louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03661034: Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Official title: Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Alzheimer Disease
Alzheimer Dementia
Mild Cognitive Impairment
Memory Disorders
Memory Loss
Memory Impairment
Memory Disorders, Age Related
Alzheimer Disease, Late Onset
Cognitive Impairment
Dementia, Mild
Dementia, Alzheimer Type
Cognitive Decline
Keywords: Dementia
Alzheimer's Disease
Memory Loss
Lead sponsor: Cognito Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, four-arm prospective dose-adjusting study (2 cohorts sequentially enrolled, each with 2 randomly assigned dose levels)
Primary purpose: TREATMENT

Brief summary: The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.

Detailed description: Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.

Eligibility criteria: Inclusion Criteria:

* \>= 50 Years Old
* MMSE 24 - 30
* Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
* Participation of a caregiver / care partner
* Amyloid Positive PET Scan

Exclusion Criteria:

* Profound hearing or visual impairment
* Seizure Disorder
* Use of memantine (Namenda or Namzaric)
* Implantable devices (non-MR compatible)

Primary outcomes:
measure: Change in Amyloid Positron Emission Tomography (PET) Scan
timeFrame: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)
measure: Adverse Events
timeFrame: Over 12 months
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
timeFrame: Baseline, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
Study officials:
affiliation: Cognito Therapeutics
name: Evan R Hempel
role: STUDY_CHAIR
References:
Clinical trial NCT00564434: Postoperative Delirium in Hip Fracture Patients
Official title: Postoperative Delirium in Hip Fracture Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: delirium
pathophysiology
risk factors
pain
dementia
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 364
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Study population: Patients with hip fracture admitted to Ulleval Hospital and Diakonhjemmet Hospital

Brief summary: Risk factors for postoperative delirium in hip fracture patients.


Eligibility criteria: Inclusion Criteria:

* hip fracture
* age 65 or older

Exclusion Criteria:

* critical ill/ dying
* aphasia

Primary outcomes:
measure: Delirium/ no-delirium
timeFrame: 5 days postoperative
Secondary outcomes:
measure: Severity of delirium, length of delirium, complications, comorbidity, one-year mortality.
timeFrame: 5 days postoperative, one year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal Hospital
Study officials:
References:
Clinical trial NCT05065034: Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments
Official title: Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments: Impact of Risk Factors and Treatment Characteristics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis, Adult
Keywords: Periodontitis
Inflammatory diseases
Periodontal
Teeth
Aesthetic morbidity
Cardiovascular risk
Supragingival
Subgingival
Biofilms
Prosthetic restorations
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient adult treated for periodontitis

Brief summary: Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.


Eligibility criteria: Inclusion criteria:

* Patient over 18 years old
* Patient treated for periodontitis between 01/01/2012 and 07/31/2021
* Patient whose medical and periodontal file contains all the elements necessary for data analysis
* Subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study
* Patient without periodontitis
* Patient smoking more than 10 cigarettes / day
* Patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment
* Impossibility of giving the subject informed information
* Subject under safeguard of justice
* Subject under guardianship or guardianship

Primary outcomes:
measure: A retrospective study of the use of antibiotic therapy on the short and long-term results of periodontitis treatments
timeFrame: Files analysed retrospectively from January 01, 2012 to July 07, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg
name: Jean-Luc DAVIDEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04689334: General Surgery Residency Training in Low Income Countries
Official title: Surgical Residency Training Program in Somalia: Outcomes of 7 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Global Surgery
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 14 general surgeon who completed the program

Brief summary: The general surgery residency program was initiated in 2013 between Istanbul Medeniyet University and Benadir University. A formal training program was established that covered 3-year theoretical and practical training that would form the structure of academic, clinical and technical criteria by evaluating all the requirements of the surgical residency training. A resident logbook was prepared to track exam results, practices, knowledge and skill status that the residents achieved in the training process. Candidates who graduated from medical school and were successful in the multiple-choice exam consisting of basic and clinical sciences were accepted to the program each year in different numbers according to the capacity. From the initiation, 16 surgeons -9 in 2016, 3 in 2017 and 4 in 2018- graduated from the program. This study was designed after the last resident group graduated and worked as an attending surgeon at least for a year.

Detailed description: The data were collected from graduates who were working as surgeons in Somalia to reveal the features and numbers of elective, emergency, trauma, and non-general surgical interventions performed in a month. A questionnaire consisting of pathology, type and numbers of interventions performed in one month by graduate surgeons (GS), including general surgery and other specialties, was prepared.

Eligibility criteria: Inclusion Criteria:

1. surgeons who completed program
2. surgerons who currently working as an attending physician in Somalia

Exclusion Criteria:

1. surgeons who has not completed program
2. surgeons who did not completed the questionare

Primary outcomes:
measure: number of surgical interventions in one month
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadikoy
Study officials:
References:
Clinical trial NCT02422134: Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Pregnancy
implantation
Cytokine
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banon IVF Center Assiut, Egypt
First posted: 2015-04-21
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.

Detailed description: The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

Eligibility criteria: Inclusion Criteria:

* all patients

Exclusion Criteria:

* above 40 years old

Primary outcomes:
measure: Pregnancy rate ( % )
timeFrame: 9 months
Secondary outcomes:
measure: Implantation rate ( % )
timeFrame: 9 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon IVF center
city: Sohag
country: Egypt
facility: Ibnsina IVF center
Study officials:
References:
Clinical trial NCT01210534: Physiological Brain Atlas Development
Official title: Physiological Brain Atlas Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Dystonia
Tremors
Obsessive Compulsive Disorder
Depression
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 456
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are undergoing DBS implantation surgery at the Ohio State University.

Brief summary: Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.

Detailed description: The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely.

The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy.

Eligibility criteria: Inclusion Criteria:

* Any patient between the age of 7-90
* Patients who have undergone deep brain stimulation (DBS) surgery as standard of care at The Ohio State University

Exclusion Criteria:

* None

Primary outcomes:
measure: optimal DBS target location
timeFrame: intra-operative identification
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio Sate University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Vibhor Krishna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02411617: Single vs. Double Drain in Modified Radical Mastectomy
Official title: Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Memon Medical Institute
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage.

The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.

Detailed description: Modified Radical mastectomy is commonly performed procedure for carcinoma breast. After surgery two drains are placed, one in axilla and one beneath the flap. The use of two drains is associated with significant post operative discomfort and pain. On the other hand two drains have not been proven to decrease post operative seroma formation.

Eligibility criteria: Inclusion Criteria:

* All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion Criteria:

* Immediate reconstruction
* Patient refusal to participate in study

Primary outcomes:
measure: seroma formation
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Duration of hospital stay,,
timeFrame: 30 days after surgery
measure: wound infection
timeFrame: 30 days after surgery
measure: postoperative pain
timeFrame: 30 days after surgery
measure: hematoma
timeFrame: 30 days after surgery
measure: flap necrosis
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06935617: Hiatus Hernia in Old
Official title: Hiatus Hernia and Frailty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiatus Hernia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-04-20
Enrollment: 266
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly pt with hh

Brief summary: hiatus hernia in frail patient is common and requires suregry

Detailed description: severe frail patients had high incidence of recurrence

Eligibility criteria: Inclusion Criteria:

* EP aged ≥60 years for giant sliding HH with

Exclusion Criteria:

* • who required a concurrent abdominal procedure at the same time as fundoplication (e.g., cholecystectomy)(n=5)

  * esophageal dysmotility(n=2)
  * progressive systemic sclerosis (n=1)

Primary outcomes:
measure: recurrence
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01989117: Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement
Official title: Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Osteoarthritis of the Knee
Preoperative Osteopathic Care
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for primary total knee arthroplasty (TKA) for osteoarthritis.

Brief summary: Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.


Eligibility criteria: Inclusion Criteria:

* Primary total knee arthroplasty (TKA)
* For osteoarthritis of the knee
* Without surgical history on the operated knee

Exclusion Criteria:

* Previous surgery on the operated knee
* Bilateral TKA
* Patient refusal

Primary outcomes:
measure: Self-assessment of knee pain on Visual Analog Scale (VAS)
timeFrame: At one month postoperatively
Secondary outcomes:
measure: Pain self-assessment during the first postoperative month on Visual analog scale (VAS)
timeFrame: Twice daily during the first postoperative month
measure: Functional assessment of the knee with International Knee Society (IKS) score
timeFrame: At six months postoperatively
measure: Functional assessment of the knee with International Knee Society (IKS) score
timeFrame: At one year postoperatively
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hopital Ambroise Pare
Study officials:
References:
Clinical trial NCT04526717: Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection
Official title: Phase 1, Open Label, Single Arm Study to Evaluate the Safety, Tolerability and Efficacy of MPT0B640 in Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Covid19
Lead sponsor: J Ints Bio
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Classical 3+3 design to determine MTD.
Primary purpose: TREATMENT

Brief summary: Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective

1. Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640
2. Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640


Eligibility criteria: Inclusion Criteria:

Subjects must meet all inclusion criteria as listed below:

1. Age ≥18 years at time of signing Informed Consent Form
2. Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.
3. Lung involvement confirmed with chest imaging
4. Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio \<300mgHg
5. ≤7 days since illness onset
6. Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.

Exclusion Criteria:

1. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
2. Severe liver disease (e.g. Child Pugh score ≥ C, AST\>5 times upper limit)
3. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
4. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
5. Will be transferred to another hospital which is not the study site within 72 hours.
6. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.

Primary outcomes:
measure: MTD
timeFrame: 28days(+/-2days)
Secondary outcomes:
measure: Viral load
timeFrame: Time Frame: Day 1, 3, 5, 7, 9 and 12
measure: Time to clinical improvement
timeFrame: Time Frame: dialy up to Day 10
Other outcomes:
measure: Pharmacokinetic (PK)
timeFrame: Day 1,3 and 5.
measure: Pharmacokinetic (PK)
timeFrame: Day 1,3 and 5.
measure: Pharmacokinetic (PK)
timeFrame: Day 1,3 and 5.
Locations:
Study officials:
affiliation: J Ints Bio
name: Ethan Seah
role: STUDY_DIRECTOR
References: