louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03917602: Human Amniotic Membrane Plug for Large Macular Holes
Official title: Human Amniotic Membrane Plug for Large Macular Holes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Keywords: Human amniotic membrane; large macular holes
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.

Detailed description: This is a prospective, interventional, consecutive case series conducted in Alexandria university. The aim of the study is to evaluate the therapeutic efficacy of human amniotic membrane in promoting closure of large macular holes.

Included participants with large macular holes will undergo complete vitrectomy is performed with an accurate vitreal base shaving (Constellation; Alcon Surgical). A human amniotic membrane hAM plug is taken from the hAM patch, and the final dimensions are adjusted with vitreoretinal scissors before insertion into the vitreous. The hAM plug is rolled inside the vitreoretinal forceps and inserted through the trocar into the vitreous. Then the human amniotic membrane is transplanted through macular hole into the subretinal space; it is then spread to cover the entire portion of the hole. Afterward, perfluorocarbon is injected to a complete overfilling of the break to permit good adhesion of the hAM plug to the underlying RPE and the overlying retina. Fluid-air exchange and an endotamponade injection is performed at the end of surgery.

Eligibility criteria: Inclusion Criteria:

* large macular hole confirmed by optical coherence tomography

Exclusion Criteria:

* patients who had diabetic retinopathy, vascular occlusion, retinal neovascularization, inflammatory disease and optic atrophy

Primary outcomes:
measure: closure of the macular hole
timeFrame: at the 6 month follow up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT00641602: A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
Official title: A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erosive Esophagitis
Keywords: Erosive Esophagitis
Nexium
Heartburn
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole


Eligibility criteria: Inclusion Criteria:

* Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.
* Confirmed Erosive Esophagitis within 1 week prior to starting the study.

Exclusion Criteria:

* Any signs of gastrointestinal bleeding at the time of the starting the study.
* Any previous gastric or esophageal surgery.
* Various gastrointestinal diseases as listed in the protocol.

Primary outcomes:
measure: To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.
timeFrame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
Secondary outcomes:
measure: 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.
timeFrame: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
measure: 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.
timeFrame: Dairy card to be completed by patient daily
measure: To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.
timeFrame: Adverse event collection on an ongoing basis
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT03211702: Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma Patients-2 (GERIAD2)
Official title: Multi-center, Prospective Cohort Study-II to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP (GERIAD2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Large B-cell, Diffuse
Keywords: geriatric assessments
diffuse large B-cell lymphoma
activity of daily living
instrumental activity of daily living
Charlson's comorbidity index
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
name: Kyungpook National University Hospital
name: Keimyung University Dongsan Medical Center
name: Korea University Anam Hospital
name: Korea University Guro Hospital
name: Kosin University Gospel Hospital
name: Pusan National University Hospital
name: Soonchunhyang University Hospital
name: Ajou University School of Medicine
name: Chonnam National University Hospital
name: Chungnam National University Hospital
name: Yeungnam University Hospital
First posted: 2017-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly DLBCL patients (≥ 65 years) treated with R-CHOP

Brief summary: This study will validate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed CD20+ DLBCL
* 65 years old or over
* Scheduled to receive R-CHOP chemotherapy
* Informed consent

Exclusion Criteria:

* Other histology than CD20+ DLBCL
* Primary central nervous system DLBCL
* Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer \[papillary or follicular thyroid cancer\]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry
* Consent withdrawal

Primary outcomes:
measure: Event-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
measure: Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation
timeFrame: 1 year
Other outcomes:
measure: Average received ralative dose intensity
timeFrame: 6 months
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
References:
Clinical trial NCT03335202: Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
Official title: Longitudinal Analysis of Respiratory and Intestinal Microbiome in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: respiratory and intestinal microbiome
antibiotic therapy
cftr modifier
diversity
Lead sponsor: University of Kiel
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel

Brief summary: Respiratory und intestinal microbiome will bei analyzed during a period of 6 months. In a retrospective analysis it will be looked for correlations between microbiome and cf therapy (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump Inhibitors, enzymes, nutritional habits), clinical status and self reported outcome.

Detailed description: DNA will be isolated from sputum, throat swabs and stool samples and used for the generation of microbial profiles. Both bacterial and fungal profiles will be analyzed by next generation sequencing.

Clinical outcome parameters (lung function test, weight, calprotectin, elastase, blood parameters, self reported outcome) will be recorded and analyzed along with medication.

Eligibility criteria: Inclusion Criteria:

* subject has confirmed diagnosis of cystic fibrosis (sweat chloride \>60mmol/l and/or 2 mutations in the cftr gene known to cause cystic fibrosis)
* subject is able to perform informed consent

Exclusion Criteria:

* inability to give informed consent
* antibiotic therapy in the last 4 weeks prior to study start (exception: long term azithromycin therapy, long term antistaphylococcal therapy, long term inhaled antibiotics)

Primary outcomes:
measure: respiratory microbiome
timeFrame: 24 weeks
measure: intestinal microbiome
timeFrame: 24 weeks
Secondary outcomes:
measure: Forced Exspiratory Volume FEV1 [%pred]
timeFrame: 24 weeks
measure: weight (kg)
timeFrame: 24 weeks
measure: Quality of life [score]
timeFrame: 24 weeks
measure: Quality of life [score]
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Klinik für Innere Medizin I, UKSH KIel
state: Schleswig Holstein
Study officials:
affiliation: Klinik für Innere Medizin I, UKSH Kiel
name: Ingrid CF Bobis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06474702: Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.
Official title: Predicting Violent Outburst in Inpatient Pediatric Psychiatry Ward Using a Wearable Device.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Child Behavior Disorders
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with mental ilnesses hospitalized at out inpatient psychiatric ward

Brief summary: The investigator will investigate the use of non-invasive wearable device physiological measures. this in order to predict aggression, and violence outburst in children under 12 years old, which are admitted at an inpatient psychiatric ward. also, the investigator will try to do a characterization of those physiological measures in the prediction of aggression and violence outbursts.


Eligibility criteria: Inclusion Criteria:

* the investigator will include patients under the age of 13 with various mental disorders admitted to our inpatient psychiatry ward at 'Edmond and Lily Safra' Children's Hospital, Sheba Medical Centre, Tel Hashomer, Ramat Gan, Israel during 2024.

Exclusion Criteria:

* the investigator will exclude patients that were hospitalized but did not want to participate, or couldn't participate due to increased sensorial sensitive to the device. the investigator will exclude patients with no violence outburst or aggressive attitude that were hospitalized at our inpatient psychiatric ward during 2024. additional, patients who suffers dermatological illnesses and might show allergic reactions to the device material on their wrist will be excluded.

Primary outcomes:
measure: physiological parameter
timeFrame: 12 months (july 2024-july 2025)
measure: physiological parameter
timeFrame: 12 months (july 2024-july 2025)
measure: physiological parameter
timeFrame: 12 months (july 2024-july 2025)
measure: physiological parameter
timeFrame: 12 months (july 2024-july 2025)
measure: movements.
timeFrame: 12 months (july 2024-july 2025)
Secondary outcomes:
measure: violence assessment with 'MOAS' score system.
timeFrame: 12 months (july 2024-july 2025)
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Doron Gothelf, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04882202: Acetaminophen and AKI After Aortic Surgery
Official title: Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Surgery
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Acute kidney injury is commonly accompanied major complication after aortic surgery.

Cardipulmonary bypass lyses erythrocyte and induces lipid peroxidation. This increases plasma free hemoglobin, F2-isoprostane, and isofuran concentration. Cell free hemoglobin have been reported to be associated with poor prognosis such as acute kidney injury, myocardial infarction, and death.

Acetaminophen is reported to attenuate hemeprotein mediated lipid peroxidation. Thus, investigators hypothesized that acetaminophen might have protective effect on the incidence of acute kidney injury in patients undergoing aortic surgery with moderate hypothermic circulatory arrest.


Eligibility criteria: Inclusion Criteria:

1) Patients undergoing aortic surgery with moderate hypothermic circulatory arrest.

Exclusion Criteria:

1. patients with chronic kidney disease or with dialysis, eGFR \< 15ml/min/1.73m2
2. allergy to acetaminophen or propacetamol HCl
3. history of liver cirrhosis or total bilirubin \> 2.0mg/dL

3) patients taking acetaminophen or diclofenac 4) patients who cannot understand informed consent

Primary outcomes:
measure: Incidence of acute kidney injury after aortic surgery with moderate hypothermic circulatory arrest
timeFrame: Postoperative 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
citation: Simpson SA, Zaccagni H, Bichell DP, Christian KG, Mettler BA, Donahue BS, Roberts LJ 2nd, Pretorius M. Acetaminophen attenuates lipid peroxidation in children undergoing cardiopulmonary bypass. Pediatr Crit Care Med. 2014 Jul;15(6):503-10. doi: 10.1097/PCC.0000000000000149.
Clinical trial NCT05023421: Investigation of the Relationship Between the Use of Social Media and Functional Level in Children With CP
Official title: Investigation of the Relationship Between the Use of Social Media and Gross Motor Function, Hand Function, Communication, Eating and Drinking and Visual Function Children With Cerebral Palsy in Turkey.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Media Addiction
Cerebral Palsy
Keywords: problematic media use
cerebral palsy
physical therapy
motor function
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 158
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants in the current study were parents of children with CP aged 4-18 years.

The inclusion criteria were having a child with CP aged 2-18 years without severe cognitive problems, being a primary caregiver.

Brief summary: The aim of this study is to examine the relationship between screen usage time and problematic social media use in children with Cerebral Palsy (CP) with motor function, hand function, speech and vision function.

Detailed description: Problematic Media Use Measure, Strengths and Difficulties Questionnaire were administered to 158 parents of children with CP. In order to determine the screen usage time, parents were asked about the screen usage time of their children on weekdays and weekends, and the average usage time in a week was calculated. Gross Motor Function Classification System (GMFCS), Manual Abilities Classification System (MACS), Eating and Drinking Ability Classification System (EDACS), Communication Function Classification System (CFCS),and Visual Function Classification System (VFCS) were used to determine functional levels.The structural equation model was used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Parents of children with CP aged 4-18 years
* Parents of children with CP without severe cognitive problems, being a primary caregiver.

Exclusion Criteria:

* Not being a primary caregiver

Primary outcomes:
measure: Problematic Media Use Measure
timeFrame: At baseline
Secondary outcomes:
measure: Strength and Difficulties Questionniare
timeFrame: At baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Eyalet/Yerleşke
Study officials:
References:
Clinical trial NCT05777421: Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis
Official title: Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: Range of Motion, Proprioception
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Natural apophyseal glides and the second will receive Natural Apophyseal Glides in addition to cranial base release with conventional physical therapy. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: Knee Osteoarthritis is one of the most prevalent degenerative conditions in Pakistan. Although a variety of Physical therapy treatments have been proven to be beneficial in patients with early stages of knee Osteoarthritis. However, a few secondary impairments like Kinesiophobia which is the fear of movement have been unaddressed. Usually after conventional physical therapy, patients find immediate or short-term relief and that leads to cessation of follow up sessions. In situations like these, kinesiophobia is the greatest threat to mobility and can eventually effect quality of life by decreasing functional disability.


Eligibility criteria: Inclusion Criteria:

* Patients with unilateral knee OA involving mediolateral compartment
* Knee OA grade 2
* Aged 40-65 years
* Both Male and Female
* NPRS value greater than

Exclusion Criteria:

* Patients with history of
* History of systemic disorder (e.g., rheumatoid arthritis, ankylosing spondylitis).
* History of malignancy.
* History of trauma.
* Previous knee surgery.
* Congenital musculoskeletal deformity (e.g., scoliosis, kyphosis).
* Patients with history of fracture
* Patients with history of Chondropatella Malacia

Primary outcomes:
measure: Kinesiophobia
timeFrame: 6 weeks
measure: Pain intensity
timeFrame: 6 weeks
measure: Functional Disability
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT03687021: Clinical Study on Endometrial Receptivity
Official title: Clinical Study on the Impact of Route of Administration of Progesterone and Endometriosis on Endometrial Receptivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Endometrial Receptivity;RNA; Progesterone
Keywords: endometrial receptivity
RNA
progesterone
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: to explore the differential expression of miRNA in the implantation window of patients with endometriosis and the time of progesterone and route of administration on planting window


Eligibility criteria: Inclusion Criteria:

1. The endometriosis group treatment group: Previous laparoscopy or laparotomy confirmed endometriosis;Regular menstruation, no rule vaginal bleeding;Ovarian reserve function is normal.

   control group: Laparoscopic bilateral salpingectomy was performed due to ectopic pregnancy, benign ovarian changes and other reasons, with the exception of endometriosis during the operation.Regular menstruation, no rule vaginal bleeding;Ovarian reserve function is normal
2. progesterone group Women with hypothalamic amenorrhea or premature ovarian failure;Ages 18-40

Exclusion Criteria:

Patients with medical complications

Primary outcomes:
measure: endometrial receptivity measured by pathology
timeFrame: 3 months
Secondary outcomes:
measure: endometrial receptivity measured by immunohisochemistry
timeFrame: 3 months
measure: endometrial receptivity measured by Ribose Nucleic Acid （RNA）
timeFrame: 3 months
measure: endometrial receptivity measured by scanning electron microscope
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: