cyrilzakka/clinical-trials huggingface dataset:
Maternal and Newborn Safety Profile of Progestogens in EARLY Pregnancy

This multinational, prospective, active surveillance, registry study following two cohorts will include study participants who are pregnant and seeking any type of medical treatment, including dydrogesterone and other progestogens, for either (A) recurrent pregnancy loss and/or bleeding in early pregnancy or (B) as In-Vitro Fertilization (IVF)/Assissted Reproductive Technology (ART) support. Pregnant women not taking progestogen and are advised an alternative non-medical treatment, in the context of bleeding in early pregnancy, recurrent pregnancy loss, or undergoing natural cycle frozen embryo transfer (NC-FET) can also be included in this study. Eligible study participants will be recruited via an international network of prescribing Health Care Practitioners (HCPs) in China, Turkey, and Russia with the aim to collect data related to maternal safety and newborn safety in women prescribed progestogens during early pregnancy. Study participants will be followed from early pregnancy until 6 - 12 weeks after giving birth. All malformations will be captured via direct contacts with the study participants. Study participants will be sent online questionnaires via the electronic Patient Reported Outcomes (ePRO) solution provided by MediData. Major malformations reported by the study participants will be validated by ZEG Berlin via relevant source documents and if necessary, via contacting the treating HCPs. The total study duration is planned for approximately 4 years including recruitment and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who wish to sustain their pregnancy
* Women who have tested positive (blood or urine) for pregnancy in the first trimester
* treated with progestogens or any alternative treatment for early bleeding in pregnancy with evidence of an intrauterine pregnancy / unexplained recurrent OR pregnancy loss (with ≥ 2 previous pregnancy losses) with evidence of an intrauterine pregnancy OR having undergone IVF/ ART embryo transfer and taking progestogen for luteal phase support (LPS), with evidence of an intrauterine pregnancy
* Signed informed consent, allowing consent to contact all treating, or diagnosing HCP
* Able and willing to read and comprehend written instructions; comprehend and complete the questionnaires required by the protocol

Exclusion Criteria:

* Serious disease or disease requiring teratogenic treatment (e.g., Lupus Erythematosus, Multiple Sclerosis, cancer)
* Multifetal pregnancy
* More than four (4) previous IVF embryo transfers
* Previous exposure to dydrogesterone in index pregnancy
* Documented substance abuse
* Treatment with hormones which are known to cause malformations
* Participation in an observational study that might, in the recruiting HCP's opinion, influence the assessment for the current study
* Participation in a randomized clinical trial in the last 3 months
* Previous enrollment in the PEARLY study
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

The goal of this study is to provide access to brexucabtagene autoleucel for patients diagnosed with a disease approved for treatment with brexucabtagene autoleucel, that is otherwise out of specification for commercial release.


Eligibility Criteria:
Inclusion Criteria:

* Have commercially manufactured brexucabtagene autoleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria
* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential)
* Deemed medically fit and stable to receive the product per the investigator's evaluation
* Repeat leukapheresis is not feasible per the investigator's assessment
* Be diagnosed with 1 of the approved labeled indications for brexucabtagene autoleucel that is intended for release
* In the Investigator's opinion, there is no satisfactory alternative therapy available to the individual

Exclusion Criteria:

* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as brexucabtagene autoleucel
* Uncontrolled active infection or inflammation per physician assessment
* Primary central nervous system (CNS) lymphoma
Development and Validation of an Internet-based Near and Intermediate-vision Reading Test

Primary objective of our study is to develop and validate an internet-based digital near and intermediate-vision reading test in the greek language.

Present study aims to develop and validate a computer-based digital near-vision reading test (web Democritus Digital Acuity Reading Test - wDDART) based on the validated digital DDART.

Specifically, present study aims to develop a new online reading test (wDDART) based on the corresponding digital DDART reading test for Windows and to evaluate the level of agreement between the two reading tests, as well as test-retest reliability of the online wDDART reading test.

The first part of the study is the development of the online reading test, which will include the following new smart features:

1. Automatic calculation of the reading time of each sentence (each logMAR)
2. Automatic calculation of the basic reading parameters - RA, MRS, CPS, ACC - immediately after the completion of the examination
3. Adjustment of the font size according to the size of the computer screen used for the examination
4. Real time calculation of the patient-screen distance through a face detection system

The second part of this study is the clinical validation of the online wDDART reading test. In this part, four reading parameters measured with the digital and the online version are compared. These parameters are the following:

1. Reading Acuity (RA)
2. Maximum Reading Speed (MRS)
3. Critical Print Size (CPS)
4. Accessibility Index (ACC) All the comparisons take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the reading capacity in a population with a wide range of vision.

Eligibility Criteria:
Inclusion Criteria:

* Adequate literacy of written Greek language
* Age between 18 to 75 years

Exclusion Criteria:

* Dyslexia
* Attention-deficiency
* Former diagnosis of mental and/or psychiatric diseases
COVID-19 Phobia in Patients With Bronchiectasis During Covid-19 Pandemic

In the literature, there are no studies evaluating COVID-19 phobia, quality of life, health anxiety, physical activity level and quality of sleep in patients with bronchiectasis during COVID-19 pandemic. The investigators will evaluate these parameters in patients with bronchiectasis and compare the findings of healthy individuals during COVID-19 pandemic


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with non-cystic fibrosis bronchiectasis
* No acute bronchiectasis exacerbation or infection in the past 2 weeks
* Volunteering to participate in the research

Exclusion Criteria:

* Having a cognitive problem
* Not being literate
Prospective Study in Pregnant Women With Hypercoagulopathy

Pre-eclampsia is one of the most common causes of maternal and fetal morbidity and mortality. The aim of this study is to identify pregnant women at risk for pre-eclampsia or other cardiovascular complications at a very early state of the disease, and thereby improve the current method of screening.

600 pregnant women will be included in the project and followed in a standardized manner during their pregnancy. On a regular basis blood- and urine samples will be taken throughout their pregnancy and until 1 month after delivery and analyzed for a large variety of coagulation factors in order to identify factors that might predict an increased risk of developing pre-eclampsia and/or cardiovascular events. In addition a DNA-sample is taken if consented in order to evaluate genetic factors.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending the midwife at Hilleroed Hospital, Frederiksborg County, Denmark.

Exclusion Criteria:

* Mental disease.
* Problems understanding or reading Danish.
A Randomized Comparison of Personalized Therapy Mgmt Based On Coronary Atherosclerotic Plaque Vs. Usual Care for Symptomatic Patients With Suspicion of CAD

PARAMOUNT is a prospective randomized open-label trial testing the hypothesis that a personalized management strategy in symptomatic patients with suspicion of coronary artery disease (CAD), using a CT-based coronary atherosclerotic plaque assessment by AI-enabled quantitative software improves: certainty for diagnosis of CAD, control of CAD risk factors and efficiency of ICA referral with appropriate PCI compared to the usual care strategy based on current AHA/ACC guidelines for care of symptomatic patients with suspicion of CAD.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* Symptomatic patients with suspicion of CAD, including those referred for elective, non-urgent diagnostic testing (e.g. stress test)

Exclusion Criteria:

* LDL \< 100 mg/dL
* Currently or previously treated beyond primary prevention guidelines
* Suspected acute coronary syndrome or otherwise unstable clinical status
* Planned cardiovascular procedure (e.g. coronary angiography, cardiac surgery, non-coronary vascular procedure)
* Noninvasive or invasive CV testing for CAD within 1 year (e.g. invasive coronary angiography (ICA), coronary CT angiography (CCTA) including calcium scoring)
* Known history of obstructive CAD (prior myocardial infarction, CABG or PCI, stenosis ≥50%)
* Known EF ≤40% or other moderate to severe valvular or congenital cardiac disease
* Contraindications to CCTA
Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy

"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. In a case-control study of patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas passing and defecation time.

Recently, a study reported that mosapride citrate acts on the α7nACh receptor and, consequently, suppresses the inflammatory response of macrophages, thereby suppressing the mechanism that induces paralysis after surgery.

To date, this study is intended to analyze whether mosapride citrate significantly affects the improvement of bowel movement after surgery after gastrectomy."


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with gastric cancer pathologically before surgery
2. Patients who underwent surgical resection (R0 resection)
3. Patients with an ASA score of 3 or less

Exclusion Criteria:

1. Patients over 80 years old
2. When there are multiple or peritoneal metastases
3. Intestinal obstruction before surgery
4. When chemotherapy was performed before surgery
5. When cancer other than stomach cancer is diagnosed
6. If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy
7. In case of liver failure or kidney failure
8. When it is judged that uncontrolled diabetes may affect intestinal function
An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients

The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode.

The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.


Eligibility Criteria:
Key Inclusion Criteria:

* Provided written informed consent to participate in Study AXS-05-301
* Has treatment-resistant depression, defined as an inadequate response to 2 or 3 prior ADTs
* Body mass index (BMI) between 18 and 40 kg/m2, inclusive

Key Exclusion Criteria:

* Suicide risk
* Treatment with any investigational drug within 6 months
* History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.

OBJECTIVES: I. Determine whether ciprofloxacin improves the recurrence-free survival of patients with superficial transitional cell carcinoma of the bladder treated with a transurethral tumor resection.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (first occurrence vs recurrent disease). Patients are randomized to receive either oral ciprofloxacin or oral cephalexin 2 times a day for 3 days starting the night before resection. Patients who are allergic to penicillin or a cephalosporin receive oral co-trimoxazole 2 times a day for 3 days. All patients undergo complete resection of all bladder tumors. Patients are followed every 3 months for the first 2 years, every 6 months for the next 2 years, and at the end of the fifth year.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study over 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Stage Ta (any grade) transitional cell carcinoma of the bladder on basis of cystoscopy Recurrent disease no greater than T1 Must not be at high risk for upper tract (ureter or renal pelvic) transitional cell cancers

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission No allergies to fluoroquinolones If allergic to penicillin or cephalosporin, must be able to take co-trimoxazole

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 28 days since prior intravesical therapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 28 days since prior radiotherapy and recovered Surgery: Not specified Other: At least 3 months prior to cystoscopy since prior fluoroquinolones No concurrent fluoroquinolones No concurrent hemodialysis or peritoneal dialysis No concurrent probenecid or theophylline No concurrent antacids containing aluminum, magnesium or calcium, products containing iron or zinc, caffeine, cyclosporine, or warfarin
Emergence Delirium and Recovery Time in Children

In this study, inhalation anesthesia procedure and intravenous anesthesia method will be compared in terms of emergence delirium and recovery time in children who are scheduled for dental treatment under general anesthesia.

Pediatric Anesthesia Early Delirium Scale (PAEDS) will be used to evaluate postoperative emergence delirium.

Eligibility Criteria:
Inclusion Criteria:

1. Indication of dental treatment under general anesthesia.
2. No systemic disease (ASA1).
3. Child and parent agree to participate in the work

Exclusion Criteria:

1. Do not accept to participate in the work.
2. The child is not systemically healthy.
3. Children with allergies to general anesthetic drugs.
4. Contraindicated children to take general anesthesia
5. Children with upper respiratory tract infection on the day of operation
Investigation of the Duration of Low-intensity Focused Ultrasound

This project examines the effects of various durations of noninvasive neuromodulation on muscle contractions. The investigators believe this study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in addiction, pain, and mental health issues. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) and transcranial magnetic stimulation (TMS) devices to temporarily change brain activity. Electromyography (EMG) will be used to record muscle contractions of the hand.


Eligibility Criteria:
Inclusion Criteria:

* Above criteria and must understand and speak English.

Exclusion Criteria:

* Contraindications to MRI, CT, or TMS

  1. Claustrophobia
  2. Pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Pregnancy
  4. Active medical disorder or treatment with potential CNS effects
  5. History of neurologic disorder
  6. History of head injury resulting in loss of consciousness for \>10 minutes
  7. History of alcohol or drug dependence
A Study of Elecsys® Troponin T hs Gen 6 in Participants With Symptoms of Acute Coronary Syndrome

This prospective, non-interventional, single arm, longitudinal cohort multicenter study will recruit approximately 5600 consecutive all-comers, consisting of patients with signs and symptoms of acute coronary syndromes (ACS) who present in the emergency department (ED). The main objective of the study is to determine the clinical performance of Elecsys Troponin T hs Gen 6 versus the centrally adjudicated clinical diagnosis at various time points after ED presentation using the previously determined clinical cut-off of a universal 99th percentile upper reference limit.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years
* Signed Informed Consent Form
* Troponin or other cardiac marker determination planned as part of suspected acute coronary syndromes routine care
* Demonstrating symptoms suggestive of acute coronary syndrome and/or myocardial ischemia, such as any of the following:

  1. Chest pain, pressure, or a burning sensation across the precordium and epigastrium;
  2. Pain that radiates to neck, shoulder, jaw, back, upper abdomen, or either arm;
  3. Acute onset or worsening dyspnea;
  4. Nausea, vomiting or indigestion;
  5. Lightheadedness or syncope;
  6. Diaphoresis;
  7. Generalized weakness or fatigue; OR, asymptomatic subjects or patients with atypical symptoms in whom myocardial infarction is being suspected.

Exclusion Criteria:

* None
A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).

A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).

This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven mantle cell non-Hodgkin's lymphoma,
* One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
* Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
* ECOG performance status score of ≤ 2
* Willing to follow pregnancy precaution

Exclusion Criteria:

* Patients who have received more than 1 line of induction chemotherapy;
* Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
* Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
* Any of the following laboratory abnormalities:
* Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5\*10\^9/L)
* Platelet count \< 60,000/mm\^3 (60\*10\^9/L)
* Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) \> 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
* Serum bilirubin \> 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
* Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of \< 30 mL /min
* Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
* Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
Therapeutic Effects of Robotic Exoskeleton-Assisted Gait Re-habilitation and Predictive Factors of Significant Improvements in Stroke Patients

Investigators aimed to examine the effectiveness of robotic exoskeleton-assisted gait training in stroke rehabilitation, and to determine predicting factors of significant improvements in post-stroke patients. Investigators hypothesized that robotic assisted gait training brings better strength recovery and functional improvement.


Eligibility Criteria:
Inclusion Criteria:

* patients aged from 30 to 80 years
* hemiparesis due to ischemic or hemorrhagic stroke in the last 6 months

Exclusion Criteria:

* with a significant history of pain or injury of lower limbs that affected their walking ability,
* with cardiopulmonary diseases that prohibited exercise training
* with impaired cognitive function
* unable to complete the timed up-and-go test
* able to complete the timed up-and-go test in \<20 seconds using walking device
Cortical Excitability Assessment Using Paired Pulses

The identification of the epileptogenic zone (EZ) during pharmacoresistant focal epilepsy presurgical assessment frequently requires intracranial recordings like stereo-electroencephalography (SEEG). Cortical direct electrical stimulation (DES) is commonly used during SEEG for functional mapping or to induce seizure.

However, the recording of seizures is sometimes insufficient to circumscribe the EZ and development of new biomarkers is necessary.

The cortex within the EZ is thought to be hyperexcitable. The "paired pulses" paradigm, using transcranial magnetic stimulation (TMS), allows determining the hemispheric cortical excitability level. The investigators hypothesize that paired pulses DES during SEEG could provide useful information for EZ identification.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old
* Pharmacoresistant focal epilepsy patients undergoing a stereo-electroencephalographic recording
* Provide written consent to the study after receiving clear information
* Be a beneficiary or member of health insurance plan

Exclusion Criteria:

Patient with contraindication for MRI scanning

* Pregnancy
* Prohibition on participation in other research, apart from any other non-interventional research