cyrilzakka/clinical-trials huggingface dataset:
Acupuncture Combined With Hydroxychloroquine

To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.

Methods: Seventy-two patients with primary Sjögren's syndrome who met the inclusion criteria were randomly divided into the experimental group (36 patients, 3 patients who fell out) and the control group (36 patients, 4 patients who fell out). The control group was treated with oral hydroxychloroquine sulfate tablets alone, 0.2g each time, taken twice a day, 4 weeks for 1 course of treatment, a total of 2 courses of treatment, and the experimental group was treated with acupuncture treatment on the basis of the control group, acupuncture once a day, acupuncture for 5 days and 2 days of rest, 4 weeks for 1 course of treatment, a total of 2 courses of treatment. The changes in the outcome indicators of the two groups before and after treatment were observed, and the main outcome indicators included salivary flow rate (SFR) and Schirmer test. Secondary outcomes included the European League Against Rheumatism (EULAR) Sjögren's Syndrome Patient-Reported Index (ESSPRI), the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and laboratory measures (ESR, CRP, IgG).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary Sjögren's syndrome
* Must be able to receive acupuncture treatment and swallow tablets

Exclusion Criteria:

* Patients with malignant tumors or severe organ function impairment
* Patients who are lactating or pregnant.
* Persons who are participating in clinical trials of other drugs.
Testing and Comparing the Impacts of Mhealth-Based and Web-Based Education on Oral Cancer

Introduction: Oral cancer is a malignant neoplastic disease affecting the lip, oral cavity (mouth) and/or the oropharynx. Despite the intense and diverse public health interventions on oral cancer prevention, the global prevalence rates of oral cancer and its major risk factors are still very high. Hence, oral cancer is an issue of serious global health importance.

Aim: To test and compare the effectiveness, usability, uptake, and acceptability of an educational website and a mobile health application prototype on oral cancer in improving oral cancer knowledge among university students.

Methods: This study will adopt a randomised control trial design, and it will be conducted among 75 first-year bachelor's degree students from five universities across two continents: University of Rwanda (Rwanda, Africa), Usmanu Danfodiyo University (Nigeria, Africa), University of Peradeniya (Sri Lanka, Asia), University of Ibadan (Nigeria), and Saveetha University (India, Aisa). The study participants will be in three groups (Group 1, Group 2, and Group 3). The participants in Group 1 will be the control group (n = 25 participants; 5 participants from each university); that is the group that will not receive an educational intervention. However, those in Group 2 (n = 25 participants; 5 participants from each university) will receive a web-based educational intervention on oral cancer while those in Group 3 (n = 25 participants; 5 participants from each university) will receive an app-based educational intervention on oral cancer. Pretest survey and posttest survey will be done for all participants. The data collected will be statistically analysed using the Statistical Package for Social Sciences (SPSS) version 28 software. Descriptive statistics will be done for all variables while inferential statistics (analysis of variance) will be done to test for associations between variables of interest.

Conclusion: The findings of this study will determine the effectiveness, usability, uptake, and acceptability of the tested digital intervention tools.


Eligibility Criteria:
Inclusion Criteria:

* being a first-year bachelor degree student of either University of Rwanda (Rwanda), University of Peradeniya (Sri Lanka), Usmanu Danfodiyo University (Nigeria), University of Ibadan (Nigeria), or Saveetha University (India)
* being within the age range of 18 to 39 years
* having a personal smartphone
* willingness to participate in the study

Exclusion Criteria:

* being a member of staff or a visitor or a non-first year bachelor degree student of University of Rwanda (Rwanda), University of Peradeniya (Sri Lanka), Usmanu Danfodiyo University (Nigeria), University of Ibadan (Nigeria), or Saveetha University (India)
* being a student of a tertiary institution not selected for the study
* being below the age of 18 years or above the age of 39 years.
* not having a personal smartphone
* not willing to participate in the study
Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST

With the aim of evaluating the putative impacts of emotion related personality factors on physical and mental disease and the mechanisms of these impacts, 58 students were submitted to a social stress test (Trier Social Stress Test) and salivary cortisol samples were taken. The subjects were also submitted to several personality trait inventory, that evaluated respectively Alexithymia, Emotional Intelligence, Resilience and the Five Factor Model of Personality.

