cyrilzakka/clinical-trials huggingface dataset:
Effect of Different Surgical Approaches of Granulomatous Mastitis

The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.

Granulomatous mastitis is a rare benign inflammatory breast disease first described by Kessler and Wollock in 1972. It resembles inflammatory breast cancer disease in imaging and mainly affects women of childbearing age. Treatment methods include steroid therapy, antibiotics and surgical treatment. However, due to the adverse reactions of drug treatment and the high recurrence rate after traditional surgery, there is no definitive preferred treatment form at present, and most clinicians are still in the stage of empirical treatment.

Breast-conserving plastic surgery has been widely used by surgeons because it can remove a larger range of breast cancer, so it has higher safety and aesthetics compared with traditional breast conserving surgery. So, if patients with mastitis are treated surgically, will they also benefit from breast-conserving surgery? At present, the commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on. Therefore, this study prospectively grouped mastitis patients who selected surgery, and divided them into traditional surgery group and plastic breast-conserving surgery group. The postoperative recurrence, adverse reactions, aesthetics and satisfaction of the two groups were compared.

It is hoped that this study will bring a new research direction for the surgical treatment of mastitis and provide a clearer guiding significance for clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

Only the subjects who meet all the following criteria may be included in this study:

1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
2. 18≤Age≤75 years old, female;
3. Histologically confirmed granulomatous mastitis;
4. low and moderate risk for anesthesia.

Exclusion Criteria:

The subjects who meet any of the following criteria shall not be included in this study:

1. Absolute and relative contraindication for surgery;
2. Previous history of breast cancer or other malignancies;
3. Pregnancy;
4. Any serious complications which caused patients not suitable to participate this study.
ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars

Visit the study website https://dawnacnescarstudy.com/ACT for more information. Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars.

ELAPR002f Injectable Gel is an investigational device being developed for the treatment of facial atrophic acne scars. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 156 adult participants with moderate to severe atrophic acne scarring on both cheeks will be enrolled in the study in approximately 12 sites in Germany and Canada.

Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants in general good health, with no active COVID-19 infection, and seeking improvement of atrophic acne scars.
* Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan ASIS) on each cheek based on Evaluating Investigator's live assessment (both cheeks must qualify but do not need to have the same score) at the first screening visit.
* At least 5 rolling or boxcar-type acne scars in total within the predefined assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator.

Exclusion Criteria:

* The participant has clinically significant acne on the face.
* Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
* The participant presents with predominantly ice pick scars.
* History of keloid scar formation, hypertrophic scarring and/or post inflammatory hyperpigmentation or hypopigmentation.
* History of granulomatous or connective tissue disease.
* Diagnosed autoimmune disease (eg, Type 1 diabetes, rheumatoid arthritis, scleroderma, vitiligo).
* Diagnosed history of lung disease.
* Known hypersensitivity to the constituents of the device.
* Visual acuity of 20/100 or worse or abnormal confrontational visual fields or ocular motility.
Medications Development for Drug Abuse Disorders

This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.


Eligibility Criteria:
Inclusion/Exclusion Criteria:

* Participants in this study will be males and females between the ages of 18 and 60 years.
* Applicants must be opioid dependent based upon the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID); in addition, they must have an opioid positive urine during the screening process (or have evidence of opioid withdrawal).
* They must be healthy, with no significant medical illnesses (e.g., insulin dependent diabetes), and without significant psychiatric illness (e.g., schizophrenia) besides their drug dependence.
* Females will have a pregnancy test prior to study enrollment, and if found to be pregnant will be excluded and referred to a substance abuse program for pregnant women (the Center for Addiction and Pregnancy) on the campus.
* Volunteers will also be excluded if they have pre-admission hypotension (due to the use of clonidine in the study).
* Applicants with a history of seizures (including substance-related seizures, such as alcohol withdrawal related) will be excluded.
* Alcohol and/or sedative dependence will be specific exclusionary criteria (given the small risk of seizures associated with tramadol use).
* Allergies to any of the study medications will be grounds for exclusion.
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma

60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and control group will receive Sorafenib plus placebo


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Child A and B cirrhosis with hepatocellular carcinoma
* Biochemical, Radiological, histological evidence of advanced hepatocellular carcinoma diagnosed as stage C and stage d with serum bilirubin \<5 mg/dl according to BCLC staging system
* HCC with portal vein thrombosis
* Unresectable cancer, as assessed carefully by individual experts
* No recent active treatment like surgery, radiofrequency ablation, trans arterial chemo embolization, radiotherapy, chemotherapy (within the past 6 months)

Exclusion Criteria:

* Patients with end-stage hepatocellular carcinoma (Stage D, BCLC)with poor performance status
* Child C cirrhosis with HCC (Hepatocellular carcinoma)
* HCC with acute decompensated state of CLD - GI bleed, increased jaundice, HE, SBP (Spontaneous Bacterial Peritonitis)
* Acute febrile illness
* Pregnancy or lactation
First-In Man (FIM) Study MR-Linac

Investigational device is the Magnetic resonance imager linear accelerator. Five (5) patients with bone metastases will be treated with palliative intention in this study. The goal is to confirm the pre-clinically demonstrated technical accuracy and safety of the newly developed MR-Linac in the clinical setting.

This is a single center prospective proof of concept study including accuracy and safety aspects according to R-IDEAL stage 1 criteria. Five (5) patients with bone metastases will be treated with palliative intention in this study. Treatment will consist of a single fraction.

The MR linear accelerator (MRL) integrates a radiotherapy accelerator and a diagnostic quality 1.5T MRI, enabling soft-tissue visualization during the actual radiation delivery for improved targeting. This enables on-line treatment optimization for precise radiation delivery. Better visualization of the tumour targets and the surrounding healthy tissues, at the exact moment of treatment, makes it possible to adapt the dose to the actual anatomy while optimally sparing normal tissues.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a patient must meet all of the following criteria:

* Painful bone metastases in the lumbar spine
* Radiographic evidence of bone metastases
* Histologic proof of malignancy (primary carcinoma)
* Karnofsky Performance Score ≥ 50
* Age ≥ 18 years
* Able to provide written informed consent

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Prior radiation therapy within the region planned to be irradiated
* Contraindication for MRI according to screening protocol radiology department UMCU (e.g. cardiac pacemakers, and defibrillators, artificial heart valves or cochlear implants, https://richtlijn.mijnumc.nl/Beeld/MRI/Paginas/MRI-Veiligheid-Contra-indicaties.aspx
* Claustrophobia
* Standard systemic anti-cancer therapy or radionuclide therapy within 48 hours before or after treatment.
* Any other type of not standard systemic anti-cancer treatment, except for endocrine treatment.
* Unstable spine requiring surgical stabilization
* Neurological deficit due to bone metastasis
Carbetocin Versus Misoprostol in High Risk Patients for Postpartum Hemorrhage After C.S.

We will compare between Carbitocin and Misoprostol in prevention of postpartum hemorrhage in high risk patients after C.S.

* Postpartum hemorrhage was traditionally defined as blood loss in excess of 500 mL from a vaginal delivery or 1000 mL at cesarean section. It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (Almog et al, 2011)
* Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. Many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -Misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. The most common regimen reported for the treatment of post-partum hemorrhage is rectally. (Oladapo et al., 2012)
* Misoprostol is a prostaglandin E1 analogue. It has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (Hofmeyr et al, 2009)
* Carbetocin is a long-acting oxytocin studied by Dansereau et al.; 1999.They found that the carbetocin group of patients had a decreased incidence of PPH and of the need for therapeutic oxytocics. The recommended dose of carbetocin is 100 mg given either IM or slowly (over 1 minute).
* Risk factors may present antenatally or intrapartum; care plans must be modified when risk factors present. Clinicians must be aware of risk factors for PPH and should take these into account for the wellbeing and safety of both the mother and the baby.RCOG GUIDLIN Table 1: Risk factors for PPH

  * Suspected or proven placental abruption
  * Known placenta praevia
  * Multiple pregnancy
  * Pre-eclampsia/gestational hypertension
  * Previous PPH .
  * Obesity (BMI \>35)
  * Anaemia (\<9 g/dl)
  * Delivery by elective caesarean section
  * Induction of labour
  * Retained placenta Tissue
  * Prolonged labour (\> 12 hours) .
  * Big baby (\> 4 kg) Royal College of Obstetrics and Gynecology.Green-top Guideline No. 52 May 2009 Minor revisions November 2009 and April 2011. Prevention and Management of Postpartum Hemorrhage. Thus our aim is to compare the effeciency and cost effectiveness of Carbitocin and Misoprostol in patients at high risk of PPH after C.S. in prevention of PPH.

Eligibility Criteria:
Inclusion Criteria:

* Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.

Any medical disorder with pregnancy that carries a risk factor for PPH.

Exclusion Criteria:

* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation.
Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* 21 years or older;
* need spherical correction between 10-30 Diopters (D);
* corneal astigmatism less than 0.75D as measured by keratometry;
* willing to sign an Informed Consent Form and complete all visits;
* pupil dilation greater than 6mm;
* expected Visual Acuity (measured in logMAR)=0.3 or better

Exclusion Criteria:

* Women of childbearing potential;
* irregular corneal astigmatism;
* keratopathy/keratectasia;
* cornea inflammation or edema;
* cornea reshaping surgery;
* corneal dystrophy;corneal transplant;
* amblyopia;
* glaucoma;
* Retinal Pigment Epitheliopathy (RPE)/Macular changes;
* proliferative diabetic retinopathy
Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops

Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation.

Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses.

The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myopia - measured under cycloplegia - defined by:

  1. A sphere power between -1 and -6 Diopters, on at least one of the two eyes
  2. AND a cylindrical power strictly inferior to 2 Diopters
  3. AND a maximum refractive error strictly inferior to 8 Diopters in the flattest axis
* Not benefiting and never having benefited from a myopia control strategy (orthokeratology, soft defocusing lenses, low concentration atropine eye drops, peripheral defocusing corrective lenses)
* Written consent of both parents

Exclusion Criteria:

* History of genetic disease, or general condition suggesting a syndromic myopia (including an axial length greater than 27 mm)
* Strabismus
* Amblyopia defined by a best corrected visual acuity strictly inferior to 10/10 on one of the two eyes
* Anisometropia defined by a difference of 2 Diopters or more between the two eyes (in spherical equivalent)
* History of allergy to atropine
* History of severe anaphylaxis
* Optical correction with contact lenses
* Previous ophthalmologic surgery of the cornea, lens, retina
* History of glaucoma or any other chronic ophthalmological disease in the course of treatment (including vernal keratoconjunctivitis)
Perioperative Anxiety in Children

The study was conducted to evaluate the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years. The research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients, 22 patients in each group, who met the inclusion criteria and were included in the stratified randomization method, were included in the planned quasi-experimental study. Research data were obtained by using the "Patient Diagnosis Form" and the "Anxiety Scale in Preschool Children" administered before and after the surgery.

Pre-operative patient education was given to the children in the first experimental group by the service nurse. The children in the second experimental group were given pre-operative patient education by the service nurse, in addition, patient visits were provided by the operating room nurse and the operating room environment was explained through play. The children in the third experimental group were given pre-operative patient education by the service nurse, after which they listened to the mother's voice recording and loving words until they went to the operating room. It was determined that 69.7% of the mothers of the children participating in the study were 30 years and older, 81.8% were married, 37.9% were undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of those who had no previous surgery experience were found significantly higher than those who had previous surgery experience (p\<0.05). In terms of affecting the anxiety level, there was a significant difference between the preoperative methods (p\<0.05). It was determined that the education given by both the service nurse and the operating room nurse together was more effective than other methods in reducing the anxiety levels of children, and there was a statistically significant difference between them. (p\<0.05)

Eligibility Criteria:
Inclusion Criteria:

* Planned elective surgery related to pediatric surgery,
* Having no problems in communicating,
* Volunteer to participate in the research
* Children aged 4-7 years

Exclusion Criteria:

* Children scheduled for emergency surgery
Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer

The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.

This study is carried out in two steps :

* Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
* Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.

8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.

Focus groups will be conduct to :

* Identify the representations associated with erectile dysfunction
* Identify the representations related to treatments for erectile dysfunction.
* Score patient knowledge about treatments and their managements.
* Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.
* Assessing the needs and expectations of patients

Eligibility Criteria:
Inclusion Criteria:

* Patients followed in urology department Lyon Sud CH:
* Aged over 18 year
* Having a prostate cancer
* Treated with radical prostatectomy with or without conservation strips neuro vascular
* More than 1 month postoperative
* Having a normal preoperative erectile function defined by a score IIEF EF ≥ 26.
* And who signed the informed consent form for participation in the study

Exclusion Criteria:

* Score preoperative IIEF EF \<26
* Refusal of participation, signed consent major patients protected under guardianship.
* Patients unable to understand the course of the study
* Patient (s) with a documented history of cognitive or psychiatric disorders.
* Geographical remoteness of more than 100 Kms.
Energy Expenditure Estimation in Cardiac Surgery

Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Different predictive equations have been developed, but not evaluated in cardiac population and have low accuracy in compare to the indirect calorimetry. The aim of present study is to develop cardio-specific equation for resting energy expenditure estimation.


Eligibility Criteria:
Inclusion Criteria:

* Patient of cardiothoracic ICU

Exclusion Criteria:

* Shock
* patients on ECMO
* Hypoxemia \<60 mmHg
* Active bleeding
* Ventilation with FiO2 \>0.6
Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in a Large Population

This study is an interventional trial to evaluate the effectiveness of a cognitive and physical program (Intervention), in reducing the frequency of head and neck pain in the population of an extensive territory of Italy.

In a previous non-randomized-controlled study in which the cognitive and physical programme was applied to a consistent number of office workers, a significant reduction of frequency of pain in the head and neck areas and of analgesic drug consumption was obtained. The results were stable at a 12 month follow up. More recently a controlled, cluster randomised, interventional trial was conducted on 1930 local government employees of the Municipality of Turin. The data obtained confirm those of the previous studies.

The present study was designed to confirm the data in a much more extensive population , that is, residents of the Italian Region Piemonte (Piedmont) who will apply to participate.

Primary objective is to confirm the effectiveness of the cognitive and physical programme (Intervention), in reducing the frequency of pain involving the head and neck area in a large population of a territory.

Secondary objective is to confirm the effectiveness of the Intervention, in reducing analgesic drugs consumption after the Intervention in the same population.

Eligibility Criteria:
Inclusion Criteria:

* All residents of the Region Piemonte (Italy) may apply for recruitment

Exclusion Criteria:

* Because of the pragmatic design, no exclusion criteria are required for this study