cyrilzakka/clinical-trials huggingface dataset:
Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer

Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis. Unfortunately, available treatments result in few durable responses. Pemetrexed is a well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity of pemetrexed in this palliative setting

OUTLINE: This is a multi-center study.

* Pemetrexed 500 mg/m2 i.v. q 3 wks

All patients will also receive folic acid 350-1000 mcg. po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, Vitamin B12 1000 mcg. IM every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, and dexamethasone 4 mg po bid the day before, the day of, and the day following each treatment with pemetrexed

Chest x-ray will be performed prior to each cycle (if other disease assessment by imaging is not performed) in order to ensure patients are not rapidly progressing.

Cycles are repeated every 3 weeks for up to 6 cycles or PD or intolerable side effects.

Performance Status: ECOG 0, 1, or 2

Life Expectancy: Not specified

Hematopoietic:

* WBC \> 3000/mm3
* ANC \> 1500/mm3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 8 g/dL

Hepatic:

* Bilirubin \< 1.0 X upper limit of normal
* Aspartate aminotransferase (AST, SGOT) \< 2.5 x upper limit of normal. AST may be \< 5 x upper limit of normal for patients with liver metastasis

Renal:

* Creatinine clearance of \> 45 ml/ min (by Cockcroft-Gault)

Cardiovascular:

* No unstable or uncompensated cardiovascular conditions

Pulmonary:

* No unstable or uncompensated respiratory conditions

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological proof of neuroendocrine cancers (including small cell cancers of any site \[including lung\] or poorly differentiated neuroendocrine cancers of the lung with (unidimensionally) measurable disease as per the RECIST criteria
* Chemoresistant or chemosensitive disease
* Patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent
* Radiation therapy must have completed their radiation at least 14 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to \< grade 1 or baseline prior to registration
* Negative pregnancy test

Exclusion Criteria:

* No clinically significant infections as judged by the treating investigator
* No symptomatic CNS metastasis
* No radiation to \> 25% of the marrow containing spaces
* No previous treatment with pemetrexed
* No uncontrolled pleural effusions
* No current breastfeeding
Three Times Daily Dosing of UT-15C

To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers


Eligibility Criteria:
* Healthy male and female subjects
* aged 18-55 years of age;
* weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and
* weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.
Assessment of Hypotonia in Children With Down Syndrome

Hypotonia is a common trait in infants with Down syndrome, resulting in pathologies and delays in gaining basic motor skills. There are no screenings available to aid in early diagnosis, therefore, the purpose of this study is to develop a way to test for hypotonia in children with Down syndrome.

Hypotonia is usually diagnosed by observation and clinical assessment. Aiming to develop an instrument for early diagnosis, a systematic review was carried out which compiled characteristics and testing that are attributed to or used in the diagnosis of hypotonia. They were presented as an item group and a first stage was created and administered to 50 children with Down's Syndrome between the ages of 7 months to 8 years old. The study of the results showed which characteristics were really related to the convention and which were more affected by changing factors. Then a final scale was developed that met the expected requirements of validity and reliability.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer parents who have Infants with Down Syndrome Between the ages of 7 months to 8 years old

Exclusion Criteria:

* Other hypotonic syndromes
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.

Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK Biologicals' Havrix + DTPa combined vaccine

Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
Treatment of Lambert-Eaton Syndrome With 3,4 DAP

A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS). This is an expanded access trial, which means that although data from this study will be collected and reported to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal study of drug in LEMS.

If you decide volunteer, you will be evaluated by a neurologist to determine your eligibility to receive 3, 4-DAP by a review of your medical history, medication regimen (the medications you are taking) and a neurological examination. If you are a female of child-bearing potential, a serum pregnancy test will be done to ensure that you are not pregnant. Once it is determined that this treatment is appropriate for your care, you will begin taking 3, 4 DAP by mouth in slowly increasing doses. Treatment will begin with 5mg three times a day, as clinically needed, and if tolerated. You will be monitored for strength and side effects by routine clinic visits at initial intervals of once a month, increasing to intervals of every 12 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic visit or as often as the investigator deems necessary to assess your liver/kidney function and blood counts. You will have an EKG (a test to see how your heart is functioning) at your first study visit, after 6 months of taking 3,4 DAP and again every 2 years. Treatment will be continued indefinitely if a good clinical response is achieved. This study is planned to last indefinitely.

