louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00803244: Safety and Efficacy on Phase III Study on 300 IR SLIT to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Official title: A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Disease
Keywords: allergic rhinoconjunctivitis
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 381
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

Detailed description: To assess the efficacy of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season on:

- The Average Adjusted Symptom Score (AASS).

To document the safety of the treatment.

Eligibility criteria: Inclusion criteria:

1. Male or female outpatients aged 12 to 65 years (inclusive).
2. Patients with grass pollen-related allergic rhinoconjunctivitis for at least the last two grass pollen seasons.
3. Positive SPT
4. RRTSS during the previous pollen season of greater than or equal to 12 out of a possible 18.

Exclusion Criteria:

1. Positive SPT to any other seasonal allergens present during the grass pollen season
2. Patients with clinically significant confounding symptoms of allergy to other allergens
3. Significant symptomatic perennial allergy due to an allergen to which the patient is regularly exposed.
4. Patients with moderate or severe persistent asthma (Global Initiative for Asthma \[GINA\] 3 or 4).

Primary outcomes:
measure: Average Adjusted Symptom Score (AAdSS)
timeFrame: Pollen period (average of 32.1 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Antony
country: France
facility: Stallergenes Sa
city: Montauban
country: France
facility: Hop Montauban
city: Orange
country: France
facility: Cab medical
city: Parma
country: Italy
facility: Azienda Ospedaliera
city: Caceres
country: Spain
facility: Complejo Hospitalario de Caceres
city: Madrid
country: Spain
facility: HGU La Paz
Study officials:
affiliation: NHC, Hôpitaux Universitaires de Strasbourg
name: DE BLAY Frédéric, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02317744: Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
Official title: Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.


Eligibility criteria: Inclusion Criteria:

* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
* BMI between 30 kg/m2 and 50 kg/m2
* Not taking anti-depressant medications
* Read English proficiently enough to read study assessments
* Available for duration of treatment plus follow-up period
* Able to travel to study location (New Haven, CT) for monthly visits
* Agree to study procedures

Exclusion Criteria:

* Medical status judged by study physician as contraindication
* History of seizures
* Past or current anorexia nervosa, bulimia nervosa
* Current medications that influence eating/weight
* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
* Pregnant or breastfeeding

Primary outcomes:
measure: Binge Eating Frequency (Continuous)
timeFrame: Post-treatment (at 3 months)
measure: Binge Eating Frequency (Continuous)
timeFrame: 6 month follow-up (an average of 6 months following treatment)
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Post-treatment (at 3 months)
measure: Body Mass Index (BMI)
timeFrame: 6 month follow-up (an average of 6 months following treatment)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos M Grilo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clin Ther. 2021 Jan;43(1):112-122.e1. doi: 10.1016/j.clinthera.2020.10.010. Epub 2020 Nov 18.
Clinical trial NCT04989244: Infertile Polycystic Ovary Syndrome (PCOS) Women With Obesity and Lifestyle Changes
Official title: Weight Loss Program in Infertile PCOS Women With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Slovenian Research Agency
First posted: 2021-08-04
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Infertile PCOS women with obesity were included into lifestyle change weight loss program prior to inclusion to IVF procedures. They attended group as well as individual workouts and they were advised on healthy eating.

Detailed description: The weight loss program will consist of dietary change and exercise program which will be performed 3 times weekly.

Eligibility criteria: Inclusion Criteria:

* BMI over 30 kg/m2
* PCOS
* Primary or secondary infertility
* normal partner's semen

Exclusion Criteria:

* Other identifiable causes of infertility

Primary outcomes:
measure: Body weight (kg)
timeFrame: 8 weeks
measure: BMI (kg/m2)
timeFrame: 8 weeks
measure: Waist circumference (cm)
timeFrame: 8 weeks
measure: Abdominal circumference (cm)
timeFrame: 8 weeks
Secondary outcomes:
measure: Spontaneous conception rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Division of gynecology, Department of human reproduction
Study officials:
References:
citation: Abdulkhalikova D, Sustarsic A, Vrtacnik Bokal E, Jancar N, Jensterle M, Burnik Papler T. The Lifestyle Modifications and Endometrial Proteome Changes of Women With Polycystic Ovary Syndrome and Obesity. Front Endocrinol (Lausanne). 2022 Jun 22;13:888460. doi: 10.3389/fendo.2022.888460. eCollection 2022.
Clinical trial NCT02780544: Infant-parent Skin-to-skin Contact During Screening for Retinopathy
Official title: Is There a Difference in Pain Score, Stress Response and Motor Repertoire in Infants Given Skin-to-skin Contact With the Mother/Father or Standard Care During Screening for Retinopathy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Keywords: Infant, premature
Pain
Stress, physiological
Stress, psychological
skin-to-skin contact
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2016-05-23
Enrollment: 34
Sex: ALL
Minimum age (years): 31
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced. Premature infants are therefore examined regularly after birth. However, the examination is painful and stressful for the infant. Painful experiences might lead to a pathological stress response later in life and should therefore be prevented.

In this study skin-to-skin contact with a parent is tested for relief of pain and stress in preterm infants being examined for retinopathy of prematurity.


Eligibility criteria: Inclusion Criteria:

* Infants \< 32 weeks of gestational age (\< 31+6 weeks)

Exclusion Criteria:

* Infants with ongoing analgesic treatment

Primary outcomes:
measure: pain score
timeFrame: during eye examination
Secondary outcomes:
measure: cortisol in saliva
timeFrame: 60 minutes after eye examination
measure: General movements
timeFrame: in 5 minutes after eye examination
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St.Olavs University Hospital
state: Trondelag
Study officials:
affiliation: St.Olavs University Hospital
name: Hakon Bergseng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristoffersen L, Stoen R, Bergseng H, Follestad T, Theodorsson E, Vederhus B, Adde L, Austeng D. Skin-to-skin contact during eye examination did not reduce pain compared to standard care with parental support in preterm infants. Acta Paediatr. 2019 Aug;108(8):1434-1440. doi: 10.1111/apa.14699. Epub 2019 Jan 18.
Clinical trial NCT00675844: An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment
Official title: An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment for 48 Weeks in Participants Who Have Completed 96 Weeks of Elvucitabine Therapy in Protocol ACH443-015 or 48 Weeks of Therapy in Protocol ACH443-018
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Extension study
HIV-1 infection
Treatment naive
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2008-05-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Extension study for participants currently participating in Protocols ACH443-015 and ACH443-018.

Detailed description: Human immunodeficiency virus (HIV)-1-infected, clinically stable, treatment-naïve adult participants who have completed 96 weeks of elvucitabine therapy and whose HIV ribonucleic acid (RNA) levels remain below 50 copies/milliliter (mL) at the 92-week assessment in Protocol ACH443-015 or participants who have completed 48 weeks of elvucitabine therapy and continue to maintain an HIV-1 RNA viral load below their baseline level upon entry into Protocol ACH443-018.

Eligibility criteria: Inclusion Criteria:

• Participants must have successfully completed 96 weeks of elvucitabine therapy in Protocol ACH443-015 or participants have completed 48 weeks of elvucitabine therapy in Protocol ACH443-014A-018 .

Exclusion Criteria:

* Participant has experienced virologic rebound as defined in Section 5.6.1.3 of Protocol ACH443-015.
* Participant has exceeded their Baseline HIV-1 RNA level by Week 44 as measured in Protocol ACH443-014A-018
* Participant is experiencing a drug-related Grade 3 or 4 rash or a drug-related Grade 3 or 4 laboratory toxicity other than Grade 3 or 4 cholesterol, triglyceride, creatinine kinase, or lactate dehydrogenase (LDH).

Primary outcomes:
measure: Determine Safety Profile Of Elvucitabine Measured By Incidence Of Study Discontinuations And Incidence, Severity, And Type Of Adverse Events And Clinically Significant Changes Or Abnormalities In Participant's Clinical Laboratory Results.
timeFrame: 48 months
Secondary outcomes:
measure: Determination Of The Continued Efficacy Of Elvucitabine As Measured By The Change In Helper T Cell (CD4) Count.
timeFrame: 48 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Clinical Trial Site
state: Florida
city: Pensacola
country: United States
facility: Clinical Trial Site
state: Florida
city: Newark
country: United States
facility: Clinical Trial Site
state: New Jersey
city: Austin
country: United States
facility: Clinical Trial Site
state: Texas
city: Dallas
country: United States
facility: Clinical Trial Site
state: Texas
Study officials:
References:
Clinical trial NCT04833244: Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use
Official title: Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Tree Number(s) C26.761.340 C26.803.063 C26.874.400
Unique ID D000070636
Lead sponsor: Manhattan Physical Medicine and Rehabilitation, LLP
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2021-04-06
Enrollment: 198
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled study in which the patient and investigator are blinded.
Primary purpose: DIAGNOSTIC

Brief summary: 170 patients with rotator cuff syndrome will be filmed abducting and flexing their arms before learning a simple maneuver that alleviates most of the pain 90% of the time. They will then be filmed performing the same abduction and flexion of their arms. The patients will rate their pain on the common 10-point pain scale after abducting and flexing their arms before and after the maneuver.

Detailed description: Facial expression and truncal metrics correlate strongly with occurrence and intensity of pain. Rotator cuff syndrome almost invariably gives significant pain, especially with abduction and flexion of the arms. A simple maneuver that alleviates that pain 90% of the time, by activating the subscapularis to perform the function of the damaged supraspinatus muscle. This study strives to correlate facial and truncal characteristics with the ten-point pain scale by correlating the filmed changes in facial and truncal characteristics with the variations in patient-rated pain before and after the pain-controlling maneuver.

Once effective, the maneuver may be repeated for a number of days, after which time patients generally remain pain-free permanently.

Eligibility criteria: Inclusion Criteria:

Rotator cuff syndrome -

Exclusion Criteria:

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

-

Primary outcomes:
measure: Correlation between facial expression parameters and patient pain-scale ratings
timeFrame: Outcome measured within 1 minute of intervention
measure: Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.
timeFrame: Outcome measured within 1 minute of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cara Cipriano
state: New York
Study officials:
References:
citation: "Yoga-Based Maneuver Effectively Treats Rotator Cuff Syndrome." Fishman, Loren M.; Wilkins, Allen N.; Ovadia, Tova; Topics in Geriatric Rehabilitation . 27(2):151-161, April/June 2011.
Clinical trial NCT03487744: Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
Official title: Comparison of the Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tube Feeding
Keywords: Tube Feeding
Diarrhea
Enteral Nutrition
Critically Ill
Surgical
Cardiovascular
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* admitted to SICU or CVICU requiring TF for enteral nutrition
* anticipated ICU stay and TF requirement \>72 hours

Exclusion Criteria:

* Contraindication to receiving one of the study TF formulations
* Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
* Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
* Presence of an ileostomy or colostomy
* History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea

Primary outcomes:
measure: Incidence of diarrhea at 72 hours
timeFrame: 72 hour
Secondary outcomes:
measure: Incidence of diarrhea at 14 days
timeFrame: 14 days
measure: Mean frequency of diarrhea days
timeFrame: 14 days
measure: Total number of diarrhea days
timeFrame: 14 days
measure: Mean diarrhea scores
timeFrame: 14 days
measure: Time at 75% or more of goal tube feeding rate
timeFrame: 14 days
measure: Incidence of hypokalemia
timeFrame: 14 days
measure: Incidence of perineal dermatitis
timeFrame: 14 days
measure: Number of Clostridium difficile assays sent
timeFrame: 14 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
References:
Clinical trial NCT00656344: Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
Official title: Cognitive Behavioral Treatment of Posttraumatic Stress Disorder Enhanced by Virtual Reality for Individuals With PTSD and Substance Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Substance Abuse
Keywords: PTSD
Substance Abuse
WTC attacks
Iraq War
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Between the ages of 18 and 70
* Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
* Diagnosed with PTSD symptoms
* Current substance abuse disorder or history of substance abuse disorder

Exclusion Criteria:

* Presence of current organic mental disorder
* Presence or history of schizophrenia, bipolar disorder or depression with psychotic features, delusional disorder
* Active suicidal ideation, intent, or plan
* Active homicidal ideation, intent, or plan
* Use of pacemaker
* Medically unstable
* History of seizures

Primary outcomes:
measure: posttraumatic stress symptomatology
timeFrame: prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment
Secondary outcomes:
measure: substance use symptomatology
timeFrame: prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: JoAnn Difede
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191644: Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
Official title: Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prediabetes
Type-2 Diabetes
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.

Detailed description: Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy.

Eligibility criteria: Inclusion Criteria:

* subjects who had IFG (100≤ fasting glucose \<126 mg/dL)
* or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)

Exclusion Criteria:

* current and/or past history of cardiovascular disease including angina
* liver or kidney dysfunction
* thyroid or pituitary disease
* pregnancy or lactation
* taking medications or supplements

Primary outcomes:
measure: Lp-PLA2 Activity in Plasma
timeFrame: Change from baseline in Lp-PLA2 at 12 weeks
measure: Lp-PLA2 Activity in PBMC
timeFrame: Change from baseline in Lp-PLA2 at 12 weeks
Secondary outcomes:
measure: PBMC metabolites
timeFrame: Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)
Other outcomes:
measure: LDL particle size
timeFrame: Changes from baseline in LDL particle size at 12 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Song G, Kang M, Yoo HJ, Jeong TS, Lee SH, Lee JH. Replacing carbohydrate with protein and fat in prediabetes or type-2 diabetes: greater effect on metabolites in PBMC than plasma. Nutr Metab (Lond). 2016 Jan 19;13:3. doi: 10.1186/s12986-016-0063-4. eCollection 2016.