any type of ear implant, metal in your eye, any implanted device (i.e. insulin pump, drug infusion device) or any metallic foreign body, shrapnel, or bullet.
LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris

The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs
* Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA)
* An Investigator's Global Assessment of disease severity (IGA) of at least mild at Day 0 (Visit 1)
* A modified PASI (m-PASI) score of at least 2 at Day 0 (Visit 1)
* A target lesion of a minimum of 5 cm at its longest axis and preferably not located on the extensor surface on an elbow or knee, scoring at least 1 for each of redness, thickness and scaliness, and at least 4 in total by the Investigator's Assessment of Severity of the Target Lesion

Exclusion Criteria:

* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

  * etanercept - within 4 weeks prior to randomisation
  * adalimumab, infliximab - within 8 weeks prior to randomisation
  * ustekinumab - within 16 weeks prior to randomisation
  * other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)
* Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
* Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
* PUVA therapy within 4 weeks prior to randomisation.
* UVB therapy within 2 weeks prior to randomisation.
* Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation.
* Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
* Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
* Previously randomised in this trial or any previously conducted trial of LEO 90100.
Comparison of Two Counseling Induction Strategies

New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on methadone and randomly assigned to one of two induction conditions: 1) routine stepped care, or 2) low threshold stepped care. All participants will continue with routine stepped care in month 4. Treatment retention is the primary outcome measure, while drug use (measured via weekly urinalysis testing) is the major secondary outcome.

This randomized clinical trial will evaluate two induction strategies for helping out-of-treatment opioid abusers transition to methadone maintenance treatment. All study participants (n = 120) will be new admissions to the Addiction Treatment Services at Hopkins Bayview (ATS), stabilized on 80 mg of methadone, and randomly assigned to one of two study conditions. The experimental induction condition will receive low threshold stepped care (LTSC) for the first 3-month of treatment that reduces the counseling demands of maintenance treatment (i.e., one counseling session / month). This condition will be compared to routine stepped care (RSC) for the first 3-months, which provides escalating intensity of counseling schedules contingent on drug use or poor adherence. RSC is routine treatment at ATS. All participants will receive routine stepped care following the 3-month induction phase, and will have the opportunity to remain in treatment at ATS following study participation. Participation is for 4-months. Retention is the primary outcome. Participants will also submit urine samples weekly on a random schedule each month. We hypothesize that LTSC participants will exhibit better retention than RSC participants, and that both conditions will exhibit reductions in drug use compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

* New admissions to methadone maintenance

Exclusion Criteria:

* Pregnant
* Acute medical or psychiatric condition
Drug Interaction Oral Contraceptive Pill (OCP)

To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug

Exclusion Criteria:

* Abnormal pap smear within 1 year prior to day 1
* Any significant or chronic uncontrolled medical illness
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects

CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). CSL is evaluating CSL760 as a passive immunotherapy for COVID-19 (Coronavirus Disease 2019).


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 65 years of age
* Female subjects must be postmenopausal or have a negative pregnancy test
* Body weight in the range of ≥ 50 kg and ≤ 100 kg and have a body mass index of ≥ 18 to ≤ 32 kg/m2

Exclusion Criteria:

* History of acute or chronic renal failure, thromboembolism, chronic respiratory illness, aseptic meningitis syndrome, or recurrent severe headaches or migraines.
* Positive viral serology test for HIV -1/2 antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody
* Positive viral serology test for SARS-CoV-2 antibodies
* Received any live viral or bacterial vaccinations within 8 weeks
* Evidence of current active infection.
* Known malignancy or a history of malignancy in the past 5 years
* Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable double barrier method of contraception to avoid pregnancy during the study
Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.
Effectiveness of Modified Integrated Colorectal Cancer Screening System in Saudi Arabia

In order to encourage the population at risk to participate in colorectal cancer screening, this clustered trial intends to determine the efficacy of specific messages(Nudge), single FIT testing, and the primary care physician's clinical judgment on referral to colonoscopy.

It primarily seeks to provide answers to the following questions: How effective is the modified integrated CRC screening system (MICRCSS) for individuals with average colorectal cancer risk? based on the percentage of individuals who had CRC screening, registered for the follow-up, and were discovered to have precancerous CRC issues a year after the program's start, as contrasted to individuals receiving standard medical care? All public government entities in the Hail region will be contacted with invitations to participate in the study (outreach). the organization

Introduction:

Incidence of colorectal cancer (CRC), which starts in the innermost lining mucosa of the colon or rectum, is third (10.2%) in the globe behind lung and breast cancers (11,6%), according to the Global Cancer Observatory (GCO) 2018. According to a 2010 research, Saudi Arabia had an incidence of 10.4/100,000; regrettably, the incidence among young age groups is greater than that in countries with high incidence.

The majority of colorectal malignancies (CRCs) are first identified as polyps, which are small benign growths or projections seen inside the lumen of the colon. If a polyp is larger than 1 cm, if there are more than two polyps present, or if dysplasia is seen after the polyp is removed, the polyp is considered to be precancerous. Precancerous adenomas, hyperplastic polyps, or inflammatory polyps

Eligibility Criteria:
Inclusion Criteria:

* Age 40 -75

Exclusion Criteria:

* Sever ill patient
Sofia hCG FIA Field Study

The objective of this field study is to demonstrate the clinical performance of the Sofia hCG FIA Test, using urine specimens from females of childbearing age.

Subjects presenting for pregnancy testing will provide urine specimens that will be tested with the Sofia hCG FIA test and the comparator pregnancy test that will detect levels of hCG of 20mIU as positive for pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects of childbearing age, who are being screened for pregnancy and who have signed the informed consent

Exclusion Criteria:

* Subject is post-menopausal.
* Subject within the past six weeks has experienced any of the following: delivered a newborn; had an abortion or a natural termination (miscarriage); or, received hCG supplements.
* Subject has had a hysterectomy.
* Unable to understand and consent to participation.