cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.


Eligibility Criteria:
Inclusion criteria:

* Clinical labs are within acceptable ranges.
* A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
* At least 18 years of age.
* Females must meet certain criteria specified in protocol.
* Ability to swallow and retain oral medication.
* Ability to follow and understand directions.

Exclusion criteria:

* Female who is pregnant or lactating.
* Medically unfit by the doctor as a result of the medical interview or physicals.
* Received treatment of an investigational drug within 4 weeks of study start.
* Currently receiving treatment with prohibited meds listed in protocol.
* Had major surgery in previous 2 weeks.
* Had prior radiation therapy to the chest to treat this incidence of breast cancer.
* Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
* Has a malabsorption syndrome.
Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.

The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of failure of office hysteroscopy

Exclusion Criteria:

* Pelvic inflammatory disease
* Severe vaginal bleeding
* Pregnancy
* Allergy to lidocaine, prilocaine or diclofenac potassium
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations.


Eligibility Criteria:
Inclusion Criteria:

* Documented IDH1R132-mutant tumors
* ECOG performance status ≤ 2

Exclusion Criteria:

* Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
* Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
* Acute Promyelocytic Leukemia
* Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply
The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)

A randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. The trail is about to examine the effect of Brizo® on reduction of BPH related symptoms.

1. Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia.
2. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients)
3. Duration - 12 weeks with 3 visits: 0,6,12 weeks
4. The following procedures are utilized:

   * Physical exams - visit 1,3.
   * Drugs/food supplement usage questionnaire - visit 1.
   * Product supply Control - visit 1,2.3
   * Clinical laboratory tests : psa, cbc, bun - visit 1,3.
   * Uroflowmetry test visit - visit 1,3.
   * IPSS- International Prostate Symptom Score - questionnaire - visit 1, 3.
   * IIEF questionnaire - visit 1, 3.
5. dosage: 1 capsule twice daily (morning \& evening) can be taken with or without food

Eligibility Criteria:
Inclusion Criteria:

Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia

Exclusion Criteria:

* Inability to complete the questionnaire.
* Patients with or suspected of having prostate cancer.
* Patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat BPH.
* Patients treated with drugs for kidney / urinary tract problems.
* Allergy to soy.
Pilot Study of the 'Thriving With PMDs' Program

This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-42
* Either meeting diagnostic criteria for premenstrual dysphoric disorder (to be confirmed by researchers through daily symptom ratings for two menstrual cycles) or major depressive disorder with perimenstrual exacerbation (i.e. at least a 30% increase in 4 symptoms in the perimenstrual phase)

Exclusion Criteria:

* Taking oral contraceptives
* Currently in psychotherapy
Impact of Mindful Awareness Practices in Pediatric Residency Training

This study evaluates the effect of a standardized mindfulness based intervention compared to control on self-reported levels of stress in residency trainees.

Recent research studies have indicated that the practice of mindfulness is strongly correlated with enhanced well-being and improved resilience in a variety of populations. Mindfulness-based interventions have been shown to reduce stress and symptoms of burnout in physicians. However, the two studies that included residents were observational trials evaluating the effect of an abbreviated, informal mindfulness course.

The aim of the investigator's study is to assess whether a standardized course in mindfulness meditation (Mindful Awareness Practices, MAPs) reduces self--reported signs and symptoms of stress, burnout, depression, anxiety, loneliness and poor sleep quality in residents in pediatrics training. This study is a randomized controlled trial using 2 parallel groups. The pediatrics residents randomized to the intervention will participate in a standardized mindful awareness practices intervention consisting of one live 45- minute session and 5 web--based self--study sessions. The live session will be administered by a trained mindfulness educator at the UCLA Westwood, Olive View Medical Center and Cedars--Sinai Medical Center campuses. The waitlist group will have the opportunity to participate in the same course once the study has been completed. Participants will respond to questionnaires to assess for levels of stress and other mental health measures before and after the intervention to see if the intervention group had a reduction in symptoms compared to the waitlist group.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric resident at the University of California Los Angeles's Mattel Children's Hospital
* Medicine/Pediatric resident at University of California Los Angeles's Mattel Children's Hospital

Exclusion Criteria:

-None
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation

This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized colorectal cancer database in Shanghai, this multi-center simulated randomized controlled trial will evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.


Eligibility Criteria:
Inclusion criteria:

1. Age from 18 years to 80 years;
2. American Society of Anesthesiologists (ASA) class I - III;
3. Histologically proved rectal adenocarcinoma;
4. Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
5. Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
6. No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc;
7. No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
8. Received either robotic or laparoscopic surgery; 9） Surgery with radical intent;

10) Informed consent.

Exclusion criteria

1. Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
2. Synchronous colon surgery for multiple colorectal tumors or other schedules;
3. Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
4. Co-existent inflammatory bowel disease;
5. Pregnancy or lactation;
6. Patients received treatment other than preoperative radio- or chemoradiotherapy.
Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD

* Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore® device on central and peripheral airway dimensions in patients with COPD.
* Indication: COPD patients
* Study Design: Open-label, prospective design
* Study Phase: II
* Test treatment duration: 1 day
* Test treatment: AlphaCore® device
* Dosage regimen: 1 session of stimulation during 90 seconds
* Patient number: up to 10 evaluable patients with COPD
* Patient age: ≥ 18 years
* Sex: male or female
* Primary objective: The evaluation of the effect of the AlphaCore® device on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD).
* Secondary objectives: The assessment of the effect of the AlphaCore® device on lung function (spirometry, diffusion and resistance) and on patient reported outcomes (PRO's).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented diagnosis of COPD
* Male or female patients aged ≥18 years
* Patients with a co-operative attitude to be treated with the AlphaCore® device
* Patients should take anti-cholinergics
* Female patient of childbearing potential who confirm to use a contraception method during the study
* Written informed consent obtained

Exclusion Criteria:

* Pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period
* Inability to carry out pulmonary function testing
* Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
* Patients with an electrical and/or neurostimulator device (e.g. a cardiac pacemaker, a vagal neurostimulator, a defibrillator, a cochlear implant, ...)
* Patients with an abscess or other infection or lesion (incl. lymphadenopathy) at the therapy head placement site
* Patients with a compromised cervical anatomy (such as from scaring, infection or suspected carotid artery disease) or a cervical vagotomy
* Patients with a history of carotid endarterectomy or vascular neck surgery on the right side
* Patients with coagulopathy, irregular heart rhythm or that are on pressor medication
* Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
* Patients who received any investigational new drug within the last 4 weeks prior to the screening visit
* Patients treated with any non-permitted concomitant medication
Blood Immunophenotyping in Staging of Indolent B-cell Lymphomas V1.0

To determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.

This study will determine whether peripheral blood flow cytometry can reduce or replace invasive bone marrow examinations in patients with slow growing lymphomas.

Patients with certain types of slow growing (indolent) lymphomas, including the most common sub-type, follicular lymphoma, require a bone marrow examination for staging of their lymphoma. This provides prognostic information and can be important for planning treatment. However, despite the use of local anaesthetic, and in some cases sedation, bone marrow examinations can cause pain and discomfort to patients. Complications are rare but include risk of bleeding, infection and even nerve damage.

Flow cytometry of peripheral blood samples can detect low levels of circulating lymphoma cells. A previous study has demonstrated that detection of lymphoma cells by peripheral blood flow cytometry has a good correlation with bone marrow involvement. This study will seek to find if this correlation is evident in a larger, statistically significant patient cohort. Depending on the study results, invasive and painful bone marrow procedures could potentially be reduced or eliminated in patients with certain slow growing lymphomas. Patients diagnosed with follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma and being treated at the Royal Marsden NHS Foundation Trust will be eligible for this study. Participation in the study will require one peripheral blood sample to be taken before the patient's routine bone marrow biopsy. The study is expected to last between 2 - 3 years for data collection of 108 samples.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥18yrs of age
* Able to provide informed written consent
* Patients with a diagnosis of follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma requiring staging or re-staging as part of clinical management
* pre-transplant bone marrow assessment
* High grade transformation associated with the above lymphomas will be allowed.

Exclusion Criteria:

* Patients with a histological diagnosis other than those mentioned above or those diagnosed with 2 or more different lymphomas, excluding transformed lymphoma.
* Patients not fit enough to undergo bone marrow examination.
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging

There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.

Exclusion Criteria:

* Patient with Incompatibility with magnetic resonance imaging or echocardiography
* Another valve disorder that requires treatment
* Severe precapillary pulmonary hypertension
* Unstable angina or percutaneous coronary intervention within the last 30 days
* Previous pacemaker/defibrillator implantation with intracardiac leads
* Patients with cardiac cachexia or a life expectancy less then 12 months
* Allergies to the material used.
Helminth Infection During Pregnancy on Vitamin D Regulation: HELMVIT Study

Purpose: To examine whether helminth infection during pregnancy alters Vitamin-D-metabolism and reactivity of the child's immune system

Hypothesis: Helminth infection during pregnancy is associated with altered Vitamin D levels and Vitamin D receptor expression in the placenta and modified immune reactivity in the infant.

Objectives The primary objective of the proposed research project is to study the impact of helminth infection in general and particularly of infection with S. haematobium during pregnancy on Vitamin D metabolism and its related factors as well as the impact of maternal infection on infants developing immune system and health.

Specific Objectives To assess the effect of maternal helminths infections on Vitamin D and vitamin-D-related factors in the serum of pregnant women and cord blood of their infants,

To assess the effect of helminth infection on placental biology:

Determine expression levels of VDR and inflammatory genes Investigate histologically the gestational age and other functional aspects of the placenta Determine the influence of helminth driven inflammation and helminth antigens on placental tissue by establishing a (co-)culture system using primary placental cells and a placental cell line To assess whether helminth infections influence the infant's peripheral immune system by analyzing composition, reactivity and lineage determination of fetal cord blood mononuclear cells (CBMCs) in relation to the maternal and fetal immune and Vitamin D status.

