cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants

The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay paradigm in healthy participants.

The drug being tested in this study is called TAK-994. The study will evaluate the safety/tolerability, PD, and PK of TAK-994 in an acute sleep phase delay paradigm in healthy participants.

The study will enroll up to approximately 18 healthy participants. Participants will be randomly assigned to 1 of the 3 treatment sequences which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* TAK-994 Dose A + Placebo + TAK-994 Dose B
* TAK-994 Dose B + TAK-994 Dose A + Placebo
* Placebo + TAK-994 Dose B + TAK-994 Dose A

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 10 weeks. Participants will be followed up remotely on Day 7 after the last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months prior to the first dose of study drug.
2. Have regular sleep-wake habits (example, routinely spending 6.5 to 8 hour sleeping nightly, not oversleeping by more than 3 hour on weekends \[that is, total sleep not more than 11 hour\]) as determined by investigator interviews and confirmed in 5-day actigraphy records and regularly fall asleep between 9:30 PM and 12:00 AM.

Exclusion Criteria:

1. Have a positive alcohol or drug screen or a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\] per day).
2. Have excessive sleepiness, defined by a self-reported Epworth Sleepiness Scale (ESS) score at screening greater than (\>) 10; irregular work hours; or routine night-shift work within 1 month before randomization.
3. Have a prior history of or currently is experiencing any known/suspected sleep disorder (including obstructive sleep apnea and restless leg syndrome), any disorder associated with excessive daytime sleepiness (EDS), or any diagnosis interfering with assessment of sleepiness.
4. At the time of screening, be receiving treatment with nasal/oronasal positive airway pressure for any reason.
5. Have abnormal findings on the initial polysomnography conducted on Day -1 (check-in) of the first treatment period.
6. Have traveled across 2 or more time zones within the 2 weeks before screening.
7. Have caffeine consumption of more than 400 milligram (mg)/day for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 mg of caffeine).
Diet, Exercise, and Cardiovascular Health Among Ethnic Children

To analyze data collected over a four year period on an initial cohort of 3 or 4 year old children and their parents in Galveston, Texas, and in Augusta, GA, in regard to cardiovascular disease (CVD) physical risk factors and risk related behaviors.

BACKGROUND:

Little was known about tracking of cardiovascular disease (CVD) risk factors and risk related behaviors, or about predicting these variables in young children. Tracking was an important issue because it reflected the extent to which the disease processes found among adults start in childhood, and whether behavioral or social factors could be used to interrupt that tracking.

DESIGN NARRATIVE:

In Texas, physical risk factor data were collected at four annual clinics. Data on childrens' physical activity and diet were collected for up to four times per year for the three years between the annual measurement clinics. Similar data, although with some different measurement techniques, were collected in Georgia. For this data analysis, specific longitudinal research questions addressed whether these physical risk factors (blood pressure, lipids, lipoproteins and body composition) and risk related behaviors (diet and physical activity) tracked across the annual assessments, whether a variety of behavioral and social factors (demographic characteristics and family function) affected that tracking, and whether relationships obtained among adults between physical risk factors and these other variables could be found in this age child. The testing of these relationships was enhanced by the availability of multiple assessments of blood pressures and body composition at each point for more reliable assessments, and by multiple assessments of diet and physical activity within each year. It was further enhanced by the availability of observational data on physical activity and diet, which overcame the limitations of the more common self report approach to measurement. Models were developed in each data set and cross validated in the other. Procedures were employed to determine reasons for differences and to revise the models to produce maximal fit in both data sets. The results of these analyses contributed to a better understanding of at what age, and with what factors, it was most appropriate to intervene to mitigate CVD.

Eligibility Criteria:
No eligibility criteria
Detecting Auricular Points in MMG by a Novel APD ( APD-MMG )

This pilot study is designed to validate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device.

This pilot study is designed to evaluate the diagnostic ability of a novel APD for auricular point detection among patients with menstrual migraine (MMG), as compared with an already commercialized device. The investigators will test if the novel APD could provide a more reliable and quantifiable diagnosis of MMG-related auricular point than traditional devices currently available in the market; The study will also use the APD device to test whether the cutaneous electrical impedance detected from the corresponding auricular points by the novel device is the lowest in the reproductive organ and facial area in the MMG population. As a pilot study, 12 patients with MMG will be recruited from the School of Chinese Medicine, the University of Hong Kong. 12 healthy subjects will be recruited from the university community. Auricular acupoint detection will be accomplished with the new device and a control device. The electrical impedance will be measured and recorded. Patient's condition will also be evaluated by the visual analogue scale (VAS) and the Modified New England Center of Headache (NECH) headache calendar. The specificity and sensitivity of the auricular point detection by the APD device will be calculated. Cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. Moreover, the Pearson Correlation Coefficient will be used to test the correlation between the electrical impedance of the auricular point and the pain intensity score.

