cyrilzakka/clinical-trials huggingface dataset:
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.

This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.

There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.

Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females, \>/= 18 years of age.
2. Chronic spontaneous urticaria (CSU) \>/= 6 months prior to Screening (Visit 1).
3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

   1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
   3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to study treatment.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
7. Participants with and without prior biologic experience are eligible.

Key Exclusion Criteria:

1. Women who are pregnant or nursing.
2. Chronic urticaria whose predominant manifestation is due to CIndU.
3. Other diseases associated with urticaria.
4. Active pruritic skin condition in addition to CSU.
5. Medical condition that would cause additional risk or interfere with study procedures.
6. Known HIV, hepatitis B or hepatitis C infection.
7. Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
8. History of anaphylaxis.
9. Prior treatment with barzolvolimab.

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures

Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. The question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? Methods: The investigators carried out a single-centre retrospective study at Nice University Hospital.

From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients.

The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a coagulation test.

The imaging work-up systematically included MRI, unless contraindicated, in which case CT alone was performed.

Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic guidance. The systematic biopsy sample was then sent to the anatomopathology department for analysis.

Findings :

The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion.

All the incidental findings were haemopathies, including 4 myelomas and one lymphoma.

Conclusion :

These results highlight the good performance of MRI in distinguishing osteoporotic vertebral fractures from solid tumour metastases.

However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion.

The investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.


Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent a vertebroplasty with bone biopsy

Exclusion Criteria:

* non-vertebral bone biopsies
* not performed during vertebroplasty
The Efficacy and Safety of tDCS in Patients With Mild to Moderate Major Depressive Disorder

This study evaluated the effectiveness and safety of improving depressive symptoms by applying tDCS for 6 weeks to patients with mild to moderate depression.

Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5\~7 times a week and they were evaluated every 2weeks through questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of a major depressive disorder as confirmed by the DSM-V and MINI (without psychotic features)
* Patients with a K-BDI-II score of 14 or more and 28 or less
* In the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, Patients with sufficient drug treatment periods of at least 5 times the drug half-life.

Exclusion Criteria:

* Patients diagnosed with Axis I disorders other than major depressive disorder
* Patients diagnosed with other depressive disorders besides major depressive disorder
* Patients who have attempted suicide within 6 months of screening
* Patients who are considered to have problems with EEG and DC stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems
* Patients judged to have other reasons for prohibition of use of tDCS medical devices
* Patients currently taking antidepressants
National Survey on Hypertension

Describe the clinical characteristics of hypertensive patients aged of 75 years and older seen in general practitioner consultation according to their renal damage


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 75 years or older
* With a diagnosis of Hypertension treated or not, seen in general practitioner consultation
* Who has given his/her consent to participate to the study.

Exclusion Criteria:

* Patient who participated to a clinical trial
Feasibility Study on the Use of Redormin®500 on Day-time Cognition

Randomized, double-blind, parallel groups, placebo-controlled, baseline/run-in period of 21 days followed by trial period of 21 days, digital phenotyping (sleep, cognitive/psychological parameters and HRV).

The aim of this study is to determine the feasibility of investigating the effects of Redormin® 500 on day-time cognition and to assess psychological parameters (subjective cognitive performance, tiredness, mood, stress level, quality of life, motivation), in people with occasional sleep problems.

Sleep tracking data will be collected using consumer devices of the Charge series by Fitbit.

The overall objective of this study is to evaluate the feasibility of the planned study design and to evaluate the effect of Redormin® 500 on cognitive performance (reaction time, working memory) and psychological parameters with daily measures.

The primary objective of this study is to evaluate the feasibility of the study design to be able to design a confirmatory study.

The secondary objectives are to assess the influence of Redormin® 500 on cognitive performance (reaction time, working memory) and psychological parameters (subjective cognitive performance, stress levels, tiredness, mood, quality of life, and motivation; all of these measures with reference to the current day) with daily measures in the evening, and on sleep parameters and heart rate variability (HRV) as an objective measure for the stress level during day as assessed by the Fitbit tracker.

Safety objectives: Safety will be evaluated by obtaining and analysing adverse events during run-in period and treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male or female
* Age: 18-65 years old
* Occasional sleep problems (in average 1-2 nights per week, PSQI-score \>5) with accompanying subjective cognitive problems (in average at least on one day per week) in the last month
* Fluent in German
* Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

* DSM-V diagnosis of insomnia
* History of neurologic disorder
* Current psychiatric disorder
* Presence of moderately severe or severe depressive disorder (PHQ-9 ≥ 15)
* Current chronic intake of prescription drugs with psychotropic effects
* Current intake of OTC drugs for sleep or mood problems
* Presence of pain condition
* Diabetes mellitus
* Coronary Heart Disease
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

The aim of the current clinical investigation is to evaluate a new filter

The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age and have full legal capacity.
* Have given written informed consent.
* Be able to fill in the Case Report Form.
* Be ileostomy operated and have had a stoma for at least 6 months.
* Experience ballooning at least once per week.
* Be able to manage the bags themselves (application, removal).
* Be able to use a flat base plate.
* Have a stoma with a diameter less than 60 mm

Exclusion Criteria:

* Persons who irrigate
* Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* Pregnant or breastfeeding.
* Participate in other test at the same time.
Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease

The purpose of this study is to see whether power Doppler sonography (PDS) can be used to diagnose synovitis in patients with inherited bleeding disorders.

Aim #1 - To determine if PDS can be used to diagnose synovial hypertrophy and inflammation in joint disease associated with inherited bleeding disorders. MRI will be used as a reference standard.

Aim #2 - To determine if PDS can be used to assess therapeutic response to treatment.

Aim #3 - To determine if PDS can be used as a screening tool for diagnosing early synovitis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of inherited bleeding disorder

For Aim 1:

* Age of at least 6 years
* History of at least 4 bleeds in the same joint in the preceding 6 months
* Joint swelling, synovitis or deformity

For Aim 2:

* Meet inclusion criteria for Aim 1 and will be having a synovectomy

For Aim 3:

* Age of at least 1 year
* Have had at least 2 joint bleeds

Exclusion Criteria:

* Not meeting inclusion criteria
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration

This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.


Eligibility Criteria:
Inclusion Criteria:

* Women \>=18 years-old
* Presenting for a surgical abortion
* No contraindication to outpatient abortion
* No contraindication to gabapentin
* Fluency in English and able to provide informed consent

Exclusion Criteria:

* Allergy, sensitivity or contraindication to gabapentin
* Severe renal disease
* Currently using gabapentin or pregalabin
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.

This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years and less than 65 years
* Good general and mental health in the opinion of the investigator
* Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:

  (i) At least one of pain symptoms: sore throat, headache, or extremities pain (ii) Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or sneezing
* Onset of first symptoms of cold must have occurred within 48 hours of screening.

Exclusion Criteria:

* Pregnant or breast feeding women
* History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator
* Concurrent illness or medical history that is contraindicated or cautioned about in the drug label
* Anatomical factors causing nasal congestion
* Fever with body temperature \>38.5°C at baseline
* Have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours)
* Any medication that has potential drug-drug interactions with study medications
* Known or suspected intolerance or hypersensitivity to the study materials
* Have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse
Validating the Clinical Effect of a Knee Orthosis

The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem.

Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from medial gonarthrosis
* Receiving a regular model of the O3D orthosis

Exclusion Criteria:

* Suffering from tricompartmental gonarthosis
* Having completed the delivery appointment for a O3D orthosis
Management of Oxaliplatin-related Gastroesophageal Variceal Bleeding

In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Oxaliplatin is used as the first-line chemotherapy for colorectal cancer. However, oxaliplatin-induced hepatotoxicity could lead to sinusoidal injury and portal hypertension in the long term. Variceal bleeding, as the most common complication of portal hypertension, threaten these patents' life. Endoscopic treatment and Transjugular Intrahepatic Portosystemic Shunt (TIPS) are both recommended management of gastroesophageal variceal bleeding. In this randomized controlled study, we aim to compare the efficacy and safety of these two interventions in patients with oxaliplatin-induced gastroesophageal variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

1. Having received oxaliplatin-based chemotherapy for at least one cycle
2. History of variceal bleeding (including hematemesis or melena)
3. Portal hypertension confirmed by CT or MRI
4. Esophageal and / or gastric varices confirmed by endoscopy
5. Informed consent signed

Exclusion Criteria:

1. With serious life-threatening diseases of circulation / blood / respiratory system
2. With known causes of liver cirrhosis (hepatitis B, hepatitis C, autoimmune, schistosomiasis, non-alcoholic fatty liver disease, and etc.)
3. With contraindications of endoscopic treatments and TIPS;
4. Participation refused
Stress Level and the Relationship With IVF Outcomes.

The effect of stress on IVF outcomes.

The purpose of this study is to describe the pattern of psychological distress (depression, anxiety and stress) as assessed by both subjective and objective measures throughout the course of IVF treatment and to investigate its impact on IVF outcome.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women undergoing IVF at CRMI Ages 20-44

Patients will be divided in different groups depending on whether:

1. They are donating oocytes (control group).
2. They are undergoing IVF for the first time.
3. They are undergoing IVF for the third time and have either failed or succeeded the prior time.

Exclusion Criteria:

* Any patients who are not candidates for IVF
* Any women who have any past or current medical condition unrelated to their infertility concurrent to their history of infertility (e.g., gastrointestinal disease)
Evaluation of Low Phenylalanine Formulas

Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes.

Study Design This is a 2-stage, 15-week randomized crossover trial. The randomized crossover design was chosen as it reduces the influence of differences among individuals; and it offers statistical efficiency (requires fewer subjects than non-crossover designs).

In summary, 2 groups of 9 participants each will be assigned to either (1) sequence 1: take GMP-AA-based PS for the first 4 weeks and then take only L-AA-based Protein Substitute for 4 weeks, or (2) take only L-AA-based Protein Substitute for the first 4 weeks and then take GMP-AA-based PS for 4 weeks. At the end of the first 4 weeks, a 2-week washout period will follow with both groups only consuming L-AA-based PS. Randomization will be generated by a block randomization system and the random order will be kept within a sealed envelope.

Primary research objective The principal research objective of this study is to evaluate the effect on Phe levels of a low-Phe diet combined with a purified GMP-AA-based protein substitute (containing 1 mg Phe/g Protein Equivalent), in the treatment of paediatric patients with PKU.

Secondary research objectives The secondary objectives of the study aim to investigate whether there are any differences between the GMP-AA-based protein substitute and L-AA-based protein Substitute in the frequency and quantity of protein substitute intake, if any GI (gastrointestinal) symptoms occur with ingestion of the GMP-AA-based protein substitute, effect on satiety (hunger) and mood and any differences in anthropometric data.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PKU, aged 5 to 16 years of age, currently compliant with protein restricted diet and L-AA- and/or GMP-AA-based protein substitute willing to switch to a GMP-AA-based only product for 4 weeks.

  * 2 out of 4 last blood Phe levels within target range (i.e. 50%): Target range 120-360µmol/l \<12 years Target range 120-600µmol/l \>12 years

Exclusion Criteria:

* • Milk protein allergy

  * Pregnancy
  * Severe medical diagnosis not related to PKU
  * Treatment with Sapropterin hydrochloride (KUVAN)