cyrilzakka/clinical-trials huggingface dataset:
Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia

The radio-labeled anti-CD66 monoclonal antibody (with 111In for dosimetry and 90Y for therapy) will be administered in the T11 North room, UCLH, while the reduced intensity conditioning regimen and the allogeneic hematopoietic stem cell transplant will be performed in 2 centers, according to the age of the patient: A) patients aged \< 13 years will be transplanted at the Bone Marrow Transplantation Department, Great Ormond Street Hospital (GOSH), and B) patients aged 13-18 years will be transplanted at the Bone Marrow Transplantation Department, University College London Hospitals (UCLH).


Eligibility Criteria:
Inclusion criteria:

1. An underlying haematological malignancy including:

   1. isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation;
   2. isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation;
   3. bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation;
   4. refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts;
   5. refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts;
   6. refractory AML (\> 20% blasts in BM) with expression of CD66 on blasts;
   7. refractory ALL (\> 20% blasts in BM) with expression of CD66 on blasts;
2. be ≥ 1 year old and ≤ 18 years old;
3. must not be eligible for therapy of higher curative potential. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study;
4. have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
5. provide signed, written informed consent from parent or guardian;
6. be able to comply with study procedures and follow-up examinations;
7. have normal cardiac function without specific treatment;
8. have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;
9. patients who have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment;
10. be negative for human-anti-murine antibodies (HAMA). Exclusion criteria

1) patients with CNS disease; 2) patients with BM cellularity \< 10%; 3) patients with ≥ 20% blasts in BM and no expression of CD66 on blasts; 4) patients who are positive for human-anti-murine antibodies (HAMA); 5) patients with compromised organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion; 6) patients with extensive chronic GvHD; 7) patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment; 8) patients who are pregnant or lactating; 9) patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
Protocol for CAMUS Nurse Delphi Study

Multi-staged, international Nurse Delphi study that aims to validate the newly proposed CAMUS System and CAMUS CCI in an experienced nursing staff population.

Background: Comprehensive and reproducible assessment of post-operative complications are essential for reliable evaluation of quality of care and subsequent reformation of hospital safety infrastructure. At present, significant discrepancies exist in complication reporting and grading, and current complication systems lack holistic assessment of patient care by failing to consider and incorporate nursing insight and perception of patient burden.

Objective: To gain experienced nursing perspective on current and future complication reporting and grading in Urology, validate the CAMUS-CCI, and quality control the use of the CDC in nurses.

Design, Setting, and Participants: The 12 part REDCap-based Delphi survey was developed in conjunction with methodologist review, experienced nursing and urologist opinion. Certified local and international inpatient and outpatient nurses specialised in urology, perioperative nurses, and urology-specific advanced practice nurses/nurse practitioners will be included. A minimum sample size of 250 participants is targeted.

Outcome Measurements and Statistical Analysis: The survey assesses participant demographics, nursing experience and opinion on complication reporting and the proposed CAMUS reporting recommendations, grading of intervention events using the existing Clavien-Dindo Classification and the proposed CAMUS Classification, and rating various clinical scenarios. Consensus will be defined as ≥75% agreement. If consensus is not reached, subsequent Delphi rounds will be performed under Steering Committee guidance.

Eligibility Criteria:
Inclusion Criteria:

* Certified nurses
* Local or international nurses
* Inpatient or outpatient nurses
* Peri-operative nurses
* Urology-specific advanced practice nurses/nurse practitioners

Exclusion Criteria:

* Under 18 years of age
Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).


Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study, patients must meet all of the following inclusion criteria:

* be between 8 and 70 years old with a diagnosis of HoFH;
* be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
* have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
* be male or nonpregnant, nonlactating female;
* give informed consent; and
* meet body weight and height requirements.

Exclusion Criteria:

In order to participate in this study, patients must not meet any of the following exclusion criteria:

* recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
* uncontrolled hypothyroidism or other uncontrolled endocrine disease;
* known, clinically significant eye abnormalities (e.g., cataracts);
* appropriate serum creatinine phosphokinase levels;
* history of liver disease or liver enzyme levels above appropriate levels;
* alkaline phosphatase above appropriate levels;
* liver cirrhosis and severe liver steatosis;
* clinically significant infection, malignancy, or psychosis;
* use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
* participation in any other investigational study, including device or observational studies, within 30 days;
* lactating or have a positive serum pregnancy test;
* history of or current drug or alcohol abuse; or
* unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator.
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

The purpose of the Phase Ib is to:

1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients
2. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in Japanese patients
3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (surgery and/or radiotherapy).
* Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer
* Patient has HER2-negative breast cancer
* Patient has adequate bone marrow and organ function

Exclusion Criteria:

* Patient who received any CDK4/6 inhibitor.
* Patient has a known hypersensitivity to any of the excipients of LEE011 or letrozole
* Patients with inflammatory breast cancer.
* Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
* Patient is currently using other anti-cancer therapy
* Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
* Patient who has received radiotherapy ≤ 4 weeks
* Patient has a concurrent malignancy or malignancy within 3 years
* Patient has metastases to the central nervous system (CNS).
* Patient has a known history of HIV infection

Other protocol-defined inclusion/exclusion criteria may apply
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence

This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence

Exclusion Criteria:

* Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).
Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment

In This Study, Our Goal is to Compare the Effects of Recruitment Manoeuvre Which is Applied With Different Oxygen Concentrations on Oxygenation and Respiratory Mechanics During Pneumoperitoneum

Detailed Description:

"Recruitment manoeuvre" which has been defined and become popular in the recent years is nowadays widely accepted and applied. The positive effects of the recruitment manoeuvre during and after surgery on respiratory mechanics and oxygenation have been reported. The duration and the applied pressure values of recruitment manoeuvre have been defined well and in detail regarding the definitions for this manoeuvre (1-3). Despite these definitions, no detailed information has been provided on the effects of the oxygen and oxygen concentration during recruitment manoeuvre .

Atelectasis develops after the induction of anaesthesia, even in healthy subjects, and is associated with an increase in intraoperative shunt leading to impairment of gas exchange (4). It is well known that in patients, who have undergone mechanical ventilation with high oxygen concentration levels, oxygen replaces the less insoluble nitrogen. Partial oxygen pressure increases with the implementation of oxygen in high concentrations, and the oxygen flow into the blood increases. But when the gas flow into the blood is more than inspired, absorption atelectasis develops in lungs - due to appliance of high oxygen concentration. Atelectasis may also develop due to different reasons such as failure in secretion clearance during the surgery, replacement of nitrogen with inhalation anaesthetics and appliance of pneumoperitoneum.

In the recent years, many studies have analyzed the effects of recruitment manoeuvre during pneumoperitoneum and laparoscopic surgery on respiratory mechanics and oxygenation, and reported the benefits of recruitment in these operations (4-6).

In this study, our goal is to compare the effects of recruitment manoeuvre which is applied with different oxygen concentrations on oxygenation and respiratory mechanics during pneumoperitoneum.

Eligibility Criteria:
Exclusion Criteria:

* Patients, who were older than 65 years,
* had respiratory system and cardiovascular diseases,
* used medication that could affect the respiratory function or smokers have been excluded.
Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease

Background:

Arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. Many older people with arterial disease of the legs also have problems with their thinking and memory. Blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems.

Aim:

The aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking.

Research plan:

Twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. Arterial disease in the legs will be measured using ankle blood pressures before and after walking. Blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. Results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking.

Benefits to society:

This project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. It will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs.


Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide Informed volunteer/patient consent
* Male or female, aged ≥50 years of age
* Able (in the Investigator's opinion) and willing to comply with all study requirements
* Good understanding of written and verbal English

Peripheral arterial disease specific inclusion criteria:

* Clinical diagnosis of symptomatic PAD (intermittent claudication) confirmed by positive haemodynamic tests (ABPI \<0.90 in the symptomatic leg; and/or,
* Post-exercise \[walk test\] reduction in ABPI of \>20% or post-exercise \[walk test\] reduction in absolute ankle pressure of \>30mmHg)

Exclusion Criteria:

* Male or Female, aged under 50 years
* Pregnant
* Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
* Major co-morbidity likely to affect cerebral autoregulation; severe respiratory disease, unilateral carotid artery stenosis (≥50%), atrial fibrillation, severe cardiac failure (left ventricular ejection fraction \<20%), or extreme frailty
* History of significant diagnosed psychiatric disorder, learning disability (e.g. dyslexia) or neurological disorder (head injury, epilepsy, stroke and/or transient ischaemic attack \[TIA\])
* Diagnosis of dementia
* Uncorrected hearing impairment and/or significant visual impairment

