cyrilzakka/clinical-trials huggingface dataset:
Effects of Traditional Chinese Medicine on Bronchiectasis Patients

The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.

Bronchiectasis is a common and frequently occurring respiratory disease, with more hospitalization rate and mortality, poor quality of life and heavy financial burden. The main clinical manifestations are persistent or recurrent cough, expectoration, sometimes accompanied by hemoptysis, which can cause respiratory dysfunction and chronic pulmonary heart disease. There are some randomized controlled trials of TCM for bronchiectasis, and have the effect in the treatment of bronchiectasis, reducing the number of acute aggravation and alleviating dyspnea. However, some TCM interventions lack comprehensive syndrome differentiation and the placebo control.

This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy to evaluate the effectiveness of TCM on patients with clinically stable bronchiectasis. 216 subjects will be randomly assigned to one therapies (TCM treatments based on syndrome differentiation) and the other therapy (placebo of TCM treatment) for 24 weeks. After the treatment period, the subjects will be followed up for 24 weeks. The primary outcomes include the frequency of bronchiectasis exacerbation, and the secondary outcomes include quality of life (SGRQ, LCQ, QOL-B), pulmonary function, safety observation index.

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of clinically stable bronchiectasis
* Age between 18 and 80 years
* Syndrome differentiation meets criteria of syndrome of Qi deficiency of lung and phlegm-turbidity obstructing the lung, syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung
* Without participations in other interventional trials in the previous one month
* With the informed consent signed

Exclusion Criteria:

* Current respiratory disorders other than bronchiectasis (e.g. COPD,bronchial asthma, lung cancer,active tuberculosis, Interstitial lung disease, pulmonary thromboembolic, or Other patients who have an impact on the observation of disease)
* Patients with severe cardiovascular disease (e.g. Acute myocardial infarction,Acute heart failure)
* Severe liver disease(e.g.Active phase of hepatitis, Cirrhosis, Severe impairment of liver function by portal hypertension)
* Severe renal disease(e.g. renal transplant, dialysis)
* Patients with large hemoptysis in the last month
* Pregnant and lactating women
* Insanity, Dementia, and all kinds of Psychosis
* Smoking patients (Years of smoking10/ package year)
* Participating in other clinical trials with other interventions;
* Allergic to the used medicine.
Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate

Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

Eligibility Criteria:
IInclusion Criteria:

* Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
* Glaucoma - Have glaucoma and no history of other retinal pathology.
* Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
* Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria:

* Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
* Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
* Retina - Unable to complete required exams.
* Cornea - Unable to complete required exams.
Effects of Deep Brain Stimulation in Parkinson's Disease

The purpose of this study is to identify factors predicting good results in patients treated with deep brain stimulation for Parkinson's disease. The study includes a comparison of two surgical methods used to provide this therapy.

The study will prospectively examine the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on motor function, quality of life and cognitive function in Parkinson's disease (PD) patients treated at Rikshospitalet University Hospital. The aim is to identify which factors that predict good treatment outcome, in order to improve patient selection of this generally highly effective, but specialized and expensive treatment.

The study has several aims:

1. Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement.
2. To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus.
3. To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus
4. To study social functioning of patients after STN-DBS and quality of life of patient caregivers

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease
* Symptoms ≥ 5 years
* Severity of Parkinson's disease ≥ 20 points in UPDRS motor scale (scale 0-108) in OFF medication state
* Marked fluctuations of motor symptoms AND/OR troublesome dyskinesias AND/OR severe tremor AND/OR intolerable side-effects of dopaminergic drugs
* Failure of medical treatment to sufficiently control symptoms
* L-dopa responsive symptoms with ≥30% reduction in UPDRS motor score in drug ON state compared to OFF state OR severe l-dopa unresponsive tremor

Exclusion Criteria:

* Previous surgery for Parkinson's disease
* Marked axial motor symptoms unresponsive to treatment with l-dopa
* Dementia (Mattis dementia rating scale \< 130).
* Patient suffering from untreated moderate or major depression or anxiety disorder
* Presence of other psychiatric disorder preventing necessary co-operation
* Brain MRI showing marked atrophy or white matter changes
* Increased risk of bleeding
* Presence of medical illness with short life expectancy
* Other surgical contra-indications
Virtual Prism Adaptation Therapy on Hemispatial Neglect

The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. Behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.


Eligibility Criteria:
Inclusion Criteria:

* 3 months after stroke onset
* 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test.
* Ability to recognize the target object, hand trajectory in the immersive virtual reality
* 16 points or more in the Korean version of mini-mental state examination

Exclusion Criteria:

* Previous stroke or traumatic brain injury history
* Can not cooperate during the therapy, due to delirium or aphasia
* Unstable medical conditions
* Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms)
* Pregnancy
* Can not maintain sitting posture
A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers

The main objective of this study was to compare the bioavailability of two test formulations of Naloxone Nasal Spray with the reference formulations of Naloxone HCl IV and IM injection under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* A minimum body weight of 50 kg. Body mass index (BMI) between 18.0 and 32.0 kg/m2
* A seated blood pressure between 90 and 140 mmHg systolic/50 and 90 mmHg diastolic
* Female subjects had a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test at screening

Exclusion Criteria:

* A known allergy or history of significant adverse reaction to naloxone, other opioids or related compounds, or to any of the excipients
* Any documented clinically significant infection, injury, or illness within 1 month prior to screening
* An active malignancy of any type, or had been diagnosed with cancer within 5 years prior to screening
* A documented history of alcohol or drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within 2 years prior to screening
* A positive urine test result for alcohol, drugs, or cotinine at screening or check-in
* A condition that the investigator believed would have interfered with the ability to provide informed consent or comply with study instructions, or that could confound the interpretation of the study results or put the subject at undue risk
* Used any opioids for 30 days prior to Day 1
* Required treatment with monoamine oxidase inhibitors (MAOIs) within 30 days prior to Day 1 and during the study.
* Presence of an ongoing upper respiratory infection, rhinitis, rhinorrhea, or nasal congestions
Prosthetic Valve and Graft Endocarditis With Mycobacterium Chimaera

Mycobacterium chimaera infections have occurred in post-cardiac surgery patients in association with contaminated cardiac bypass heater-cooler devices.

So far optimal therapeutical concepts are not clear. At the University Hospital Basel Mycobacterium chimaera- infected protheses are replaced to decrease pathogenic burden and to support antibiotic long- term treatment. This study is to analyze the efficacy of this therapeutic approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Mycobacterium chimaera infections after cardiac surgery at University Hospital Basel

Exclusion Criteria:

* none
Avonex 15 Year Long Term Follow-up Study

The Avonex Fifteen-year Long-term Follow-up of Patients with Relapsing Multiple Sclerosis: ASSessment of Drug Utilization, EaRly TreAtmeNt, and Clinical OutcomEs (ASSURANCE), was a single-time-point evaluation of patients conducted 15 years after the pivotal MSCRG study, evaluated the impact of IM IFNβ-1a treatment on long-term disability and Quality of Life outcomes in patients who completed 2 years in a previous Multiple Sclerosis Collaborative Research Group (MSCRG) study.

The primary objective of this study is to determine the impact of early versus delayed initiation of treatment on the long-term physical status of patients with relapsing forms of MS measured by the self-reported EDSS.

Primary endpoints for this study were as follows:

1. Changes in EDSS score from baseline for original Avonex® pivotal trial
2. Percentage of patients with EDSS scores less than or equal to 4
3. Percentage of patients with EDSS scores less than or equal to 6
4. Percentage of patients with EDSS scores less than or equal to 7

Secondary endpoints were:

1. Percentage of patients alive
2. Percentage of patients living independently
3. SF 36 Quality of Life status
4. Self-reported VAS of independence with self-care

Eligibility Criteria:
Inclusion Criteria:

1. Patients having completed at least 2 years of treatment (Avonex® or placebo) in the original Avonex® pivotal trial.
2. Subjects (or their caregivers) must be willing to complete a multi-page questionnaire.
3. Signed written informed consent form

Exclusion Criteria:

1. Unwillingness or inability to comply with the requirements of this protocol.
2. Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study
The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , respectively, to study the difference in efficacy between the groups.

This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique.

Eligibility Criteria:
Inclusion Criteria:

* acute closed single-legged complete Achilles tendon rupture .
* age of 18 to 60 years.

Exclusion Criteria:

* patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment).
* an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) .
* those without rehabilitation or follow-up outcomes.
Intravenous Access Time in Pediatric Patients

In pediatric patients with no vascular access, anesthesia induction is usually achieved with sevoflurane. The aim of investigators to evaluate the optimum intravenous access time and the corresponding bispectral index (BIS) value in pediatric surgery under sevoflurane anesthesia.

Patients undergoing anesthesia induction must have at least one vascular access opened for administration of intravenous drugs and fluid. In pediatric patients, fear of needles and anxiety about pain can cause discomfort. For this reason, inhalational anesthetics are commonly used for anesthesia induction in children. An ideal inhalational anesthetic agent should have a smooth and fast onset, little irritation to the respiratory tract, and no undesirable side effects. Sevoflurane meets almost all these criteria, so it is commonly used for anesthesia induction in pediatric patients.

Studies related to the induction of anesthesia with sevoflurane have mostly focused on the ease of LMA insertion, the recovery characteristics, the hemodynamic variabilities, comparison of high and low initial sevoflurane concentrations, and cost comparisons between fixed 8% versus incremental techniques. However, after loss of consciousness, children subjected to early intravenous cannulation during sevoflurane induction can display movement, breath holding, coughing, and even laryngospasm. Only limited data are available in the literature regarding intravenous access time at anesthesia induction. The aim of the present study was to evaluate the bispectral index (BIS) values and sevoflurane concentrations during induction of anesthesia and to determine the optimum intravenous access time in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* Age between 2 months to 11 years
* Patients scheduled for day case surgery (including inguinoscrotal hernia or hydrocele, undescended testis, hypospadias, or routine circumcision)
* Diagnostic procedures (e.g., cystoscopy) or external ventricular drainage.

