louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02629705: Study of Carrageenan's Effect on Insulin Resistance in Humans
Official title: Investigation of the Effect of Carrageenan as Food Additive on Insulin Resistance in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Insulin Resistance
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the ingestion of the common food additive carrageenan contributes to insulin resistance and thus to the pathogenesis of type 2 diabetes in humans.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) 18.5 - 29.9 kg/m²

Exclusion Criteria:

* any chronic illness
* any ongoing medication
* known infections
* known liver disease
* known renal insufficiency
* alcohol consumption over 30 g/d
* shift work

Primary outcomes:
measure: Insulin sensitivity assessed by oral glucose tolerance test (OGTT): Matsuda index
timeFrame: 2 weeks
measure: Insulin sensitivity assessed by hyperinsulinemic clamp: M-value
timeFrame: 2 weeks
Secondary outcomes:
measure: Endogenous glucose production measured by tracer-method
timeFrame: 2 weeks
measure: Cerebral insulin sensitivity measured by MRI
timeFrame: 2 weeks
measure: Intrahepatic triglyceride content
timeFrame: 2 weeks
measure: Glycemia during OGTT
timeFrame: 2 weeks
Other outcomes:
measure: Intestinal permeability
timeFrame: 2 weeks
measure: Intestinal microbiome constitution
timeFrame: 2 weeks
measure: Markers of systemic inflammation including lymphocyte activation, cytokines and adipokines
timeFrame: 2 weeks
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Internal Medicine
Study officials:
affiliation: University of Tübingen, Department of Internal Medicine
name: Robert Wagner, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05301205: Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption
Official title: Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gabapentin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gabapentin, a structural analog of gamma aminobutyric acid (GABA), was introduced within the us as an anticonvulsant, used clinically to treat epilepsy. The drug causes amino acids release within the medulla spinalis dorsal horn and thus decreasing response to neural inputs and stabilizing the nervous activity. The mechanism of action of gabapentin on neuropathic pain is assumed to bind to the alpha 2 delta subunit of the voltage-dependent calcium channel within the central systema nervosum , reducing calcium influx into the nerve terminals and decreases the release of neurotransmitters like glutamate . Gabapentin, therefore, can be used for controlling chronic pain, as in diabetic neuropathy and other neuropathic disorders . Some studies examined the effectiveness of gabapentin for acute postoperative pain management for gynecological surgery, lumbar spinal surgery, arthroplasty, and thoracic surgery . A recent study concluded that gabapentin has a role in preoperative anxiolysis, attenuation of hemodynamic response to intubation, prevention of postoperative nausea and vomiting (PONV) and finally postoperative delirium . Up to date, the effect of preoperative gabapentin on inhaled anesthetic depth is unknown


Eligibility criteria: 1. Inclusion criteria:

   * Patients aged from 18 to 60 years.
   * ASA I-II.
   * Undergoing craniotomy for intracranial tumors.
2. Exclusion criteria:

   * Patient refusal
   * Patients younger than 18 or above 60 years old
   * patients with (ASA) physical status ≥ III
   * patients with compromised cardiovascular, renal, hepatic or neurological function
   * Known allergy to study drug.
   * Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs
   * Suffered from severe psychiatric disease or drug addiction;
   * History of parenteral or oral analgesic intake within the last 48hours

Primary outcomes:
measure: sevoflurane consumption
timeFrame: 4 hours
Secondary outcomes:
measure: nalbuphine consumption
timeFrame: 24 hours
measure: Intraoperative fentanyl consumption.
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT02363205: Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression
Official title: Guided Internet-Delivered and Tailored Cognitive Behaviour Therapy for Adolescents With Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2015-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 15-19 years old
* Have symptoms of depression, major depression

Exclusion Criteria:

* Suicidal ideation
* Alcohol addiction
* other major primary psychiatric disorder
* Ongoing psychological treatment
* recent (during last 4 weeks) change in psychiatric medication

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
Secondary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
measure: The General Self-Efficacy Scale (GSE)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
measure: Subscale Life activites, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
measure: Knowledge of CBT strategies (developed by the research group)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
measure: The Mood and Feelings Questionnaire (MFQ)
timeFrame: Baseline, post treatment, 6 months- and 12 months post treatment
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
state: Östergotland
Study officials:
affiliation: Linkoeping University
name: Gerhard Andersson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Topooco N, Bylehn S, Dahlstrom Nysater E, Holmlund J, Lindegaard J, Johansson S, Aberg L, Bergman Nordgren L, Zetterqvist M, Andersson G. Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 1;21(11):e13393. doi: 10.2196/13393.
Clinical trial NCT04150705: PET/MR for Rectal Cancer Treatment Monitoring and Surveillance
Official title: A Pilot Study of PET/MR for Rectal Cancer Treatment Monitoring and Surveillance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Cancer of the Rectum
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of pilot study is to assess the feasibility of FDG-PET/MRI for monitoring rectal cancer disease status in the setting of rectal cancer non-operative management (NOM). Data from this study will be used to guide the design of future clinical trials involving FDG-PET/MRI for rectal cancer NOM.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Biopsy-proven rectal adenocarcinoma of the rectum with clinically suspected or previously known stage I-IIIB (cT1-4, N0-2, M0) disease
* Anticipated or prior chemoradiation as part of an NOM treatment strategy
* Ability to understand and willingness to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Prior surgical resection of rectal cancer (endoscopic or TME)
* Contraindication to MRI
* Comorbidities that would limit patient's ability to cooperate with a PET/MRI examination (e.g. dementia, inability to follow commands, claustrophobia, tremors, requirement for oxygen by nasal cannula, etc...).
* Implanted devices or materials that may interfere with MRI imaging or create significant artifact
* Pregnancy
* Contraindication to gadolinium contrast or FDG
* End-stage renal disease

Primary outcomes:
measure: Technical Feasibility of PET/MRI as Measured by the Completion of the Study With Acceptable Image Quality in ≥70% of Scans
timeFrame: Up to 12 months after completion of enrollment of all patients (26 months)
Secondary outcomes:
measure: Percentage of Scans With Changes in Perceived Disease Status as Measured by PET/MRI Tumor Regression Grade Relative to the Conventional MRI Only Tumor Regression Grade
timeFrame: Up to 12 months after completion of enrollment of all patients (26 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tyler Fraum, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00603005: Adherence Improvement in Glaucoma Patients
Official title: Adherence Improvement in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Adherence
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2008-01-28
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.


Eligibility criteria: Inclusion Criteria:

* Diagnosis glaucoma or ocular hypertension
* Treatment with travoprost or travoprost/timolol

Exclusion Criteria:

* High risk of side effects expected from travoprost or travoprost/timolol
* Absolute inability to administer eye drops
* Difficulty in reading or speaking Dutch

Primary outcomes:
measure: Intraocular pressure
timeFrame: 6 months
Secondary outcomes:
measure: Information with regard to the use of eye drops from data generated by the TravAlert dosing system
timeFrame: 6 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medisch centrum Alkmaar
city: Assen
country: Netherlands
facility: Wilhelmina ziekenhuis
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: den Bosch
country: Netherlands
facility: Jeroen Bosch ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Gouda
country: Netherlands
facility: Groene hart ziekenhuis
city: Heerenveen
country: Netherlands
facility: ziekenhuis de Tjongerschans
city: Heerlen
country: Netherlands
facility: Atrium medisch centrum
city: Hoorn
country: Netherlands
facility: Westfries gasthuis
city: Maastricht
country: Netherlands
facility: University hospital
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus medisch centrum
city: Zwolle
country: Netherlands
facility: Isala klinieken
Study officials:
affiliation: Maastricht University Medical Center
name: Helena J Beckers, MD/phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04746105: A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
Official title: A Study to Evaluate the Respiratory Safety of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Patients with Mild Obstructive Sleep Apnea Hypopnea
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.


Eligibility criteria: Inclusion Criteria:

* Japanese male and female, age 20 years or older at the time of informed consent
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder
* Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea
* Patients with percutaneous arterial oxygen saturation (SpO2) \<94% by pulse oximetry at visit 1
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Least square mean difference of Apnea hypopnea index (AHI) from placebo
timeFrame: Day 1
Secondary outcomes:
measure: Least square mean difference of the mean SpO2 in total sleep time from placebo
timeFrame: Day 1
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Direcoter
role: STUDY_DIRECTOR
References:
Clinical trial NCT02066805: Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
Official title: Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: XGEVA Off-label Use
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: University of Aarhus
First posted: 2014-02-20
Enrollment: 142
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 include 108-200 patients who receive a prescription in secondary care of XGEVA during the first year after the initial market availability. These patients will be identified from the Danish National Registry of Patients and other sources in the Northern Jutland Region and Copenhagen.

Brief summary: This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.


Eligibility criteria: Inclusion Criteria:

The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.

Exclusion Criteria:

n/a

Primary outcomes:
measure: on or off label individual prescription type
timeFrame: 12 months
measure: on or off label patient treatment
timeFrame: 12 months
Secondary outcomes:
measure: type of off-label use
timeFrame: 12 months
measure: off-label use stratified by administering department
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03284905: Probiotic Intervention for Acute Stress
Official title: Probiotic Intervention for Acute Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Efficacy of probiotics on acute stress


Eligibility criteria: Inclusion Criteria:

* 19-35 years
* SMBQ-score ≥3.75
* Understand Swedish in spoken and written terms
* Willing and able to give written informed consent for participating in the study
* Intake of probiotics within two weeks prior to the start of the study

Exclusion Criteria:

* BMI\> 30
* Pregnant
* Antibiotic treatment in the last three months
* Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness
* Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment

Primary outcomes:
measure: Reduction of the cortisol level during acute stress
timeFrame: 2.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Food Technology, Engineering and Nutrition, Lund University
Study officials:
References:
Clinical trial NCT02044705: Impact of Active and Healthy Families
Official title: Impact of Active and Healthy Families (Familias Activas y Saludables): A Family-Based Group Medical Appointment Model for Childhood Obesity in Federally Qualified Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Primary Health Care
Pediatrics
Obesity
Overweight
Clinical trial
Hispanic Americans
Family
Body mass index
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 55
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of the 10-week Active and Healthy Families (AHF) intervention on body mass index (BMI) in Latino youth aged 5-12 years.


Eligibility criteria: Inclusion Criteria:

* Aged 5-12 years
* Body mass index greater than or equal to the 85th percentile for age and sex
* Patients seen at Contra Costa County clinics participating in Active and Healthy Families
* Spanish speaking
* Parent of participant

Exclusion Criteria:

* Previous participation in Active and Healthy Families

Primary outcomes:
measure: Changes from baseline in body mass index (BMI)
timeFrame: Baseline and at week 10
Secondary outcomes:
measure: Change from baseline in blood glucose
timeFrame: Baseline and week 10
measure: Changes from baseline in fasting lipids
timeFrame: Baseline and week 10
measure: Change from baseline in insulin resistance
timeFrame: Baseline and week 10
measure: Change from baseline in blood pressure
timeFrame: Baseline and week 10
Other outcomes:
measure: Change in parent weight
timeFrame: Baseline and week 10
Locations:
city: Pittsburg
country: United States
facility: Pittsburg Health Center
state: California
city: San Pablo
country: United States
facility: West County Health Center
state: California
Study officials:
affiliation: University of California, Berkeley
name: Kristine A Madsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381405: A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)
Official title: A Randomized Open Label Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diarrhea
Lead sponsor: GenesisCare USA
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 7
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: This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI\*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.


Eligibility criteria: Inclusion Criteria:

1. Patients with any combination of therapies including radiation therapy alone, chemotherapy alone, TKI alone, or any combination are eligible.
2. This includes patients with therapies including Xeloda (capecitabine), Camptosar (irinotecan) or 5-FU (fluorouracil) with cancer.
3. Patients who have been diagnosed with a CID CTCAE toxicity of grade 3 or higher
4. Patients must be at least 18 years of age.
5. ECOG performance status 0-2.
6. Patients must have diarrhea symptoms, judged secondary to the systemic therapy, combined systemic therapy, and/or radiation, and must be requiring loperamide or similar (Imodium®) for symptom management. For the purposes of this study, diarrhea will be defined as three or more loose or liquid stools per day or loose watery stool (greater volume of stool) that occur more frequently than usual and lasting for more than three days.

Exclusion Criteria:

1. ECOG performance status 3 or greater.
2. Pregnant and/or breast-feeding women
3. Pre-menopausal subjects as well as subjects with ovarian radiation or concomitant treatment with an LH-RH agonist/antagonist must have a negative pregnancy test and agree to use an adequate method of contraception as recommended by their treating physicians
4. Post-menopausal status is defined either by:

   1. age ≥55 years and one year or more of amenorrhea,
   2. age \<55 years and one year or more of amenorrhea with an estradiol assay \<20 pg/mL
   3. bilateral oophorectomy
   4. CID CTCAE grade 1 or 2 (not requiring Loperamide or similar)

Primary outcomes:
measure: Patient reported gastrointestinal (GI) symptoms using EPIC
timeFrame: 12 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: 21st Century Oncology
state: Florida
Study officials:
References: