cyrilzakka/clinical-trials huggingface dataset:
Outcomes of a Deep Inferior Epigastric Perforator Flap Program

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.

Eligibility Criteria:
Inclusion Criteria:

* Intraductal carcinoma
* Lobular carcinoma
* Infiltrating ductal carcinoma
* Paget's disease
* BRCA positive

Exclusion Criteria:

* Inflammatory carcinoma of the breast
Hemodialysis Reliable Outflow (HeRO) Vascular Access Patency Study

Compare the HeRO Vascular Access Device to a conventional ePTFE graft.

The purpose of this study is to compare the HeRO Vascular Access Device to a conventional ePTFE graft. It is hypothesized that HeRO patency will be comparable to the conventional ePTFE graft control.

Eligibility Criteria:
Inclusion Criteria:

1. 22 years of age or older.
2. Male or non-pregnant female.
3. Life expectancy 2 years.
4. End-stage renal disease requiring an arm vascular prosthesis for dialysis access.
5. Ability to understand and provide written informed consent.
6. Willing and able to cooperate with follow-up examinations.
7. Subject's upper arm can be used for implant (Note: The GVAS device must be implanted in the upper arm only, but the Control group graft can be implanted in the upper or lower arm location.).
8. Able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen.

Exclusion Criteria:

1. Potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure.
2. Documented history of drug abuse within six months.
3. "Planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures.
4. Currently being treated with another investigational device or drug.
5. Known bleeding diathesis or hypercoagulable state.
6. Peripheral white blood cell count 1500/mm3 (1.5 K/mm3) or platelet counts 50,000/mm3 (50 K/mm3).
7. Degenerative connective tissue disease, e.g., Marfan's and Ehlers Danlos Syndrome. Subjects with Lupus Erythematosus may be included.
8. Subjects with known or suspected concomitant bacterial, fungal, viral, or parasitic infection. Subjects with Hepatitis B may be included. Subjects who are HIV + with CD4 count of \<200 are excluded.
9. Severe underlying co-morbidity or immediate life-threatening condition.
10. Subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety.
11. Subjects who are candidates for autologous fistulas.
12. Subjects with scheduled renal transplant within the next 12 months.
Short- and Long-Term Impact of Subtotal Parathyroidectomy on the Achievement of Bone and Mineral Parameters Recommended by Clinical Practice Guidelines in Dialysis Patients

The impact of parathyroidectomy (PTX) on the bone mineral parameters in dialysis patients with secondary hyperparathyroidism (SHPT) remains unclear. The investigators performed this study to present the short- and long-term impact of PTX on calcium, phosphorus and intact parathyroid hormone control in dialysis patients with severe SHPT after operation. In particular, the investigators evaluate the impact based on the achievement of recommendations of the current clinical practice guidelines for bone and mineral parameters in dialysis patients after PTX.

1. A retrospective chart review of dialysis patients including referred cases, receiving surgical PTX, which was performed by one surgeon at the Far Eastern Memorial Hospital, a 1084-bed tertiary-care medical center in northern Taiwan will be performed.
2. Serum levels of calcium, phosphorus and intact parathyroid hormone were routinely measured for three consecutive post-operative days and subsequent laboratory values were checked during out-patient follow-up period. Patients with postoperative 6-month laboratory data are included in the short-term group and those with more than 6-month available data are in the long-term one.
3. The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI™) Clinical Practice Guidelines provided recommended target values for serum intact parathyroid hormone (iPTH)(150-300 pg/ml), phosphorus (3.5-5.5 mg/dl), calcium (8.4-9.5 mg/dl) and the calcium-phosphorus product (\<55 mg2/dl2). The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines suggested maintaining serum calcium in the reference range (8.5-10.5 mg/dl), phosphorus (2.7-4.5 mg/dl) and PTH values in the range of two to nine times the upper reference limit (130 - 585 pg/ml) in dialysis patients.
4. The investigators evaluated the impact of subtotal PTX on the control of bone and mineral parameters in dialysis patients with secondary HPT as the percentages of cases achieving the recommended K/DOQI and KDIGO targets.

Eligibility Criteria:
Inclusion Criteria:

* dialysis patients
* secondary hyperparathyroidism refractory to medical treatment
* patients receiving subtotal parathyroidectomy by one surgeon
* available laboratory data for at least six months after surgery

Exclusion Criteria:

* patients receiving parathyroidectomy other than subtotal type by other surgeon
* available laboratory data less than six months after surgery
Evaluation of the Accuracy of the Vessel Navigator Tool for Catheterization of Supra-aortic Vessels - ARCHIBALD

This study compares the accuracy of fusion imaging (Fusion Roadmap) versus real-time X-ray imaging (Roadmap) during catheterization of supra-aortic trunks of in patients with aneurysms or arteriovenous malformations.

Catheterization of is performed for the diagnosis and treatment of cerebrovascular diseases. It is performed under X-ray scopy in frontal incidence with possible variations of the angulation of the arch to optimize the visualization of vessels 'origin (brachiocephalic trunk, left and right common carotid arteries, subclavian arteries).

Before the beginning of catheterization, a conventional arterial roadmap with iodine injection is usually performed. The Vessel Navigator (VN) developed by Philips allows the use of pre-acquired angio-scan or angio-MRI image by superimposing it (X-ray Fusion) on X-ray scopy to provide the arterial tracing (Fusion Roadmap).

An angio-MRI (Philips 3 Tesla MRI) imaging of the aortic arch will be first performed (as part of preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations). A first operator will perform the arteriography under the usual conditions without using the VN. A second operator will have access to the fusion imaging and will assess the accuracy of the coregistration. Snapshots will be taken by the second operator.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative assessment or systematic follow-up of aneurysms or arteriovenous malformations, arterial cervical or intracranial stenosis, head and neck vascular tumors.

Exclusion Criteria:

* Patients with contraindication to intravenous contrast.
* Patients with catheterization of the supra-aortic vessels in an emergency settings (Stroke, acute bleeding)
Effect of PUR003 on Asthma

PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.

Study objectives are to :

1. to evaluate the safety of PUR003 in subjects with asthma, and
2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
3. Adult male or female subject, 18-60 years of age.
4. Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
5. No smoking within six months prior to entry
6. Must be medically stable.
7. Female subjects must have a negative pregnancy test
8. Subjects of child bearing potential should be sexually inactive (abstinent) for 14 days prior to the first dose of study medication or using an acceptable form of birth control methods.

Exclusion Criteria:

1. History or presence of significant co-existing chronic diseases.
2. History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
3. Pregnancy, breastfeeding.
4. Abused alcohol or illicit drugs that required treatment.
5. Participated in any other investigational drug evaluation within last 30 days.
6. Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.
Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients

Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. We will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine effects and neural mechanisms of upper-limb movement training involving RAS in PD patients.

Methods This study will recruit patients with PD and healthy controls. This study will randomly assign PD patients into two groups: the PD-RAS group and the PD-noRAS group, and healthy controls into the HC-RAS group and the HC-noRAS group. A 7-day upper-limb training involving RAS (for the PD-RAS group and the HC-RAS group) or without RAS (for the PD-noRAS group and the HC-noRAS group) will be provided. EEG and behavioral assessments will be conducted before and after the first day of training, and after the seven-day training program. Two-way repeated measures analysis of variance will be performed to investigate the group and time effects on upper-limb function and neural activity.

Study significance The training program will serve as a reference for clinical practitioners who are interested in using RAS in clinical training for PD patients.


Eligibility Criteria:
Inclusion Criteria:

* (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria;
* (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability;
* (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions;
* (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed;
* (e) types and doses of medications remain unchanged in the past month right before participation.
* Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities.

Exclusion Criteria:

* the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
Vitamin D Supplementation Prevents Elderly Pneumonia

Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized elderly people in Japan. Recently, several clinical and experimental studies have reported the importance of vitamin D in the regulation of immune functions and its deficiency is associated with susceptibility to some infections. In the present study, the investigators hypothesize that deficiency of serum vitamin D is associated with development of pneumonia, and supplementation of vitamin D may lower the incidence of pneumonia and prolong survival in institutionalized elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are more than 65 years old and were resident in the facility for at least 6 months.
* Subjects have no conditions known to interfere with vitamin D metabolism.

Exclusion Criteria:

* Subjects are excluded if they have:

  * renal failure
  * hepatic failure
  * hyper- or hypo-parathyroidism
  * HIV infection, or malignant diseases
* Subjects are also excluded if they are taking corticosteroid, thiazide diuretics, or supplementary vitamins.
First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study

The goal of this first-in-human study is to evaluate a novel ultraflexible microelectrode in children undergoing neurosurgery to remove tissue that causes epilepsy (seizures) in focal cortical dysplasia (FCD) or long-term epilepsy-associated tumours (LEAT).

The main questions it aims to answer are:

1. The safety and feasibility of the novel microelectrode into current operative workflow
2. The unique electrophysiological tissue signatures in FCD or LEAT

Epilepsy affects 100,000 people under 25. Many children with epilepsy also have a learning disability or developmental problems and 25-30% continue to have seizures despite best medical treatment.

Neuromodulation or brain stimulation is the delivery of electricity to the brain cells. It may alter the brain activity and overall brain connectivity and currently is rarely used as a treatment for epilepsy. However, it has the potential to reduce the number of seizures and improve other problems that children with epilepsy may have such as concentration, memory and learning. 'Precision neuromodulation', which involves individually tailored treatments requires us to identify where in the brain to stimulate and what the best settings are in each individual. A limitation of current neuromodulation treatment is limited understanding of the abnormal signatures of electrical activity in abnormal tissue.

The investigators have developed a novel electrode that can record signals from the brain at higher resolution than current electrodes. The 2 micrometer, ultraflexible, low-impedance electrode arrays are smaller, less damaging, and provide multiple contacts at multiple depths. The investigators propose a first-in-human study to investigate the feasibility and safety of using these electrodes in patients undergoing surgery for epilepsy - either focal cortical dysplasia (FCD) or long-term associated epilepsy tumours (LEAT).

The investigators will insert the electrode into brain tissue that is going to be removed as part of the planned surgery. The extent of tissue damage caused by insertion will be examined, and whether the electrode is able to capture signals at difference scales from the brain will be assessed; this includes signals from an area of tissue (termed local field potential) and signals from single nerve cells (termed single unit recordings). If safe, it will lay the foundation to use these electrodes in future precision neuromodulation platforms that can be applied to epilepsy and other neurological diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Radiologically visible epileptogenic lesion (focal cortical dysplasia or long-term epilepsy associated tumour) undergoing planned resective surgery

Exclusion Criteria:

1. Unable to provide informed consent
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms

The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by individuals in their own homes.

Human Factors Validation Testing will initially be conducted to valuate a lay person's ability to understand and apply as applicable the information contained in the THL™ Use Device Proper Use Reference Guide, and device packaging and labeling materials to correctly, safely, and successfully activate and operate the THL™ to administer the treatment; and to identify any and all use difficulties, problems and errors, including those pertaining to critical tasks and close calls demonstrated by the lay person during device operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification, as applicable

Phase Two will commence following the successful completion of Phase One. Phase Two comprises the performance of a double-blind, randomized, placebo-controlled, clinical study of the efficacy of the Erchonia® THL™, manufactured by Erchonia Corporation (the Sponsor), for prescription home use application in providing relief of tinnitus symptoms when used by individuals in their own homes.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral tinnitus
* Current diagnosis of subjective tinnitus
* No hearing loss or sensorineural hearing loss only
* 18 years of age or older
* Able to read and write English
* Constant tinnitus on-going over at least the past 6 months
* Willing to abstain from other tinnitus-related treatments, except existing hearing aid use, throughout the study duration.
* Tinnitus Functional Index (TFI) total score of 32 to 72 (Moderate to Big Problem)
* Degree of hearing loss is less than 60 dB (Moderate or less)

Exclusion Criteria:

* Tympanosclerosis
* Meniere's disease
* Acoustic neuromas
* Current and consistent use of ototoxic medications
* Presbycusis
* Thyroid disease
* Skull fracture
* Traumatic brain injury (TBI)
* Depression
* Syphilis
* Retrocochlear tumors
* Conductive hearing loss
* Pregnant, think they might be pregnant, or breastfeeding.
* Open wounds (sores, cuts, ulcers, etc) around ears or neck
* Cancerous growths around ears or neck
* Difficulty with hand dexterity sufficient to impact the ability to administer treatments with the laser such as from severe arthritis in the hands, Multiple Sclerosis, -Cerebral Palsy, Parkinson's Disease, Huntington's Disease, etc.
A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination

A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity

A Multicenter, Randomized, Double-Blind, Controlled, Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity in Healthy Population Aged 18 Years Old and Above

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
2. Basic or booster immunization with COVID-19 vaccine ≥6 months.
3. ≥3 months of SARS-CoV-2 infection history, or never infected.
4. Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.

Exclusion Criteria:

1. Axillary temperature ≥37.3℃.
2. SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
3. Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
4. It is in the advanced stage of malignant tumor and the disease control is unstable.
5. Female pregnancy (pregnancy test results are positive), lactation period.
6. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
7. Have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions.
8. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection.
9. People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past.
10. Congenital or acquired angioedema/neuroedema.
11. Asplenia or functional asplenia.
12. Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
13. Received another investigational drug within 1 month prior to receiving the investigational vaccine.
14. Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
15. Fertile female subjects did not use effective contraception within 1 month prior to enrollment.
16. Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization.
17. Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
18. Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
Safety and Efficacy of Dexmedetomidine in Painless Colonoscopy

104 patients who undergo painless colonoscopy from Decemenber 1,2019 to June 30,2022 will be randomized to two groups: propofol group and dexmedetomidine group.

In the dexmedetomidine group,dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1 during the whole process.

104 patients who undergo painless colonoscopy from Decemenber 1,2019 to June 30,2022 will be randomized to two groups: propofol group and dexmedetomidine group.

In the dexmedetomidine group,dexmedetomidine was infusion intravenously with a loading dose of 0.5 μg kg-1 for 10 min, then infusion at 0.3 μg kg-1 h-1 according to the ideal body weight of the patient until the end of colonoscopy. In the propofol group, Propofol was administrated 1 mg kg-1 intravenously, then titrated given by 0.5 mg kg-1.For all patients, if Ramsay sedation scale score reached 3, colonoscope was inserted. During the whole process, maintenance Ramsay score of 3 to 4. Propofol 10 mg was administrated as the rescue dose if body movement occurred during colonoscopy

The primary outcome was the occurrence of hypotension. Secondary outcomes included the followings:(1) the duration and the maximum decreasing in BP. The time-weighted average which is measured by calculating the area under the threshold (AUT) divided by the total duration of colonoscopy. AUT = (depth of hypotension below a 20% decrease in systolic blood pressure or diastolic blood pressure from pre-procedure baseline or SBP of 90 mm Hg or DBP of 50 mm Hg× time in minutes spent of hypotension); (2) the incidence of bradycardia and hypoxemia, mask-assisted ventilation and body movement；(3) the discharge time , patients and endoscopists satisfaction score.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged above 18 years
2. American Society of Anesthesiologists (ASA) physical status of 1-2
3. Patients scheduled for sedation colonoscopy

Exclusion Criteria:

1. Emergency patients
2. Body weight \< 40 kg or \>100 kg
3. Allergy to dexmedetomidine, propofol in this trail, a previous adverse reaction to dexmedetomidine or propofol
4. Pregnancy or lactation
5. Drug abusers
6. Participation in other clinical studies within the previous 3 months