cyrilzakka/clinical-trials huggingface dataset:
FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma

This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum.
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
* ECOG performance status 0 - 1.
* Adequate hematological, renal and hepatic function.

Exclusion Criteria:

* Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
* Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
* Previous radiotherapy delivered to the upper abdomen.
* Peripheral neuropathy \> grade 1 (NCI-CTCv3).
Finding Consensus in Fasting Terminology

A consensus-based decision making process on fasting terminology will be conducted using the Delphi technique. To this aim, experts around the world are invited.

The consensus-based decision making process on fasting terminology will include a maximum of five rounds of questionnaires that experts are invited to complete online using a pseudonym. Prof. Dr. med. Michalsen's department has prepared rough definitions of key terms for the questionnaire to be evaluated by the experts. These terms should serve as a starting point for the discussion. After each questionnaire round the experts' comments are reviewed by the project team and a new questionnaire with the suggested modifications from the previous round will be sent to the experts.

If consensus can't be reached by round three, a live-online-discussion will be held to facilitate the further proceedings.

The results are to be published in a peer-reviewed journal; individual statements will not be shared in the publication.

Eligibility Criteria:
Inclusion Criteria:

* clinicians or scientists with at least 5 peer-reviewed publications on fasting or
* at least one peer-reviewed publication and 5 years of clinical experience with fasting

Exclusion Criteria:

- not more than 2 experts from one institution are allowed to participate
Hydration Sensor for Atopic Dermatitis

Pilot study of a soft, flexible hydration sensor

Assessment of accuracy and feasibility of a skin hydration sensor at detecting differences in skin hydration between skin affected by atopic dermatitis and areas not affected.

Eligibility Criteria:
Inclusion Criteria:

* Children \<18 years of age
* Children with new or prior atopic dermatitis diagnosis
* English speaking
* Children who are healthy, aged matched controls

Exclusion Criteria:

* Individuals who are pregnant
A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

This is a dose finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a Screening Period of up to 6 weeks, a 104-week masked Treatment Period, followed by a 30-day Follow-up after the last dose. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Vaccination for Neisseria meningitidis.
* Capable of giving signed informed consent.
* Presentation of GA secondary to AMD in at least 1 eye
* The entire GA lesion must be \> 1 μm outside of the foveal center

Key Exclusion Criteria:

* GA in the study eye due to cause other than AMD.
* Have previously received intravitreal anti-vascular endothelial growth factor injections in study eye for intraocular vascular disease.
* Have previously received any stem cell/gene therapy for any ophthalmological condition in either eye.
* Use of any investigational medicinal product (ie, participation in interventional clinical studies for any ophthalmic indications) or use of any regulatory approved treatment for GA in the study eye regardless of route of administration within the last 3 months or 5 half-lives of the last dose of the investigational or commercial product (whichever is longer).
* Presence of active ocular diseases in the study eye that in the opinion of the Investigator compromises or confounds visual function or interferes with study assessments.
* Known or suspected complement deficiency.
* History or presence of any medical or psychological condition that, in the opinion of the Principal Investigator, would make the patient inappropriate for the study.
* Hypersensitivity to fluorescein sodium for injection, the investigational drug (danicopan) or any of its excipients.

Note: Additional inclusion/exclusion criteria may apply, per protocol.
Erector Spinae Block for Spine Surgery

This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.

This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:

The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine

The secondary objectives include:

Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.

Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.

Eligibility Criteria:
Inclusion criteria:

* Adults aged greater than or equal to 18 years old and less than or equal to 85 years old.
* Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent.

Exclusion criteria:

* Patients with a history of chronic opioid use for \> 3 months including but not limited to fentanyl, morphine, oxycodone, methadone.
* Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications.
* Patients with a history of alcohol or drug abuse.
* Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency.
* Patients with renal insufficiency.
* Patients who are pregnant.
* Patients with American Society of Anesthesiologists physical status of 4 or greater.
* Patients on immunosuppressive therapy. Pregnant patients.
Fluorescent Imaging & Methylene Blue: Ureter Study

The main aim of this project is to assess whether intravenous methylene blue can help identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small tubes that link the kidney to the bladder and, if not properly identified during surgery, may be damaged.

Methylene blue has been safely given to patients for many years and it is fluorescent. It is removed by the kidney and will therefore travel through the ureters. Methylene blue shines brightly (becomes fluorescent) when viewed under red light.

This study aims to compare the ability of methylene blue with white light to identify the location of the ureters during colorectal surgery. Recruitment will include 50 patients undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each patient will act as their own control.

To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be utilised, and a wide-field camera will be used for open surgery.

The potential benefits of this procedure are to identify the ureters during surgery and therefore prevent inadvertent damage to them

It is hoped that near infra-red light emitting from the ureters will be detected. This will allow the surgeon to determine the anatomy of the ureters during the operation and avoid inadvertent injury.

Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment sites: Oxford University Hospitals NHS Trust.


Eligibility Criteria:
Inclusion Criteria

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Patients undergoing laparoscopic or open colorectal surgery
* In the Investigator's opinion, is able and willing to comply with all study requirements.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

* Patient who is unable or unwilling to give informed consent
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
* Significant renal or hepatic impairment.
* Any patients with previous allergies to Methylene Blue
* Any patients at risk of serotonin syndrome, including those taking serotonin reuptake inhibitors (SSRIs) or serotonin reuptake inhibitors (e.g. duloxetine, sibutramine, venlafaxine, clomipramine, imipramine)
* Patients with glucose-6-phosphate dehydrogenase (G6PD deficiency)
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system


Eligibility Criteria:
Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF \<30%
The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery

It reduces pain scores in patients with block and improves the quality of recovery in the postoperative period. In patients who will undergo spinal anesthesia, it will be questioned whether the application of the block before or after surgery makes a difference in the quality of recovery.

American Society of Anesthesiologists (ASA) physical status I-III patients who are planned for partial hip arthroplasty will be studied in patients over 65 years of age. The patients will be equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal). The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine position and aseptic conditions are provided, the fascia on the Iliacus muscle will be determined with the help of an 8-12 MHz linear probe, and the block will be applied with the in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and sedation need, postoperative pain scores, additional analgesic need, hospitalization and 24th-hour recovery scores will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Partial Hip Arthroplasty
* American Society of Anesthesiologists (ASA) physical status I-III,
* Patients aged ≥ 65 years

Exclusion criteria:

* Contraindication for central or peripheral blocks,
* Cognitive Dysfunction,
* History of chronic opioid use,
* Previous hip surgery,
* Serious organ dysfunction,
* Allergy to any drug used in the study,
* Body mass index (BMI) ≥30,
* Infection in the area to be treated,
* Refusal to participate in the study
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer

This study is aimed to establish a registry of women undergoing intensive surveillance for the early detection of breast cancer in high-risk women.


Eligibility Criteria:
Inclusion Criteria:

- Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS.

OR

* With life time risk of 30% or higher, based on Polygenic Risk Score that integrates genetic and non-genetic factors OR
* 5-years risk ≥ 6% for women 40-64 OR
* 5-years risk ≥ 6% for women 65+ AND breast density C or D AND a lifetime risk \>= 20% (BCSC+PRS LTR or Tyrer-Cuzick LTR) OR
* Patients with history of chest wall radiation received before age 35. OR
* To promote health equity, women of African Ancestry \< 45 years with at least one 1st or 2nd degree relative with breast or ovarian cancer are eligible because PRS Scores are not currently reported for AA women.
* Must be at least 25 years old.
* Willing to travel to participating site for imaging studies as well as any necessary follow-up procedures.
* Be able to give informed consent.

  * Patients with prior history of breast or ovarian cancer are eligible if they have completed all active treatments and are cancer free for two years.

Exclusion Criteria

* Undergoing active cancer treatment at the time of enrollment.
* Current pregnancy or plans for pregnancy within two years of enrollment.
* Presence of a pacemaker or any other metallic foreign object in their body that interferes with an MRI.
* Breast surgery within two weeks of study entry.
* Women with history of bilateral mastectomy are not eligible
* History of kidney disease or abnormal kidney function.
* History of dye allergy unless it can be mediated with antihistamines and/or steroids

  * Women can be taking hormone replacement therapy, tamoxifen, raloxifene, aromatase inhibitors, Parp Inhibitors as adjuvant therapy or participating in a chemoprevention trial.
Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients

Local recurrence after surgical resection is a complex phenomenon. An important predictive factor is the response to chemotherapy. Central site of disease may be a second independent predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free Survival \[EFS\] of 47% after 10 years. Patients with good histological response (\< 10% viable tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.

However, further studies are necessary to determine the merit of adjuvant radiation for high-risk patients (poor responders). Taking into consideration that the toxicity and morbidity of combined surgery and radiation is greater than either alone and must be closely monitored.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old.
* Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy.
* Negative surgical margins.
* Patients show good safety profile and acceptable performance status.

Exclusion Criteria:

* Patients who show progressive disease and undergo surgery before the time of local control.
* Patients who undergo Amputation or Rotationplasty will be excluded.
* Post-surgical complications that may hinder the administration of radiotherapy
The Effect of Bunsimgieum on the Chest Discomfort of Hwa-byung's Major Symptom

The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom and develope and establish pattern identification system in Hwa-byung.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged 20-65
* subjects who meet structured interview criteria for Hwa-Byung Diagnosis

Exclusion Criteria:

* duration of illness less than 6 months
* current or past history of delusions, hallucination
* past history of at least one manic episode, hypomanic episode, or mixed episode
* current or past history of alcohol abuse or alcohol dependence history
* taking substances(e.g. steroids) which might affect symptoms
* medical conditions(e.g. hyperthyroidism, hypothyroidism, heart disease) that might affect symptoms
* current with hepatoma, hepatic cirrhosis, chronic renal failure, congestive heart failure
* pregnancy, lactation, women not using medically accepted means of birth control
* considered not apt to carry out clinical trial
THE EFFECT OF SEX EDUCATION AND COUNSELING GIVEN TO WOMEN WITH STOMIA WITH THE EX-PLISSIT MODEL ON SEXUAL LIFE

In this study, it was aimed to determine the effect of sexual education and counseling given to women with stoma with the Ex-PLISSIT model on their sexual life quality and sexual life satisfaction.

H1: Female patients with permanent stoma who were given sexual education and counseling with the EX-PLISSIT model had a higher quality of life score measured by the Sexual Quality of Life scale.

H2: Female patients with permanent stoma who were given sexual education and counseling with the EX-PLISSIT model had higher mean scores of sexual life satisfaction.


Eligibility Criteria:
Inclusion Criteria for Research

* Permanent stoma for at least 6 months
* Not receiving active surgical treatment, chemotherapy and radiotherapy (at least 6 previous treatments have been completed)
* Married
* Agreeing to participate in the research and obtaining written permission,
* Over 18 years Research Exclusion Criteria
* Using antidepressants or using sedatives
* Having a diagnosed psychiatric problem,
* Women with diagnosed sexual dysfunction will not be included in the study. Exclusion Criteria from Research
* Do not complete the study,
* Surgical treatment, radiotherapy or chemotherapy started due to an urgent necessity during the working process, Patients who die during the study will be excluded.
A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem

Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.

The purpose of this study is to assess performance and safety of the Smith \& Nephew REDAPT Sleeved Stem by collecting retrospective 2 year post-op with PROMs or prospective 2 year post-op with PROMs.

Eligibility Criteria:
Inclusion Criteria:

* Primary and revision surgery for hip degenerative joint disease including osteoarthritis, avascular necrosis, and traumatic arthritis.
* Rheumatoid arthritis, congenital dysplasia, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, and fracture-dislocation of the hip.

Exclusion Criteria:

* Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriate size implant (blood supply limitations, osteoporosis/metabolic disorders, infections)
* Mental or neurological conditions impairing or precluding cooperation with post-operative protocols and proper response to PROMs.
* Skeletal immaturity.
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)

SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo in a 1:1:1:1:1 ratio in parallel groups on an outpatient basis with study center visits.

Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria:

* Males, or females who are not of child-bearing potential
* Aged 20-80 years (inclusive) with a diagnosis of OABS based on symptomatic reporting over a period of 6 months (micturition frequency, and urgency with or without incontinence) prior to screening.

Exclusion Criteria:

Main Exclusion Criteria:

* Patients will be excluded if there is an indication of any bladder outlet obstruction or polyuria
* Patients with the following conditions, or who have undergone the following procedures, will be excluded:

  * stress urinary incontinence
  * pelvic organ prolapse ( stage 2)
  * genitourinary or lower bowel surgery (within 12 months prior to screening),
  * pathological conditions including poorly controlled diabetes, painful bladder syndrome/interstitial cystitis or history of chronic urinary tract infection
  * neurological conditions including multiple sclerosis, Parkinson's disease or neuropathy)
* Patients will also be excluded if they have an indwelling catheter or perform intermittent self catheterisation
* Patients should not have a current or past medical condition contraindicating the use of antimuscarinics and must have discontinued use of the following drugs:

  * drugs used to treat OABS or urinary incontinence
  * cholinergics
  * anticholinergics
  * alpha adrenergic antagonists
  * opioid analgesics
  * compound analgesics containing an opioid
  * warfarin
* Patients with a current or past malignancy (within the last 5 years)
* Patients who have ever had a tumour affecting the genitourinary tract (not including benign prostatic hyperplasia) will be excluded.
* Patients will be ineligible if they have a clinically significant cardiac, neurological, hepatic, renal, respiratory, haematological or gastrointestinal disorder (including, a significant history of constipation or an active bowel disease e.g. inflammatory bowel disease) or any other illness which in the opinion of the Investigator would preclude the safe or compliant participation of a subject.
* Patients will be excluded if they are unable to complete the study diary