cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effects of Dual Task Training on Dual Task Performance in Individuals With Scoliosis

In this study, "Single Task" and "Dual Task" groups will be formed in individuals aged 10-18 years with scoliosis. For 12 weeks, scoliosis-specific three-dimensional exercises will be applied to both groups. The Single Task group will receive only motor exercise training, while the Dual Task group will receive both motor and cognitive exercise training. At the end of the study, the dual-task performance of both groups will be evaluated and the effects of dual task training on individuals with scoliosis will be analyzed.

Scoliosis is a term used to describe changes in the shape and position of the spine and chest cage. Essentially, scoliosis involves lateral deviation and rotations of the vertebrae, accompanied by changes in the sagittal plane, creating a three-dimensional deformity. The progressive nature of scoliotic deformity underscores the importance of controlling these components through conservative methods. Without control, scoliosis can lead to postural, balance, and locomotor disorders due to compromised sensory integrity and inadequate proprioceptive feedback. Despite compromised postural control and continuity in individuals with Adolescent Idiopathic Scoliosis (AIS), maintaining daily life activities and body orientation is crucial for controlling the progression of scoliosis. The daily routine of individuals with AIS often involves simultaneous engagement in postural control alongside other daily activities. These routines and exercises frequently incorporate dual-task components. Our study aims to examine the effectiveness of single-task and dual-task walking and balance exercises in individuals with scoliosis, as well as their contributions to scoliosis-specific assessments

Eligibility Criteria:
Inclusion Criteria:

1. Individuals between the ages of 10-16
2. Individuals with idiopathic scoliosis
3. Individuals with curve degrees between 10 and 40
4. Individuals with a body mass index of less than 30 kg\\m2.
5. Be willing to participate in the tests and have the cognitive ability to complete the tests.

Exclusion Criteria:

1. Having other types of scoliosis other than idiopathic scoliosis
2. Individuals with previous scoliosis or any spine-related conservative treatment or surgery
3. Acute (fracture, surgery); cardiovascular system (heart failure, arrhythmia...); nervous system diseases (epilepsy, vertigo...); sensory organs (vision or hearing loss...); musculoskeletal disorders (rheumatism, hypermobility syndrome...)
4. Taking any regular medication that may affect balance (ssri, psycholeptic, anti-epileptic medication...)
5. Playing sports at a professional level
6. Using a brace, starting to use a brace
Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis

This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.


Eligibility Criteria:
Inclusion Criteria:

- Males and females at least 18 years of age with moderate to severe plaque psoriasis

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque psoriasis
* Previous exposure to IL-17A or IL-17 receptor targeting agents.
* Other active or ongoing disease that may interfere with evaluation of psoriasis or places the patient at unacceptable risk
* Other protocol-defined inclusion/exclusion criteria may apply
Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects

This is a Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects.

This is a Phase 1, single centre, randomized, double-blind, placebo-controlled, single dose, parallel group study in healthy Chinese male or female subjects. 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose) to receive a single dose of tezepelumab or placebo in a 3:1 ratio. Each subject will only participate in one cohort. Dose level is unblinded and treatment (tezepelumab or placebo) will be double-blinded within each treatment cohort. Following a screening period of a maximum of 28 days, subjects will stay at the study facility for two nights starting from the day before dosing (Day -1) to Day 2. Subjects will receive a single dose of tezepelumab or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period. The follow up period after the dosing will be 112 days.

Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy Chinese subjects
* Age 18 to 45
* Body weight ≥ 40 kg
* Body mass index (BMI) between 19-24 kg/m2

Exclusion Criteria:

* History or evidence of a clinically significant disorder
* History of cancer
* Smokers of \> 5 cigarettes/day
* Receipt of any marketed or investigational biologic within 4 months or 5 half-lives/non-biologic agent within 30 days or 5 half-lives prior to randomization
* History of chronic alcohol or drug abuse
* Hepatitis B, C or HIV
* Pregnant or breastfeeding
* History of anaphylaxis following any biologic therapy
Spanish Registry of Erythropoietic Stimulating Agents Study

Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.

Review of RESMD data base in the group of patients with MDS from diagnosis of low risk myelodysplastic syndrome (MDS) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (ESAs) / support transfusional before December 31, 2011. In all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* The patient has given consent to the collection of data in the RESMD.
* Age ≥ 18 years.
* Patient must be diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL).
* The patient has studies at the time of diagnosis discard the possibility that MDS anemia is due to deficiency of factors (iron, vitamin B12 or folic acid).
* Initiation of treatment with ESAs or support transfusional at any spanish hematology service before December 31, 2011.

Exclusion Criteria:

* Pretreatment of SMD with hypomethylating agents, lenalidomide, chemotherapy, other.
The Influence of High Impact Exercise on Musculoskeletal Health in Older Men

Osteoporotic fractures are an extremely common and serious public health issue which contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in bone strength combined with an increase risk of falls (associated with decline in muscular function with age) are the main determinants of fracture risk. Exercise that is novel and involves impact loading has the potential to improve bone strength and neuromuscular function (strength, power and balance). It is thus imperative to evaluate potential benefits of exercise in older people. The musculoskeletal responses to exercise may also be influenced by vitamin D status. It is the purpose of this study to consider the influence of a one year unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically bone structure, muscle strength and power in older caucasian men. It is also the purpose of this study to determine whether this differs according to vitamin D status. The findings will reveal whether exercise can improve bone health and/or neuromuscular function, and whether improvements are dependent upon vitamin D status.


Eligibility Criteria:
Inclusion Criteria:

* Healthy community dwelling men of white european origin

Exclusion Criteria:

* BMI \>30 kg/m2
* History of strength training or recently ( previous 12 months) doing moderate physical activity (weight bearing, high impact)
* Recent ( previous 12 months) or current medical or surgical problems likely to affect bone metabolism or provide contraindications to high impact exercise, balance or neuromuscular function
* Any previous or existing lower back or limb problems that could be exacerbated by undertaking high impact exercise
* Any history of diagnosed or symptomatic diseases likely to influence strength, power, bone or habitual activity (including osteomalacia or impaired liver/renal function and locomotor disease, hypertension) that influences bone or muscle or precludes exercise
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities

The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.


Eligibility Criteria:
Inclusion Criteria:

* Subject is female of any race and ethnicity
* Subject is at least 40 years old
* The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
* Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
* Subject will undergo study imaging within 30 days of standard of care imaging

Exclusion Criteria:

* Patients who are pregnant or think they may be pregnant
* Patients who are breast feeding
* Subjects unable or unwilling to undergo informed consent
* Subjects with breast implants
Anaerobic Exercises on Cardiac Workload, Peripheral Resistance and Lipid Index Among Grade 1 Hypertensive Young Adults

Impact of resistance exercises on grade I hypertensive patients were monitored on three outcome measures that were blood pressure, peripheral resistance and lipid index after 12 weeks of intervention


Eligibility Criteria:
Inclusion Criteria:

* grade I HTN Age 20-40years Both male and female

Exclusion Criteria:

* unable to perform exercises Comorbidities like Diabetes
Monitoring by Microdialysis of Postoperative Complications After Proctectomy

The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* rectal disease requiring proctectomy with anastomosis and stomy
* proctectomy by laparoscopy or laparotomy
* written consent

Exclusion Criteria:

* history of colorectal surgery
* rectal surgery without anastomosis
* breastfeeding or pregnancy
* ASA score IV
Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures

Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events.

Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).

Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.

BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.

Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy.
2. At least 21 years of age
3. Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
4. Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.
5. Single ablation, using a single ablation needle, per tumor.
6. Able and willing to give informed consent.

Exclusion Criteria:

1. Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
2. Subject cannot tolerate/undergo contrast-enhanced CT.
3. Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.
4. Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
5. Pregnant or lactating
6. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
7. Unable or unwilling to give informed consent.
Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects

This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. To evaluate the effect of multiple doses of lansoprazole on the absorption and pharmacokinetics (PK) of a single dose of neratinib in healthy subjects.

This is an open label, 2-period, fixed-sequence study in 15 healthy adult subjects under fed conditions. On Day 1 of Period 1 (Treatment A), a single oral dose of neratinib will be administered followed by PK sampling for 72 hours. In Period 2 (Treatment B), multiple oral doses of lansoprazole will be administered once daily for 7 consecutive days with a single oral dose of neratinib administered on Day 5. PK sampling for neratinib will be taken for 72 hours following neratinib dosing on Day 5. The washout period will be at least 14 days between each neratinib dose.

Eligibility Criteria:
Inclusion Criteria:

Healthy, adult, men or women, 18 to 55 years of age, inclusive, at screening. Body Mass Index ≥ 18.5 and ≤ 32.0 kg/m2 at screening. Non to moderate smokers (up to 10 cigarettes a day for at least 3 months prior to screening).

Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or 12-lead electrocardiograms (ECGs), as deemed by the principal investigator (PI).

Women of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and for at least 28 days following the last dose or be using one of the protocol-specific birth control methods.

Exclusion Criteria:

Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days prior to the first dose of study drug.

History or presence of alcoholism or drug abuse within the past 2 years prior to screening.

History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (eg, proton-pump inhibitors \[PPIs\]).

Women who are pregnant or lactating. Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.

Unable to refrain from or anticipates the use of:

* Any drug, including prescription and nonprescription medications, herbal remedies, or vitamin supplements (including proton-pump inhibitors) beginning 14 days prior to the first dose of study drug and throughout the study. Acetaminophen (up to 2 g per 24 hour period) and/or loperamide (up to 6 mg per 24 hours) may be permitted during the study at the direction of the PI.
* Any drugs known to be significant inducers of cytochrome p450 enzymes and/or P glycoprotein, including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/pharmacodynamics interaction with study drug.
A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer

This study is for people with advanced cancer for which no curative treatment exists.

The purpose of this study is to test the safety and effectiveness of the combination of the drugs Temsirolimus and Capecitabine and see what effects it has on cancer.

Temsirolimus is a drug that is given by vein that targets a protein important for the growth of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer cell growth and even lead to their death.

Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in the body to the very common chemotherapy known as 5-fluorouracil.

This research is being done because it is not known if the combination of Temsirolimus and Capecitabine will work better than Capecitabine or Temsirolimus alone.

This is a Phase I study designed to assess the safety and clinical activity of temsirolimus in combination with capecitabine in patients with advanced malignancies. Because the toxicities of capecitabine are well established, and based on a previous clinical trial of temsirolimus and continuous infusion 5-fluorouracil, an alternating dose escalation plan will be employed.

The first stage of the study will be performed to identify the maximally tolerated dose of the combination, when capecitabine is given on a every 2 week schedule. The starting dose of temsirolimus will be 15-mg IV on day 1 and 8 plus capecitabine 1000 mg/m2 by mouth twice a day on days 1-7 of a 14 day schedule. Patients will be enrolled in a standard 3+3 dose escalating fashion to a maximum dose of temsirolimus of 25-mg and a maximum dose of capecitabine of 1750 mg/m2 twice a day.

If the maximally tolerated dose is determined for the every 2 week schedule, then in the second stage of the study a similar dose escalation plan will be employed for an every 3 week schedule.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma with measurable or evaluable disease
* Disease for which capecitabine is approved or compendia listed
* Advanced unresectable, and/or metastatic disease for which there is no known curative therapy
* Performance status 0-2
* Adequate hepatic, bone marrow, and renal function

Exclusion Criteria:

* Brain metastases not under control for at least 3 months
* Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus
* Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
* Life-threatening visceral disease or other severe concurrent disease
* Women who are pregnant or breastfeeding
* Anticipated patient survival under 3 months
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).


Eligibility Criteria:
Inclusion Criteria:

* Signed ICF (Informed Consent Form)
* Subject-reported history of Drye Eye Disease (DED) in both eyes
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning pregnancy
* Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/peri-ocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that are expected to be active during the study
* Ongoing ocular or systemic infection
* Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or saline components
* Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers

This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers between the ages of 19 and 55 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
* Female subjects showing positive results on a serum pregnancy test before the study, and those who were of childbearing potential agreed to use one of the following medically accepted methods of contraception during the entire period of the study: abstinence, documented tubal ligation at least 1 year before enrollment in the study, documented placement of an intrauterine device with a proven failure rate of \<1% per year, or double barrier methods (a spermicide plus a male condom or female diaphragm).

Exclusion Criteria:

* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
* Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
* Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
* Use of any substance that could induce CYP3A4 synthesis (eg, St. John's wort, other herbal medications).
Reduction Ratio and Clearance During Hemodialysis With MCO-filter Compared to HDF With Standard High-flux Filter

The Medium Cut-Off dialysis (MCO) membrane has been developed to improve middle molecule removal compared to standard high-flux dialysis filters.

The major aim of this study is to compare the reduction ratio of middle molecules, during a single hemodialysis session with MCO-filter, compared to hemodiafiltration (HDF) with standard high-flux filter.

Secondary aims are to compare the reduction ratio of small and large molecules between the treatments.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing HDF treatment
* CRP \<30
* No Acute Myocardial Infarction within 3 months.

Exclusion Criteria:

* Not able to understand the study information.