louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03102138: Retinal Pigment Epithelium Safety Study for Patients in B4711001
Official title: Long Term, Open-Label, Safety Follow Up Study Following Transplantation of Pf-05206388 (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)) in Subjects with Acute Wet Age Related Macular Degeneration and Recent Rapid Vision Decline
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Age Related Macular Degeneration
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AMD treated in main study

Brief summary: This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.


Eligibility criteria: Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Previous participation in Protocol B4711001 and received treatment with PF-05206388.
* Subjects who are willing and able to comply with scheduled visits, and study procedures.

Exclusion Criteria:

* there are no exclusion criteria

Primary outcomes:
measure: incidence of serious adverse events and ocular adverse events
timeFrame: 4 years
Secondary outcomes:
measure: Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA)
timeFrame: 4 years
measure: Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints.
timeFrame: 4 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Lyndon da Cruz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02431338: Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention
Official title: Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Keywords: Remote ischemic conditioning
Cost-effectiveness analysis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2015-05-01
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a Danish healthcare system.


Eligibility criteria: Inclusion Criteria:

(1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads

Exclusion Criteria:

(1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain \> 12 hours prior to admission

Primary outcomes:
measure: Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups]
timeFrame: 4-years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology, Aarhus University Hospital
Study officials:
affiliation: Department of Cardiology, Aarhus University Hospital, Denmark
name: Astrid D Sloth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02440438: Host Immune Response to Clostridium Difficile Infection (ICD)
Official title: Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea Due to Clostridium Difficile
Keywords: Clostridium difficile, recurrence, relapse, antibodies, immune response, prognosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A\&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.


Eligibility criteria: Inclusion Criteria:

* Hospitalized
* Suffering from diarrhea related to C. difficile
* Confirmed diagnosis of CDI
* Informed consent by the patient
* Affiliated to the social security regime

Exclusion Criteria:

* Out-patient
* No confirmed diagnosis of CDI
* Decline of participation
* Patient not affiliated to the social security regime

Primary outcomes:
measure: immune response rate
timeFrame: up to 60 days after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Service d'Hygiène, Epidémiologie et Prévention - Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT02765438: Lower Limb Muscle Activity With "BOBO"
Official title: Lower Limb Muscle Activity During Task-specific Exercises With "BOBO"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Balance disorders are sometimes treated with exercises performed on unbalanced surfaces. The "BOBO" system allows connection of a standing platform attached to any of these surfaces, to a screen, where the user can control games with his or her body movements. In this study, the lower limb muscle activity of healthy individuals will be monitored during different games in order to assert the the ability of each game in strengthening certain muscle groups.

Detailed description: Healthy subject will fill out a demographic questionnaire following the exercise they will fill out a subjective questionnaire for assessment of the exercise. Each subject will play 4 games using the "BOBO" while surface electrodes are placed on the gluteus max/medius, quadriceps, hamstring, peroneal ,tibialis anterior, gastrocnemius.

Eligibility criteria: Inclusion Criteria:

* Native Hebrew speaking

Exclusion Criteria:

* Familiar with the "BOBO" system
* Previous lower limb injuries
* Have a pacemaker
* Have neurological or vestibular deficiencies

Primary outcomes:
measure: Measuring the muscle activity using an Electromyography device
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04508738: Effects of Combined Interventions to Optimize Recovery During High-intensity Exercises in Healthy Adults
Official title: Effects of Combined Interventions to Optimize Recovery During High-intensity Exercises in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be tested on 4 different days with a control, a placebo and an interventional condition in random order.
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the effects a complex recovery intervention during the breaks of a repeated sprint test on exercise performance compared to placebo and control conditions. The enhanced recovery package (ERP) includes neck cooling with an iced gel pad, drinking a 6% CHO solution, mouth-rinsing with a 10% CHO, 6 mg･kg -1 caffeine solution, performing submaximal squats and hyperventilating a hyperoxic mixture; all applied in each 3-min break in-between the six 30-s sprints. This intervention will be compared to a placebo and a control condition.


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Healthy
* Male
* Age: 18-40 years
* Body-Mass-Index (BMI): 18.5-24.9 kg･m-2
* Trained individuals: max. Power output ≥ 4.0 Watts･kg-1
* Non-smoking
* Willingness to adhere to the study rules

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participants
* Previous enrolment into the current study
* Intake of medications affecting performance or the respiratory, cardiovascular or neuromuscular system
* Acute or chronic illness affecting performance or the respiratory, cardiovascular or neuromuscular system

Primary outcomes:
measure: Change in mean power output
timeFrame: through study completion, an expected average of 3 weeks per participant
measure: Change in fatigue index
timeFrame: through study completion, an expected average of 3 weeks per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH Zürich, Exercise Physiology Lab
state: ZH
Study officials:
affiliation: Christina M. Spengler, Prof. Study Principal Investigator Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
name: Christina M. Spengler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319238: OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN
Official title: OBSERVATIONAL STUDY OF THE MANAGEMENT OF PATIENTS WITH CHRONIC PAIN
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Chronic pain
Neuropathic pain
Ketamine
Concomitant treatment
Adverse effect
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 1000
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: Patients with chronic pain

Brief summary: The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.

Detailed description: This is an observational, longitudinal and multicenter study about use of ketamine. Benefits are assessed with pain intensity, anxiety, depression, quality of life and global impression of change. Risks are also assessed with adverse event collection.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* Patients with chronic pain (more than 6 months)
* Patients with peripheral or central neuropathic pain, fibromyalgia, algoneurodystrophy

Exclusion Criteria:

* Patient under 18 years of age,
* Patient not requiring prescription of ketamine

Primary outcomes:
measure: Descriptive analysis of benefit
timeFrame: At baseline
Secondary outcomes:
measure: Descriptive analysis of risk (by collecting adverse event) of ketamine use.
timeFrame: At baseline
measure: Neuropathic Pain in 4 questions (DN4),
timeFrame: At baseline
measure: Patient Global Impression of Change, the characteristics of pain (PGIC)
timeFrame: At baseline
measure: Emotional status by Hospital Anxiety and Depression scale (HAD)
timeFrame: At baseline
measure: Quality of life (Short Form 12 items Short Form survey)
timeFrame: At baseline
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle PICKERING
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corriger A, Voute M, Lambert C, Pereira B, Pickering G; OKAPI Consortium. Ketamine for refractory chronic pain: a 1-year follow-up study. Pain. 2022 Apr 1;163(4):690-701. doi: 10.1097/j.pain.0000000000002403.
Clinical trial NCT04328038: Personalized Exercise Oncology
Official title: Personalized Exercise Oncology (PEXO) - Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Health Behavior
Keywords: Physical Activity
Exercise
Health literacy
cancer-related symptoms
treatment-related symptoms
personalized Medicine
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2020-03-31
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mixed Cohort of adult cancer patients undergoing treatment Special Subgroup: Multiple Myeloma Patients

Brief summary: The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the likelihood that patient get involved in physical activity.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cancer diagnosis
* Females and males ≥18 years of age
* Undergoing either chemo-, immune-, radio- or anti-hormonal treatment
* Last surgery more than 6 weeks in the past
* Ability to understand English or German
* Be able to provide and understand informed consent
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Score of ≤ 2

Exclusion Criteria:

* Heart insufficiency \> NYHA III (New York Heart Association) or uncertain arrhythmia
* Uncontrolled hypertension
* Severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl)
* Reduced standing or walking
* Current pregnancy
* Any other evidence in the medical record of an absolute contraindication for exercise

Primary outcomes:
measure: Patient Clusters
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Questionnaire: Physical Activity Associated Health Literacy
timeFrame: through study completion, an average of 1 year
measure: Questionnaire: Health Literacy
timeFrame: through study completion, an average of 1 year
measure: Questionnaire: Health Related Quality of Life
timeFrame: through study completion, an average of 1 year
measure: Questionnaire: Fatigue
timeFrame: through study completion, an average of 1 year
measure: Questionnaire: Physical Activity
timeFrame: through study completion, an average of 1 year
measure: Questionnaire: Emotion Thermometers
timeFrame: through study completion, an average of 1 year
measure: Questionnaire: Brief Pain Inventory (BPI)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
Study officials:
References:
Clinical trial NCT02496338: Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction
Official title: Effect of Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction During Transitional Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause
Quality of Life
Marital Satisfaction
training
Lead sponsor: Gonabad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Sadoughi University of Medical Sciences and Health Services
First posted: 2015-07-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators conducted a clinical trial to evaluation the effect of a menopausal health training for Husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause.

Detailed description: The investigators applied a menopausal health training program for Husbands of 45-60 years women. The content of menopausal health training program was about the nature of menopause, signs and symptoms, complications, treatment option and health behavior during transitional period. Training program lasted 3 sessions. The investigators assessed quality of life and marital satisfaction using Hildich marital satisfaction questionnaire and Menopause Quality of Life questionnaire(MENQOL), respectively, three month after intervention.

Eligibility criteria: Inclusion Criteria:

* living with their spouse
* no history of premature menopause
* no history of hysterectomy
* no history of oophorectomy
* no history of acute disease
* no history of burden chronic disease

Exclusion Criteria:

* no participation of spouse in all of training session
* uncompleted all of equation
* favorite to exclude from study

Primary outcomes:
measure: Quality of Life
timeFrame: 3 months
Secondary outcomes:
measure: Marital satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Yazd University of Medical Sicences
name: MahamadAli MorovvatiSharifabad, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02751138: Determination of Immune Phenotype in Glioblastoma Patients
Official title: Determination of Immune Phenotype in Glioblastoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma Multiforme
Keywords: Immune phenotype
Cytokines
Genetic aberration
Overall survival
Progression free survival
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult glioblastoma multiforme

Brief summary: Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the current observational study is to determine immune phenotypes in individual patients with GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as progression free and overall survival, Karnofsky index (progression free survival (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual GBM patient.


Eligibility criteria: Inclusion Criteria:

* adult glioblastoma multiforme

Exclusion Criteria:

* pregnancy, unable to give consent

Primary outcomes:
measure: Overall survival
timeFrame: 3 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 3 months
measure: Karnofsky performance score
timeFrame: 3 months
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Neurosurgery
Study officials:
References:
Clinical trial NCT06190938: Diabetes Complications and Hearing Loss
Official title: The Relationship Between Diabetes, Its Neurological and Optical Complications, and Hearing Loss.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetes Complications
Hearing Loss
Keywords: Diabetes retinopathy
Cataract
Lead sponsor: Syrian Private University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We collected participants from the clinical of Damascus hospital

Brief summary: Observation study, shows the relation between diabetes, its neurological and optical complication and hearing loss, by asking participants questions about there age,BMI,job,the history of any cataract,diabetes retinopathy or heart attack,hypertension,swollen or tingling legs and take there consent to measure the hearing impairment.


Eligibility criteria: Inclusion Criteria:

* Diabetics who signed consent for the study.
* Diabetics who have filled out the form completely.
* Diabetics who have undergone a pure tone hearing screening test .

Exclusion Criteria:

* Patients with glandular disease causing hearing loss.
* Patients with traumatic ear injury.
* Patients who have recently had a middle or inner ear infection.
* History of acoustic neuroma.
* Patients are under active treatment with medications that have a toxic effect on the auditory cells.
* Patients with diabetic foot.
* The patient's occupation or residence is within a noisy environment.

Primary outcomes:
measure: The Demographic characteristics were classified into four groups: Gender, Financial status, Educational level, and Profession.
timeFrame: The study took 6 months to finish it with hard work, it was hard to reach our participants so it tooks 2 weeks from us for each participant to finish our survey
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Mohamad Zaid Ahmad Abdalla
Study officials:
References: