cyrilzakka/clinical-trials huggingface dataset:
Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity, experience with concurrent radiation therapy is limited. In this trial, we will evaluate the feasibility, toxicity, and effectiveness a novel combination of chemotherapy, radiation therapy, and gefitinib.

Upon determination of eligibility, patients will receive:

Induction Therapy

* Docetaxel
* Carboplatin
* 5-FU
* Gefitinib

Combined Modality Therapy

Cohort 1:

* Radiation therapy
* Gefitinib

Cohort 2:

* Radiation therapy
* Gefitinib
* Docetaxel

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Squamous carcinoma of the head and neck.
* Primary tumor nasopharynx, oral cavity, oropharynx, hypopharynx, and larynx
* Squamous carcinoma in cervical nodes no identified primary site
* Must be considered to have low cure rates with local therapy
* Previously untreated with chemotherapy or radiation therapy.
* Able to perform activities of daily living without assistance
* Adequate bone marrow, liver, and kidney function
* Mild peripheral neuropathy is allowed
* Measurable or evaluable disease
* Voluntarily give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* History of prior malignancy within the last five years
* Severe or uncontrolled systemic disease
* Significant clinical disorder or laboratory finding
* Women who are pregnant or breast-feeding
* Active interstitial lung disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
The Effect of Oculo-Motor Exercises in Intermittent Exotropia

In childhood strabismus, exotropia is most frequently seen with intermittent exotropia and convergence failure in the first decade of life. This situation adversely affects children's psychosocial development and creates worries about personal relationships and work life in their future lives. Patients' hesitant attitudes towards surgical treatment led to the out-of-surgery techniques such as exercise therapy. No studies have been found in the literature on the efficancy of the intermittent exotropia treatments with oculo-motor exercises. In our study, it was aimed to investigate the effects of oculo-motor exercises on intermittent exotropia in children.

50 volunteer school-aged children between 2-17 years of age) were included in our study. Oculo-motor home exercise protocols were given to all participants for 2 sessions per day for 6 weeks, and regular phone calls were made once a week. Participants were assessed cycloplegic refraction by autorefractometry, corrected and uncorrected visual acuity by snellen chart, ocular motility test, near and distant alternating prism cover test, streopsis test and patient satisfaction levels by intermittent exotropia survery.

Eligibility Criteria:
Inclusion Criteria:

* Be between 2 and 17 years of age
* Intermittent exotropia diagnosis
* To have mental capacity in the level to understand and do exercises

Exclusion Criteria:

* Not complying with age criteria
* Constant exotropia
* Having undergone eye surgery
* Those with systemic disease that prevent exercise
HM vs Fibreglass Cast Immbolization for Supracondylar Fractures

Supracondylar humeral fractures are the most common elbow fractures in children and cast immobilization continues to remain as the recommended treatment for modified Gartland's classification Type I and Type IIa injuries. Apart from plaster of Paris and fibreglass casts, the use of waterproof, tubular hybrid mesh (HM) casts have been gaining traction for cast immobilization. Although the use of HM cast has been reported to have similar clinical outcomes and overall patient satisfaction scores to the fibreglass cast, the results of the recent studies are only limited and generalizable only to paediatric distal radius fractures.

As the application method of HM and fibreglass casts are fundamentally different, it has not been reported if the difference in application duration between the cast materials is significant and its potential implications in outpatient clinic operation.

Hence, through a randomized controlled trial, this study primarily aims to investigate if the clinical outcomes, patient satisfaction and duration of cast application with the HM casts would be comparable with fibreglass casts in children with supracondylar humeral fractures.

Through this study, the investigators hope to evaluate the advantages and disadvantages of the respective casting material which may better aid physicians in deciding a more appropriate cast material for treating paediatric supracondylar humeral fractures with cast immobilization and the implications of casting duration on clinic operations.


Eligibility Criteria:
Inclusion Criteria:

* First Presentation of Supracondylar humeral fracture (Type I and IIa modified Gartland's classification)

Exclusion Criteria:

* Prior treatment of supracondylar humeral fracture
* Previous elbow injuries
* Open fractures
* Polytrauma
* Neurovascular injuries
CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for a minimum of 3 years and up to 5 years for recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
2. Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:

   1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
   2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.

   i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.
3. Pathologic stage II or III
4. ECOG performance status ≤ 2 (0, 1 or 2).
5. Able to understand and provide written informed consent.
6. Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.

Exclusion Criteria:

1. Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
2. Pregnant or breastfeeding at time of enrollment.
3. Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
4. Prior transplant history:

   1. Prior allogeneic hematopoietic stem cell transplant at any time.
   2. Prior solid organ transplant within the last 2 years prior to enrollment.
5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.


Eligibility Criteria:
Inclusion Criteria:

* Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana

Exclusion Criteria:

* pregnancy
* coagulation disorders
* Hypertriglyceridemia-induced acute pancreatitis
* hepatic disorders
PTSD, AUD, and Interpersonal Conflict: Within-person Associations

The present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.


Eligibility Criteria:
Inclusion Criteria:

* OIF/OEF/OND veterans
* At risk for PTSD (i.e., PCL-5 ≥33) and/or AUD (i.e., AUDIT ≥ 7 (women) ≥ 8 (men))

Exclusion Criteria:

* Psychosis or severe Alcohol Use Disorder that contraindicates participation (based on interview)
* Active suicidal or homicidal ideation that contraindicates participation (based on interview)
* \[exclusion criteria removed 6/2022\] - Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea
Personalized Post-Operative Pain Management

The main questions this study aims to answer are:

Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?

Participants will:

Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.

Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.


Eligibility Criteria:
Inclusion Criteria:

1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.

Exclusion Criteria:

1. \<18 years of age and \>85 years of age
2. Unable to understand study procedures.
3. Unwilling to give consent.
4. Patients with cognitive impairment that can affect their ability to give consent.
5. Previous Surgery \<14 days from time of enrollment.
6. Allergies to study intervention or oxycodone.
Coagulation Disturbances in COVID-19 Septic Patients

Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* all adult critically ill patients tested positive for reverse transcriptase polymerase chain reaction (RT-PCR) of nasopharyngeal swabs to coronavirus 2 (SARS-CoV-2)
* patienets admitted to the ICU and presented with acute hypoxemic respirator failure

Exclusion Criteria:

* patients younger than 18,
* immunodeficient patients,
* patients with a history of malignancies,
* patients who developed septic state before admission,
* patients with a history of previous coagulopathy, liver and platelet disease.
A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases

This study will evaluate the safety and efficacy of MCS110 in patients with prostate cancer and bone metastases


Eligibility Criteria:
Inclusion Criteria:

* Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment
* 18 years old and over

Exclusion Criteria:

* Plan to be on cytotoxic or biologic therapy during study
* Active dental problems
* Active heart complications
* Active infection
* Patients with moderate to severe swelling due to fluid

Other protocol-defined inclusion/exclusion criteria may apply
Transplantation of Acellular Corneal Matrix to Treat Corneal Ulcer

This study is to develop a lamellar keratoplasty method for corneal ulcer using acellular corneal matrix (ACM) and to make an analysis among patients for its therapeutic effect.

Infections, chemical injury, and other diseases result in acute or chronic corneal ulcer, which may damage corneal stroma and may lead to permanent corneal scars and blindness. Corneal transplantation is standard method for corneal ulcer, but severe shortage of donor corneas limits its application. Acellular porcine corneal matrix is similar to the native cornea, especially with the biological property and microstructure. Recently, this matrix has been proved to be safe when transplanted to animal subjects and will not be rejected by the recipient. In animal lamellar keratoplasty experiments, acellular corneal matrix showed that they can integrate into the corneal wound bed and help reconstruction of the lamellar integrity of corneal stroma. This study will investigate its healing effect on human corneal ulcer. It will provide a potential corneal substitute for this disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 yrs.
* Corneal ulcer.
* Informed consent.

Exclusion Criteria:

* Corneal perforation.
* Other ocular diseases.
* The presence of systemic connective tissue diseases
* Severe allergic constitution
* Pregnancy
* The presence of chronic disease, such as significant cardiovascular illness
* The patients who received clinical experiments for other medicine or medical devices within 3 months prior to the transplantation.
* Any patient that is not suitable for recruitment, in the judgment of the investigator.
Observation of Blood Orphanin and Norepinephrine Levels in Diabetic Patients Under Subarachnoid Anesthesia

This study aims to investigate the Influence of Intraspinal anesthesia to the concentrations of blood orphanin, norepinephrine in patients with diabetes mellitus. We hope to explain the relationship between sensory and sympathetic nerves in diabetic patients undergoing intraspinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lower limb surgery under spinal anesthesia

Exclusion Criteria:

* Emergency surgery
* The operation time is more than 3 hours
* Combined general anesthesia or nerve block anesthesia
Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD)

A pilot study of zoledronic acid as adjuvant therapy to standard anti-vascular endothelial growth factor (anti-VEGF) treatment for neovascular age-related macular degeneration (AMD).

This is a one-year, randomized, controlled pilot study. A total of 40 treatment-naïve nAMD patients will be allocated 1:1 to receive an intravenous infusion of either zoledronic acid (ZA) 5 mg or placebo at baseline and after 26 weeks as adjuvant therapy to intravitreal anti-VEGF injections in accordance with a treat and extend algorithm; bevacizumab is the first-line treatment, and refractory eyes are converted to aflibercept.

The participants will be recruited among patients admitted to the Department of Ophthalmology at Oslo University Hospital (OUH). The department is the largest provider of retinal care in Norway and serves a local community of almost one million people, which makes it well-suited for recruitment. Administration of ZA or placebo will take place at Pilestredet Park Specialist Centre, an endocrinology clinic in Oslo with particular interest in treatment of osteoporosis. The Clinical Trial Unit at OUH will monitor the study.

Eligibility Criteria:
Inclusion Criteria:

1. Active, treatment-naïve neovascular AMD in the study eye, intraretinal or subretinal fluid involving the fovea centre on optical coherence tomography (OCT), and evidence of choroidal neovascularization on fluorescein angiography (FA) and/or OCT angiography (OCT-A).
2. Age ≥50 years
3. Best-corrected visual acuity (BCVA) between 0.1 and 1.0 logMAR
4. Menopausal for at least one year
5. Only one eye per patient will be recruited for the study. If both eyes are eligible for the study, the eye with the wors best-corrected Visual acuity (BCVA) will be selected as the study eye.
6. Subjects must give written informed consent before any study related procedures are performed

Exclusion Criteria:

1. Lesions comprising more than 50% blood or fibrosis involving the fovea centre
2. Polypoidal choroidal vasculopathy (PCV) - indocyanine green (ICG) angiography is performed at the discretion of the investigator on clinical suspicion of PCV
3. Presence of other ocular disease causing concurrent vision loss
4. Presence of ocular disease making intravitreal treatment contraindicated (e.g. current ocular or periocular infection, active uveitis or uncontrolled glaucoma/intraocular pressure ≥ 25 mmHg)
5. Systemic anti-vascular endothelial growth factor (anti-VEGF) or bisphosphonate treatment within one year preceding the initial study treatment
6. Confirmed or suspected active malignancy
7. Other factors (i.e. lack of cooperation) that, in the opinion of the investigator, can interfere with the study protocol
8. Known or suspected hypersensitivity to any of the trial products
9. Hypocalcemia (total Ca \< 2.15 mmol/L)
10. Renal impairment (estimated ClCR \< 35 ml/min).
Effect of Ceftobiprole on Human Intestinal Microflora

The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.

This is an open-label, single center study to investigate the effect on human intestinal microflora of multiple doses of ceftobiprole treatment administered at 8 hours intervals for 7 consecutive days. Careful investigation of the effect of Ceftobiprole treatment on the intestinal microflora is of importance since alteration of the intestinal microflora balance may facilitate colonization by pathogenic bacteria strains or enable microorganisms already present in the normal microflora to develop resistance. A total of 7 fecal samples will be collected on day 2, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in fecal, intestinal microflora pattern and measuring the susceptibility for Ceftobiprole of isolated bacterial strains. A total of 13 plasma samples will be collected on day 1, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in plasma. Safety evaluations including physical examination, vital signs, clinical laboratory tests, electrocardiogram and adverse event monitoring will be performed throughout the study. 500 mg ceftobiprole, intravenous infusion over 120 minutes, every 8 hours for 7 consecutive days

Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteers with body weight \>= 50 kg and body mass index between 18 and 30

* Agree to remain hospitalized at the trial unit during the 7-day drug administration period and will only leave the trial unit under supervision of a study nurse twice a day for one hour maximum
* Refrain from excessive jogging and any strenuous exercise during the study
* Be able to adhere to the dietary, fluid and smoking restrictions during the study
* Have negative pregnancy test result at the screening and agree to use adequate contraception method and not to become pregnant or donate sperm throughout the study

Exclusion Criteria:

* No clinically significant medical illness, abnormal findings in physical examination, vital signs, laboratory tests and electrocardiogram, or known allergy to the study drug, cephalosporins, beta-lactam antibiotics or other clinically significant allergies requiring treatment
* No antibiotic treatment within the last 3 months
* No drug or alcohol abuse within the last 5 years
* No blood donation or substantial loss of blood of more than 500 ml within the last 3 months or intention to donate blood during the study or within 1 month after study completion
* No history of smoking of more than 10 cigarettes , or 2 cigars, or 2 pipes of tobacco or 5 sniffs per day within the last 3 months
Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance.

The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.

To determine if TAP block have an analgesic effect in post operative period of abdominoplasty this study was made versus placebo: one group of patients will have a TAP block of levobupivacaine, the second group will have a TAP block with placebo before the surgery. Patient follow up includes data collected before surgery (at pré anesthesic visit and just before surgery) and data collected immediately after surgery (at post operative time) and at distance of the surgery (15 days and 3 months after the surgery). The principal aim is to show if TAP block have an analgesic effect in post operative period after abdominoplasty. To answer this question we will compare opioid intake during the two days after the surgery between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* ASA1 or 2 patients
* Undergoing abdominoplasty surgery in Centre François Xavier Michelet at Bordeaux University hospital
* Age \>18 years old
* Patient agreement by signing an informed consent

Exclusion Criteria:

* Psychiatric or neurological disease
* Contraindication to regional anesthesia (haemostatic disorders, infection near to insertion point)
* Double surgery
* Long term opioid therapy
* Pregnancy or breast-feeding
* Allergy to any drug used in anesthesic or surgical procedure