louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05046743: Intestinal Dysmotility: Effect of Colonic Load
Official title: Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Abnormal motility patterns in the jejunum can be detected in patients with prominent colonic distension, and it is not clear whether these abnormalities reflect a primary jejunal dysfunction or are due to a reflex distortion. The aim of the study is to determine the effect of colonic filling on jejunal postprandial motility using high-resolution manometry.

Healthy subjects will be studied following a controlled, parallel, randomized, single-blind experimental design. On the study day, nutrients will be continuously infused in the proximal jejunum (2 Kcal/min) during a 2-h period to induce a steady-state postprandial motor pattern. Jejunal motility will be concomitantly recorded using a water-perfused, high-resolution manometry catheter. After 1 hour of postprandial recording (basal period), a gas mixture will be infused during 7.5 minutes via a rectal tube (720 mL or sham infusion), and jejunal motility will be recorded for another hour.


Eligibility criteria: Inclusion Criteria:

* No digestive symptoms

Exclusion Criteria:

* Organic diseases

Primary outcomes:
measure: Small bowel contractility
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
Clinical trial NCT05210543: Acquisition and Long-term Observation of Patients With Severe Allergic Reactions
Official title: Acquisition and Long-term Observation of Patients With Severe Allergic Reactions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anaphylaxis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who experienced a severe anaphylactic reaction and presenting in a participating center

Brief summary: The Anaphylaxis Registry aims to assess data in a standardized form about symptoms, triggers, cofactors and therapy management from patients who experienced an anaphylactic reaction. This should improve diagnosis and long-term management of these life-threatening allergic reactions.

Detailed description: A better understanding of the triggers and pathology of anaphylactic reactions could lead to a better diagnosis and prophylaxis to avoid the occurence of these life-threatening allergic reactions. This can be an advantage for affected persons regarding the their treatment and long-term management.

The Anaphylaxis Registry is an opportunity to gather these standardized data. The blood sampling is optional for the patient, however, it will contribute to the better understanding of the sensitization profile and possible mechanisms. Recent publications showed a correlation between an anaphylactic reaction and certain biomarkers. Those data will be validated in a larger number of population with identification of further biomarkers. It is presumed that certain genetic and epigenetic polymorphisms are abundant for patients who experienced an anaphylaxis.

To summarize, this study aims to contribute to a better understanding of the anaphylaxis in general, the diagnosis, and the prognosis with different severities. With the identification of a certain trigger, the obtained understanding may help to decrease the risk of or prevent future repeating reactions.

Eligibility criteria: Inclusion Criteria:

* Anaphylactic reaction within the past 12 months

Exclusion Criteria:

-

Primary outcomes:
measure: Influence of risk factors
timeFrame: 10 years
Secondary outcomes:
measure: Epiphenomenon
timeFrame: 10 years
measure: Current use of adrenaline
timeFrame: 10 years
measure: Future use of adrenaline
timeFrame: 10 years
measure: Country-specific differences in anaphylaxis handling
timeFrame: 10 years
measure: Biomarkers
timeFrame: 10 years
measure: Epigenetics
timeFrame: 10 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Margitta Worm, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01306643: Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
Official title: Single-agent Idelalisib for Previously Treated Low-grade Lymphoma: A Phase 1/2 Study of Safety, Efficacy, and Flow-cytometric Assessment of Tumor-cell Signaling Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Indolent Non-Hodgkin's Lymphoma
Follicular Lymphoma
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Keywords: Indolent Non-Hodgkin's Lymphoma
Non-Hodgkin Lymphoma
iNHL
NHL
CAL-101
PI3K
Phosphatidylinositol 3-kinase
Follicular Lymphoma (FL)
Small Lymphocytic Lymphoma (SLL)
Marginal Zone Lymphoma (MZL)
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL).

Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.


Eligibility criteria: Inclusion Criteria:

* Previously treated relapsed or refractory B-cell iNHL
* Provide written informed consent

Exclusion Criteria:

* Pregnant or nursing
* Active, serious infection requiring systemic therapy
* Positive test for HIV antibodies
* Active hepatitis B or C viral infection

Primary outcomes:
measure: Overall Safety of Idelalisib
timeFrame: 30 days post last study treatment (up to 12 months)
measure: Clinical Response: Overall Response Rate
timeFrame: Up to twelve 28-day cycles (maximum of 12 months)
Secondary outcomes:
measure: Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells
timeFrame: Up to twelve 28-day cycles (maximum of 12 months)
measure: Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
timeFrame: Up to twelve 28-day cycles (maximum of 12 months)
measure: Changes in Concentration of Peripheral Blood Chemokines and Cytokines
timeFrame: Up to twelve 28-day cycles (maximum of 12 months)
measure: Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast
timeFrame: Up to twelve 28-day cycles (maximum of 12 months)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Center
state: California
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05084443: Effect of Roselle-based Drink on Blood Pressure and Skin
Official title: Effect of Roselle-based Drink on Blood Pressure, Antioxidative Activity and Skin Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Skin and Subcutaneous Infections
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This randomized, placebo-controlled, double-blind, and cross-over study was designed to check whether the roselle-based drink (2 bottles every day) can alter blood pressure and skin condition in elderly healthy subjects.

Detailed description: The subjects were assigned into two groups (control group and test group), each group subject was requested to drink 2 bottles every day (100 mL/bottle, one in the morning and another in the evening), the rate of drinking is 75.42%. There are 39 subjects (25 females and 14 males) completely involved in the thirteen-month trial (cross-over). Blood samples were collected at the initial, 3rd, 6th, 7th, 10th, 13th months of the trial. Skin examinations were performed at the initial, 6th, 7th, 13th months.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Subjects should not be under any medication
* Subject must be able to drink

Exclusion Criteria:

* Subjects with chronic renal, liver or cardiac disorders, Diabetes, hyperlipidemia.
* Also pregnant women, chain smokers, high alcohol consumers should not be included.

Primary outcomes:
measure: Blood pressure by sphygmomanometer (mmHg)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung city
country: Taiwan
facility: Chung Shan Medical University
state: Taichung
Study officials:
affiliation: Chung Shan Medical University
name: Chin-Kun Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179543: Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients
Official title: Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-09-16
Enrollment: 122
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.

Detailed description: The purpose of this study is to determine whether the relaxation response is more effective than health education training (attention control) in reducing systolic blood pressure and anti-hypertensive medication elimination in elderly adults with isolated systolic hypertension.

Eligibility criteria: Inclusion Criteria:

* 55 years or older
* currently taking at least 2 anti-hypertensive medications
* systolic blood pressure between 140-159 mmHg
* diastolic blood pressure less than 90 mmHg
* read and understand English
* access to a telephone
* ability to attend all study visits

Exclusion Criteria:

* other cardiovascular disease
* major medical illness
* previous experience with any RR eliciting technique
* current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication

Primary outcomes:
measure: Determine whether the relaxation response is more effective than a health education control in reducing blood pressure in elderly adults with isolated systolic hypertension.
Secondary outcomes:
measure: Evaluate whether the relaxation response is more effective than a health education control to safely reduce blood pressure medications in elderly adults with isolated systolic hypertension..
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Herbert Benson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463343: Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals
Official title: Neurophysiologic Effects of Cervical Spinal Manipulation in Asymptomatic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study had the goal of analyse the neurophysiologic effects of both mechanical and manual cervical manipulation, in asymptomatic individuals.

Detailed description: In this study, the investigators compared the effects of manual manipulation and instrument assisted manipulation of C3/C4 on muscle tone, elasticity and stiffness and on pressure pain threshold , and pressure pain perception. The muscles evaluated were upper trapezius and biceps brachialis, bilaterally. The study also had a placebo and a control group. All individuals were asymptomatic.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects.
* Minimum of 18 years old.

Exclusion Criteria:

* Pain in cervical region, shoulders or arms.
* History of trauma or disease in the cervical region or upper limb.
* Use of medication that could affect the outcomes (painkillers, NSAID, or anti depressives) during the last week.

Primary outcomes:
measure: Pressure pain thresholds
timeFrame: Immediately after the intervention
measure: Pressure pain perception
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Muscle tone
timeFrame: Immediately after the intervention
measure: Muscle stiffness
timeFrame: Immediately after the intervention
measure: Muscle elasticity
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Politécnico da Saúde do Norte
name: Nuno Nogueira, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01216943: Safety and Efficacy of Triple Combination Therapy in Patients With Glaucoma or Ocular Hypertension
Official title: A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Twice-daily 0.01% Bimatoprost/0.15% Brimonidine/0.5% Timolol Ophthalmic Solution (Triple Combination) in Patients in India, Who Have Glaucoma or Ocular Hypertension With Elevated IOP, and Are on Twice-daily 0.2% Brimonidine/0.5% Timolol Ophthalmic Solution (Dual Combination) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Glaucoma and/or ocular hypertension in both eyes
* Requires IOP-lowering treatment in both eyes

Exclusion Criteria:

* Other active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
* Current or anticipated use of ocular medications other than study medications, except for intermittent use of artificial tears
* Use of oral, injectable or topical corticosteroids within 21 days
* Iridectomy or laser peripheral iridotomy in the study eye within 3 months
* Uncomplicated cataract surgery in the study eye within 6 months
* Incisional glaucoma surgery in the study eye within 12 months

Primary outcomes:
measure: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbatore
country: India
state: Tamil Nadu
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02035943: Tight Glycemic Control and Insulin Administration During Parenteral Nutrition
Official title: Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Ill Patient Undergone Parenteral Nutrition
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study the investigators want to comare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.

Detailed description: In this study the investigators want to compare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.

Eligibility criteria: Inclusion Criteria:

* Critical ill patients undergone parenteral nutrition

Exclusion Criteria:

* Acute cerebral injury, pregnancy

Primary outcomes:
measure: Number of glucose level control out of range (80-110 mg/dl)
timeFrame: ICU stay (a week on average)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
state: MI
Study officials:
affiliation: Policlinico Hospital
name: Sergio De Chiara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06764043: Molar-Incisor Hypomineralization Vs Periodontal Health
Official title: Molar-Incisor Hypomineralization (MIH) Vs Periodontal Health: Evaluation of Clinical Periodontal Indexes and Biomarkers (MMP-8, MMP-20 and TGF- Β1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Molar-Incisor Hypomineralization
Peridontal Disease
Keywords: Gingival crevicular fluid
Matrix metalloproteinase 8
Matrix metalloproteinase 20
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric population with MIH

Brief summary: Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1 (TGF-β1), and MIH.

Methods: The study was conducted on 40 pediatric patients diagnosed with MIH (Study Group/SG), and 40 pediatric patients healthy for MIH (Control Group/CG). Clinical periodontal measurements (plaque index (PI), gingival index (GI), probing pocket depth (PPD), and GCF volume were performed. Concentrations of MMP-8, MMP-20, and TGF-β1 in GCF were determined using enzyme-linked immunosorbent assay (ELISA). Mann-Whitney U test and T-test were used for comparisons between groups. Significance was set at p=0.05 for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* the ages of 8 and 14 who were diagnosed with MIH in their maxillary permanent first molars,
* had healthy maxillary permanent first molars,
* scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale,
* had no mental or physical disability,
* did not need urgent treatment and/or were not in pain,
* agreed to participate in the study with their parents and signed the consent form.

Exclusion Criteria:

* Children with systemic, chronic, and/ or metabolic diseases,
* under active orthodontic treatment, with developmental defects of enamel (excluding MIH), or born prematurely

Primary outcomes:
measure: Periodontal indexes measurement
timeFrame: 1 day
measure: GCF measurement
timeFrame: 1 day
measure: Evaluation of MMP-8, MMP-20 and TGF-β1 Levels by ELISA Method
timeFrame: for three days from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdoğan University Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01510743: Ultrasound Guided Central Vein Catheterization and Complications
Official title: Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Keywords: open heart surgery
lung surgery
spine surgery
hepatobiliary surgery
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 1484
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.

Exclusion Criteria:

* Refuse
* hematologic disorder
* Anatomical abnormalities of central vein structure

Primary outcomes:
measure: complication
timeFrame: during central vein catheterization and operation day
Secondary outcomes:
measure: Access time
timeFrame: during central venous catheterization
measure: Number of attempts
timeFrame: during central venous catheterization
measure: catheter tip placement
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin-Hee Kim, Professor
role: STUDY_DIRECTOR
References: