cyrilzakka/clinical-trials huggingface dataset:
Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

PURPOSE: This phase I trial is studying chronic graft-versus-host disease in patients who have undergone donor stem cell transplant.

OBJECTIVES:

* To determine and define the biological basis of different subtypes of chronic graft-vs-host disease using a targeted single nucleotide polymorphisms approach in patients who have undergone allogeneic stem cell transplantation.

OUTLINE: Two important aspects of the methodologies that will be employed for the analysis of SNPs associated with GVHD are throughput efficiency to be able to perform the assays on a reasonable number of samples as well as having the ability to add or remove SNPs to the assay panel. While a genome-wide association study to identify variants associated with GVHD would offer an unbiased approach, our patient cohort size would not allow significant statistical power in the study. Therefore, a more targeted approach using two established technologies is proposed.

The Sequenome assay uses the unique combination of a single-base primer extension assay incorporating one of four modified nucleotides. The four modified nucleotides each have a unique mass that allows them to be distinguished from one another using mass spectrometry. Each SNP is determined analyzing the primer extension product from a PCR amplicon that surrounds the SNP of interest. The development of each assay involves designing flanking PCR primers and an internal extension assay using web-based software provided by Sequenome. The assays can be designed to analyze up to 30 SNPs in a single reaction, providing a customizable, efficient and high-throughput assay for SNPs of interest.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Underwent prior matched related or unrelated allogeneic stem cell transplantation (SCT)

  * Presence OR absence of chronic graft-vs-host disease after day 100 and alive after day 180 post-transplantation
* No T-cell depleted SCT, cord blood transplantation, mismatched allogeneic transplantation, or autologous transplantation
* Available recipient and donor DNA (samples collected from the Vanderbilt University or the Fred Hutchinson Cancer Center tissue bank)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Adipose Tissue Gene Expression Profiles in Women With Polycystic Ovary Syndrome (PCOS) Versus Controls

Adipose tissue is a central organ in mediating metabolic health. There is some evidence that women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. The aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with a control population matched on the basis of age and body mass index (BMI). A secondary aim was to then relate these gene expression profiles to the biochemical environment.

Adipose tissue is a central organ in mediating metabolic health. There is some evidence that women with polycystic ovary syndrome (PCOS) have a degree of adipose tissue dysfunction which may negatively affect their metabolic health. The aim of this study was to assess transcriptomic profiles of subcutaneous adipose tissue of women with PCOS in comparison with a control population matched on the basis of age and body mass index (BMI). A secondary aim was to then relate these gene expression profiles to the biochemical environment.

Eligibility Criteria:
Inclusion Criteria:

* Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
* Were between the ages of 18 and 40

Exclusion Criteria:

* Were under 18 years or greater than 40 years old,
* Were non-Caucasian
* Were pregnant, lactating or trying to conceive
* Had a body mass index (BMI) \<18kg/m2 or \>50kg/m2
* Had a recent illness or any chronic illness likely to influence results
* Were taking hormonal contraception
Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery

Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.

Intraoperative neurophysiological monitoring (IONM) measures neural function and integrity during surgical procedures. Through IONM, neurodiagnostic procedures can help determine whether any nerves have become compressed or if the brain or spinal cord has any reduced vascular flow, allowing the surgical team to take immediate and corrective actions to prevent a bad outcome. Essentially, IONM acts as an early warning system for surgeons to gain reliable insight into a patient's condition during surgery, adding a layer of safety to the measures already in place that monitor cardiac and respiratory function while a patient is anesthetized.

We propose an observational research study to enhance the evidence-base for IONM. A novel prospective neuromonitoring database will be implemented. In addition to the usual contingency data to assess prediction accuracy, other measures will be examined:

1. A "dose effect of injury" assessment. Three categories of injury will be recorded by physicians: (a) No New Deficit; (b) New Minor Deficit; and (c) New Severe Deficit.
2. The outcome effect of intraoperative test frequency will be evaluated (infrequent vs average vs very frequent), leading to a "dose effect of neuromonitoring" assessment. Here we hypothesize that within our prospective sample, there is a relationship between the proportion of total new neurological deficits (New Minor Deficit + New Severe Deficit) and the frequency of IONM testing. More frequent testing is associated with fewer total new neurological deficits.
3. Patient reported outcomes will be evaluated longitudinally in conjunction with clinical outcomes data. Patient interviews will be conducted by a trained research assistant aided by department technologists. Patient-reported neurological outcome assessments will be supplemented/confirmed by review of in- and outpatient surgical/neurophysiologist physician chart notes.

Data from this proposed observational study will allow real-life outcomes based improvement in the field of IONM.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18+ years old
* Patients must be undergoing cervical and/or thoracic spine surgical procedure at Abbott Northwestern Hospital in Minneapolis, MN

Exclusion Criteria:

* Patients who are non-English speakers
* Patients with ongoing psychiatric concerns are excluded
* Patients unwilling to be contacted for a 6-month follow-up
To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.


Eligibility Criteria:
Inclusion Criteria:

* Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
* Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
* Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
* Willing to give written informed consent

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
* ALT or AST \> ULNⅹ2.5
* Platelet count \< 100ⅹ103/ μL
* WBC \< 3,000/mm3
* Absolute neutrophil count \< 1,000/mm3
* Absolute lymphocyte count \< 500/mm3
* Total bilirubin \> ULNⅹ2
Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment

Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance.

Objectives: the primary aim is to determine changes in strength after US-guided PNM or Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as well as its effectiveness in changes of muscle function, pain and disability.

Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.

Shoulder pain is the third reason for medical consultation in the world. Many treatment techniques have been proposed. Neuromodulation techniques through the application of an analgesic electric current using a needle as an electrode, are increasingly used in the treatment of pain.

In this study, the investigators will compare whether the application of a neuromodulation technique is more effective than applying the dry needling technique in isolation.

Eligibility Criteria:
Inclusion Criteria:

* Chronic mechanical unilateral shoulder pain of non-specific origin of at least 3 months of evolution
* Weakness in the abduction force and / or external rotation of the shoulder.

Exclusion Criteria:

* Previous shoulder surgery.
* Previous history of shoulder dislocation
* Whiplash.
* Cervical radiculopathy.
* Total rupture of the rotator cuff.
* Adhesive capsulitis.
* Fibromyalgia diagnosis.
* Diabetes.
* Needle phobia or some contraindication for dry needling (anticoagulants or psychiatric disorders).
* Bilateral shoulder pain.
* Pregnancy or having received a dry puncture in the shoulder region in the last 6 months
Evaluation in Elderly Individuals with Chronic Obstructive Pulmonary Disease(COPD)

This study is conducted on the evaluation of balance, physical activity, functional capacity and activities of daily living in frail elderly individuals with COPD.

Patient evaluation form and socio-demographic form of all individuals participating in the study. Characteristics will be questioned: Name-surname, address, telephone, age, gender, weight, height, body mass index, occupation, marital status, social security, any systemic other than COPD whether he has a disease, whether he has social security, whether he smokes, It will be questioned whether there is any other COPD patient in the family and whether there is pain. To assess pulmonary functions at the assessment stage for all individuals pulmonary function test to evaluate dyspnea Modified Medical Saint George Respiratory Research Council to assess health-related quality of life Two Minute Walk Test to assess exercise capacity, frailty Frail fragility scale to detect frailty, Prisma-7 Vulnerability scale to assess fragility The scale was Pase to assess physical activity, Berg Balance to assess balance scale, digital hand dynamometer to assess quadriceps muscle strength, hand grip hand dynamometer to assess strength, fatigue levels Fatigue Severity Scale will be used to evaluate.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with COPD according to the Gold criteria
* Be over 65 years old
* Volunteering to participate in the study
* Not having mental and communication problems that prevent filling out the questionnaires to be used in the research.
* Not having an attack in the last 2 months

Exclusion Criteria:

* Being in a COPD exacerbation process
* Having been diagnosed with a physical and mental illness
* Having unstable COPD
* Unstabile angina, previous Myocardial Infractus, uncontrolled hypertension, cancer, with functional limitations concomitant neurological or musculoskeletal disorders
* Currently addicted to alcohol or drugs
* Having severe vision and hearing problems
* Have had major surgery in the last few months
* History of recurrent significant clinical infection
Drinking Habits of Glaucoma Patients and Age Matched Controls

The purpose of this study is to examine if a chronic dehydration is a risk factor for the developement or progression of some forms of glaucoma.

Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment are asked about their drinking habits. Objective evaluation of hydration status is assessed with the Body Composition Monitor (Fresenius). Retinal Vessel Analysis and Laser Doppler Flowmetry are investigated in subgroups.

The control group are also hospitalized patients who do not suffer from glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* glaucoma patients
* controls

Exclusion Criteria:

* psychiatric disease,
* epilepsy, pregnancy,
* nutritional disorder,
* malfunction of blood clotting and wound healing,
* pacemaker,
* metallic stents
A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis

The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of signing the informed consent form, regardless of gender.
2. BMI (Body Mass Index) ≥ 18 kg/m² at the time of screening.
3. Presence of objective signs of inflammation at the time of screening.
4. The subject voluntarily signs the ICF (informed consent form) before the start of any study-related procedures.
5. The subject is able to communicate effectively with the investigator, understands and is willing to strictly adhere to the requirements of the clinical study protocol to complete the study.

Exclusion Criteria:

1. Subjects with active systemic infection or severe infection.
2. Subjects with active tuberculosis or latent tuberculosis infection.
3. Subjects with lymphoma or lymphoproliferative disease.
4. Subjects with uncontrolled hypertension.
5. Subjects with history of malignancy within the past 5 years or current malignancy.
6. Subjects with moderate to severe congestive heart failure.
7. Subjects with history of organ transplantation, or severe, progressive, or uncontrolled diseases of any organ system.
8. Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG at the time of screening.
9. Pregnant or breastfeeding women.
10. known allergy to the study drug or any of its components.
11. Subjects with history of alcohol abuse or illegal drug use within the past year.
12. Receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period.
13. Blood donation of approximately 500 mL within 8 weeks before randomization, or plans to donate blood during the study period.
Validity and Reliability of the Turkish Version of WOOS

Various clinical scales are available to investigate shoulder diseases. Some of them, culturally adapted to the Turkish population. However, none of them are specific for osteoarthritis of the shoulder. Thus, this study aimed to translate the WOOS index into Turkish and investigate its psychometric properties in the Turkish population.

Purpose; The aim of this study is to adapt the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) specific to shoulder osteoarthritis, to Turkish and evaluate its validity and reliability.

Methods; WOOS index was translated and culturally adapted to Turkish, systematically. It was applied to 68 patients with osteoarthritis of the shoulder treated conservatively. The reliability of the scale was checked through internal consistency and test-retest methods. Internal consistency was analyzed with Cronbach's alpha value. Test-retest reliability was assessed using an intraclass correlation coefficient with 25 patients. The Western Ontario Rotator Cuff (WORC), The Shoulder Pain and Disability Index (SPADI), and The Society of American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) score were used to conduct concurrent validity.

Eligibility Criteria:
Inclusion Criteria:

* Presence of the shoulder osteoarthritis, to be a native Turkish speaker

Exclusion Criteria:

* Illiteracy, cognitive impairment, presence of shoulder circumference fractures
Relationship Between ANI, Anxiety, and Pain in Conscious Hernia Patients Undergoing CSEA

Analgesia Nociception Index can be used to detect noxious stimulation during general anesthesia.The aim of this study is to observe ANI under combined spinal epidural anesthesia procedures in conscious hernia patients.

Analgesia Nociception Index which is derived by heart rate variability, can be used to detect noxious stimulation during general anesthesia. However, the impact of anxiety on ANI evaluation and the correlation between ANI, pain, and anxiety in awake patients remains unclear. This study aimed to investigate the correlation between ANI, pain, and anxiety in conscious hernia patients undergoing combined spinal epidural anesthesia procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18- 80 years
* ASA physical status I or II
* Scheduled for inguinal hernia, umbilical hernia or incisional repair under CSEA
* Written informed consent

Exclusion Criteria:

* Use of CNS-active medication or abuse of alcohol
* History of cardiac arrhythmia
* Contraindications of combined spinal epidural anesthesia
* Previous exposure to CSEA or surgery
The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion

This experimental study will evaluate the effect of an esthetic Twin-block appliance on the correction of class II malocclusion compared with the traditional Twin-block appliance.

The study sample will consist of 50 patients with class II malocclusion. The sample will be allocated randomly into two groups: the control group and the experimental group.

The traditional Twin-block appliance will be applied for the control group patients, while the esthetic Twin-block appliance will be applied for the experimental group patients. The dentoskeletal, soft tissue changes and esthetic and functional efficacy occurring after functional treatment will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. Changes for each group will be evaluated individually, and the two groups will be compared.

Class II malocclusion is one of the most frequent orthodontic problems, and most class II malocclusion cases are the result of mandibular deficiency. Twin block (TB) is one of the most popular functional appliances to treat this condition. Despite excellent treatment results with TB, its acceptance and compliance may be hampered by its wiry structure and appearance. Furthermore, it has a side effect of causing the proclination of lower incisors, which reduces skeletal change. Various modifications were proposed to reduce lower incisors proclination but had no significant effect. Patient cooperation is one of the most important factors for successful functional appliance treatment, and it depends upon comfort and esthetic acceptability, which ensures good patient compliance. so, in order to enhance the esthetic appearance and overcome the disadvantages of a conventional Twin-Block (CTB), a novel esthetic Twin-Block (ETB) was fabricated from a specific material using a pressure molding device and acrylic bite blocks. There is only one study that evaluated this appliance which is a pilot study that compared the treatment effects of the (ETB) and (CTB) in the treatment of Class II malocclusions. However, this study has a lot of limitations, making it difficult to evaluate this appliance's efficiency accurately. The aim of this study is to study the dento-skeletal, soft tissue changes, and esthetic and functional efficacy that result from treatment by this appliance (ETB) and to compare them to the changes in the matched group will be treated with (CTB), by studying the cephalometric radiographs, profile photographs, and a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Angle class II malocclusion because of mandibular retrognathia
* O.J \> 5 , SNB \< 78
* Patient during growth spurt
* Normal or horizontal growth pattern Björk \> 402

Exclusion Criteria:

* TMJ disorders
* Poor oral hygiene
* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Reason of contraindication of functional treatment
Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital

This is a prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known. Although basilar artery occlusion has been reported in 2 per 1000 autopsy cases, basilar artery thrombosis may, in stroke registries, explain as many as 27% of ischemic strokes occurring in the posterior circulation.Various treatments were tried in groups of patients with vertebrobasilar territory infarction but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Eligibility Criteria:
Inclusion Criteria:

* Patients admit to 115 hospital in 24h of Basilar Artery Occlusion Stroke
* NIHSS \> 4 points

Exclusion Criteria:

* Patients refuse to participate in studies
* Patients with contraindication of either rTPA or thromboectomy
Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

This study evaluates two different techniques for ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance.

Peripheral venous catheter placement is one of the most common interventions in emergency medicine. When performed by conventional approach, the failure of the first attempt occurs up to 22 % and cannulation time exceed 2 minutes in up to 15 %. Ultrasound guidance of peripheral venous catheter (PVC) insertion may improve both. However, this approach has not been verified in the setting of pre-hospital emergency care so far.

Eligibility Criteria:
Inclusion Criteria:

* Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service

Exclusion Criteria:

1. Coma
2. Age \<18 years
3. Patient disagreement with the insertion of peripheral venous catheter
4. Disagreement of the patient with inclusion in a clinical trial
5. Contraindication of ultrasound examination of the venous system
6. Contraindication of the introduction of peripheral venous cannula on both upper limbs
7. Investigator's opinion that ultrasonic control cannulation would cause undue delay and a other procedure is required