cyrilzakka/clinical-trials huggingface dataset:
Evaluation on the Availability of Tongue Diagnosis System

The aim of the proposed study is to investigate the agreement between the measurement of the tongue diagnosis system (TDS) and the conventional way of tongue diagnosis about the tongue coating thickness (TCT) in the tongue diagnosis of the traditional Korean medicine (TKM).

Tongue diagnosis is one of the important diagnostic techniques to examine the physiologic functions and pathologic changes of the internal organs in TKM.

However, traditional tongue diagnosis has inevitable limitations because of the clinician's subjectivity and environmental factors influencing on the diagnostic results.

Therefore, it is necessary to investigate the availability of the tongue diagnosis system (TDS).

The aim of the this study is to investigate the agreement between the measurement of TDS and the conventional way of tongue diagnosis about TCT in the tongue diagnosis of TKM. So, we will assess the agreement between the measurement of TDS and the final diagnosis of 5 clinicians with five or more years of clinical experience about TCT.

Additionally, we will evaluate the reproducibility of TDS. In the 2nd visit, taking tongue images of each patient with TDS will be performed again at 30 minute-intervals in the same way. And then, we will compare the two TDS measurements of each patient about TCT.

After twice examination of TDS, the weight of tongue coating (mg) will be measured quantitatively by tongue scraping to analyze the correlation between the weight of tongue coating and the measurements of TDS.

In addition, after the collection of 60 patients' tongue images is completed, we will ascertain the validity of the five clinicians for diagnosing the TCT by assessing the inter-and intra-rater reliability of the five clinicians.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older
* One who meet the Rome III criteria for functional dyspepsia
* One who is able to read, write, hear, see something
* One who agree on consent form

Exclusion Criteria:

* Mental disorders
* Pregnancy
* Severe systemic organ diseases such as cancer
* Infectious or other serious consumptive diseases
* Geographic tongue
* One who cannot open his/her mouth or protrude his/her tongue
CSS-Assessing the Course of Degenerative Cervical Spinal Stenosis Using Functional Outcomes

The study will consist of two parts:

* In Study A, objectively assessed physical activity, gait, balance, range of movement of specific joints during walking and neurophysiological findings between patients with cervical spine stenosis (CSS) without myelopathy who will be treated conservatively and patients with stenosis and signs of myelopathy who are candidates for surgical Treatment will be compared.
* In Study B, the 6-month changes in the same outcomes in patients treated conservatively (from the first specialist consultation until 6 months later) and in patients treated surgically (preoperative day and 6-month post-operatively) will be quantified.

Study A is a single centre cross-sectional study with two study groups, one that will be treated conservatively (stenosis) and one that will be treated surgically (stenosis and myelopathy).

Study B is a single centre longitudinal study where the same patient groups will be followed up during the course of their treatment.

Clinical, radiological, biomechanical (kinematic and electromyographic), neurological and neurophysiological data will be collected. Differences in and the relationship between the clinical, radiological, biomechanical, neurological and neurophysiological data will be determined .

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of degenerative cervical spine stenosis defined by MRI (stenosis grade 2 or grade 3
* Local clinical symptoms due to degenerative changes of the cervical vertebral column with or without clinically defined myelopathy

Exclusion Criteria:

* Stenosis after trauma or neoplasm
* Prior decompressive surgery
* Previous spine or extremity surgery with a consequent sensorimotor impairment
* Other pathologies than cervical spine stenosis causing gait disturbance
* BMI \> 35 kg/m2
* Use of walking aids
* Inability to provide informed consent
* Contraindications for recording of Motor evoked potentials (MEP)
* Contraindications to safely undergo MRI
The Immunologic Reaction to Polypropylene Mesh in Inguinal Hernioplasty

The notable development and diffusion of prosthetic surgery of the abdominal wall over the last few years has led to the introduction of light weight meshes. The efficacy of inguinal hernia repair with light weight prosthesis, as well as the better or worse biotolerability with respect to those of light weight, remains questionable in literature, where a clear answer still remains to be given. If there exists a connection between the quantity of material implanted, the immunological reaction to the mesh, the induced oxidative stress and the degree of cicatrization, and consequently the long-term result of the efficacy of the operation, remains to be demonstrated. There are few studies on the immunological reaction to polypropylene meshes, and none on the oxidative stress induced by the mesh. Moreover, only one study has been published that clearly correlates the immunological reaction to the amount of prosthetic material, but was carried out on only a few patients.

