louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06441201: Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes
Official title: Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: GastroIntestinal Bleeding
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 10
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: Subjects undergoing emergent endoscopic evaluation for active gastrointestinal bleeding at Mayo Clinic, Rochester, Minnesota.

Brief summary: The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.

Detailed description: The maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. Pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings.

Eligibility criteria: Inclusion Criteria:

- Adults (age \>18yr) undergoing emergent endoscopy for active GI bleeding.

Exclusion Criteria:

* Patients with pre-existing heart failure (ejection fraction \<40%), cardiac rhythm abnormalities and peripheral vascular disease.
* Patients with underlying implanted cardiac electrical devices and spinal cord stimulators.

Primary outcomes:
measure: Changes in peripheral pulse volume with and without active bleeding
timeFrame: Baseline, approximately 2 hours post endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrew Storm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04691167: the Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
Official title: The Role of Repetitive Trans Cranial-magnetic Stimulation in Craving Reduction Among Opioid Use Disorder Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.

Administering high frequency rTMS to the left dorsolateral prefrontal cortex is possible to increase brain activity in the stimulated area and to change brain activity in associated regions that are part of the same neural circuit which may reduce craving.


Eligibility criteria: Inclusion Criteria:

1. Age range: 18-45 years old
2. Gender: males
3. Opioid Use disorder according to the DSM-5 (early abstinence starting 1 week up to 1 month).

Exclusion Criteria:

1. Presence of other serious mental illness (e.g.; psychotic disorders, bipolar affective disorder, depression with psychotic features).
2. Patients with any other serious medical illness.
3. Previous treatment with repetitive Trans- cranial magnetic stimulation.
4. Patients with contraindications to rTMS as cardiac patient with pacemaker.

Primary outcomes:
measure: craving severity
timeFrame: 6 weeks
measure: heroin craving
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: professor at ain shams university, faculty of medicine
name: amany haroun, BCH, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04817267: Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
Official title: Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Pear Therapeutics, Inc.
First posted: 2021-03-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.

Detailed description: This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Opioid use disorder
* Eligible for buprenorphine treatment
* Has reSET-O compatible mobile device

Exclusion Criteria:

* Pregnancy
* Significant psychiatric comorbidity

Primary outcomes:
measure: Percentage of approached patients who are eligible for and interested in participation
timeFrame: 3 months
measure: Acceptability as assessed by the Treatment Acceptability Questionnaire
timeFrame: 3 months
measure: Acceptability as assessed by the System Usability Scale
timeFrame: 3 months
Secondary outcomes:
measure: Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge
timeFrame: 30 days
measure: Percentage of drug-negative urine samples during the 3-month intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayivew Emergency Department
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: August Holtyn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812067: A Safety and Efficacy Trial of TTHX1114 in People With CED
Official title: A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Corneal Endothelial Dystrophy
Lead sponsor: Trefoil Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older
* Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
* Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
* Fellow Eye with 20/100 BCVA or better
* No concurrent ocular or medical condition that would impair the assessment of safety and efficacy

Exclusion Criteria:

* Prior exposure to TTHX1114
* Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
* Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
* History of:

  * Ocular cancer (including melanoma)
  * Herpetic keratitis
  * Documented and repeated elevated IOP in either eye
  * Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
  * Uveitis
* Use of any concomitant medications that may interfere with the assessment of safety and efficacy
* Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study

Primary outcomes:
measure: Specular Microscopy
timeFrame: Day 28
Secondary outcomes:
measure: Pachymetry
timeFrame: Day 28
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Trefoil Study Site
state: Georgia
city: Washington
country: United States
facility: Trefoil Study Site
state: Missouri
Study officials:
affiliation: Trefoil Therapeutics.com
name: Thomas Tremblay
role: STUDY_DIRECTOR
References:
Clinical trial NCT04480567: AAV Gene Therapy Study for Subjects with PKU
Official title: A Phase 1/2 Open-Label, Dose Escalation Study to Determine the Safety and Efficacy of BMN 307, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Phenylalanine Hydroxylase in Subjects with Phenylketonuria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Phenylketonuria (PKU)
Keywords: PKU
PAH Deficiency
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1/2, open-label, dose escalation study to evaluate the safety, efficacy and tolerability of BMN 307 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of BMN 307 and will be followed for safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency
* Ability and willingness to maintain dietary protein intake consistent with baseline intake
* Willingness to abstain from hepatotoxic substances post-BMN 307 administration
* Willingness and capable per investigator opinion to comply with study procedures and requirements
* Willingness to use effective methods of contraception
* Plasma Phe levels \> 600 µmol/L

Exclusion Criteria:

* Subjects with primary BH4 deficiency or other forms of BH4 metabolism deficiency
* Clinically significant liver dysfunction or disease
* Prior treatment with gene therapy
* Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study
* History of malignancy

Primary outcomes:
measure: Change from baseline in mean Plasma Phe levels
timeFrame: baseline, week 12
Secondary outcomes:
measure: Change from baseline in mean Plasma Phe levels
timeFrame: baseline, week 96
measure: Change from baseline in dietary protein intake from intact food
timeFrame: baseline, week 96
measure: Number of participants with treatment-emergent adverse event
timeFrame: At 5 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
Study officials:
affiliation: BioMarin Pharmaceutical
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00055367: Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
Official title: A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2003-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352.


Eligibility criteria: Male and female patients, 12-17 years of age, who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Females must not be breastfeeding or pregnant, and must not become pregnant during the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai IBD Center
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Mass General Hospital for Children, Pediatric GI & Nutrition
state: Massachusetts
city: Boston
country: United States
facility: The Children's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Sick Children
city: London
country: United Kingdom
facility: Royal Free Medical School
Study officials:
References:
Clinical trial NCT01292967: Influence of Sugar on the Bioavailability of Cocoa Flavanols
Official title: The Influence of Maltitol on the Absorption and Metabolism of Flavanols From Chocolate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Flavanol
cocoa
maltitol
absorption
metabolism
chocolate
food matrix
bioavailability
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary propose of this study is to determine the impact of ingredients and matrices on flavanol absorption and metabolism.

Detailed description: The investigators have conducted a randomized, triple-blind, cross-over study in 15 healthy human volunteers to investigate the absorption and metabolism of cocoa flavanols from a high-flavanol chocolate made with added sugar and a high-flavanol chocolate containing the sugar substitute maltitol; a nutrient-matched low flavanol control product was also fed. All products were matched for macro-nutrients, as well as for alkaloids (theobromine and caffeine), and were similar in taste and appearance. Both high-flavanol products contained \~259 mg cocoa flavanols, whilst the low-flavanol chocolate contained 48 mg of cocoa flavanols. On each study day, subjects were cannulated and baseline blood samples were collected prior to consumption of any of the test chocolates. Additional blood samples were collected at 1, 2 and 4 hours and plasma levels of flavanols were assessed using HPLC with fluorescence detection. All test products were well-tolerated by study participants.

Eligibility criteria: Inclusion Criteria:

* a signed consent form
* age of 18-50 years inclusive

Exclusion Criteria:

* did not suffer from any form of disease, including liver disease, diabetes mellitus or a myocardial infarction
* not on medications for the treatment of hypertension, elevated lipids or diabetes (type I and II).
* did not suffered gall bladder problems or abnormalities of fat metabolism
* weight reducing dietary regimen or taking any dietary supplements, including dietary fatty acids
* did not consume more than 15 units (120g) of alcohol per week
* did not have sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten.
* Vegetarians and vegans
* taken antibiotics in the last 8 weeks

Primary outcomes:
measure: Impact of ingredients and matrices on flavanol absorption and metabolism.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06219967: Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy
Official title: Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy: A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overdose
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Activated charcoal (AC) is an established, effective means of gastrointestinal decontamination. Providers give it to patients who have ingested something that is thought to be potentially poisonous to prevent it from being absorbed. However, one limitation to its use is palatability of the AC for the patient, potentially limiting how much, if any, is taken.

Other studies have suggested that mixing AC with various substances improves the rating on various scales (taste, etc). An important question is whether mixing the AC with other substance effects the ability of the AC to bind to xenobiotic in the gut. This small study investigates whether mixed cola with charcoal affected its ability to prevent the absorption of acetaminophen. It also performs a survery to see if participants preferred the AC-cola mixture. The investigators hypothesize that the AC will be equally as effective with cola as without. The investigators also hypothesize that participants will prefer the AC-cola mixture.


Eligibility criteria: Inclusion Criteria:

* No self-reported history of any hepatic, gastrointestinal, or renal disease
* No self-reported history of alcohol or substance use disorder
* No daily prescribed medications
* Weight between 60-93 kg

Exclusion Criteria:

* pregnant,
* imprisoned
* allergy or intolerance to acetaminophen or gluten

Primary outcomes:
measure: Absorption of Acetaminophen as Indicated by Area Under the Curve
timeFrame: 240 minutes
measure: Maximum Concentration Acetaminophen
timeFrame: 240 minutes
measure: Time to Maximum Concentration of Acetaminophen
timeFrame: 240 minutes
Secondary outcomes:
measure: Appeal of Charcoal Mixture
timeFrame: 5 minutes
measure: Smell of Charcoal Mixture
timeFrame: 5 minutes
measure: Flavor of Charcoal Mixture
timeFrame: 5 minutes
measure: Texture of Charcoal Mixture
timeFrame: 5 minutes
measure: Overall Appeal of Charcoal Mixture
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Clinical Research Unit
state: New York
Study officials:
References:
Clinical trial NCT06927167: Effect of Exercises on Forward Head Posture
Official title: The Effect of Chin Tuck Exercises and Cervical Extension Exercises on Forward Head Posture
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postural; Defect
Keywords: Forward Head Posture, chin tuck exercises.
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Study aims to evaluate the effectiveness of chin tuck exercises in improving forward head posture.

To assess the impact of cervical extension exercises on forward head posture. To determine which exercise protocol provides superior results for FHP

Detailed description: The study focus on understanding Forward head posture (FHP). Forward head posture (FHP) is a common musculoskeletal disorder characterized by a shift of the head forward in relation to the vertical axis of the body. This condition increases the load on the cervical spine, causing discomfort, pain and impaired musculoskeletal function. The incidence of FHP has increased significantly due to sedentary lifestyles and prolonged use of electronic devices, making it a pressing problem for healthcare providers.

Eligibility criteria: Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Adults aged 30-45 years with diagnosed forward head posture.
* Chronic nonspecific neck pain for at least 3 months.
* FHP diagnosed via craniovertebral angle measurement.

Exclusion Criteria:

* Participants fall in this category would be excluded of the study.
* History of cervical spine surgery or trauma.
* Severe cervical instability or neurological deficits.
* Systemic diseases affecting posture.

Primary outcomes:
measure: Craniovertebral angle measurement
timeFrame: 4 weeks
Secondary outcomes:
measure: Numerical Pain Rating Scale (NPRS) for pain.
timeFrame: 4 weeks
Other outcomes:
measure: Neck Disability Index (NDI) for functional outcomes.
timeFrame: 4 weeks
Locations:
city: Malakand
country: Pakistan
facility: Riphah international University malakand campus
state: KPK
Study officials:
affiliation: Riphah International University
name: Ataur Rahman, MS-PT
role: PRINCIPAL_INVESTIGATOR
References: