louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02038244: Integrative Medicine for Chronic Pain
Official title: Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: University of Witten/Herdecke
First posted: 2014-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated.

Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.


Eligibility criteria: Inclusion Criteria:

* diagnosed with any chronic pain condition
* at least 6 months pain duration
* written informed consent

Exclusion Criteria:

* participation in any other clinical study

Primary outcomes:
measure: Pain Intensity
timeFrame: 14 days
Secondary outcomes:
measure: Pain Intensity
timeFrame: 6 months
measure: Pain Disability
timeFrame: 14 days, 6 months
measure: Health-related quality of life
timeFrame: 14 days, 6 months
measure: Life satisfaction
timeFrame: 14 days, 6 months
measure: Depression
timeFrame: 14 days, 6 months
measure: Acceptance
timeFrame: 14 days, 6 months
measure: Mindfulness
timeFrame: 14 days, 6 months
measure: Subjective stress
timeFrame: 14 days, 6 months
measure: Easiness of life
timeFrame: 14 days, 6 months
measure: Ability and will to change
timeFrame: 14 days, 6 months
measure: Safety
timeFrame: 14 days, 6 months
measure: Pain Disability
timeFrame: 14 days, 6 months
Other outcomes:
measure: Body awareness
timeFrame: 14 days, 6 months
measure: Body responsiveness
timeFrame: 14 days, 6 months
measure: Body awareness and dissociation
timeFrame: 14 days, 6 months
measure: Postural awareness
timeFrame: 14 days, 6 months
measure: Body awareness
timeFrame: 14 days, 6 months
measure: Daily log
timeFrame: 2 weeks
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
References:
Clinical trial NCT04114344: Clinical Trial to Compare TAPP (Transabdominal Preperitoneal) vs TEP (Totally Extraperitoneal) y Approach for Women's Inguinal Hernia on an Outpatient Basis
Official title: Randomized Clinical Trial to Compare TAPP vs TEP Approach for Women's Inguinal Hernia on an Outpatient Basis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: Woman
Inguinal Hernia
TAPP
TEP
Outpatient Surgery
Ambulatory Surgery
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open prospective randomised clinical trial enrolling women who suffer from inguinal or femoral hernia, to evaluate if TEP approach is superior to TAPP concerning postoperative development, principally postoperative pain, with no increase of recurrent hernia at the one-year follow-up visit.

Detailed description: Randomised phase IV clinical trial enrolling women suffering from inguinal hernia in Virgen del Rocío University Hospital influence area, from March 2019 to March 2021.

The aim of the study is to conclusively stablish whether there is real and significant benefit in using TEP approach over TAPP, in an outpatient basis, concerning postoperative evolution. Secondary objectives are the assessment of postoperative pain, using VAS (visual analogic scale), of both techniques, and evaluation of hernia recurrence during the first postoperative year The individuals will be assigned to each group according to simple random sampling.

Eligibility criteria: Inclusion Criteria:

* Inguinofemoral hernia, EHS (European Hernia Society) classification.
* Patient over 18 years old.
* Signed informed consent form.
* Female
* Meeting of outpatient discharge criteria, determined by Aldrete´s test

Exclusion Criteria:

* Loss of domain.
* Abdominal skin grafts.
* Previous preperitoneal (open or laparoscopic) prosthetic mesh.
* Incarcerated hernia.
* Previous complications such as infection, fistulae...
* Not candidate for ambulatory surgery
* Pregnancy or desire for pregnancy in the first postoperative year

Primary outcomes:
measure: Post operative pain
timeFrame: 24 hours
measure: Recurrence
timeFrame: One year
measure: Complications
timeFrame: One year
Secondary outcomes:
measure: Operating time
timeFrame: 180 minutes
measure: Hospital stay
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Virgen del Rocío University Hospital
Study officials:
References:
Clinical trial NCT04369144: Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder
Official title: Effect of Adding Continual Vertical Downward Correction to Dynamic Scapular Recognition Exercise on Scapular Dyskinesis and Shoulder Pain and Disability in Patients With Frozen Shoulder: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded Randomized Controlled study
Primary purpose: TREATMENT

Brief summary: OBJECTIVE: To study the effect of adding a continual vertical downward correction to dynamic scapular recognition exercise on scapular dyskinesis and shoulder pain and disability in patients with frozen shoulder.

Design: A double-blinded randomized controlled study Setting: Out-patient clinic Subjects: Sixty-seven subjects with unilateral frozen shoulder Interventions: Participants were distributed into two groups. The intervention group performed the dynamic scapular recognition exercise and continual vertical downward correction using rigid taping with 50%-75% tension. The control group performed a similar dynamic scapular recognition exercise using a wireless biofeedback system and placebo taping. A scapular dyskinesis test with caliper was utilized to measure scapular dyskinesis, a digital inclinometer was utilized to evaluate the scapular upward rotation and shoulder ROMs, and the Shoulder Pain and Disability Index (SPADI) was utilized to evaluate the shoulder pain and disability.


