cyrilzakka/clinical-trials huggingface dataset:
The Effect of Baduanjin on Shoulder Function in Maintenance Hemodialysis Patients

The aim of this study is to examine the effect of 18-month Baduanjin exercise on shoulder joint function in maintenance hemodialysis (MHD) patients. 60 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities.

The aim of this study is to observe the therapeutic effect of Baduanjin on improving shoulder joints in MHD patients. A total of 60 maintenance hemodialysis patients will be included and randomized into an intervention group of 30 cases and a control group of 30 cases. The intervention group underwent a 30 minute Baduanjin exercise under the guidance of a professional doctor before the dialysis day, including a 5-minute warm-up exercise, a 20 minute Baduanjin exercise, and a 5-minute relaxation exercise. The intervention group practice Baduanjin three days a week, while the control group maintain routine treatment and daily activities. Measure the indicators of each group at baseline, months 6, 12, and 18. The evaluation of shoulder joint function is based on the shoulder Constant score (which includes three dimensions: pain, daily living activities, and active range of motion); The quality of life score is based on the SF-12 score, and the emotional score is based on the Anxiety and Depression Scale.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old, ≤ 75 years old
* Maintenance dialysis treatment for ≥ 3 months, three times a week
* The six minute walking experiment were used to screen patients for suitability for Baduanjin
* Right handedness, fistula in left hand

Exclusion Criteria:

* The vascular pathway is a tunnel catheter with a polyester sheath
* The vascular pathway is a right arteriovenous fistula
* Known infectious diseases
* Individuals with primary or secondary muscle diseases, mental abnormalities, lack of autonomous behavior ability, and lack of cooperation with clinical observation and treatment.
VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome

To evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye syndrome and Sjögren's syndrome

Method: This study wants to evaluate the Chinese herbal tea VGH-DESJS-1 on Nourishing Yin and Moistening Dryness the ocular dryness from dry eye syndrome (DES) and Sjögren's syndrome (SJS). One hundred dry eye subjects are composed of 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC). DES, SJS, and NHC received VGH-DESJS-1 daily during 8 weeks for the evaluation before and after the subjects receiving the VGH-DESJS-1. Moreover, we could use the Whole-genome genotyping, Schirmer's test, Tear breakup time (TBUT), Cytokines, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), Traditional Chinese Medicine (TCM) pattern, TCM tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability, and it could be applied for the goal of holistic health care.

Expected Results:

1. To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, and Cytokines for DES, SJS, and NHC.
2. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES and SJS.
3. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES.
4. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for SJS.

Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness

Eligibility Criteria:
Dry eye syndrome

-Inclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm/5 min

-Exclusion Criteria: Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye

Sjögren's syndrome

-Inclusion Criteria: primary or secondary SS aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) had no abnormal findings of immune, liver, kidney, or blood function evaluations.

-Exclusion Criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study.

non AIDDES Healthy Controls

-Inclusion Criteria: aged between 20 and 75 years without any Chronic disease

-Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD

This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Age \>=7 and \<18 years of age
* Primary diagnosis of major depressive disorder (MDD)
* CDRS-R score \>40

Exclusion Criteria:

* History of suicidal behaviour, or requires precaution against suicide
* Not in generally healthy medical condition
* History of psychosis or bipolar disorder
* Seizure disorder
Computer Based Assessment and Treatment

This study aims to investigate computer based symptom assessment in an outpatient cancer population, and the use of a computer based decision support system to facilitate the diagnosis and treatment of cancer related pain.

Primary hypothesis is, that this approach improves pain control and pain management in an unselected group of cancer patients in an outpatient setting.

* Improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale
* Improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale
* An alteration in the prescribing dose of opioids in equipotent opioid dosage

Secondary hypothesis is, that this system improves overall symptom control and symptom management in an unselected group of cancer patients in an outpatient setting.

The traditional way of symptom assessment is by the paper-and-pen method, which suffers from several limitations. The assessment items are not individually adjusted to each patient and his/her subjective symptoms, the collected data is rarely used in clinical practice, and decision-support for the physician is not possible.

Although the body of evidence is accumulating regarding the benefits of computerised symptom assessment in cancer patients, there is still insufficient knowledge of the impact of computerised assessment tools on the management of cancer pain and other cancer related symptoms.

The COMBAT study aims to investigate if a computer based assessment of cancer related symptoms, and a computerized decision support can improve treatment of pain and other symptoms in cancer patients.

This is an open, comparative study with a sequential design with two consecutive study periods, the non-intervention period and the intervention period.

The computer-based clinical decision support system will utilize the following data to generate one or several treatment options:

1. Data from self assessment of cancer related symptoms
2. Data from relevant variables reported by the physician
3. Revisited guidelines on treatment of cancer pain

Eligibility Criteria:
Inclusion Criteria:

* attending the outpatient clinic at the Cancer Clinic, St. Olavs Hospital Trondheim
* histologically verified malignancy
* able to follow study instructions
* able to read the information on the computer screen in the intervention period of the study
* able to use a touch screen in the intervention period of the study
* cancer related pain measured as average pain in last 24 hours of 4 or above on a numeric rating scale
* elective or emergency consultation with a physician
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management

Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management compared with ropivacaine.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
3. Male or female，aged 18-75 years inclusive
4. Body mass index (BMI) 18-28 kg/m2 inclusive
5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅱ

Exclusion Criteria:

1. Subjects with deformity of the involving operative limb, or other neuropathy
2. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
3. Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
4. Subjects with a history of mental system diseases and cognitive dysfunction
5. Combination of other pain conditions that may affect postoperative pain assessment
6. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
7. Subjects with a history of deep vein thrombosis-related disease
8. Clinically significant abnormal clinical laboratory test value
9. Allergic to a drug ingredient or component
10. Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure
11. History of alcohol abuse or prescription and/or illicit drug abuse
12. Subjects with special diets (including tobacco, grapefruit and caffeine)
13. Pregnant or nursing women
14. No birth control during the specified period of time
15. Participated in clinical trials of other drugs (received experimental drugs)
16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Magnesium Replacement Therapy to Prevent Acute Renal Failure in Critically Ill Patients

Acute renal failure (ARF) is a serious and common complication in hospitalized patients, occurring in more than 25% of intensive care unit (ICU) patients. Hypomagnesemia is a common disorder, occurring in approximately 12% of hospitalized patients, with an incidence of 60% in ICU patients. The majority of those patients have are asymptomatic hypomagnesemia, and patients with mild hypomagnesemia do not need treatment, only the correction of the underlying cause. Hypomagnesemia potentiates postischemic renal failure in rats, and is associated, in humans, with acute renal failure. To date, there is no study that demonstrated a benefit of maintain normal levels of magnesium in the incidence of ARF in critically ill patients. Thus, we suggest that a treatment aimed to maintain normal magnesium levels during ICU stay can decrease the incidence of ARF. We will perform a randomized clinical trial that will include all patients admitted to an ICU that, develop hypomagnesemia. It will be excluded from the study: patients younger than 18 years, participants from other studies, pregnant women, patients with creatinine greater than or equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological studies, patients weighing less than 40kg, suffering from advanced malignant disease, with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), with a diagnosis of Torsades de Pointes or symptomatic hypomagnesemia prior to randomization. Patients included in the study will be randomized to one of the following groups: placebo (saline solution 0.9%) or 50% Magnesium Sulfate. Patients will receive an administration of 48 mEq Magnesium diluted in 250 ml saline 0.9% for 24 hours in an infusion rate of 10.4 ml / hr. Therapy will be continued for 3 days, and repeated during ICU stay to maintain magnesium levels in the normal range. Placebo group will receive exactly the same infusion only with saline administration. The therapy will be discontinued if the patient has hypermagnesemia or signs of magnesium intoxication. The main outcome measurement will be the occurrence of ARF during ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* All patients, clinical or surgical, who signed (or their relatives) the informed consent form, which presented hypomagnesemia (with serum magnesium between 1.2 and 1.8 mg / dL), with no symptoms of hypomagnesemia.

Exclusion Criteria:

* Patients younger than 18 years, participants from other studies, pregnant women, patients with admission plasma creatinine greater than or equal to 3.5 mg / dl or on dialysis, patients who used intravenous contrast for radiological studies, patients weighing less than 40kg, patients suffering from advanced cancer, patients with severe hypomagnesemia (serum magnesium less than or equal to 1.1 mg / dl), patients with a diagnosis of Torsades de Pointes or patients with symptomatic hypomagnesemia prior to randomization.
Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)

Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18 to 50 years (inclusive).
2. Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
3. All female volunteers must have a negative urine pregnancy test prior to participation.

Exclusion Criteria:

1. A room-air baseline % modulation \< 1.5% on all four fingers on the test hand
2. Pregnancy or lactating women
3. History of syncopal episodes
4. Hypertension (defined as a systolic pressure of \>145 mmHg or a diastolic pressure \>90 mm Hg on three consecutive readings)
5. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
6. History of seizures (except childhood febrile seizures) or epilepsy
7. Routine use of tranquilizers and/or excessive anxiety
8. History of frequent headaches or migraines
9. History of stroke
10. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
11. History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (\> 1 hour)
12. History of significant respiratory disease, such as severe asthma, emphysema, etc.
13. Sickle cell disease or trait.
14. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
15. A clinically significant abnormal finding on medical history, physical examination, clinical laboratory test or ECG. Clinical significance will be assessed by the principal investigator or designee.
16. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
17. Prior or known allergies to heparin
18. History of transient ischemic attacks or carotid artery disease
19. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
20. History of chronic renal impairment
21. History of recent arterial cannulation (less than 1 month prior to study)
22. History of complications from previous arterial cannulation
23. Current use of blood thinners
Abnormal Vaginal Flora and Vaginal Lesions at Delivery: is There a Relationship?

The main objective of this study is to assess whether the presence of abnormal vaginal flora (intermediate flora or vaginosis) is a risk factor for vaginal lesions at the time of delivery. For this, the primary endpoint will be the proportion of vaginal lesions according to the presence or absence of abnormal vaginal flora.

A more precise qualitative and quantitative study of vaginal flora isolated from pregnant women and its association with vaginal lesions will also be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a gestational age \> 34 weeks delivering at the Nîmes University Hospital

Exclusion Criteria:

* Patient under judicial protection
* Adult patient under any kind of guardianship
* Patient refuses participation
Change in Plaque Characteristics With Atorvastatin

To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.

Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of \>25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI.
* plasma LDL cholesterol levels : \>=100mg/dL and ≤160mg/dL
* at least one atherosclerotic lesion of \>25% stenosis other than culprit lesions of current ACS

Exclusion Criteria:

* Patients who will undergo coronary bypass surgery.
* Patients with major complications during treatment of culprit coronary lesions.
* Patients with an atherosclerotic lesion with \>50% stenosis at a left main trunk.
Simulator Versus Box Trainer on Laparoscopic Suturing

This is prospective randomized controlled study to compare the proficiency of novices in acquiring laparoscopic suturing skills following either training in a virtual reality simulator or box trainer.

Participants will be randomized into three groups by computer-generated sequence to the virtual reality simulator, box trainer and control groups. They will be shown a video demonstration and given simple instructions on laparoscopic suturing and intracorporeal knot tying at the beginning of the training. Both the virtual reality simulator and box trainer groups will be allowed a maximum of 4 hours of training (2 sessions of 2 hours each). The participants could terminate training at any time point during the 4-hour if they felt competent to perform the task.The control group will not receive any further training.

They will then be asked to perform laparoscopic suturing (which would involve needle loading and insertion via 2 pre-marked circles, and knot tying which includes at least 2 single throws) on a box trainer. Participants will be asked to complete a modified GOALS questionnaire at the end (which will take around 5 minutes) to evaluate their experiences and assess their own proficiency. The procedure will also be recorded (with a number identifying the participant only) and assessment will be performed when the study is completed by 2 experienced laparoscopic gynecologists blinded to the participants who will review the recorded procedure. The time to complete each task, total procedural time and proficiency will be assessed, which will be compared against the participants' own evaluation.

Eligibility Criteria:
Inclusion Criteria:

All trainees and interns working in the Department of Obstetrics and Gynecology who have (i) no laparoscopic experience or (ii) laparoscopic experience but no laparoscopic suturing experience, will be invited to participate in the study.

* Older than the age of legal consent (i.e. 18 years old)
* Willing and able to participate after the study has been explained

Exclusion Criteria:

- Cannot understand English, Cantonese or Putonghua
VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.
* Able to understand and sign an informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Glaucoma or ocular hypertension.
* Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.
* Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.
* Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.
* Planned use of contact lenses in the study eye during the study period.
* Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.
* History of clinically significant trauma to the study eye within the past 12 months.
* Other protocol-defined exclusion criteria may apply.
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male, age below 6 years of age at the time of signing informed consent
* Diagnosis of severe haemophilia A (FVIII activity level 1%) based on medical records or central laboratory results
* No prior use of purified clotting factor products (5 previous exposures to blood components is acceptable)

Exclusion Criteria:

* Any history of FVIII inhibitor (defined by medical records) - Known or suspected hypersensitivity to trial product or related products
* Previous participation in this trial. Participation is defined as first dose administered of trial product
* Receipt of any investigational medicinal product within 30 days before screening
* Congenital or acquired coagulation disorder other than haemophilia A
* Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
* Patient's parent(s')/legally acceptable representative (LAR(s')) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation