cyrilzakka/clinical-trials huggingface dataset:
Laser Speckle Imaging During Breast Reconstruction

Around 3500 women a year have surgery to reconstruct a breast/s after cancer. Breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation. This is distressing and often leads to more medical care or surgery. These problems are often caused by poor blood flow to the skin and deeper tissues used to reconstruct the breast. The investigators have developed a new device that does not touch the skin and provides immediate, continuous images of skin blood flow (the flow that surgeons cannot see). To test this device the investigators took images of blood flow during breast reconstruction surgery. The investigators found that imaging was good at showing where skin blood flow was poor and led to problems with healing and where flow was good and there were fewer problems after surgery (from minor problems, e.g. delayed healing; to major problems, e.g. loss of new breast).

The investigators think this device can help surgeons choose healthy skin during breast reconstruction and so help more patients to heal without surgical problems. The investigators need to test the new imaging device in a large clinical trial to find out how effective it is at improving healing for women after breast reconstruction. Before this, the investigators need to find out if such a trial is possible and acceptable to patients, theatre staff and surgeons. The investigators will recruit 60 women who are having breast surgery and will randomly choose 30 to have surgery without blood flow imaging and 30 to have surgery with blood flow imaging. The investigators will follow up the women whilst in hospital and for the following 6 months to record any problems. In particular the investigators need to find out how many patients will volunteer for the study and the study can collect all the information needed during the 6 months after surgery. The results from this study will be used to plan a much larger clinical trial that will test whether blood flow imaging is effective, improves patient recovery after surgery and provides good value for money for the NHS.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18 or over;
* Able and willing to provide informed consent;
* Scheduled for breast reconstruction by autologous free flap surgery (either immediately post-mastectomy or delayed).

Exclusion Criteria:

* Unable to give written informed consent.
Poppy Seed Use in Gastroenteric Fistula Diagnosis

Primary objective of the present study is to compare the diagnostic efficacy of oral poppy seed ingestion versus the classic abdominopelvic computed tomography scan with oral, ıntravenous and rectal contrast in diagnosis of gastrointestinal fistulas in gynecologic oncology practice.

Gastrointestinal fistulas are pathologic epithelial bridgings and connections between various loops or intestines and abdominal cavity, bladder, vagina, skin or any other organ. Fistulas are potentially dangerous since they may cause electrolyte imbalance, sepsis and abscesses and malnutrition. However, their diagnosis may not be easy since the sensitivity of the abdominopelvic computed tomography scan with oral, ıntravenous and rectal contrast is around 60% percent which is low for such an life threatening emergency. In gynecologic oncology large and small intestine procedures including resection and anastomoses are frequently performed. These procedures may rise suspicions the integrity of anastomoses and may lead to dilemma to intervene or not in case of a diversion from usual clinical progress. Poppy seed ( pappaver somniferum) is a small (about 1 mm each), non digestible cultivable plant seed used in various foods. It is innocent and does not contain any opium or related ingredient. When ingested with yogurt or soup in small amounts it is not absorbed or ingested within intestine and appears as small gray-blue small spheric seed in abdominal drains, vaginal fluid, urine or skin depending on the fistula formation. Poppy seed was first used in diagnosis of intestinal fistulas by Lippert et al. in 1984. Various studies followed in various fields of surgical medicine. However, there have been no reported studies using poppy seen in diagnosis of enteric fistulas in gynecologic oncology practice.

The aim of the present study is to compare the diagnostic efficacy of orally ingested poppy seed and computed tomography in diagnosis of fistulas related to gynecologic malignancies.

Eligibility Criteria:
Inclusion Criteria:

* pre and postsurgical gynecologic oncology patients who were suspected to have fistulas connecting gastrointestinal system and skin, bladder, vagina.

Exclusion Criteria:

None

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Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke.

Gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. The aim is not simply walking in controlled environment, but to achieve dynamic walking. Dynamic walking is the ability of an individual to adjust to the changing surfaces and terrains. thereby returning to achieve active participation in the community. Hence, recovery of walking ability is the primary goal when planning treatment for patients with stroke.


Eligibility Criteria:
Inclusion criteria:

* Had experienced stroke for the first time.
* Unilateral involvement.
* Demonstrate motor stage 3 or 4 on Brunnstrom motor recovery.
* Able to walk 12 m with or without assistive devices.
* Medically stable.
* Able to follow simple commands.

Exclusion criteria:

* Patient exhibits comorbid disease other than stroke that may affect gait.
* Any conditions contra indicated to exercises
* Any other cardio-pulmonary or orthopedic disorders that affects walking ability of the participant.
Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospitalization and may die. According to estimates by the US Centers for Disease Control and Prevention in 2018, influenza causes approximately 290,000 to 640,000 deaths worldwide each year. Therefore, the prevention and treatment of influenza has become a serious public health problem.

The GP681 in this test is a prodrug of a polymerase acidic protein (PA, Polymerase Acidic protein) inhibitor. Its metabolite GP1707D07 can selectively inhibit the cap-dependent endonuclease of influenza virus and prevent influenza virus replication. Mechanism of action against influenza virus. The results of previous non-clinical studies show that GP681 can effectively inhibit influenza virus replication, has good safety, and has antiviral activity 1,000 times that of oseltamivir phosphate. It also has good antiviral activity against oseltamivir resistant strains. And it is expected to have a longer half-life than oseltamivir phosphate. Therefore, it is expected that a new type of PA inhibitor can be developed to provide patients with influenza with a new mechanism of action, better efficacy, and higher compliance.

Eligibility Criteria:
Inclusion Criteria:

- 18-45 years old, male or female (the food impact test is limited to males); male ≥50 kg, female ≥45kg,BMI19-26; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.

Exclusion Criteria:

- history of allergies, allergic diseases or allergies to drugs in research; medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. or other diseases that are not suitable for participating in clinical trials (such as mental illness history, etc.); donated blood or blood loss ≥ 400 mL within 3 months before enrollment;
Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign the informed consent
* Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self evaluations.
* Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery.
* Patients requiring a primary total knee replacement.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.

Exclusion Criteria:

* Patients with inflammatory arthritis.
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* Patients with a history of total or unicompartmental reconstruction of the affected joint.
* Patients that have had a high tibial osteotomy or femoral osteotomy.
* Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
* Patients that are immunologically compromised, or receiving chronic steroids (\> 30 days).
* Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
* Patients with knee fusion to the affected joint.
* Patients with an active or suspected latent infection in or about the knee joint.
* Patients that are prisoners.
NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment

The NR600 is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with severe to profound vision loss due to degenerative retinal disease. The system is consisting of an autonomous epiretinal implant with penetrating electrodes, Glasses and a Clinician Station. The implant is Infrared (IR) powered and is designed to convert visual input into well-defined electrical stimulation patterns suited to elicit neuronal retina activity. All study subjects will be implanted with the device in one eye and will be followed for 18-months.

Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as RP or cone-rod dystrophy
* Visual acuity in both eyes from light perception to no light perception
* Confirmed functional ganglion cells and optic nerve in the implanted eye
* History of useful vision
* Mentally competent

Exclusion Criteria:

* Diseases or condition that affect retinal and or optic nerve function
* Optic Nerve diseases
* Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning
* Dry eye
* Pre-disposition to eye rubbing
* Posterior pole severe staphyloma
* Strabismus superior to 10 prismatic diopter
* Severe nystagmus
* Corneal endothelium density \< 1500 cells/mm2
* Refractive error ≥±8 diopters spheric and 3.5 diopter cylindric
* Currently pregnant (female subject) or inadequate contraceptive treatment in female subjects \<50 years of age.
* Hyperthyroidism or hypersensitivity to iodine
* Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression)
* Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up or testing of this study
* Conditions likely to limit life to less than 1 year from time of recruitment to the study
Role of Low Carbohydrate Nutrient in Healing of Infected Diabetic Foot

A low-carbohydrate diet, when combined with standard wound care and diabetes management, appears to accelerate the healing of infected diabetic foot, improve blood glucose control, reduce systemic inflammation and promoting overall patient recovery. This approach could be considered a beneficial adjunct therapy in the treatment of diabetic foot infections.

The research was a case control study. It conducted prospectively from January 2019 to December 2023 in the surgery department of Aswan university hospital. It involving patients with diabetic foot infections. The patients were divided into two groups of patients. The first group committed to not eating carbohydrates in food. The second group ate their daily routine and did not adhere to the carbohydrate's restriction. The diabetic food infection classified from mild, moderate and sever, as per the Infectious Diseases Society of America (IDSA) Infection Severity Classification.

Eligibility Criteria:
Inclusion Criteria:

Patients complained of diabetic foot infections graded 0 to 4 with absent signs of ischemia.

Exclusion Criteria:

Patients with foot gangrene grade 5 The presence of foot ischemia Those who refused to participate
Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

This is a Phase 2, multicenter, randomized, double-masked, controlled, parallel-group study of 6 months duration in treatment-naïve subjects with DME. This study is projected to enroll approximately 60 subjects, randomly assigned 1:1 to one of two treatment groups.

The study design includes up to 8 clinic visits over approximately 24 weeks. Subjects will attend visits for Screening (Visit 1, Days -30 to 0); Randomization and Baseline (Visit 2, Day 0 before dosing); Dosing and Evaluation (Visit 2 after dosing to Visit 5, Day 0 through Week 12); As-needed (PRN) Dosing and Follow up (Visit 6 through Visit 7, Week 16 through Week 20), and End of Study (Visit 8, Week 24).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 or type 2 DM
* DME with central involvement (\> 300 µm in the central subfield on spectral-domain optical coherence tomography \[SD-OCT\], in the study eye
* ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
* Naïve to local pharmacologic treatment for DME in the study eye

Exclusion Criteria:

* IOP \> 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is \<22 mmHg in the study eye with no more than 1 IOP lowering medication
* Any previous treatment in the study eye with an ocular corticosteroid implant
* Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
* History of glaucoma or optic nerve head change consistent with glaucoma damage
* History of glaucoma surgery
* History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")
Adaptive Decision Support for Addiction Treatment Master

This study refines and optimizes the EMBED\* clinical decision support (CDS; see NCT03658642) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder.

This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases.

Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures in serial randomized tests.

Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.

\*EMBED is a user user-centered, clinician clinician-facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community


Eligibility Criteria:
Inclusion Criteria:

* Emergency department patient
* 18 years of age or older
* Moderate to severe opioid use disorder

Exclusion Criteria:

* Under 18 years of age
* Pregnant
* Currently receiving medication for opioid use disorder
Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer

Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and neoplastic cells. Because of the potential importance of such a capability, the investigators undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell lines as well as an initial sample of clinical cases. This goal was pursued by investigating four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to non-neoplastic squamous cells in cytological preparations. The clinical material was also stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes. The investigators found that all CellDetect®-stained cells exhibited one of the two tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm, whereas the differentiated phenotype changed the color to blue/green.


Eligibility Criteria:
Inclusion Criteria:

1. FEMALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE.
2. ABILITY TO PROVIDE INFORMED CONSENT

Exclusion Criteria:

1. SUBJECT WITH KNOWN PREGNANCY AT TIME OF SCREENING.
2. PREVIOUS HISTORY OF HYSTERECTOMY
3. PARTICIPATION IN ANOTHER CLINICAL TRIAL WITHIN LAST 30 DAYS.
Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

Meal ingestion induces sensations that are influenced by a series of conditioning factors.

Aim: to determine the conditioning effect of previous digestive symptoms to a standardized probe meal.

Controlled randomized parallel study in healthy subjects on the conditioning effect of previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be induced by lipid (or sham) infusion into the intestine. On three separate days, digestive sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response to a comfort meal will be measured before, during and after the intervention. Primary outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5 scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic sensations (satiety, fullness, discomfort, nausea).

Participants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the comfort meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On each study day, participants will be intubated with a nasoduodenal feeding tube under fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and perception of digestive sensations will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain

This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The population pharmacokinetics of hemoporfin in children will be investigated as well.


Eligibility Criteria:
Inclusion Criteria:

* Children with clinical diagnosis of PWS；
* Age range: 7 to 14 years-old；
* Voluntarily participated and Written informed consent signed

Exclusion Criteria:

* Therapy area located outside of head and neck;
* Other skin diseases that might interfere with the efficacy evaluation;
* Therapy area was previously received isotope or PDT or other treatment which might interfere with the efficacy evaluation;
* Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
* Scar diathesis;
* Immunocompromised conditions;
* Electrocardiographic abnormalities or organic heart diseases;
* Coagulation disorders;
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN);
* Psychiatric diseases; Severe endocrinopathies;
* Previous therapy of PWS within the last 4 weeks;
* Participation in any clinical studies within the last 4 weeks;
* Be judged not suitable to participate the study by the investigators
A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)

A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
* Participant is female and ≥18 years of age

Exclusion Criteria:

* Participant is pregnant, breastfeeding or planning to become pregnant while in the study
* Participant has received prior chemotherapy, biological therapy or radiation
* Participant has participated in a clinical trial in the last 30 days
* Participant has a history of drug or alcohol abuse in the last year
* Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C
* Participant has poorly controlled diabetes mellitus