Current study focusing objectives In the present study the investigators explore if and how Vitamin D and its related signals are modulated by helminth infection and how helminth infection could thereby shape the developing immune system of the newborn by analyzing CBMCs.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending antenatal care from Lambaréné and Fougamou areas
* Pregnant women who have given written informed consent to the study for herself and for her unborn child and live infant.

Exclusion Criteria:

* Known of chronic infections and diseases(e.g. diabetes, HIV, Hepatitis B and C, anemia).
The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment

To evaluate whether treatment with Estradiol supplementation during the luteal phase improves IVF outcomes

Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day 21 and 28 after embryo transfer

The study will include Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a daily GnRH analog in a long protocol,older then 18, .The women will be randomised to two groups.Both groups will be given vaginal tabs of natural micronized progesterone(Uterogestan)

The study group will be given oral estradiol Valerate 4 mg.Prior to treatment, each patient will be signed on informed concent.

Patients will be excluded if they are older than 40, have any systemic illnesses or a personal or family history of a thromboembolic event.

Follow up:

Verification of pregnancy status and hormonal profile will be carried out on day fourteen after embryo transfer by means of serum hCG,P and E2. clinical pregnancy will be defined as the presence of a gestational sac on ultrasonography on day 21 after embryo transfer and fetal heart will be evaluated on day 28

Eligibility Criteria:
Inclusion Criteria:

* Women treated for infertility with controlled ovarian hyperstimulation using daily GnRH agonist

Exclusion Criteria:

* Women younger then 18 or older then 40
* Women with systemic disease
* Women with a family or personal history of thromboembolic event
Microbiology of Para- og Retropharyngeal Abscess

The aims of the study are:

1. Explore the bacteriology of para- and retropharyngeal abscess.
2. Validate the bacterial findings by exploring antibody development against F. necrophorum, F. nucleatum and S. pyogenes.
3. Compare bacteriologic findings in concomitant peritonsillar and parapharyngeal abscesses.
4. Characterize patients with para- and retropharyngeal abscess.
5. Compare the concentration of amylase in para- and retropharyngeal abscesses and neck abscesses without relation to the pharynx or salivary glands.
6. Perform gene-sequencing of F. Necrophorum strains, and compare these with strains recovered from patients with acute tonsillitis, peritonsillar abscess, and Lemierre´s syndrome.

Patients:

Sixty patients aged 18 years or older with para- or retropharyngeal abscess and 12 patients with neck abscess without relation to the pharynx or salivary glands (controls) will be included at five Danish centers. Estimated time of inclusion: Four years.

Data:

Symptoms, findings, and other relevant information will be obtained at admission. Data regarding treatment and complications will be obtained after discharge.

Samples:

1. Tonsillar surface swabs (bilaterally)
2. Pus aspirate from para- or retropharyngeal abscess
3. Pus aspirate from peritonsillar abscess, if present
4. Biopsy or the entire tonsil (bilaterally)
5. Blood samples (acute and convalescent)

Investigations:

1. Bacterial cultures from tonsillar surface swabs, pus aspirates, and tonsillar tissues.
2. Antibody development against F. necrophorum, F. nucleatum and S. pyogenes from the two sera.
3. Gene-sequencing of F. Necrophorum strains.
4. Measurement of amylase concentrations in pus aspirates.

Power calculations:

Patients needed to show significant increase in anti-F. necrophorum antibody development.

Assumptions:

1. The found anti-F. necrophorum antibody levels will be compared to previous findings in electively tonsillectomized patients (9 of 47 patients had two-fold or higher increase in anti-F. necrophorum antibody levels).
2. Level of statistical significance: P = 0.05
3. Power: 90%.
4. Part of F. necrophorum-positive para- or retropharyngeal patients WHO develop two-fold or higher anti-F. necrophorum antibody levels: 73%.
5. Part of para- or retropharyngeal patients with F. necrophorum: 20%. Number of para- or retropharyngeal patients needed: 60.

Concerning comparison of amylase concentrations between patients with para- or retropharyngeal abscess and patients with neck abscesses without relation to the pharynx or salivary glands:

Assumptions:

1. Amylase concentration \> 20 U/L in 0% of controls.
2. Amylase-concentration \> 20 U/L in 50% af patients with para- or retropharyngeal abscess .
3. Inclusion of controls 1:3 compared to patients with para- or retropharyngeal abscess .
4. Level of statistical significance: P = 0.05
5. Power: 90%. Number of para- or retropharyngeal patients needed: 36. Number of controls needed: 12.

Eligibility Criteria:
Inclusion Criteria:

* para- or retropharyngeal abscess

Exclusion Criteria:

* refuse to participate