cyrilzakka/clinical-trials huggingface dataset:
Amplatzer Amulet China Post Market Study (PMS)

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Atrial fibrillation (AF) is the most common sustained heart rhythm disorder. During AF, chaotic electrical activity results in rapid, uncoordinated, and insufficient contractions of the atrial chambers. Stagnation of blood flow in the left atrium (LA) can lead to hypercoagulability. The left atrial appendage (LAA), given its location and complex shape is often the primary site of stasis and thus increases the risk for thrombus formation. Approximately 90% of all thrombi in patients with non-valvular AF (NVAF) forming in the LA originate in the LAA.

Patients with NVAF are at an increased risk of systemic embolism and stoke due to the potential for clot forming in the LAA. OAC is the recommended first-line therapy for NVAF at increased risk of stroke, however, many patients have relative or absolute contraindications to taking OACs. LAAO offers a non-pharmacological option for stroke risk reduction in these patients unable to take OAC.

The Amulet occluder is Abbott's second-generation LAA occlusion device. It received CE Mark in 2013, and FDA approval in August 2021. Observational studies performed in multiple geographies show that the Amulet occluder can be safely implanted with good procedural outcomes and reduce the risk of stroke as compared to a predicted rate without the need for anticoagulation in most patients. This led to the National Medical Products Administration (NMPA) approval of the Amulet occluder in 2020.

The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.

Eligibility Criteria:
Inclusion Criteria:

1. Documented non-valvular atrial fibrillation and contraindicated for long-term oral anticoagulation, or in those who are taking oral warfarin but still develop stroke or relevant events
2. Meets the current device indications and per physician discretion for Amulet implant
3. Able to provide written Informed Consent prior to any study related procedures
4. 18 years of age or older at the time of enrolment

Exclusion Criteria:

1. With the presence of intracardiac thrombus
2. With active endocarditis or other infections producing bacteremia
3. Patients whose low risk of stroke (CHA2DS2-VASC score is 0 or 1) or bleeding (HAS-BLED score \< 3)
4. Where placement of the device would interfere with any intracardiac or intravascular structures
5. Has a life expectancy of less than 2 years due to any condition
6. Currently participating or planning on participating during the follow up period of this study in a clinical study that includes an active treatment arm or a concurrent clinical study which may confound the results of this trial
Study of PG2 Injection for Improving Fatigue in Patients After Palliative Abdominal Surgery for Cancer

PG2 has been approved in Taiwan to treat cancer-related fatigue for advanced cancer patients. The primary objective of this study is to evaluate the efficacy of PG2 on fatigue relief in patients undergoing palliative abdominal surgery for cancer. The secondary endpoints, including the length of hospital stay, postoperative complications, HRQL, inflammatory biomarkers, the duration of antibiotic therapy, mortality during the hospital stay, weight loss and body composition, will be evaluated among these patients.

This will be a double-blind, randomized, and placebo-controlled study. At least 40 evaluable patients who are scheduled for palliative abdominal surgery for cancer will be randomly assigned to the control or treatment group. Each group will have at least 20 patients and be treated as follows: 1) control group: patients will accept placebo 1 dose a day (POD-1) before surgery and 1 dose a day for 3 days after surgery (POD+0 to POD+2); 2) treatment group: patients will accept PG2 1 dose a day (POD-1) before surgery and 1 dose a day for 3 days after surgery (POD+0 to POD+2).

Eligibility Criteria:
Inclusion Criteria:

* Patients who have cancer and are scheduled for palliative abdominal surgery for cancer
* Age \> 20 years older
* Patients who signed the informed consent form

Exclusion Criteria:

* Patients, at screening, has levels greater than 2.5 times the upper limit of normal liver function of alanine aminotransferase or aspartate aminotransferase.
* Patients has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for range); or the subject is on dialysis.
* Patients have ongoing infection, respiratory tract dysfunction, cardiac dysfunction or immune disorder that, in the opinion of the investigator, may interfere with conduct of the study.
* Patients who are not suitable for undergoing surgery (e.g. congenital hemostatic disorders) by the investigator's judgment.
* Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening.
* Female patients are pregnant or breast-feeding.
* Patients who require preoperative nutritional support
* Patients with serious comorbidities (American Society of Anesthesiologists Risk Class of 4 or 5).
* Patients who is unwilling or unable to answer the quality of life questionnaires i.e. the BFI-T and EORTC QLQ-C30.
Pharmacokinetic Study to Determine Time to Steady-state

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Eligibility Criteria:
Inclusion Criteria:

* Male, age 18-75
* Morning serum testosterone (T) \<300 ng/dL on two occasions
* Naive to androgen-replacement therapy or willing to wash-out from current T therapy

Exclusion Criteria:

* Significant intercurrent disease
* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.
* Serum transaminases \>2 times upper limit of normal
* Serum bilirubin \>2.0 mg/dL
* Hematocrit \<35% or \>50%
* BMI \>36
* Untreated, obstructive sleep apnea.
A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents

A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering ASNase results in the depletion of asparagine circulating in the blood, which starves the leukemic cells and results in their death. But indeed the use of ASNase varies between protocols considering the different brands, the dose and the administration modalities. Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native ASNase.

This is a French prospective multicentric cohort study of children and adolescents with ALL, stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3 groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).

It aims to answer to two different issues:

1. Randomized question: what is the best way to administer pegaspargase? A cohort of children and adolescents with standard or medium risk ALL will be randomized to receive during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or 1250 IU/m2 per dose during consolidation and delayed intensification according to the initial arm of randomization.
2. Non randomized question: In the High/Very High Risk groups, a non randomized intensification of the scheme of asparaginase administration is proposed during induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All patients will receive 2500 IU/m2 per dose during consolidation and delayed intensifications.


Eligibility Criteria:
Inclusion Criteria:

* ALL L1 or L2
* B-lineage or T- lineage ALL

Exclusion Criteria:

* L3 (Burkitt's leukemia)
* Mixed Phenotype Acute Leukemia (WHO criteria).
* Infant ALL (age ≤ 365 days)
* Philadelphia (Ph)+/Breakpoint Cluster region (BCR)-Abelson (ABL) ALL
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa

The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children. The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels.

A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey's Hospital in Pietermaritzburg, South Africa. Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months. Baseline measurements of plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were established at two study visits prior to randomization, and measurements were repeated 3, 6 and 9 months after starting supplementation. Plasma HIV-1 viral load and the percentage of CD4+ T-lymphocytes were compared before and after supplementation.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infection
* 6 to 60 months of age
* Not receiving antiretroviral therapy
* Cared for as outpatients at Grey's Hospital

Exclusion Criteria:

* Receiving antiretroviral therapy
The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization

Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.

Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* Being in accordance with time and place
* Being aged between 18 and 65 years
* Being able to evaluate the visual analog scale correctly
* Participating voluntarily in the research.

Exclusion Criteria:

* Not participating voluntarily in the research
* Not fitting the inclusion criteria of the research
* Having a vision or hearing problem
* Having a mastectomy
* Having any illness which could affect pain perception, such as sensory-motor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy
* Having an allergy to heat and cold application
* Having phlebitis, scar tissue, dermatitis, an incision or findings of infection at the place where the intervention was to be performed
* Having taken an analgesic (within the previous six hours) or an anesthetic agent before the peripheral intravenous catheterization procedure
Use of Canagliflozin in Conjunction With Insulin in a Real-world Setting

This study is a retrospective chart review study aiming to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy. Furthermore, the project aims to establish an EMR-based cohort of patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin to allow for future longitudinal studies that investigate outcomes over a longer follow-up period, and whether canagliflozin (when used in addition to insulin therapy) has an impact on diabetes-related healthcare costs.

This retrospective study will use data from an Electronic Medical Record (EMR)-based database (Web based Diabetes Records (Web DR) researchable database), which has been used to study patient's socioeconomic characteristics, treatment patterns and health outcomes of patients with diabetes. The Web DR de-identified researchable database contains integrated demographic, clinical and laboratory test result data of patients who received care from outpatient diabetes clinics in London, Ontario. The database includes more than 16,000 patients and their clinic visit information since 2000.

Adult individuals (age\>=18) with type 2 diabetes receiving , registered in Web DR who have been treated with canagliflozin in conjunction with insulin therapy will be selected for this study. The baseline period will be 6 months to allow for more complete observation of comorbidities and medication use patterns.

The main objective of this project is to assess the characteristics and health outcomes of patients with type 2 diabetes treated with canagliflozin when used in addition to insulin therapy.

HbA1c, lipid, blood pressure, weight and other clinical indicators will be gathered from lab results during the baseline period closest to the date of canagliflozin prescription and follow up period (the last clinical value within the follow-up period and \>=30 days after the start of the medication data will be selected.

The type of insulin used and dosages prescribed during the study follow-up period will be extracted from the database to examine the insulin dosage prescription pattern and understand the use of insulin with canagliflozin and its impact on clinical outcomes.

Furthermore, use of oral antihyperglycemic agents (metformin, sulfonylureas, thiazolidinedione, alpha-glucosidase inhibitors, meglitinides, Dipeptidyl peptidase-4 (DPP-4) inhibitors, bromocriptine) and injectable antihyperglycemic therapies (pramlintide, Glucagon-like peptide-1 (GLP-1) receptor agonists) will be measured during the 6 months baseline period and the follow-up period of 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Type 2DM \>18 years of age, diabetes patients on insulin who initiated Canagliflozin due to a need of tighter glycemic control .

Exclusion Criteria:

* glomerular filtration rate (GFR)\<45, pregnancy, type 1
Effects of Sand Exercise Program On Foot Posture , Navicular Drop and Dynamic Balance in Children With Pronated Foot

This randomized controlled trial investigates the effects of combining sand training with navicular drop interventions on foot posture and dynamic balance in children aged 6-11 with pronated feet. Pronated foot posture, marked by inward foot rolling and a lowered arch, can impair gait and balance. Early intervention is key to preventing long-term issues. Twenty participants will be divided into experimental and control groups. Over eight weeks, the experimental group will perform sand and towel curl exercises, while the control group will do towel curls only. Foot posture, navicular drop, and balance will be assessed using the FPI-6, Navicular Drop Test, Y Balance Test, and Feiss Line Test at baseline, 4 weeks, and 8 weeks. The study aims to evaluate the added benefits of sand training in improving pediatric foot health.

The effects of sand training exercises combined with navicular drop interventions on dynamic balance and foot posture in children aged 6 to 11 years with pronated feet. Pronated foot posture, characterized by the inward rolling of the foot and a lowered medial arch, is prevalent in pediatric populations and can lead to altered gait mechanics and reduced dynamic balance. Early intervention is crucial to prevent long-term deformities and improve overall foot health. The study aims to provide evidence-based insights into the benefits of integrating proprioceptive training with specific sand exercises program targeting the navicular bone, thereby enhancing foot posture and dynamic balance in affected children.

This randomized controlled trial (RCT) will involve 20 participants divided into an experimental group and a control group to assess the effects of an 8-week exercise program on foot health in children with pronated feet. The experimental group will perform sand activities and towel curl exercises three times a week, while the control group will only perform towel curl exercises. The study will measure foot posture, navicular drop, and dynamic balance using the Foot Posture Index (FPI-6), Navicular Drop Test, Y Balance Test, and Feiss Line Test, with assessments conducted at baseline, 4 weeks, and 8 weeks post-intervention. This study aims to provide evidence on the effects of combining sand training with towel curl exercises for determining foot posture.

Eligibility Criteria:
Inclusion Criteria:

* Children aged \[6-11\] years with bilateral pronated feet.
* Both gender
* No recent foot injury or lower extremity pain from last six months
* Has no history of foot and ankle surgery lifetime
* All eligible children were assessed with the Feiss line method

Exclusion Criteria:

* the presence of pain in the foot at the time of physical examination
* injury to the lower limbs, such as musculoskeletal injuries, during the previous 6 months congenital structural abnormalities, cerebral palsy, motor dysfunction prior surgery affecting the foot
Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles

The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich in polyunsaturated fatty acids (PUFA) in individuals with or without obesity and Type 2 diabetes (T2D)

The gut microbiota interacts with the host's enteric and systemic functions through the production of gut microbiota-derived metabolites. A subset of these metabolites, the endocannabinoids (eCB) and their congeners are derived from fatty acids and play a crucial role in metabolic health.

The research project aims to study gut microbiota-derived metabolites, including the eCB and their congeners, in response to a 2-day diet rich in polyunsaturated fatty acids or rich in saturated fatty acids in individuals with or without abdominal obesity and type 2 diabetes.

The investigators hope to better understand the kinetic production of circulating endocannabinoidome mediators derived from fatty acids in the diet.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 45 and 65 years, menopaused women ;
* Body mass index between 20 to 35 kg/m² ;
* General good health ;
* Score of diet quality (HEI) between 40 and 70 ;
* Computer and Internet access ;
* Basic understanding of written French ;
* Daily stool frequency.

Exclusion Criteria:

* Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers ;
* Alcohol consumption greater than 15 portions for men and 10 for women weekly.
* Active tobacco and cannabis usage ;
* Consumption of omega-3 dietary supplements ;
* Consumption of dietary supplements (vitamins and probiotics) - must be ceased 2 weeks before the dietary intervention ;
* Completion of a course of antibiotics in the past 3 months ;
* Important weight change (+/- 5 kg) in the past 6 months ;
* Type 1 diabetes or insulin-treated diabetes.
Endoscopic Anatomy of the Breast Fascia System

This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory. The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions. However, an intriguing phenomenon contradicting this developmental process was discovered through endoscopic mastectomy, which has not been previously discussed. Based on the aforementioned theoretical analysis, this study includes patients who underwent endoscopic and reduction mammaplasty in the Department of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University. The investigators proposed the following research framework: firstly, comprehensively understanding the structure of the breast fascia and the sequence of breast development through endoscope and existing research; secondly, exploring the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty; lastly, proposing a reverse development theory for breast fascia based on these theories in order to provide standardized and procedural guidance for breast surgeons.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.

Exclusion Criteria:

* breast conserving surgery
Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.

Eligibility Criteria:
Inclusion Criteria:

Advanced Parkinson's disease

* The clinical decision of DBS treatment
* The clinical inclusion criteria of DBS treatment:
* drug-resistant tremor
* severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication
* an improvement of UPDRS III scores over 30 % in levodopa challenge test.

Exclusion Criteria:

* The general exclusion criteria for DBS treatment:
* a major depression
* on-going psychosis
* a significant brain atrophy observed in a brain MRI
* a suspicion of atypical parkinsonism
* marked cognitive decline.
Kinect-based Upper Limb Rehabilitation System in Stroke Patients

The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.

In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.

20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.


Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 80 years
* Stroke within prior 3 months
* Unilateral upper extremity weakness

Exclusion Criteria:

* Uncontrolled medical conditions
* Who cannot obey the simple command
* Who has the hemispatial neglect, visual impairment, apraxia