Healthy control specific exclusion criteria

* Symptoms of intermittent claudication; and/or,
* Clinical diagnosis or history of PAD
Visual Communication: Digital Tool to Improve the Understanding of Treatment Options for Patients With Cancer and Increase Satisfaction of the Overall Experience for Patients, Caregivers, and Providers

This is a study in patients with newly diagnosed cancer to prospectively evaluate the feasibility of integration of a visual communication tool for patients/caregivers/providers by determining whether such a tool can increase overall satisfaction with the patient experience.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patients seen in consultation from 12/1/2024-6/1/2025
* Patients aged 18 years to 100 years old
* Patients with a malignancy of breast or head and neck
* English speaking patients
* Patients being treated with definitive intent
* Patients treated at NYU Langone Health for their malignancy
* Willing and able to provide consent

Caregivers:

* Any adult caregiver(s) (aged 18 years to 100 years old) to a patient who fulfills the inclusion and exclusion criteria above.
* Willing and able to provide consent

Providers:

* Doctors and nurse practitioners in medical oncology and radiation oncology, and in the ear nose throat (ENT) department.
* Willing and able to provide consent
* aged 18 years to 100 years old

Exclusion Criteria:

Patients:

* Patients with any other site of disease other than listed above
* Non-English-speaking patients, as the tool is currently available in English only. Translation into additional languages such as Spanish and Russian is currently in process.
* Patient unable to complete the survey portion of the study independently

Caregivers:

• Unable to complete the survey portion of the study independently
Effectiveness of Three Steps Hysteroscopic Repair of Post Caesarean Isthmocele in Patients With Post Menstrual Spotting

Isthmocele is one complications of repeat cesarean sections which is considered as a pocket .that accumulate menstrual blood causing post- menstrual spotting Hysteroscopic resection of the edges of the isthmocele is considered the best treatment option available up to date. Aim of the work: Asses the effectiveness of three steps method resection using hysteroscopy of an isthmocele in patients complained of post -menstrual bleeding with confirmed presence of isthmocele.

.

The incidence rate of cesarean deliveries has been dramatically increased in Egypt.(1) Isthmocele is one of the known complications of repeat cesarean sections.(2) Post- menstrual spotting and many other gynecological complains have been correlated to this isthmocele which is considered as a pocket that accumulate menstrual blood. (3) Hysteroscopic resection of the edges of the isthmocele is considered the best treatment option available up to date.(4) Aim of the work: Asses the effectiveness of three steps method resection using hysteroscopy of an isthmocele in patients complained of post-menstrual bleeding with confirmed presence of isthmocele.

Patients: 50 patients complained of post-menstrual bleeding with confirmed presence of isthmocele. After written consent, the patient will be subjected to three steps hysteroscopic resection of an isthmocele by removing the distal edge of the niche then the proximal edge and lastly ball cauterization of the floor of the pouch of the isthmocele. Post-operative trans-vaginal ultrasound and follow up for 2 menstrual cycles.

Eligibility Criteria:
Inclusion Criteria:

* female
* previous cesarean sections
* complain post menstrual spotting

Exclusion Criteria:

* other genital tract abnormality
* other uterine causes pf bleeding residual myometrial thickness less than 3mm
Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects

The purpose of this study is to evaluate the effect of single doses of midazolam on the plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to assess the safety of co-administration of moxidectin and midazolam.


Eligibility Criteria:
Inclusion criteria:

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.

   WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle-stimulating hormone \[FSH\] ≥38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
2. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria:

1. Women of childbearing potential.
2. Presence or history of any disorder that may prevent the successful completion of the study.
3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Feasibility of Ayurveda in Patients With Mild-to-Moderate COVID-19: A Community-Based Participatory Research

Innovative strategies are required to manage COVID-19 in the communities. Back to Roots community based project was a collaborative, pilot intervention program in British Asian community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of mild-to-moderate COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
* With mild or moderate manifestations of COVID-19
* Willing to participate, and consent by signing the informed consent and
* not involved in another clinical trial during the study

Exclusion Criteria:

* Patients suffering from severe COVID-19 Disease as per World Health Organisation criteria (REF)
* Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
* Patients with ongoing immunosuppressive therapy for any reasons
* Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
* Pregnancy and lactation
* Ayurveda practitioner decision that involvement in the study is not in the patient's best interest