cyrilzakka/clinical-trials huggingface dataset:
Transradial Access for Ruptured Intracranial Aneurysms Embolization

The goal of this clinical trail is to compare the difference between transradial access (TRA) and transfemoral access(TFA) for ruptured intracranial aneurysms embolization. The main question it aims to answer is: whether is TRA not inferior to TFA？ In the experimental group, the transradial access (TRA) was used, which was to puncture the radial artery and insert a radial sheath to establish a surgical pathway for embolization of the aneurysm; In the control group, transfemoral access (TFA) was used to embolize the aneurysms, which was to puncture the femoral artery and insert the femoral sheath to establish a surgical pathway for embolizing the aneurysms.The two groups of patients received an oral loading dose of aspirin (300mg) plus clopidogrel (300mg) on the day of surgery, while patients who were unable to take orally were given nasal feeding. During the operation, systemic heparinization was performed with a starting dose of 75U/kg intravenous injection, and the injection was halved every 1h until 1000U. After the operation, protamine neutralizing heparin (1mg protamine neutralizing 100U heparin) was used.


Eligibility Criteria:
Inclusion Criteria:

1. The age is between 18 and 75 years old.
2. Receiving interventional embolization treatment for intracranial aneurysms.
3. CT scan of the skull shows subarachnoid hemorrhage, and CTA or DSA of the skull shows the presence of an intracranial aneurysm, and it is determined to be aneurysm-related subarachnoid hemorrhage after evaluation by a neurosurgical specialist.
4. At least one side of the bilateral radial arteries can be used to establish surgical access.
5. Evaluation of radial artery patency: Barbeau test type A-C .
6. Hunt-Hess grade 1-3, Glasgow coma score ≥ 8.
7. Agreed to participate in this study and willing to cooperate with follow-up. -

Exclusion Criteria:

1. Preoperative upper limb ultrasound or DSA showed radial artery spasm and arteriovenous fistula.
2. Artery CTA or DSA showed vascular anatomical abnormalities such as axillary artery occlusion, and acute angle between the left common carotid artery and the subclavian artery, which may affect the operation.
3. The patient's condition is serious and may die or remain in a coma after surgery, as assessed by a specialist.
4. Received radial or femoral artery puncture examination or treatment within 1 month.
5. The patient refused to participate in the study or cooperate with follow-up.
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®

The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC.

The study will enroll individuals treated with Transurethral resection of bladder tumor (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable candidates for BCG therapy and who meet all eligibility criteria.

Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of 25 μg RUTI® or placebo. After vaccination, individuals will receive the standard induction course, of intravesical Bacillus Calmette-Guerin (BCG)therapy (weekly BCG for six weeks).

4 to 8 weeks after the last intravesical BCG administration (BCG6) a visit will be performed (Visit 1, end of the interventional phase). Once all participants have performed VISIT 1 immunological assays will be performed and data will be analyzed.

At the end of the Interventional Phase the blind will be opened, except for the study physicians who will remain blind during all the follow-up. All the individuals will be followed up for three years since TURBT.


Eligibility Criteria:
Inclusion Criteria:

1. Written ICF for participation in the study.
2. Age ≥18 years.
3. General health status according to WHO ≤ 2.
4. Have primary histologically confirmed T1 and/or high grade tumors and/or CIS.
5. All visible papillary tumors must be completely resected.
6. Early postoperative (within 24 hours of TURBT) single dose chemotherapy is allowed.
7. BCG therapy indication.
8. Never treated with BCG immunotherapy
9. Willing to comply with study visits and procedures as per protocol
10. Use of reliable contraception (see section 8.6) from the screening visit to 30 days after the last RUTI® or placebo injection.

Exclusion Criteria:

1. Life expectancy \<5 years.
2. Have a severe concomitant disease that might limit compliance or completion of the protocol.
3. Have any other malignancy that might impact 3-year survival or might be potentially confused with NMIBC.
4. Have other neoplasms.
5. Have congenital or acquired immune deficiencies or under immunomodulatory treatment.
6. Be receiving cytotoxic drugs or systemic corticosteroids within 8 weeks of receiving the first administration of BCG.
7. Have received radiation therapy for their bladder cancer within 4 months prior to study entry.
8. Have active infections (including urinary tract infections) defined as viral, bacterial, or fungal infections requiring therapy, HIV-positive status, concurrent febrile illness, gross hematuria or other factor that could influence tolerability to intravesical BCG therapy.
9. Have biopsy, TURBT, or traumatic catheterization within 14 days of start of intravesical BCG treatment.
10. Have active tuberculosis at screening visit.
11. Active pregnancy or breastfeeding.
12. Soy allergy
Identification and Therapy Efficacy of Type 2 Diabetes in Hispanic Patients

The two major types of diabetes are type 1 and type 2 diabetes. Although most patients with type 2 diabetes are older than age 40, type 2 diabetes has been reported with increasing frequency among patients under the age of 20. This form of diabetes has been called type 2 diabetes of youth, abbreviated type 2Y. Little is known about the etiology of type 2Y; however, clinicians believe that it occurs most commonly in obese children of particular ethnic groups. A positive family history appears to be one major risk factor for developing type 2Y diabetes. The individual contribution of ethnicity, obesity, and genetics to type 2Y have yet to be elucidated. There is no consensus regarding treatment with type 2Y diabetes. Observation of our Hispanic patients in the Houston area reveals a large number with type 2Y. The major purpose of this study is to examine the genetic and environmental risk factors such as family history, ethnicity, and obesity in Hispanic children with type 2Y diabetes. SPECIFIC AIMS: 1) To examine the genetic and environmental risk factors and clinical signs associated with type 1 diabetes and type 2 diabetes of youth. 2) To compare the efficacy of the treatment modalities, insulin and oral agents, in type 2Y patients. METHODS: We will undertake a retrospective case study, to include a review of hypothesized risk factors in all the medical records of pediatric diabetes patients seen at University of Texas. We anticipate that approximately 200 patients with type 1 diabetes and 30 patients with type 2Y diabetes will be identified. A Sustacal challenge test will be done in patients with a suspected diagnosis of type 2Y in order to confirm the clinical diagnosis. Parents will be contacted by phone for a detailed pedigree intake. Type 1 and type 2Y patients will be compared for each of the studied features. A retrospective review of diabetes type 2 therapies used in type 2Y patients will be undertaken through further examination of the medical records in order to compare insulin treatment to oral agents. We will also test a subset of the patients for the gene identified in adult Hispanics with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year.

Exclusion Criteria:

* Patients over the age of 18 or under the age of 10
* Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol.
Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant

During the course of an endoscopic procedure, air has historically been used to inflate the lumen to provide adequate visualization and allow for the endoscope to advance as necessary. In many adult centers, carbon dioxide is used for insufflation for all procedures. Many pediatric centers have started using carbon dioxide for insufflation during endoscopy based on the adult studies. Few pediatric studies have been done. This study is designed to test whether carbon dioxide is associated with any negative, post-procedural, outcomes in pediatric patients.

Luminal inflation is essential for adequate visualization and endoscope advancement during endoscopy. Although air has previously been the standard gas used, CO2 is increasing preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal discomfort compared to air. Few published studies in children demonstrated decreased abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy remain.

This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing procedures involving upper endoscopy in the Childrens Hospital \& Medical Center. Randomization will be for patients undergoing upper endoscopy related procedures. Patients will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure, throughout the procedure and after the procedure until fully awake. While in the procedure room, end-tidal CO2 level will be continuously recorded.

Eligibility Criteria:
Inclusion Criteria:

* Children 6 months to 19 years old and
* Undergoing upper endoscopy at Children's Hospital \& Medical Center in Omaha, NE and
* Parents or legal guardians consent to the study

Exclusion Criteria:

* Patients and legal guardians who decline participation in the study
* Patients with chronic respiratory disease (defined as severe asthma, bronchopulmonary dysplasia and cystic fibrosis-related pulmonary disease)
* Patients with cyanotic heart disease
* Patients with an ASA status of ≥ 3.
* Patients who are wards of the state or in foster care
* Prisoners
* Patients undergoing colonoscopy only procedures or procedures not related to upper endoscopy
(Cost-)Effectiveness Interdisciplinary Community-based COPD Management Program (INTERCOM)

There is growing evidence that COPD is a multi-organ system disease. Besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. Based on earlier succesful intervention studies in pulmonary rehabilitation settings, Máxima Medical Centre developed an integrated, inter-disciplinary approach to the management of COPD including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. This COPD management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals.

The exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. A program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. This study investigates the (cost-)effectiveness of the COPD management program compared to usual care in a randomized controlled trial.

Patients with moderate to severe COPD and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. The treatment group will participate in the COPD management program during the first 4 months after which they will be followed up for the remaining months. Both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. A cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. The analysis is conducted from a societal perspectice, including the program costs and all COPD-related direct costs within and outside the healthcare sector ans costs of lost productivity.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe COPD according to the recent GOLD guidelines
* Reduced exercise capacity during an incremental exercise test of less than 70% of predicted normal values

Exclusion Criteria:

* Lack of motivation to participate in the treatment program
* Other pathologic conditions unabling participation in the training program (e.g. coronary, orthopaedic, neurological or severe endocrine disorders)
* participation in other pulmonary rehabilitation projects
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV

This is a randomized, double-blind, placebo-controlled Phase Ib/IIa study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of XW001 inhalation in children with RSV infection in China

In this study, eligible participants will be randomized in a 4:1 ratio to receive XW001 inhalation (one of three dosage groups) or placebo once a day for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 1 to 24 months (inclusive) at screening;
2. Weight: 3-20 kg, inclusive;
3. Positive RSV test within 36 hours before randomization;
4. Symptomatic at screening and randomization, and the onset of RSV symptoms is within 5 days prior to the first dose of XW001;
5. Parents/legal guardians are able to understand the purpose and procedures of the study, and are able to provide informed consent.

Exclusion Criteria:

1. Immunocompromised as determined by the investigator;
2. Known to have undergone or planned for bone marrow, stem cells, or other organ transplants, or are currently on immunosuppressive treatment;
3. Positive for HBV, HCV or HIV, or patient \<6 months old whose mother is positive for HIV;
4. History of seizures or epilepsy, including febrile seizure;
5. Known to have received any prohibited medications defined by the protocol within 3 days prior to randomization;
6. History of any surgery within 30 days prior to randomization;
7. Severe dental or facial deformity that will impact on usage of nebulizer;
8. History of receiving measles, mumps, rubella or other vaccines within 7 days prior to screening;
9. Known to have received any investigational medicinal products or devices in the past 30 days;
10. Any other underlying conditions that make the patient unlikely to complete the study in the opinion of the investigator.
A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot

A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako.

This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker's robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
2. The patient has no fixed flexion greater than 10 degrees.
3. The patient has maximal flexion greater than 100 degrees
4. The patient has a passively correctable varus deformity
5. The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
6. The patient has no significant patellofemoral malalignment
7. The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
8. The patient has pain that is not localised to the medial compartment only
9. The patient is a male or non-pregnant female.
10. The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations

Exclusion Criteria:

1. The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
2. The patient is undergoing revision surgery
3. The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
4. The patient has active, local infection or previous intra-articular infection
5. The patient has skeletal immaturity
6. The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
7. The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
8. The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
9. Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it
10. Patients with tricompartmental disease are contraindicated from the study
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer

RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer.

PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.

OBJECTIVES:

Primary

* Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.

Secondary

* Determine the effect of this drug on overall quality of life of these patients.
* Determine the effect of this drug on depression in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning on the first day of chemotherapy treatment, patients receive oral coenzyme Q_10 and oral vitamin E three times daily.
* Arm II: Beginning on the first day of chemotherapy treatment, patients receive oral vitamin E and an oral placebo three times daily.

Treatment in both arms continues for 24 weeks in the absence of unacceptable toxicity.

Quality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks.

PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent
* Hg \> 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels
* Total cholesterol \> 160mg/dL.
* Female with primary cancer diagnosis (breast)
* Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)
* KPS \> 60
* Bilirubin \< 1.5 x ULN
* SGOT \< 2.5 x ULN
* SGPT \< 2.5 x ULN

Exclusion Criteria:

* Recent involuntary weight loss (\> 5% of body weight in the past 3 months)
* Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)

  * Atorvastatin (Lipitor)
  * Cerivastatin
  * Fluvastatin (Lescol)
  * Lovastatin (Mevacor, Altocor, Advicor)
  * Mevastatin
  * Pravastatin (Pravachol)
  * Rosuvastatin
  * Simvastatin (Zocor)
* Current or planned use of the following medications for fatigue

  * Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)
  * Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)
* Patients diagnosed with uncontrolled hypertension
* Breast cancer patients who are male
* Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.
* Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)
* Patients with uncontrolled thyroid dysfunction
The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement

The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.

A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.;

Exclusion Criteria:

* Those who do not meet the inclusion criteria;
* Neuromuscular dysfunction;
* Diseases affecting postoperative efficacy evaluation