Exclusion Criteria:

* Obesity
* Malnutrition
* Gastroesophageal reflux disease
* Allergy
* Sensitivity to volatile anesthetics
* Procedures lasting more than two hours.
A Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of DWC202206 and DWC202207 in Patients With Concomitant Hypertension and Hyperlipidemia

This study aims to evaluate the efficacy and safety of co-administration of DWC202206 and DWC202207 in patients with concomitant hypertension and hyperlipidemia.

The study design is a randomized, double-blind, multicenter clinical trial. The patients were randomly assigned to each group. Primary endpoint was the change of MSSBP based on baseline between Treatment arm and control 1 arm and the change of LDL-C based on baseline between arm and control 2 arm.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 80 years
* Patients with hypertension and hyperlipidemias

Exclusion Criteria:

* Orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* Uncontrolled diabetes mellitus
The Effect of Intranasal Insulin on Hepatic and Intestinal Triglyceride-rich Lipoprotein Production

This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut. Recent research suggests that insulin may work through the brain. The investigators hypothesize that preferential delivery of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats made by the liver and gut.

Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. In study A they will receive a single dose of insulin 40 IU through nasal spray. In study B they will receive placebo. On the day of the study subjects will drink regular liquid nutrient formula to maintain a constant fed state. A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) will be started at 7am. From 9am a regular infusion of a stable isotope tracer will be started together with nasal spray of either insulin/placebo. Regular blood samples will be drawn to assess lipoprotein kinetics.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18 to 60 years
2. Body mass index 20 to 40 kg/m2
3. Hemoglobin in the normal range.
4. Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
5. Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.

Exclusion Criteria:

1. Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
2. Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
3. Any current or previous history of endocrine disease, dyslipidemia or malignancy
4. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine \> 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic pressure \> 100 or systolic \> 180 or systolic pressure \<100) or proliferative retinopathy
5. Use of immunosuppressive agents at any time during the study
6. Allergy to any study medication
7. Pregnancy or breastfeeding
8. Heavy smoker
9. Fasting blood glucose \> 6.0 mmol/l or known diabetes.
10. Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on electrocardiogram, unstable angina, or decompensated heart failure.
11. Any nasal pathology.
12. Any laboratory values: aspartate aminotransferase \> 2x upper limit of normal ; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 milliunit per litre
Prognostic Factors for Treatment Responses in Patients With Active Lupus Nephritis at Sohag University Hospital

Systemic lupus erythematosus (SLE) is an autoimmune disease which may give rise to multiple organ involvement because of immune complex deposits. Lupus nephritis (LN) is one of the severe manifestations of systemic lupus erythematous (SLE) and a common cause for end-stage renal disease, significantly affecting the survival of SLE patients Immunosuppressive treatment is the major therapy for active LN. Generally, at least six months are needed to assess treatment responses Failure to respond to immunosuppressive therapy can lead to a worsening of renal function

This study will be prospectively analyzing the clinical data of LN patients who received standard immunosuppressive therapy and were regularly followed up at our center for more than six months. These patients will not change treatment regimen during the six months.

As remission is an independent predictor of good long term prognosis in lupus nephritis. We aim to examine the predictors of sustained complete renal remission in patients with lupus nephritis at Sohag University Hospital and to analyze data of lupus nephritis patients to find parameters that can predict remission and improve outcome of our cases

Eligibility Criteria:
Inclusion Criteria:

* o Patients diagnosed with LN at Sohag University Hospital

  * Patients in regular follow-up for more than six months after immunosuppressive therapy
  * Baseline urinary protein/creatinine ratio (UPCR) more than 1 g/g
  * Baseline C3 less than 55 mg/ dl
  * No change in immunosuppressive therapy within six months

Exclusion Criteria:

* o Patients with incomplete pathological data and the number of glomeruli being \<10 per biopsy specimen

  * Age \<14 years old End-stage renal disease (ESRD) status on admission (sustained estimated glomerular filtration rate (eGFR) \<15 ml/min per 1.73m2)
  * Patients with advanced comorbid conditions like advanced liver cirrhosis or heart failure or malignancy
Prevention of Pelvic Lymphocele by Floseal During Pelvic Lymphadenectomy for Gynecologic Cancer

Pelvic lymph node dissection (PLND) is an important step in the surgical staging and treatment of gynecologic malignancies.

Sometimes, complicated lymphoceles after PLND often delay adjuvant treatment including chemotherapy and radiation therapy, which potentially affects the success of cancer treatment.

A number of surgical techniques have developed, but failed to reduce the incidence of pelvic lymphoceles after PLND.

The investigators hypothesized that floseal can prevent lymphoceles in patients with gynecologic cancer who has undergone PLND.

The investigators designed prospective randomized controlled study as a pilot study.

The investigators will randomly apply floseal to one side of pelvis after bilateral PLND, and observe the occurence of pelvic lymphoceles after 6 months later.


Eligibility Criteria:
Inclusion Criteria:

* Gynecologic cancer patients who need laparotomic bilateral PLND

Exclusion Criteria:

* Incomplete PLND which can influence the occurrence of lymphocele (surgeon's decision)