louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02328053: Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Official title: Clinical & Visual Outcomes of Collagen Cross Linking for Fungal Keratitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mycotic Corneal Ulcer
Keywords: fungal keratitis
collagen cross linking
Lead sponsor: Aravind Eye Care System
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a randomised control trial to assess the visual and clinical outcomes of collagen cross linking in fungal keratitis. Fungal keratitis is a major cause of corneal blindness in India and the therapeutic options available are minimal to handle the advanced complications and sequalae caused by the disease.The antimicrobial and tissue remodeling role of corneal cross linking was demonstrated by several studies earlier,we anted to specifically assess the role of corneal cross linking in non resolving fungal keratitis in prevention of perforation and enhancement of healing process.

Detailed description: Patients with culture positive deep stromal fungal keratitis not responding to appropriate medical therapy for a period of two weeks were randomized to receive or not receive adjuvant CXL. The medical therapy was continued in both the groups and were followed up for 6 weeks after randomization. Healing of the ulcer was taken as successful outcome, while perforation and increase in ulcer size of more than 2 sq.mm from the baseline was considered as treatment failure.

Eligibility criteria: Inclusion Criteria:

* Ulcer size more than 5 mm
* Ulcer depth upto 70% of stromal depth
* Corneal thickness of 400 microns and above

Exclusion Criteria:

* Corneal thickness of below 400 microns
* Ulcers involving the limbus
* Pregnant women
* Children below the age of 18 years

Primary outcomes:
measure: size of infiltrate or scar, corneal structural integrity
timeFrame: 6 months
Secondary outcomes:
measure: visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamilnadu
Study officials:
affiliation: CHIEF CORNEA SERVICES
name: Dr. Venkatesh Prajna, DNB,FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
citation: Uddaraju M, Mascarenhas J, Das MR, Radhakrishnan N, Keenan JD, Prajna L, Prajna VN. Corneal Cross-linking as an Adjuvant Therapy in the Management of Recalcitrant Deep Stromal Fungal Keratitis: A Randomized Trial. Am J Ophthalmol. 2015 Jul;160(1):131-4.e5. doi: 10.1016/j.ajo.2015.03.024. Epub 2015 Apr 1.
Clinical trial NCT04223453: Body Composition Measurements in Pneumonia
Official title: Body Composition in Patients With Acute Pneumonia Measured by Bioimpedance and DXA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Infection Respiratory
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hillerod Hospital, Denmark
First posted: 2020-01-10
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: X-ray verified acute pneumonia \> 65 years of age

Brief summary: The purpose of this study is to validate and standardize bioelectrical impedance analysis (BIA, Maltron BioScan touch i8) for estimating body composition in hospitalized elderly patients with pneumonia. Body composition assessments with BIA and dual-energy x-ray absorptiometry (DXA,

Detailed description: Holigic Discovery) was performed on 36 non-fasting patients over 65 years of age. 29 patients had BIA performed within 24 hours after hospital admission and at the date of discharge. 17 patients had BIA performed in fasted state and one hour after an intake of 300 ml glucose solution.

Eligibility criteria: Inclusion Criteria:

* Acute pneumonia,
* Accept participation (informed consent)
* Understand the given instructions and information

Exclusion Criteria:

* None

Primary outcomes:
measure: Correlation between LBM (lean body mass) with DXA and BIA
timeFrame: within 3 days
Secondary outcomes:
measure: Development in lean-body-mass during hospital stay
timeFrame: 3-10 days (hospital stay)
measure: BIA measured before and after oral glucose load test
timeFrame: 1 hour
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Hillerød Hospital
Study officials:
affiliation: University of Copenhagen, Department of Nutrition, Exercise and Sports
name: Jens R Andersen, MD,MPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06295653: Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
Official title: Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: dental implant
Subepithelial Connective Tissue Graft
Amniotic Chorion Membrane
for Peri-implant Mucosa
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.


Eligibility criteria: Inclusion Criteria:

* Patients with good systemic health with no contraindication for periodontal surgery.
* No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing.
* Ability to maintain good oral hygiene as evidenced in recall visits.
* Aged 30 to 55 years.
* Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (\< 2mm bucco- lingual thickness).

Exclusion Criteria:

* Medically compromised patients and systemic conditions precluding periodontal surgery.
* Smokers.
* Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure.
* Patients subjected to irradiation in the head and neck area.
* Patients treated or under treatment with intravenous amino bisphosphonates.
* Patient affected by active periodontitis or has poor oral hygiene and motivation.
* Uncontrolled diabetes mellitus.
* Pregnant women or planning become pregnant, and nursing mothers.

Primary outcomes:
measure: measure changes in periimplant mucosal thickness
timeFrame: six months
Secondary outcomes:
measure: mid-buccal keratinized mucosal width
timeFrame: six month
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculity of Dentistry Tanta University
state: Elgarbia
Study officials:
References:
Clinical trial NCT01795053: Effects of Playtraining in ADHD Preschoolers on ADHD Symptoms and Play Persistence and Intensity
Official title: Randomized Controlled Trial to Evalualte Effects of Playtraining as Manualized in THOP, a Modulized German ADHD Manual, in 3 to 6 Year Old Children With a Diagnosis of ADHD on ADHD Symptoms and Play Persistence and Intensity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Keywords: ADHD preschoolers
playtraining
child-focused intervention
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A sample of 60 children is randomly assigned to an intervention and a control condition. The intervention group receives 15 sessions of child-focused treatment with play training to enhance play persistence and intensity. The control group receives the same amount of placebo play sessions. The intervention group receives subsequently 15 sessions of parent training. All children are 3 to 6 years old and meet diagnostic criteria for ADD or ADHD. Main hypothesis are a stronger reduction of ADHD symptoms of the child in different settings in the intervention than in the control group. Play-persistence and -intensity should also increase more in the intervention group. An additional effect of a subsequent parent training shall furthermore be tested.


Eligibility criteria: Inclusion Criteria: Diagnosis of ADHD or combinde ADHD/ ODD, age 3 to 6, 5 Items regarding play behavior on DSM-IV symptom checklist above 95th percentile, parents motivation to provide 15 to 30 weekly sessions

Exclusion Criteria: Autism Spectrum Disorder, IQ below 80, massive actual impairment, that requests sudden in-patient treatment, school entry in less than 2 months

Primary outcomes:
measure: FBB-ADHD-V
timeFrame: 20 minutes
Secondary outcomes:
measure: VBV-EL SUBSCALE play productivity and play-intensity
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, clinic, department for child and adolescent psychtherapy and psychiatry
state: Nordrhein-Westfahlen
Study officials:
affiliation: University of Cologne
name: Manfred Doepfner, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05884853: The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
Official title: The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.
Primary purpose: TREATMENT

Brief summary: "Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 50
* diagnosed with ASD from licensed mental health or medical professional based on DSM5
* have social problems
* motivated to participate in the treatment
* fluent in chinese
* caregiver also fluent in chinese and motivated to participate
* had a full-scale IQ \> 70 on WAIS-IV
* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

Exclusion Criteria:

* history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases
* visual impairment and/or hearing impairment
* any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.

Primary outcomes:
measure: Autism Diagnostic Interview Revised, ADIR
timeFrame: 16 weeks
measure: The Autism Diagnostic Observation Schedule, ADOS
timeFrame: 16 weeks
measure: Autism Spectrum Quotient
timeFrame: 16 weeks
measure: Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: 16 weeks
measure: Quality of Socialization Questionnaire (QSQ)
timeFrame: 16 weeks
measure: The Empathy Quotient (EQ)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist.
Study officials:
References:
Clinical trial NCT00002453: A Compassionate Use Study of Tenofovir Disoproxil Fumarate as Treatment for HIV Infection
Official title: An Open-Label, Multicenter, Compassionate Access Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Disease Progression
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study allows patients who need a new anti-HIV treatment to take tenofovir disoproxil fumarate (tenofovir DF), an experimental drug. This study also looks at any side effects the drug causes.

Detailed description: HIV-1-infected patients who are currently receiving stable antiretroviral therapy add tenofovir DF to their regimen. Study participation lasts for approximately 48 weeks. Interested patients should contact their physicians.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a viral load greater than or equal to 10,000 copies/ml.
* Have a CD4 count less than or equal to 50 cells/mm3, or have a CD4 count greater than 50 and no more than 200 cells/mm3 with an opportunistic (AIDS-related) infection within 90 days of study entry. (Patients with a CD4 count above 200 cells/mm3 may be considered depending on drug supply.)
* Are at least 18 years old.
* Agree to use barrier methods of birth control (such as condoms) while on the study and for 30 days afterward.
* Have a life expectancy of at least one year.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of a serious kidney or bone disease.
* Have severe nausea, vomiting, or trouble taking medications by mouth.
* Are pregnant or breast-feeding.
* Abuse alcohol or other substances that your doctor thinks would interfere with taking this medicine.
* Are taking any medicines that interfere with kidney functions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Foster City
country: United States
facility: Tenofovir Coordinating Center
state: California
Study officials:
References:
Clinical trial NCT06627153: Epidemiological Assessment of Technical Diving Accidents in Mainland France and Factors Predictive of Severity (TEKCare)
Official title: Epidemiological Assessment of Technical Diving Accidents in Mainland France and Factors Predictive of Severity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Decompression Sickness
Pulmonary Edema - Acute
Oxygen Toxicity
Carbon Dioxide Poisoning
Nitrogen Narcosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Technical divers are defined by specialized equipment (e.g. rebreather) and/or helium based mixed-gases used to conduct deeper and longer dives. All divers who consulted hyperbaric installations after one of these dives with a retained diagnosis of a diving accident are eligible to participate.

Brief summary: This retrospective study aims at an epidemiological description of the clinical presentation of medical problems in technical diving. It assess anthropometric data, diving experience and dive planification, clinical presentation, treatment received and pronostic to understand specificity of this community.

Detailed description: In recent years, the increased availability of breathing gas mixtures, together with progressive technical development of specialized diving equipment, has contributed to expansion of the diver's community. Deep and long dives expose to decompression sickness (DCS) risk and hyperbaric oxygen therapy (HBO) is the definitive treatment. Incidence, clinical expression or prognosis of pathological events after technical diving might differ from recreational ones. A better knowledge of these specificity will facilitate risk assessment, analysis and medical care for hyperbaric physician community.

Eligibility criteria: Inclusion Criteria:

* Civilian technical diver
* Diving accident history (decompression sickness, biochemical accident or immersion pulmonary edema) following a technical dive in a trimix and/or rebreather dive
* Treated in a hyperbaric center on the coast of mainland France

Exclusion Criteria:

* Participation denied by the diver
* Diving incident diagnosis not retained by the hyperbaric physician

Primary outcomes:
measure: Demographic description of injured technical divers treated in French hyperbaric center
timeFrame: 15 years
Secondary outcomes:
measure: Predictive factor of severity
timeFrame: 15 years
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT05125653: Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy
Official title: Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Chronic Calculous Cholecystitis
Acute Calculous Cholecystitis
Keywords: Laparoscopic Cholecystectomy
Indocyanine Green Fluorescent Cholangiography
Indocyanine Green Fluorescent Angiography
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms, randomized, double blinded
Primary purpose: DIAGNOSTIC

Brief summary: This was a double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy

Detailed description: A double blinded, randomized, controlled trial involved patients underwent laparoscopic cholecystectomy in Ain-Shams University Specialized Hospital in the period from January 2020 till July 2021. Group A (n=60) underwent laparoscopic cholecystectomy using the usual white light, Group B (n=58) underwent laparoscopic cholecystectomy with ICG florescence cholangiography and intraoperative ICG florescence arteriography.

Eligibility criteria: Inclusion Criteria:

* adults (from 18 to 75 years old)
* suffering from a gall bladder disease
* with valid indication for laparoscopic cholecystectomy (e.g., calculus gall bladder with cholecystitis)
* accepted to participate in the study.

Exclusion Criteria:

* Patients with history of previous biliary surgery
* Patients with abdominal malignancy
* Patients with advanced chronic liver disease
* pregnant women

Primary outcomes:
measure: Visual identification of the biliary tree
timeFrame: during the procedure
measure: Visual identification of the cystic artery
timeFrame: during the procedure
Secondary outcomes:
measure: Visual identification of injuries
timeFrame: during and imediatly after the procedure (24 hours)
measure: Compare operative time
timeFrame: during the procedure
measure: Compare blood loss
timeFrame: during the procedure
measure: Compare blood loss in cc
timeFrame: during the procedure
measure: Percentage of patients of ICG adverse reactions
timeFrame: Within 24 hour of the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals - AUSH
Study officials:
affiliation: Ain Shams University
name: M Abd-erRazik, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05813353: Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements
Official title: Usability Study of the BAMCOG Followed by Concurrent Validation of the BAMCOG With the MoCA as a Monitoring Instrument for Perioperative Cognitive Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Older People--Abuse of
Aortic Stenosis, Severe
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients undergoing TAVI surgery

Brief summary: Purpose:

1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning)
2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener
3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements


Eligibility criteria: Inclusion Criteria:

* \> 65 years old
* Scheduled for TAVI surgery
* Able to play games on a tablet
* For usability part \> MoCA score of 26 or higher
* Near native dutch speaker

Exclusion Criteria:

* Mental disorder (unable to play games)
* Alcohol abuse (women \<15 and men \>22 alcoholic drinks/week)
* No informed consent
* Atrial fibrillitation (for ultrasound doppler)

Primary outcomes:
measure: Usability of BAMCOG
timeFrame: 3 months preoperative
measure: Concurrent validation of BAMCOG with MoCA
timeFrame: 3 months preoperative - 3 months postoperative
measure: Cerebral perfusion/carotid flow measurements
timeFrame: Peroperative
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
Study officials:
References: