cyrilzakka/clinical-trials huggingface dataset:
The Androtriol Injection for the Treatment of Acute Ischemic Stroke

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, phase IIb clinical trial of Androtriol injection for the treatment of acute ischemic stroke. The goal of this trial is to explore the efficacy and safety of different doses of Androtriol injection in patients with acute ischemic stroke (AIS) who received vascular recanalization treatment within 24 hours of symptom onset.

Participants will receive a low-dose Androtriol injection (100 mg BID), a high-dose Androtriol injection (300 mg BID), or a placebo intravenously within 24 hours of stroke onset. They will be treated twice daily (every 12 hours) for 7 days, with a total of 14 doses over the course of the study. Each infusion will last approximately 30±5 minutes.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18- 80 years, male or female；
2. mRS score ≤1 prior to this onset;
3. Planning to receive or have received intravascular recanalization therapy at our center within 24h of onset;
4. To complete the first administration of the investigational medication within 24h of onset;
5. NIHSS（National Institutes of Health Stroke Scale）score≥6 prior to intravascular recanalization;
6. Informed consent.

Exclusion Criteria:

1. Intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
2. Severe disorders of consciousness: NIHSS 1a≥2 points;
3. Large infarct core (ASPECTS \<6, or\>1/3 of MCA territory involved, as evidenced by CT or MRI);
4. Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after medication control;
5. History of severe kidney disease (such as dialysis), or eGFR \<45 mL/min/1.73m²;
6. History of severe liver disease, or ALT, AST levels more than 3 times of the upper limit of normal, or bilirubin more than 3 times of the upper limit of normal;
7. Cardiovascular diseases, such as complete atrioventricular block, history of congestive heart failure (CHF), or heart function classification≥NYHA Class III;
8. Critically ill patients with an expected lifespan≤90 days;
9. History of epilepsy or epilepsy-like symptoms during stroke or severe psychiatric disorders, intellectual disability, or dementia;
10. History of intracranial hemorrhage;
11. Severe injury or surgery history within 3 months of onset;
12. Have received\>1 dose of neuroprotective drugs after this onset, such as edaravone, edaravone dexborneol injection, ginkgo lactone, ginkgo diterpene glucamine，etc;
13. Allergy to the investigational drug (either the active ingredient androtriol or the excipient hydroxypropyl beta-cyclodextrin) or similar chemical structure drugs;
14. Pregnant or breastfeeding;
15. Participation in other clinical trials within 3 months of onset;
16. Unsuitable for participating in this study judged by investigator.
Impact of Hospital Pharmacist Intervention on Medication Management in Dialysis Patients

The goal of this clinical trial is to learn if an intervention of a hospital pharmacist could help, dialysis patients managed his treatment. In a first time, the health literacy level will be assed.

The main questions it aims to answer are:

What is the impact of the clinical pharmacist intervention on the understanding level and management level of his treatment by the patient? Does the intervention of the pharmacist has an effect on the biologicals parameters of the patient? Researchers will compare a group with a pharmacist intervention VS a group without pharmacist intervention for dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* On dialysis (peritoneal dialysis, hemodialysis) for at least 3 months
* Prescription for at least 5 daily medications
* Patient who has not received any pharmaceutical consultation from a hospital pharmacist as part of his or her treatment for chronic renal failure.

Exclusion Criteria:

* Patient does not speak and/or understand French
* Patient's cognitive state does not permit an interview
* Patient not autonomous in managing his or her daily medication (e.g.: patient in nursing home)
* Patient refusal
Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma

Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.


Eligibility Criteria:
* 15 years of age or older
* Patients with metastatic sarcoma who have had no more than one prior systemic treatment for metastatic disease
* Patients with recurrent sarcoma at relapse
* Patients with confirmed histological diagnosis of sarcoma or suspected diagnosis of sarcoma. Some specific subtypes of sarcoma are NOT eligible (Gastrointestinal Stromal Tumor (GIST), carcinosarcoma, sarcomatoid mesothelioma, and metastatic phyllodes tumor)
* If initial suspected diagnosis of sarcoma, must have sarcoma diagnosis confirmed prior to proceeding with PDX drug sensitivity testing
* Must have measureable disease for computed tomography (CT) scan or magnetic resonance imaging (MRI) evaluation following biopsy or surgery to obtain tissue for PDX development.
* No plan for concurrent chemoradiation, for target lesions that will be used for drug treatment correlation with PDX
* Fresh tumor tissue available for PDX development
* Eastern Cooperative Oncology Group performance status of 0-1
* Life expectancy exceeds 6 months
* Plan to receive systemic therapy
* Informed consent
PUMP (Providing the Underprivileged With Manual Pumps): An RCT

The primary objective of this study is to pilot an intervention of providing manual breast pumps at hospital discharge to low-income, first-time mothers and to generate initial estimates of the effect of this intervention on exclusive breastfeeding rates at 3 months (12 weeks). In this pilot study, we will compare receipt of a breast pump and brief instructions of its use to the active control of receipt of a children's book and brief instructions about reading with baby. As a secondary objective, we will investigate mothers' attitudes and opinions about the manual breast pump intervention with the goal of fine-tuning it to best fit mothers' needs before a larger, multi-center trial. To support our objectives, we will examine the following specific aims:

1. To test the intervention of providing low-income, first time mothers with a manual breast pump at hospital discharge on exclusive breastfeeding rates at 12 weeks.

   Hypothesis: Among low-income first-time mothers, receipt of a manual breast pump at hospital discharge will lead to improved exclusive breastfeeding rates at 12 weeks postpartum compared to receipt of a children's book.
2. To use qualitative methods to determine best practices associated with successful implementation of a breast pump intervention to improve breastfeeding rates among low-income, first-time mothers.
3. To test the effect of receiving a children's board book during the birth hospitalization on parents reading to the baby at 3 months (12 weeks).


Eligibility Criteria:
Inclusion Criteria:

* WIC-eligibility (income below 185% the federal poverty line)
* liveborn infant
* in the well newborn nursery
* 12-96 hours of age
* infant is breastfeeding

Exclusion Criteria:

* maternal age \<18 years
* maternal incarceration
* mother does not speak or read in English
* infant is a twin or higher level multiple
* infant has cleft lip and palate or a known syndrome
Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers

Study to demonstrate bioequivalence of a 2.5 mg linagliptin/1000 mg metformin fixed-dose combination (FDC) tablet compared with single tablets of linagliptin 2.5 mg and metformin 1000 mg administered together.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women according to the following criteria: based upon a complete medical history, including physical examination, vital signs (Blood pressure (BP), Pulse Rate (PR)), 12-lead ECG, clinical laboratory tests
2. Age 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
6. History of relevant orthostatic hypotension, fainting spells or blackouts
7. Chronic or relevant acute infections
8. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
9. Intake of drugs within 1 month or less than 10 half-lives of the respective drug prior to first study drug administration
10. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
11. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
12. Alcohol abuse (average consumption of more than 20 g/day in women and 30 g/day in men)
13. Drug abuse
14. Blood donation (more than 100 mL within 4 weeks before Day 1 of Visit 2)
15. Any laboratory value outside the reference range of clinical relevance
16. Inability to comply with dietary regimen of trial site

    For female subjects of childbearing potential only:
17. Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
18. No adequate contraception during the study and until 1 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, hormonal intrauterine device, sexual abstinence for at least 1 month prior to first study drug administration, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilization (including hysterectomy). Women who did not have a vasectomised partner, were not sexually abstinent or surgically sterile were asked to use an additional barrier method (e.g. condom).
19. Lactation
12 Month Follow up in Vivo Icon Study on Fluorotic Teeth

Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.

Dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. Anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. In addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact.

The aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. Resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. This approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies.

This study will be conducted in the provinces of Pichincha and Cotopaxi, Ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the Thylstrup and Fejerskov (TF) scale or questionable, very mild, and mild fluorosis according to Dean's Index will be recruited. In addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Questionable, Very mild, and Mild (Dean's Index) dental fluorosis as well as TF scale grades 1, 2, and 3 of the upper anterior teeth.
* Parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups.

Exclusion Criteria:

* Teeth without fluorosis.
* Teeth with hypoplasia.
* Teeth with incipient caries lesions observed at gingival level and differentiated by the Presence of plaque.
* Teeth previously restored or with aesthetic corrective treatments
* Teeth with endodontic treatment.
* Patients with low or questionable hygiene.
* Malnourished patients or that have some underlying disease.
* Teeth with less than two thirds of its visible crown.
* Children that have less than six teeth in their oral cavity.
* Allergic reaction to methylmethacrylate.
Anti-phospolipid Antibodies in Lyme Borreliosis

Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B. burgdorferi sensu lato accumulates intact phospholipids from its environment to support its growth. Several of these environmentally acquired phospholipids including phosphatidylserine, phosphatidylcholine and phosphatidic acid may be recognized by anti-phospholipid antibodies that are believed to arose early in infection. Here we aimed to investigate the levels of anti-phospholipid antibodies in patients with Lyme borreliosis.

Methods

Participants included in the study:

* 150 patients with well-defined Lyme borreliosis, of which 30 presented with solitary erythema migrans (EM), 30 with multiple EM (MEM), 30 with Lyme neuroborreliosis (LNB), 30 with Lyme arthritis (LA), 30 with acrodermatitis chronica atrophicans (ACA);
* 50 patients with nonspecific symptoms and positive borrelial antibodies in serum; and
* 40 healthy blood donors (control group; samples from healthy blood donors were used to determine the threshold for the assays).

Specimens:

* 4 serum samples from each individual patient with well-defined Lyme borreliosis (1 before antibiotic treatment, 3 during follow-up up to 1 year);
* 2 serum samples from patients with nonspecific symptoms and positive borrelial antibodies (1 before antibiotic treatment and one 3 months later);
* healthy blood donors: 1 serum specimen.

Anti-phospolipid antibodies:

Levels of IgG and IgM isotypes of 4 anti-phospholipid antibodies including anti-cardiolipin (aCL), anti-phosphatidylserine (aPS), anti-phosphatidic acid (aPA) and anti-phosphatidylcholine (aPC) will be analyzed with in-house ELISAs.


Eligibility Criteria:
Inclusion Criteria:

Fulfillment of clinical case definition criteria for European Lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.).

Exclusion Criteria:

Autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.
Post-stroke Pain taVNS

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.

In this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (taVNS) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. Each participant will undergo an in-person visit. Participants will first finish the pain questionnaires and have quantitative sensory testing (QST) conducted to determine baseline pain thresholds. Participants will then receive 30 minutes of taVNS (either active or sham). Upon the completion of the stimulation intervention, participants will then be tested for another QST and pain questionnaires.

Aim 1: Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain.

Over the last 8 years, investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies. Specifically, investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial. In this study, investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain.

Aim 2: Investigate whether taVNS can modulate pain in this population compared to sham.

In this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention, as well as between active and sham taVNS. The findings will help investigators understand whether taVNS can modulate pain in this population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
* Ischemic or hemorrhagic stroke that occurred at least 6 months prior
* Unilateral stroke lesions in the left hemisphere
* Right upper extremity pain

Exclusion Criteria:

* Primary intracerebral hematoma or subarachnoid hemorrhage
* Documented history of dementia
* Documented history of uncontrolled depression or psychiatric disorder
* Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) \>=180/100mmHg
* Pregnancy
Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery

Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new 4-wavelength generation of NIRS monitors which could reliably assess real-time absolute values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass
* Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France)
* Patient agreement

Exclusion Criteria:

* Age\<18 years
* Black skin
* Emergencies
* Patient refusal
Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)

The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).

This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.

Eligibility Criteria:
Inclusion Criteria:

* All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Exclusion Criteria:

* None
Intraoperative Radiotherapy After the Resection of Brain Metastases

INTRAMET examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. Patients won't receive further radiation therapy of the intraoperatively treated lesion.

Brain metastases occur in up to 40% of all patients diagnosed with systemic cancer. Without adjuvant radiotherapy after resection of space occupying lesions local recurrence rates are high. That is why guidelines recommend a cavity boosting with x-rays. External beam radiotherapy can lower the risk of local recurrence but means longer hospitalization, prolongs the time to systemic salvage therapies and bears risks of radionecrosis and leucoencephalopathy with neurological and cognitive decline. A solution for this problem could be onetime intraoperative radiotherapy (IORT) with soft x-rays to sterilize the resection cavity, which may provide both: freedom from local recurrence fast track salvage therapy initiation.

INTRAMET is a single institution, open-label, prospective, phase 2 feasibility study for intraoperative radiotherapy immediately following resection of brain metastases. 50 adult patients with resectable not dural brain metastases should be treated in surgery after tumor resection with IORT with 20-30Gy prescribed to the margin of the resection cavity. The highest dose tolerable to surrounding risk structures (N. opticus, brainstem) should be used.

With this method, the investigators hope to show similar local control rates to postoperative external beam radiotherapy in line with guideline recommendations with less patient hospitalization and faster start of rescue therapies which could lead to a favorable overall outcome and less cognitive side effects.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance index ≥ 50%
* MRI T1 Gadolinium enhancing non-dural resectable lesion
* Informed consent
* Adequate birth control
* Frozen section confirms metastasis
* Adequate distance to optic nerve and brainstem

Exclusion Criteria:

* Dural lesions or meningeal carcinomatosis
* Frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma
* Psychiatric or social condition interfering compliance
* Contraindication against anesthesia, surgery, MRI and/or Gadolinium
* Pregnant or breast-feeding women