Eligibility criteria: Inclusion Criteria:

* The existence of a unilateral frozen shoulder with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula.
* Aa restriction in both passive and active shoulder ROM
* The existence of pain that affects performing activities of daily living\[19\]

Exclusion Criteria:

* The presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries nearby the shoulder region. Furthermore, the patient was excluded if he/she had no signs of scapular dyskinesis.

Primary outcomes:
measure: Scapular dyskinesis
timeFrame: 2 months
measure: Scapular Upward rotation
timeFrame: 2 months
measure: Shoulder Pain and disability index (SPADI)
timeFrame: 2 Months
Secondary outcomes:
measure: Shoulder ROMs
timeFrame: 2 months
Other outcomes:
Locations:
city: Beni-Suef
country: Egypt
facility: beni Suef University
Study officials:
References:
Clinical trial NCT07013344: Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease
Official title: Association of Plasma N-terminal Pro-Brain Natriuretic Peptide Levels With the Burden of Coronary Artery Disease: Insights From a Real-World Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Coronary Syndrome
Chronic Coronary Total Occlusion
Coronary Arterial Disease (CAD)
Stable Chronic Angina
NT-pro-BNP
Keywords: NT-pro-BNP
Coronary Arterial Disease (CAD)
Chronic Coronary Syndrome (CCS)
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to San Raffaele Hospital between September 2021 and July 2024 for elective coronary angiography due to the suspected CAD (i.e. presence of suggestive signs or symptoms and positive non-invasive functional and/or anatomical tests).

Brief summary: This study aim to investigate the association between plasma NT-proBNP levels and the presence, extent and severity of stenosis in patients with suspected coronary artery disease.

Detailed description: The investigators prospectively measured plasma NT-proBNP levels in consecutive patients referred to the center for elective diagnostic coronary angiography due to symptoms or signs of coronary artery disease over a two- year period. Patients with conditions known to elevate NT-proBNP levels, including heart failure, severe valvular disease, atrial fibrillation, severe chronic kidney disease (eGFR \< 30 mL/min), prior coronary artery bypass grafting, or age over 80 years, were excluded.

Eligibility criteria: Inclusion Criteria:

* patient referred for elective coronary angiography due to suspected CAD.
* NT-proBNP measurement during hospitalization

Exclusion Criteria:

* heart failure
* severe valvular disease
* atrial fibrillation
* severe chronic kidney disease (eGFR \< 30 mL/min)
* prior coronary artery bypass grafting
* age over 80 years

Primary outcomes:
measure: Association between plasma NT-proBNP levels and the presence, extension and severity of angiographic lesions in patients with suspected CAD.
timeFrame: Plasma NT-proBNP levels are quantified on the morning before coronary angiography. The CAD burden is independently evaluated by two experienced interventional cardiologists periprocedurally and immediately after the coronary angiography.
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT01529944: Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
Official title: Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genetic Disorder
Noonan Syndrome
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.


Eligibility criteria: Inclusion Criteria:

* Participation in the GHNOO-1658 trial
* Subject has completed genetic testing of PTPN11 mutation

Primary outcomes:
measure: Change in height SDS (Standard Deviation Score) (referenced to normal population)
timeFrame: From baseline until final height is reached
Secondary outcomes:
measure: Final height SDS (referenced to normal population)
timeFrame: From baseline until final height is reached
measure: Final height SDS (referenced to Noonan population)
timeFrame: From baseline until final height is reached
measure: Change in height SDS (referenced to Noonan population)
timeFrame: From baseline until final height is reached
measure: Number of subjects with final height SDS above - 2SDS (reference to normal population)
timeFrame: When final height is reached
measure: Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
timeFrame: When final height is reached
measure: Adverse events
timeFrame: From baseline until final height is reached
Other outcomes:
Locations:
city: Göteborg
country: Sweden
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03190044: Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis
Official title: A Fixed Combination of Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) as Prophylactic Treatment for Migraine: a Randomized Controlled Double Blind Study (ParMig Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Disorders
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Gianluca Coppola
name: Francesco Pierelli
First posted: 2017-06-16
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Migraine is a highly disabling disorder that affects hundreds of millions of people around the world. Yet, a little number of prophylactic treatments are available still now. The limited number of available drugs leads to a wide use of nutraceutical compounds in migraine therapy. To improve the efficacy, some of these nutraceuticals were combined. So far, we do not know if these combinations are really more effective than the single compounds alone, or an anti-synergic effect could be present because of a reciprocal antagonism of effects. For this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium, andrographis, co-enzyme Q10 and riboflavin (PACR) as prophylactic treatment for migraine in a randomized controlled double blind study.


Eligibility criteria: Inclusion Criteria:

* diagnosis of migraine (with or without aura)
* both genders
* age between 18 and 65 y.o.
* more than 1 year of migraine history
* no other headache conditions
* a migraine frequency between 2 and 8 per month

Exclusion Criteria:

* Prophylactic treatments in the last 3 months
* pregnancy or lactation
* other medical conditions that requires a daily drug assumption
* intolerance or allergic reactions to some of compounds of the product.

Primary outcomes:
measure: Migraine improvement in terms of responder rate
timeFrame: 3 months
Secondary outcomes:
measure: Migraine improvement in terms of frequencies
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Umberto I
Study officials:
affiliation: University of Roma La Sapienza
name: Francesco Pierelli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00211744: Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Official title: Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive-compulsive Disorder
Keywords: OCD
Obsessive-Compulsive Disorder
OCD treatment
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Pharmaceutical
First posted: 2005-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for adults with obsessive-compulsive disorder and who are currently on serotonin reuptake inhibitor medications (ages 18-65).

Detailed description: The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of Topiramate (Topamax) added to an SSRI for the management of treatment-resistant Obsessive-Compulsive Disorder. The purpose of the study is to evaluate the safety and efficacy of Topiramate versus placebo added to a selective serotonin reuptake inhibitor (SRI) in patients with treatment resistant OCD. The program is 12 weeks in duration and involves regular visits with a psychiatrist as well as complete psychiatric and medical evaluations. Treatment and medication for the study will be provided free of charge.Participants must be between the ages of 18 and 65 and have an onset of OCD at least 1 year prior to screening. In addition, participants must be taking a clinically effective dose of an SSRI for at least 3 months and must maintain their current dose throughout the study. Participants must not have a primary OCD symptom of hoarding.

Eligibility criteria: Inclusion Criteria:

Males and Females 18-65 years of age diagnosed with OCD and currently taking SSRI medication(s)

Exclusion Criteria:

major medical disorders

Primary outcomes:
measure: To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Erik Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berlin HA, Koran LM, Jenike MA, Shapira NA, Chaplin W, Pallanti S, Hollander E. Double-blind, placebo-controlled trial of topiramate augmentation in treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2011 May;72(5):716-21. doi: 10.4088/JCP.09m05266gre. Epub 2010 Aug 10.
Clinical trial NCT04812444: Peripheral Venous Stent System in the Treatment of Iliac Vein Stenosis or Occlusion
Official title: Safety and Efficacy of Peripheral Venous Stent System in the Treatment of Patients With Iliac Vein Stenosis or Occlusion: a Prospective, Multicentre, Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iliac Vein Stenosis
Iliac Vein Occlusion
Keywords: Peripheral venous stent system
Iliac vein patency rate
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 220
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: Clinical study on safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusion.

Detailed description: The purpose of this study was to evaluate the safety and efficacy of Zylox peripheral venous stent system in the treatment of iliac vein stenosis or occlusive lesions compare with conventional venous stent.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 75 years old, male or female
* Subject's target lesions were stenosis and/or occlusion
* CEAP≥C3
* Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent

Exclusion Criteria:

* Pregnant woman or who's pregnancy test is positive
* Lactation period woman or woman/man with fertility plan

Primary outcomes:
measure: Target vascular patency rate at 12 months after operation
timeFrame: 12 months
Secondary outcomes:
measure: The incidence of major adverse events
timeFrame: 12 months
measure: Adverse Event
timeFrame: Preoperative、Intraoperative、up to 1 month、3 month、6 month、12 month、2 years、3 years、5 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Yu Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04101344: Fiber Blends and Gut Microbiota (FB)
Official title: Effect of Dietary Supplementation With Fiber Blends on the Gut Microbiota and Host Metabolome and Proteome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to determine whether consuming snacks containing different blends of dietary fibers alters the type and number of bacteria found in your gut and improves markers of overall health.

Detailed description: All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome). The information gained from this work will increase our understanding of the importance of specific dietary fibers in manipulating the composition of the gut microbiota in ways that may improve our metabolic health.

Eligibility criteria: Inclusion Criteria:

* BMI ≥25.0 and ≤35.0 kg/m2
* ≥18 and ≤60 years

Exclusion Criteria:

* previous bariatric surgery
* significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney, liver or cardiovascular disease)
* cancer or cancer that has been in remission for \<5 years
* major psychiatric illness
* inflammatory gastrointestinal disease
* pregnant or lactating women
* use of medications that are known to affect the study outcome measures and that cannot be temporarily discontinued for this study
* use of medications known to affect the composition of the gut microbiota within the last 30 days (most notably antibiotics)
* bowel movements \<3 times per week
* vegans, vegetarians, those with lactose intolerance and/or severe allergies/aversions/sensitivities to foods and ingredients included in the prescribed meal plan
* persons who are not able to grant voluntary informed consent
* persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.

Primary outcomes:
measure: Effect of fiber blend snacks on gut microbiota
timeFrame: 1 year
Secondary outcomes:
measure: Effect of fiber blend snacks in blood and urine
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: