cyrilzakka/clinical-trials huggingface dataset:
Effects of Chinese Medicine on Early Pregnant Women

From April 2021 to December 2021, 55 pregnant women who received intro fertilization-embyro transfer (IVF-ET) were recuited. According to their own wishes, 38 of them took Chinese medicine from the 2nd week after embryo transfer (intervention group), while the remaining 17 did not intake Chinese medicine (control group). Blood and feces samples were collected in the early morning of the 4th and 6th week after embryo transfer to detect 16S DNA sequences in feces, plasma metabolites, and whole blood transcriptomics.

Investigators planned to performed a observational clinical trial to determine the effects of the Chinese medicine (Gushen Antai recipe) including mainly Rehmannia glutinosa used in pregnant women for fetal protection. Two groupswere recruited, Chinese medicine intervention group and control group without Chinese medicine. In the 4th and 6th week after embryo transfer, blood and fetal were sampled for metabolic and intestinal microbiota analysis.

Eligibility Criteria:
Inclusion Criteria:

* recieved IVF
* childbirth without miscarriage
* taking vitamins during pregnancy

Exclusion Criteria:

* miscarrige
* missed sampling in the fourth week of pregnancy
* not appropriate judged by the doctor
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Eligibility Criteria:
Inclusion Criteria:

* Patient with severe degenerative native aortic stenosis (AS).
* Patient at high risk for open surgical valve replacement
* Patient symptomatic according to NYHA functional class II or higher

Exclusion Criteria:

* Congenital uni- or bicuspid aortic valve morphology
* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
* Endocarditis or other active infection
* Need for urgent or emergent TAVR procedure for any reason
* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
Retrospective Study of the Results of Cooled Radiofrequency for Genicular Nerves Neurotomy in 40 Consecutive Patients With Osteoarthritis of the Knee and Painful Knee Arthroplasty

Analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow- up.

The investigators performed a retrospective case-series reviewed of 40 patients who underwent cooled RF of genicular nerves. The investigators evaluated results of the survey of quality of life (SF36), knee society score (KSS) and the Visual Analogue Scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Chronic knee pain (older than 3 months, with no response to physiotherapy, medication or hyaluronic acid infiltration) with a pain intensity according to VAS\>7/10
* The radiological criteria were witness of OA with Kellgren-Lawrence index of 2 to 4.
* Painful TKA with no apparent cause and with a radiological image where a proper placement was observed

Exclusion Criteria:

* Infection or lymphangitis of the member
* Acute knee pain
* Corticoids or hyaluronic acid infiltration with a high molecular weight prior to the surgery
* Pregnancy
* Severe neurological or psychiatric disorders
* Patients with pacemakers
Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in ACS Patients

The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute Coronary Syndrome (ACS) patients.

This is a prospective, open-label, parallel group study to evaluate the efficacy of rosuvastatin 10mg/d or 20mg/d on critical coronary atherosclerosis in Chinese ACS patients. The anticipated duration of the study is approximately 36 weeks, Patients with angiographic luminal diameter narrowing in any non-culprit site between 40%-70% will be enrolled from the study site. The primary efficacy parameter is the percent change of Total Atheroma Volume (TAV) of critical coronary atherosclerosis after 36 weeks of treatment.

For inclusion in the study subjects should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures
2. 18 to 75 years old ACS patients, male or female
3. The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%
4. statin-naive, defined as receiving no statin therapy within 3 monthsThe primary efficacy variable of the study is percent change of TAV from baseline after rosuvastatin 10mg/d or 20mg/d for 36 weeks as determined by IVUS imaging.

The secondary efficacy variables are:

* Change of blood lipid level from baseline at 12th, 24th, 36nd week
* Change of inflammatory markers from baseline at 36nd week
* Change of Percent Atheroma Volume (PAV) as determined by IVUS imaging at 36nd week

Eligibility Criteria:
Inclusion Criteria:

1.Provision of informed consent prior to any study specific procedures; 2.18 to 75 years old ACS patients, male or female; 3.The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%; 4.statin-naive, defined as receiving no statin therapy within 3 months;

Exclusion Criteria:

1. Have received statin therapy within 3 months;
2. The angiographic luminal diameter narrowing in any coronary vessels is more than 70%;
3. Active liver disease, ALT≥3\*ULN;
4. Renal function damage, CrCl\<30ml/min;
5. Myopathy;
6. Pregnancy, lactation female;
7. Using cyclosporine;
8. Patients with uncontrolled triglyceride levels TG≥5.65 mmol／L;
9. Poorly controlled diabetes (HbA1c≥10%）Hypersensitivity to rosuvastatin or any of the recipients.
Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery

The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old who agree to participate in the study having signed informed consent
* Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).
* Chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery

Exclusion Criteria:

* Presence of other ophthalmological pathologies (except cataract)
* History of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery
* Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry \< 490 μm or \> 620 μm.
* Presence of severe systemic pathologies, pregnant or breastfeeding woman
Effects of a Carbonated Water Enriched With Amino Acids and Chromium Picolinate (Good Idea®) on Glucose Homeostasis.

It has previously been shown in healthy subjects, that a carbonated water containing a mix of amino acids and chromium picolinate can decrease postprandial blood glucose. Based on these findings, a flavored sparkling water product called Good Idea® with a proprietary blend of five amino acids and chromium picolinate has been developed. This product, along with an identical placebo, are included in this study to evaluate the effects on postprandial blood glucose in healthy, overweight adults when consumed with a standardized, high glycemic test meal. The study will be conducted in a cross-over design, double-blinded and placebo controlled, including 45 participants. The primary endpoint of the study is the incremental area under the curve (iAUC) for capillary blood glucose within 180 minutes after ingestion of the meal.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 50 years of age
* BMI 25-29.9 (±0.5) kg/m²
* Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
* Healthy as determined by medical history and information provided by the volunteer
* Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Elevated fasting blood glucose (at or above 6.1 mmol/L)
* Women who are pregnant or breast feeding
* Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
* Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the qualified investigator (QI). Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
* Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
* Use of antibiotics within 2 weeks of enrollment
* Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
* Allergy to ingredients included in investigational product, placebo or standardized meal
* Participants restricted to a vegetarian or vegan diet
* Intolerance to lactose or gluten
* Individuals who are averse to venous catheterization or capillary blood sampling
* Currently active smokers (or using other tobacco products, and e-cigarettes)
* Unstable medical conditions as determined by QI
* Participation in other clinical research trials
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Acute infection
* Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)

This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.


Eligibility Criteria:
Inclusion Criteria:

* Macular Edema
* Prescribed OZURDEX®

Exclusion Criteria:

* None
Value-based Cognitive Behavioral Therapy for Prevention of Chronic Whiplash-associated Disorders

The purpose of this study is to determine whether a specifically tailored value-based cognitive behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury.

The primary objective of the present study is to test whether a specifically tailored value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development of persistent disability, pain, and psychological distress if delivered within the first three months after a whiplash injury. Methods. The current study is a two-armed randomized controlled study with a crossover design. Group A is scheduled for V-CBT within one week of randomization and group B with a delayed onset 3 months after randomization.

Eligibility Criteria:
* 18 and 65-years-old
* WAD level I-II.
* 3-months post-injury
* Disability in at least one important life domain (≥ 5 on the pain disability index) and moderate levels of pain (average pain intensity ≥ 4 on the NRS scale).
* Meet at least one of the psychological risk criteria:
* Elevated levels of pain catastrophizing, fear-avoidance-beliefs, symptoms of anxiety and/or depression, and posttraumatic stress symptoms.
Effect of Limb Occlusion Pressure Attainment on Cardiovascular, Perceptual, and Performance Responses

To test the effect of limb occlusion pressure attainment in the supine, seated, and standing position on exercise performance, vascular physiology, and muscle.

The purpose of this study is to investigate the attainment of limb occlusion pressure (LOP)in the supine, seated, and standing positions on indices of arterial stiffness, muscle morphology, participant perception, and performance responses. Thirty adults aged 18-40 will undergo four treatment sessions (control (no BFR), supine LOP, seated LOP, and standing LOP) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). All sessions will consist of four sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, perceptual responses, and exercise performance.

Eligibility Criteria:
Inclusion Criteria:

* Physically active (\> 1,000 MET/min/wk) for at least six months. Weight stable for previous 6 months (+/-2.5 kg) Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion Criteria:

1. BP\>140/90 mmHg
2. BMI\>40 kg/m2
3. Diabetes
4. Familial hypercholesterolemia
5. Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
6. Women must not be pregnant, plan to become pregnant during the study, or be nursing
7. Active renal or liver disease
8. All medications and supplements that influence dependent variables\*
9. Recent surgery \< 2 months
10. Alcohol abuse
11. Sleep apnea
12. Claustrophobia
Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

There are publications showing a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing Extracorporeal Membrane Oxygenation (ECMO) however, there is not enough data. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency.

The Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.

ECMO is applied in patients with acute severe heart or lung failure. The treatment protocol of patients undergoing ECMO is carefully arranged against the risk of bleeding / thrombosis.

According to the general protocol, heparin infusion therapy is started at the 24th hour after ECMO application. The risk of bleeding / thrombosis is avoided by adjusting the heparin infusion dose with Activated Clotting Time (ACT) control. However, over time, thrombocytopenia and fluctuations in ACT level are observed in patients. It may be necessary to increase the dose of heparin given during the prolonged period. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency. There are publications reporting a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing ECMO; however, there is not enough data.

The Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Patients with ECMO run for 3 days or more (to be able to determine at least 3 antithrombin 3 levels)

Exclusion Criteria:

* Patients with ECMO run less than 3 days
Tracking CF Lung Disease Through the Early Years: Utility of the LCI

This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.

This is a prospective observational cohort study. During the 3 year study period, each participant will be followed for a period of 2 years. The study will include quarterly measurements of the lung clearance index (LCI), as well as spirometry, for CF patients at their routine clinic visits. Parents of patients with CF will be asked to call the study nurse or clinical nurse if they experience a worsening of pulmonary symptoms and to come to the clinic for assessment of lung function. CF patients will then be assessed by a CF physician to assess whether they require antibiotic treatment based on a clinicians decisions to treat with antibiotics. The treatment decision will be left to the discretion of the patient's responsible physician, who will be blinded to the MBW results. All patients who meet the symptom based definition of a pulmonary exacerbation, regardless of treatment decision, will have MBW measured after 4 weeks. Following these visits at the time of an exacerbation, patients will have their MBW measured at their next clinic visit (usually within 3 months), and every 3 months thereafter until the end of the 2 year observation period, or the repeat onset of symptoms.This study will capture a maximum of two exacerbations per patient over the 2 year study period.

Eligibility Criteria:
Inclusion Criteria for Healthy Controls:

* Informed consent by patient or parent/legal guardian, verbal assent where appropriate
* Age 3 years to 16 years old
* Clinically stable with no signs of an acute exacerbation at enrollment visit
* Previously participated in a longitudinal MBW study at the Hospital for Sick Children and at the Riley Hospital for Children

Inclusion Criteria for CF Patients:

* Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
* Informed consent by patient or parent/legal guardian, verbal assent where appropriate
* Age 3 years to 16 years old
* Clinically stable with no signs of an acute exacerbation at enrollment visit

Exclusion Criteria:

* Previous organ transplantation
* Chronic lung disease not related to CF, such as asthma
* Use of intravenous antibiotics or other course of oral antibiotics (excluding maintenance treatment antibiotics) within 14 days of enrollment visit
* Physical findings at screening that would compromise the safety of the participant or the quality of the study data
Retrospective Analysis of Renal Prognosis in Patients With Chronic Kidney Disease

During 1993 and 2006, a total of 987 patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital. 404 patients with membranoproliferative glomerulonephritis and mesangioproliferative glomerulonephritis, and patients with secondary glomerulonephritis or other renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis, acute tubular necrosis, and tubulointerstitial nephritis will be analyzed. The demographic characteristics and laboratory data of these patients at presentation or before renal biopsy will be recorded. These data included parameters such as age, sex, diabetes, hypertension, immunosuppressants treatment, BUN, serum creatinine, albumin, hemoglobin, total cholesterol, triglycerides, and urine protein. All subjects will be followed until 2015 for occurrence of primary endpoints, including all-cause death or ESRD requiring long-term dialysis or renal transplantation. A total of 433 patients who had been followed for 3 years during 2003 and 2007 will receive regular clinic follow-up. GFR will be estimated according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula: 186 x Scr -1.154 x age -0.203 x 0.742 (if female). CKD stage will be determined as described by the National Kidney Foundation of the United States. At the time of entry, GFRs of 30-59, 29-15 and \< 15 ml/min/1.73 m2 for more than 3 months will be classified as CKD stages 3, 4 and 5, respectively. Baseline Data of the 433 patients are used as recorded at the beginning during 2003 and 2007. The observation period of each patient is defined to start immediately after the registered measurement of serum creatinine satisfying the above criteria (designated as the index date) and lasted until ESRD or end of 2015. ESRD is defined as initiation of RRT, i.e. chronic dialysis or renal transplantation.


Eligibility Criteria:
Inclusion Criteria :

* Patients older than 20 years.
* Patients underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as diabetic nephropathy, lupus nephritis, rapid progress glomerulonephritis.
* Patients were classified as CKD stages 3A, 3B, 4 and 5 at the time of entry.

Exclusion Criteria :

* Patients younger than 20 years.
* Patients older than 20 years underwent native kidney biopsy at the Renal Division of this hospital, and with renal pathologies, such as membranoproliferative glomerulonephritis, mesangioproliferative glomerulonephritis, secondary glomerulonephritis, or other renal pathologies, such as, acute tubular necrosis, and tubulointerstitial nephritis.
* Patients older than 20 years but eGFR ≧ 60 ml/min/1.73 m2 at the time of entry.