louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05698030: Efficacy and Saffety of Oral Immunotherapy to Pistachio
Official title: Efficacy of Oral Immunotherapy to Pistachio in Children on the Oral Tolerance to Pistachio and Cashew Nuts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Food Allergy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients meeting the inclusion criteria (between 10 and 50)

Brief summary: The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the Nancy University Hospital.
* Patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022

Exclusion Criteria:

* Patients who have received oral immunotherapy to pistachio for less than 18 months.
* Patients lost to follow-up for more than 2 years or last consultation dating from 2020 or earlier

Primary outcomes:
measure: Absence of moderate to severe allergic reactions
timeFrame: during the 6 months of maintenance
Secondary outcomes:
measure: Frequency and severity of allergic reactions
timeFrame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
measure: Decrease in specific IgE and increase of IGg4 to pistachio
timeFrame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
measure: Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of pistachio
timeFrame: 3 months after stopping daily consumption of 2g pistachio
measure: Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut
timeFrame: 3 months after stopping daily consumption of 2g pistachio
measure: Reactogenic or tolerogenic threshold of cashew nuts
timeFrame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalo-Universitaire de Nancy
Study officials:
affiliation: Centre hospitalo-universitaire de Nancy
name: Amandine DIVARET-CHAUVEAU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573530: We Walk Plus Study for Older Adults With Intellectual Disabilities
Official title: We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Keywords: physical activity
walking
older adults with an intellectual disability
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants are randomized to the intervention or control group
Primary purpose: OTHER

Brief summary: Determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities (ID).

Detailed description: We Walk Plus study consists of: (1) a user friendly physical activity tracker (i.e., Fitbit Charge HR ); (2) user-centered social networking (e.g., Fitbit community); and (3) the iCardia platform for monitoring daily Fitbit physical activity and wear time and sending personalized text-messages targeting physical activity and self-efficacy. The specific aims of this two-arm RCT pilot are to: 1) assess the feasibility and acceptability of the We Walk Plus intervention and 2) explore the preliminary efficacy of We Walk Plus on physical activity and well-being.

Eligibility criteria: Inclusion Criteria:

* Men and women with mild or moderate intellectual disabilities;
* ages 35-60;
* able to speak, read English and willing to provide consent to enroll;
* able to follow instructions and walk, physically inactive;
* willing to receive SMS, wear Fitbit throughout the study;
* living with family or in a community residence;
* support persons are willing to assist participants to ensure the Fitbit functions properly.

Exclusion Criteria:

* Inability to follow instructions;
* diagnosis of coronary disease or uncontrolled hypertension, smokers, physically active;
* participating in a health promotion program;
* having mental illness or behavior problems;
* support persons unable or unwilling to assist participants with Fitbit devices, if needed.

Primary outcomes:
measure: Physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Cardiovascular fitness
timeFrame: 12 weeks
measure: Self-efficacy to physical activity
timeFrame: 12 weeks
measure: Attention & executive function
timeFrame: 12 weeks
measure: Working memory
timeFrame: 12 weeks
measure: Executive function
timeFrame: 12 weeks
measure: Processing speed
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: New Lenox
country: United States
facility: Trinity Services Inc.
state: Illinois
Study officials:
References:
Clinical trial NCT06303830: Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate
Official title: Changes Induced by Bariatric Surgery in Cardiovascular Responses to Dietary Supplementation With Sodium Nitrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate.


Eligibility criteria: Inclusion Criteria:

* For volunteers who underwent bariatric surgery:

  1. Female;
  2. Age over 18 years old and under 60 years old;
  3. Having had bariatric surgery more than 1 and a half years ago;
  4. Present stabilized weight loss;
* For voluntary controls:

  1. Female;
  2. Age over 18 years old and under 60 years old;

Exclusion Criteria:

* For volunteers who underwent bariatric surgery and controls:

  1. Having uncontrolled blood pressure (above 160/100 mmHg), even with use regulate up to two antihypertensive agents;
  2. Hypertensive patients must be using a maximum of two antihypertensives;
  3. Have Diabetes Mellitus or other endocrinopathy;
  4. Have kidney or liver failure;
  5. Individuals who smoke.

Primary outcomes:
measure: Assess changes in s-nitrosothiols
timeFrame: 14 days
Secondary outcomes:
measure: Assess changes in blood pressure
timeFrame: 14 days
measure: Assess changes in endotelial function
timeFrame: 14 days
measure: Assess changes in Vascular stiffness
timeFrame: 14 days
measure: Assess changes in nitrate concentration
timeFrame: 14 days
measure: Assess changes in nitrite concentration
timeFrame: 14 days
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão
state: São Paulo
Study officials:
References:
Clinical trial NCT02376530: Price Changes and Nutrient Profiling Among Adult Grocery Shoppers
Official title: Price Changes and Nutrient Profiling Among Adult Grocery Shoppers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Food Purchases
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 788
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the research is to examine the association between price changes, nutrient profiling, and grocery food purchases among household grocery shoppers.

Detailed description: Participants will be asked to select a week's worth of groceries for their household from a virtual online grocery store. Shoppers will be randomly assigned to one of four conditions (control, nutrient profiling, price change, nutrient profiling and price change).

Eligibility criteria: Inclusion Criteria:

* primary household grocery shopper
* at least 19 years old
* one or more child (2-18yrs) living full time in the household

Exclusion Criteria:

* not the primary household grocery shopper
* no dietary, medical, or psychopathology conditions that could interfere with the study
* under the age 19
* no children (2-18yrs) living full time in the household

Primary outcomes:
measure: Nutritional Quality of Food Purchases
timeFrame: Participants were followed for one shopping session, an average of 2.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Leonard Epstein, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02433730: Testosterone Therapy in Hypogonadal Men Treated With Opioids
Official title: The Effect of Testosterone Replacement in Patients With Hypogonadotrophic Hypogonadism Due to Opioid Treatment for Non-malignant Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy of testosterone replacement therapy in men with low testosterone due to opioid treatment on body composition, the haemostatic system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids, sexual function and quality of life.

Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40 patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20 patients per arm

A double blinded randomized placebo controlled trial

Detailed description: The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4 ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.

Outcome measures will be evaluated at 0 and 14 weeks.

Eligibility criteria: Inclusion Criteria:

* Male patients 18-75 years
* Treatment with opioid for \>3 months, daily dose \>50-100 mg
* Total testosterone \< 12 mmol/L
* Follicle Stimulating Hormone (FSH)/Luteinizing Hormone (LH) levels normal og below normal laboratory values
* Normal prolactin levels

Exclusion Criteria:

* Hematocrit\> 54% at screening
* Prostate Specific Antigen (PSA) \> 3 ng/ml
* Severe organic and mental disease
* current or present cancer diagnosis
* Previous venous thrombotic embolism and cerebrovascular disease
* Uncontrolled hypertension
* Epilepsy or migraine not adequately controlled by therapy
* Severe benign prostate hypertrophy with symptom score \>19
* Sleep apnea
* Alcohol or drug abuse
* Implantation of sustained action sex hormone in the last 12 months
* Use of oral, buccal or transdermal testosterone in the last two weeks
* Treatment with glucocorticoids \> 5 mg/day or 5 alfa reductase inhibitors
* Hypersensitivity to Nebido

Primary outcomes:
measure: lean body mass
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Odensen
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT02511730: Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm Full Field Digital Mammography (FFDM) Plus Digital Breast Tomosynthesis (DBT) Versus FFDM Alone in the Detection of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Mammography
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

Detailed description: This pilot reader study was to determine the following:

1. the radiologist's performance metrics for the two reading modalities, i.e., "FFDM read on the Aspire Bellus workstation" and "FFDM read in conjunction with DBT read on the Aspire Bellus workstation",;
2. the magnitude and direction of differences between performance metrics for the two modalities; and
3. variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.

Eligibility criteria: Inclusion Criteria:

* Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

* Subjects with unknown clinical status not participating in FMSU004A protocol.

Primary outcomes:
measure: Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Limited (SMIL)
state: Arizona
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care, LLC (EWBC)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - at Chapel Hill
state: North Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Fujifilm Medical Systems USA, Inc.
name: Robert M Uzenoff
role: STUDY_DIRECTOR
References:
Clinical trial NCT02314130: No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Official title: No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the effect of no-commercial enteral diet for patients in home nutritional therapy in anthropometric and biochemical indices comparing to patients using commercial enteral diets.


Eligibility criteria: Inclusion Criteria:

* patients in home nutritional therapy receiving no-commercial enteral diets

Exclusion Criteria:

* baseline diseases others than neurological

Primary outcomes:
measure: Recovery of malnourished patients (weight, height, arm circumference)
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal of University of Sao Paulo
name: Tania Morais, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santos VF, Morais TB. Nutritional quality and osmolality of home-made enteral diets, and follow-up of growth of severely disabled children receiving home enteral nutrition therapy. J Trop Pediatr. 2010 Apr;56(2):127-8. doi: 10.1093/tropej/fmp033. Epub 2009 May 19.
Clinical trial NCT06870630: Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
Official title: Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Diseases
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: - Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.

Detailed description: . Primary objective -

• To study the incidence of true reflux on 24 hour pH analysis with manual study.

Secondary objective -

* To analyse treatment success which is defined as Eckdart score \< 3 at follow up assessment ( 3rd month)
* To analyse the recovery of peristalsis after POEM using High resolution manometry
* To study total procedure time , intra operative adverse effects and duration of hospital stay.
* Severity of oesophagitis
* Presence of GERD symptoms based on GERD questionnaire \& Quality of life questionaire post procedure.

Eligibility criteria: Inclusion Criteria:

* Adult \>18 years
* Diagnosis of Type 2 Achalasia cardia based on High resolution manometry.

Exclusion Criteria:

* Patients with Type 1 \& 3 ACHALASIA CARDIA
* Patients with previous endoscopic or surgical treatment for achalasia
* Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio \> 1.5, platelet count \< 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.

Primary outcomes:
measure: Incidence of true reflux based on 24-hour pH impedence
timeFrame: 3 months
measure: Integrated Relaxation Pressure (IRP) at High resolution manometry test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology /Aig Hospitals
state: Telangana
Study officials:
affiliation: AIG Hospitals
name: Mohan Dr Ramchandani, MBBS MD
role: STUDY_DIRECTOR
affiliation: AIG Hospitals
name: Zaheer Dr Nabi, MBBS MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AIG Hospitals
name: Pradev Dr Inovolu, MBBS MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449930: Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
Official title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes


Eligibility criteria: General Inclusion Criteria:

* Patient has type 2 diabetes mellitus (T2DM)
* Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea
timeFrame: Baseline to Week 24
measure: Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea
timeFrame: Baseline to Week 24
measure: Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain
timeFrame: Baseline to Week 24
measure: Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, Goldstein BJ; Sitagliptin Study 049 Group. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Mar;12(3):252-61. doi: 10.1111/j.1463-1326.2009.01187.x. Epub 2009 Nov 25.