cyrilzakka/clinical-trials huggingface dataset:
Study of Effects of L-Arginine in Colitis and Colon Cancer

The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell.

The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.

Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (HPLC). Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (PCR) analysis of mRNA expression.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis)
* Screening for cancer

Exclusion Criteria:

* refusal to participate
* age less than 18 years at time of colonoscopy
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 - 39 years inclusive
* Provide written informed consent to participate
* Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality

  o As determined by medical history, physical exam, laboratory screening
* Body Mass Index 18-35 kg/m2, inclusive, at screening

Exclusion Criteria:

* Any medical condition that in the judgement of the investigator would make subject participation in the study unsafe.
* Having cancer or received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
* Impaired immune responsiveness (of any cause), including diabetes mellitus.
* Receipt or plan to receive a non-study vaccine within 30 days prior to vaccination or 60 days after vaccination.
* Receipt of any influenza vaccine in previous 24 months and/or planned receipt of influenza vaccine for the duration of the study.
* Diagnosed influenza infection in the previous 24 months prior to screening.
* Diagnosed COVID infection via medical personnel or at home test within the past 60 days prior to screening
* Allergy to influenza vaccine or components, or history of severe local or systemic reaction to any vaccination.
* History of anaphylactic type reaction to injected vaccines
* History of or current allergy to latex
* History of Guillain-Barré Syndrome.
* Positive test result for hepatitis B surface antigen (HBsAg,), hepatitis C virus antibody (HBcAb), or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
* History of chronic obstructive pulmonary disease or history of other lung disease.
* History of severe allergic reactions to eggs.
Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

The goal of this clinical trial is to compare Leflunomide in Idiopathic pulmonary hemosiderosis. The main questions it aims to answer are:

* The efficacy and safety of Leflunomide in Idiopathic pulmonary hemosiderosis
* The mechanism of leflunomide in treating Idiopathic pulmonary hemosiderosis Participants will be treated with leflunomide plus stroid. A comparison group: Researchers will compare the control group treated with stroid to see if the efficacy of Leflunomide would be better than control group.

This study conducted a prospective, open, parallel controlled, single center clinical trial on the combination of Leflunomide and Stroid therapy for children with IPH, and conducted a one-year follow-up. The main indicators (pulmonary hemorrhage/hemoptysis frequency) and secondary indicators (serum iron metabolism level, T lymphocyte subpopulation, lung function, inflammatory cells, and inflammatory factors) were evaluated before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of IPH, it is expected that the combination of leflunomide and conventional treatment can improve the remission rate of clinical symptoms in children with IPH, inhibit the progressive deterioration of lung function, and the research results are expected to bring new treatment methods and strategies for this group of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age range from 6 months to 18 years old;
2. Diagnose as IPH;
3. Parents or guardians agree to treatment and sign a written informed consent form.

Exclusion Criteria:

1. Individuals who are allergic to any ingredients used in leflunomide tablets;
2. Complicated with serious basic diseases (such as systemic malignant diseases, heart failure, liver and kidney failure, immune deficiency, serious infectious diseases, Lung transplantation or other patients with immediate surgical indications);
3. Patients with other lung diseases;
4. Have a history of abnormal coagulation or abnormal coagulation function in the past;
5. Clinical trial participants who have previously participated in the treatment of flumiphene;
6. Other situations where the researcher deems it inappropriate to participate in the study.
Clinical Evaluation of a Multifocal Contact Lens on Symptomatic Patients

The purpose of this study is to evaluate the effect of a multi-focal contact lens on symptomatic patients.


Eligibility Criteria:
Inclusion Criteria:

* To have signed an informed consent form (documented by the investigator in the Case Report Form \[CRF\]).
* Be existing daily wear spherical single-vision soft CL wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
* Between 35 and 47 years of age (inclusive).
* Have a CL spherical distance requirement between -1.00D and -6.00D (-6.50D refractive) in both eyes.
* Refractive astigmatism of 0.75D or less in both eyes.
* Visual symptoms associated with near vision
* Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
* Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having:

  1. No amblyopia.
  2. No evidence of lid abnormality or infection.
  3. No conjunctival abnormality or infection.
  4. No clinically significant slit lamp findings (i.e. stromal haze, staining, scarring, Vascularization, infiltrates or abnormal opacities).
  5. No other active ocular disease.

Exclusion Criteria:

* Monovision user or multifocal CL wearer.
* Regular user of reading spectacles (i.e. daily usage).
* Requires concurrent ocular medication.
* Clinically significant (Grade 3 or 4) corneal stromal haze, corneal Vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate CL wear.
* Corneal staining Grade 3 in more than two regions.
* Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study.
* Pre-existing ocular irritation that would preclude CL fitting.
* Keratoconus or other corneal irregularity.
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease

This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.


Eligibility Criteria:
Inclusion Criteria:

* Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)

Exclusion Criteria:

* Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)
Dose-effect of HIIT on Cardiovascular Health of Children

An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.

The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.

School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

All school children able to attend the physical education sessions of the school

-

Exclusion Criteria:

* Children with medical condition that limits physical activity
Small Children, Big Emotions

The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.


Eligibility Criteria:
Inclusion Criteria:

* Referred children aged 2-5 years
* The child is enrolled in daycare
* The child is displaying problems with emotional dysregulation

Exclusion Criteria:

* Parent not sufficiently proficient in Norwegian Language to Complete assessment
* Child Protective Services have ongoing assessment where the outcome may be that the child will be placed in care outside of the home of the biological parent(s) or other current caregiver
* The child has already been diagnosed with an autism spectrum disorder
Comparison Between Different Psychotherapy Interventions Regarding Their Effect on Substance Craving

the study aim is to compare betwenn the effect of mindfulness based relapse prevention and other evidence based psychotherapy interventions regaring substance craving.

In this prospective study, the population included opioid-dependent men (aged 18-50 years), some of them were admitted to El Maamora hospital and others were attendees in NA. To conduct this research, considering the drop-out rate, the list of 60 persons applying for treatment was prepared based on inclusion and exclusion criteria.

Then, three groups of 20 were randomly selected and placed in three intervention groups, group one received CBT, group two received MBRP, and group three received twelve-step therapy.

The subjects were assigned randomly to the treatment condition via a computer-generated random number with the aid of trained staff at the clinic blindly.

All participants completed the measurement scales immediately after detoxification (pre-test) and after the end of therapeutic sessions (post-test).

Eligibility Criteria:
Inclusion Criteria:

* Age: 15-50 years.
* Male gender.
* Patients meet DSM-5(3) criteria of opioid abuse.
* Had completed detoxification in a treatment center.
* Willing to give consent they will be randomly assigned to either CBT, MBRP, or twelve-step treatment group.
* Patients have dual diagnoses.
* Patients have poly-substance use disorder.

Exclusion Criteria:

* Participants with significant cognitive disorder.
* Participants with suicidal thoughts.
* Participants with any organic condition affecting stress response and so craving such as hypertension, respiratory or cardiovascular disorders.
* Participants taking any medications (e.g., antipsychotics in high doses) known to affect the stress response.
* Participants relapsed to drug abuse during therapy.
Carriage of Beta Haemolytic Streptococci During Pregnancy

This is a prospective clinical study that aims to investigate asymptomatic carriage of beta haemolytic streptococci (especially group A streptococci, GAS and group B streptococci, GBS) during pregnancy. Association of asymptomatic carriage to possible complications of the mother or the newborn as well as the transmission between spouses will be evaluated. Maternal microbiota during labour will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* partner of the pregnant women
* over/equal 18 years of age
* willing to participate the study

Exclusion Criteria:

* multiple pregnancy
* age \<18 years
Non-Specific Effects of Manual Therapy

The mechanism responsible for improvement following manual physical therapy techniques is unknown. Previous studies have indicated both biomechanical and neurophysiologic effects which may be responsible for clinical changes observed. Yet, other studies report clinical changes following sham interventions. Through a mixed-methods design, this study aims to gain more understanding of the social and contextual factors that may be related to the improvement often observed following manual therapy techniques.

A convenience sample will be utilized to obtain subjects. Subjects will be given a brief questionnaire to identify possible contraindications for manual therapy treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of eight groups (three variables, each with two conditions including: therapist gender match/mismatch, lab coat worn/not worn, detailed explanation/colloquial conversation about the technique) and participate in neurodynamic testing for the upper quarter via the Upper Limb Provocation Test. Subjects who are determined to be positive for one or more extremities will receive a sham thoracic spine manipulation technique. After application of the technique, previously positive limbs will be retested. Individuals who respond favorably to the sham technique upon reassessment will participate in an exit interview with open-ended questions in attempt to gain more insight into the factors which may have influenced their neurodynamic mobility improvement.

