louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01834053: Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.
Official title: Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Huntington Disease
Keywords: Huntington Disease,stem cell therapy
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.

Detailed description: This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.

Eligibility criteria: Inclusion Criteria:

* Patient should suffer from Hunting tons Chorea,
* Hunting tons chorea commonly become noticeable between the ages of 35 -44
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

* Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure.
* alcohol and drug abuse / dependence.
* Severe skin infection.
* Haemodynamically unstable.

  =subject with primary and secondary diabetes , Insulin dependence.
* Neurological disease caused by autoimmune or genetic cause.
* patients suffering from peripheral muscular dystrophy.

Primary outcomes:
measure: Improvement in Cognitive and psychiatric symptoms
timeFrame: 6 Months
Secondary outcomes:
measure: Improvement in neuropsychiatric behaviour
timeFrame: 6 Months
measure: Increase in life expectancy
timeFrame: 6 Months
measure: Improvement in writhing motions or abnormal posturing
timeFrame: 6 month
measure: Improvement in compulsive behaviour
timeFrame: 6 month
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05207553: A Reliability and Validity Study of Urdu Version of Lysholm Knee Scoring Scale.
Official title: Validity and Test Re-test Reliability of the Urdu Version of Lysholm Knee Scoring Scale in Patients With Anterior Cruciate Ligament Injuries in the Pakistani Clinical Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Lysholm Knee Scale
Anterior Cruciate Ligament Injuries
Knee disorders
Validity
Urdu Version
Reliability
Arthroscopic Knee
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani population with anterior cruciate ligament injuries was included in the study.

Brief summary: The study will be intended to translate and check if the Urdu Version of Lysholm Knee Scoring Scale is reliable and valid in the Pakistani patients with anterior cruciate ligament injuries.

Detailed description: A detailed research will be conducted on nearly 100 patients after ethical approval from the Ethical Review Board of Riphah International University Faisalabad Campus. A total of 100 patients with Anterior Cruciate Ligament injuries will be selected from different areas of community and rehabilitation centers. Informed consent will be taken from each patient. The tool will be used three times in the same Pakistani population with Anterior Cruciate Ligament injuries to check inter and intra-observer reliability of the final Urdu-LKS. The Lysholm questionnaire translation will be carried out in 6 steps by the guidelines of the early researches and the Consensus-based Standards for the selection of health Measurement Instruments standard. Statistical Package of Social Sciences 23 will be employed to do data analysis.

Eligibility criteria: Inclusion Criteria:

* From17 years Old to 60 Years Old
* Presence of an Anterior Cruciate Ligament Injury or Ligament Repair
* No intervention between the test-retest assessments.

Exclusion Criteria:

* To complete the forms because of a psychological Impairment.
* Illiteracy or lack of understanding of Urdu Language
* Had a condition that couldn't be settled after a second assessment for different sicknesses like cancer, any other serious Infection, or inflammatory disease
* The presence of neurologic or musculoskeletal disorders other than the knee Condition.

Primary outcomes:
measure: Lysholm Knee Scoring Scale
timeFrame: 1st day
measure: Kujala Anterior Knee Pain Scale
timeFrame: 1st day
measure: International Knee Documentation Committee Questionnaire
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT01379053: Volatile Organic Compounds in Staphylococcus Aureus Patients
Official title: Detection of Methicillin Resistant Staphylococcus Aureus Colonization Using the zNose®, an Ultra-fast Gas Chromatograph
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Methicillin-resistant Staphylococcus Aureus
Nosocomial Disease
Keywords: Staphylococcus aureus
Methicillin-resistant staphylococcus aureus
Nosocomial disease
Electronic nose
Gas chromatography
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected upon suspicion of MRSA or MSSA infection or colonization. Increased concentration will be give to selection of persons from the following high risk groups:

* It has been documented that the patient has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission.
* The patient will be admitted to an intensive care unit or burn unit of the hospital.
* The patient receives inpatient dialysis treatment.
* The patient is being transferred from a skilled nursing facility

Brief summary: The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists of:

* A collection apparatus for collection of volatile compounds from suspected infection sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate sample of room air.
* Analysis of the volatile organic compounds from suspected infection sites and room air by short acoustic wave gas chromatography.
* Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of Staphylococcus aureus infection and colonization.

This study will test the hypothesis that we can identify the presence of MRSA by sampling the "head space" above culture media of anterior nare samples provided by patients with MRSA. Additionally, this study will test the hypothesis that we can identify the presence of MRSA by sampling air exhaled through the nostrils (nasal exhalant).


Eligibility criteria: Inclusion Criteria:

* Suspicion of staphylococcus aureus infection or colonization
* Able to give samples for zNose® analysis

Exclusion Criteria:

* Inability to provide sample for zNose® analysis

Primary outcomes:
measure: Identification of Methicillin Resistant Staphyloccus aureus
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Ventura County Medical Center Hospital
state: California
Study officials:
References:
Clinical trial NCT02961153: Mortality in Pediatric Intensive Care Unit
Official title: Epidemiology of Death in the PICU of Southeast China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Units, Pediatric
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALL patients admitted to the PICU of eight study centers

Brief summary: With the development of national economy and medical technology, patients can extend life rely on high-end medical facilities. At the same time, the continued treatment cannot bring benefits to children, even resulting in poor quality of life of children and bringing high medical costs. This makes the limited medical resources are unreasonable distributed. Research showed that PICU mortality rate halved over ten years ago, but the data did not include death cases who left hospital before death. However, the death number of out-hospital were more than death in-hospital. Therefore, the data cannot actually reflect China's mortality rate of PICU. The reason analysis was limited to the cause of the disease, and does not take the social, economic factors into account. This study include eight PICUs of children's Hospital PICU. Critically ill patients are prospectively studied from death risk factors, admission status, disease diagnosis, severity of illness, analyzing of the risk factors of death from disease diagnosis and death risk factors. In addition, we will illuminate the relationship of death and economic factor, especially for who died out-hospital after withdraw or stop treatment.


Eligibility criteria: Inclusion Criteria:

* ALL patients admitted to the PICU of eight study centers

Exclusion Criteria:

* Postoperative monitoring of patients with stable hemodynamics
* PCIS score \>90 and not up to the United States PICU admission standards

Primary outcomes:
measure: Pediatric Critical Illness Score（PCIS）
timeFrame: first 24 hours after admission
measure: Pediatric Risk of Mortality score (PRISM III)
timeFrame: 24 hours
measure: Pediatric logistic organ dysfunction (PELOD) score
timeFrame: 24hour
Secondary outcomes:
measure: all cause mortality
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children'S Hosptial of Fuan University
Study officials:
affiliation: Children's Hhospital of Fudan University
name: LU guoping, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02835053: Frailty and Postoperative Outcomes After Emergency General Surgery
Official title: Frailty and Postoperative Outcomes After Emergency General Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Geriatrics
Outcomes Research
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 150000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult residents of Ontario with valid provincial health insurance who have an emergency general surgery procedure (large bowel surgery, small bowel surgery, cholecystectomy, control of hemorrhage from duodenal ulcer, lysis of adhesions, appendectomy, laparotomy)

Brief summary: The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.


Eligibility criteria: Inclusion Criteria:

* All residents of Ontario aged more than 65 years on their surgery date with valid provincial health insurance who have an emergency general surgery procedure (large bowel surgery, small bowel surgery, cholecystectomy, control of hemorrhage from duodenal ulcer, lysis of adhesions, appendectomy, laparotomy)

Exclusion Criteria:

* No valid provincial health insurance

Primary outcomes:
measure: Mortality
timeFrame: 365 days (from date of surgery)
Secondary outcomes:
measure: Hospital length of stay
timeFrame: day of surgery to 365 days after surgery
measure: Intensive care unit admission
timeFrame: from date of surgery to 30 days after surgery
measure: Institutional discharge
timeFrame: Date of surgery to hospital discharge or 365 days after surgery (at which time participants will be censored)
measure: Costs
timeFrame: day of surgery to 365 days after surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
References:
Clinical trial NCT05986253: BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
Official title: BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A two arm, acute, randomised, double blind, placebo controlled, crossover design feeding study will be used to establish the impact of co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.
Primary purpose: BASIC_SCIENCE

Brief summary: Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a population with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Aged 18-67

Exclusion Criteria:

* Terminal disease
* Exclusively receiving enteral or parenteral nutrition
* Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and standard operating procedures
* Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment

Primary outcomes:
measure: Postprandial blood glucose area under the curve (AUC)
timeFrame: 120 minutes
Secondary outcomes:
measure: Timecourse of blood glucose concentration
timeFrame: 0, 15, 30, 45, 60, 90, 120 minutes
measure: Postprandial serum insulin area under the curve (AUC)
timeFrame: 120 minutes
measure: Postprandial serum insulin concentration
timeFrame: 0, 15, 30, 45, 60, 90, 120 minutes
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
Study officials:
affiliation: University of Limerick
name: Brian Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05492253: First Complementary Foods and the Infant Gastrointestinal Microbiota
Official title: Effect of First Complementary Foods on the Infant Gastrointestinal Microbiota: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Infants
Gastrointestinal Microbiota
Keywords: Healthy term infant
Complementary diet
Gastrointestinal microbiota
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: American Society for Nutrition Foundation
First posted: 2022-08-08
Enrollment: 43
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effect of different complementary foods on the gastrointestinal microbiota of exclusively human milk fed infants.

Detailed description: The introduction of solid foods plays a role in shaping the microbial communities of the gastrointestinal microbiota. This randomized, controlled, single-blinded trial will evaluate the effect of four infant foods (oatmeal cereal, carrot puree, prune puree, beef and gravy puree) on the gastrointestinal microbiota of exclusively human milk fed infants that have not previously consumed solid foods and who are developmentally ready for the introduction of solid foods.

Eligibility criteria: Inclusion Criteria:

* Infant was born vaginally
* Infant was born full term
* Infant has no significant gastrointestinal medical issues/diagnoses (e.g., gastroesophageal reflux, malabsorption syndromes, Celiac disease, Crohn's disease, or physician diagnosed or suspected food allergies)
* Infant is at least 5 months old, but not 8 or more months old
* Infant consumes an exclusively human milk liquid diet only
* Infant has not yet begun consuming solid foods
* Infant is developmentally ready to begin consuming solid foods (i.e., has good head and neck control, can sit upright when supported, and has at least doubled their birth weight)
* Infant has not had antibiotics within the past month
* Infant's nursing mother has not had antibiotics within the past month
* Parent/legal guardian is at least 18 years old

Exclusion Criteria:

* Infant is not developmentally ready to begin solid foods
* Infant has a family history of food allergy

Primary outcomes:
measure: Change in gastrointestinal microbiota
timeFrame: Day 0, 3, 7, 10, 14
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Jillian Trabulsi, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080153: Effect of Vitamin Supplementation in Glaucoma Patients
Official title: The Effects of Vitamin Supplementation Containing L-Methylfolate (Ocufolin® Forte) on Retinal Venous Pressure and Homocysteine Plasma Levels in Patients With Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Homocysteinemia
Elevated Retinal Venous Pressure
Abnormal Steady State Pattern Electroretinography
Keywords: glaucoma
homocysteine plasma levels
L-methylfolate
ophthalmodynamometry
retinal venous pressure (RVP)
steady state pattern electroretinography
Lead sponsor: Devogelaere Vision
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with glaucoma and/or ocular vascular disease with signs of progression in spite of well controlled IOP and elevated RVP, with fasting serum Hcy level \> 12 µmol/l

Brief summary: The impact of targeted vitamin supplementation on retinal venous pressure (RVP) and steady state pattern ERG (SSpERG) in patients with RVP 15mmHg or more above intra-ocular pressure (IOP) and serum homocystein 12µmol/l or more, with signs of progression in spite of adequate IOP control, as evidenced by SSpERG abnormality with or without structural progression or visual field progression,

Detailed description: Provided the inclusion criteria were met, RVP measurement was repeated, and a 1 capsule/day regimen of Ocufolin® forte was subsequently carried out for a duration of 3 months, after which repeat measurements of IOP, SSpERG, and RVP were performed, along with dilated fundoscopy. .

Eligibility criteria: Inclusion Criteria:

* glaucoma and/or ocular vascular disease in at least on eye
* abnormal SSpERG
* RVP measured using an ophthalmodynamometer at least 15 mmHg higher than intra-ocular pressure (IOP),
* fasting serum Hcy level \> 12 µmol/l
* stable and well-controlled IOP (with or without IOP-lowering treatment)

Exclusion Criteria:

* starting other systemic or ocular medications with potential impacts on RVP within a month before entering the study or during the course of the study
* starting or changing the dosage of other medications with potential impact on SSpERG within 3 months before entering the study or during the course of the study
* non-adherence to the follow-up schedule
* inability to perform a proper RVP measurement using ophthalmodynamometry.

Primary outcomes:
measure: RVP effect
timeFrame: 3 months
measure: SSpERG effect
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oudenburg
country: Belgium
facility: Devogelaere Vision
Study officials:
affiliation: Vision Devogelaere
name: Thibaut Devogelaere, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References: