cyrilzakka/clinical-trials huggingface dataset:
Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer

RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.

PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving cetuximab or another epidermal growth factor receptor inhibitor therapy for cancer.

OBJECTIVES:

Primary

* Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.

Secondary

* Determine the efficacy of this drug in reducing the severity of rash in these patients.
* Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.
* Determine the tolerability of this drug in these patients.

OUTLINE: This is a prospective study.

* Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.
* Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.

Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* No known history of hypersensitivity to amine-type local anesthetics or to other components of MPM Regenecare® wound gel
* No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of EGFR inhibitor-induced rash

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No other concurrent topical facial creams or lotions
Immune System Modulation and Outcome in High-risk cSCC Treated With Surgery and Radiotherapy

Treatment with adjuvant radiotherapy modulates immune system in many diseases as witnessed by dynamic changes of humoral and cellular immunity. Moreover, the persistent lymphopenia after radiation therapy is a negative prognostic factor. This study is aimed to explore the changes in immune-cell populations during radiotherapy given as adjuvant treatment for high-risk cutaneous squamous cell carcinomas and to correlate them with patient's outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Signed written informed consent.
* Histologically confirmed diagnosis of cSCC.
* cSCC categorized as high risk according to ASTRO Guidelines:

  * close or positive margins that cannot be corrected with further surgery (secondary to morbidity or adverse cosmetic outcome).
  * gross perineural spread, as identified by radiological or pathological assessment.
  * disease recurrence after a prior margin-negative resection.
  * pathological stage T3 and T4.
  * desmoplastic or infiltrative tumors in the setting of chronic immunosuppression at pathological exam, cSCC involving regional lymphnodes, with the exception of a single, small (\<3 cm) cervical lymph node harboring carcinoma, without extracapsular extension.
* cSCC addressed to adjuvant radiotherapy as per clinical practice (a complete post-operative treatment should be administered with 50-54 or 60-66 Gy depending on the margin status).
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.

Exclusion Criteria:

* cSCC not eligible for surgery.
* cSCC not eligible for adjuvant radiotherapy for any condition depending on disease characteristics or patient characteristics, co-morbidities or refusal.
* Any concurrent investigational product, biologic, or hormonal therapy for cancer treatment.
* Concurrent treatment with chemotherapy for the purpose of cSCC cure.
* History or current evidence of any condition that, in the opinion of the treating investigator, might interfere with the subject's participation for the full duration of the trial.
* Any major surgery, different from that planned for the protocol, in the 15 days before the protocol starting.
* Any radiotherapy treatment in the 28 days before the protocol starting
* Pregnant or breastfeeding.
Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 months to 5 years with episodic (periodic) asthma

Exclusion Criteria:

* Patients who are not in otherwise good health
* Patients who have persistent asthma (continual asthma symptoms)
Diurnal Changes of the Cornea - a Pilot Study

Aim of this study is to gain a better understanding of the diurnal changes of the cornea to improve toric IOL power calculations.

Higher patient expectations concerning unaided visual acuity after cataract surgery has led to an increase in use of toric intraocular lenses (toric IOLs) for the correction of corneal astigmatism. Although it was shown that toric IOLs significantly reduce astigmatism, there is still some difficulty in predicting the remaining astigmatism correctly. The main source of error appears to be the pre-operative measurement of the cornea. However, it is questionable, if this error derives from a measurement error due to the imprecise measurement technique, or natural diurnal changes of the cornea. Additionally, measurements of the cornea pose several challenges: different corneal biometry devices cannot be used interchangeably and it is difficult to decide, which device is measuring the cornea correctly as there is no gold standard.

Especially, in eyes with small corneal astigmatism the error increases. Recently it was shown that the astigmatism meridian was on median 9° off for corneas with 1.0D of astigmatism and only 4° for corneas with 2.0D of astigmatism. Similar findings were observed by Shammas et al. Norrby furthermore showed that 5% of all corneas show more than 0.5D of fluctuations between measurements at different (post-operative) time-points. The reasons are not explored, but diurnal changes, temperature and humidity potentially influencing the tear film, as well as pupil size and asphericity of the cornea could play a role. Read and Collins observed diurnal changes of corneal radii within 24 hours, but in their study only young healthy volunteers were included and only one measurement device (Scheimpflug imaging, Pentacam HR) was used. Lau and Pye and Shen et al. measured the diurnal changes of the cornea, but no data concerning corneal radii were reported. Harper et al. observed diurnal changes of the central corneal thickness. However, none of these studies investigated on diurnal changes of the corneal radii in the elderly population. Aim of this study is to gain a better understanding of the diurnal changes of the cornea to improve toric IOL power calculations.

Eligibility Criteria:
Inclusion Criteria:

* 21 years, or above
* Signed informed consent

Exclusion Criteria:

* Ophthalmic diseases such as significant macular degeneration, glaucoma, diabetic retinopathy, etc.
Efficacy of the Extracorporeal Shock Wave Therapy in Athletes With Patellar Tendinopathy

The aim of this study is to investigate the effectiveness of extracorporeal shock wave therapy (ESWT) in addition to eccentric exercise on the clinical outcomes of PT in the treatment of athletes with patellar tendinopathy (PT). Participants will be randomly divided into two groups. The intervention group will receive focus ESWT 3 times a week in addition to 6 weeks of exercise. The control group will be given 6 weeks of exercise. Evaluations will be made at the 3rd and 6th weeks, and at the 3rd, 6th and 12th months. Patient evaluation will begin with obtaining sociodemographic information. Patients' pain level will be assessed using visual analog scale (VAS), tendon pain and function VISA-P, functional capacity; The patients will be assessed with the maximal vertical jump test (MDS), single leg jump distance test (SLHD), single leg squat test (STS) on the incline board, pain catastrophe with the pain catastrophe scale (PCS), kinesiophobia with the Tampa Kinesiophobia Scale (TKS), quality of life short form-12 (SF-12) and physical activity level with the Tegner Activity Scale (TAS).


Eligibility Criteria:
Inclusion Criteria:

* Localized pain in the inferior pole of the patella during single-leg squatting due to load,
* Pain or tenderness with palpation of the patellar tendon,
* Complaints of pain in the patellar tendon due to training, competition or physical activity in the last 6 months,
* Performing sports/physical activities related to jumping and landing,
* Professional and recreational athletes who perform at least 5 and above according to the Tegner Activity score,
* VISA-P scale score \<80 out of 100.

Exclusion Criteria:

* Presence of other knee pathologies,
* Known presence of inflammatory joint diseases or familial hypercholesterolemia,
* Daily use of drugs with presumed effects on the patellar tendon (e.g. fluoroquinolones) in the last 12 months,
* Local injection therapy with corticosteroids in the last 12 months,
* Previous patellar tendon rupture,
* Any lower extremity surgery in the last 6 months.
Total Marrow Irradiation With Volumetric Arc Therapy for Patients Unfit for a 12 Gy TBI

Total body irradiation (TBI) is a standard part of the conditioning regimen for bone marrow transplantation (BMT). Several randomized trials have shown superior outcomes using TBI compared with non TBI-containing regimens. Standard TBI is usually delivered over three days for a total dose of 12 Gy with two daily fractions. However, as demonstrated by our group, increasing the TBI dose above 10 Gy is not necessarily associated with better outcome in patients undergoing allogenic BMT for hematologic malignancies. For this reason, patients older than 40 or grafted after relapse are treated at our center with a reduced-dose 10 Gy TBI regimen. This pilot study wishes to investigate in 10 patients with hematological malignancies unfit for a standard 12 Gy TBI conditioning regimen a more targeted, conformal form of treatment, referred as total marrow (TMI), using volumetric Arc Therapy (VMAT). Our hypothesis is that using this technique that can allow deliver a higher total dose to the target while at the same time assuring to the organs at risk (OAR) the same dose normally delivered with a 10 Gy TBI we will improve the therapeutic ratio in these patients.

This is a feasibility prospective pilot study. Ten patients ≥ 40 years with hematologic malignancies prior to Bone Marrow Transplant (BMT) will receive a dose escalated hypofractionated Total Marrow Irradiation (TMI) (12 Gy in 3 fractions, daily, on 3 consecutive days).

The current project is a joint initiative in translational and clinical medical research between the Radiation-oncology workgroup and the Bone Marrow transplant workgroup of University Hospitals of Geneva (HUG).

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky performance status ≥ 70
* Presence of any kind of haematological malignancy in complete remission (CR1, CR2 ore CR3) at time of transplantation, with the exception of patients with myelodysplastic syndrome.
* Patients that are scheduled for a BMT either using stem cell derived from bone marrow or peripheral blood stem cells.
* Candidates to receive a 10 Gy TBI treatment.
* Ability to stay still and lying on the treatment couch for at least 45 minutes.
* Informed Consent as documented by signature.

Exclusion Criteria:

* Karnofsky performance status \<70 intended as a patient unable to work; able to live at home and care for most personal needs with varying amount of assistance needed.
* Concurrent treatment with other experimental drugs or other anti-cancer therapy.
* Participation in another clinical trial and any concurrent treatment with any investigational drug within 4 weeks prior to trial entry/randomisation.
* Inability to comply with study and follow-up procedures.
Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who have presented neonatal acute renal failure. The investigators hypothesize that signs of nephronic reduction would appear earlier in former preterm with neonatal acute renal failure than in control preterm infants.

50 former preterm infants who presented acute renal failure will be evaluated between 3 to 10 years.

They will be compared to 25 control former preterm infants without renal dysfunction for signs of nephronic reduction.

At inclusion, in order to analyse renal function, all infants will have blood sampling, renal echography and blood pressure measurement. Urine sample will also be collected.

Two months later, parents will be informed on the results.

Eligibility Criteria:
Inclusion Criteria:

* For both group of cases (50 infants having presented acute renal failure in preterm) AND group of control cases (25 infants without this) :former preterm infant born before 33 weeks of gestational age between january 2003 and june 2010 and hospitalized in the neonatal intensive care unit of Nantes University Hospital.
* Specific to cases: neonatal acute renal failure: serum creatinine\>130 micromol/l from the third day of life.
* Control cases: no such renal dysfunction

Exclusion Criteria:

* no parental consent
* other causes of renal failure: congenital uropathy, congenital nephropathy
* congenital cardiopathy, polymalformative syndrome
Ridge Preservation Following Tooth Extraction

An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.

The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
* a tooth requiring extraction

Exclusion Criteria:

* thyroid dysfunctions
* diabetes mellitus
* history of a chronic use of corticosteroids (\>6 months)
* history of oral/intravenous bisphosphonates within the past 2 years
* smoking
* history of other systemic conditions that could affect bone integrity.
Local Anesthesia With Sedation for Cochlear Implant Surgery

ABSTRACT

Objectives: The aim of this article is to illustrate the possibility of performing a cochlear implant with local anesthesia and sedation, the anesthesic technique and the advantages of that in comparison to a general anesthesia.

Materials and method: The investigators describe two successful surgeries done with local anesthesia, including the neural telemetry and the conditions the patient presented after the surgery, with a very good recovery and no complications during and after the procedure.

Key words: local anesthesia, cochlear implant


Eligibility Criteria:
Inclusion Criteria:

* adult patients with total deafness

Exclusion Criteria:

* children under 18 years old
Preoperative VR Cartoon Viewing Reduces Postoperative Pain and Anxiety in Pediatric Tonsillectomy Patient

The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years.

The aim of this study is to determine the effect of watching a cartoon with a virtual reality headset before surgery on the pain and anxiety levels of children aged 7-12 years. In line with this aim, children aged 7-12 who were scheduled for tonsillectomy and adenoidectomy at the Ear, Nose, and Throat Department of Uşak University Education and Research Hospital were shown a cartoon with a virtual reality headset before surgery, and their pain and anxiety levels were examined. The study was conducted as a randomized controlled experimental study at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The population of the study consisted of children aged 7-12 who applied for tonsillectomy and adenoidectomy surgery at the Ear, Nose, and Throat Unit of Uşak University Education and Research Hospital. The sample of the study included a total of 102 children, with 51 in the experimental group and 51 in the control group, who met the research criteria and volunteered to participate in the study between November 10, 2023, and June 1, 2024. Data collection tools included the informed consent form, sociodemographic questionnaire, vital signs assessment form, Visual Analog Scale, and the Perioperative Multidimensional Anxiety Scale for children.

Eligibility Criteria:
Inclusion Criteria:

Child's criteria:

* Children aged between 7 and 12 years
* Ability to understand pain and anxiety scales
* Possession of communication skills
* Absence of mental issues
* Absence of physical illnesses
* Absence of chronic illnesses
* Willingness of the child and family to participate in the study
* No visual, hearing, or speech problems

Exclusion Criteria:

* Children younger than 7 years or older than 12 years
* Presence of any chronic illness that could affect pain and anxiety levels
* Presence of psychosocial issues
* Children or parents who meet the inclusion criteria but do not wish to wear the virtual reality headset (VRH) glasses
* Children who need to wear glasses other than the virtual reality headset (VRH)
* Children with hearing problems
* Children who do not wish to watch the shrek cartoon
The Effectiveness of Group-Delivered Revised Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents

The study aims to examine the effectiveness of the group-delivered revised written exposure therapy (WET-R) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 70 participants, with 35 randomized to the WET-R group and 35 randomized to the waiting list (WL) group. The WET-R intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

1. Adolescents aged 10-18 years.
2. Meeting full or subthreshold PTSD (up to one symptom missing) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
4. Capable of writing and understanding written instructions.

Exclusion Criteria:

1. Presence of severe psychopathology necessitating immediate medical attention
2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future
3. Evidence of a moderate or severe traumatic brain injury
4. Currently undergoing psychotherapy specifically for PTSD.
Efficacy and Safety of Two Different Botulinum Toxin Type A Treatments for Moderate to Severe Cervical Dystonia

The purpose of this study is to compare two types of botulinum toxin type A to treat the involuntary muscle contractions in the neck


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervical dystonia/spasmodic torticollis for at least 18 months
* Successfully treated previously with botulinum toxin type A

Exclusion Criteria:

* Breast feeding, pregnant, or could become pregnant
* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol, alcohol for cervical dystonia
Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course

To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.

During pregnancy, obstructive sleep apnea (OSA) prevalence is estimated between 5% and 15% and is associated with maternal and fetal comorbidities such as preeclampsia, neonatal intensive care admission , fetal growth retardation , preterm birth but even if growing, literature is still relatively poor about this topic.

To date, there is no systematic screening of OSA performed in at-risk pregnant women (obesity, hypertension, diabetes, fetal growth retardation, suggestive symptoms), probably mainly because of polysomnography complexity and accessibility.

As in non pregnant woman, OSA must be treated adequately during pregnancy. Continuous positive airway pressure (CPAP) is the reference treatment for severe OSA. This device, by blowing air under pressure in upper airways, via a nasal of an oro-nasal mask, is able to alleviate the upper airway collapse responsible for the occurrence of obstructive sleep apnea. It has been proven to offer a survival benefit in patients with severe disease and to improve sleep quality, cardiovascular variables and health-related quality of life . CPAP have been shown to improve fetal well-being in pre-eclampsia .

Oral appliance can be an alternative for mild to moderate disease and in patients who do not tolerate CPAP. Positional counselling can be sufficient in case of mild to moderate positional OSA. Associated behavioural strategies (diet and exercise) are always recommended in case of excessive weight. Surgical treatments are dedicated to patients with specific anatomic problems but cannot be performed during pregancy.

Aim of the study:

The primary aim of this study is to screen OSA in at risk pregnant women with Watch-PAT 200, a simplified sleep study tool used on ambulatory mode and able to detect accurately OSA in suspected patients. As secondary aim, we will observe the impact of OSA on a composite endpoint assessing materno-fetal wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* 12-15weeks of pregnancy
* obese (body mass index\>30)

Exclusion Criteria:

* known sleep apnea syndrome
* mental illness, deficiency