The dosage of 3, 4DAP is individually adjusted. The usual range is 10-15 mg 3-4 times per day for the full effect and will increase by 50% every two weeks to 10-15 mg three to six times a day, as needed and if tolerated. Dosages above the full effect level will not provide an additional benefit and should not be used. 3, 4 DAP is a convulsant (causes seizures). A total of 100 mg/day is the maximum dosage allowed.

Patients with clinically-confirmed LEMS will receive 3, 4-DAP by mouth in slowly increasing doses. Treatment will begin with 5 mg, three times a day and will increase by 50% every two weeks to 10-15 mg, three to six times a day, as clinically needed, and if tolerated. Patients will be monitored for strength and side effects via routine out-patient clinic visits at initial intervals of 1 month, increasing to intervals of 12 months as permitted. Results of treatment and adverse events will be reported to the FDA. Treatment will be continued indefinitely if a good clinical response is achieved and side effects are tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older, diagnosed with LEMS
* If female, have negative pregnancy test and if premenopausal, be willing to practice an effective form of birth control during the study.

Exclusion Criteria:

* Is known to have a sensitivity to 3, 4 DAP
* Has a history of past or current seizures
* Has a history of past or current severe asthma
* Is believed by the investigator to be unable to comply with the protocol
* Unable to give informed consent
The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment

Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.

The study will include two phases. The first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive TIPN screening each week till they develop grade 1 or higher by CTCAE criteria. The patients with TIPN grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve TIPN pain. The participant may also participate in Part 2 of the study if they begin to experience TIPN but do not participate in Part 1.

Eligibility Criteria:
Inclusion Criteria:

Screening Phase:

* English or Spanish-proficient men and women aged ≥18 years
* Histological diagnoses of invasive carcinoma of the breast
* Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care

Intervention Phase:

* TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
* ≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
* Willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period
* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments

Exclusion Criteria:

Screening Phase:

* Pre-existing peripheral neuropathy within 28 days of screening consent
* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine

Intervention Phase:

* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
* Use of acupuncture for symptom management within 28 days of intervention consent
Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery

The specific aim of this prospective, randomized controlled trial is to compare the effect of chewing gum on the return of bowel function in a group of patients undergoing spinal surgery with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in time to passage of first flatus will be considered an important clinical difference.

The research questions are:

1. Does providing chewing gum post-operatively hasten the return of bowel function?
2. Does providing chewing gum post-operatively reduced overall length of stay?
3. Does providing chewing gum post-operatively have any associated complications?
4. Does providing chewing gum post-operatively result in higher objective outcomes scores?

The secondary aims are:

1. To compare hospital length of stay between the groups with a mean of ½ day considered clinically important.
2. To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant.
3. To compare incidence and nature of complications between the two groups.
4. To compare the time until completion of rehab milestones with 1 day being considered clinically important.
5. To compare the requirement for nutrition evaluations
6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10 points or more measured between the two groups upon discharge from hospital and at six-weeks after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Lumbar decompression 2+ levels
* Posterior spinal instrumentation and fusion 1+ levels
* Combined anterior (ALIF/XLIF) and ANY posterior procedure (ie - decompression +/- fusion)

Exclusion Criteria:

* Age \< 18
* Trauma
* Tumor
* Infection
* Stand-alone anterior surgery
* Allergy to chewing gum
Multicentre Registry of CCTA, IVUS and OCT

The Invictus Registry will compare the diagnostic performance of coronary computed tomography angiography (CCTA) versus intravascular imaging by intravenous ultrasound (IVUS) or optical coherence tomography (OCT) for the measurement of minimum lumen area, the identification of stenosis severity, burden, morphology and vulnerability of coronary atherosclerosis.

Clinical Significance:

Coronary computed tomographic angiography (CCTA) is a robust non-invasive modality to evaluate the presence, extent and severity of Coronary Artery Disease (CAD). For a plaque assessment, previous studies demonstrated that CCTA provides a high correlation with intravascular imaging by intravenous ultrasound (IVUS) in assessing coronary plaque characteristics stenosis severity and volume. High risk (vulnerable) plaque characteristics (positive remodeling, low attenuation plaque, spotty calcifications) are recognized to be more prone to rupture with increased rates of short-term cardiovascular disease events. Although several studies similarly demonstrated the good concordance between CCTA and IVUS or optical coherence tomography (OCT) in assessing high risk plaque features, patient numbers in these prior studies were limited to fully understand the effect of CCTA for the assessment of coronary atherosclerotic plaque features.

The Research is a multi-center, registry enrolling patients with single/multi vessel atherosclerotic coronary artery disease. The study will be conducted in up to 15 Medical Centers in Japan. In each patient, a CCTA, IVUS), and/ or OCT will be performed, to provide a total of 1,300 vessels from 1,000 patients. Thus, the full cohort (Prospective plus Retrospective patients) will provide a total of 2,000 vessels as basis for a diagnostic performance comparison between CCTA and IVUS or OCT. Accrual is expected to take 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
* Age 18 years or older
* Known or suspected Coronary Artery Disease and subsequently indicated for coronary artery angiography

Exclusion Criteria:

* Individuals unable to provide informed consent
* Acute ST elevation myocardial infarction
* Pregnant woman
* Angiographically visible thrombus at the site of the lesion interrogated by IVUS or OCT
* Patients with lesions required balloon angioplasty before OCT and/or IVUS
COMET India Follow-up Trial

We are evaluating an online single-session intervention for mental health promotion among Indian college students.


Eligibility Criteria:
Inclusion Criteria:

* College Student
* Access to internet
* Proficient in English

Exclusion Criteria:

-
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects

The purpose of this study is to determine whether a lower dose of inactivated polio vaccine (IPV) injected into the skin (intradermal administration) can work equally well or better than the standard dose injected into the muscle (intramuscular administration). There are more immune cells in the skin than in the muscle, and other vaccines have been shown to require a lower dose when administered intradermally. The study is being done in participants infected with HIV because HIV-infected people are known to respond less well to vaccines than other groups, so it is particularly important to know if IPV might work better in HIV-infected people if administered intradermally.

If it is possible to lower the dose of IPV by intradermal administration, this would make inactivated polio vaccine more affordable in the developing countries where it is most needed

Oral polio vaccine (OPV) will not be sufficient to eradicate polio. OPV has failed to provide adequate polio immunity in certain immunocompromised populations, such as people with AIDS. Also, OPV can mutate and form neurovirulent strains capable of causing polio outbreaks. Inactivated polio vaccine (IPV), which cannot mutate into neurovirulent strains and which is more effective in populations that have failed to respond to OPV, will be needed globally to eradicate polio, but it is unaffordable for many developing countries. Because there are more immune cells in the skin than in the muscle, intradermal administration of IPV may be a way to increase the efficacy and reduce the dose (and thus the cost) of IPV. We plan to conduct a clinical trial randomizing 231 HIV-infected adults to receive a booster of two-fifths dose intradermal IPV, one-fifth dose intradermal IPV, full dose intramuscular IPV, or two-fifths dose intramuscular IPV. We will measure polio immunity before and after vaccine administration. Through this study, we will determine the optimal booster dose of intradermal IPV, whether intradermal works better than intramuscular IPV administration, and whether intradermal IPV is effective in an immunocompromised population. The data from this trial could contribute to global polio eradication.

Eligibility Criteria:
Inclusion Criteria:

* documented HIV infection
* age of at least 18 years old
* HIV viral load \<400 on the most recent test

Exclusion Criteria:

* current acute moderate to severe illness (demonstrated by fever over 100.4 Fahrenheit, shortness of breath, altered mental status, or by judgment of the primary clinician)
* current pregnancy
* history of allergic reaction to a polio shot,
* history of a life-threatening allergic reaction to neomycin, streptomycin, or polymyxin B
Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic

The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: \[PCR-COVID 19-Neg \& Sero-COVID 19-Neg\] versus \[PCR-COVID 19-Neg \& Sero-COVID 19-Pos\] versus \[PCR-COVID 19-Pos\].


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years,
* Diagnosed for pulmonary embolism between April 1st and April 30th, 2020; (treated by ambulatory care or hospitalized),
* Having given free and informed written consent,
* Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

* Subject to a measure for the protection of justice.
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C

This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a monotherapy.

Additionally, the study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to previous conventional-interferon based therapy.

Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.

All patients who had received previous treatment with conventional interferon but had failed to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had relapsed (reversion to HCV-RNA positive state after suppression) received the combination of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
* elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
* liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

* Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
* leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
* thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
* anemia (less than 12 g hemoglobin per deciliter )
* hepatitis B co-infection
* decompensated liver disease
* organ transplant
* creatinine clearance less than 50 milliliters per minute
* poorly controlled psychiatric disease
* poorly controlled diabetes
* malignant neoplastic disease
* severe cardiac or chronic pulmonary disease
* immunologically mediated disease
* retinopathy.