The aim of this research is to show if there is a relationship between the amount of prosthetic material used and immunological reactions as well as postoperative oxidative stress, and thus to evaluate, if present, the differences in the biological reaction and biotolerability between light-weight and heavy-weight meshes on a statistically significant number of patients.

Double blind randomization. The recruitment of patients will take place in the order that they are referred to the hernia service of the General Surgery and Week Surgery Unit of the University Hospital of Catania. After the examination confirming the diagnosis of inguinal hernia and once surgery has be indicated, informed consent will be obtained from the patient by means of a standardized form. The assignment to group H or group L will be made following a simple criterion of alternation that is completely random: i.e. patient 1 (Group H), patient 2 (Group L).A total of 60 patients will be recruited and divided into the two groups. For group H inguinal hernioplastic surgery will be carried out with the so called "heavy-weight" mesh (about 220 g/m2 of polypropylene), for Group L, on the other hand, the mesh will be of the "light-weight" type (about 40 g/m2).

A preoperative blood test will be carried out to determine the basal levels of IL-6, TNF-alpha, nitrites, GSH and isoprostanes) and 3 postoperative tests (at 6 h, 3 days and 12 days), all samples will be frozen for reference.

All the data from each patient will be collected in a personal file compiled by the surgeon. When all the blood samples are collected a laboratory technician and a biochemist will determine the levels of the above mentioned substances, these data will then undergo statistical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* All patients affected by primary inguinal hernia

Exclusion Criteria:

* Diabetes
* Corticosteroids treatment
* Immunosuppressive drugs
* Cirrhotic patients
* Chronic inflammatory disease
* Neoplastic patients
Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer

This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically
* CT/MRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of distant metastasis
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* Estimated survival time was over 3 months
* The major organs are functioning normally and meet the following criteria:

  (1) Blood routine examination should meet the requirements (no blood transfusion within 14 days):
  1. HB≥100g/L，
  2. WBC≥3×109/L
  3. ANC≥1.5×109/L，
  4. PLT≥100×109/L； （2）Biochemical tests must meet the following criteria：

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  1. BIL \<1.5×upper limit of normal (ULN)，
  2. ALT and AST\<2.5ULN，GPT≤1.5×ULN；
  3. Cr≤1ULN，Ccr \>60ml/min
* Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug
* Did not participate in other clinical studies before and during treatment
* Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up

Exclusion Criteria:

* History of other malignant disease within past five years
* History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation
* Accompanied by serious heart, lung, liver and kidney diseases, neuropsychiatric disorders, jaundice or associated severe infection
* Women during pregnancy or breast-feeding
* Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:

  1. NYHA class II or more serious heart failure
  2. unstable angina pectoris
  3. myocardial infarction within 1 year
  4. clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention
Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout

Gout is an autoinflammatory disease characterized by flares of painful joint inflammation. This inflammation occurs in response to uric acid that crystallizes. After a gout attack, patients usually enter a period that is accompanied by low grade inflammation but is otherwise relatively asymptomatic. Gout is typically associated with certain markers, and this study is going describe specific markers in patients that are in between gout attacks. Research has been focused on studying this phase between gout attacks in hopes to manage and prevent the onset of future gout attacks. Biopsies will be taken from the affected joint and blood will be drawn from patients who are currently in between gout attacks. This work will provide important information regarding how crystals in the joint lining are associated with chronic inflammation in the periods between gout attacks. Moreover, this study will identify novel biomarkers that may be useful in determining the severity of disease activity through a blood test.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with gout diagnosed by a Rheumatologist.
2. patients with a history of at least two gout attacks in the target joint
3. Patients with a target joint amenable to biopsy. Target joint defined as:

Joint that has been affected by acute gout attack at least twice in the 12 months prior to enrollment.

Ultrasound finds grade 2 gray-scale synovitis in joint. Joint is amenable to biopsy. At the time of enrollment, the joint is without signs of acute inflammation: redness, swelling, and severe pain (\>7/10).

Exclusion Criteria:

1. Patients on anti-coagulation therapy.
2. Patients with an active infection.
3. Tophus present at the biopsy site.
4. Target joint with signs of acute gout attack (pain \>7/10, redness, warmth)
5. Known chondrocalcinosis
Predicting Obesity Consequences Using Body Measure and Urine Metabolomics

This is a prospective observational study which will recruit up to 1200 participants over a two-year period to investigate whether non-invasive methods such as bioelectrical impedance analysis parameters and urine metabolic profile are predictors for pediatric non-alcoholic liver disease.

Obesity is associated with non-alcoholic fatty liver in children. Currently, body mass index is used for stratification risk for non-alcoholic fatty liver disease in children. However, body mass index represents the adjusted weight status for height and may not be a perfect surrogate for body fatness. This study assumes that a combination of body measures including parameters of bioelectrical impedance analysis and hand grip strength may better represented body fatness and healthy status than body mass index. Moreover, non-alcoholic fatty liver disease is strongly associated with the metabolic syndrome and non-invasive urine metabolic profile may be used to predict the disease status. The aim of this study will be to develop non-invasive methods using body measures and urine metabolic profile to predict pediatric fatty liver disease.

This study will recruit 1200 apparently healthy children at Year 1 to Year 6 in the primary schools in Taiwan within a two-year period. A series of tests including body measures, bioelectrical impedance analysis, hand grip strength and urine metabolomics by nuclear magnetic resonance will be performed in each participant. These data will be used as features to predict the results of Fibroscan test.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy male or female children
* Students in Year 1 to Year 6 of primary schools

Exclusion Criteria:

* Unknown liver disease
* Metal implant or splint
* Pacemaker implantation
* Limb defect or injury
* Pregnancy
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine

This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. in kidney transplant recipients after two doses of Sinopharm's inactivated virus vaccine. A total of 100 adult individuals receive a single dose of the SpikoGen COVID-19 vaccine at 1 to 3 months after the second dose of the Sinopharm COVID-19 vaccine. The injection is given in the deltoid muscle of the non-dominant arm. For immunogenicity assessments, blood samples will be collected one month after the booster injection. For safety assessments, all participants will be followed up for one month.

Study hypotheses include:

1. A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.
2. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years
* Willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests
* Kidney transplant recipients who had received two doses of Sinopharm vaccine after transplantation
* Females must not be pregnant or breastfeeding
* At least six months should have passed from the time of transplantation
* Between 1 to 3 months should have passed from the second dose of Sinopharm vaccine

Exclusion Criteria:

* Subjects with signs of active SARS-CoV-2 infection at the screening visit
* Subjects with a history of SARS-CoV-2 infection based on a positive PCR test result after the second dose of the primary vaccination
* Subjects with an active CMV infection that requires treatment
* Subjects who have received rituximab within 6 months prior to the screening visit
* Subjects who have received intravenous immune globulin (IVIG) within 6 months prior to the screening visit
* Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products.
* Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study.
* Subjects who have experienced transplant rejection within 30 days prior to the screening visit
* Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease

The primary objective of the study is to compare the adhesiveness of 2 different patch formulations of Rotigotine using the largest patch size of 40 cm\^2, under the assumption that both patch formulations show similar adhesiveness properties.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of idiopathic Parkinson's Disease
* Subject has been on continuous treatment with commercially available Rotigotine transdermal patches (Neupro®) for at least 3 months prior to enrollment
* Subject has been taking a stable Rotigotine dose including an 8 mg/24 hours (40 cm\^2) patch for at least 2 weeks prior to enrollment

Exclusion Criteria:

* Subject has any medical or psychiatric condition which, in the opinion of the investigator, could jeopardize or would compromise the subject's well-being or ability to participate in this study
* Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recently unsolved contact dermatitis
* Subject has a history or present condition of an atopic or eczematous Dermatitis, Psoriasis, or an active skin disease
* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1) or Baseline (Visit 2)
Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage

The purpose of this study is to evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.


Eligibility Criteria:
Inclusion Criteria:

* Vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication.
* Age ≥ 18 years
* Hematological functions : leucocytes \> 1500/mm3, hemoglobin \> 8 g/dl, blood platelets \> 150000/mm3.
* Well informed written consent signed by the patient
* Negative pregnancy test for female patient of child-bearing potential.

Exclusion Criteria:

* Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted)
* Massive lymph node invasion with femoro-vessels attack
* Inclusion in another study (excepted study turned to inguinal lymph node)
* Pregnant or nursing women
* Patient under guardianship or trusteeship
Number of Meals With Adequate Protein Intake and Functionality in Middle to Older Aged Mexican Adults

The objective of this study was to analyze if the number of meals with adequate protein intake is associated with functionality in middle to older aged mexican adults.

Dietary protein intake per meal was assessed with 24-h dietary recalls to determine the number of meals with adequate protein intake (\>30 g, \>0.4 g/kg). Functionality was assessed with self-reported questionnaires about daily living activities (Barthel), and instrumental activities of daily living (Lawton). Subjects were categorized according the number of meals with adequate protein intake (zero meals, one meal, two or three meals), and their functionality score for both questionnaires (high, middle, and low scores).

With multinomial logistic regression, the investigators assessed if consuming zero or one meal with adequate protein intake could be associated with lower functionality in comparison with consuming two or three meals with enough protein. The logistic regression was adjusted for covariables (age, sex, BMI categories for the elderly, number of diagnosed diseases, inadequate protein intake per day \[\<1.2 g/kg/d\]).

Eligibility Criteria:
Inclusion Criteria:

* Subjects able to stand up and walk independently or with walking sticks only.
* Subjects able to answer questionnaires independently or with minimum caregivers' assistance

Exclusion Criteria:

* Subjects reporting any kind of hospitalization within the last year.
An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy

This study is an open-label extension to protocol B5161002 and will provide an assessment of the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects will be assigned to receive a monthly individualized maximum tolerated dose based on their tolerability profile/data from B5161002. This study will not contain a placebo comparator. Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test and pulmonary function tests) and pharmacokinetic testing.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with Duchenne muscular dystrophy who enrolled and completed study B5161002.
2. Signed and dated informed consent document (ICD) indicating that the subject's parent or legal guardian/caregiver has been informed of all pertinent aspects of the study.
3. Subjects and their legal guardians/caregivers who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
4. Subject have;

   1. Adequate hepatic function on screening laboratory assessments
   2. GLDH less than 20 units/liter (2 x upper limit of normal \[ULN\])
   3. Iron content estimate on the liver MRI within the normal range.

Exclusion Criteria:

1. Unwilling or unable (eg, metal implants) to undergo examination with closed MRI.
2. All male subjects who are able to father children and are sexually active and at risk for impregnating a female partner, who are unwilling or unable to use a highly effective method of contraception. In addition, all sexually active male subjects who are unwilling or unable to prevent potential transfer of and exposure to drug through semen to their partners by using a condom consistently and correctly. .
3. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are related to Pfizer employees directly involved in the conduct of the study.
4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
5. Participation in other studies involving investigational drug(s), with the exception of B5161002.
6. History of allergic or anaphylactic reaction to a therapeutic or diagnostic protein or additives of this investigational product.