louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05639959: Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
Official title: Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rhinosinusitis
Lead sponsor: Saffron Pharma
Sponsor class: INDUSTRY
First posted: 2022-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages Eligible for Study: 10 Years to 50 Years older Sexes Eligible for Study: All Accepts Healthy Volunteers: No Children and adults of any age who had a diagnosis of rhinitis sicca, symptoms of dry nose brought on by the use of specific drugs, or who were receiving concurrent treatment for allergies or rhinosinusitis were eligible for the study

Brief summary: Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.

Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.

Detailed description: Background Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.

Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.

Eligibility criteria: Inclusion Criteria:

1. Children and adults of age (10-50) who had a diagnosis of rhinitis
2. Ability and willingness to understand and provide informed consent.

Exclusion Criteria:

1. Known current pregnancy.
2. Current hospitalization.
3. Unable to complete online questionnaires or adhere to study requirements.
4. Kidney failure or dialysis; severe liver disease or cirrhosis.
5. Any parathyroid conditions.
6. Known current pregnancy.
7. History of SARS-CoV-2 infection.

Primary outcomes:
measure: congestion
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Saffron Pharmaceutical
state: Punjab
Study officials:
References:
Clinical trial NCT01798459: The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
Official title: A Double Blind Randomized Crossover Study of the Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Methylphenidate
Placebo
State anxiety
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.

Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of age.

Structure: the study is a randomized double blind crossover study. The subjects will complete a continuous performance test, the cambridge neuropsychological test automated Battery, before and after given methylphenidate or placebo on the first day of the study. On the second day of the study, the subjects will receive either methylphenidate or placebo based on what was given on the first day of the study and they will complete the same task.


Eligibility criteria: Inclusion Criteria:

* Attention deficit and hyperactivity disorder
* Children aged 8-18 years

Exclusion Criteria:

* Pervasive developmental disorder
* Schizophrenia
* Bipolar disorder
* Current depressive episode
* Current Anxiety disorder
* Drug use during the past 6 months

Primary outcomes:
measure: State anxiety
timeFrame: 1 year
Secondary outcomes:
measure: Cognitive function
timeFrame: 1 year
measure: Patient's perspective
timeFrame: 1 year
Other outcomes:
Locations:
city: Hod-hasharon
country: Israel
facility: Shalvata
Study officials:
affiliation: Shalvata Mental Health Center
name: Maya Kritchman Lupo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kritchman M, Koubi M, Mimouni Bloch A, Bloch Y. Effect of Methylphenidate on State Anxiety in Children With ADHD-A Single Dose, Placebo Controlled, Crossover Study. Front Behav Neurosci. 2019 May 15;13:106. doi: 10.3389/fnbeh.2019.00106. eCollection 2019.
Clinical trial NCT02018159: An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 738
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seeking fertility treatment

Brief summary: This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.


Eligibility criteria: Inclusion Criteria:

* Age 21-45 years
* In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
* Receiving follicle stimulation with Menopur 600/1200 IU

Primary outcomes:
measure: Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells
timeFrame: 1 week after oocyte retrieval
measure: Incidence of uneven blastomeres at the 2 and 4 cell stage
timeFrame: 1 week after oocyte retrieval
measure: Incidence of bi- and multinucleation at 2 cell and 4 cell stage
timeFrame: 1 week after oocyte retrieval
measure: Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage
timeFrame: 1 week after oocyte retrieval
Secondary outcomes:
measure: Positive serum human Chorion Gonadotrophin (hCG) rate
timeFrame: 13-15 days after transfer
measure: Implantation rate
timeFrame: 5 weeks after transfer
measure: Clinical pregnancy rate
timeFrame: 7 weeks after transfer
measure: Ongoing pregnancy rate
timeFrame: 10 weeks after transfer
measure: Live birth rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT04768959: Cultivating Well-being in Severe Psychiatric Conditions
Official title: Cultivating Well-being Beyond Symptomatology in Severe Psychiatric Conditions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wellbeing
Keywords: schizophrenia
severe psychiatric conditions
wellbeing
RCT
positive psychology
third-generation psychotherapy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The multicomponet psychological intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with severe psychiatric conditions. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention) with the post-intervention measures of the control group (treatment as usual + waiting list).


Eligibility criteria: Inclusion Criteria:

* 1) were aged 18-65 years
* 2) had a minimum of motivation and commitment to participate in group therapy

Exclusion Criteria:

* 1) limited cognitive resources or serious formal thinking disorder and/or
* 2) a concurrent diagnosis of substance dependence or a severe personality disorder that could interfere with benefiting from a psychotherapy group.

Primary outcomes:
measure: Well-being
timeFrame: Change from Well-being at 12 weeks and 6 months
measure: Well-being
timeFrame: Change from Well-being at 12 weeks and 6 months
Secondary outcomes:
measure: Self-esteem
timeFrame: Change from self-esteem at 12 weeks and 6 months
measure: Attachment
timeFrame: Change from Attachment at 12 weeks and 6 months
measure: Psychological Symptoms
timeFrame: Change from Psychological Symptoms at 12 weeks and 6 months
measure: Experiential Avoidance
timeFrame: Change from Experiential Avoidance at 12 weeks and 6 months
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: Carmen Valiente
state: Madrid
Study officials:
References:
Clinical trial NCT03452059: Evaluation of the Effectiveness and Safety of AI-Robotics
Official title: Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Motor Dysfunction, Spinal Cord Injury
Keywords: Paralysis
Lower Extremities
Ai-Robotics
Lead sponsor: AI-Robotics Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot

Detailed description: Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot developed by AI-Robotics Technology Co., Ltd., Beijing for who had lower limb paralysis

Eligibility criteria: Inclusion Criteria:

1. more than18 but less than 60 years old，less than 80 kilos of weight，Gender is not limited
2. Confirmed by MR/CT，AIS spinal cord injury grade: A-C level (without walking ability)：Damage plane T6-L2
3. The muscle tension of the modified Ashworth grade level is less than or equal to 2
4. The range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint Neutral position
5. Upper limb strength and physical strength are sufficient to stabilize the crutches
6. Patients are able to understand and actively participate in the training program, agree and sign the informed consent form

Exclusion Criteria:

1. The range of motion of the joints is severely limited and the walking action is limited
2. Spinal fractures are not completely healed, the clinical situation is unstable; if not fully confirmed,please go department of orthopedics or other clinical departments for diagnosing
3. Skin injury or infection of the lower extremities or the part of wearing robot
4. Unstable angina, severe arrhythmia and other heart diseases
5. Severe chronic obstructive pulmonary disease
6. Unilateral neglect
7. Severe cognitive or visual impairment
8. Other contraindications or complications that may affect walking training
9. Pregnant or lactating women
10. The investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements

Primary outcomes:
measure: Walking efficiency
timeFrame: 6 minute
measure: Walking efficiency
timeFrame: 6 minute
Secondary outcomes:
measure: Cardiovascular response
timeFrame: during 6 minute walk test and right before the 6MWT
measure: efficiency of put on or take off the Ailegs/Aiwalker/HKAFO
timeFrame: immediately before beginning (pre-) and immediately after finishing (post-) each of 6 minute walk test
measure: RPE questionaire
timeFrame: after 6 minute walk test
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01578759: Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Official title: Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Hysterectomy
Keywords: ovarian function tests
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the feasibility of performing a randomized clinical trial evaluating the effect of salpingectomy (removal of the fallopian tubes) during laparoscopic hysterectomy on ovarian function. The hypothesis is that removal of the tubes can prevent diseases of the fallopian tubes such as infection, hydrosalpinx (fluid-filled tubes)and additional invasive procedures such as further imaging work-ups and further surgery related to the tubes.


Eligibility criteria: Inclusion Criteria:

* Women ages 18-45 scheduled for laparoscopic hysterectomy with planned preservation of both ovaries.

Exclusion Criteria:

* Carrier for the gene that codes for breast cancer type 1 susceptibility protein (BRCA1) or the gene that codes for breast cancer type 2 susceptibility protein (BRCA 2).
* Personal history of gynecologic cancer
* Pregnancy
* Non-English speaking
* Unable to provide informed consent

Primary outcomes:
measure: Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH)
timeFrame: AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.
Secondary outcomes:
measure: Patient demographics
timeFrame: Prior to surgery
measure: Patient surgical outcomes
timeFrame: Postoperatively on day 1
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Division of Advanced Laparoscopy and Pelvic Pain, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Austin Findley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Findley AD, Siedhoff MT, Hobbs KA, Steege JF, Carey ET, McCall CA, Steiner AZ. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril. 2013 Dec;100(6):1704-8. doi: 10.1016/j.fertnstert.2013.07.1997. Epub 2013 Aug 29.
Clinical trial NCT01856959: Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4
Official title: Response of Asthmatic Children's Lung Function to Nebulized Magnesium Sulfate After Acetylcholine Provocation Test: a Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: magnesium sulfate
nebulized
lung function
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 330
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As a non-selective bronchodilator, magnesium sulfate (MgSO4) is effective when administered intravenously in the treatment of the patients with acute severe asthma not responding to conventional therapy (oxygen, nebulized salbutamol, and corticosteroids), which can resulted in earlier improvement in clinical signs and symptoms of asthma and PEF. However, the use of intravenous MgSO4 administered is not common in clinical practice, because it's prone to have adverse effects and side effects such as nausea, vomiting, facial flushing, hypotension, decreased tendon reflexes and so on with this treatment. The aerosolised route offers the advantage of lower dosage, a shorter time of drug being delivered to the airway smooth muscle and lower incidence of side effects when compared to the intravenous route. At present, there are only a few studies about the effects of nebulized MgSO4 in the treatment of acute asthma in children, and the conclusions are controversial.


Eligibility criteria: Inclusion Criteria:

* known cases of controlled bronchial asthma
* ≧4 years of age
* the result was positive after acetylcholine provocation test in follow-up visit

Exclusion Criteria:

* had received corticosteroids (inhaled or systemic) or β2-agonists or theophyllines before the clinic day
* had fever (axillary temperature\>38.5℃)
* history of chronic disease like bronchopulmonary dysplasia or cystic fibrosis
* history of renal insufficiency and known allergy to acetylcholine, albuterol or magnesium

Primary outcomes:
measure: changes of lung function after interventions
timeFrame: 10 min and 20 min post-dose
Secondary outcomes:
measure: effectiveness of nebulized magnesium sulfate alone
timeFrame: 10 min and 20 min post-dose
measure: the number of patients with adverse events as a measure of safety and tolerability
timeFrame: 20 min
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Center of Respiratory Disorders,Children's Hospital,Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Chongqing Medical University
name: Jihong Dai, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01855100: Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto Following an Acute Deep Vein Thrombosis (DVT)
Official title: Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Keywords: Treatment of acute deep vein thrombosis
Prevention of recurrence
Oral anticoagulation
Real-life setting
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2013-05-16
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory or hospitalized patients coming from the vascular diseases clinic of the participating hospitals

Brief summary: The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with acute deep vein thrombosis treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a diagnosis of deep vein thrombosis (DVT) within the past 9 months, enabling at least 3 months of therapy

Exclusion Criteria:

* Patients who do not fulfil the Belgian reimbursement criteria of deep vein thrombosis (DVT)

Primary outcomes:
measure: Number of patients with major bleedings
timeFrame: up to 1 year or 30 days after end of rivaroxaban
measure: Number of patients with symptomatic recurrent Venous Thrombus Embolism (VTE)
timeFrame: up to 1 year or 30 days after end of rivaroxaban
measure: All-cause mortality
timeFrame: up to 1 year or 30 days after end of rivaroxaban
measure: Adverse events
timeFrame: up to 1 year or 30 days after end of rivaroxaban
measure: Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)
timeFrame: up to 1 year or 30 days after end of rivaroxaban
measure: Quantities of resource use consumption
timeFrame: up to 1 year or 30 days after end of rivaroxaban
Secondary outcomes:
Other outcomes:
Locations:
city: Many locations
country: Belgium
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01710800: Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy
Official title: Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Keywords: impedance
reflux
GERD
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2012-10-19
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.


Eligibility criteria: Inclusion Criteria:

* All adults patients (age 18 or older) with reflux symptoms willing to participate

Exclusion Criteria:

* Pregnancy
* Prior esophageal or gastric surgery
* Achalasia
* Scleroderma
* Gastroparesis.

Primary outcomes:
measure: Number of Impedance Episodes Following PPI and Placebo
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Moawad FJ, Betteridge JD, Boger JA, Cheng FK, Belle LS, Chen YJ, Maydonovitch CL, Wong RK. Reflux episodes detected by impedance in patients on and off esomeprazole: a randomised double-blinded placebo-controlled crossover study. Aliment Pharmacol Ther. 2013 May;37(10):1011-8. doi: 10.1111/apt.12301. Epub 2013 Apr 7.