cyrilzakka/clinical-trials huggingface dataset:
Serum Cytokine Levels in Patients with Lumbal Disc Herniation and Effectiveness of Exercise

The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study.

The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist.

Eligibility Criteria:
Inclusion Criteria for patients with disc herniation:

* Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
* not an indication for lumbar disc herniation surgery
* for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
* pain intensity of VAS ≥ 3
* male and female patients between the ages of 20-55

Inclusion Criteria for heathy people

* not having low back pain complaints in the past
* female and male healthy individuals between the ages of 20-55

Exclusion Criteria:

* systemic or inflammatory disease
* pregnant or breastfeeding women
* surgery of lumbar region
* fracture of lumbar vertebrae
* lumbar scoliosis
* medication use for psychiatric disorders
* tumor
* allergy
* neurological disease
* alcohol-drug use
* generalized musculoskeletal pain
Thromboelastographic Guide for Blood Products in Cirrhotics

Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or imaging-proven liver cirrhosis of any etiology
* INR\>1.8 and/or PLTs count \<50x103/μl

Exclusion Criteria:

* Ongoing bleeding
* Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
* Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
* Presence of sepsis according to ACP-SCCP criteria
* Hemodialysis performed within 7 days
Clinical Efficacy of a 3D Foot Scanner for the Therapeutic Footwear Fitting

Patients with diabetes at high risk of ulceration require a perfect fitting shoe to avoid high shear and pressure forces. Neuropathy skews sensory perceptions and can alter the proper selection of the therapeutic footwear.

The aims of study were to evaluate the ability of high-risk patients with diabetes in remission to select the proper therapeutic footwear and to validate a novel 3D foot scanner app for selecting the proper fitting therapeutic footwear.

A Randomized Controlled Clinical Trial in 30 patients with a previous healed diabetic foot ulcer.

After parallel randomization (1:1) patients will be enrolled into two different groups:

1. Patients that will acquire the therapeutic footwear size and model according to aesthetic preferences;
2. Patients that will acquire a specific size and model according to result of a novel mobile app 3D feet scan (smart-fitting by Podiapp - Podartis s.r.l Unipersonale-Crocceta del Montello (TV), Italy).

Validation of proper therapeutic footwear fitting will be performed by a specialized podiatrist after acquisition of shoes in both groups.

Therapeutic Footwear will be recommended to change when following ill fitting reason been found: excessive length or tight, or compromise with toes

Eligibility Criteria:
Inclusion Criteria:

* High risk patients according to the International Working Group Diabetic Foot Guidelines (IWGDF-risk 3).
* Healed diabetic foot ulcer at the moment of inclusion.
* Capability to walk autonomously without walking aids.
* Diabetic Peripheral neuropathy.

Exclusion Criteria:

* Major amputation in the contralateral limb (below or above the knee).
Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively

Exclusion Criteria:

* Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of \< 25mmHg.
* Use of other investigational drugs
* Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve
* History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation
* Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk
* Women
* who were pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5 mIU/mL)
* who were menstruating and capable of becoming pregnant\* and not practicing a medically approved method of contraception (Pearl Index \<1\*\*)\*\*\* during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche was required with sufficient lead time before randomization

  * definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy

    * examples of particularly reliable methods with Pearl Index (PI) \<1, according to guidelines of "Deutsche Gesellschaft für Gynäkologie und Geburtshilfe":

      * Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)
      * Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr.)
      * Contraceptive patch (EVRA®, PI= 0.72 uncorr.; 0.9 corr.)
      * Estrogen-free ovulation inhibitors (Cerazette®, PI=0.14)
      * Progestin-containing contraceptives (Implanon®, PI=0-0.08)
      * Injectable 3-month depot progestins (PI=0.3-1.4; 0.88 corr.)
      * Intra-uterine progestin device (Mirena®, PI=0.16)
Health Coaching for Positive Airway Pressure Adherence

This study tested a low-resource, brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of sleep apnea.

We conducted post hoc analysis of a quality improvement initiative in which patients were randomly assigned to receive health coaching or usual care. Participants were English- and Spanish-speaking patients from a county-based public health system who had previously received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach called patients three times to resolve barriers to adherence. Adherence measures collected by device modem at baseline and 4 weeks were the primary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* English- or Spanish-speaking
* At least 18 years of age
* Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
* Received care from the San Francisco General Hospital Sleep Clinic

Exclusion Criteria:

* Not English- or Spanish-speaking
* Younger than 18 years
* Does not have phone number at which could be reached
Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial

Reducing the occurrence of anemia (low circulating hemoglobin levels) post-surgery has been associated with improved outcome, as it reduces complications and allows for faster return to pre-operative function. Post-operative hemoglobin level is dependent upon its pre-operative value (for a given amount of blood loss). About 17% of patients at the Ottawa Hospital (TOH), will be anemic pre-operatively, and if left untreated the patients will have significantly inferior outcomes compared to non-anemic patients. In order to improve outcomes, when a patient is identified as anemic, typically at the pre-operative assessment clinic, he/she is invited to be reviewed and optimized at the Pre-operative Blood Optimization Clinic (PBOC). However, only a quarter of anemic patients are seen in the PBOC due to the lack of time available between anemia identification and surgery and the current resources available. This project will focus on hemoglobin level optimization of pre-operative hip and knee, primary, arthroplasty patients to demonstrate whether early assessment and treatment of pre-operative anemia can be successfully integrated into practice and its impact on post-operative outcomes. Patients will be randomly assigned to either the current standard of care pathway with an anemia test at the pre-operative assessment clinic (2-4 weeks before surgery), at which time they have the option to seek treatment. Patients who are randomly selected to be in the experimental group, will undergo a test to detect anemia at the time they consent for surgery, which is usually 4-6 months prior to surgery. Patients with anemia, will be invited for treatment at the blood optimization clinic at this time. In doing so, this project will test whether timely identification and simple measures is feasible and whether such practice can reduce the overall anemia burden and ultimately improve patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Undergoing primary arthroplasty procedure
* Willing and able to provide informed consent

Exclusion Criteria:

* Patients who are not eligible for assessment and optimization in the preoperative blood optimization clinic. This includes patients with end-stage renal disease (ESRD) or other renal conditions under the care of nephrologists, receiving erythropoietin treatment
* Patients with known hematological malignancy or other hematological conditions which are already on some form of anemia treatment
Transdermal Methylphenidate for Cancer-Related Fatigue

The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication that is known to increase alertness and wakefulness. Oral methylphenidate has been used in the past to treat cancer related fatigue and is often used to treat unusual sleepiness. But this is the first time that the patch form is offered to try treating cancer fatigue in patients who cannot always swallow tablets.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head and neck cancer who underwent combined modality treatment with curative intent
* Has not undergone cancer treatment in the last 4 weeks
* Is 21 years of age or older
* Fatigue scale score of 4 or higher
* Is able to understand English, through written and verbal communication
* In the judgment of the consenting professional, is able to provide informed consent
* Physically able to present for follow-up appointments at outpatient Radiation Oncology or Pain \& Palliative Care clinics
* Probable life expectancy of more than 6 months

Exclusion Criteria:

* Pulmonary or cardiovascular failure, seizure disorder, sleep disorder, mental impairment, psychiatric disorder, or pregnancy
* Has known sensitivity or allergies to methylphenidate
* Receiving concurrent treatment with a psychostimulant
* Hospitalized patients
* Evidence of impaired hepatic or renal function (hyperbilirubinemia, greater than two fold elevation of transaminases; \>40mg/dl BUN or \>1.5mg/dl Cr )
* Anemia ( hemoglobin \<10mg/dl)
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

To estimate the percentage of children with serum IGF-1 \> 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.


Eligibility Criteria:
Inclusion Criteria:

* Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
* Measured Height \< -2.5 Standard Deviation

Exclusion Criteria:

* Pubertal signs ie: testis volume \> or = 4 ml in boys and breast stage \> or = B2 (Tanner)
* Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)
Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE

Study Title

A phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability, pharmacokinetics and preliminary efficacy of KPG-818 in patients with mild to moderate systemic lupus erythematosus

This is a Phase 1b/2a multicenter study to evaluate the safety, PK, PD, and clinical efficacy of KPG-818 in patients with SLE. The trial will consist of 2 parts: Phase 1b, a multiple-ascending dose (MAD) study; and Phase 2a, a proof of concept (POC) study.

Eligibility Criteria:
Inclusion criteria are listed as follows:

1. Age≥18
2. BMI between 18-40kg/m²
3. Diagnosed with SLE according to the 2019 EULAR/ACR criteria for SLE
4. Meeting SLE activity requirements
5. Males and females childbearing potential must agree to use contraception methods
6. All patients must:

   1. Understand that KPG-818 could have potential teratogenic risk.
   2. Agree not to share KPG-818 with another person.
   3. Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan.
7. Patients must agree not to donate blood (or any component of blood) from 3 months before Screening until 3 months after the last dose of KPG-818.
8. Patients must be willing to comply with precautions to reduce the risk of COVID-19 infection and to undergo COVID-19 PCR test.

Exclusion criteria are listed as follows:

1. Use of any prohibited medications within the pre-specified time
2. Patients must meet exclusionary lab criteria
3. Active and/or unstable neuropsychiatric SLE
4. Active or history of severe systemic bacterial, viral, fungal, mycobacterial, or parasitic infections within 6 months prior to Screening
5. Current or recent sign or symptoms of infections, or severe viral infections
6. Conditions predisposes patient to infection
7. Active TB or positive QuantiFERON®-TB Gold test
8. Patients with malignancy and antiphospholipid syndrome history
9. Inflammatory joint or skin disease, mixed connective tissue disease, scleroderma, and/or overlap syndromes, or acute or chronic disease
10. Concomitant condition that required systemic corticosteroid use within 1 year before Screening
11. Alcohol or drug abuse history
12. Positive urine drug test at screening
13. History or planned major surgery
14. Pregnant or breastfeeding female
15. Signs or symptoms of COVID-19 infection
16. Known allergic reaction to any of the ingredients for study drug or placebo
Management of Nailbed Injuries

The purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* any individual greater than or equal to 2 years of age presenting with a suspected nailbed injury (laceration adjacent to or through nail plate and/or subungual hematoma) with the nail plate present

Exclusion Criteria:

* nail plate absent over the nailbed injury
Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain

This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2 in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).

This is a randomized, controlled trial evaluating the safety and efficacy of nasal carbon dioxide for the treatment of pain and other symptoms related to temporomandibular disorders (TMD). Approximately 115 men and women ages 18 to 70 years old who have a history consistent with TMD-related pain for at least 3 months and meet all other eligibility criteria will be enrolled in this study. There may be up to two (2) visits to the clinic, screening and treatment. Screening and treatment may occur on the same day.

Eligibility Criteria:
Key Inclusion Criteria:

* Have a history consistent with TMD-related pain for at least 3 months prior to screening
* Agree not to use certain medications prior to randomization within the study specified
* Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test.

Key Exclusion Criteria:

* Have recent history of alcohol or drug abuse within 2 years prior to randomization
* Current major psychiatric disorder such as suicidal ideation, bipolar, panic disorder, schizophrenic, or psychoses
* History of asthma (other than mild or intermittent)
* Have an existing serious unstable systemic disease (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
* Clinically significant nasal disorder (such as deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities)
* Current diagnosis of fibromyalgia
* History or clear clinical evidence of osteoarthritis of temporomandibular joint (TMJ)
* A TMD diagnosis of disc displacement without reduction, "locking"
Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment

The primary purpose of this study is to determine the prevalence of adrenal insufficiency in a population of patients with kidney transplants receiving low dose prednisone treatment.

Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to glucocorticoid treatment. The study includes a control group of patients with kidney failure currently treated in dialysis, who are not in glucocorticoid treatment.

Individual genotyping is performed to determine the haplotype of glucocorticoid receptor polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid receptor gene will either have increased or diminished glucocorticoid sensitivity.

Using validated questionnaires assessing the quality of life and functional level of the patients enrolled in the study we aim to establish a link between functional level and biochemically proven adrenal insufficiency.

Other secondary outcomes in the study includes bloodpressure, body composition, bone density, metabolic syndrome, inflammation and salivary cortisol profiles.

Adrenal function is assessed in 30 prednisolon treated kidney transplanted patients and compared with 30 patients in dialysis, who are not treated with glucocorticoids. Adrenal function is evaluated using a 250µg Synacthen® test, performed fasting, in the morning, 48 h after the last prednisolone dose.

Cut-off for normal adrenal function is locally validated assay specific cut-off of 30 min P-cortisol \>420 nmol/l. The primary outcome measure of this study is P-cortisol concentrations 30 minutes after Synacthen® injection in prednisolone treated patients compared with comtrols. Secondary, 30 minutes P-cortisol is examined in relation to glucocorticoid receptor haplotypes.

The genotyping is determined using polymerase chain reaction (PCR).

The questionnaires used in this study includes EQ-5D, SF-36, Patient Life Situation Form, CushingQol and ADDOQol.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years).
* Kidney transplated patients or patients with kidney failure treated in dialysis.
* Prednisone min 5 mg/day max 7,5 mg/day for the kidney transplanted patients (control group not treated with prednisone).

Exclusion Criteria:

* Other major organ disease.
* Anemia with hemoglobin level less than 6,5 mmol/L.
* Not willing to pause any oestrogen tratment for a minimum of 6 weeks.
* Pregnancy.
* Not understanding Danish language or otherwise not able to provide a written informed concent.
I PREVENT - Irbesartan In Hypertensive Diabetic Patients

* To evaluate Blood Pressure (BP) reduction to the targeted values (Systolic BP ≤ 130 mmHg and Diastolic BP ≤ 80 mmHg) in hypertensive type 2 diabetic patients.
* To evaluate the benefit of Irbesartan in the reduction of microalbuminuria from baseline (if any at the inclusion visit) in this population.
* To demonstrate the safety of Irbesartan in this population.


Eligibility Criteria:
Inclusion Criteria:

* Proven Hypertensive Type 2 Diabetic Patients with HbA1c \> 6% and ≤ 10% (with or without microalbuminuria).
* Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). OR,
* Patients who were receiving antihypertensive agents (maximum two agents, including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

* Severe hypertension (SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg).
* Patients with secondary hypertension.
* Patients with UAE \> 200µg / min.
* Patients with HbA1c \< 6% or \> 10%.
* Significant chronic renal impairment (Serum creatinine \> 2.0 mg/dL).
* Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) \> 2.5 times the upper limit of the normal range.
* Currently pregnant or lactating females.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician).
* Known hypersensitivity to irbesartan, other ARBs(Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
* Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.