cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Early Initiation of Butylphthalide Treatment in Patients With Acute Ischemic Stroke.

This study is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to evaluate the difference in efficacy of Butylphthalide Sodium Chloride Injection treatment initiated early (\&lt;3 hours) versus late (3-6 hours) in patients with acute ischemic stroke. The aim is to determine the optimal timing window for neuroprotective therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years, gender not specified;
2. Clinically diagnosed with acute ischemic stroke;
3. Stroke onset within 3 hours;
4. NIHSS score at enrollment between 4-25 points, with Item Ia ≤1 point;
5. Pre-stroke mRS score ≤1 point;
6. Participants and their representatives capable and willing to sign an informed consent form.

Exclusion Criteria:

1. Confirmed intracranial hemorrhage within the past 3 months, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
2. Known severe hepatic or renal dysfunction or individuals undergoing dialysis for various reasons (severe hepatic dysfunction defined as ALT levels \&gt;3 times the upper limit of normal or AST levels \&gt;3 times the upper limit of normal; severe renal dysfunction defined as serum creatinine \&gt;3.0 mg/dl \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \&lt;30 ml/min/1.73m²);
3. Systolic blood pressure \&lt;90 mmHg or \&gt;220 mmHg;
4. Presence of bradycardia (heart rate below 60 beats per minute) or sick sinus syndrome;
5. History of drug or food allergies, including known allergies to the components of the study medication;
6. Treatment with medications containing Butylphthalide following the onset of the current stroke episode;
7. Congenital or acquired hemorrhagic disorders, coagulation factor deficiencies, thrombocytopenia, or similar conditions;
8. Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 90 days;
9. Severe psychiatric disorders or dementia that preclude understanding of informed consent or compliance with follow-up procedures;
10. Concurrent malignancy or severe systemic disease with a life expectancy of less than 90 days;
11. Participation in another interventional clinical study within the last 30 days before randomization, or currently participating in another interventional clinical study;
12. Any other reason deemed by the investigator as unsuitable for participation in the study.
Using Hypnotherapy For Dementia & Alzheimer's

From the past research that has been done the investigators have learned that brain cells die \& leave a deposit in the brain known as beta-amyloid. Since alzheimer's is a slow acting disease the natural immune system does not respond to this illness so this builds up in the brain. As it builds up it gets into the neurotransmitters in the brain causing more brain cells to die. As these buildups occur dementia sets in due to more of the brain dying \& effects normal activity.

STUDY WAS CANCELLED

Hypnotherapy will be used to do the following things:

* Increase the immune system
* The immune system will begin to clean up the beta-amyloid buildup
* That removes damage cells of the brain
* Increase more blood flow to the brain
* Allows the active brain cells to be trained to carry out daily activities

STUDY WAS CANCELLED

Hypnotherapy has been used for many things through the years. Today many doctors use it for their patients for operations when blood supply is low to control bleeding, pain for difficult dental work, mental issues \& many other things.

Back in the 1950's a doctor Wilhelm Reich was able to increase the immune system \& tested it by blood samples. The immune system isn't sending enough white blood cells into the brain to clean up beta-amyloids. Using hypnotherapy could increase the white blood cells to the brain to clean up the damage.

In theory the primitive part of the brain ( 1%)job is to protect the body from harm. It does this by giving out a fight or flight response to the subconscious mind which is (88%) of our brain. Then the conscious mind controls the body to either fight or flight. Since Alzheimer's is such a slow moving disease the primitive part of the brain does not react because of the slow action. So the subconscious never gets the message that there's a disease in the brain so the body could fight it off.

As the immune system cleans up the beta-amyloid buildup the healthy neurotransmitters are able to function. Healthy brain cells can be retrained so the quality of life can be more normal.

EXAMPLE:

\* If you imagine driving down the same path across a field day after day. Before to long the grass dies \& ruts start to form. Next thing you know your auto is hitting high center. So you have to move over to keep from getting stuck in the ruts. The brain works in the same way. The person do things without thinking because that is how the brain has been trained. But the brain can be retrained to do the functions as it did before the illness.

Hypnotherapy session will be:

* One hour long
* one session per month for 9 months
* 3 months free of any sessions to measure the effect

STUDY WAS CANCELLED

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed having Alzheimer
* Under doctor's care

Exclusion Criteria:

* Must be able to follow instructions
The Effective Ways of Recruiting Lapsed Blood Donors: a Stratified Randomized Pilot Study

Blood donor recruitment is an important issue in every country, since the blood supply pressure become more and more intense. Donor retention is even more important, because it is easier to recruit an old customers than a new one. Therefore, figuring the most effective ways of recruiting lapsed blood donors and understanding the reasons of not donating blood again is critical and vital for the development of blood donation.


Eligibility Criteria:
Inclusion Criteria:

* Donated blood at least once between 2009 to 2013, and the blood test result is qualified.

Exclusion Criteria:

* Having donated again before intervened.
Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.

The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.

Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.

The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.

Eligibility Criteria:
Inclusion Criteria:

* 6 months to 6 years of age
* With at least three episodes of wheezing in the previous 12 months
* Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score \[PIS\] of 7 to 13

Exclusion Criteria:

* Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
* Who had any change in their dose of ICSs in the past 2 months
* Who had taken systemic corticosteroid within 1 months
* Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp

To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on:

* Intensity of postoperative pain.
* Bacterial load reduction.
* levels of MMP -9 in Periapical Fluids.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are free from any physical or mental handicapping condition.
* Males \& Females with

  * Mandibular single rooted permanent premolar teeth.
  * Absence of spontaneous pain.
  * Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2\*2 mm radiographically.
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent (Appendix I)

Exclusion Criteria:

1. Medically compromised patients.
2. Pregnant women
3. Patients undergoing previous endodontic treatment or analgesics and/or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
4. Patients reporting bruxism or clenching.
5. Teeth that show association with acute periapical abscess and swelling.
6. Greater than grade I mobility or pocket depth greater than 5mm.
7. Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam
8. Teeth with vital pulp.
9. Immature teeth.
10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
High Resistant Starch (RS) Cookies and Appetite Control

Evaluation of the effect of ingestion of high RS-cookies prepared from high amylose corn starch on food intake and appetite control of a cohort of healthy students. Cookies were prepared with increasing RS content and were fed to 18 healthy students in a blind trial versus a placebo.

Parameters of interest were: short and long time intake (ad libitum test meal and 12 h diet diaries, respectively).


Eligibility Criteria:
Inclusion Criteria:

* self-reported healthy
* not suffering disorders of lipid metabolism and eating disorders

Exclusion Criteria:

* pregnant or breast-feeding
* consuming an energy-restricted diet
* vegan or vegetarians
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults

The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.

This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years.

The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.

BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for the prevention of anthrax infection. This study will evaluate the immunogenicity of the vaccine using a post-exposure vaccination schedule. Correlations will be drawn to immunogenicity and survival data from animal models to demonstrate that BioThrax® can elicit a protective immune response for PEP.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 65 years of age, inclusive, at the time of enrollment.
* Be in good health as determined by the investigator from medical history and a physical examination.
* If a pre-menopausal female, must be using acceptable methods of birth control.
* Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
* Be willing and able to return for all visits and blood collections for the duration of the study.
* Have read, understood and signed an informed consent form.

Exclusion Criteria:

* Prior immunization with anthrax vaccine or known exposure to anthrax organisms.
* Intend to enlist in the military during the study.
* Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
* Plan to receive experimental products at any time during the study.
* Have received a live vaccine in the 30 days before study entry.
* Plan to receive a live vaccine at any time during the study.
* Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;
* Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.
* Have a condition known to produce or be associated with immunosuppression.
* Have received cytotoxic therapy in the previous 5 years.
* A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.
Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The investigators would like to study whether an ESP block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.


Eligibility Criteria:
Inclusion Criteria:

- All adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care

Exclusion Criteria:

* concomitant life-threatening injuries and other concomitant injuries causing significant pain.
* pregnancy,
* any condition impairing patient's ability to consent to participation in study
* an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder
* infection in the vicinity of the block, and patient refusal.
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

Eligibility Criteria:
Inclusion Criteria:

* Pre-Surgery:

  * Unicentric pure DCIS
  * Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
* Post-Surgery:

  * Negative histological margins confirmed prior to beginning radiation therapy.
  * Margins are positive if there is tumor at the inked margin.
  * Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
  * Clinically node negative

Exclusion Criteria:

* Distance from the balloon surface to the surface of the skin \< 5mm as determined by CT imaging.
* Distant metastases.
* Invasive or in-situ lobular carcinoma (post-surgery assessment).
* Nonepithelial breast malignancies such as sarcoma or lymphoma.
* DCIS that is multicentric in the ipsilateral breast.
* Pregnant or lactating.
* Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
* Collagen vascular diseases
* Coexisting medical conditions with life expectancy \< 2 years.
* Serious psychiatric or addictive disorder
* Previously treated contralateral breast carcinoma
* Synchronous bilateral breast carcinoma.
* Other malignancy, except non-melanoma skin cancer, \< 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
* Patients with diffuse disease
Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section

The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.


Eligibility Criteria:
Inclusion Criteria:

- Women admitted to the prenatal wards for primary or repeat elective cesarean section

Exclusion Criteria:

* urinary infection (assessed clinically and by midstream urinalysis),
* significant vaginal bleeding,
* severe pre-eclampsia or eclampsia and/or any other conditions requiring postoperative monitoring of urinary output, and
* contraindications for general anesthesia.
Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.

The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT. The study will consist of 3 cohorts, and a subset of the patients in cohort C will participate in a test-retest study, where the baseline SPECT/CT will be repeated.

SPECT CT will be performed in all cohorts.

Cohort A will evaluate SPECT CT by comparison to a Positron Emission Tomography (PET) scan using NaF.

Cohort B will evaluate SPECT CT by comparison to 18F-DCFPyL PET/CT.

Cohort C will evaluate SPECT CT by comparison to Whole Body Magnetic Resonance Imaging (WB-MRI).

Eligible subjects will be enrolled in a non-randomized manner per the treating physician discretion.

Eligibility Criteria:
Inclusion Criteria:

Males ≥18 years of age. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.

Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer (mCRPC) with Bone metastases as manifested by one or more lesions on bone scan.

Documented castrate level of serum testosterone (≤50 ng/dl).

Documented progressive mCRPC based on at least one of the following criteria:

1. PSA progression defined as 25% increase over baseline value or nadir.
2. Radiographic progression for soft tissue lesions as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and/ or radiographic progression for bone lesions as determined by radionuclide bone scan using the consensus guidelines of the PCWG3 criteria.

Planning to receive first line novel hormonal therapy with Abiraterone or Enzalutamide for the first time for mCRPC within 4 weeks of documented progression. Baseline scans will be obtained prior to starting new therapy.

Exclusion Criteria:

Subjects who are unable to give valid informed consent Subjects who are unwilling or unable to undergo an SPECT, PET or MR exam, including subjects with contra-indications to MR exams.

Subjects with prior Enzalutamide and Abiraterone for mCRPC Subjects with prior taxane chemotherapy for mCRPC Subjects administered any radioisotope within five physical half-lives or any IV X-ray contrast medium within 24 hours or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug injection.

Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Patients with a history reaction to gadolinium contrast agent. For cohort C, patients with renal failure (eGFR \< 60ml/min/1.73m2) or patients on dialysis.
A Worldwide, Phase I, Dose-Escalating Study of a 3-Dose Regimen of the MRKAd5 (Clade B) Vaccine in Healthy Adults (V520-018)

This three stage study will evaluate the safety and tolerability of MRKAd5 HIV-1 Gag Vaccine. In Stage I subjects will be randomized to receive the vaccine at 1x10\^9 viral particles/dose (vp/d) or placebo. In Stage II subjects will be randomized to receive the vaccine at 1x10\^10 vp/d or placebo. In Stage III subjects will be randomized to receive the vaccine at 1x10\^9 vp/d, at 1x10\^10 vp/d, or placebo. Immunogenicity of the single dose regimen of MRKAd5 HIV-1 Gag Vaccine will also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good general health
* Subject tests negative for Hepatitis B, Hepatitis C, and HIV
* Subjects of reproductive potential agree to use an accepted method of birth control through the entire study

Exclusion Criteria:

* Subject has a recent history of fever at time of vaccination
* Subject has received immune globulin or blood product 3 months prior to injection
* Subject has been vaccinated with live virus vaccine 30 days prior to receipt of first dose
* Subject has been vaccinated with inactivated vaccine with 14 days prior to receipt of first dose
* Subject has a chronic medical condition that is considered progressive
* Subject has history of malignancy
* Subject weighs less than 105 lb.
* Female subject is pregnant or breast feeding, Male subject is planning to impregnate during the first year of study
* Subject has contraindication to intramuscular injection
* Subject is unlikely or unwilling to adhere to lower risk sex practices during the course of the study
* Subject has a tattoo on the deltoid region of the arm or the injection of Depo-Provera
Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel

The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. Therefore patients become first 3 cycles of Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.

Most of the women who are diagnosed with breast cancer are in the situation that an operation is possible. Using a neoadjuvant therapy the rate of breast-conserving surgery can be extended and tumor cell proliferation may be inhibited. Further the neoadjuvant chemotherapy is an in-vivo-activity-test for the used drugs. Epirubicin, Docetaxel and Carboplatin have shown antineoplastic activity against solid cancer alone and in combination.

Using two different combinations of these three drugs, first 3 cycles Epirubicin/Docetaxel and then changing to Carboplatin/Docetaxel for 3 further cycles it is assumed that the results of the therapy will improve. Main criterion is the determination of pCR, second criteria are the rate of breast-conserving surgery, tumor response and therapy-dependent toxicities.

Eligibility Criteria:
Inclusion Criteria:

* histologically assured breast cancer
* age \>= 18 years
* bone marrow function: neutrophils \>= 1.5x109/l, platelets \>= 100x109/l, hemoglobin \>=6.2 mmol/l
* sufficient renal and liver function
* ECOG 0-2
* written informed consent

Exclusion Criteria:

* pregnant or nursing women
* distant metastases
* T2-Tumour \< 3cm and G1
* existing motoric or sensoric neurotoxicity \> Grade 2
* known hypersensitivity against Epirubicin or other anthracycline or against Carboplatin or other platin derivatives or against Docetaxel or against substances in the preparing solutions