louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00950638: A Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
Official title: A Phase I Study to Establish the Safety and Tolerability of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Age-Related Macular Degeneration
Keywords: AMD
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

Dry AMD (drusen and/or geographic atrophy) in both eyes

Exclusion Criteria:

* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.

Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past twelve (12) weeks.

History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.

Any of the following underlying diseases including:

* Diabetic retinopathy
* History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV ), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
* History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
* Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or status post renal transplant or receiving dialysis) or hepatic function. Subjects with results outside these ranges may be enrolled in consultation with Ophthotech.
* Stroke (within 12 months of trial entry).
* Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.

Women who are pregnant or nursing. Known serious allergies to the fluorescein dye used in angiography or to the components of the ARC1905 formulation.

Primary outcomes:
measure: Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Ophthotech
state: New York
Study officials:
References:
Clinical trial NCT04459338: A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Official title: A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-07-07
Enrollment: 11
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in the control of blood sugar level by enhancing insulin secretion from the pancreas after eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the response to elevated glucagon concentrations.

Detailed description: Glucagon within the islet can signal the β-cell through GLP1R, and acts as an insulin secretagogue. This signaling is blocked by exendin-9,39. The relative importance of glucagon signaling through its cognate receptor or through GLP1R is unknown. Despite the lower affinity of GLP1R for glucagon, intra-islet concentrations of glucagon are sufficiently high to stimulate GLP1R. The other situation where this may occur is in response to pharmacologic doses of glucagon as used for β-cell function testing or raising peripheral glucagon concentrations above fasting values. The experiments proposed will characterize the role of GLP1R in glucagon's actions on the β-cell and the potential therapeutic role of dual (GLP-1R and glucagon receptor) agonists for the treatment of T2DM and obesity.

Eligibility criteria: Inclusion Criteria:

* 20 weight-stable, non-diabetic subjects

Exclusion Criteria:

* Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
* HbA1c ≥5.9%
* Use of glucose-lowering agents.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.

Primary outcomes:
measure: Insulin Secretion Rate During Exendin-9,39 Infusion vs. Insulin Secretion Rate During Saline Infusion
timeFrame: Area under the curve was quantified at the end of the Saline Study and at the end of the Exendin-9,39 study
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01517438: Effects of Serotonin Inhibitors on Patient-controlled Analgesia Related Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation
Keywords: agitation, desflurane, children
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or adenoidectomy in children


Eligibility criteria: Inclusion Criteria:

* tonsillectomy or adenoidectomy

Exclusion Criteria:

* development delay,
* CNS abnormality

Primary outcomes:
measure: agitation score
timeFrame: 30 minutes after postoperatuib
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04433338: The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
Official title: The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Morbid Obesity
Keywords: Bariatric surgery
Morbid Obesity
Weight Loss
Diet
RYGB
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 80
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: Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are still conflicting.

This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.


Eligibility criteria: Inclusion Criteria:

* Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
* Able to prepare the meal replacements at home

Exclusion Criteria:

* Undergoing another bariatric procedure than primary RYGB.
* Diabetes Mellitus
* Contraindication for the usage of Modifast meal replacements:

  * Allergy or intolerance to any substance in the used meal replacements (Soy, milk, gluten, egg, peanuts, nuts and seeds)
  * Veganism
  * Kidney failure (GFR \< 90 ml/min/1.73m2), liver failure or cardiac insufficiency
  * A heart attack (myocardial infarct) in the past twelve months
  * Cancer
  * Hypokalaemia: serum potassium level \<3.4 mmol/l
  * Phenylketonuria \& Porphyria

Primary outcomes:
measure: Operative time of the RYGB procedure
timeFrame: surgery
Secondary outcomes:
measure: Ease of the RYGB procedure
timeFrame: surgery
measure: Appearance of the patient's liver
timeFrame: surgery
measure: Post-operative weight loss
timeFrame: 4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery
Other outcomes:
measure: Feasibility of the diet
timeFrame: During the 14-day intervention period
measure: Compliance of the diet
timeFrame: During the 14-day intervention period
measure: Complication rate
timeFrame: First 30 days post-surgery
measure: Wound healing
timeFrame: 4 weeks
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Vitalys, part of Rijnstate hospital/Wageningen University
name: Eric J Hazebroek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06795438: Effects of Green Tea on Cardiometabolic Outcomes
Official title: Effects of Green Tea Supplementation on Cardiometabolic Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Green tea may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Between 18 \& 65 years
* Non-smoker
* BMI \< 30
* Able to give informed consent

Exclusion Criteria:

* Pregnancy
* Diabetes or any other metabolic/ uncontrolled hypertensive conditions
* Food allergies to quercetin
* Habitual consumption of quercetin
* Not regularly taking medication or antioxidant supplements

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline
measure: Systolic blood pressure
timeFrame: 20 days
Secondary outcomes:
measure: Diastolic blood pressure
timeFrame: Baseline
measure: Diastolic blood pressure
timeFrame: 20 days
measure: Percent bodyfat
timeFrame: Baseline
measure: Percent bodyfat
timeFrame: 20 days
measure: Waist to hip ratio
timeFrame: Baseline
measure: Waist to hip ratio
timeFrame: 20 days
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 20 days
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 20 days
measure: Triglyceride glucose index
timeFrame: Baseline
measure: Triglyceride glucose index
timeFrame: 20 days
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: Baseline
measure: Blood cholesterol (Total, HDL & LDL)
timeFrame: 20 days
measure: Coop-Wonka chart
timeFrame: Baseline
measure: Coop-Wonka chart
timeFrame: 20 days
measure: Beck Depression Inventory
timeFrame: Baseline
measure: Beck Depression Inventory
timeFrame: 20 days
measure: State Trait Anxiety Inventory
timeFrame: Baseline
measure: State Trait Anxiety Inventory
timeFrame: 20 days
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 20 days
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: 20 days
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Epworth Sleepiness Scale
timeFrame: 20 days
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References:
Clinical trial NCT02151838: The Thai Red Cross Society Prevention of Mother-To-Child Transmission of HIV (TRCS PMTCT) Program
Official title: The Thai Red Cross AIDS Research Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT
Keywords: HIV-infected pregnant women who request HAART from the TRCSPMTCT
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 250
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be HIV-infected pregnant women who request HAART from the TRCS PMTCT program. These pregnant women will be under the care of the health care teams in 30 hospitals throughout Thailand which have registered with the TRCS PMTCT program since April 2004

Brief summary: To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for the Prevention of Mother-To-Child Transmission of HIV (PMTCT)

Detailed description: 1. To describe characteristics of HIV-infected pregnant women who request HAART from the Thai Red Cross Society PMTCT (TRCS PMTCT) program
2. To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART
3. To study adverse events in infants born to women who receive HAART during pregnancy
4. To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission
5. To establish the pilot model of care for HIV-infected pregnant women in middle income country

Eligibility criteria: Inclusion Criteria:

Volunteers meeting all of the following criteria will be considered eligible for enrollment in the study:

1. HIV-infected pregnant women (as defined by the hospital)
2. Choose to start HAART according to protocol and do not want to receive antiretroviral treatment provided by the other health care systems
3. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
4. Availability for follow-up for the planned study duration

Exclusion Criteria:

Volunteers meeting any of the following criteria will be excluded from the study:

1.Persons who have a history of a medical or psychiatric disorder by interview and physical examination according to standard practices, that in the judgment of the treating physician, would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

Primary outcomes:
measure: HIV-infected pregnant women
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: The Thai Red Cross AIDS Research Centre
state: Bangkok
Study officials:
References:
Clinical trial NCT06289738: ICF in Takayasu Arteritis
Official title: Problem Analysis Based on the International Classification of Functioning, Disability and Health in Patients With Takayasu Arteritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Takayasu Arteritis
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim was to analyze the problem in patients with Takayasu Arteritis based on the International Classification of Functioning, Disability and Health.The sample of our study will consist of individuals between the ages of 18-65 who have been diagnosed with Takayasu Arteritis by rheumatologists and are followed by Pamukkale University Rheumatology Clinic.


Eligibility criteria: Inclusion Criteria:-Being between the ages of 18-65

* Volunteering to participate in the study
* Being diagnosed with Takayasu Arteritis by a rheumatologist

Exclusion Criteria:- Having another disease that affects your physical condition

* Having cognitive impairment that makes it difficult to cooperate
* Being pregnant
* Having a neurological disease
* Having had any surgery in the last year
* Having another concurrent rheumatic disease

Primary outcomes:
measure: 6 open-ended questions
timeFrame: 25 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Elif Gur Kabul
Study officials:
References:
Clinical trial NCT01807338: A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease
Official title: A Follow-up Study on Safety and Tolerability and Pharmacodynamic Effect, of Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Who Have Previously Been Treated With sNN0031, Using an Implanted Catheter and a SynchroMed® II Pump
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Newron Sweden AB
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
name: TFS Trial Form Support
First posted: 2013-03-08
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with idiopathic PD of moderate severity who have completed participation in study sNN0031-001.

Brief summary: The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001


Eligibility criteria: Inclusion Criteria:

* Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001
* The patient has a diagnosis of idiopathic PD
* The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
* The patient has provided written informed consent to participate in the follow-up study

Exclusion Criteria:

* The patient has been included or participates in another clinical study after participation in Study sNN0031-001
* The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation).
* Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Neurology, Skåne University Hospital
Study officials:
References:
Clinical trial NCT01106638: A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
Official title: A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
HIV Infections
AIDS
Keywords: HIV
AIDS
Smoking
Tobacco
Cessation
Tobacco use in persons living with HIV/AIDS
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: Yale University
First posted: 2010-04-20
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.


Eligibility criteria: Inclusion Criteria:

* HIV-infection
* current cigarette smoker
* high motivation to quit

Exclusion Criteria:

* Pregnancy
* breastfeeding

Primary outcomes:
measure: Three month point-prevalence abstinence from cigarettes
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Three month continuous abstinence from cigarettes
timeFrame: Three months post-intervention
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Jonathan Shuter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shuter J, Pearlman BK, Stanton CA, Moadel AB, Kim RS, Weinberger AH. Gender Differences among Smokers Living with HIV. J Int Assoc Provid AIDS Care. 2016 Sep;15(5):412-7. doi: 10.1177/2325957416649439. Epub 2016 May 23.
citation: Moadel AB, Bernstein SL, Mermelstein RJ, Arnsten JH, Dolce EH, Shuter J. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):208-15. doi: 10.1097/QAI.0b013e3182645679.