cyrilzakka/clinical-trials huggingface dataset:
ZoNantax - Zolendronic Acid as Neoadjuvant Therapy Plus Anthracycline and Taxane in Locally Advanced Breast Cancer

The purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive.

This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for neoadjuvant treatment of HER 2 positive stage II/III breast cancer.

Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for inhibition of tumor growth in pre clinical studies

The primary objective of the study is to evaluate the residual cancer burden (RCB) with the addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a continuous index combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size). RCB index is a significant predictor of distant relapse-free survival, and can be used to define categories of near-complete response and chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk factors. Additionally, the study will collect tissue biopsies and blood before and after treatment in order to correlate clinical outcomes with gene expression and radiologic data to predictive response.

Eligibility Criteria:
Inclusion Criteria:

1. Stage IIA to IIIB HER-2 positive breast cancer
2. ECOG performance ≤ 2
3. Adequate hematologic function with:

   * Absolute neutrophil count (ANC)\> 1500/mm³
   * Platelets ≥ 100.000/mm³
   * hemoglobin ≥ 9g/dL
4. Adequate hepatic and renal function with:

   * Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 2.5 x the institutional upper limit of normal (ULN)
   * Alkaline phosphatase )≤ 2.5 x the institutional upper limit of normal (ULN)
   * Serum creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) or calculated creatinine clearance \> 50 mL/min
5. Adequate cardiac function

   * Left ventricular ejection fraction (LVEF)with institutional normal range
6. Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion Criteria:

1. Previous diagnostic of breast or other cancer
2. Pregnancy
3. Metastatic breast cancer
4. Bilateral, synchronous breast cancer
5. Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this study
6. Neuropathy grade \> 2 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Acupuncture for Irritable Bowel Syndrome Patients

In this study, a 14-week, single blinded, randomized controlled clinical trial will be conducted to determine whether acupuncture could have significant benefits than sham acupuncture for IBS.

This is a single blinded randomized sham controlled clinical trial with two arms. 120 IBS patients will be recruited. The study will cooperate with Hong Kong Baptist University, and University of Toronto. After a 2-week run-in period, eligible subjects will be randomly assigned to one of two arms, acupuncture (AC) arm and sham acupuncture (SAC) arm. Each eligible subject will go through a 2-wk run-in-period, 6-wk treatment period and follow by a 6-wk of follow-up period. Five visits in total were scheduled for each subject in week 0, week 2, week 5, week 8 and week 14.

Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of the Rome IV criteria for IBS
* IBS Symptom Severity Scale (IBS-SSS) \> 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period
* Written informed consent.

Exclusion Criteria:

* Pregnancy or breast-feeding
* Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases
* Unstable medical conditions
* Unstable mental condition or with history of mental illness
* Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic
* Alcoholism or drug abuse in past 1 year
* Having needle phobia
A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity

The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.

This is placebo-controlled, parallel group and single centre study in healthy male and female participants with obesity and no known Atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), or Type 2 Diabetes Mellitus.

Participants will be randomized in the ratio of 1:1 to receive either AZD4144 or placebo.

This study will comprise of:

* A screening period of 28 days.
* The treatment duration will be up to 28 days.
* The visit frequency will be weekly up to a Follow-up Visit, followed by a Final Follow-up Visit 28 days after the final dose of AZD4144.

Eligibility Criteria:
Key Inclusion Criteria:

* Serum hsCRP \> 2 milligrams per liter (mg/L).
* All females must have a negative pregnancy test at the Screening Visit and at the randomization visit (Visit 2).
* Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception to avoid pregnancy from the time of first administration of study intervention until 3 months after the Final Follow-up Visit.
* Have a body mass index (BMI) greater than or equal to (≥) 30 and less than or equal to (≤) 45 kilograms per meter\^2 (kg/m\^2).
* Have a waist to hip ratio of ≥0.9 for male and ≥0.85 for female participants.

Key Exclusion Criteria:

* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
* History of Myocardial infarction (MI), coronary revascularisation, stroke, revascularisation for peripheral arterial disease, or other pre-existing Cardiovascular (CV) diseases.
* History of Diabetes (Type 1 and Type 2) or glycated haemoglobin (HbA1c) ≥6.5%.
* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
* Any skin disorder, history of, or ongoing clinically significant allergy/hypersensitivity.
* Clinically significant serious active and chronic infections within 60 days prior to randomization.
* Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
Safety Study of Galantamine in Tic Disorders

The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined.

Modulation of cholinergic activity is a growing focus in neurologic therapeutics especially for dementing disorders such as Alzheimer disease. Treatment with the recently developed cholinesterase inhibitor, galantamine, has demonstrated significant improvement with few issues related to tolerability. In addition to inhibiting the activity of acetylcholinesterase, galantamine also modulates the activity of nicotinic cholinergic receptors by an allosteric mechanism. As a result, galantamine therapy may be beneficial when the response to other agents has been limited.

Cholinesterase inhibitor therapy has been reported to improve motor tics in children with TS refractory to more traditional therapies. Symptoms of co-morbid behavioral disorders, primarily inattention, were also improved. Cholinergic modulation appears a promising avenue for managing tic disorders.

Men and women (18 - 50 years of age) fulfilling DSM IV criteria for the diagnosis of chronic motor tic disorder, chronic vocal tic disorder or Tourette Syndrome and experiencing suboptimal control of tics on current therapy will be enrolled into this open label evaluation of galantamine. A total of 6 visits will be required over 22 weeks. Participants will follow a standard 4 week titration schedule achieving 12 mg bid after 8 weeks. They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy. The difference in tic severity prior to and upon completion of therapy will be examined. The impact of treatment upon obsessions/compulsions, attention/concentration, depression, anxiety and quality of life will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* DSM IV criteria for the diagnosis of Tourette's syndrome, chronic motor or chronic vocal tic disorder
* Accepted method of birth control

Exclusion Criteria:

* Preganancy or nursing
* Unstable medical illness
* Unstable psychiatric illness
Brief Yoga and Mindfulness for Women Who Have Experienced Domestic Violence

This study aimed to examine the effectiveness of a brief yoga- and mindfulness-based psychoeducation program and its working mechanisms in improving psychological health parameters (depression, anxiety, and stress) among women who have experienced domestic violence (DV).

In a randomized controlled trial, 51 DV-victimized women were assigned to an intervention group (n = 27) or a waitlist control group (n = 24). The intervention was a five-week yoga- and mindfulness-based psychoeducation program.

The researchers planned to provide support for the effectiveness of a brief yoga- and mindfulness-based psychoeducation program for improving the psychological health of DV-victimized women. Self-compassion and rumination were hypothesized as working mechanisms underlying the intervention's success.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for this study required participants to be women aged 18 years or older who had experienced domestic violence in the previous 12 months but were no longer in an ongoing domestic violence situation. Additionally, participants needed to have secure access to a smartphone or a laptop / Personal Computer.

Exclusion Criteria:

* Refusal to give consent or missing more than one session of the psychoeducation program were the exclusion criteria. The individuals who met the absence criterion were still able to continue the rest of the sessions; however, their questionnaires were not included.
Epidemiology Study of Malaria Transmission Intensity in Africa

The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).

This study is a multicenter epidemiology study at centers that are participating in GSK's pivotal Phase III candidate malaria vaccine 110021 ( NCT00866619) trial and will involve 4 annual cross sectional surveys performed preferably at peak transmission.

There will be no study vaccine administered in this epidemiology study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
* A male or female 6 months or older at the time of survey.
* Written informed consent obtained from the subject/from the parent(s)/ Legally Acceptable Representative(s) of the subject.

Exclusion Criteria:

* Child in care.
* Previous or current participation in any malaria vaccine trial.
Comparative Evaluation of Implant Stability, Soft & Hard Tissue Healing Around UV Activated vs Conventional Implants

Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants.

Research is to compare and evaluate the primary and secondary implant stability, healing of the soft tissue around UV activated implants and conventional implants. The objectives are to access the primary and secondary implant stability using Resonance frequency analysis, marginal bone level using RVG with grid, healing of the soft tissue. The control group will be treated with conventional implant and test group will be treated with UV implants. The total number of participants are 12 and 24 sites (control - 12 sites, test - 12 sites) with 3 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* At east above 18 years of age
* Patients who needs replacement for at least 2 missing teeth in the posterior region of mandible
* Adequate bone volume to accommodate planned dental implants
* Patients who will comply with oral health care instructions and necessary visits

Exclusion Criteria:

* General contraindications to dental implant treatment ( uncontrolled diabetes, severe cardiovascular or infectious disease)
* Intravenous and oral bisphosphonate therapy
* Unwillingness to return for the follow up examinations
* Smokers
* Patients who are psychologically unable to participate
* Poor oral hygiene
Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device

The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.

Title: Diversion-p64. Device: p64 Flow Modulation Device. Study design: Prospective, multicenter, single arm Post Market Clinical Follow-Up Study.

Purpose: To assess safety and effectiveness of p64. Study duration: 48 months. Sample Size: 400 patients. Number of sites: \> 20. Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard.

Eligibility Criteria:
Inclusion Criteria

1. Age ≥ 18
2. Patient harbours either one saccular or one dissecting or one blisterlike or one fusiform intracerebral aneurysm or one intracerebral segmental disease, in the anterior circulation for which the indication for p64 treatment is given
3. Patient or legal representative provides written informed consent verifying that he/she consents to the use of his/her data (according to the data protection laws)

Exclusion Criteria

1. Aneurysms of the posterior circulation
2. Imaging evidence of bifurcation aneurysms
3. Imaging evidence of dissections
4. Imaging evidence of fistulae
5. Imaging evidence of arteriovenous malformations
6. Patient is harbouring another aneurysm that has to be treated within six months after first procedure
7. Known allergy to study medication, e.g. ASA, Clopidogrel, Heparin or contrast media
8. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
9. Current involvement in another study or trial
10. Parent vessel treated with other Flow Diverters than p64 during intervention and re-treatment
Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management

The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).

The main question it aims to answer is:

How does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?

Participants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.

The analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care.

Specifically, we will analyze the levels of:

* 25(OH)D,
* 1,25(OH)2D
* Calcium
* Phosphates
* PTH
* FGF23
* GDF15 to assess the efficacy and safety of cholecalciferol in dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D \< 30 ng/mL)

Exclusion Criteria:

* dialysis time of less than 3 months
* inadequately controled secondary hyperparathyroidism (iPTH\>800pg/mL)
* treatment with calcimimetics
* treatment with active forms of vitamin D3,
* parathyroidectomy
* bilateral nephrectomy
* treatment with corticosteroids
* lack of consent to take part in the study.
A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers

A study to study the potential effect of PF-00299804 inhibition of CYP2D6 on dextromethorphan.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects must be CYP2D6 extensive metabolizers, ultrarapid metabolizers or intermediate metabolizers, as predicted by CYP2D6 genotyping.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink =5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
* 12 lead ECG demonstrating QTc \>450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of \<1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results the study may be permitted on a case by case basis.
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* History of sensitivity to heparin or heparin induced thrombocytopenia.
* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
Azithromycin Microspheres in Patients With Low Risk Community Acquired Pneumonia

The study will assess the clinical efficacy at Day 14-21 (Test of Cure), 14-21 days after starting the study drug; those subjects from whom a baseline pathogen is identified will also be assessed for bacteriologic response. All subjects who receive 1 dose of study medication will be assessed for safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years age or older, for whom oral, outpatient therapy is indicated.
* Diagnosis of CAP as manifested by at least 3 or more of the following:
* cough, pleuritic chest pain, fever (temperature of \>37.8 C to \<40 C), auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation, dyspnea, tachypnea, laboratory results of elevated total peripheral white blood count (WBC\> 10,000/mm3 or greater than 15% immature neutrophils (bands)

Exclusion Criteria:

* Known or suspected hypersensitivity or intolerance to azithromycin or other macrolides.
* Previously diagnosed disease(s) of immune function, including: subjects with baseline absolute neutrophil count \< 1,000/mm3, HIV positive subjects with CD4 count \< 200 cells/mm3, any immunoglobin or neutrophil disorder.
Impact of Child Positioning on Pain During a Lumbar Puncture

This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.

It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.

In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment.

In hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.

Two positions are possible to carry out lumbar puncture: seated or lying position.

The main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.

This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.

Each patient will have 2 LP one in seated and one in lying position in a specific order determined by randomization.

All data regarding pain and anxiety will be collected the day of LP. Patients will be re contacted 48 hours and 15 days after LP procedure in order to evaluate complications such post-lumbar puncture syndrome or hematoma. The main analysis will be done on intent-to-treat-analysis basis and will compare pain intensity between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 18 years old
* Patients requiring at least 2 therapeutic lumbar punctures
* Patients able to receive analgesic procedure according to 20005 good practices recommendation
* Presence of one parent during LP procedure
* Child able to use assessment scales
* LP realized with a 20 G needle
* Platelets \> 50000
* Child with prior clinical examination
* Affiliated to a health care insurance regimen

Exclusion Criteria:

* Seated or lying position impossible
* Lumbar puncture contraindication
* Patient or parent opposition to second LP realization in the required position
* Clotting trouble on LP day not allowing the LP procedure
NovellusDx Tissue Collection Protocol

NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on patient derived tumor tissue. The assay is able to sense activating mutations by monitoring their effect on a chip-based device.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have been diagnosed positive for colon cancer.
* available treatment follow up during cancer treatment

Exclusion Criteria:

* None