cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects

The purpose of this study is to evaluate bioequivalence (biological equivalence of two formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg, prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted (without food) conditions.

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 2-way crossover (method used to switch participants from one treatment arm to another in a clinical study), single-dose, and single-center study. The study consists of 3 phases: the screening phase, treatment phase, and end-of-study or withdrawal assessment phase. In the treatment phase, participants will receive a single dose of new tapentadol ER 100-mg TRF tablet (Treatment A) and current tapentadol ER 100-mg PR2 (Treatment B) under fasted conditions in 2 treatment sequences (AB and BA). Administration of the study medication will be separated by a washout period (no treatment) of 7 to14 days. Approximately 64 participants will be enrolled in this study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. The duration of participation in the study for an individual participant will be approximately 5.5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Agrees to protocol-defined use of effective contraception
* Body mass index (BMI) between 20 and 28 kilograms per square meter, inclusive, and body weight not less than 50 kg (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\])
* Habitually smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the first study medication administration

Exclusion Criteria:

* History of seizure disorder or epilepsy or mild or severe traumatic brain injury
* Men with hemoglobin concentrations below 12.5 g/dL or women with hemoglobin concentrations below 11.5 g/dL
* Positive test for drugs of abuse, such as cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines, or barbiturates at screening or Day -1 of each treatment period
* Positive test for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies
* History of a gastrointestinal disease affecting absorption, gastric surgery or history of or current significant medical illness
Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure

Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with HF. In addition, very little information is available on the effectiveness of disease management programs in areas other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.


Eligibility Criteria:
Inclusion criteria

1. Age ≥ 18 years

Exclusion criteria

1. End-stage HF defined as requiring mechanical support or continues intravenous inotropic support
2. A serious life-threatening illness with a life-expectancy of \<6 months Within the past 3 months
3. Cognitive dysfunction
4. Substance abuse or psychotic disorder
5. Managed by visiting nursing
6. Long distance between patients' home and hospital
Minimally Invasive Radioguided Parathyroidectomy

The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).

The specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. In addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.

Eligibility Criteria:
Inclusion Criteria:

* All patients with biochemical evidence of primary hyperparathyroidism
Long-term Prognosis and Valve Durability of TAVR

This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.

2. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form

* 1. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
* 2. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form

Exclusion Criteria:

* 1. Patients who cannot provide informed consent
* 2. Patients who are participating in other clinical trials
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye except for laser treatment outside the subfoveal area
* Subfoveal CNV due to AMD
* CNV must be = or \>50 % of the entire lesion
* All lesion composition types with a lesion greatest linear dimension (GLD) \< 5400 microns (approximately = or \<9 disc areas \[DA\])
* Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive

Exclusion Criteria:

* Subfoveal geographic atrophy or subfoveal fibrosis of the study eye
* Intraocular surgery within 3 months of enrollment
* Inability to attend the protocol-required visits
* Known allergies or hypersensitivity to any of the study treatments.
* Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk
* Uncontrolled glaucoma, defined as (1)subject is on \>1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration
* If subject has had a stroke within the last year
A Study to Assess Maternal and Fetal Outcomes After Taking Prucalopride During Pregnancy

This study will collect information on pregnant women diagnosed with constipation from their health care insurance claims records.

It will include the following groups:

* Those who took prucalopride.
* Those who took other medicines for constipation.
* Those who did not take any prescription medicines for constipation.

The main aim of the study is to assess the risk of major birth defects with the mother's use of prucalopride during the first 3 months of pregnancy.

The study uses existing health care insurance information; participants are not enrolled, treated, or required to visit the doctor during this study.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with constipation.
* Maternal coverage by health care and prescriptions insurance during eligibility period:

  * Live births: 90 days prior to the last menstrual period until 30 days post-delivery;
  * abortions (spontaneous abortions): from 180 days prior to the first code for abortion to 30 days after this diagnosis;
  * stillbirths: from 180 days prior to the first code for stillbirth to 30 days after this diagnosis.
* For infant outcomes, the cohort will be restricted to pregnancies with linked offspring.
* For major malformations, only pregnancies with livebirths will be included, since information regarding the pathology results from a pregnancy loss or the indication for termination is rarely recorded. In addition, infants are required to have full insurance coverage from delivery to at least 90 days after the delivery, unless the infant died prior to the end of the 90 days, in which case a shorter eligibility period until death is permitted.
* For the analyses of pregnancy losses, the cohort also includes pregnancies ending in spontaneous abortion, stillbirth and any livebirth (linked or unlinked to a delivery).

Exclusion Criteria:

* Termination of pregnancy will be identified but excluded from analyses (since malformations are rarely coded and these pregnancies will not be at risk for other outcomes).
* Pregnancies in which prucalopride is dispensed in the 3 months prior to the LMP but not during the first trimester (to ensure that there is not misclassification of the non-exposed)
* Women with opioids dispensed in the 3 months prior to LMP or during the first trimester (to exclude potential opioid-induced constipation) and women with inflammatory bowel diseases (because they are a contraindication)
* For major malformations, the cohort excludes pregnancies with a chromosomal abnormality based on at least one inpatient or outpatient ICD-9 code for 758.xx,759.81-759.83, or 655.1x within 90 days after delivery in the infant and/or maternal claims.
* For major malformations, pregnancies with outpatient exposure to definite teratogens including warfarin, antineoplastic agents, isotretinoin, misoprostol, and thalidomide from LMP through LMP plus 90 days (that is, days of exposure overlap with 1st trimester).
Impact of Triglyceride-Glucose Index on Cardiovascular Outcomes in Patients Presented With MINOCA

This work was designed to explore the role of the triglyceride-glucose (TyG) index in the prediction of cardiovascular outcomes in Patients Presented with myocardial infarction with nonobstructive coronary arteries.

Acute myocardial infarction (AMI) remains the leading causes of high morbidity and mortality worldwide . Recently, a distinct population with myocardial infarction with nonobstructive coronary arteries (MINOCA) has been increasingly recognized because of the widespread use of coronary angiography. MINOCA occurs in 5%-10% of all AMI and they are younger and more often women compared to patients with AMI and obstructive coronary artery disease (CAD). The underlying causes of MINOCA are manifold and may include plaque rupture or erosion, thromboembolism, coronary spasm, spontaneous dissection, microvascular dysfunction and supply/demand mismatch. Some non-ischemic diseases such as myocarditis may also mimic the presentation of MINOCA . Of note, several studies have found that the prognosis of MINOCA is not trivial and patients are still at considerable risks for long-term adverse cardiovascular (CV) events despite the optimal secondary prevention treatments . Thus, it is of necessity and profound implications to find potential residual risk factors and improve prognosis in MINOCA population.

Insulin resistance (IR), a critical mechanism of the pathogenesis of diabetes, not only contributes to the development of cardiovascular diseases (CVD), but also significantly correlates with adverse CV outcomes. Additionally, IR often coexists with obesity, hypertension, and dyslipidemia , and all of these are well-known risk factors of CVD. Recently, the triglyceride-glucose (TyG) index derived from fasting triglyceride (TG) and fasting blood glucose (FBG) levels has been proposed as a new and valid surrogate indicator of IR . Till now, many studies have found that the TyG index is positively correlated with metabolic disorders, arterial stiffness , carotid atherogenesis , coronary artery calcification , and subclinical or symptomatic CAD. Moreover, growing evidence has showed that the TyG index is an independent predictor of poor CV outcomes in general population and in different cohorts with CAD, including patients with AMI or acute coronary syndrome (ACS) with or without diabetes

Eligibility Criteria:
Inclusion Criteria:

* All patients; diagnosed with myocardial infarction with nonobstructive coronary arteries (MINOCA)
* clinical symptoms
* ECG : ischemic changes with or without ST segment elevation
* Echocardiograpy : segmental wall motion abnormalities (SWMA)
* positive cardiac enzymes
* Coronary angiography: insignificant lesions ,the absence of culprit obstructive coronary artery disease (epicardial coronary artery stenosis ≥50%)

Exclusion Criteria:

* All non confirmed diagnosis of MINOCA
* cardiac

  * non-ischemic cardiomyopathies
* non-cardiac

  * pulmonary embolism
  * stroke
  * sepsis
  * ARDS
Immune Response Evaluation to Curative Conventional Therapy

The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.

The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
* fit for treatment with curative intent
* conventional primary treatment
* primary surgical treatment
* primary radiotherapeutic treatment
* informed consent
* \>18 years of age
* sufficient contraception

Exclusion Criteria:

* distant metastasis at baseline
* severe concomitant disease compromising curative treatment
* previously diagnosed other malignant diseases
* active immunosuppressive therapy
* known immune defect
* pregnancy
* anemia requiring treatment at study entry (\<9g/dl)
Image Fusion in the OR

The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.

Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound.

We have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. For ablations, we further track the needle and overlay its path on the AR view for precise needle placement. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Referred for laparoscopic cholecystectomy or liver ablation
2. Clinical indication for the use of laparoscopic ultrasound
3. Patient or an authorized guardian provides written consent

Exclusion Criteria:

Patients with pacemaker or any other ICD (intra-cardiac device) which may interfere with electromagnetic tracking
Risk Assessment Model of Trastuzumab-related Cardiotoxicity in Breast Cancer Patients

According to the existing clinical data in our hospital, retrospective study was conducted to screen the risk factors with predictive value for TRC(trastuzumab-related cardiotoxicity) risk, and to construct the risk prediction model for TRC.

The breast cancer patients with cardiotoxicity caused by trastuzumab were selected as the case group, and the breast cancer patients without cardiotoxicity were selected as the control group. The clinical baseline data, echocardiographic parameters and serum markers of the case group and the control group were compared to find out the risk factors that may have predictive value for the risk of TRC. The target factors were analyzed by univariate analysis and multivariate Logistic regression analysis, and the TRC risk prediction model was established.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients diagnosed with HER2-positive breast cancer treated in our hospital.
2. Surgical treatment combined with chemotherapy or radiotherapy was completed according to NCCN guidelines, and trastuzumab standard treatment was received for at least half a year.

(3) Cardiac function (including echocardiography or biomarkers) was assessed at least once within 3 months before trastuzumab treatment, and at least once during or after treatment was performed for heart-related tests.

(4) Complete case data.

Exclusion Criteria:

1. Patients who have not been properly treated with trastuzumab or have been treated for less than half a year;
2. Patients who did not receive cardiac function assessment before trastuzumab treatment, during or after treatment;
3. Patients whose case data were missing or lost to follow-up.
Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping sickness in children at least 6 years old and over 20 kg bodyweight.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed by one of the parents or the child's legal representative
* Child assent to participate in the study collected in the presence of an impartial witness
* Age between 6 and 15 years old
* \> 20 Kg bodyweight
* Boy or girl
* Able to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
* Able to swallow 600mg fexinidazole tablets
* Karnofsky index \> 50
* Presence of trypanosomes in blood and/or lymph and/or CSF
* Permanent address and ability to comply with follow-up visit schedule

Exclusion Criteria:

* Child refusing to be included in the trial
* Bodyweight \< 20 Kg
* Severe malnutrition, defined as having a BMI below 16 (- 2 Z-score of the norm according to WHO 2007 Growth reference data)
* Inability to take oral medication
* Pregnancy or breastfeeding
* Clinically relevant medical condition other than HAT that, in the Investigator's opinion, may jeopardize subject safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular disease, active documented or suspected infection, central nervous system (CNS) trauma or seizure disorders, coma or altered consciousness
* Severely deteriorated general condition, such as cardiovascular shock, respiratory distress, or terminal illness
* Any medical condition (except HAT-specific symptoms) hindering communication with the Investigator as required for the completion of this study
* Any contraindication to imidazole products (known hypersensitivity to imidazoles)
* History of HAT treatment in the past 2 years
* Patients previously enrolled in the study or having already received fexinidazole.
* Expected follow-up difficulties (migrants, refugees, itinerant vendors, etc.).
* Current alcohol or drug abuse
* Clinically significant abnormal laboratory findings, including ASAT and/or ALAT \> 2 times ULN // Total bilirubin \> 1.5 times ULN // Severe leukopenia (\< 2000/mm3) // Potassium (K+) \< 3.5 mmol // Any other clinically significant abnormal laboratory value (see details in Investigator Manual)
* Pregnancy confirmed by a positive urine pregnancy test obtained within 24 hours (h) prior to start of study treatment (see Section 5.8.3 Contraception; p36) for girls over 12 years old and over
* ECG abnormalities assessed by a central cardiologist
* QTcF≥ 450 ms, as measured automatically (if first measurement is abnormal, a second assessment will be done at least 10-20 min later, with the patient in resting position).
* Patients not tested for malaria and/or not treated adequately for this infection
* Patients not treated adequately for soil transmitted helminthic diseases
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)

The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of all women who were treated with Corifollitropin Alfa or recFSH and became pregnant during Base Trial P05787 (NCT00696800). For this trial, no study specific assessments are required, but information as obtained in standard practice will be used.

Eligibility Criteria:
Inclusion Criteria:

* Participants who received at least one dose of either Corifollitropin Alfa or

Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);

* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
* Able and willing to give written informed consent.

Exclusion Criteria:

* None