cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants

A study to assess and compare the effectiveness of Distraction techniques on Pain intensity during Immunization among Infants in selected hospital of Ambala, Haryana.

Immunization is an important part of public health intervention and cost effective strategy to control the infectious diseases especially in children and it is one of the most common painful procedure in infants. Pain during immunization leads to distressing experience for the infant, parents and health care worker. Distraction is non pharmacological method which is used for diverting attention from noxious stimulus by passively redirecting the attention or by actively performed by the subject in the performance of diversion technique. Aim and objectives:The aim of present study was to compare the effectiveness of distraction techniques on pain intensity during immunization among infants. The objectives of the study were to assess and compare the mean pain scores among infants receiving immunization in electronic toy group, key toy group, simple toy group and control group and to find out the association of pain scores among infants receiving immunization with their selected variables. Material and methods: A true experimental multiple intervention post test control design was used. There were 100 infants selected using simple random sampling technique and were randomly allocated in various groups such as electronic toy group, key toy group, simple toy group and control group using lottery method. During immunization, distraction techniques were shown to experimental groups and routine care was given to control group. Research tool was submitted to 7 experts from various specialists for validity. Reliability was calculated by Kappa method and it was 0.83 of FLACC pain scale to assess pain intensity during immunization among infants. Data collection was done in January 2017. The obtained data was analyzed and interpreted in terms of objectives and research hypotheses. Analysis was done by using descriptive and inferential statistics.

Eligibility Criteria:
Inclusion Criteria:

* • Infants who were-visiting immunization clinics of Civil Hospital for immunization.

having 10 and 14 weeks of age. receiving pentavalent vaccine. Parents and caregivers who were willing to give consent

Exclusion Criteria:

The study excluded infants who: had undergone any painful procedure 2 hour prior to immunization, were visually or hearing disabled.

had history of seizures, use of topical anesthetics at immunization site, use of sedatives, analgesics or opioids in the preceding 24 hours.
In-market Utilisation of Liraglutide Used for Weight Management in Europe

This study is conducted in Europe. The aim of this study is to investigate usage of liraglutide for weight management in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Initiation of liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg (initiation is defined as no prescription of the same brand within the previous 12 months)
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability of the study

Exclusion Criteria:

-Patients or physicians who previously participated in interventional studies for liraglutide 3.0 mg / liraglutide 1.2 mg/1.8 mg will not be eligible to participate in the study -For the full study, sites and patients included in the pilot will be excluded
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy

The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months)
* Treatment experienced with a direct acting antiviral medication for HCV
* Use of protocol specified methods of contraception

Key Exclusion Criteria:

* Current or prior history of clinically significant illness that may interfere with participation in the study
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Pregnant or nursing female
* Chronic liver disease not caused by HCV
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Patient Centered Quality Reporting

The purpose of this study is to develop a consumer friendly web-based interface between Nursing Home Compare (NHC) and an e-coaching/decision-aid tool (NHCPlus) and determine if use of NHCPlus facilitates and enhances access to and use of NHC.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been admitted as an inpatient into the departments of Medicine or Surgery at the UC Irvine Medical Center, and whose discharge plan is to a nursing home.
* Family members of these patients, if they are involved in the choice of nursing home, were also recruited to the study, either as joint decision makers with the patients or as proxy decision makers for the patient.

Exclusion Criteria:

* Patients less than 50 years of age.
* Patients unable to use NHCPlus technology or participate in the nursing home choice decision (i.e. non-English speaking, severely visual or hearing impaired, dementia, or other debilitating illnesses) will be excluded unless they have a representative/proxy who will be involved in the decision to select the nursing home.
Prospective Study and Analysis of Biomechanical Parameters of Human Movement Based on Disability Indicators in Older Adults

Mobility loss in older people is caused by a variety of aging impairments in various body systems.The disability, which includes physical impairments and resulting activity limitations or participation restrictions, can arise acutely from a catastrophic illness or, more commonly, from subacute functional decline without a clear triggering event. Lower physical functioning was associated with higher healthcare utilization and expenditures, leading to a large burden on government-funded healthcare services. Early identification of mobility changes and intervening in them would likely be the most effective strategy to reduce the burden of disability in the population. Overall, there is a need to develop strategies to reduce disability among older adults in which kinetic and kinematic characteristics are used to predict disability status.

Accordingly, the purpose of this prospective cohort is to identify biomechanical parameters, from the gait, sit-to-stand, timed up and go, stair ascend and descend, and quiet standing functional tasks, as predictors of changes in health and disability status in older adults.

This research was funded by Fundação para a Ciência e Tecnologia (FCT), NORTE 2020, and European Social Fund of European Union, grant number 2020.05356.BD and through R\&D Units funding (UIDB/05210/2020), Fundação para a Ciência e Tecnologia (FCT), Portugal and the European Union.


Eligibility Criteria:
Inclusion Criteria:

* older adults, 60 years or over;
* community-dwelling;
* able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently;

Exclusion Criteria:

* older adults who are institutionalized;
* older adults who have established diagnosis of malignancy or terminal diseases with an anticipated survival of less than 1 year;
* older adults who have stroke history, cerebral hemorrhage, head trauma, or Parkinson's disease;
* older adults who have cognitive impairment, specifically Mini Mental StateExamination (Portuguese version) score of 22 for 0 to 2 years of literacy, 24 for 3 to6 years of literacy and 27 for more than 6 years of literacy (Morgado et al., 2009);
* older adults who have rheumatic pathologies that interfere with the tasks performance;
* older adults who have diabetic foot, lower limb fracture less than 6 weeks, or other related conditions;
* older adults who have unstable cardiovascular disease, liver or renal function failure;
* older adults who have a body mass index greater than or equal to 30 kg/m2;
* older adults who vestibular and/or audition or vision impairments non corrected that influence the performance of tasks;
* older adults who presence of symptoms at the time of evaluation that influences the participant performance of tasks.
Acute Exposure to High Altitude on Blood and Tissue Oxygenation (ABGA, NIRS)

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on blood and tissue oxygenation (ABGA, NIRS).

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

At rest and under exercise data from ABGA and NIRS will be compared at low altitude and High Altitude.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Comparison of Picosecond Pulsed Nd:YAG Laser and Fractional Laser for the Treatment of Acne Scars

This study compares the application of a picosecond 1064-nm laser with a diffractive lens array with nonablative fractional laser for the treatment of acne scarring.

This trial is a 17-week, prospective, randomized split-face study that compares the results between two facial sides either receiving the picosecond 1064-nm laser or nonablative fractional laser treatment for atrophic acne scar.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with facial atrophic acne scars
* Subjects who observe the schedules and protocols of the clinical trial
* Subjects who give informed consent to participate in the clinical trial

Exclusion Criteria:

* Subjects who have active acne under treatment
* Subjects who had received any other treatments for acne scarring for 6 months prior to the first treatment
* Subjects who underwent other treatments including chemical, mechanical or laser resurfacing during the study period
* Subjects who have current acute illness
* Subjects who are considered inappropriate for the clinical trial under the judgement of investigators
The Feasibility Study of Dual-Section Nasogastric Tube

The purpose of this studyis to assess the feasibility and safety of novel designed two-piece nasogastric tube.


Eligibility Criteria:
Inclusion Criteria:

* dysphagia
* mouth neoplasms
* stroke
* already use conventional nasogastric tube for at least 2 weeks

Exclusion Criteria:

* unconsciousness patient
* unstable medical condition with needs of closely medical care
* unable to fill in inform consent
* the fixed length was less than 50 or more than 60 centimeter when using conventional nasogastric tube
Safety and Efficacy of Allogeneic NK Cells Therapy in Patients With Advanced Hepatocellular Carcinoma

This is a multicenter, open-label, paired control study to evaluate the safety and clinical efficacy of allogeneic NK cells combined with targeted drug in the treatment for advanced HCC.

Since killer cell immunoglobulin-like receptor (KIR) mismatch can inhibit the negative regulatory signal of autologous major histocompatibility complex (MHC) molecules and ensure sufficient NK cell activation, allogeneic NK cells therapy, as a potential therapeutic option for tumor, has achieved good results in patients with acute myeloid leukemia. In this study, investigators evaluate the safety and efficacy of allogeneic NK cells in the treatment of advanced HCC. 200 patients from three hospitals will be enrolled in this study and followed up for 1 year. Peripheral blood mononuclear cells (PBMCs) were isolated from patient-related donor and cultured in vitro for 15 days and infused to the patient in two consecutive days. Clinical data and laboratory data were collected and analyzed, including survival, impact indicators, hematology, biochemical indicators, and immunological indicators to evaluate the safety and efficacy of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* According to the 2010 edition of the diagnostic criteria for primary liver cancer BCLC, the patient was diagnosed as advanced hepatocellular carcinoma by pathology and imaging (BCLC C phase);
* Child-Pugh A/B (5-9), Eastern Cooperative Oncology Group (ECOG) PS score less than 2 points;
* Laboratory criteria:

  1. Liver function: Child A/B, ALT \< 200 U/L, AST \< 200 U/L, Tbil \<51μmol/L
  2. Renal function: Creatinine clearance ≥ 60ml/minute
  3. Hematologic function: PLT ≥40×10'9/L, WBC ≥2×10'9/L, HGB\>80 g/L
  4. Cardiac function: No abnormality in cardiac enzyme and ECG
* Survival expectation is greater than 6 months;
* Patients with active hepatitis B or C were treated with the appropriate NA or DAA medication, and all patients enrolled in the group were treated with targeted drugs.
* The patient has a donor who meets the donor enrollment criteria and all patients and donors sign the Informed Consent Form;

Exclusion Criteria:

* Women who are pregnant or breast-feeding.
* Co-infected with hepatitis A, hepatitis E, AIDS or other infectious diseases.
* Patients with serious complications such as acute infection and gastrointestinal bleeding within 30 days.
* Patients with other serious systemic and psychiatric diseases.
* Exposure to any cell therapy such as, but not limited to CIK, DC, CTL , PD-1 and stem cells therapy 6 months prior to study drug administration.
* Other conditions that researchers believe may increase the risk of subjects or lead to affected study results, such as the presence of mental illness in subjects.
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle

A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years old
* have a positive history of allergic conjunctivitis and positive skin test reaction to allergens
* be willing to avoid disallowed medications for the appropriate washout period and throughout the trial
* be willing to avoid contact lens use
* be willing to have a pregnancy test
* must be able to read an eye chart from 10 feet away

Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial
Study of Methotrexate Efficacy Versus Cyclosporine in Moderate to Severe Atopic Dermatitis Patients

The systemic treatments for moderate to severe atopic dermatitis (AD) are limited to phototherapy and cyclosporine with the risks respectively of either carcinoma, or hypertension or nephropathy.

Methotrexate was effective in 75% of moderate to severe AD patients with good tolerance in an open retrospective study.

We want to confirm our observations: a non inferiority multicenter clinical trial, methotrexate versus cyclosporine, will be conducted in 100 patients for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18 years old.
* Both genders eligible for study.
* Moderate to severe AD.
* Scorad \> 15.
* Participants must use a contraceptive method during the trial and for 3 months after the end of the trial for female and 5 months for male participants.
* Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
* Patients must be registered in a social security system or with a health insurance coverage.

Exclusion Criteria:

* Pregnant or lactating women.
* Evolutive skin disease.
* Patients with a clinically significant disease (chronic, recurrent or active).
* Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid the week before the inclusion.
* Contra-indication to methotrexate and cyclosporine.
* Exposure to phototherapy: cumulative dose \> 2000 J/cm2.
* Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
* Patients under a protection measure.
* Patients in a critical medical situation.
* Patients with a personal situation evaluated by the investigator as unable to give optimal participation to the study, or where the study could constitute a risk for the patient.
Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology

The goal of this clinical trial is to compare in describeparticipant population. The main question it aims to answer is:By using intelligent portable isokinetic tester and traditional isokinetic tester, isokinetic knee flexor and extensor muscles of stroke patients with hemiplegia were trained respectively, so as to observe and compare the effects of the two treatment methods. In addition, the therapeutic effect of the above two treatments was compared with that of exercise therapy alone. Participants will be divided into three groups: control group, intelligent isokinetic treatment group, and traditional isokinetic treatment group. Participants of both the control group and the two treatment groups received exercise therapy. On the basis of exercise therapy, participants of the intelligent isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle, while the participants of traditional isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cerebral apoplexy's Disease
* Confirmed by CT or MR Examination of the head
* First onset, duration ≤1 month
* The lower extremity of the hemiplegic limb was above Brunnstrom stage III
* Must be able to sign the informed consent form

Exclusion Criteria:

* Vital signs are unstable
* Severe cognitive, visual and hearing impairment
* Orthopaedic disease
* Muscle pain lower extremity
* Congenital disease
* History of other encephalopathy
* History of mental illness
Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple

When dimples are detected in the sacral region, most practitioners consider it to be a sign of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical features for caudal block in normal children and in children with sacral dimple will be informative for practitioners.

A dimple over the sacrum may be an isolated finding or a sign of underlying spinal abnormality. Therefore, most practitioners are confused to perform a caudal block. Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound guided investigation of the anatomical features of sacral region may play a key role to eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural sac level, distance between dural sac and estimated needle insertion site or needle entry angle. In this study, we will examine whether there is a difference between normal children and children with dimple in the sacral region.

Eligibility Criteria:
Inclusion Criteria:

-Children aged 1-72 months who are taken to the operating room for any reason

Exclusion Criteria: Patients with

* spinal anomalies,
* history of prematurity,
* neurological disorder
* syndromic illness.
Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine

Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.

Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 10 to 25 years of age
* Diagnosis of idiopathic scoliosis is established
* Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate
* American society of Anesthesiology physical status one/two
* Patients scheduled for posterior spinal fusion only

Exclusion Criteria:

* • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities

  * Patients with allergy to, or contraindication for the drugs or techniques used in the study
  * Morbid obesity (Body mass index higher than 40)
  * History of malignant hyperthermia
  * Patient with severe cardiopulmonary disease (pulmonary hypertension, cardiomyopathy, mechanical ventilation)