Eligibility Criteria:
Inclusion Criteria:

* When attacks, average migraine pain severity \>=5 point measured by a 10-point VAS scale;
* Diagnosed pure menstrual migraine without aura or menstrually related migraine without aura according to The International Classification of Headache Disorders: 2nd edition;
* Provide written inform consent;
* Free of any other diagnosed psychological conditions;

Exclusion Criteria:

* with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease
* Pregnancy or lactation
* Participation in a clinical study that may interfere with participation in this study
* History of or current tobacco, alcohol use
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
* Unable to provide written informed consent due to any reason.
Systematic Wide-Field EMR Scar Assessment and Therapy Audit

The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.

Removal of colonic polyps reduces colon cancer and although most polyps found are small, removal of large polyps can now be safely and effectively removed with wide field EMR. Residual polyp tissue is found at follow up colonoscopy in approximately 15% of cases however and remains a focus of attempts to improve EMR efficacy. All patients undergoing surveillance colonoscopy after EMR at Westmead Hospital Endoscopy unit will have steps of assessment and therapy of the scar recorded. Data will be entered into the large prospective audit database and also analysed separately. Data will be stored in coded format. The individual steps and the outcome of the scar interrogation and therapy will also be assessed and analysed. It is expected that these results will help guide the optimal approach to assessment and confirm the efficacy of therapy of recurrence further aiding the endoscopic approach to large colonic polyps.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
* Age \> 18 years
* Able to give informed consent to involvement in the clinical study

Exclusion Criteria:

* Unable to provide informed consent for involvement
Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I)
* Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II)

Secondary

* Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I)
* Evaluate the safety profiles of this regimen in these patients. (Phase I)
* Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II)
* Determine the overall survival of patients treated with this regimen. (Phase II)
* Determine the overall response in patients treated with this regimen. (Phase II)
* Evaluate the safety and toxicity of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter study.

Patients receive paclitaxel-loaded polymeric micelle and carboplatin.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced ovarian cancer
* Measurable disease by RECIST criteria
* No prior or concurrent CNS metastasis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Life expectancy \> 6 months
* Clinically acceptable blood, kidney, and spleen function
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No preexisting sensory or motor neuropathy ≥ grade 1
* No other malignancies within the past 5 years

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for ovarian cancer
* No prior immunotherapy or hormonal therapy for ovarian cancer
* No prior radiotherapy to the pelvis or abdominal cavity
* More than 2 weeks since prior major surgery other than debulking surgery
Culturally Aware AET Non-Initiation Intervention

The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.

This is a single-arm pilot trial to examine the feasibility and acceptability of a patient-centered, evidence-based, culturally competent, nurse-led intervention to encourage breast cancer survivors who have not begun taking adjuvant endocrine therapy (AET) to initiate the medication.

The research study procedures include:

* screening for eligibility
* two individual study intervention sessions
* study assessment follow-up questionnaires

This research study involves two individual sessions with a nurse practitioner which will take place via videoconferencing sessions either in-person or via telephone. Participants will also complete three brief questionnaire packets over the 12-week course of the study.

It is expected that up to 35 people will take part in this research study. The investigators plan to enrich the study sample for patients of a racial and/or ethnic minority in order to ensure the generalizability of the study findings.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 21 or older
* Diagnosis of early-stage (Stage 0-IIIB), hormone receptor-positive breast cancer
* Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start AET in the future and reports hesitations to start AET as determined by a score of \>/= 4 (range =0-10) when asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)"
* Ability to read and respond in English or Spanish
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* For at least 10 participants, identify as a member of a racial or ethnic minority community per self-report

Exclusion Criteria:

* Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year
* Cognitive impairment that prohibits participation in the study
* Undergoing primary treatment for other cancer (i.e., advanced stage cancer)
* Participating in a clinical trial involving AET
Fingolimod Real World Experience: the French Grand-Est Cohort

Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014.

Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the European Database for Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients have been treated for at least 6 months with Fingolimod, the first oral therapy for patient with very active relapsing-remitting MS.

Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod in the 6 university hospitals, general hospitals and private neurologists were reviewed in a retrospective study after identification of the clinical files reported in the EDMUS database.


Eligibility Criteria:
Inclusion Criteria:

* Patients with MS treated with Gilenya because of the disease

Exclusion Criteria:

* contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014
Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair

Hernia repair is one of the most common operations. Whilst there are few complications, pain may last for several weeks and extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. This study will determine whether ALGRX 4975 can provide pain relief following hernia repair.

Inguinal hernia correction in adults is one of the most common operations with an annual rate of approximately 2,800 per 1 million people in the United States. Whilst there is little intra and postoperative morbidity, pain may persist for one to several weeks postoperatively and may extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. The purpose of this study is to determine whether a single dose of ALGRX 4975, administered by instillation, is able to reduce the postoperative pain following inguinal hernia correction and to evaluate the potential for long term pain relief.

Eligibility Criteria:
Inclusion Criteria:

• The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.

Exclusion Criteria:

* The subject has undergone a lower abdomen surgical procedure in the past.
* The subject is currently scheduled to undergo bilateral inguinal hernia repair.
* Personal or familial contraindications in undergoing general anesthesia.
* Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg
Safe Access: Trial With RemovAid Device

This randomized trial will compare different approaches to removing a subdermal contraceptive implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held device (RemovAid) that incises the skin and grasps the implant for extraction. Safety and efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps, tweezers).

The trial assigns participants to one of three arms: RemovAid+lidocaine patch (n=75), RemovAid+lidocaine injection (n=75) or traditional approach+lidocaine injection(n=75). Complication rates in the different arms will be compared. Efficacy (successful implant removal) will be the secondary comparisons. Finally, pain during removal and duration of removal procedure will be compared. Participants will return to the clinic within 4 weeks of the removal procedure to record the healing process and final interventions (if any).

Eligibility Criteria:
Inclusion Criteria:

* seeking voluntary removal of a one-rod subdermal implant
* willing to sign an informed consent document
* willing to be randomized to the new device vs. standard technique
* willing to follow-up at the study clinic for any subsequent removal-related complications
* willing to have any follow-up complications recorded and shared
* has an implant that is completely and easily palpable
* has an implant that is easily pinched and lifted
* no known allergies to skin preparation products or local anesthetics

Exclusion Criteria:

* Implants that are not easily palpable
* Previous failed implant removal
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®

The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.


Eligibility Criteria:
Inclusion Criteria

* Male or female participants must be 18 years or older.
* Histologically confirmed melanoma.
* Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.
* Sexually active participants must agree to use effective contraception.

Exclusion Criteria

* Active brain or leptomeningeal metastases unless stable for 8 weeks.
* Ocular melanoma.
* Prior active malignancy within the last year untreated or still requiring treatment.
* Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.
* Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Epirubicin in the Neoadjuvant Therapy for Breast Cancer

This is a multicenter, open, randomized, comparison study. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.

Neoadjuvant therapy is often used to reduce the size of tumors, especially in locally advanced tumors. The purpose of this therapy is to make part of patients operable and to facilitate breast-conserving surgery.

The purpose of this study is to assess the efficacy and safety of the following two proposals: nab-paclitaxel plus carboplatin versus nab-paclitaxel plus epirubicin, in order to provide support for rational clinical application.

The total number of patients to be included in this study is 520 patients.


Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 to 70 years old;
2. Histologically confirmed primary invasive breast cancer;
3. Histologically confirmed triple negative breast cancer;
4. Patients who planned to accept preoperative neoadjuvant therapy and had a mass larger than 2 cm.
5. Blood specimens and 5 sections of tumor tissue at baseline, blood specimens at surgery can be obtained.
6. Have at least one measurable lesion as per the RECIST criteria (version 1.1);
7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
8. LVEF≥55%；
9. Bone marrow function：neutrophils (≥1.5×10\^9/L), platelets (≥100×10\^9/L), hemoglobin (≥90 g/L);
10. Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
11. Patients had good compliance with the planned treatment, understood the research process and written informed consent.

Exclusion Criteria:

1. Previous treatment with any cytotoxic chemotherapy, endocrine therapy, biotherapy or radiotherapy;
2. Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
3. Patients with severe systemic infection or other serious diseases;
4. Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
5. Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
6. Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
7. Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
8. The researchers considered the patients who were not suitable for enrollment.
Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.

77 randomized, 37 paricalcitol, 40 no treatment

Eligibility Criteria:
Inclusion Criteria:

* kidney transplant patients

Exclusion Criteria:

* Previously transplanted