cyrilzakka/clinical-trials huggingface dataset:
Performance and Safety of Lubri-cream for Pain Minimization During Urethral Catheterization and Cystoscopy

The primary aim of this study is to collect clinical data on the performance of Lubri-cream applied in routine clinical practice.

Safety and efficacy parameters of Lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.

The study is designed as a prospective, multicenter, single-group, observational study to evaluate Lubri-cream for urethral catheterization and cystoscopies lubrication. At least 2 different centers located in Spain will participate.

It is primarily aimed to collect data on the performance of the product under investigation in a large patient population when used in routine clinical practice. Safety and performance of Lubri-cream will be assessed to study the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Any patient who needs urethral catheterization or cystoscopy (rigid or flexible).
* Signed informed consent

Exclusion Criteria:

* Contraindications as stated in the Instructions for Use
* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures
* Inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the Investigational Product.
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)

This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of venetoclax (ABT-199) in combination with posaconazole.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
* Subject must have received no prior treatment for AML with the exception of hydroxyurea
* Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects greater than or equal to 60 to 74 years of age
* Subject must have adequate kidney and liver function as described in the protocol

Exclusion Criteria:

* Subject has received treatment with the following hypomethylating agent and/or chemo therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have been treated with other agents for AHD i.e., Myelodysplastic syndrome \[MDS\])
* Subject has history of Myeloproliferative Neoplasm (MPN).
* Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version 2, 2014 for AML.
* Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.
* Subject has acute promyelocytic leukemia.
* Subject has known active central nervous system involvement with AML.
* Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
* Subject has a history of other malignancies prior to study entry, with the exception of:

  * Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
* Subject has a white blood cell count \> 25 × 10\^9/L. Note: Hydroxyurea is permitted to meet this criterion.
Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers

The main objective of this research is to develop and validate a technology-based solution that addresses the diminished mobility, increased fall risk and impaired cognitive function that are so common among older adults, enabling them to live longer successfully and independently.

A comprehensive system will be developed to promote mobility, enhance cognitive function, reduce sedentary behavior, increase independence and encourage social inclusion. This novel system will have two distinct yet complementary features: monitoring and treatment that will serve as an "all in one system". The system will consist of wearable sensors and a proprietary developed application. The wearable inertial sensors will measure the acceleration and orientation of the feet during movement. The sensors will feed real-time data to the system, which will process this data using a set of proprietary algorithms enabling continuous monitoring of activity, gait and fall risk, and independence. In addition, designated applications for direct cognitive assessment and training of older adults in their home and community environment will also be used via the Smart phone or mobile tablet. The training, both physical and cognitive, will also include multi-user interactions .Data collected by the system will be processed and integrated to provide comprehensive feedback from multiple domains to the user, caregiver and clinician by way of recommendations and personalized treatment goals.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 65-85 years
* History of 1 fall or more in the year prior to the study.

Exclusion Criteria:

* Signs of dementia : Montreal Cognitive Assessment (MoCa) \<21 and/or mini mental state examination(MMSE) \<24.
* Psychiatric co-morbidities :major depression as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria
* Co-existing somatic disorders
* History of stroke
* Neurologic disorders that interferes with normal walking (e.g., Parkinson's disease or Alzheimer's disease),
* Cannot walk without assistance,
* Severe head trauma or brain tumor,
* Severe hearing or visual loss (determined by the visual acuity test),
* Cardio-vascular contradictions (as determined by a physician),
* Inability to use a Smart phone because of visual and manual impairment or have unstable medical conditions.
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants

The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).

Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).

Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject
* Body Mass Index (BMI) between 21.0 and 29.9 kg/m\^2, both inclusive
* Body weight of at least 70.0 kg
* Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent
* Further inclusion criteria apply

Exclusion Criteria:

* History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
* Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg
* Symptoms of arterial hypotension
* Further exclusion criteria apply
Identifying Genetic Causes of IC/BPS

Interstitial cystitis (IC), also called Bladder Pain syndrome (BPS) is a common condition with no known cause or cure. Twin studies and family accounts have suggested that the condition may be genetic or passed down (inherited) from one generation to another.

In this study, we are collecting genetic material via blood or saliva and medical information from families in North America in an attempt to identify genetic factors that may cause IC/BPS. We are enrolling inviduals with IC/BPS and their family members (family members with and without IC like symptoms). Travel to Boston not required.

We are trying to identify a genetic cause of interstitial cystitis (IC)/bladder pain syndrome (BPS). We are looking to enroll individuals with a clinical diagnosis of IC/BPS and their family member. We are attempting to determine if there is a connection between symptoms of IC/PBS and changes in specific genes or a pathway of connected genes. We will use several genetic technologies including but not limited to; linkage analysis, genome sequencing, RNAseq and candidate gene studies to try to identify the cause of IC/BPS. Once we identify the cause of IC/BPS we will be able to identify and design more effective treatments for affected individuals. We are looking for families with IC/BPS symptoms to give a DNA sample (from blood/saliva), urine samples, and answer several questionnaires. Travel to Boston NOT necessary.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IC/BPS
* Males and females of any age
* Urinary frequency - more than 1X/hour, and/or
* Dysuria, and/or
* Pelvic, suprapubic, or abdominal pain - for 3 months or longer
* Nocturia
* Normal urinary stream (by history)
* No evidence of active bacterial UTI (no pyuria \& negative urinary culture for last 3 months)
* First degree relative of someone with above symptoms

Exclusion Criteria:

* Major structural/anatomical urinary tract abnormalities by ultrasound
* Underlying inborn conditions affecting the urinary tract
* Surgery/chemotherapy affected pelvic area
* GI or GU cancers
* Severe Constipation in children only
Influence of Hawthorne Effect and Dual-tasks on Gait in CP

It is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. Possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the Hawthorne effect), and the lack of dual-tasks (DT) during the analysis (which are common during daily life walking). Since so far there is no technique to reliably measure gait kinematics in children with CP outside of the laboratory, the researchers aim to objectify the influence of both the Hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3D gait analysis.

Study design: Observational study

Study population: Patients with cerebral palsy, bilateral spastic, knee flexion gait pattern, GMFCS classification I-III, age 4-16 years.

Objective: To determine the effect of observational awareness (the Hawthorne effect) and dual-tasks on spatiotemporal and kinematic variables during a clinical 3D gait analysis.

Primary research question:

Does reduced observational awareness and/or introduction of a dual-task influence knee flexion in stance phase in children with spastic diplegie cerebral palsy and knee flexion gait?

Secondary research questions:

1. Does reduced observational awareness and/or introduction of a dual-task increase toe walking in children with spastic diplegie cerebral palsy and knee flexion gait?
2. In children with spastic diplegic cerebral palsy and knee flexion gait, do spatiotemporal gait parameters change when observational awareness is reduced and/or a dual-task is introduced?

Conditions in which gait data will be gathered:

1. With awareness of observation + without Dual-task
2. With awareness of observation + with Dual-task
3. Without awareness of observation + without Dual-task
4. Without awareness of observation + with Dual-task

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy, bilateral spastic, GMFCS classification I-III
* Age \<16 years
* Use of bilateral AFO's (rigid or ground reaction AFO's) to improve knee extension in stance

Exclusion Criteria:

* Behavioural issues or poor instructability which might affect participation in the protocol
* Significant visual disorders
* Other diagnoses influencing gait
* Not willing to sign informed consent before inclusion
Effectiveness and Safety of Lactobacillus Rhamnosus Lcr35® in the Treatment of Recurrent Aphthous Stomatitis

Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe side effects or inconstant effectiveness. The aim of this study is to assess the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3 months.All patients will be then followed up for additional 3months without treatment. The main outcome measure will be the number of occurring aphtae.

Recurrent aphthous stomatitis (RAS) is the most common chronic disease of the oral cavity, affecting 5-25% of the population. This condition is characterized by recurrent and painful oral ulcers. The discomfort of RAS can impact negatively on quality of life that is why the therapeutic demand is strong. Currently, there is no curative treatment for RAS, and suspensive treatments such as colchicine and thalidomide are no definitive or can induce severe side effects. The pathophysiology of RAS remains largely unknown. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Increasing data underline the potential interest of using probiotics in conditions due to microbiota disorder. To the best of our knowledge, no study has evaluated the effectiveness of probiotic in RAS. The main objective of this double blind clinical trial is to evaluate the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35®, in the treatment of RAS in adults. 40 patients suffering from minor RAS for 6 months will be included and randomly assigned to 2 group of 20. Patients of group A will took the Lactobacillus rhamnosus Lcr35® orally daily for 3 months and patients of group B will took the placebo similarly. All patients will be then followed up for 3 additional months without treatment. The primary outcome measure will be the monthly number of aphthae occurring during the 3 months of treatment. The secondary outcomes measures will be the monthly number of aphthae occurring during the 3 months of follow up, the pain reduction, the impact on quality of life according to the OHIP-14 score and the side effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 year-old or more
* Recurrent idiopathic aphtous stomatitis with at least one new lesion per month during the past 6 months.

Exclusion Criteria:

* Symptomatic aphtosis associated with Crohn or Behcet disease
* Concomitant use of probiotic for any other reason
* Systemic use of colchicine or steroids or immunosuppressive drugs during the past 3 months
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.

Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.

In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.

In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.


Eligibility Criteria:
Inclusion criteria:

1. Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be \>=90 and \<=114 mmHg and mean seated systolic blood pressure (SBP) must be =\<200 mmHg
2. Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
3. Age 20 years or older

Exclusion criteria:

1. Patients with known or suspected secondary hypertension
2. Patients with clinically relevant cardiac arrhythmia
3. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
4. Patients with recent cardiovascular events
5. Patients with recent stroke events
6. Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
7. Patients with hepatic and/or renal dysfunction
8. Pre-menopausal women who are nursing or pregnant
Live Your Life Without Diabetes

Aim: To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes.

Methods: A randomised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose: 6.1-6.9 mmol/l and/or HbA1c : 6.0-\<6.5% (42- \< 48 mmol/mol) recruited from general practice in Holstebro, Denmark. Participants were randomised to a control group or to receive the intervention delivered over four 2 h group sessions during five weeks, and two further sessions after one and six months. Questionnaire data and clinical measures were collected at baseline, three months and one year after intervention.


Eligibility Criteria:
Inclusion Criteria:

* resident in the Municipality of Holstebro
* aged \<70 years
* a measurement of fasting plasma glucose: 6.1-6.9 mmol/l (the thresholds for Impaired Fasting Glucose according to clinical guidelines) and/or HbA1c : 6.0-\<6.5% (42- \<48 mmol/mol) within the previous six months.

Exclusion Criteria:

* none
Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

No study have evaluated the efficacy and safety of airway clearance therapy (ACT) and bronchoalveolar lavage (BAL) under bronchoscope for bronchiectasis.

This study aimed to evaluate the clinical efficacy and safety of tran-bronchoscopy airway clearance and bronchoalveolar lavage in the treatment of moderate to severe bronchiectasis with acute exacerbation:A randomized, prospective cohort study.

The aim of this study was to evaluate the efficacy and safety of ACT combined with BAL for bronchiectasis patients with acute exacerbation through the whole study process, which will provide a high quality of evidence-based strategies for the treatment, revision and optimization of international and domestic clinical guidelines for bronchiectasis. All the participants will be required to check the various efficacy and safety indicators.

Eligibility Criteria:
Inclusion Criteria:

* Willing to join in and sign the informed consent form;
* The diagnosis of bronchiectasis need reference to the definition of "European Respiratory Society guidelines for the management of adult bronchiectasis." published by the european respiratory journal in 2017, defined by the presence of both permanent bronchial dilatation on computed tomography (CT) scanning and the clinical syndrome of cough, sputum production and/or recurrent respiratory infections;
* Pulmonary exacerbation in patients with bronchiectasis was required to meet three or more of the following key symptoms for at least 48h: Cough; Sputum volume and/or consistency; Sputum purulence; Breathlessness and/or exercise tolerance; Fatigue and/or malaise; Haemoptysis, and a clinician determines that a change in bronchiectasis treatment is required;
* According to the researchers, the subjects were willing and able to follow the protocol and were able to tolerate bronchoscopy;
* Patients with good compliance: the subject must be willing to follow the test plan requirements in the research center to complete all the assessment of the visit.

Exclusion Criteria:

* Pregnant or lactating women;
* Hypogammaglobulinemia or other autoimmune diseases;
* Clinical diagnosis of ABPA;
* Non tuberculosis mycobacteria positive 2 years before;
* Allergies or allergic to a variety of drugs;
* Poor compliance or can not cooperate judged by doctors;
* Participated in other clinical trials for nearly three months;
* The researchers considered that the subject had other circumstances that were unfit to attend;
* Suffering from a significant disease or condition outside of bronchiectasis, as judged by the researchers, may lead to subjects at risk due to participate in the study,or the disease that have an impact on the research result and the ability of subjects to participate in this study;
* Bronchoscopy contraindication;
* Patients with heart, liver and kidney, nervous system, endocrine and other systemic diseases, may not be able to adhere to the completion of the study, or will affect the research process;
* Patients who refused to sign informed consent after targeted explanation.
Effect of Cryotherapy on Postoperative Pain in Vital Pulp Treatment of Molar Teeth

The goal of this clinical trial was to evaluate the effect of cryotherapy with salin solution on the intensity of postoperative pain after total pulpotomy procedures in molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

- Does controlled irrigation with cold saline in total pulpotomy reduce the severity of postoperative pain? In the cryotherapy group, unlike the control group, after hemostasis was achieved, the coronal pulp cavity was irrigated with 2 °C saline solution for 5 minutes.


Eligibility Criteria:
Inclusion Criteria:

Teeth with

* moderate or severe pain
* diagnosed with symptomatic irreversible pulpitis
* no tenderness to percussion and palpation
* positive response to cold test and electric pulp test
* no signs of periapical pathology

Exclusion Criteria:

Teeth which

* could not be restored or required post-core
* had periapical lesions,
* had poor periodontal status (pocket depth\> 4 mm),
* had negative responses to pulp sensitivity tests,
* had no pulp exposure after caries removing Patients who
* had no preoperative pain or had mild preoperative pain
* had bleeding disorders
* had systemic diseases such as immunosuppressive disease or diabetes