louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03352128: Creatine Supplementation and Cognitive and Physical Tests
Official title: The Effect of Creatine Supplementation on Cognitive and Physical Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Creatine Supplementation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess whether brain creatine availability has an effect on cognition. To do so we will seek to increase brain creatine concentration via a creatine supplementation protocol.


Eligibility criteria: Inclusion Criteria:

* Healthy (No neurological illness including cardiovascular, renal, and endocrine disorder)
* Male/female
* No medication / supplements
* Non-smoker
* Low to moderately active
* Between 18 and 35 years old

Exclusion Criteria:

* Injuries
* Illness
* Use of medication
* Use of creatine in the last 3 months
* History of head trauma or seizure
* Vegetarian diet \[24\]
* Not being able to follow up the restrictions and prohibitions for the subjects (see Restrictions and prohibitions for the subjects)

Primary outcomes:
measure: Cognitive performance - change in accuracy (%) during a 90-min cognitive task (i.e. Stroop task)
timeFrame: During both lab visits (i.e. after both 7-day supplementation protocols); Accuracy (%) will be assessed during both lab visits with a 90-min cognitive task; Accuracy during the 90-min task will be reported as mean accuracy during 8 blocks of 11min15sec
measure: Cognitive performance - change in reaction time (milliseconds) during a 90-min cognitive task (i.e. Stroop task)
timeFrame: During both lab visits (i.e. after both 7-day supplementation protocols); Reaction time (RT) will be assessed during both lab visits with a 90-min cognitive task; RT during the 90-min task will be reported as mean RT during 8 blocks of 11min15sec
Secondary outcomes:
measure: Physical performance - reaction time (milliseconds) during a 7-min visuomotor reaction time task
timeFrame: During both lab visits (i.e. after both 7-day supplementation protocols); visuomotor reaction time will be assessed during both lab visits with a 7-min visuomotor reaction time task.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Human Physiology and Sports Physiotherapy Research Group
Study officials:
References:
Clinical trial NCT06650228: Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis
Official title: Assessment of Knowledge of Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankylosing Spondylitis (AS)
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 18-65 years who are clinically stable and diagnosed with ankylosing spondylitis according to ASAS diagnostic criteria and who are being followed up at the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study.

Brief summary: A review of the literature did not identify any studies that assessed knowledge of cardiovascular disease risk factors and healthy lifestyle behaviours in patients with ankylosing spondylitis. The aim of this study is to assess knowledge of cardiovascular disease risk factors, healthy lifestyle behaviours and physical activity levels in patients with ankylosing spondylitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria
* Being aged 18-65
* Stable medication use for at least 3 months
* Voluntary participation in the study

Exclusion Criteria:

* Having uncontrolled cardiopulmonary disease
* Being pregnant
* Having undergone recent surgery
* Presence of malignancy

Primary outcomes:
measure: Knowledge of cardiovascular disease risk factors
timeFrame: 10 minutes
measure: Healthy lifestyle behaviors
timeFrame: 15 minutes
Secondary outcomes:
measure: Physical activity
timeFrame: 5 minutes
measure: Cardiovascular risk
timeFrame: 5 minutes
measure: Comorbidity
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Merve Firat
role: PRINCIPAL_INVESTIGATOR
affiliation: Kirsehir Ahi Evran University
name: Basak Kavalci Kol
role: STUDY_CHAIR
affiliation: Kirsehir Ahi Evran University
name: Figen Tuncay
role: STUDY_CHAIR
References:
Clinical trial NCT04505228: The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
Official title: The Personalized Chinese Herb Formulas Are Evaluated for Their Effectiveness to Relieve Symptoms in Hypertensive Bradyarrhythmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Heart Disease
Lead sponsor: Macrohard Institute of Health
Sponsor class: OTHER
Collaborators: name: Qingdao Fifth People's Hospital
First posted: 2020-08-10
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.

Detailed description: To test the effect of Chinese herb against the hypertensive heart disease, we designed this randomized controlled clinical trial. 72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. 2 weeks after treatment, all the symptoms were graded again.

Eligibility criteria: Inclusion Criteria:

\* Clinical diagnosis of hypertensive bradyarhhythmia

Exclusion Criteria:

* With other elementary diseases
* With pregnant
* With receiving other treatment within past half year from the beginning of trial.

Primary outcomes:
measure: typical symptoms in patients with hypertensive bradyarrhythmia
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The fifth Qingdao people's hospital
state: Shandong
Study officials:
References:
Clinical trial NCT05806528: Role of Placental Invasion Index in Decision Making of Placenta Accreta
Official title: Role of Placental Invasion Index in Decision Making of Placenta Accreta
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant female with placenta previa

Brief summary: This study will be conducted on women who have a diagnosis of placenta previ and using ultrasound to make the placenta invasion index and compare the accuracy of the diagnosis during the caesarean section whether it is accreta or not with determining the site and depth of invasion

Detailed description: This study will be conducted on women who have a diagnosis of placenta previ and using ultrasound to make the placenta invasion index and compare the accuracy of the diagnosis during the caesarean section whether it is accreta or not with determining the site and depth of invasion and whether there is injury occurred in the urinary system and Determining the amount of blood transfusion and admission of intensive care, or whether the patient death

Eligibility criteria: Inclusion Criteria:

* all placenta previa and low laying placenta will be included

Exclusion Criteria:

* patient with sever attack

Primary outcomes:
measure: Role of placental invasion index in decision making of placenta accreta
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag univesity hospital
name: Mariam S Mahmoud, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05467228: Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
Official title: Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adductor Spasmodic Dysphonia
Abductor Spastic Dysphonia
Laryngeal Dystonia
Keywords: Adductor Spasmodic Dysphonia
Abductor Spastic Dysphonia
Laryngeal Dystonia
Vibtro-tactile stimulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.

Exclusion Criteria:

* Regular intake of benzodiazepines
* Cognitive impairment: score \< 27 on the Mini-mental State Examination (MMSE).
* Identify with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia other than LD, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis.
* Non-English speaker. We will not enroll people who cannot speak English, because the voice assessment procedures (Test sentences, CAPE_V clinical rating) have only been validated for English speakers at this point.
* Pregnant people. We will not enroll pregnant people as the device used in this study is investigational.

Primary outcomes:
measure: Change in perceived speech effort (PSE)
timeFrame: 24 months
measure: Change in smoothed cepstral peak prominence (CPPS)
timeFrame: 24 months
measure: Change in speech quality vector (SQV) (%)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT03895528: Lonafarnib for Patients With Hutchinson-Gilford Progeria Syndrome or Progeroid Laminopathy
Official title: A Treatment IND (Investigational New Drug) Protocol for EAP (Expanded Access Program) for the Use of Lonafarnib in Patients With Hutchinson-Gilford Progeria Syndrome (HGPS) or Progeroid Laminopathy
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Progeria
HGPS
Lead sponsor: Eiger BioPharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-03-29
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This treatment IND protocol will allow patients with HGPS and progeroid laminopathies access to lonafarnib, the only compound shown to have an effect on the HGPS disease process resulting in improved outcomes (Gordon et al, 2018). There are no approved treatments for HGPS and progeroid laminopathies.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of HGPS or progeroid laminopathy by qualified medical doctor (based on common phenotype as described in Gordon 2015 and Merideth 2008). Confirmation with genetic testing is preferred but not required.
* Adequate hepatic function as defined by SGPT (ALT) and SGOT (AST) ≤ 5 times upper limit of normal range for age

Exclusion Criteria:

* Taking medications or foods that are known to be moderate or strong inducers or inhibitors of CYP3A4 or sensitive CYP3A substrates; or if a patient is taking one of these drugs and cannot safely discontinue or take an alternative drug, the dose of the inhibitor/inducer must be adjusted per the treating physician
* Taking digoxin, a P-gp substrate with a narrow therapeutic window.
* Severe renal impairment (GFR \< 30 mL/min/1.73m2).
* Uncontrolled infection.
* Presence of any active clinically relevant medical condition that in the opinion of the treating physician would preclude patient from safely participating in the program.
* Pregnant or breast-feeding or plan to become pregnant while on therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gordon LB, Shappell H, Massaro J, D'Agostino RB Sr, Brazier J, Campbell SE, Kleinman ME, Kieran MW. Association of Lonafarnib Treatment vs No Treatment With Mortality Rate in Patients With Hutchinson-Gilford Progeria Syndrome. JAMA. 2018 Apr 24;319(16):1687-1695. doi: 10.1001/jama.2018.3264.
Clinical trial NCT04063228: High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
Official title: High Level Mobility Training in Ambulatory Patients With Acquired Non-progressive Central Neurological Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurological Injury
Keywords: non-progressive central neurological injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brain injuries are a significant cause of loss of movement. It has been shown that physical therapy can help patients to regain movements. The purpose of this study is to see if it is possible to perform a new exercise program that will help patients regain movement. This new exercise program will involve practicing walking, stairs, jumping and running. Participation in this study will involve physical therapy 1 to 2 times a week for 12 visits over 6 to 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Referred to physical therapy with an Acquired Non-Progressive Central Neurological Injury (traumatic brain injury, stroke, brain tumor, spinal cord injury) for 3 months or more
* capacity to consent
* ability to read and write English at the sixth grade level
* able to walk twenty meter without physical assistance or an assistive device, however they can use a brace.
* self-selected gait speed of 0.6 m/s or greater when performing 10 meter walk test.

Exclusion Criteria:

* Adults subjects diagnosed with a progressive central or peripheral neurological disorder or an acute non progressive central neurological disorder (less than 3 months)
* Subjects who require physical assistance or an assistive device to walk twenty meters or demonstrate self-selected gait speed less than 0.6 m/s
* Subjects who are already able to run independently in the community
* Participants who are unable to complete the 12 physical therapy visits at prescribed skill level as established by protocol
* Participants who reports \>4/10 on NPRS with lower extremity weight bearing.

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 2 Years
measure: Training feasibility
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Estelle Gallo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00598728: Quality of Life Among Survivors of Hodgkin Lymphoma
Official title: A Global Assessment of Medical Morbidities and Quality of Life Among Survivors of Hodgkin Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Disease
Keywords: Survivors
Quality of Life
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-22
Enrollment: 255
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be recruited from over 800 patients who were enrolled on IRB approved protocols for the firstline treatment of HL between 1975-2000.

Brief summary: The purpose of this study is to collect information on the long-term side effects of treatment for Hodgkin Lymphoma. We hope to study about 500-800 survivors of Hodgkin Lymphoma. We plan to use the findings from this study to better understand Hodgkin Lymphoma survivors' health and quality of life.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven HL Participation in IRB-approved protocols for the first-line treatment of HL between 1975-2000 (IRB #75-104, #75-103, #79-17, #81-103, #90-44, #91-69).
* English speaking

Exclusion Criteria:

* None

Primary outcomes:
measure: To evaluate the prevalence of late medical complications among HL survivors
timeFrame: conclusion of study
Secondary outcomes:
measure: To study the effect of HL and its treatment on QOL among HL survivors.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Straus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03245528: Expanded Access for LJPC-501
Official title: Expanded Access for LJPC-501
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Catecholamine Resistant Hypotension (CRH)
Distributive Shock
High Output Shock
Sepsis
Vasodilatory Shock
Lead sponsor: La Jolla Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2017-08-10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

Detailed description: Primary Objective

The primary objective of the study is to provide access to LJPC-501 for distributive shock patients who remain hypotensive despite receiving fluid and vasopressor therapy.

Secondary Objective

The secondary objective of the study is to assess the safety of LJPC-501.

Eligibility criteria: Inclusion Criteria:

* Patients must be adults ≥ 18 years of age who remain hypotensive despite fluid therapy and vasopressor therapy and who received or are receiving a total sum norepinephrine (NE) equivalent unit dose of \> 0.2 µg/kg/min for at least 2 hours prior to LJPC-501 infusion.
* Patients must have central venous access and an arterial line present, which is expected to remain for the duration of the LJPC-501 infusion.
* Patients must be adequately volume resuscitated in the opinion of the treating investigator.
* Patients must have clinical features of distributive shock documented by either estimated or measured CI \> 2.3 L/min/m\^2 determined by echocardiogram or another cardiac output monitoring modality OR a concurrent CVP \> 8 mmHg and ScvO2 \> 70%.
* Patient or legal surrogate is willing and able to provide informed consent per local guidance and patient/legal surrogate is willing to comply with all protocol requirements.

Exclusion Criteria:

* Patients with a MAP \> 80 mmHg.
* Patients diagnosed with acute occlusive coronary syndrome requiring intervention.
* Patients who have been on ECMO \< 6 hours.
* Patients in liver failure with a MELD score ≥ 30.
* Patients not mechanically ventilated with a history of asthma or who are currently experiencing bronchospasm requiring the use of inhaled bronchodilators.
* Patients with acute mesenteric ischemic or history of mesenteric ischemia.
* Patients with Raynaud's phenomenon, systemic sclerosis, or vasospastic disease.
* Patients with an expected lifespan of \< 24 hours.
* Patients with active bleeding AND an anticipated need for transfusion of \> 4 units PRBCs within 48 hours of the initiation of LJPC-501.
* Patients with active bleeding AND hemoglobin \< 7 g/dL.
* Patients with an ANC \< 500 cells/mm\^3.
* Patients with a known allergy to mannitol.
* Patients who are currently participating in an investigational interventional trial.
* Women who are known to be pregnant at the time of Screening or have a positive serum or urine β-hCG, if of childbearing potential.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: