cyrilzakka/clinical-trials huggingface dataset:
Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic Hepatectomy

Compared the effects of Sodium bicarbonate Ringer's solution and lactate Ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate Ringer's solution in Laparoscopic hepatectomy.

The study was a single-center prospective randomized controlled study. A total of 100 patients undergoing laparoscopic hepatectomy under general anesthesia were randomly divided into 2 groups: Group A, sodium bicarbonate Ringer's solution group(n=50); Group B, Lactate Ringer's solution group (intraoperative crystal fluid dilatation was lactate ringer's injection, n=50); Collect patients' arterial blood gas, blood pressure, heart rate, peripheral vascular resistance, heart rate, blood vessels, the active drug usage, 5% sodium bicarbonate injection usage, inflammation factors, transaminase, creatinine, etc. with the point of preoperative (T0), during liver specimens resected(T1), after liver specimens resected(T2), and the end of surgery (T3). Then statistical analysis and observe the application prospect of sodium bicarbonate Ringer's injection in Laparoscopic hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old,
2. patients who plan to undergoing laparoscopic hepatectomy ;
3. Willing to sign informed consent.

Exclusion Criteria:

1. age \<18 years
2. pregnancy
3. active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
4. history of significant cerebrovascular disease
5. restrictive or obstructive pulmonary disease
6. uncontrolled hypertension
7. renal dysfunction (glomerular filtration rate \<60 mL/min),
8. evidence of hepatic metabolic disorder (bilirubin \>35 mmol/L)
9. presence of active infection
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
* Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
* Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

Exclusion Criteria:

* Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug
* Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug
* Subjected to any of the following within 4 weeks before administration of the study drug:

  1. Surgical treatment (operations,etc.).
  2. Plasma exchange method
Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.

* The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depressive or irritable symptoms.
* To assess the back ground and baseline features associated with response/non-response to risperidone plus mood stabilizer in patients with mania with depressive or irritable features.
* To assess the symptomatic dimensions of response of risperidone added to mood stabilizers in patients with mania with depressive or irritable features.

Eligibility Criteria:
Inclusion Criteria:

* DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
* YMRS score\>/= 16
* One or more of following:

  1. 3 MADRS depression items scoring \>/=3
  2. 3 BISS depression items scoring \>/=3
  3. YMRS irritability and aggressive items sum score\>/=4
* Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level
* age 18 and over
* Male or female
* Inpatient or outpatient

Exclusion Criteria:

-
Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method

This study plans to assess eyelid topology (such as margin reflex distance, eyelid contour, and corneal exposure area) and blinking (such as frequency, velocity, and duration), using deep learning method to automatically extract eyelid topological features, and to predict subtypes of levator function, using deep learning method to extract blinking features, in order to provide new ideas and means to assess eyelid topology and kinetics.


Eligibility Criteria:
Inclusion Criteria:

1. normal volunteers without eyelid diseases
2. patients with blepharoptosis
3. patients with blepharospasm
4. patients with dry eye disease
5. patients with Graves' disease

Exclusion Criteria:

variable ptosis (e.g., myasthenia gravis), entropion, ectropion, enophthalmos, exophthalmos, strabismus, and abnormalities of pupil
Comparison of Corticotomy and Micro-Osteoperforation During Canine Retraction

Corticotomy and micro-osteoperforation (MOP) have been proven to accelerate tooth movement and shorten orthodontic treatment time, compared to conventional treatment. MOP is less invasive; however, it is unclear whether it is as effective as a corticotomy. The purpose of this study was to compare the maxillary canine retraction achieved by these techniques.

Thirteen patients (5 females, 8 males; mean age, 18.07±6.74 years) with healthy permanent dentition requiring the extraction of maxillary first premolars were included in a split-mouth randomized clinical trial. Subjects with previous orthodontic or endodontic treatment of canines were excluded. At least 3 months post-extraction, MOPs, and corticotomies were performed distal to the canines. Mini-screws with closed-coil springs (150g) were used for canine retraction. Dental casts were attained at baseline (T0) and 3 months post-intervention (T1). Calibrated examiners measured the distances from the canine to the second premolar on both sides. A Signed-rank sum test was used to compare canine retraction achieved in 3 months (T0-T1) in two sides

Eligibility Criteria:
Inclusion Criteria:

* Healthy permanent dentition requiring the extraction of maxillary first premolars with less than 8mm of maxillary anterior crowding

Exclusion Criteria:

* Previous orthodontic or endodontic treatment of the canines
Study Comparing Two Different Methods of Treating Periodontal Disease

The purposes of this study are to:

1. compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
2. determine the value of the two approaches to periodontal therapy.

This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis.

There are two significant reasons for testing a medical model of care. If the hypothesis is correct:

1. this would increase access to periodontal care; and
2. it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems.

These points argue for a direct comparison of the medical and traditional models of care.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 4 or more periodontally involved teeth as defined by pocket depth of \>/= 6mm.
* \>/= 14 teeth.
* \> 18 years of age.
* Reside in the greater Boston area.

Exclusion Criteria:

* Those patients requiring prophylactic antibiotic for dental treatment.
An Investigation of the Effects of a Skin Serum Containing Propolis on Skin Health and Appearance

This is a virtual, single-group clinical trial that will last 8 weeks. Participants will use the Manuka Health Pro Vitality Daily Restorative Face Serum with Propolis \& Vitamin C twice daily and complete questionnaires at Baseline, Week 2, Week 4, and Week 8. Participants will also undergo skin analysis via the Optic Elite facial skin analysis system at Baseline and Week 8.


Eligibility Criteria:
Inclusion Criteria:

* Female between 30-42 years of age.
* Must be in good general health.
* Must have concerns with overall skin health and appearance, including:

Spots or blemishes Uneven skin tone Dull-looking skin

* Must be using the same cleanser, toner, and moisturizer for at least one month prior to starting the study.
* Must be willing to keep using the same cleanser, toner, and moisturizer for the duration of the study.
* Must not be using oral or topical retinoids.
* In the last three months, has not introduced any new medications or supplements that target skin health.
* Must be willing to comply with the protocol.

Exclusion Criteria:

* Anyone with an allergy to bees or bee products.
* Females who are pregnant or breastfeeding.
* Unwilling to follow the protocol.
* Unwilling to maintain use of the same cleaner, toner, and moisturizer for the duration of the study.
* Currently participating in another study.
* Use of oral or topical retinoids.
* Individuals with cystic acne or otherwise self-reported very acne-prone skin.
* Use of a prescription medication relevant to the skin.
* Anyone undergoing cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
* Anyone sensitive or allergic to any ingredients found in the products.
* Anyone with severe chronic conditions, including oncological conditions, psychiatric disorders or diabetes.
Metabolic Syndrome and Leptin Level Associated With Fructose Consumption in Spain

A Food Frequency Questionnaire (FFQ), will be provided to 800 adults to assess overall fructose intake and this will be related to a number of features related to the metabolic syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass index, waist circumference, plasma lipids, blood pressure, HOMA index,fasting glucose and fasting insulin levels) and other as: CRP, fibrinogen, homocysteine and uric acid.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 18-70 years of age

Exclusion Criteria:

* Diabetes
* Kidney Failure
* Heart Failure
* Cancer
Validation of BRACS to European Portuguese

The goal of this observational study is to translate and validate the fiberoptic endoscopic evaluation of swallowing scale "The Boston Residue and Clearance Scale - BRACS" to European Portuguese

The Boston Residue and Clearance Scale (BRACS) is a multidimensional scale developed and validated to assess the severity of residues observed during fiberoptic endoscopic evaluation of swallowing (FEES).

It differs from other FEES residue scales, since it considers all aspects related to pharyngolaryngeal residues, specifically, the location, amount and the patient's clearance ability.

The purpose of this study was to translate and cross-culturally adapt the English version of the BRACS into European Portuguese and to investigate the reliability and validity of the translated version of the scale.

Eligibility Criteria:
Inclusion Criteria:

* FEES recording that allowed good visualisation of the pharynx and larynx.
* FEES recording of patients after head and neck surgery who had anatomical alterations of the structures, but which did not interfere with good visualisation of the residues.
* FEES recording of patients with a tracheostomy or under tube feeding.

