cyrilzakka/clinical-trials huggingface dataset:
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)

The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.


Eligibility Criteria:
Inclusion Criteria:

* All Participants
* Is in good general health.
* Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.
* HCV Participants
* Has documented GT1, GT2, or GT3 chronic HCV infection.

Exclusion Criteria:

* All Participants
* Is pregnant or breastfeeding.

HCV Participants

* Has received prior HCV treatment.
* Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
Post Transplant Study

Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Adults \>= 18 years old
* Subjects who have received Sensipar for a duration of at least 3 months, beginning at least 3 months after a kidney transplant. Subjects must have begun Sensipar teatment no later than Februry 28, 2005 at treating physician's discretion.

Exclusion Criteria:

* Subjects who received Sensipar before undergoing a kidney transplant
* Subjects receiving dialysis post-transplant
High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain

High intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain. To our knowledge, the effectiveness of HILT in patients with hemiplegic shoulder pain (HSP) with partial thickness rotator cuff tear (PTRCT) is unknown. In this study, we intended to investigate the effectiveness of HILT on pain, disability, function and quality of life in patients with HSP accompanied by PTRCT.

The study was designed as prospective, randomized, controlled trial. Patients with HSP accompanied by PTRCT (n=44) were randomly assigned to HILT and control groups. Group 1 (HILT group, n=22) received 3 sessions of HILT per week for 3 weeks in addition to the exercise program which performed 5 sessions per week for 3 weeks. Group 2 (Control group, n=22) received an exercise program for HSP of 5 sessions per week for 3 weeks.

Participants were evaluated with Visual Analog Scale (VAS), passive Range of Motion (ROM), Shoulder Pain and Disability Index (SPADI), Nottingham Health Profile (NHP), Functional Independence Measure (FIM) and ultrasonographic PTRCT size.

Eligibility Criteria:
Inclusion Criteria:

* Patients with HSP (at least 4/10 points from VAS) aged 18-75 years with hemiplegia duration\> 6 months, suffered a stroke resulting in unilateral hemiplegia for the first time, and who had partial thickness RCT after ultrasonographic evaluation due to shoulder pain

Exclusion Criteria:

* Cases who had inflammatory rheumatic disease, cervical radiculopathy, diabetes mellitus, thyroid disease, coronary heart disease, cardiac pace-maker, neurological disease, shoulder surgery, and shoulder injection in the last 3 months
Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PNU-100480 (PF-02341272) after a single dose in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
* Women of non-childbearing potential only.

Exclusion Criteria:

* History of hypersensitivity to, or intolerance of, linezolid.
* Antibiotic treatment within 14 days prior to dosing.
The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia

Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent epidural injections appear to reduce the incidence of maternal intra-partum fever compared to continuous epidural infusion during labor analgesia. However, the optimal combination of bolus volume and administrating interval has not yet been compared. The purpose of this prospective, randomized, double-blind trial was to determine how intermittent epidural bolus reduced the incidence of maternal intra-partum fever compared with continuous epidural infusion during labor.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* Required labor analgesia
* Chinese
* Spontaneous labor

Exclusion Criteria:

* Contraindications for epidural analgesia
* Allergic to opioids and/or local anesthetics
* Failed to performing epidural catheterization
* Organic dysfunction
* Those who were not willing to or could not finish the whole study at any time
* Using or used in the past 14 days of the monoamine oxidase inhibitors
* Alcohol addictive or narcotic dependent patients
* Subjects with a nonvertex presentation or scheduled induction of labor
* Twin gestation and breech presentation
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation

The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Metastatic breast Cancer
* Treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012

Exclusion Criteria:

* Lack of follow-up data
Comparison of Trifecta Analysis of Standard Versus Mini Percutaneous Nephrolithotomy in the Management of Urolithiasis

Introduction: Urolithiasis is a common urological condition, and percutaneous nephrolithotomy (PCNL) is a widely used treatment option. Trifecta analysis, which includes stone-free rate, reduced complications (Clavien- Dindo classification), and minimal need for auxiliary procedures, provides a standardized way to compare outcomes. This study evaluates the trifecta outcomes of standard PCNL and mini PCNL.

Methodology: This prospective cohort study was conducted at the department of urology, Institute of Kidney Diseases, Peshawar from Jan 2022 to March 2024. 180 consecutive individuals who were subjected to percutaneous nephrolithotomy (PCNL) were registered for the study. Patients were randomly assigned into two equal groups using a lottery method. Both the standard PCNL group and mini PCNL group consisted of 90 patients each. Patients who required a change in the planned surgical procedure were replaced with new participants from the sample frame. A structured proforma was filled out for all preoperative, perioperative, and postoperative variables in administration of trifecta, and the data was analyzed using SPSS. An assessment was done for predictive factors for the trifecta using logistic regression to calculate the odds ratio, confidence interval (CI), and p value.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 16 and 65 years having renal stones exceeding 20 mm in diameter or having a density more than 1000 Hounsfield Units (HU) were included.

Exclusion Criteria:

* Patients with residual stones following prior PCNL or other endourological procedures or active, untreated urinary tract infections or sepsis or patients with deranged coagulation profiles, were excluded
Validity and Reliability of Rebee Sensor to Measure Knee ROM

This study was conducted to investigate:

The criterion related validity of Rebee wearable sensor in measuring active flexion and extension of knee joint ROM compared with digital goniometer measurement.

The intra-rater reliability of Rebee wearable sensor in measuring active flexion and extension of knee joint ROM compared with digital goniometer measurement.

Range of Motion (ROM) of the joint is one of the factors that determine function of the musculoskeletal system. This parameter should be measured and recorded by a valid and reliable method . It is considered to be an essential component of lower limb physical examination, which can be applied using various instruments such as goniometers and inclinometers .

Range of motion of the knee joint is one of the major factors determining the outcome after knee injuries. It is also an important measurement required by many knee scoring systems to determine the preoperative status and postoperative outcome .

Measurements are used by physical therapists to quantify limitations of motion, it used to decide an appropriate therapeutic interventions and document the effectiveness of these interventions. The ideal measuring device should give reproducible valid and reliable data .It is required an essential skill in the musculoskeletal assessments commonly performed by physiotherapists.

Two-arm digital goniometer is still widely used in measuring uniaxial ROM of the joint of extremity, there is high validity, intra- rater and inter-rater reliability of the digital goniometer. It is considered valid and reliable tool that simplify physical therapists' work .The digital goniometer is the most commonly utilized clinical tool for measuring joint range of motion, the evolution of sensors technology and applications are easy to use, relatively inexpensive, and highly accessible .

Rebee is a wearable motion sensor package of sensor with its own mobile application, which measures range of joint movement in different planes easily which the patient able to wear the sensor and move easily to measure ROM and record the measurement at the application software, that is facilitate the tele-measurement which the patients are supposed to put on the sensors and perform the actions themselves, or with assistance from physical therapist.

There is lack in the literature about using Rebee wearable sensor in measuring the range of knee joint so this study was conducted to test the criterion related validity and intrarater reliability of the rebee wearable sensor in measuring active knee joint ROM compared with digital goniometer measurement.

Eligibility Criteria:
Inclusion Criteria:

* Forty normal participant's age ranged from 30 to 45.
* The participant from both sex.
* Participant Body mass index (BMI) from (19 to 25) normal weight (BMI= weight (kg) / \[height (m)\] 2)
RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).


Eligibility Criteria:
Inclusion Criteria:

* Complex regional pain syndrome (IASP, 1994) involving an upper limb;
* Pain scores in excess of five visual analog scale (VAS);
* Poor outcome to treatment (less than 50% reduction in VAS scores) -

Exclusion Criteria:

* History of severe brain injury, epilepsy and stroke
* Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
* Severe systemic disease
* Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
* Refusal to participate or not initial adherence to orientations
* Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.
Nutritional Supplementation in Children at Risk of Undernutrition

This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.


Eligibility Criteria:
Inclusion Criteria:

Child is between 1 year 0 days to 5 years 364 days old at enrolment

Undernourished or at risk of undernutrition, defined as:

* WHZ \<- 1 and HAZ \<-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
* BMIAZ \<-1 and HAZ \<-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards

Child is not currently breastfed

Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period

Child is a singleton

Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study

Child's parent(s)/LG is not planning to relocate during the study period

Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study

Exclusion Criteria:

Child participates in another study that has not been approved as a concomitant study

Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product

Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG

Child had birth weight \< 2500 g or \> 4000 g

Child whose either parent has BMI ≥ 27.5 kg/m2

Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis

Child has been diagnosed with the following:

* Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
* Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia
* Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
* Disorders of hemoglobin structure, function or synthesis

Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product)

Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study
Isokinetic Exercises in Patients With Multiple Sclerosis

The investigators evaluated the effects of isokinetic muscle strengthening exercises of the quadriceps and hamstring on muscle strength, joint position sense, pain, kinesiophobia and quality of life in patients with multiple sclerosis.

Objective: To evaluate the effects of isokinetic exercises on muscle strength, knee joint position sense, pain, kinesiophobia, and quality of life in patients with multiple sclerosis.

Design: Randomized controlled trial. Setting: Outpatient clinic. Participants: Fifty patients with multiple sclerosis. Interventions: Fifty patients who met the inclusion criteria were randomized to an isokinetic exercise (n:25) or home exercise programme (n:25). Sequentially numbered opaque envelopes were used for randomization.

Outcome measures: The outcome measures were the peak torque/body mass index of quadriceps and hamstring muscles at 60°/s and 180°/s velocities, the hamstring/quadriceps ratios at the same velocities, absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of joint position sense of the less and more affected knees, and the scores of Multiple Sclerosis Quality of Life-54, Visual Analogue Scale, and Tampa Scale of Kinesiophobia.

Eligibility Criteria:
Inclusion Criteria:

* definite relapsing remitting MS and secondary progressive MS diagnosis
* mild and moderate MS determined by Kurtzke Expanded Disability Status Scale (EDSS) scores below 6.5
* a disease duration of more than one year.

Exclusion Criteria:

* having an acute exacerbation within the last three months
* intravenous pulse steroid therapy in the last four weeks
* grade 3-4 spasticity according to the Modified Ashworth Scale
* severe vision impairment
* severe fatigue and depression
* past knee surgery
* other neurologic diseases
* systemic diseases
* pregnancy
* having received an exercise program within the last four weeks.
Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 to 80 years at informed consent
* Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, \< 1000 mg/g/Cr)
* Subjects with hypertension (Sitting SBP ≥ 140 mmHg, \<180 mmHg and Sitting DBP ≥ 80 mmHg, \<110 mmHg
* Treatment with an ARB or ACE inhibitor
* eGFR ≥ 30 mL/min/1.73m\^2

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Type 1 diabetes
* Secondary glucose intolerance
* Diagnosed with non-diabetic nephropathy
* Serum potassium level \< 3.5 or ≥ 4.8 mEq/L
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.


Eligibility Criteria:
Key Inclusion Criteria:

1. Aged ≥12 years and older inclusive of either sex.
2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) during the study season for the mountain cedar pollen
3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

Key Exclusion Criteria:

1. Pregnant or lactating women.
2. Plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period.
3. History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
7. Subjects with an active pulmonary disorder or infection.
8. Subjects with posterior subcapsular cataracts or glaucoma.
Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC)

Chronic pain (CP) is disabling for people triggering important costs for society. A deficit of diffuse noxious inhibitory controls (DNIC) is one of the CP mechanisms. DNICs are evaluated in research setting using a CPM protocol (conditioned pain modulation). There is a lack of reference values on the effectiveness of DNICs. Wider research on DNIC will help to understand CP and to develop a clinical screening test evaluating DNICs.

This study aims:

1. To establish baseline values of DNICs using CPM protocol
2. To identify the variables that will be integrated in the algorithm of the clinical screening test (clinical decision rule).

First the target population will be healthy volunteers, male and female, stratified by age. The reference values will be established via a non-parametric method for a standard CPM protocol in which two different pain stimuli are applied. Two "stimuli tests" of the same intensity and nature (heat) will be applied before and after the application of another "conditioning stimulus" (cold water bath). The perceived pain difference between the 1st and 2nd stimuli tests will reflect the intensity of the DNICs.

Secondly, these results will be compared to those from volunteers suffering of chronic pain. The clinical decision rule will result from clinical and paraclinical elements correlating with the amplitude of the efficacy of CPM (serum noradrenaline, intensity of pain, heart rate and blood pressure measurements, psychometric questionnaires assessing anxiety, depressive feelings and pain catastrophizing). Logistic regression analysis will determine the best predictors of a CPM deficit.

Eligibility Criteria:
Inclusion Criteria:

* 18-79 years old
* Able to provide consent

Exclusion Criteria:

* cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)
* Raynaud syndrome
* severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)
* injuries or loss sensitivity to their forearms or hands
* pregnant women or in post-partum period (\<1 year)
Clinical Application of Near-infrared Fluorescence Guided Localization on Breast Surgery in Breast Cancer

Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Indocyanine green, ICG (ICG-fluorescence)

* ICG is the most commonly used fluorophore which approve by FDA.
* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

* New method for the localization and resection of non-palpable breast lesions.
* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Eligibility Criteria:
Inclusion Criteria:

* nonpalpable breast tumor ≤ 2cm in patients with breast cancer.
* patients who need breast biopsy as treatment for breast cancer.
* Eastern Cooperative Oncology Group Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years

Exclusion Criteria:

* nonpalpable breast tumor ≥ 2cm in patients with breast cancer.
* pregnancy
* history of severe allergy to ICG(Indocyanine Green)
* iode hypersensitiveness