The moderating impact of these factors on the cortisol response were analysed


Eligibility Criteria:
Inclusion Criteria:

* Students

Exclusion Criteria:

* Female,
* Smokers,
* Medication or alcohol abuse
A Model Based on Computed Tomography Imaging Parameters to Predict Poor Survival in Patients With Liver Cirrhosis

Cirrhosis, as the end stage of most chronic liver diseases, is an important clinical landmark portending high risk of death. Early identification and accurate prognostic scores is critical issue to improve survival rate. Loss of muscle mass and other body features, which can be determined from CT, have been associated with mortality in cirrhosis or hepatic carcinoma. In this study, we sought to investigate serial changes of CT imaging parameters, such as the skeletal muscle index (SMI), liver volume, adiposity density and so forth, to develop a new prognostic model for long-term motality in patients with liver cirrhosis. The final predictive model was developed under the Cox regression framework with MELD, Child-Pugh score, baseline and serial changes of CT imaging parameters. The discrimination of the new risk score was assessed by the overall C index.

Cirrosis, which is always manifesting as ascites, hepatic encephalopathy, upper gastrointestinal bleeding, severe jaundice and coagulopathy, deteriorates rapidly with a high mortality. Early identification and accurate predicted model may be the key to make duly clinical decision and improve prognosis.

When hepatic disorders accur, cirrhosis is often accompanied by varying degrees of malnutrition, which is accurately reflexed by the cross-sectioned areas of the muscles at the third lumbar vertebra level normalized by the square of the height （L3-SMI）. In addition, previous studies have shown that lower density of adiposity and altered liver volume were often associated with adverse clinical events.

These changes in body composition can be accurately assessed and measured by using CT scans. However, there is no ideas whether these imaging patameters are reliable indicators to predict the mortality of cirrhosis. In this study, we aimed to evaluate the difference of serial changes of L3-SMI, the density of adiposity and liver volume between 5-year survival and non-survival group and develop a new prognostic model based on these CT imaging data. This study highlighted the clinical significance of serial changes of CT imaging data in predicting the long-term outcome of patients with cirrhosis for the first time.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years
2. The diagnosis of liver cirrhosis based on imaging, laboratory and/or histological patameters from a board-certified hepatologist.
3. Patients who underwent at least two abdominal CT examinations, and the interval between the first and the second check was more than one year.
4. CT examination included the cross-sectional areas of muscle at L3 level.
5. Basic patient data included age, gender, weight, height, biochemical examination, complications and 5-year survival.
6. Biochemical examinations were available within 7 days before or after CT scan.

Exclusion Criteria:

1. patients with liver cancer and other malignant tumors.
2. Patients accompanied by severe respiratory and circulatory diseases.
3. Patients had a history of previous transplantation.
Laryngomalacia No Longer An Ambiguity

The purpose of this study is to expose some of the factors that may be associated or predisposing to development of laryngomalacia.

Laryngomalacia is the most common congenital malformation of the larynx and it is a self-limited disorder. It is the most common cause of stridor in newborns and infants. It results from an abnormal prolapse of supraglottic structures during inspiration. Despite its widespread prevalence, the etiology of laryngomalacia is unclear. Most infants will squeaky but otherwise well. Although affected patients do not exhibit much in the way of other physical symptoms, the unusual voice is worrisome to their parents.

Eligibility Criteria:
Inclusion Criteria:

* Babies delivered with laryngomalacia with ≥ 37 weeks of gestation
* Delivered with birth weights ≥ 2.5 kg
* No history of natal or post-natal complications
* From the same community

Exclusion Criteria:

* Pre-term babies
* History of natal or post-natal complications
[KSR-001-P01]Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristic of KSR-001

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristic of KSR-001.

After single dose, safety and local tolerability were confirmed and repeated test was conducted according to the investigator's judgment.

Eligibility Criteria:
Inclusion Criteria:

1. Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.
2. Body weight \>= 50 kilogram and ideal body weight within the range ±20%.
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. A subject who has symptoms of suspected acute disease at the time of screening.
2. Subjects with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, musculoskeletal, immune, the nose and ears, psychiatry, stomach system.
3. A subject determined to be unsuitable as a subject through a physical examined during screening.
4. A subject who is determined to be unsuitable as a subject through an ophthalmologic examination performed during screening.
5. A subject with a history of ophthalmic surgery, trauma and chronic diseases.
6. A subject who has acute or chronic eye disease requiring the use of local eye drops at the time of screening.
7. Subjects who need to wear contact lenses during clinical trial period.
8. A subject with clinically significant allergic disease.
9. A subject with a history of drug abuse.
10. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.
11. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).
12. A subject who takes drugs that induce and inhibit drug metabolises such as barbital medicines within one month before the administration of clinical trial drugs.
13. A subject who donates blood to the whole blood within 60 days before the administration of a clinical trial drug or a person who donates blood to the component within 20 days before the administration of a clinical trial drug.
14. A subject who has taken a specialty drug or herbal medicine within 14 days of administration of a clinical trial drug or a general medicine or vitamin formulation within 7 days.
15. A subject who can not continually ingest caffeine or ingest caffeine-containing foods during the period from 24 hours to discharge from hospital.
16. A subject who can not drink alcohol continuously or during the period from 24 hours to discharge from hospital.
17. A subject who can not smoke excessively or quit smoking during the period from 24 hours to discharge from hospital.
18. A subject who investigator that a tester is unsuitable for participating in clinical trials due to other reasons.
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction

This is a three-month randomized controlled trial to investigate the effects of auricular acupressure versus Intermittent carbohydrate restriction on cardiometabolic risk in obese children with gastric heat and dampness obstruction.

Obesity in childhood is associated with multiple cardiometabolic risk factors including hyperglycemia, dyslipidemia and hypertension, which predicts increased risk for developing obesity-driven complications in adulthood. Auricular acupuncture therapy is an intervention with purported success for the treatment of obesity. However, traditional intervention rarely has long-term success in children and adolescents. Low-carbohydrate diets have also been shown to reduce body weight and improve insulin sensitivity in children.

This is a three-month randomized controlled trial in children with gastric damp-heat obstruction, in order to explore the effects of traditional Chinese medicine auricular acupressure and intermittent carbohydrate restriction on cardiovascular metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Have at least one of the following cardiometabolic risk factors: overweight or obesity, prediabetes, dyslipidemia or elevated blood pressure.
* Traditional Chinese medical syndrome type is gastric heat and dampness obstruction syndrome.

Exclusion Criteria:

* Diagnosis of obesity associated with genetic or endocrine diseases, including hypercortisolism, polycystic ovary syndrome, primary hypothyroidism and hypothalamic obesity.
* Participating in other clinical trials or have participated in other clinical trials in recent 3 months.
* Diagnosis of organic diseases, including heart, liver, kidney and brain or infectious diseases and mental diseases.
Application of 3D Printing Technique in Radical Gastrectomy With Leonardo da Vinci Robot

The incidence of gastric cancer is the highest in China, and surgery is one of the most effective treatment methods. Da Vinci robot radical gastrectomy for gastric cancer has the advantage of minimally invasive and fine operation. However, due to complicated perigastric anatomy, abundant blood supply and wide distribution of lymph nodes, it is widely used in clinical use of .Combine the 3D printing technique with imaging examination (digestive endoscopy,3Dct cta/ctv, etc.) ,making the 3D model of da Vinci robot assisted radical gastrectomy can fully show the anatomical relationship around gastric cancer, determine the flow and variation of splenic portal vessels, and the distribution of splenic hilar lymph nodes. In order to eliminate the imagination difference of spatial anatomical structure before operation, it is easier for surgeons to optimize the operation plan, to control the operation process and to improve the accuracy, and to adopt individualized operation suitable for the patients.

The investigators will work with general surgery, imaging department and 3D printing center to try to print gastric cancer model and guide the operation. After obtaining the approval of the Hospital Ethics Committee, 20 patients with gastric cancer were collected for imaging examination and evaluation, and the normal physical model of 70% normal volume was printed with Guang Min resin material.The investigators will analyse the anatomical relationship between the tumor and surrounding tissues,and determine the range of tumor excision and the feasibility and safety of radical gastrectomy with Leonardo da Vinci robot for gastric cancer.Through the assistance of the 3D model,The investigators will select the suitable operation path to determine the extent of tumor excision and lymph node dissection.Furthermore, 3D print model is used to provide real-time navigation for key steps of surgery. The purpose of this research is to observe the application value of 3D printing technique in gastric cancer laparoscopic surgery with Leonardo da Vinci robot radical gastrectomy, and to provide reference for the development of 3D printing model of other complicated digestive tract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients without contraindications gastroscope，surgery and anesthesia;
* There is no history of abdominal surgery, no severe abdominal cavity adhesion;
* Not found the tumor metastasis;
* Normal coagulation function;
* There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
* Patients and their families volunteered choice the surgical procedure and signed informed consent.

Exclusion Criteria:

* Patients with preoperative assessment of distant metastasis;
* Patients with preoperative radiation and chemotherapy or hormone therapy;
* Patients with acute obstruction, bleeding or perforation of the emergency surgery;
* Patients with a history of abdominal trauma or abdominal surgery;
* Patients with contraindications gastroscope，surgery and anesthesia.
Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events


Eligibility Criteria:
Inclusion Criteria:

* moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
* others per protocol

Exclusion Criteria:

* sensitivity to NSAIDs and lecithin
* hypertension
* history of GI and other specific problems
* use of medications and other criteria per the protocol
Comparison of Continuous and Pulsatile Apomorphine in Parkinson's Disease

The purpose of this study is to compare the effects of apomorphine, given by two different methods, to determine how best to manage dyskinesias.