Exclusion Criteria:

* FEES recording of patients under 18 years of age.
Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars

This randomized controlled trial (RCT) will evaluate the cost-effectiveness of combining extracorporeal shock wave therapy (ESWT) with standard rehabilitation versus standard rehabilitation alone for the management of hypertrophic post-burn scars in adults. The study will assess clinical outcomes-such as pain intensity, pruritus, and scar quality-alongside economic outcomes including cost per quality-adjusted life year (QALY) gained, direct medical costs, and indirect costs (e.g., absenteeism and reduced productivity). Results will inform health policy and resource allocation decisions for advanced burn rehabilitation interventions.

Post-burn hypertrophic scars can cause significant pain and pruritus, substantially affecting quality of life and functionality. Although ESWT has been recently associated with enhanced scar maturation and symptom reduction (Yang et al., 2022), its implementation into standard care is limited by a lack of economic evaluation. This trial is a prospective, randomized controlled study with an integrated cost-effectiveness analysis. Adult patients (aged 18-65) with hypertrophic scars at least 6 months post-burn injury will be recruited and stratified by scar severity. Participants will be randomized into one of two arms:

Arm 1 (Experimental): ESWT combined with standardized rehabilitation therapy. Arm 2 (Active Comparator): Standard rehabilitation therapy alone.

Primary clinical outcomes will include changes in pain intensity (measured on a Visual Analog Scale \[VAS\]), pruritus intensity (using the Itch Man Scale), and scar quality (assessed through the Vancouver Scar Scale \[VSS\]).

Economic outcomes will be determined by calculating the cost per QALY gained along with an assessment of both direct (therapy sessions, equipment use, hospital visits) and indirect costs (absenteeism, lost productivity).

Data will be collected at baseline and at follow-up visits at 1, 3, and 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

Adults aged 18-65 years. Documented hypertrophic scars following a burn injury, with scars present and stable for at least 6 months.

Moderate to severe scar severity as measured by a standardized clinical assessment.

Experiencing significant pain and/or pruritus related to the scar, with a baseline VAS score of ≥4.

Able to provide informed consent and comply with study procedures. Employed or engaged in daily activities such that indirect costs (absenteeism/reduced productivity) can be recorded.

Exclusion Criteria:

Pregnant or lactating women. Individuals with previous surgical scar revision or other invasive scar treatments within the last 6 months.

Patients with comorbid conditions (e.g., severe cardiovascular disease, uncontrolled diabetes) that could interfere with rehabilitation or ESWT.

Active skin infection in the area of the scar. Use of concurrent investigational therapies for scar management.
A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold

Healthy persons are invited to participate in the study and are given a home protocol (WURSS21), nasal spray and a sample pin. The included persons are told to make a nasopharyngeal sampling from the nose when they are sure that they have caught a common cold. After the sampling they start to spray and also fill in the records daily. The aim of the study is to investigate whether a nasal spray with glucose oxidase could shorten an episode of common cold.

Persons working in a military unit in Boden and persons connected to the Department of Sports Medicine in Umeå were invited to participate in this study. Only persons older than 18 years was included in the study. The persons included received one bottle of study medicine, a home protocol (WURSS 21) and a viral sampling kit. Whenever the included persons were sure that they had received an episode of common cold they were told to perform a viral sampling from the nose, fill in the protocol and start to use the nasal spray several times daily for one week. The treatment was either a) a saline solution with 5% glucose or b) a saline solution with 200U/ml of glucose oxidase and 5%glucose (active treatment group). The combination of glucose oxidase and glucose produces an acid environment, imitating the effect of the normal nasal flora and Human Rhinoviruses are sensitive to an acid environment. After one week of treatment and daily records of the WURSS 21 protocol the persons returned the spray bottles (Bag-on-Valve), the virus vials and the protocols.

A total of 146 persons were included in the study and 98 persons returned protocols.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Ongoing allergy
ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation

The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician requests.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with confirmed diagnosis of CF who have an F/any genotype
* Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment)
* Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) \<40 for a minimum of 60 consecutive days before the date of completion of the request form

Key Exclusion Criteria:

* Patients with severe hepatic impairment

Other protocol-defined inclusion/exclusion criteria may apply
Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety

Proof of effectiveness of Pascoflair using qantitative measurement of electric brain activity during examination stress in 40 subjects suffering from test anxiety. A double-blind, randomized, placebo-controlled, 2-armed, Phase IV study in parallel design.

Anxiolytic effects of PASCOFLAIR® shall be tested in subjects suffering from test anxiety after single intake by aid of a newly developed, validated method consisting of a combination of eye tracking (following glances) with neurocode tracking (quantitative EEG with a time resolution of 364 ms).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects.
* Age between 18 and 40 years (both included).
* Anxiety questionnaire PAF (pre-selection of subjects) - values above T\> 60 are regarded as conclusive.
* Inconclusive case history and diagnosis.
* Subject must be capable of giving informed consent.
* Acceptance of written consent to participate in the study after education in written and oral form (informed consent).

Exclusion Criteria:

* Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
* Clinically relevant pathological findings from clinical and laboratory findings.
* Presence of clinically relevant pathological EEG features or artifact-free portion of the screening EEG \<30%.
* Clinically relevant allergic symptoms.
* Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history.
* Detection of drugs (positive drug test) at the time of initial examination (day SC).
* Consumption of clinically relevant medication during last fourteen days before and during the active study period based on the notification of the subject or his case history.
* Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensives).
* Known intolerance / hypersensitivity (allergy) to plant derived extracts (Passion flower dry extract) or any of the ingredients of the investigational product (anamnestic).
* Presence of a rare, genetic disease such as fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency (anamnestic).
* BMI (Body Mass Index) \<18 or\> 32.
* Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day) or tobacco (more than 20 cigarettes per day).
* Smoking on day of A.
A Prospective Multicenter Clinical Study： IntracOnary NeaR-Infrared Spectroscopy and OptIcal Coherence Tomography for Evaluating Coronary VulNerable Plaque in Patients with DiabeTes

To evaluate the correlation between maxLCBI4mm/FCTmin(a new index of lipid plaque based on NIRS-OCT technology) and fiber cap thickness , and the prognosis of patients, providing a new quantitative index for early, accurate and comprehensive identification of vulnerable plaques, and exploring preventive measures for adverse events such as cardiac death and recurrent myocardial infarction caused by vulnerable plaques, so as to improve the long-term prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* 1: Aged 18-80 years, gender is not limited

  2: Patients with diabetes who require interventional therapy (diabetes definition: active treatment with insulin or oral hypoglycemic agents at admission). For patients with diabetes who are treated with diet only, abnormal fasting blood sugar (\>7 mmol/l), blood sugar \>11.1 mmol/l at any time, or abnormal glucose tolerance tests based on World Health Organization standards need to be recorded.

  3: Endoscopic imaging examination or interventional therapy under the guidance of endoscopic imaging is required

  4: Be able to understand the purpose of clinical research, voluntarily participate can complete the observation as required and sign the informed consent form

  5: At least 2 coronary arteries (including suspected criminal coronary arteries) are suitable for NIRS-OCT imaging

  6: Stenosis with non-target lesions \> 50%

Exclusion Criteria:

* 1: Severe coagulation dysfunction (APTT greater than 3 times the upper limit of the normal range)

  2: Severe hemodynamic disorder or shock that cannot be corrected

  3: Patients with renal impairment（eGFR\<30 mL/min/1.73m2）

  4: Severe symptoms of heart failure (NYHA III and above) or left ventricular ejection fraction \<30%

  5: The presence or suspected presence of infective endocarditis or systemic active infection

  6: Patients with refractory ventricular arrhythmias who have previously undergone coronary bypass transplantation (CABG) or plan to undergo CABG during the study

  7: Patients with serious concurrent diseases such as advanced cancer have a life expectancy of less than 24 months

  8: Pregnant or lactating women, have a family plan within 24 months or are unwilling to take effective contraceptive measures

  9: The target vessel has severe calcification or severe tortuosity, which cannot be examined by OCT

  10: Have participated in other clinical trials or are participating in other drug/device clinical trials within 3 months prior to enrollment and have not met the primary endpoint

  11: Investigators believe that those who are unnecessary for OCT or not suitable for inclusion in this trial.

  12: There are multiple lesions in the same blood vessel, and the non-target lesion distance requiring treatment vascular segment is less than 5mm