cyrilzakka/clinical-trials huggingface dataset:
H-reflex Measurement in Hemiplegic Stroke Patients

As human beings live longer, geriatric disease develop, one of which was stroke whose prevalence elevated by aging. Increased spasticity is a common symptom after stroke and may hinder patient from rehabilitation. The spasticity was evaluated by subjective judgement before. However, in the recent studies, the electrophysiological test, an objective evaluation, showed possibly positive correlation with the spasticity. They compared stroke patients' hemiplegic side with non-hemiplegic side by H/M ratio which showed significant difference. The stroke patients included in studies had stroke onset over 2 years. Therefore, investigators wonder if H/M ratio can evaluate spasticity in stroke patients onset within 2 years and if H/M ratio is correlated to spasticity.

Stroke is a condition that insufficient brain blood supply due to ischemia or hemorrhage causes brain cell death, which impacts normal function of motor, sensory, and speech, depending on the damaged location. Over the world wide, the incidence of stroke is 119 per 100,000 population per year with death rate up to 10-42% in one month after stroke. The survivor developed varying degrees of spasticity up to 42.6%.

In the conventional physical examination, modified Ashworth scale is used to evaluate spasticity, but its results may be influenced by temperature, joints range of motion, subjective judgement by tester or patient's nervousness. In the previous studies, spasticity between hemiplegic side and sound side showed significant difference in ratio of H/M amplitude, H/M threshold and H/M slope. Among them, H/M slope is the most sensitive tool and may be correlated to increased spasticity because H/M slope showed higher value in people with Brunnstrom stage III.

However, patients included in previous studies had disease onset over 2 years. The gold recovery stage after stroke is within 6 months. During this time, many methods can be used to reduce spasticity, such as medicine, stretching exercise, and injection. Therefore, it is very important whether H/M ratio for spasticity evaluation can be performed in patients with disease onset less than 2 years.

In our study, according to onset time, participants will be assigned to three groups: less than 6 months, 6 months to 2 years, and over 2 years. All the participants will accept electrophysiological test over four limbs to collect data of H/M ratio of slope, maximal amplitude and threshold. Hemiplegic side will be compared with sound side for significant difference. The relation between H/M ratio and modified Ashworth Scale will also be identified.

Eligibility Criteria:
Inclusion Criteria:

* Single episode of stroke
* Single side hemiplegia after stroke

Exclusion Criteria:

* Other diagnosis of neurovascular disease or major cardiovascular disease
* Poor cognition
* Poor cooperation
* Aphasia
* People who can not tolerate the exam
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis

Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations.

If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality.

Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Adult-onset disease.
2. Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.

Exclusion Criteria:

1. Any patient with any collagen disease rather than Rheumatoid arthritis.
2. Patients with joints deformities.
"Escape" Phenomenon of the Antihypertensive Therapy Efficacy

A little attention is paid to the AHT efficacy escaping problem, which can be explained by the AHT correction simplicity and rapid achievement of the target BP level. Nevertheless, modern statistic data on the effective AH treatment described above let us assume that AHT correction is either totally absent or is untimely in case of the "escape" phenomenon development. This could be one of the main reasons for the high prevalence of ineffective AH treatment. The aim of this study is to determine AHT efficacy "escape" phenomenon timeline and its predictors in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Arterial hypertension (AH) grade 1-3, stage I-II
* High compliance during the follow-up period (≥ 85%)
* Initially achieved target office BP levels while taking 2-3-component AHT

Exclusion Criteria:

* Secondary AH
* Resistant AH,
* AH III stage,
* PAP- therapy,
* type 2 diabetes mellitus,
* pregnancy
* history of low adherence to treatment
The Physiological Impact of CTO PCI on Coronary Pressure Measurements and Correlation in Donor Vessel

This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment options; medications, stents or potentially bypass surgery, for patients with Chronic Total Occlusion (CTO).

The patients in this study are planned to have a Percutaneous Coronary Intervention (PCI) with recanalization of Chronic Total Occlusion (CTO) on clinical grounds alone.

This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment option. To date there is no data available on instantaneous wave free ratio (iFR) measurement (a pressure derived assessment of flow limitation) in patients with blocked arteries.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years of age
2. Stable angina / ischaemic symptoms
3. Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory
4. Participant is willing and able to give informed consent for participation in the study
5. Presence of a chronic total occlusion (CTO) in RCA:

   * Duration of the occlusion \> 3 months;
   * Thrombolysis In Myocardial Infarction (TIMI) (50) coronary flow grade 0;
   * Spontaneously visible collaterals, Rentrop classification grade 1 or 2 or 3 from contralateral donor artery
6. Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery
7. Eligible for PCI to a chronic total occlusion (CTO)

Exclusion Criteria:

1. Previous CABG with patent grafts to the interrogated donor artery
2. Left main stenosis of \> 40 %
3. Presence of severe flow limiting stenosis in the contralateral donor artery (typically \> 70 % stenosis)
4. Haemodynamic instability at the time of intervention (heart rate \<40 beats per minute, systolic blood pressure \<90mmHg), balloon pump)
5. Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
6. Contraindications to PCI
7. Severe hepatic or lung disease (chronic pulmonary obstructive disease)
8. Pregnancy
9. ACS within 48 hours of procedure
10. Severe valvular heart disease
11. Severe cardiomyopathy / Infiltrative heart disease
12. eGFR \< 40
ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study

SCOPE-PLUS is an optional substudy of the observational SCOPE Study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). The objective of the SCOPE-PLUS study is to derive new equations based on innovative and novel biomarkers of CKD function and compare its accuracy to measure GFR in the population older than 75 years.

SCOPE-PLUS is an optional substudy of the SCOPE cohort study (Screening for Chronic Kidney Disease among Older People across Europe, NCT02691546). SCOPE has retrieved data on a wide panel of biomarkers of CKD in a large study cohort enrolling about 2,450 older people in Italy, Spain, Germany, Austria, Netherlands, Poland and Israel. The innovative biomarkers have been already validated by the literature, and include e.g. Cystatin C (CysC), β-Trace protein (BTP), and Beta2-microglobulin. Others promising novel biomarkers of CKD, based on metabolomic and proteomic determinations or other techniques have been evaluated. The objective of the SCOPE-plus study is to to verify the accuracy of newly developed equations based on innovative and novel biomarkers of CKD function by calculating the percentage of estimates within 30% (P30) of the measured GFR (mGFR). The mGFR will be obtained by the assessment of nonradioactive iohexol clearance. Patients previously enrolled in the SCOPE study, are invited to participate in this additional protocol. Iohexol is an iodinated contrast medium with characteristics similar to those of inulin, being freely filtered by the glomerulus, neither secreted nor reabsorbed by the renal tubules and recovered almost 100% in the urine. These characteristics made it an ideal agent for the determination of the renal function.

Eligibility Criteria:
Inclusion Criteria:

* to be eligible for this study, subjects must have been enrolled in the SCOPE study

Exclusion Criteria for substudy:

* a thyroid-stimulating hormone level less than 0.3 mlU/L
* a known iodine allergy
* oedema
* ascites
* clinically symptomatic heart failure
Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions

The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II.

This study is a randomized-controlled clinical trial of 6 months duration.

According to the medical databases, there are limited randomized clinical trials comparing xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a possible alternative to connective tissue graft.

The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root coverage using the tunnel technique with the collagen matrix and the same technique with CTG for the treatment of multiple recessions Miller class I and II.

Twenty eight patients are enrolled in the study. Patients in the test group are treated with xenogenic collagen matrix using the tunnel technique whereas patients in the control group with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.

Exclusion Criteria:

* Approximal Plaque Index (API) \> 15%,
* Sulcus Bleeding Index (SBI) \> 10%,
* Systemic diseases with compromised healing potential or infectious diseases,
* Untreated periodontal conditions,
* Pregnant and lactating females.
Intravenous Iron Versus Oral Iron for Severe Postpartum Anemia

The aim of the study is to compare the effect of intravenous versus oral iron in women with severe postpartum anemia.

Postpartum anemia is commonly defined as hemoglobin levels less than 8.5 g/dl and it is usually treated with oral iron supplements. Blood transfusion is reserved to women with hemoglobin levels \< 6 g/dl and/or clinical symptoms of anemia. Without treatment, the restoration of blood parameters in postpartum anemia can take approximately one month (hemoglobin levels increase to 2.8 g/dl in 30 days). Several reports have demonstrated the efficacy of intravenous iron in severe anemia in non-obstetric pathologies. However, the clinical effect of intravenous iron in patients with postpartum hemoglobin levels ranging from 6.0 to 8.0 g/dl has been not reported. There has not been evaluated its capacity to restore hemoglobin levels and to minimize clinical side-effects of anemia (sickness, weariness, depression, anxiety).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older,
2. Diagnosis of postpartum anemia within the first 48 h postpartum with an haemoglobin level equal or higher than 6 g/dL and lower than 8.0 g/dL,
3. Ability to read and understand the relevant purpose of the trial and consent obtained in accordance with specifications of the local research ethics committee.

Exclusion Criteria:

1. Clinical symptoms or suspicion of acute or chronic infection.
2. Allergic history or iron intolerance.
3. Indication of blood transfusion.
4. Non iron deficit anemia.
5. Hepatopathy.
6. Parenteral iron hypersensitivity.
Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function

This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal hepatic function and liver parameters within normal range
* Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C
* Body Mass Index between 18.5-40.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Liver transplanted subjects
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Signs of acute liver insufficiency
* Positive HIV (human immunodeficiency virus) 1+2 antibodies
* Cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment
* Impaired renal function
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
Pharmacokinetic Study in Healthy Volunteers

Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.

Phase 1, single-center, open-label, randomized, crossover clinical trial to evaluate insulin exposure using the 3 U/mg and 4 U/mg Technosphere Insulin Inhalation Powder formulations administered using the Gen2 inhaler in 31 healthy volunteers. Drop outs will be replaced. Each subject will undergo a screening visit and either 4 or 5 days of in clinic stay and dosing, depending on randomization schedule.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking (within the last 6 months) men and women aged 18 to 45 years who are considered healthy
* Body mass index (BMI) \< 32 kg/m2
* FEV1 ≥ 80% of the Third National Health and Nutrition Examination Survey (NHANES III) predicted

Exclusion Criteria:

* Pre-existing asthma or chronic obstructive pulmonary disease (COPD)
* History of coronary artery disease, peripheral vascular disease, or congestive heart failure
* Blood donation within the previous 3 months
Prospective Evaluations of Infectious Complication in Lung Transplant Recipients

The primary aim of this study is to determine prospectively the viral and C. pneumoniae infection prevalence and outcomes of infections in lung transplant recipients. The study will also determine the correlation of C. pneumoniae infection with the development of obliterans in lung transplant recipients.

This is a prospective cohort study of lung transplant recipients and those who will undergo lung transplantation. Patients will be identified by the pulmonologist performing the bronchoscopy. The patient's sera (obtained from a one time blood draw of 10 milliliters - two tablespoons) and cell pellet of BAL will be frozen at -70º C. Once the active or non- OB status is determined by the pathologist, stored BAL fluid (cell pellet) will be analyzed. C.pneumoniae serum titers will also be measured and compared with stored pre-transplant sera. Left over cell pellet of the BAL fluid will be used to measure the presence of C. pneumoniae by PCR method. Additionally PCR will be performed for other viruses (CMV, EBV, HHV6 \& 7, human metapneumo virus and human rhino virus). In addition, during the bronchoscopy procedure as part of the patient's standard of care, a biopsy is obtained. This is done during the bronchoscopy procedure. The tissue is then sent to the pathology lab. We will collect residual (excess) tissue samples to perform research related testing. This testing will determine if we can predict other types of infections and early onset of rejection. These determinations will assist clinicians in administering appropriate dosage levels of antibiotics required to prevent or treat infections and help stop the rejection process. The subject will be asked a few questions about pulmonary symptoms that will not take more than five minutes by one of the investigators or study coordinator. The subject's medical record will be reviewed for demographic information (age, sex, and race), lab results (standard to post transplant care), medication information, as well as any testing/procedures during the transplant follow-up period. This information and results of the tests/procedures will become part of the research record.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone lung transplantation or will undergo a lung transplant at the University of Pittsburgh Medical Center and are alive following transplant period will be eligible for the study.

Exclusion Criteria:

* Subjects not willing to participate in the research study.
Dexmedetomidine for Catheter-related Bladder Discomfort

To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.

Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for transurethral bladder resection
* ASA I-III

Exclusion Criteria:

* Patient who disagrees to participate this investigation
* Patient with severe cardiovascular disease
* Patient with small-sized foley catheter (less than 18 Fr.)
* Patinets with any urinary tract obstructions
* Patient with hyperactive or neurogenic bladder
* Patients with chronic renal failure
* Patient with morbidly obese
* Patients with neurogenic disorder
* Patient with medications for chronic pain
Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri

This study evaluates the effect of two different doses of Lactobacillus reuteri ATCC PTA 6475 (L.reuteri 6475) on bone loss in early postmenopausal women. One third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.

We have previously shown that daily supplementation of the probiotic Lactobacillus reuteri ATCC PTA 6475 (10E10 colony-forming units (CFU)) was able to reduce bone loss over 12 months in 76-year-old women compared to placebo.

It is not known if the probiotic is effective over longer time periods or if the effect is dose-dependent. The aim of this study is to investigate if two different doses of Lactobacillus reuteri ATCC PTA 6475 (total daily dose of either 1x10E9 or 1x10E10 CFU/day) can prevent or reduce bone loss, compared to placebo, in early (1-4 years since last menses) postmenopausal women over 24 months. All women will receive 400 IU of vitamin D (cholecalciferol) per day. Changes in bone mineral density, bone geometry and microstructure will be measured using dual x-ray absorptiometry and high resolution peripheral computed tomography.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, 45 years or older, within 1-4 years from their last menses.
* Vitamin D levels above 25 nmol/L.
* Signed informed consent.
* Stated availability throughout the entire study period.
* Ability to understand study instructions and willingness to adhere to the protocol.

Exclusion Criteria:

* Bone mineral density of \< -2.5 combined with a fracture risk assessment tool (FRAX) score of 20% or higher for major osteoporotic fracture.
* Severe osteoporosis, defined as bone mineral density of \< -3.0 in either the total hip, femur neck or lumbar spine L1-L4.
* Vertebral fracture (grade II or III) diagnosed using lateral spine imaging with DXA.
* Untreated hyperthyroidism or hyperthyroidism within the last 5 years.
* Known untreated hyperparathyroidism.
* Rheumatoid arthritis.
* Diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus.
* Recently diagnosed malignancy (within the last 5 years).
* Oral corticosteroid use.
* Previous (within the last 5 years) use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab.
* Systemic skeletal disease (including e.g. Paget's disease and osteogenesis imperfecta).
* Any systemic disease that could affect bone loss, as judged by the investigator.
* Use of teriparatide (current or during the last 3 years).
* Participation in other clinical trials.
* Current antibiotics treatment or within the last 2 months prior to inclusion.
* Current and within the past 2 months use of probiotic supplement
* Vitamin D deficiency (25-OH vitamin D\<25 nmol/l)
* Hypo- or hypercalcemia.
* Osteosynthesis materials in both lower legs (tibia).
Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer

Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy extensively in China, no strong evidence exists to demonstrate the safety and survival outcomes of TCM herbal therapy combined with conventional western medicine for treatment of this disease. The purpose of this multi-center perspective cohort study is to evaluate the relationship between TCM herbal therapy and survival outcomes in patients with advanced colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed adenocarcinoma of the colon or rectum
* TNM classification of stage IV disease according to American Joint Committee on Cancer
* Between 18 and 80 years old
* Progression or inability undergone conventional chemotherapy (Conventional chemotherapy regimen containing fluorouracil, oxaliplatin, irinotecan based chemotherapy, and all the above regimen should be used before)
* Expected survival time is over 3 months
* Signed informed consent

Exclusion Criteria:

* serious non-malignant diseases such as heart, renal, and hepatic illnesses
* the presence of other types of malignancies
* The patients can not take medicine for intestinal obstruction
Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current/previous PRECISION1 or INFUSE contact lens wearer.
* Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
* Routinely sleeps in contact lenses.
* Other protocol-defined exclusion criteria may apply.