cyrilzakka/clinical-trials huggingface dataset:
Narrowband UVB for Children With Moderate to Severe Atopic Eczema

To assess prospectively, the response of moderate to severe atopic eczema to a standard course of narrowband ultraviolet B phototherapy by using validated objective and subjective scoring systems.

Children with moderate to severe atopic eczema prescribed a course of narrowband UVB phototherapy were scored (using validated scoring systems) objectively and subjectively before, during and after the course of treatment, as well as 3 and 6 months post treatment (to determine length of remission). Their scores were compared to a control group. The control group comprised children with moderate to severe atopic eczema who were offered UVB but were unable to undertake the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3-16 years with moderate to severe atopic eczema (as defined by the modified Hannifin and Rajka criteria) in whom there is a clinical indication for phototherapy (as deemed by their specialist Dermatology consultant).

Exclusion Criteria:

* Children under the age of 3 years or any child who lacks the maturity needed to stand in the phototherapy cabinet unsupervised.
* Mild disease (defined as a Six Area Six Sign Atopic Dermatitis (SASSAD) score \<10)
Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery

The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care unit.

Our hypothesis is that the use of a comfort scale will lead to significant postoperative opioid sparing, and consequently to a decrease in the opioid-related side effects The aim of this study is to compare postoperative opioid consumption between patients whose pain is assessed by a numerical verbal scale and those assessed with a comfort scale.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patient eligible for any surgery requiring postoperative opioid administration;
* Patient with a social security plan;
* French-speaking patient
* Free, informed and oral consent by the patient.

Exclusion Criteria:

* Woman claiming to be pregnant or breast feeding;
* Emergency surgery;
* Patients using preoperative opioids ;
* Opioid addiction;
* Patients unable to understand the assessment scales;
* Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
GATT Versus Canaloplasty (GVC)

Study aims to compare the effectiveness and safety profile of Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Gonioscopy-assisted Transluminal Trabeculotomy is the procedure that aims the same mechanism of aqueous outflow, however is perform with ab interno approach, which comprise it to the minimally invasive glaucoma surgery techniques. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication burden and complications rate. So far there is no comparison of the Gonioscopy-assisted Transluminal Trabeculotomy and canaloplasty available.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older (Adult, Older Adult)
* patients with confirmed uncontrolled open angle glaucoma
* no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

Exclusion Criteria:

* angle closure glaucoma
* congenital glaucoma
* inflammatory glaucoma
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma

Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.

CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.

Subjects will be closely monitored for DLT and safety.

Eligibility Criteria:
Inclusion Criteria:

Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:

1. Signed Informed Consent Form
2. Male or female patients who are 18-75 years of age
3. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
4. Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
5. At least 1 measurable lesion according to the Lugano Classification
6. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy \>12 weeks

Exclusion Criteria:

1. CNS involvement by malignancy
2. Inadequate laboratory abnormalities at screening:

   Hgb ≤ 8.0 g/dL Total bilirubin \> 1.5 x ULN (\>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR \>1.5 x ULN aPTT\> 1.5 x ULN
3. Active uncontrolled bleeding or a known bleeding diathesis
4. Inadequate pulmonary function defined as pulse oximetry \< 90% on room air
5. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (\>10 mg/day prednisone or equivalent for \>48 hours)
6. Received prior therapy of:

   Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days
7. Active GVHD requiring immune suppression regardless of grade
8. HIV positive
9. Active HBV and/or HCV
The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery

Regardless of the type of surgical intervention, it is a negative life experience for the child and family members and is known to cause anxiety. Having a surgical incision in the child's body and the likelihood of developing conditions such as pain, organ loss or death, change in the parental role, and the hospital environment are situations that increase the stress of the parents. Hernia is the most common surgical pathology in children. Hernias are also risky in terms of complications.

Parents' experiencing severe anxiety may prevent their ability to understand the child's explanations correctly, interpret events realistically, make correct decisions, participate in the care of the child, and use appropriate coping methods. Parents abandon their habitual attitudes because they feel anxiety and sadness. Their tolerance increases and, as a result, they do whatever their children want. This change in the attitudes of the parents may increase the anxiety of the child and make him feel more sick than he is. Therefore, it is very important for the child to reduce the parent's anxiety.

At the pathological level, anxiety requires pharmacological and / or psychosocial intervention. The main purpose of psychosocial intervention is to understand and discover one's emotions. Some authors mention the benefits of using expressive methods. Art practices are at the top of the expressionist methods, and according to the nursing interventions classification system (NIC), art therapy is among the nursing interventions.

Studies have shown that art practices reduce women's stress, anxiety, depression and fatigue. On the other hand, occupational therapy is another example of the use of art in psychotherapy. Various crafts and decorations are made in this type of therapy.

Most of the studies on knitting in the literature have been conducted with groups, and there is no study examining the effect of knitting in reducing the anxiety of mothers whose children underwent surgery. In this study, which was planned as a randomized controlled experimental study, it was aimed to examine the effect of knitting on the anxiety levels of the mothers of children who underwent hernia surgery.

The objectives of the study; To determine the anxiety levels of mothers of children who underwent planned surgery. To determine the effects of demographic characteristics on mothers' anxiety levels. To determine the effect of knitting knitting method on the anxiety levels of the mothers of children who underwent hernia surgery.

Eligibility Criteria:
* Inclusion criteria in the study;

  1. Mothers know how to knit,
  2. Mothers' willingness to participate in the study,
  3. The child has not had a previous surgical operation.
  4. The mother has not had any psychological trauma or psychiatric diagnosis in the last six months.

exclusion criteria in the study;

1. Mothers do not know how to knit,
2. Refusal of mothers to participate in research,
3. The child has had previous surgery,
4. The mother's history of any psychological trauma or psychiatric diagnosis in the last six months.
Dronabinol After Arthroscopic Surgery

The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patient who will undergo arthroscopic surgery of the knee including, but not limited to,

  * Meniscectomy
  * Synovectomy
  * Chondroplasty
  * Loose body removal

Exclusion Criteria:

* Patients under age 18 years
* Patients who cannot provide consent
* Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
* Patients with an allergy to any of the study drugs
* Patient who are lactose-intolerant
* Revision surgery
* Open surgery
* Comorbidities preventing surgery
* Patients with a history of mania, depression, or schizophrenia
* Patients taking any of the following drugs or supplements

  * Anticholinergic agents
  * Benzodiazepines
  * Central nervous system depressants
  * Droperidol
  * Hydroxyzine
  * Levomepromazine or methotrimeprazine
  * Monoamine oxidase inhibitors
  * Ritonavir
  * Selective serotonin reuptake inhibitors
  * Sympathomimetics
  * St. John's Wort
* Current diagnosed alcohol or drug abuse
* Patients who cannot or will not abide by the medication restrictions listed below

Medication restrictions

* Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period
* Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen
Wearable Device-Based Analysis of the Relationship Between Sleep Patterns and Clinical Prognosis in Patients With Traumatic Brain Injury

In patients with traumatic brain injury, post-traumatic sleep patterns have the potential to impact clinical prognosis. While some progress has been made in the study of sleep and prognosis in patients with traumatic brain injury, there is still lack of research on the relationship between sleep and clinical prognosis in post-traumatic patients due to differences in study design, patient age, severity of trauma, and definitions of sleep disorders. Additionally, the primary data collection methods employed in most studies have been self-reported sleep assessments, which are subject to potential biases and inaccuracies. Therefore, explore the impact of sleep patterns on clinical prognosis in post-traumatic patients, with potential to advance our comprehension of recovery outcomes in this patient group.


Eligibility Criteria:
Inclusion Criteria:

1. 18\~60 years old.
2. The patient had no sleep disturbance problems prior to traumatic brain injury.
3. The patient has a definite diagnosis of traumatic brain injury and the Glasgow score is \>8.
4. The patient had abnormal imaging scans.
5. It has complete preclinical data.

Exclusion Criteria:

1. Patients with a previous history of traumatic brain injury, mental illness, alcohol abuse or sleep disorders.
2. Patients admitted for surgical intervention.
3. Patients with a combination of other heavy visceral injuries.
4. Women during pregnancy and lactation.
5. The patents' use of medications that interfere with sleep
A Study of Mirikizumab in Healthy Participants

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 17 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined through medical history and physical examination

Exclusion Criteria:

* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
* Must not have significant allergies to humanized monoclonal antibodies
129 Xenon MRI As a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)

The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).

Subject Enrollment This study will consent and enroll 20 subjects total.

• For Arm 1, 10 subjects with Idiopathic Pulmonary Arterial Hypertension (IPAH) will be consented and enrolled. For Arm 2, 10 subjects with Connective Tissue Disease Associated Pulmonary Arterial Hypertension (PAH-CTD) will be consented and enrolled.

Study Design This study will be observational. Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months. In addition to the this, data from standard of care assessments, such as labs, echocardiography, and six-minute walk distance (6MWD), will also collected at these timepoints.

Primary Study Endpoints The primary endpoint for this trial will be the change in defect + low percentage of RBC signal on hyperpolarized 129Xe MRI from baseline to 12 months

Secondary Study Endpoints

There will be several secondary endpoints for this trial:

* Change in regional and global RBC Oscillation Amplitudes on hyperpolarized 129Xe MR spectroscopy from baseline to 12 months
* Change in 6MWD from baseline to 12 months
* Change in NTproBNP from baseline to 12 months
* Change in WHO FC from baseline to 12 months

Primary Safety Endpoints

There will be several primary safety endpoints for this trial:

* Frequency of Adverse Events (AE) and/or Serious Adverse Events (SAE)
* Withdrawals due to adverse event or death
* Incidence of Adverse Events of Significant Interest (AESI):
* Electrocardiogram and any findings
* Physical examination and vital signs

Eligibility Criteria:
Inclusion Criteria:

Arm 1 -IPAH

* Age: 18-75 years
* WHO functional class 2 or 3
* Mean pulmonary artery pressures \> 20 mmHg
* Pulmonary capillary wedge pressure ≤15 mmHg
* Pulmonary vascular resistance \> 2 Wood Units (WU)
* No other cause identified for PAH

Arm 2 -PAH-CTD

* Age: 18-75 years
* WHO functional class (FC) 2 or 3
* Mean pulmonary artery pressures \> 20 mmHg
* Pulmonary capillary wedge pressure ≤15 mmHg
* Pulmonary vascular resistance \> 2 WU
* Diagnosis of connective tissue disease

Exclusion Criteria:

* PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.
Blood Flow - an Underlying Mechanism Behind Clinical Improvements in Patients With Subacromial Pain Syndrome?

The purpose of this randomized clinical trial is two-fold. Firstly to see if patients suffering Subacromial Pain Syndrome can improve blood flow in the supraspinatus muscle in their shoulder, and secondly to investigate how changes in this blood flow are related to pain experience and shoulder function.


Eligibility Criteria:
Inclusion Criteria:

* shoulder pain for longer than three months
* clinical findings indicative of subacromial pain syndrome (evaluated by Hawkins-Kennedy sign, Neers sign, painful arch and Yokum test)
* normal passive range of motion of the shoulder

Exclusion Criteria:

* subjects unable to provide an informed consent
* lack of ability to complete the intervention
* full rupture of the tendon of m. supraspinatus
* planned shoulder surgery, or previous shoulder surgery on affected shoulder
* other musculoskeletal problem that could explain the symptoms
* adhesive capsulitis
* pregnancy
* rheumatoid arthritis
* symptomatic osteoarthritis of the shoulder/shoulder girdle
* glenohumeral instability
* widespread pain syndrome
* unstable underlying heart disease
* cortisone injections in the shoulder the last month
* allergies
* other serious mental or somatic disease (i.e. psychosis or active cancer disease).
Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment

The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.


Eligibility Criteria:
Inclusion Criteria:

* Frankl scale score 2.
* ASA I or II physical status.
* Dental intervention under local anesthesia not requiring more than 30 minutes.
* No previous dental experience.
* Parent/guardian's written consent.

Exclusion Criteria:

* Dental treatment indicated under general anesthesia.
* Presence of facial or nasal deformities.
* History of neurological or cognitive alterations.
* Mouth breathers
Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children

To evaluate the effect of probiotic gummies on serum metabolite levels, clinical efficacy, and regulation of gut microbiota in children with allergic rhinitis compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary, written, signed informed consent to participate in this study;
2. be able to complete the study in accordance with the requirements of the test protocol;
3. Age 4-14 years old;
4. Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);
5. Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes;
6. Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;

Exclusion Criteria:

1. Drugs that affect the intestinal flora (including antimicrobial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used continuously for more than 1 week within 1 month before screening;
2. Patients with pulmonary tuberculosis;
3. Combined with allergic asthma;
4. Those with nasal polyps or severe nasal septum deviation;
5. Patients with severe systemic diseases or malignant tumors;
6. Those with congenital genetic diseases and congenital immunodeficiency diseases;
7. Those who regularly use probiotics or prebiotics within 6 months before the screening period;
8. Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
9. Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
10. Patients with sinusitis, otitis media, or respiratory tract infection;
11. Those who are allergic to the probiotic-related ingredients used in this trial;
12. Those who stop taking the test sample or add other drugs in the middle of the test, and the efficacy cannot be judged or the data is incomplete;
13. Those who take items with similar functions to the test in a short period of time, which affects the judgment of the results;
14. Subjects who are unable to participate in the test due to their own reasons;
15. Subjects who are judged by other investigators to be insuitable to participate.
Characterization of Phenotypes of Occupational Asthma

The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patient
* Patient who performed a specific inhalation test with a positive result between January 2006 and December 2015.- Subject giving their consent for their participation
* Patient agreeing to use his data for research purposes

Exclusion Criteria:

* Patient objecting to the use of his data for research purposes
* Subjects under safeguard of justice
* Subject under guardianship or curatorship