Levodopa is a drug that can be taken by mouth, and improves the symptoms of Parkinson's disease (PD). However it can eventually cause involuntary movements called dyskinesia and motor fluctuations-fluctuations in the control of symptoms, often referred to as "off" and "on." Apomorphine is a drug that works as well as levodopa, but does not work if taken by mouth.

The purpose of this study is to compare the effects of apomorphine in people with PD who have levodopa-induced motor fluctuations and dyskinesias. In the trial, researchers will compare the effects of apomorphine administered by subcutaneous bolus injections (pulsatile) and by ambulatory infusion pumps (continuous) in 24 people with PD, for 6 months.

After an initial screening, potential participants will undergo a test to verify that they can tolerate and respond to apomorphine. Those who meet all of the requirements will be randomized to receive the study drug via injections (shots) using an injector pen or a portable infusion pump. Apomorphine will be given either continuously using the portable pump during the waking day or intermittently by injection, for 6 months. The pump will be carried on a belt and connected by a tube to a small needle under the skin. Injections of apomorphine under the skin will be self-administered by the participants or administered by friends or family members using injector pens.

After 6 months, the effects of apomorphine use will be assessed by measuring how the participants respond to levodopa and by measuring their symptoms during the course of the study. Participants will be followed initially every week, then biweekly, and then monthly in an outpatient clinic for 6 months. During this time, they may receive adjustments of apomorphine doses as well as doses of other antiparkinson medications.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's Disease
* clear response to levodopa (sinemet)
* "off" at least 20% of waking day
* dyskinesias present for at least two hours of waking day
* subject or caregiver able to master use of drug delivery system (injector pen or pump)

Exclusion Criteria:

* physical complications that would preclude safe participation
* standing systolic BP of \<80
* lack of tolerance or response to apomorphine
* drug/alcohol abuse
Study on the Treatment With Water-filtered Infrared-A (wIRA) Radiation in Patients With Morphea and Sclerotic Graft-versus-host Disease

This is a prospective, intra-individual comparative study to evaluate the effectiveness of local-water filtered infrared-A (wIRA) irradiation (applied by Hydrosun® radiator 750 for radiation at the clinic, or Hydrosun® 575home for home treatment) in patients with morphea or sclerotic GVHD (Graft-versus-host Disease). The purpose of the study is to determine whether wIRA irradiation can reduce fibrotic skin alterations in circumscribed scleroderma (morphea) or chronic graft versus host disease. wIRA irradiation is applied for 30 minutes 3 times per week for 20 weeks to a diseased skin area and a lesional skin on contralateral body site remains untreated. A total of 22 patients (20 evaluable patients with an expected drop-out rate of 10%) are to be included in this study. Group A: 11 patients with plaque morphea Group B: 11 patients with sclerotic GVHD.

A sclerotic plaque or area of skin on the right side of the body and contralaterally on the left half of the body (each maximum size: 25 cm in diameter, corresponding to the radiation field of the Hydrosun® heater 750) is selected. The assignment of one side of the body to irradiation or non-irradiation is randomized (using the MedUni Graz randomizer). The plaque randomized for irradiation is irradiated on 3 days a week for 30 minutes each time. The treatment period extends over 20 weeks, the total number of radiation treatments is therefore 60. If the patients cannot come to the radiation treatment, home therapy can be carried out according to the same treatment scheme. The radiation at the clinic is carried out with a Hydrosun® lamp 750, the home treatment with the Hydrosun® 575home (Hydrosun Medizintechnik GmbH, Mauchener Str. 14, D-79379 Muellheim, Germany). The radiation intensity at the distance of 33 cm between the device and the skin surface standardized by a distance rod is 200 mW / cm2 (visible light 50 mW / cm2, infrared A 150 mW / m2). The contralateral plaque or skin area of comparable clinical characteristics and duration of existence was included as an unirradiated control. Target and control areas will be photo-documented in the course of the study. Before the first irradiation, after the 30th and after the 60th irradiation, the skin thickness and hardness of the target and control regions are measured by a blinded examiner and the skin status including mRSS (Rodnan skin score) is recorded. In addition, at the beginning and at the end of the study, the patient's assessment of the effect (PGIC scale) and tolerability of the therapy is asked. Any side effects of the irradiation are continuously documented.

Eligibility Criteria:
Inclusion Criteria:

* Morphea
* Sclerotic graft-versus-host disease (GVHD)

Exclusion Criteria:

* Inability to cope with the treatment plan
* Pregnant or breastfeeding women and women of childbearing potential without effective contraception