cyrilzakka/clinical-trials huggingface dataset:
Support of the Sexual Health in Oncology

Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health.

There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner .

Finally, the oncologist continue during the treatment to evaluate the benefit of this program and adapt their counselling according to the needs


Eligibility Criteria:
Inclusion Criteria:

* all patient consulting in oncology service
* age \> 18 years
* accepting to participate

Exclusion Criteria:

* Age\< 18 years
* Refusing to participate
The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section

The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

Eligibility Criteria:
Inclusion Criteria:

* Cesarean section with general anesthesia.
* The ASA classification was from II to III

Exclusion Criteria:

* The acute fetal impairment.
* The severe live or renal failure.
* Tolerance opioids
Sexual Health of Spinal Cord Injured Females

The purpose of this study is to assess the impact on sexuality in women with a spinal cord injury, twelve months after their first return to home, of a program including structured information and education on sexuality, delivered 6 months after their first return to home.

Multicentre, prospective study, aiming to assess the effect on sexuality of an information and education program in women with spinal cord injury.

Included patients will be women hospitalized for initial rehabilitation, and will be included two weeks before their first return to home.

Socio-demographic data, diagnosis and etiology, secondary conditions, treatment, comorbidities and expectations towards rehabilitation care will be assessed at inclusion.

At M3 Patients will be randomized in either the intervention arm or the control arm.

Patients enrolled in the intervention arm will benefit from a standardised information and education consultation on physiology of sexual response 6 months after their return home.

Patients enrolled in the control arm will undergo the same follow-up but will only have the usual unstructured and unformalized information provided by the clinical team.

At M3, M6, M12 secondary conditions , sexual function index (FSFI), social integration (LHS), treatment and expectations towards rehabilitation care will be assessed

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury including cauda equina injury of traumatic etiology or not
* Hospitalization for initial post-injury rehabilitation in a study center
* First return at home scheduled within the 14 days following inclusion date
* Understanding of the French language allowing to answer questionnaires
* Affiliation to health insurance
* Written informed consent

Exclusion Criteria:

* Full recovery of sensory-motor functions (AISE)
* Associated brain injury
* Psychiatric disease previously diagnosed, excepted treated and remitting mood disorders
* Patients with tutorship / guardianship
* Spinal cord injury of malignant origin
* Spinal cord injury associated with multiple sclerosis
* Anticipated loss-to-follow-up (patient moving outside of the usual hospital catchment area)
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration

This was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.

The primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (PFS) in subjects with neovascular age-related macular degeneration (nAMD) with the primary endpoint being the incidence of ocular and non-ocular adverse events (AEs). There were no other objectives for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection.
3. Subjects \>= 50 years of age.

Exclusion Criteria:

1. Active infection or inflammation in the eyes.
2. Uncontrolled glaucoma.
3. History of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered.
4. Treatment with anti-VEGF intravitreal injection in the study eye within one month prior to enrollment.
5. The use of intraocular corticosteroids in the study eye within the last three months prior to enrollment.
6. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation.
7. Uncontrolled hypertension.

Other protocol defined inclusion and exclusion criteria may apply.
Conservative Nodal Surgery (Node-picking) of Patients With Stage III Melanoma With Low-burden of Nodal Disease (MELCONSURG MULTICENTRE COHORT)

Background: Standard treatment for stage III melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. Conservative surgery for low-burden nodal metastasis involves removal of the metastatic lymph node or nodes ("node-picking"), leaving uninvolved nodes within the regional basin. This is expected to provide adequate regional control of the disease with no negative impact on patient survival and a lower rate of surgical complications.

Aims: The MelConSurg Cohort will provide the first data on conservative surgery for patients with stage III melanoma with nodal metastases detected clinically or by imaging.

Methods: A multicentre, single-arm prospective cohort study. Inclusion criteria: Patients with melanoma aged between 18 and 90 years, Eastern Cooperative Oncology Group performance status 0-1, non-matted regional lymph node metastasis (N1b or N2b) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan). Study period: A 3-year recruitment period and a 3-year follow-up phase.

Intervention: Patients will undergo conservative nodal surgery using conventional surgery, radio-guided surgery, or imaging guided surgery.

Outcome measures: 3-year nodal relapse-free survival, 3-year disease-free survival, 3-year melanoma-specific survival, rate of surgical complications, and quality of life (SF-36 questionnaire).

Sample size \& Statistics: the estimated sample size to be recruited is 68 patients. Survival outcomes will be analysed through the Kaplan-Meier method, with the log-rank test. Conclusions: This Project is expected to provide unique evidence regarding a less radical nodal surgery for patients with melanoma. If favourable results are obtained, controlled studies could be conducted and changes in current clinical practice could be considered.


Eligibility Criteria:
Inclusion Criteria:

* Patients with melanoma aged between 18 and 90 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Nodal stage N1b or N2b (American Joint Committee on Cancer 8th edition) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan).

Exclusion Criteria:

* Single lymph node metastasis in more than one regional basin.
* Multiple primary melanoma (except for limb melanoma).
* Primary occult melanoma.
* Previous nodal, locoregional, or distant metastasis.
* Previous lymph node surgery, except for SLNB.
* Distant metastases detected at the screening evaluations or first postoperative PET-CT scan.
Primary Care Transition Study

This study is looking at ways to help young people with chronic health conditions take better care of their health and find an adult doctor.

The purpose of this study is to determine whether providing targeted transition-related skills through interventions with varying degrees of intensity (from the low intensity Basic intervention group, to the mild intensity Group Intervention group, to the high intensity Full Intervention group) results in improved transition readiness and self-care skills and improved successful transition to adult-based services for young adults with chronic health conditions. Secondary objectives include determining if the transition interventions enhance transition-related satisfaction among participants, their caregivers and the involved pediatric and adult providers.

Eligibility Criteria:
Young Adult Inclusion Criteria:

* Males or females age 19 years of age or older
* Presence of at least 1 Chronic Condition and/or Cognitive Disability
* Last visit with pediatric primary care provider occurring on or after January 1, 2011
* Currently active in one of four identified pediatric practices (Cobbs Creek, Chestnut Hill, Market Street, West Chester)
* Current primary care provider approval for participation
* English speaking

Young Adult Exclusion Criteria:

* Male or female age \< 19 years
* No presence of a chronic condition or cognitive disability
* Last visit with pediatric PCP occurring prior to January 1, 2011
* Not currently active in one of four identified pediatric practices (Cobbs Creek, Chestnut Hill, Market Street, West Chester)
* Current PCP disapproves participation
* Non-English speaking

Caregiver Inclusion Criteria:

* Has a child enrolled in the study
* Child has consented/assented to allow them to participate
* English speaking

Caregiver Exclusion Criteria:

* Child did not consent/assent to allow them to participate
* Non-English speaking
Neuro-immunological Analysis of Idiopathic Rhinitis Patients and Controls Treated With Capsaicin.

The term idiopathic rhinitis (IR) is used in this study to describe a patient group with following characteristics: patients with complaints of nasal obstruction, sneezing and/or rhinorrhea for a period of over 1 year, which cannot be attributed to allergy, nasal or paranasal infection, anatomical disorders, pregnancy or lactation and/or systemic disorders. These patients are non-smokers and do not use medication affecting nasal function. They have no beneficial effect of intranasal steroid spray (INS) treatment.

The population incidence of IR is estimated to be as high as 10%. The pathophysiology of IR is largely unknown. Several hypotheses have been put forward. In general it is assumed that neurogenic mechanisms play an important role. Neuropeptides like CGRP, SP, NKA/B, NPY, NGF are released from afferent neurons in the nasal mucosa after activation by unspecific stimuli and can be responsible for the symptoms of IR.

For this group of IR-patients, there is until now only one treatment option: intranasal capsaicin application. Capsaicin, the pungent agent in hot pepper, is supposed to exert its' therapeutic effect via degeneration or desensitization effect on the afferent C-fibers.

The hypothesis is that nasal capsaicin treatment reduces neurogenic inflammation and reduces in that way nasal symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with persistent (\> 12w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial.
2. Age \> 18 and \< 50 years
3. Written informed consent
4. Willingness to adhere to visit schedules
5. Adequate contraceptive precautions in female patients with childbearing potential
6. Unresponsiveness to nasal steroid spray (4 weeks of use)

Exclusion Criteria:

1. Age \< 18 and \> 50 years
2. Patients with AR, demonstrated by either positive skin prick test or RAST
3. Presence of IgE in nasal lavage fluid
4. Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
5. Systemic steroid treatment less than 4 weeks before the inclusion in the study.
6. Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
7. Inability of the patient to stop taking medication affecting nasal function.
8. Evidence of infectious rhinitis/rhinosinusitis.
9. Pregnancy or breastfeeding.
10. Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
11. Enrollment in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
12. Contra-indications for local anaesthesia (Cocaïne 5%).
13. Smoking.
14. Systemic disease with lesions in ENT domain.
15. Malignancies or severe comorbidity.
Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.

This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis

Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were as follows:

* Age 18-30 years.
* Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.

Exclusion Criteria:

* known history of hypersensitivities to Chlorhexidine or hyaluronic acid.
* Use of any medication as a treatment for the present active ulcer.
* Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease.
* Pregnant or breast-feeding women.
* Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus.
* Treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or other immune modulatory agents, oral antihistamines, or systemic antibiotics in the previous 3 months.
Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients

The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Age was above 18 years
* Hemodialysis patient
* All patients had undetectable hepatitis B virus surface antigen and antibody

Exclusion Criteria:

* A positive serum hepatitis B virus surface antigen and antibody
* patient received a previous course of hepatitis B virus vaccine
Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation

Hypoxic ischemic brain injury is a devastating illness that occurs after cardiac arrest (the heart stopping) and can yield irreversible brain damage, often leading to death. The mainstay in therapy is to optimize the delivery of oxygen to the brain to help it recover. In patients with traumatic brain injury (similar to HIBI), the investigators are able to optimize oxygen delivery to the brain with the use of wires placed into the brain that sense the pressure and oxygen in the skull to find the ideal blood pressure for each individual patient. This strategy is associated with improved outcomes. The investigators are conducting a prospective study investigating whether the perfusion within proximity to the optimal MAP is associated with improved brain oxygenation and blood flow .


Eligibility Criteria:
Inclusion Criteria:

* Confirmed cardiac arrest with return of spontaneous circulation \> 10 minutes
* post resuscitation GCS \< 9

Exclusion Criteria:

* concurrent coagulopathy
* prior history of TBI, intracranial hemorrhage, subarachnoid hemorrhage
* anticipated cardiac catheterization within next 7 days
* anticipated or current use of anticoagulants or anit-platelets
Parents' Expectations and Experiences Around Cesarean Section in Belgium

The aim of this study is to gain insight in the experiences and expectations of Belgian parents concerning primary cesarean section. This will be achieved by structured patient interviews and questionnaires in 24 women undergoing the procedure and their partners. This group will be divided into two subgroups of 12 multiparous and 12 nulliparous women and their partners.

The subjects in both groups will be interviewed twice and will receive three questionnaires. One to two weeks prior to the scheduled cesarean section and during a scheduled obstetric outpatient visit, the first interview and questionnaire will be administered to the couple. A second questionnaire will be provided while still hospitalized (5 days post partum), to both mother and partner. Six weeks post partum, during a scheduled obstetric outpatient visit, the couple will be interviewed for the last time and will be asked to complete the third and last questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Partner available
* 18-50 years of age
* Singleton pregnancy
* Booked for planned cesarean section ≥37 weeks of gestation
* Dutch-speaking
* Informed consent given

Exclusion Criteria:

* Emergency cesarean section
* \<18 years of age or \>50 years of age
* Multiple pregnancy
* Inability to provide consent (language, etc.)
* Partner not consenting
* BMI \>35 kg/m2
* Maternal or fetal pathologies expected to affect pre and postnatal maternal/neonatal management
Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass

The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.

Esophageal syndromes were evaluated according to the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.

Esophageal acid exposure was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH \< 4 for at least 4% of the total monitoring time.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity
* Acceptance to undergo open gastric bypass

Exclusion Criteria:

* Prior gastroesophageal surgery
* Achalasia
Alveolar Management Following Teeth Extraction

Investigation of the volume stability of the alveolar ridge, the bone structure and soft tissue appearance at a delayed dental implantation using two bone substitute materials (1. Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Indication for tooth extraction resulting in a edentulous gap
* Male and female patients with an age range 20-60 years
* Caucasian
* For female patients: a negative pregnancy test
* Normotonic blood pressure (according to the WHO definition):

  * Men: 110/70 - 140/90 mm Hg
  * Women: 100/60- 140/90mm Hg

Exclusion Criteria:

* Parallel implantation of another implant
* Parallel planned prosthetic restoration of the adjacent teeth
* Smoker (less than 5 years non-smoker)
* Nursing women
* Participation in another clinical trial which dates back to less than 3 months before inclusion in this clinical trial
* Intake of bisphosphonates
* Radiation therapy (medical history or current)
* Known Diabetes mellitus
* Inflammatory processes in the mouth (PSI\> 2)
* Presence of autoimmune diseases (Rheumatoid arthritis, Sjögren's syndrome, Systemic lupus erythematosus)
* Presence of blood coagulation disorders (Haemophilia A/B), or the intake of anticoagulants (Warfarin, new oral anticoagulants, aspirin\> 100 mg)
* Osteogenesis imperfecta
* Osteoporosis
* Leukemia
* Agranulocytosis
* Immunocompromised patients
* Acute phase and rehabilitation phase of myocardial infarction
* Oncogenes diseases
* Patients undergoing chemotherapy
* Sepsis
* Acute and chronic infections: sinusitis, rhinitis, pharyngitis and Otitis media
* Wound healing disorders
* Seizures
* Gingival hyperplasia
* Alcohol abuse
* Drug abuse
* Infectious diseases (HIV, Hepatitis B and C)
The iPeer2Peer Program for Adolescents With Juvenile Idiopathic Arthritis

The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Arthritis is a common childhood illness that makes everyday activities hard for young people. It is a long-lasting illness that can make you feel pain, tired and emotionally upset. This can make it hard for children and teens to see friends and do the activities that they like. The goal of this project is to find out if the newly developed peer mentoring program called iPeer2Peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. The iPeer2Peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. This study will compare two groups of teens: those who are in the iPeer2Peer Program and those in the control group (no mentor).

Eligibility Criteria:
Inclusion Criteria:

* males and females 12-18 years old
* rheumatologist-diagnosed JIA according to ILAR criteria
* able to speak and read English
* access to a computer, smartphone or tablet capable of using free Skype software (note: participants who do not have adequate Internet access will be provided with portable Internet sticks)
* willing and able to complete online measures.

Exclusion Criteria:

* significant cognitive impairments
* major co-morbid illnesses (medical or psychiatric conditions) likely to influence HRQL assessment
* participating in other peer support or self-management interventions.