cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back.

The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma breast cancer
* ECOG performance status of 0 or 1
* peripheral neuropathy less than or equal to 1
* discontinued hormonal therapy as a chemoprevention while onstudy
* LVEF by MUGA \> 55%?
* Absolute neutrophil count (ANC)\> 1000/µL)
* platelet count \> 100,000/µL)
* SGOT OR SGPT \< 92.5 units/L

Exclusion Criteria:

* Stage IV breast cancer
* any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast cancer
* pregnant or lactating patients
* active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer
* previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or other drugs formulated in Cremophor EL?
* unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months
* psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements?
* active, unresolved infections
* sensitivity to E. coli derived proteins
* prior chemotherapy with an anthracycline
* prior Herceptin therapy
Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia

Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia

Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia a placebo controlled clinical trial

Eligibility Criteria:
Inclusion Criteria:

* of in¬fertility of 1 year or more without the use of contraception

Exclusion Criteria:

* o Active genital infections.

  * Patients with ejaculatory dysfunction
  * Azoospermia
Human Chorionic Gonadotropin Stimulation Effects on Steroidogenesis in Men With Klinefelter Syndrome

The study design included six visits. During the first visit (visit 0), the subjects underwent physical examination(height, weight, body mass index (BMI), arm span, and upper segment measurement) and testicular ultrasound (US) for the calculation of testicular volume. At 0800 h of day 0, all subjects provided a basal blood sample immediately followed by a single intramuscular injection of hCG of 5000 IU. Further five visits were performed each of five following consecutive days after the hCG injection. A blood sample was taken at each visit after an overnight fast

Blood samples were centrifuged at 2955 g for 15 min. Sera were transferred into plain polypropylene tubes and stored at -20°C until assayed. P, 17OHP, AS, DHEA, and TS were determined by LC-MS/MS at the laboratory of the Centre for Applied Biomedical Research of the S. Orsola-Malpighi Hospital, Alma Mater Studiorum, University of Bologna, Bologna, Italy.

Eligibility Criteria:
Inclusion Criteria:

* Klinefelter syndrome diagnosis at kariotype evaluation for the study group
* Healthy age-matched men in the control group

Exclusion Criteria:

* previous or ongoing androgen therapy
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients

In this study, the investigators propose Pulsed Low-Intensity Focused Ultrasound (PLIFU) stimulation of brain regions that modulate (thalamus) or generate focal motor seizures (primary motor cortex), with the goal of ameliorating seizure activity in subjects in non-convulsive or focal motor status epilepticus. The course of treatment will consist of an initial 10 minute PLIFU treatment session with an option for a 2nd session if necessary.

The primary objective of this study is to determine whether PLIFU reduces or suppresses epileptic activity in patients with Non-Convulsive Status Epilepticus (NCSE)/Focal Motor Status Epilepticus (FMSE) that have not responded to standard of care.

This study proposes to sonicate epileptic zones or circuits at the bedside with a custom built PLIFU device in two groups of participants experiencing non-convulsive seizures while treated in the Intensive Care Unit (ICU): 1) non-convulsive SE or 2) focal motor Status Epilepticus (SE), targeting the thalami or motor cortical areas responsible for generating ictal activity, respectively.

PLIFU modulation is non-ablative, nonionizing, and noninvasive, while it also preserves the integrity and function of brain tissue. The aim is to quantify ictal and interictal EEG before, during, and after sonication. Experiments will not alter the standard of care and only be implemented after antiseizure medications (ASMs) have been delivered to the patient. PLIFU sonication will be delivered to participants using burst tone and nonthermal parameters for 10 minute exposures.

Hypothesis: PLIFU is a safe and non-invasive treatment that can reduce or suppress epileptic activity.

The pilot data acquired is intended to be used as preliminary data for justifying a larger study.

Recruitment was put on hold from Dec. 2023 to Oct. 2024 due to personnel changes and modifications to study needing approval.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with ongoing NCSE or FMSE despite treatment with at least 2 ASMs
* Provision of signed and dated informed consent form obtained from the next-of-kin/legally authorized representative
* Treated in the ICU while monitored with continuous scalp EEG electrodes

Exclusion Criteria:

* Unable to obtain informed consent
* Presence of an implanted cranial neuromodulation device for treatment of epilepsy
* Pregnancy
* Treatment with another investigational drug or other intervention within 24 hr
* Presence of burr hole(s) or craniotomy
* Subjects with ferromagnetic materials in the head
* Subjects with a TENS unit
Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.

All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.

Three study groups are defined using the following inclusion and exclusion criteria:

* lung cancer: male \& female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
* healthy individual: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
* chronic obstructive lung disease: male \& female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests

For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.

Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:

* 5 BS are presented in 1 experiment:

  * Test I: lung cancer vs healthy individual
  * Test II: lung cancer vs chronic obstructive pulmonary disease
  * Test III: lung cancer vs healthy individuals \& bronchitis
* for every experiment 1 BS of a lung cancer patient is used

  * the lung cancer sample is placed randomly in one of the five test tubes
  * the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
  * neither the dog handler nor the dog know the loading of the test tubes
* experiments are repeated 5 to 10 times

For analysis, the sensitivity and specificity of the dog's reaction is determined.

The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80
* competent
* confirmed lung cancer

Exclusion Criteria:

* history of other cancers
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma

This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.

Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen.

The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* ovarian carcinoma relapse

Exclusion Criteria:

* neurotoxicity grade III renal clearance \< 60 ml/min
To Explore the Effect of GH on Outcomes of IVF and Telomerase Activity of Granulosa Cells in Women With POR

It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Growth hormone (GH) is currently one of the main adjuvant for improving pregnancy outcomes in patients with POR, and the investigators' previous retrospective study suggested GH was effective in live birth rate in subgroup of patients with POR older than 35 years old. To further figure out the mechanism of GH effectiveness in POR patients and the effect on clinical outcomes in POR patients, the investigators designed this prospective observational cohort study.


Eligibility Criteria:
Inclusion Criteria:

For patients with poor ovarian response, the criteria is based on POSEIDON criteria\[1\]:

1. low ovarian reserve(AMH \<1.2ng/ml, or AFC \<5);
2. younger than 40.

For patients with normal ovarian reserve, the criteria is as follow:

1. Patients who are between 20-40 years old;
2. clinical diagnosis of non-functional fallopian tube;
3. regular menstrual cycles.

Exclusion Criteria:

1. BMI ≥28kg/m2;
2. medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc;
3. ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery;
4. adenomyosis or endometriosis confirmed by surgery;
5. untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
6. untreated hydrosalpinx;
7. polycystic ovary syndrome.
Personalized TACS to Reduce Rumination in Patients with Active Suicidal Ideation

The goal of this clinical trial is to determine whether modulating default mode network (DMN) alpha connectivity using transcranial alternating current stimulation (tACS) can reduce rumination and, in turn, mitigate feelings of entrapment and suicidal ideation in individuals with active suicidal ideation and depression.

The main questions it aims to answer are:

1. Is personalized tACS stimulation of the DMN associated with reduced rumination 24 hours after stimulation?
2. Does a reduction in rumination result in lower feelings of entrapment and suicidal ideation?
3. Does personalized tACS stimulation of the DMN lead to a reduction of DMN alpha connectivity?

Researchers will compare active tACS stimulation to sham stimulation to assess whether modulating alpha connectivity has a specific effect on rumination, entrapment, suicidal ideation, and DMN alpha connectivity.

Participants will:

* Receive either active or sham tACS stimulation during stimulation sessions, but all participants will receive active tACS at least once.
* Complete self-report measures of rumination, entrapment, and suicidal ideation before and after stimulation.
* Undergo EEG recordings to assess changes in DMN alpha connectivity.

This clinical trial will be preceded by a pilot study in healthy participants with an anticipated completion of data collection in August 2025.


Eligibility Criteria:
Inclusion Criteria:

* Active suicidal ideation defined by a score ≥3 on item #10 of the Montgomery-Asberg Depression Rating Scale (MADRS) and a combined score of ≥2 on items #4 + #5 of the Beck Scale for Suicide Ideation (BSS)
* Clinical diagnosis of a mild to severe depressive episode without psychotic symptoms
* Voluntary patients at inpatient, outpatient, or day-clinic units of mental health care settings in the greater Zurich area
* Aged 18-65 years
* Fluent in German
* Ability to give written informed consent

Exclusion Criteria:

* Mental disorders due to known physiological conditions
* Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders
* Intellectual disabilities
* Concurrent vagus nerve stimulation, transcranial magnetic stimulation, electro-convulsive therapy, or treatment with nitrous oxide
* Pregnancy or breast-feeding
* Chronic migraines
* Metal implants or any other factor that - in the investigators' judgment - would unduly affect patient safety or compliance during this study
Ozone Application Before Fissure Sealants

Decay is a multifactorial infective degenerative disease of hard dental tissues, caused by Streptococcus mutans and Lactobacillus forming the bacterial biofilm of teeth surfaces. Decays generally evolve in fissures and pits of secondary molars. Pits and fissure sealants prevent decays if performed in two years from eruption. Ozone has bactericidal effect and remineralizing capacity on enamel.

The aim of this study is to assess the effectiveness of ozone application before sealants in increasing their duration in time.


Eligibility Criteria:
Inclusion Criteria:

* first or second secondary molars to be sealed
* possibility to isolate with rubber dam both the teeth involved
* no clear signs of pigmentations
* good general health

Exclusion Criteria:

* latex allergy
* epilepsy or other severe neurological pathologies
* psychiatric disease
* excessive sensibility to electrical current
* severe asthma
* enamel disorders, such as amelogenesis imperfect, white spots, fluorosis or Molar Incisors Hypomineralization
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients

This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile.

The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous infusion administered at a dose of 2 x 10\^13 gc/kg.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age ≥18 years
3. Subjects with congenital hemophilia B, classified as severe or moderately severe, and are currently on factor IX prophylaxis
4. \>150 previous exposure days of treatment with factor IX protein

Exclusion Criteria:

1. History of factor IX inhibitors
2. Positive factor IX inhibitor test at screening
3. Select screening laboratory value \>2 times upper limit of normal
4. Positive human immunodeficiency virus (HIV) test at screening, not controlled with anti-viral therapy
5. Active infection with hepatitis B or C virus at screening
6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy at the end of the lead-in phase
7. Previous gene therapy treatment
8. Receipt of an experimental agent within 60 days prior to screening
9. Current participation or anticipated participation within one year after study drug administration in this trial in any other interventional clinical trial involving drugs or devices
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery

The aim of the study was to analyse eating rate in comparison to other aspects of eating habits in women suffering from severe/massive obesity.

Eating rate is associated with BMI and weight gain in various populations and is a factor modulating the risk of complications after bariatric surgery. The aim of the present study is to determine whether common difficulties to change eating rate in subjects with obesity candidate to bariatric surgery could be due to more extensive abnormalities in eating behaviour.

Eligibility Criteria:
inclusion criteria :

* BMI ≥ 35 kg/m
* responses to a self-administered questionnaire distributed between November 2011 and March 2014 to female patients attending a nutrition consultation for overweight, or attending an outpatient visit prior to bariatric surgery, both within the Champagne-Ardenne Specialized Obesity Clinic, at the University Hospital Robert Debré in Reims, France
* Patients who agree to participate to the study
* Major patient

exclusion criteria :

* Patient under law protection
* Minor patient
* Patients with uncontrolled diabetes (HbA1c ≥ 8.0% at inclusion) or those treated with glucagon-like peptide-1 (GLP-1) receptor antagonists, as well as patients treated by glucocorticoids (their current treatment was systematically reported)
Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth

In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?

-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory

Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University

* Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures.
* Conservative cavity design will be used according to the principals of minimal invasive dentistry.
* All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system.
* All internal line angles will be slightly rounded.
* Each bur will be discarded after 5 preparations
* If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity.
* Isolation will be maintained by using Rubber Dam.
* The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried.
* The restorations will inject into the cavity.
* After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds.

In control group ketac molar with coating:

-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.

In study group " Ketac Universal Aplicap 3M without coating":

-The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer restorative is a self-cure, one-step placement material designed to help to finish faster. There's no need for conditioning, coating or light-curing steps.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 2 carious class I in same patient.
* The absence of tooth mobility.
* Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
* Accessible isolation and observable and easily accessible.

Exclusion Criteria:

1. Patients with poor oral hygiene. According to DMF or ADA criteria.
2. The presence of any para functional habit.
3. Abnormal occlusion.
4. Any regurgitation problem.
5. Subjects with compromised medical history.
6. Pulpitis, non-vital or endodontically treated teeth.
MEdication Counselling Models for Outpatient oRal antIcoaguLation

The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* taking oral anticoagulants
* using smartphones that can access the telepharmacy application
* agreeing to participate

Exclusion Criteria:

* pregnancy or lactation
* having cancer
* having immunodeficiency disorders or using immunosuppressants
* renal impairment (creatinine clearance \<30 mL/min)
* hepatic impairment (Child-Pugh B or C cirrhosis)
* heart failure (class IV, New York Heart Association)
* history of myocardial infarction or stroke within the latest 2 months
Italian Network MDS Registry

Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS) newly diagnosed.

Development of an Italian regional registries MDS network using the same electronic case report form for data storage, with the following broad aims:

* Ability to aggregate and process anonymous epidemiological data collected by individual regional registers;
* Ability to aggregate the available data with those of other international registries existing.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of MDS

Exclusion Criteria:

* Patient who refuse the signature of informed consent
SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement

The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
* Ability of a minor subject ages 7 to 18 to provide written assent
* Ability to have multiple noninvasive blood pressures taken at one sitting
* Ability to apply three lead ECG, if needed for investigation
* Ability to detect the natural presence of an irregular pulse, for irregular pulse studies

Exclusion Criteria:

* Any subject who cannot tolerate multiple blood pressure measurements
* Any subject who cannot undergo 3-lead ECG, if needed
* Any subject deemed unstable by the principal investigator
* Any subject for whom precautions are necessary because of communicable disease
* Any subject that has a known disease or condition compromises musculoskeletal integrity
* Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.