cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety

The study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. It is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. This type of cancer is called metastatic castration-resistant prostate cancer, also called mCRPC. Sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives.

In this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. The patients in this study will already be receiving treatment with radium-223 as part of their routine care. The tests and measurements in this study will be done by the patients' own doctors. The researchers will collect information about the patients' treatment and results.

The study will include patients with mCRPC who have at least 2 tumors in their bones. These patients will have recently started treatment with radium-223. The patients will have also had surgery or treatment to lower their testosterone levels. But, the treatment did not help their cancer. The study will include about 105 men in Colombia who are at least 18 years old.

All of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. They will visit their doctor's office up to 8 times during 28 weeks. At these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. The doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male adult patients (\> 18 years)
* Label Xofigo
* Signed informed consent
* No participation in an investigational program with interventions outside of routine clinical practice.
* Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice, as treatment option for mCRPC either as first line (naïve), second line (after progression during treatment with enzalutamide or abiraterone) or third line (post-Docetaxel).

Exclusion Criteria:

* Patients with contraindications to the use of Radium-223 according to the local label.
* Patients and who refused to sign the informed consent form.
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children

To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.

The purpose of this study is to assess the efficacy (ability to meet prescribed calorie and protein needs), tolerance, and safety of a pediatric enteral formula (i.e., the study product) in participants aged 1-13 years for 14 days of use.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable, enterally tube-fed children
* Aged 1 to 13 years (inclusive) at the time of screening.
* Currently tolerating enteral feeding and should be appropriate for study formula
* Requires enteral tube feeding to provide 90% or more of their nutritional needs
* signed informed consent

Exclusion Criteria:

* Has a condition which contraindicates enteral feeding (e.g., intestinal obstruction).
* Currently using or has previously used the study product
* Any medical condition or contraindicated medications that would contraindicate use of the study product
* Any illness within \~5-7 days of screening and/or baseline lasting \>48 hours and assessed by the PI to have affected nutritional intake on a case-by-case basis.
* Participation in another interventional clinical study
* Any condition or abnormality that, in the opinion of the PI, would compromise the safety of the participant or the quality of the study data.
Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients

To depict the incidence, outcomes and standards of care (SoC) of adenovirus (AdV) infections and associated practice patterns in allogeneic hematopoietic cell transplant recipients. It is expected that participating centers will be in the United Kingdom, France, Spain, Germany, and Italy.


Eligibility Criteria:
Inclusion Criteria:

* At least one AdV positive test, regardless of specimen within 6 months following the first allo-HCT
* Subjects first allo-HCT must have been performed between 1 January 2013 and 30 September 2015

Exclusion Criteria:

* AdV negative
Pilot Text Message for Influenza Vaccination

Influenza is an important and potentially preventable cause of morbidity and mortality, yet only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite influenza vaccination being widely recommended, effective, and safe. Influenza vaccination rates are even lower in racial/ethnic minority groups. In order to address the problem of low influenza vaccination rates in minority adults, we plan to build on the well-accepted practice of immunization recall-reminders and the emerging practice of using text message to pilot the feasibility of using text messaging to improve influenza vaccination coverage rates in a low health literacy, largely minority, publicly insured adult population.


Eligibility Criteria:
Inclusion Criteria:

* \> or = 18 years of age,
* at least one visit to the AIM clinic during the previous year
* a cell phone number in the registration system
* fluent in English or Spanish. Exclusion criteria

Exclusion Criteria:

* Receipt of influenza vaccination during the 2012-2013 influenza season prior to randomization.
Intravenous CG7870 in Combination With Docetaxel in Patients With Metastatic Hormone-Refractory Prostate Cancer

V-0039 is a Phase 1/2 dose escalation trial of CG7870 in combination with Docetaxel in metastatic hormone-refractory patients who have not received chemotherapy.

All patients will receive docetaxel. In the dose escalation phase of the study, patients will receive treatment intravenously with CG7870 at one of up to four dose levels. In the Phase 2 portion of this study, additional patients will be added at the maximum tolerated dose that is determined in Phase 1.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy)
* Detectable metastases by bone scan, and/or CT scan, and/or MRI, and/or CXR
* ECOG performance status 0-1

Exclusion Criteria:

* Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
* History of deep vein thrombosis or pulmonary embolus
* Patients taking anticoagulants (such as coumadin or Heparin). The use of aspirin while on study is acceptable.
* History of a bleeding disorder or recent clinically significant bleeding
* Seropositive for HIV
* History of Hepatitis B, Hepatitis C, or chronic liver disease
* Prior gene therapy or immunotherapy
* Prior chemotherapy for prostate cancer
* Radiation therapy within 4 weeks of the first treatment.
* History of myocardial infarction within 6 months of the first treatment
* History of cerebrovascular accident
* History of previous malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
* Evidence of active prostatitis
* Known hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
Prevention for the Development of Liver Tumorigenesis by the Oral Supplementation of Branched-chain Amino Acids

The long-term outcomes of branched-chain amino acid (BCAA) administration in patients undergoing hepatic resection remain unclear. The aim of this study is to assess the impact of oral supplementation with BCAA on the prevention for the development of liver tumorigenesis in patients undergoing liver resection.

This study might demonstrate a tendency of the improvement in the cumulative tumor recurrence rate after hepatectomy for liver neoplasm in the Livact group compared to that in the Control Group. The investigators believe that BCAA seems to be a remarkable benefit for liver resection, especially on its reduction in the recurrence of liver cancer. This treatment regimen has potential to offer benefits for clinical use selectively, especially for patients with chronic liver diseases.

Eligibility Criteria:
Inclusion Criteria:

* These patients were scheduled for elective liver resection to treat hepatocellular carcinoma or adenocarcinoma of the liver.

Exclusion Criteria:

* a body-weight loss greater than 10% during the 6 months prior to surgery,
* the presence of distant metastases, or
* serious impairment of organ function due to respiratory, renal, or heart disease.
Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues in one or both eyes
* Is willing to stop other intraocular pressure (IOP)-lowering medications and switch to GANFORT® as a single agent in affected eye(s).

Exclusion Criteria:

* Reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive pulmonary disease
* Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.
Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

An exploratory study investigating the direct application of potassium nitrate (KNO3) solutions of different concentrations in reducing dentine hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth
* Three teeth that can be isolated that meet all of the following criteria at the screening visit:
* Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3 mm recession at the facial surface midpoint
* Teeth must be visually stain and calculus free
* Teeth having a gingival index score of less than or equal to 2
* Teeth with a clinical mobility less than or equal to 1
* Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS

Exclusion Criteria:

* Chronic disease or other condition that is associated with intermittent episodes of constant daily pain, such as arthritis, low back pain, etc.
* An condition or medication that causes xerostomia as determined by investigator
* Sensitive teeth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
* Teeth with exposed dentine but with deep, defective or facial restorations
* Teeth used as abutments for fixed or removable partial dentures
* Teeth with full crowns, orthodontic bands, extensive caries or cracked enamel
* Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine.
* Dental prophylaxis within 3 weeks of the screening visit
* Tongue or lip piercing or presence of dental implants
* Subjects not using the same brand of toothpaste for at least 4 months prior to the screening visit
* Subjects who have used desensitizing toothpaste during the 4 weeks before Treatment Visit 1
* Taking daily dose of medication which may interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquillizers, mood-altering drugs or anti-inflammatory drugs
Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis

Objectives; This study was conducted to investigate the effect of pulsed magnetic therapy and aerobic exercise on post thyroidectomy osteoporosis.

Methods; Forty-five female patients, age ranged from 40 to 50 years old with osteoporotic changes in hip and pelvic region post thyroidectomy, were included in this study. They were selected from Endocrinology private clinics. They were assigned randomly into three groups, equal in number. Magnetic Therapy Group (group A); patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks (3 sessions/ week). Exercise group(group B); patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks (3 sessions/week). Combined Magnetic Therapy and Exercise Therapy group (group C): patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks. Evaluation of the three groups was performed at baseline and after 12 weeks of treatment by dual energy x-ray absorptiometry (DEXA).


Eligibility Criteria:
Inclusion Criteria:

* All participants had undergone thyroidectomy since 6 months and had cognitive and educational level enough to understand the requirements of the study

Exclusion Criteria:

* All Patients with malignancies or receiving radiotherapy or chemotherapy, skin diseases, deep venous thrombosis or venous insufficiency, sensory impairment, renal failure, recent therapy with immunosuppressant or anticonvulsants, psychological problems or alcoholic drinkers were excluded from this study.
fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.

In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.


Eligibility Criteria:
Inclusion Criteria:

Outcome Measure #1 and #2

* Healthy individuals with pigmented lesions or a partially biopsied melanoma whose treatment plan includes excision
* Participants must be 18 years or older
* Participants must be able to understand and willing to sign a written informed consent document

Outcome Measures #3 and #4

* Patients with either cutaneous, visceral or brain melanoma metastases.
* Participants must be 18 years or older.
* Participants must be Eastern Cooperative Oncology Group (ECOG) status 0-3.
* Participants must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from this study
* ECOG status \> 3
Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease

This study is designed to test the use of G-CSF in peripheral vascular disease. The investigators hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate the formation of new blood vessels and result in a sustained improvement in blood flow in patients with severe peripheral arterial disease.

One fourth of patients with peripheral artery disease (PAD) of the lower extremities have severe symptomatic disease and 1-2% have critical limb ischemia (CLI). In patients with CLI, the risk of limb amputation at 1 year is 50%. In addition, patients with CLI often have rest pain, non-healing ulcers and severe limitations of ambulation. Revascularization procedures, including bypass surgery, percutaneous transluminal angioplasty and angioplasty with stenting, are currently the only treatment options. However, many patients are not eligible for a revascularization procedure due to small vessel disease or coexisting medical problems. Moreover, restenosis rates are high.

There is currently no effective non-invasive treatment for critical limb ischemia. We hypothesize that mobilization of angiogenic cells into the blood by granulocyte colony stimulating factor (G-CSF) may stimulate angiogenesis in areas of ischemia and result in a sustained improvement in blood flow in patients with severe PAD.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have critical limb ischemia secondary to PAD, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene.
* Patients must have a toe pressure ≤ 30 mm Hg.
* Patients must be ≥18 years old.
* Patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection.
* Patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. If they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of G-CSF treatment.
* After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. A built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment.

Exclusion Criteria:

* Patients with transmetatarsal or higher amputations in the affected limb are excluded.
* Patients who are candidates for a revascularization procedure.
Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode

This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array.


Eligibility Criteria:
Inclusion Criteria:

* MED-EL CI recipients
* FLEX electrode array

Exclusion Criteria:

* Lack of compliance with any inclusion criterion
Irinotecan Plus Lobaplatin Versus Irinotecan in the Second-line Treatment of Small Cell Lung Cancer

This randomized phase II study compare survival outcomes and toxicity of two chemotherapy regimens (irinotecan plus lobaplatin or irinotecan) for the second-line treatment of recurrent small-cell lung cancer.

The most widely applied first-line treatment mode for small-cell lung cancer (SCLC) patients was chemotherapy as initial treatment. Etoposide with cisplatin or carboplatin were considered the standard first-line regimen in SCLC. As for second-line chemotherapy, single regimen irinotecan or a combined regimen containing irinotecan were one of preferred regiems. While there still is no consensus on second-line therapy. Clinical studies have demonstrated that the combination of irinotecan and carboplatin or cisplatin did not improve outcome in recurrent SCLC patients compared with irinotecan alone. One of the main reasons is that carboplatin or cisplatin has been used in the first-line treatment, and SCLC showed cross-resistance to carboplatin and cisplatin.

Lobaplatin is a platinum complex with DNA alkylating activity that was developed by ASTA Medica (Degussa) for the treatment of cancer. Lobaplatin as the third-generation platinum antineoplastic agent, showed promising antineoplastic effects in variety of preclinical test tumor models, which overcomes some forms of cisplatin or carboplatin resistance in preclinical tumour models. Retrospective studies also have demonstrated the efficacy of Lobaplatin in patients with relapsed SCLC. Thus, we perform this randomized study to compare the efficacy and safety of irinotecan plus lobaplatin versus irinotecan in patients recurrent SCLC.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed SCLC
* Etoposide with cisplatin or carboplatin was first-line chemotherapy in SCLC
* At least 30 days after the completion of first-line chemotherapy
* Either sex, age between 18 to 70 years
* Expected life time ≥ 3 months
* Performance status ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator. Patients with PS 2 as a result of comorbid conditions will be excluded.
* Adequate bone marrow and organ function as defined below:

Neutrophils ≥ 1.5 × 109/L, platelets 80 × 109/L, hemoglobin ≥80 g/L; AST and ALT ≤2× the upper limit of the institutional normal range, total bilirubin ≤1.25× the upper limit of the institutional normal range; Creatinineconcentration ≤120 μmol/L

* Had measurable or assessable disease

Exclusion Criteria:

* Concomitant with other malignant disease
* Pregnancy or lactation at the time of enrollment
* Any contraindications for chemotherapy
* Received target therapy or immunotherapy