cyrilzakka/clinical-trials huggingface dataset:
TheraTogs Versus Reciprocal Electrical Stimulation on Children With Diplegic Cerebral Palsy: a Randomized Controlled Trial

Children with diplegic cerebral palsy exhibit postural restrictions as a result of both primary and secondary brain damage impairments. One of the main goals of cerebral palsy rehabilitation is to improve balance and stability. As a result, the purpose of this study is to compare the effects of TheraTogs and reciprocal electrical stimulation on postural stability in children with diplegic CP.


Eligibility Criteria:
Inclusion Criteria:

* Diplegic children of both sexes are between the ages of 8 and 12. The level of spasticity in the lower limbs ranged from grade 1 to grade +1 on the modified Ashworth scale (MAS). The levels of motor function were between levels I and II, according to the Gross Motor Function Classification System (GMFCS).

Exclusion Criteria:

* If they had no major medical issues, according to their medical report. Skin diseases and allergic reactions to the adhesive tape used in this study were excluded, as were any deformities that interfered with lower limb functions, children with pace- makers who were contraindicated by electrical stimula- tion, children with visual, auditory, or perceptual deficits, and children with seizures.
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics

This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.

The objective of this study is to examine the association between cannabis and/or cannabinoid use and cancer-related symptoms assessed monthly for one year in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning or recently started to receive one or more systemic cancer directed therapies with chemotherapy and/or immune check point inhibitors (ICIs) targeting PD-1, PD-L1 or CTLA-4.

Participants complete surveys and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer.
* Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.
* Participants must be able to comprehend English or Spanish (for survey completion).
* Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.
* Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.

Optional Sub-study (available at select sites only):

* Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).
* Must be receiving treatment at the WF CCC and VCU.
* Must be diagnosed with non-small cell lung cancer.
* Must be receiving paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
* Must be enrolled and complete baseline survey before cycle 1 begins

Exclusion Criteria:

* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.
* Participants with known pregnancy.

Optional Substudy (available at select sites only):

* Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed.
* Participants with a history of HIV, hepatitis B or hepatitis C.
Consumption Status of Caffeine and Adverse Effects Experience Among Anesthetists

High-caffeine consumption has been increasing in physicians, frequently causing the most common symptoms such as tremor, insomnia, anxiety, and nervousness and rarely leading to serious adverse effects like seizure, acute mania, and stroke due to caffeine overdose. There have been no studies regarding analysis of high-caffeine consumption and its adverse effects among anesthetists.

This study was to examine high-caffeine consumption patterns, associated factors, and adverse effects based on responses anesthetists with different age of experience.

Eligibility Criteria:
Inclusion Criteria:

* Any anesthetist

Exclusion Criteria:

* Pregnancy
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Topical Applications of AP611074 5% Gel for up to 16 Weeks in Condyloma Patients

This is a double-blind placebo controlled, randomized, phase 2 study to assess the safety, tolerability, pharmacokinetics and efficacy of twice daily topical applications of AP611074 5% Gel for up to 16 weeks in condyloma patients


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient aged between 18 and 55 years.
2. External condylomas, 2-30 lesions (no more than 2 lesions side by side); flat or papular, but not pediculated.
3. Lesions must not be internal. Lesions that originate internally, but are visible externally will be considered internal and are not allowed in the study.
4. Total wart area (diameter x diameter) should not be less than 10mm2 and not more than 800 mm2
5. Individual wart area should not measure more than 50mm2, and the major perpendicular diameter should not measure more than 10mm (1cm).
6. Lesions to be treated should have appeared between 1 to 6 months before screening, and patients should not have received any previous condyloma treatment during the last 2 months before enrollment.
7. For female patients: either postmenopausal, taking adequate contraceptive method or surgically sterile.

Exclusion Criteria:

1. Patients should not have received genital wart treatment for previous condylomas (other than the prior treatment for current condylomas referred at inclusion criteria) in the last 12 months before enrollment
2. Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease, transplanted or immunosuppressed patients or other clinical condition that, in the Investigator's judgment, prevents the patients from participating to the study.
3. Patients with any clinically significant abnormality following review of screening laboratory tests, vital signs, full physical examination and ECG.
4. Patients with history or presence of drug or alcohol abuse.
5. Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
6. Patients using any dermatological drug therapy in the treatment area during the last month prior the first application of the study drug.
Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol

Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened regarding their baseline heart rate. If heart rate was \> 75, patients were pretreated with 10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart rate one our before CCTA was performed.

Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and drug tolerance was monitored.

Aim of the study is to evaluate if ivabradine, an inhibitor of the funny channel (If), in addition to bisoprolol is effective in lowering heart rate before coronary computer tomographic angiography (CCTA) if administered orally one hour before the scan.

Out-patients of a single radiology center are included in this retrospective analysis. All patients are referred to an ambulant CCTA. All scans are performed with a Siemens Somatom Sensation Cardiac 64 Computer Tomograph and analyzed with Siemens Syngo Plaza software. Patients with an initial heart rate of ≥ 75 bpm are either pretreated with bisoprolol 10mg p.o. alone (group 1) or a combination of bisoprolol 10mg and ivabradine 7.5mg p.o. (group 2) one hour before the CT scan.

The change in treatment from bisoprolol only to the combination of bisoprolol and ivabradine was introduced as a change in standard treatment independent of the study. The study was only plannend and performed as a retrospective analysis after the last patient included into the analysis was already treated.

Additional betablocker is administered intravenously right before the scan if heart rate remains elevated.

The hypothesis is that the addition of ivabradine to bisoprolol results in a pronounced heart rate reduction. This heart rate reduction will lead to a reduced need of i.v. bradicardic drug use, a reduction in motion artifacts and a reduced radiation dose to to a higher rate of flash sequences.

Eligibility Criteria:
Inclusion Criteria:

* all comer study

Exclusion Criteria:

* none
Use of Bone Scintigraphy, CT and MRI in Breast Cancer

A new imaging modality combining CT and tomographic bone scintigraphy (SPECT/CT) has enabled the combination of functional and anatomical imaging. Its use in cancer patients has not yet been evaluated or validated against a relative gold stand or clinical follow up. The purposes of this study are: 1: to validate the use of conventional planar bone scintigraphy and SPECT combined with low-dose or diagnostic CT and compare this to 3 Tesla MRI and clinical follow up. 2: to compare the specificity of low-dose and diagnostic CT, respectively, combined with bone SPECT. 3: to construct an algorithm for optimal evaluation of disease dissemination in breast cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Histological verified breast cancer
* Age 18-80 years
* Investigation for metastases using imaging modality/modalities planned
* Written consent to participate in trial

Exclusion Criteria:

* Overweight limiting the use of MRI
* Metal parts in body
* Claustrophobia
* Allergy to contrast agents used in trial
* Pregnancy
Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty

The fascia iliaca compartment block (FICB) is a regional block that anesthetizes the femoral, obturator, and lateral femoral cutaneous nerves around the hip. The purpose of this study is to determine whether FICB can reduce postoperative pain and increase progress with physical therapy after total hip arthroplasty (THA). This randomized, double-blind, clinical trial will randomize patients to receive either a FICB or placebo after THA. The primary outcomes will be pain scores reported by the patient post-operatively.

The FICB is a regional block that anesthetizes the femoral, obturator, and lateral femoral cutaneous nerves around the hip joint. There have been numerous study assessing it's ability to control pain in the pre and post operative period in patients with hip fractures. However, there is a limited amount of literature on its efficacy after total hip arthroplasty, and no data when a posterior surgical approach to the hip was utilized. Because regional blocks have been shown to decrease pain post operatively after total knee arthroplasty, we hypothesize that the FICB will decrease pain and narcotic use in patients after total hip arthroplasty. This study will aim to recruit 120 patients that will be randomized to receive a FICB or placebo in the recovery room within 30 minutes of leaving the OR. Once the intervention is complete we will collect data on the patients' pain levels, morphine equivalents of narcotic that they used, and how well they worked with physical therapy during their inpatient stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Scheduled for total hip arthroplasty at Henry Ford Hospital
* Epidural anesthesia during surgery

Exclusion Criteria:

* Pregnancy
* Known intolerance to local anesthetic or narcotics
* Revision hip surgery
A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

A phase II randomised, open label study of pre-operative endocrine therapy with \& without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-) breast cancer.

There is bidirectional interplay between the progesterone receptor (PR) and oestrogen receptor (ER) in human breast cancers. There is evidence for a reprogramming of ER chromatin binding sites with 470 genes differentially regulated by dual treatment with estrogen plus progestogen compared to estrogen alone in breast cancer cell lines. Functionally, there was an additive anti-cancer effect with the addition of natural progesterone to endocrine therapy in preclinical breast cancer models.

This is a phase II multi-site, randomised, open-label, three-arm, study in 200 postmenopausal women with early-stage ER+, PR+, HER2-negative breast cancer. Eligible patients will be randomised (1:1:1) to receive 14 days of intervention with either letrozole 2.5mg PO daily (arm 1), letrozole 2.5mg + prometrium 300mg PO daily (arm 2) or tamoxifen 20mg + prometrium 300mg PO daily (arm 3), between diagnosis of breast cancer and definitive surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed ER+ and PR+ breast cancer (defined as ≥10% positive staining cells)
2. Histologically confirmed HER2-negative breast cancer (defined as IHC 0-1 and/or FISH/CISH \<2.2)
3. Tumour size ≥1 cm as measured by ultrasound and/or mammogram
4. Ability to understand all patient information and informed-consent documents, written informed consent to participate in the trial, and to avail tissue and blood samples for research
5. Aged 18 years or older

Exclusion Criteria:

1. Women currently on hormone therapies, including hormone replacement therapy and oral contraceptive pill
2. Locally advanced/inoperable and inflammatory breast cancer
3. Planned for a mastectomy (due to increased risk of venous thromboembolism)
4. Clinical evidence of metastatic disease
5. Patients treated with other preoperative systemic therapies
6. Nut allergy (prometrium contains peanut oil)
7. Prior history of uterine cancer, deep vein thrombosis, pulmonary embolism or clotting disorder
8. Women who are pregnant or breast-feeding
Mini-sized MCE for Detection of Small Bowel in Children Under the Age of 10 Years

In this prospective randomized controlled trial, pediatric volunteers were enrolled and randomly underwent mini-sized MCE and normal-sized CE to compare the success rate of self-swallowing between mini-sized MCE and normal-sized CE during gastrointestinal examination.

Magnetic controlled capsule endoscopy (MCE) is comparable to traditional gastroscopy (EGD) in the diagnosis of gastric diseases, and has been widely used in clinical practice. However, there are still some limitations in the application of MCE in digestive tract examination. Due to the large size of capsules at present, some patients have difficulty swallowing capsules during capsule swallowing, which leads to the failure of examination, and the proportion is higher in children patients. Therefore, in order to further improve the patient's comfort in swallowing capsules, our team developed a small MCE with a smaller size combined with innovation, which is 0.6 times of the conventional MCE in terms of volume and weight. This study aims to clarify the application efficacy of mini-MCE in gastrointestinal examination of adults and children through a multicenter clinical study comparing conventional capsule endoscopy with mini-magnetic-controlled capsule endoscopy. In order to ensure the efficacy of the capsule in the examination of digestive tract mucosa, and improve the ease of swallowing in children.

Eligibility Criteria:
Inclusion Criteria:

* Patients and their legal guardians agreed to participate in the study and signed informed consent;
* 2 years ≤ age \< 10 years;
* Pediatric patients with suspected small bowel disease who are scheduled for small bowel capsule endoscopy

Exclusion Criteria:

* Intestinal obstruction, stenosis, or fistula is known or suspected;
* Dysphagia or gastric emptying dysfunction;
* Severe asthma, dysphagia or gastroparesis and other emptying disorders;
* Known or suspected possibility of major bleeding from active digestive tract;
* The presence of a pacemaker in the body, except where the pacemaker is a new MRI-compatible product;
* Implanted cochlear implants, magnetic metal drug infusion pumps, nerve stimulators and other electronic devices, as well as magnetic metal foreign bodies;
* Those who plan to undergo magnetic resonance imaging (MRI) examination before capsule endoscopy discharge;
* Previous history of abdominal surgery affecting the normal structure of the digestive tract;
* Patients with mental illness;
* Allergic to macromolecular materials such as dimethyl silicone oil;
* Refuse to use electronic gastroscopy to deliver the capsule to the duodenum if the capsule cannot be swallowed by itself;
* Contraindications of intravenous anesthesia;
* Patients who have participated in or are participating in other clinical trials within three months;
* Any other factors considered by the investigator to be inappropriate for enrollment or to affect the participant's participation in the study.
Investigation of Hepatitis B and Hepatitis C in Taiwan

The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan.

The purpose of this study is investigating the differences of genotypes and DNA level or RNA level of hepatitis B and hepatitis C in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Born before 1985/01/01
* HBV or HCV carriers

Exclusion Criteria:

* N/A
Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason

TRUS guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment

chronic non bacterial prostatitis is usually due to congestion combined with severe inflammatory process of the prostate, it is usually a recurrent bothersome problem, so patients who fail to response to classic medical treatment are expected to benefit from a strong anti inflammatory injection like betamethasone, which has strong anti inflammatory plus anti oedematous properties so limitation of this inflammatory process across the prostate is expected to relieve the patients symptoms

Eligibility Criteria:
Inclusion Criteria:

* chronic non bacterial prostatitis who failed medical treatment

Exclusion Criteria:

* chronic bacterial prostatitis patients
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

Primary:

To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.

Secondary:

* To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.
* To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.


Eligibility Criteria:
Inclusion Criteria:

* Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography
* Suffering for at least 6 months from lower urinary tract symptoms related to BPH
* An I-PSS total score ≥ 13
* Out patient

Exclusion Criteria:

* Patients previously treated with SL77.0499-10.
* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.
* Isolated bladder neck disease.
* Diagnosed carcinoma of the prostate.
* Previous prostatic surgery or other invasive procedures (thermotherapy...) for the treatment of BPH.
* Patients having an indwelling catheter.
* A residual urine \> 200mL.
* Patients with Moderate or sever hepatic insufficiency.
* Known hypersensitivity to alpha1-blockers.
* Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening
* Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva

This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.

It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals (male or female) referred to Dept of Oral \& Maxillofacial surgery to have a lower wisdom tooth surgically extracted
* ≥ 20 and ≤ 40 years of age
* Analysis results of blood status within normal reference ranges
* Ability to attend the scheduled visits for evaluation procedures
* Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
* Signed informed consent

Exclusion Criteria:

* Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
* An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
* Current use of anti-coagulant therapy or within 10 days from baseline
* Current use of immunomodulating medication
* Current use of corticosteroids (Amendment 1: topical use permitted).
* Current use of lithium.
* Use of tobacco products or nicotine replacement therapy
* Alcohol or drug abuse
* HIV or hepatitis infection
* Pregnancy or lactation
* Participation in another clinical study on medicinal products at the time of inclusion
* Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.