cyrilzakka/clinical-trials huggingface dataset:
Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

There is clinical benefit of docetaxel administered to patients who have progressed to 3 or more lines of chemotherapy including prior exposure to paclitaxel or docetaxel; using docetaxel in metastatic stage breast cancer previously exposed to taxanes equal therapeutic responses are obtained that it never received taxanes.

Methodology:

Prospective non-randomized phase IIa. The selected patients with metastatic breast cancer heavily pretreated including those previously treated with taxanes, receive docetaxel administered at a dose of 45mg/m2 body surface every 2 weeks to assess the activity of this drug.

Variables:

Age. Menopausal status. Hormone receptor status. Overexpression of HER2 neu. Location of metastatic sites. Performance status (PS) 0-3. comorbidities.

Case management in the variables (patient subgroups )

The patients with HER 2 neu overexpression of anti -HER2 therapy will further chemotherapy with docetaxel.

The patients presenting with brain metastases may receive radiation therapy to the brain and then at the end of radiotherapy, start docetaxel.

Patients whose tumors express estrogen receptors and progesterone positive receive treatment with docetaxel:

Where there is visceral crisis and it is shown that they have already progressed to more than 2 lines of previously administered hormone treatment.

In no event cytotoxic chemotherapy with concurrent docetaxel was administered to an anti-estrogen drug.

And they can continue only when hormone therapy has achieved complete response measurable lesions with docetaxel and opt for a non-cytotoxic anti-estrogen therapy and when it came to presenting unacceptable toxicity with docetaxel.

Evaluations:

clinical assessment that will include physical examination and review of laboratory studies were carried out every 2 weeks before authorizing the housing management of a next cycle.

The objective assessment of tumor response was carried out by imaging studies (CT) by RECIST criteria after administration of the 4 criteria of cycles, a cycle is administered every 2 weeks with docetaxel at a dose of 45mg/m2.

Response Criteria

1. Response tumor shrinkage by royalty over 30%.
2. Greater than 1 cm in the size of tumor lesions decrease.
3. Disease-free survival
4. Progression-free survival.
5. Stable disease
6. Improved quality of life that is decreased bone pain, improvement of dyspnea.

Eligibility Criteria:
Inclusion Criteria: Women over 21 years of age diagnosed with breast cancer in clinical stage IV, who had received 3 or more lines of cytotoxic chemotherapy, which may have included paclitaxel or docetaxel, which have measurable or evaluable tumor activity in any distant organ and who are fully conscious and well oriented to permit informed consent.

Exclusion Criteria:

Male patients with metastatic breast cancer. Patients with grade 3 neuropathy by prior exposure to taxanes. Patients under 21 and over 85 years of age. Metastasis of one site in the central nervous system.
Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder

By 2030 the number of patients with Parkinson's Disease (PD) would increase by 56% affecting 1 out of 120 people older than 45 years-old. It is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called REM sleep behaviour disorder (RBD). Follow-up of those subjects showed there was a conversion rate to PD and related disorders (called synucleinopathies) over 80%.

The pathophysiology of RBD is poorly understood. The development of cutting-edge technologies such as 7 Tesla MRI and the optimisation of image processing methods made it possible to non-invasively explore in vivo small brain structures involved in sleep and movement disorders.

The investigators hypothesize that brain and brainstem microstructure, composition, sodium homeostasis and connectivity may change in 15 isolated RBD (iRBD) subjects compared with 15 healthy controls and that these changes may be correlated with clinical scores.

This study would help fill the gap in early diagnosis of synucleinopathies, by contributing to better targeting patients who could be included in therapeutic trials with a neuroprotective effect. Besides, the exploration of original pathophysiological pathways such as sodium homeostatis could provide the necessary arguments for the development of new target therapeutics.


Eligibility Criteria:
Inclusion Criteria for patients with REM Sleep Behaviour Disorder :

* Patient aged between 40 and 80 years old
* Patient fulfilling the diagnostic criteria for RBD (International Classification of Sleep Disorders version 3, American Academy of Sleep Medicine, 2014) with polysomnographic confirmation (which will be carried out as part of the routine work-up);
* UPDRS Part III score under or equal to 5
* The patient is enrolled in the French social security system
* The patient understood and signed the consent to participate in the study.

Inclusion Criteria for control group :

* Patient aged between 40 and 80 years old
* Score under or equal 4 for the RBD screening questionnaire
* UPDRS Part III score under or equal 5
* The patient is enrolled in the French social security system
* The patient understood and signed the consent to participate in the study.

Exclusion Criteria :

* Patient / Subject with a history of central nervous system disease (e.g. PD, Alzheimer's disease, stroke, brain tumour, multiple sclerosis, amyotrophic lateral sclerosis, etc.). If a doubt exist, this criterion will be left to the judgement of the principal investigator, who is a neurologist.
* Contraindications to 7T MRI: presence of a metal in the body or in the eye, patient with a pacemaker or neurostimulator, cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, aneurysm clips.
* Claustrophobia.
* Montreal Cognitive Assessment Test (MOCA) \< 25/30
* Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics

The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.

The study is a multi-center, prospective single-sample correlational design without controls.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 14 - 75 years of age at time of screening
2. A clinical diagnosis of type 1 or 2 diabetes for a minimum of 6 months duration as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Adequate venous access as assessed by investigator or appropriate staff

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Harmony 1 Sensor placement as assessed by qualified individual.
2. Subject has any unresolved adverse skin condition in the area of Harmony 1 Sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has had a hypoglycemic seizure within the past 6 months
8. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit.
9. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit.
10. Subject has a history of a seizure disorder
11. Subject has central nervous system or cardiac disorder resulting in syncope
12. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
13. Subject has a hematocrit (Hct) lower than the normal reference range
14. Subject has a history of adrenal insufficiency.
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria:

* active ocular infection; clinically significant blepharitis; follicular conjunctivitis; pterygium; narrow angle glaucoma; dry eye syndrome; ocular surgery within past 6 months; pregnancy or lactation
Modulation of Metabolic Rate by Inorganic Nitrate

The purpose of this study is to determine the effects of sodium nitrate on resting metabolic rate, glucose uptake and formation of reactive oxygen species in humans.


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers

Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease
The Safer At School Early Alert HUB

Schools serve important community roles beyond academic education. In historically marginalized communities they are trusted providers for a range of support services for families in need. The tradeoff between these crucial benefits of in-person learning against the risk of SARS-CoV-2 transmission in school settings has been hotly debated throughout much of 2020 and 2021. The stakes are particularly high in historically marginalized communities which rely most heavily on school services, but have also been hit the hardest by COVID-19 primarily due to structural issues. The Safer at School Early Alert (SASEA) program was co-developed by the University of California, San Diego, the County of San Diego, and 15 partner schools serving socially vulnerable students in 5 school districts across San Diego County. SASEA utilizes daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 infections among students and staff on campus. Positive environmental signals are immediately followed by targeted responsive testing for a whole school (in the case of wastewater) or classroom (for a positive surface sample). In this project, we will develop the Safer at School Early Alert HUB (SASEA HUB), an online school environmental monitoring report dashboard with resources to address structural barriers to COVID-19 diagnostic testing in historically marginalized communities (Aim 1). We will also create a toolkit to allow any school to rapidly adapt the template to their specific setting. In Aims 2 and 3, we will use a randomized stepped wedge trial to compare SASEA (control) vs SASEA HUB (intervention) in 26 schools across 3 diverse school clusters in San Diego County. Our primary outcome (Aim 2) is higher rates of diagnostic testing in intervention schools. Our secondary outcome (Aim 3) is increased risk mitigation behaviors in school community members when environmental surveillance data suggests a potential case on campus. In Aim 4, we will use parent-child narrative interviews with 40 parent-student pairs to understand how children perceive COVID-19 risk at school, assess differences in perceptions of testing barriers between intervention and control sites, and better understand how children understand the process of environmental surveillance and responsive testing.


Eligibility Criteria:
Inclusion Criteria:

* Individuals ages 18 and above affiliated with students attending the 3 school districts participating in the SASEA study

Exclusion Criteria:

* Children under the age of 18
Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation

This study is designed to evaluate the safety of DTI-0009 in patients with atrial fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial fibrillation with rapid ventricular response.


Eligibility Criteria:
Inclusion Criteria

* Primary diagnosis of atrial fibrillation with rapid ventricular response of any duration as documented by an ECG

Exclusion Criteria

* Presence of other significant cardiac disease or history of significant neurological, hepatic,cardiovascular, renal, gastrointestinal, thyroid, respiratory, rheumatologic, or hematologic disease or impairment that in the investigator's judgment is serious enough to preclude the patient from safely participating in the study
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis

This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.

This study is run by DNDi with Novartis as co-development partner

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years (at the time of the screening visit) who are able to comply with the study protocol. Following a favourable interim analysis result, patients ≥12 \<18 years will also be enrolled in the trial
* Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parent(s) or legal guardian for patients under 18 years of age. In the case of minors, assent from the child also needs to be obtained
* Primary symptomatic VL (defined as typical parameters including, but not limited to, fever for \> 2 weeks, weight loss, and splenomegaly)
* Visualization of Leishmania amastigotes by microscopy in tissue samples (spleen or bone marrow)

Exclusion Criteria:

* Clinical signs of severe VL (jaundice, spontaneous bleeding, edema, ascites, coma, organ failure)
* Laboratory abnormalities including ALT/SGPT \> 3 times ULN, total bilirubin \> 1.5 times ULN, creatinine \>1.5 times ULN, amylase or lipase \> 1.5 times ULN, haemoglobin \< 6 g/dL or other clinically significant abnormal laboratory parameters which, in the opinion of the investigator, may indicate severe VL
* Patients with history of previous leishmaniasis and confirmed relapse
* Patients with para-kala-azar dermal leishmaniasis
* Patients with severe malnutrition (for children ≥12-\<18 years: BMI-for-age WHO reference curves by sex, z score \< -3; for adults ≥18 years: BMI \< 16)
* History of congenital or acquired immunodeficiency, including positive HIV (test at screening)
* Known hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome®
* Concomitant infections such as tuberculosis, severe malaria, or any other serious underlying disease that may interfere with the disease assessment (e.g., cardiac, renal, hepatic, haematologic, and pancreatic)
* Infection with hepatitis B (HBV) or hepatitis C virus (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a subject. Patients with a positive HCV antibody test should have HCV RNA levels measured. Patients with positive (detectable) HCV RNA should be excluded.
* Pregnant or nursing (lactating) women
* Women of childbearing potential who do not accept to have a pregnancy test done at screening and/or who do not agree to use highly effective contraception while taking the investigational drug and for 5 half-lives or 5 days, whichever is longer, after stopping the investigational drug.
* Sexually active males unwilling to use a condom during intercourse while taking the investigational drug and for 5 half-lives or 5 days, whichever is longer, after stopping the investigational drug.
Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.

This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.

Eligibility Criteria:
Inclusion Criteria:

* Age range: 12-35 years of age at the time of follow-up.
* Gender: Both.
* Minorities: All.
* Involved in sports at the time of injury.
* Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery
* Bioabsorbable Screws used during ACL reconstruction surgery

Exclusion Criteria:

* Age: \<12 or \>35 years of age
* Non-active or unable to participate for health reasons
* Simultaneous bilateral ACL reconstruction surgeries.
* If any of the following conditions exist in the ipsilateral knee:

  * Revision ACL reconstruction
  * Complex knee injury
* If any of the following conditions exist in the contralateral knee:

  * ACL deficient
  * Prior ACL reconstruction
  * Prior surgery of any type
* Insufficient initial documentation
* Cannot be contacted by phone
* Neither Calaxo nor Milagro screw used at the time of ACL reconstruction
Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses

Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled.
* Age 21 years and above.
* Ability to provide informed consent

Exclusion Criteria:

Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are:

* Right-to-left, bi-directional, or transient right-to-left cardiac shunts;
* Worsening or clinically unstable congestive heart failure;
* Acute myocardial infarction or acute coronary syndromes;
* Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval;
* Respiratory failure;
* Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature;
* Hypersensitivity to DEFINITY™ or its components.
Pregnant Women with Placenta Previa

Placenta previa is the extension of placental tissue over the endocervical os or covering the cervical os. Placenta previa is a common complication in the third trimester of pregnancy and is a major cause of postpartum hemorrhage and perinatal death.There are many studies in the literature on attachment. However, no studies have been found on fetal movement in placenta previa pregnant women. Counting fetal movements is an easy and inexpensive assessment that pregnant women can do on their own, without the need for any specialist or equipment, and for which they take responsibility. It is assumed that the effective time spent during fetal movement counting will positively affect the attachment between the pregnant woman and the fetus, and that the stress of the pregnant woman, who is sure that her baby is well, will decrease.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-45

  * In the second trimester,
  * Primiparous,
  * With adequate communication skills
  * Literate,
  * Able to read and understand Turkish,

Exclusion Criteria:

Having any mental illness

* Having communication, hearing or vision problems that prevent you from answering the data collection tools
DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

Spasmodic Dysphonia (SD) is a neurologic condition causing inappropriate contraction of the laryngeal musculature, leading to abnormal voicing. The three types (adductor, abductor, and mixed) affect varying muscle groups which produce characteristic voice patterns. The vast majority of patients with SD have adductor type, which impacts the lateral cricoarytenoid and thyroarytenoid muscle complex. While many treatment modalities have been investigated, the most effective treatment is botulinum toxin injection to these muscle groups, performed transcervically with or without electromyography (EMG) guidance. Patients undergoing this treatment typically require re-injection every 3 months. Due to its specialized nature, the laryngeal injections are not performed routinely outside of academic medical centers; thus, patients may come from a distance to receive this treatment. Both due to the significant impact on voice quality when the injections wear off and the sometimes challenging access to treatment, a longer-acting agent is desired.

Injectible daxibotuliumtoxinA (DAXI, Revance Therapeutics Inc., Newark, CA) has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer a longer-lasting result when compared with onabotulinumtoxinA.

Thus, a study examining the effect of DAXI for patients with adductor spasmodic dysphonia is proposed. This study aims to assess the efficacy of DAXI for transcervical laryngeal injection in patients with adductor spasmodic dysphonia.


Eligibility Criteria:
Inclusion Criteria:

* greater than 18
* diagnosis of adductor spasmodic dysphonia
* previous successful treatment with BotoxA
* stabilized dose for last 3 treatments

Exclusion Criteria:

* age less than 18
* exclusively having other neurologic conditions such as:

  * abductor spasmodic dysphonia
  * ALS
  * Multiple sclerosis
  * Parkinson's disease
  * Essential tremor
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses

The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers.
* BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion Criteria:

* History of severe allergy/hypersensitivity reactions including drug-allergy or drug hypersensitivity reactions, or ongoing allergy/hypersensitivity.
* History or present symptoms or signs of Quincke oedema, angiooedema, or urticaria pigmentosa, or history of repeated episodes of urticaria.