cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma or ocular hypertension.
* Provided signed, written informed consent.
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Esketamine Combined With Dexmedetomidine Sedation in Head MRI Examination of Children With Autism Spectrum Disorder

Objective: To investigate the use of ketamine combined with dexmedetomidine for sedation in children with autism spectrum disorder, Methods:aged 2-6 years,, ASA grade I or II. The children were randomly divided into three groups using a random number table method: a low-dose dexmedetomidine group (DEXL group,n=100）The high-dose group of dexmedetomidine (DEXH group,n=100) and the group of esketamine combined with dexmedetomidine (DEXE group,n=100). The DEXL group received 2.5 μ g/kg of dexmedetomidine nasal drops, the DEXH group received 3 μ g/kg of dexmedetomidine nasal drops, and the DEXE group received 2 μ g/kg of dexmedetomidine nasal drops plus 0.5 mg/kg of ketamine nasal drops. Record the success rate of the first dose of nasal sedation, the onset time of sedation, the time of sedation recovery, the quality of recovery, and the satisfaction of the examining physician. Record the vital signs of three groups of patients during the examination process, including before sedation (T0), after successful sedation (T1), after the end of the examination (T2), and upon awakening (T3).

Autism Spectrum Disorder (ASD), also known as Autism Spectrum Disorder (ASD), is a condition in which approximately 60% to 70% of autistic children have intellectual disabilities that significantly affect their ability to take care of themselves and bring immense pressure to society and families. Autistic children often have neurological disorders, and therefore require head magnetic resonance imaging (MRI) examinations. MRI examinations can detect abnormal changes in brain structure and function, providing more objective evidence for early diagnosis and valuable treatment time for autistic patients. However, MRI examinations require children to maintain a calm and quiet state, minimizing physical activity as much as possible. Due to the specific interests and behaviors of autistic children, as well as their refusal to accept environmental changes, completing MRI examinations often requires sedation or anesthesia. The main drugs currently used for sedation in pediatric outpatient examinations include dexmedetomidine, midazolam, ketamine, etc. This study aims to select children with ASD who are scheduled to undergo head MRI in outpatient settings, and explore the safety and efficacy of intranasal administration of ketamine combined with dexmedetomidine for sedation, providing reference methods and evidence for sedation in children with autism spectrum disorder.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of autism spectrum disorder Aged 2-6 years, ASA grade I or II

Exclusion Criteria:

Upper respiratory tract infections, Severe respiratory system related diseases Congenital heart disease Liver and kidney dysfunction. Contraindications for ketamine and dexmedetomidine, Expected difficult airways. Anesthetic or sedative drugs used in the last week.
PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders

The goal of this project is thoroughly evaluate the added value of telemonitoring (TM) program for women at risk for gestational hypertensive disorders (GHD), by investigating it impact on prenatal follow-up, health outcomes for mother and child, costs and satisfaction, and by specifically investigating what are the major contributors to this added value.

A substudy (CAPROM) will be conducted at the Department of Obstetrics \& Gynecology at Ziekenhuis Oost-Limburg (ZOL) in collaboration with the Department of Physiology of Hasselt University in the framework of the Limburg Clinical Research Center (LCRC). CAPROM aims at evaluating the relationship between longitudinal (clinical) blood pressure measurements and changes in (subclinical) cardiovascular (CV) hemodynamics throughout pregnancy, as well as their responses to antihypertensive medication. To this end, CV profiling will be performed longitudinally on pregnant women at risk for developing GHD being included in the TM group of the PREMOM II study (group 1) or being followed-up via TM as part of their usual care (group 2). A separate ICF is signed for inclusion in the CAPROM substudy. The results of the CAPROM study will be performed by a researcher who is not involved in the PREMOM II main study. In addition, results of the CV profiling will not be communicated to the clinical decision makers of PREMOM II.


Eligibility Criteria:
Inclusion Criteria:

* a risk \> 1/100 on the Fetal Medicine Foundation (FMF) tool, which is used from the following website: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester
* CAPROM substudy: Pregnant women at risk for the development of GHD being followed-up via TM as part of the PREMOM II study (group 1) or usual care (group 2)

Exclusion Criteria:

* congenital malformations of the newborn,
* pregnant women who doesn't have a Smartphone,
* pregnant women \< 18 years old,
* pregnant women who doesn't understand the Dutch/French/English language. -
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.
* Participants who have documented PBC.
* Participants who have moderate to severe itch.

Exclusion Criteria:

* Total bilirubin \>2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures.
* Screening Alanine Aminotransferase (ALT) \> 6 times ULN in a single Baseline measure or ALT \> 5 times ULN using the average of two Baseline measures.
* Screening estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2).
* History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites).
* Presence of HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV and Ribonucleic acid \[RNA\] detected) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
* Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator´s clinical judgment.
* Current symptomatic cholelithiasis or cholecystitis.
* Current diagnosis of primary skin disorders with itch as a characteristic feature (e.g., atopic dermatitis, psoriasis).
* Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.
* Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening.
* Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study).
* Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching.
* Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening.
* Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study.
* History of sensitivity or intolerance to the study treatment.
One Year Clinical Evaluation of E-max CAD and Lava Ultimate Laminate Veneers

Restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (E.max) and hybrid ceramics (Lava Ultimate). The aim of this study is to compare both e.max and lava ultimate veneers clinically.

The use of E-max CAD well documented in the literatures as successful restoration modality which has superior optical and mechanical properties. The introduction of hybrid ceramic materials combined the advantages of both glass ceramics and composite resin. Resin nano-ceramic is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. The main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation.

Yet there are no studies for clinical evaluation of both mentioned laminate veneers restorations. This study is conducted to compare between both materials clinically according to modified USPHS criteria in terms of marginal adaptation, fracture, debonding, marginal discoloration and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Be physically and psychologically able to tolerate conventional restorative procedures.
3. Have no active periodontal or pulpal diseases, have teeth with good restorations.
4. Patients with teeth problems indicated for laminate veneer (e.g. discoloration, defect not involve more than 60% enamel loss, mild malposition, anterior upper....).
5. Be willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

1. Patients in the growth stage with partially erupted teeth.
2. Patient with fractured teeth of more than 60% enamel loss.
3. Patients with poor oral hygiene and motivation.
4. Pregnant women.
5. Psychiatric problems or unrealistic expectations.
6. Lack of opposite occluding dentition in the area intended for restoration.
Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)

This is a prospective, single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated TP53-mutated diffuse large B-cell lymphoma (DLBCL) patients.

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of selinexor in combination with R-CHOP for untreated TP53-mutated DLBCL patients.

The induction phase consisted of 8 cycles of selinexor in combination with R-CHOP. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted.

The primary endpoint is complete response rate.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Aged ≥18, and ≤70 years, no gender limitation.
3. Patient was histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) and had TP53 mutations.
4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
6. Expected survival ≥ 3 months.
7. Adequate function of bone marrow, liver, and kidney.

Key Exclusion Criteria:

1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients had previously received XPO1 inhibitors.
4. The patients have contraindications to any drug in the combined treatment.
5. Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B Surface Antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the further determination for Hepatitis B Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the assay) can be included. The patients with HBsAg and/or HBcAb positive need to receive anti-HBV drugs.
6. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired Immunodeficiency syndrome.
7. Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
8. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
9. Mentally ill persons or persons unable to obtain informed consent.
10. The investigators think that the patient is not suitable for the study.
the Effect of Dexmedetomidine in Coracoid Approach Brachial Plexus Block

Dexmedetomidine is an α-2 adrenoreceptor agonist and has been extensively used through intravenous infusion，in order to improved the quality of block in regional anesthesia. In this prospective, randomized study, the authors focus on the effect of dexmedetomidine mixed with ropivacaine in coracoid approach brachial plexus block.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I or II;
2. Aged 18-60 years;
3. The elbow, forearm, wrist or hand surgery

Exclusion Criteria:

1. History of allergy to local anesthetics;
2. Coagulation dysfunction, neuromuscular disease or local infection;
3. The operation time is longer than the local anesthetics effective time.
Feasibility Study of Family Teamwork Peer-Delivery

The purpose of this study is to 1) convene African American and Latino Community Coalitions to adapt Family Teamwork (FT) for school-age youth, and integrate FT with the Smart and Secure Children (SSC) program community-based, peer delivery format, 2) identify facilitators and barriers to parental involvement in diabetes management for African American and Latino parents of children (5-9 years) with T1D to refine, with Community Coalitions the adapted and integrated Family Teamwork- Peer Delivery (FT-P), and 3) evaluate the feasibility, satisfaction, and preliminary outcomes of the FT-P program among African American and Latino parents of school-aged children (5-9 years) withT1D.

A randomized pilot trials will be conducted with African American and Latino families to examine the feasibility, parent satisfaction, and preliminary outcomes of FT-P. Families will be stratified by race/ethnicity, age, and HbA1c strata, and randomized to FT-P plus standard diabetes care or to standard diabetes care alone after completion of baseline assessment using a random numbers table generated by a program created through Baylor College of Medicine's Institute for Clinical Training and Research data management specialists.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child ages 5-10 years with type 1 diabetes as defined by the American Diabetes Association criteria
* Having a child with diabetes duration of \>1 year
* Self-identified African American or Latino race/ethnicity
* Fluent in English
* Not planning to leave the geographic area during the study

Exclusion Criterion:

• Not fluent in English
Prevalence of Oral Disorders in Children in ENT Pathologies

Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). This first study will be carried out by passing the MCH (Montreal Children's Hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (Score \> 70).

Over a period of inclusion of 3 months, the doctors of the departement ONT, Robert Debré Hospital, will give written and oral information to the holders of parental authority and to the child at the beginning of the consultation. After a 15-minute reflection period (consultation time), if they agree to participate, parents will answer the doctor's questions and then complete the self-questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients consulting at ENT departement Robert Debré Hospital
* Age 0-17 years
* Parents and children informed and given their oral consent for the study and speaking french

Exclusion Criteria:

* Refusal of parents/children to participate
Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).

Observational, monocentric and prospective study. All patients with locally advanced cervix cancer will be underwent to radiochemotherapy followed by accelerated interventional radiotherapy (brachytherapy). Fist endpoints wer severe acute and late gastrointestinal, and urinary toxicities and sexual activity.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* ECOG 0-2
* Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix
* FIGO IB2 Stadium - IVA (staging 20018)
* No contraindications to performing MRI of the pelvis
* Informed consent

Exclusion Criteria:

* Age \<18 years
* PS \>2
* Previous cancer in the last 10 years
* Previous radiation treatment in the region of interest
* Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
* Presence of internal diseases that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
* Presence of distant metastases in sites other than the pelvic lymph nodes
* Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study
A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
* Must be willing and able to provide informed consent and to participate in all study procedures
* Must be in generally good health
* Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

* On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
* Use of any investigational drug within 30 days of the first visit
* Any nasal surgery or sinus surgery within the previous year
* Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
* Women who are pregnant or nursing
* Women who are not using an acceptable method of birth control
* Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
* Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
* Patients with Arrythmia
* Patients with know history of alcohol and drug abuse
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
* Use of medications that could affect the study results
Introvision for Migraine and Headaches

To evaluate the effect of Introvision, a mental and emotional self-regulation-technique developed by Angelika C. Wager, as migraine preventative compared to a waiting list group.

Randomized, single-center, waiting-list control group study: Introvision as preventative in Migraine

Randomized, single center, waiting-list group control study to evaluate the effect of Introvison, a mental and emotional self regulation method to reduce headache days in patients with migraine, migraine and tension type headache and chronic migraine. The number of headache days 3 months after completion of the last session of Introvision will be compared with the number of headache days of the waiting list group in the month before the course to learn Introvision.

Eligibility Criteria:
Inclusion Criteria:

* Episodic migraine with at least 5 headache days per month, episodic migraine and tension type headache with at least 5 migraine headache days per month, chronic migraine
* Stable prophylactic headache medication
* Stable non-medication headache prophylaxis (sports, relaxation techniques, ...)
* Informed consent

Exclusion Criteria:

* Other causes of headache, symptomatic headaches
* Other primary headaches such as Cluster headache, trigeminal neuralgia, idiopathic facial pain, new daily persistent headache
* Severe depression (more than 13 points in the Beck Depression inventory fast screen (BDI-FS)
* Drug - or alcohol abuse
* Non-compliance, especially significant missing entries in the headache diaries
* Active psychosis
Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.

The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.

Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.

The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients with right colonic cancer

Exclusion Criteria:

* Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)