Eligibility Criteria:
Inclusion Criteria:

* Upper Limb Provocation Test results with limitation greater than 60 deg of elbow extension at the time of measurement

Exclusion Criteria:

* History of cervical or lumbar pain requiring medical intervention within the last two years, history of upper or lower extremity paresthesia/numbness, self reported bone density disorders, previous spinal cord injury, diagnosed intervertebral disc herniation, previous diagnosis of spinal stenosis or disc pathology, current pregnancy, history of circulatory or neurological disorders, history of spine and extremity fractures or dislocations in the last two years
Cervicospinal Posture and Pain in Cervicogenic Headache

Cervicogenic headache (CEH) is a type of symptomatic headache that is characterized by chronic unilateral headache secondary to cervical spine dysfunction. Generally, it gets worse by neck movements, continuous placement of the head in an awkward position and exposure to external pressure on the upper cervical or occipital region.

The pain was demonstrated to originate from lower cervical disc prolapse and spinal nerve roots in some studies, while it is suggested in some others to occur due to the upper cervical region as well. Although disturbed cervical alignment has been determined in tension headache and migraine, there are few studies with controversial results in the literature investigating the effects of the change in cervical lordosis on CEH. These contradictory results strongly influence the decision of whether exercise should be added to the treatment protocol in CEH and also the creation of an appropriate treatment program by the clinicians. In light of this background, the aim of this study was to compare the cervical radiographs of patients with CEH and patients with neck pain without a headache.

The general demographics, pain status and cervical radiological evaluations of the patients was performed in this prospective, cross-sectional, single-blind study evaluating two different disease groups compatible in age and gender and the two groups were compared.

For inclusion in the Cervicogenic Headache group, inclusion criteria determined by the Cervicogenic Headache International Study Group (CHISG) were used.

Symptoms of all patients were questioned in detail and physical examinations were performed. After obtaining demographic information such as age, height and weight, severity and duration of pain were asked to the patients and Neck Disability Index (NDI) and Visual Analogue Scale (VAS) were used for pain assessment Cervical radiographic analysis was evaluated measuring general cervical lordosis and upper cervical lordosis on lateral standing X-rays using Surgimap®. General cervical lordosis and Upper cervical lordosis measurements were performed on the lateral cervical graph.

Eligibility Criteria:
Inclusion Criteria:

For Cervicogenic headache group

* Unilateral headache, starting from the upper neck/occipital region and spreading to the oculofrontotemporal area on the symptomatic side
* Pain triggered by neck movements and/or continuous awkward positions
* Decreased joint range of motion in the cervical vertebra

Exclusion Criteria:

For Cervicogenic headache group

* Previously diagnosed to have any other syndromes of headache (Migraine, Tension headache, etc.)
* Presence of bilateral headache; For the neck pain group,
* Presence of 2 or more neurological symptoms (decreased upper extremity muscle strength, decreased reflexes and hypoesthesia compatible with the dermatome regions)
* Suggesting nerve root compression (radiculopathy, plexopathy); for both groups,
* Presence of any signs suspicious of central nervous system involvement (hyperreflexia, nystagmus, decreased vision, etc)
* Reluctance to participate in the study.
Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial

The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.

Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion.

Exclusion Criteria:

* earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation

The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.


Eligibility Criteria:
Inclusion Criteria:

* patients listed for OLT with positive screening for IDA

Exclusion Criteria:

* Age \<18 years
* Hemochromatosis
* Iron utilization disorders
* Non-IDA
* Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks prior to screening
* Previous allergic reactions against intravenous iron formulations
* Transfusion within 2 weeks prior to screening
* Complete portal vein thrombosis
* High-urgency OLT
* Pregnancy
* Sepsis or severe infection
* Immunosuppressive therapy
PSA Glycomics Assay for Early Detection of Prostate Cancer

The principal aim of this pilot study is to test whether the PSA Glycomics Assay on urine and serum samples can provide insights regarding the disease state of patients with elevated PSA concentrations, as well as to accurately identify if the patient has prostate cancer and, in the case of prostate cancer, to determine its level of aggressiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated PSA (\>3 ng/mL)
* Signed informed consent

Exclusion Criteria:

* Patients that have a cystitis (bladder infection)
* Patients under chemotherapy
* Patients using 5-alpha reductase inhibitors
* History or presence of cancers, or non-prostate urological disorders.