louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05017467: The Effect of Centella Asiatica Cream on Scar Tenderness Who Underwent Open Carpal Tunnel Release Surgery
Official title: The Effect of Centella Asiatica Cream on Scar Tenderness in Patients Who Underwent Open Carpal Tunnel Release Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: To Prevent Scar Formation for Patients Underwent Surgery
Keywords: carpal tunnel syndrome
centella asiatica
surgery
cosmetic outcome
wound healing
Lead sponsor: Konya Numune Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Konya Numune Hospital
First posted: 2021-08-23
Enrollment: 280
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 280 operated patient with carpal tunnel release surgery.
Primary purpose: TREATMENT

Brief summary: The centella asiatica cream applied to the wrist after the CTR surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand.

Detailed description: Aim: This study was performed to evaluate the efficacy of centella asiatica extract in a cream preparation for the prevention of scar tenderness formation in patients who underwent conventional open carpal tunnel release surgery.

Eligibility criteria: Inclusion Criteria: patient underwent open carpal tunnel release surgery -

Exclusion Criteria:before hand surgery and recurrent carpal tunnel release surgery.

-

Primary outcomes:
measure: centella asiatica extrate
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Mustafa Balevi,MD
state: Meram
city: Konya
country: Turkey
Study officials:
affiliation: İstanbul Medipol Üniversity,Medical School
name: Ali Balevi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04867304: Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
Official title: Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Depression
Quality of Life
Chronic Pain
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population constitutes of patients with chronic pancreatic of at least 3 years duration. They are a composite with or without depression. Rationale for taking a lag time of at least 3 years was to allow development of the complications of the disease.

Brief summary: Chronic pancreatitis (CP) is associated with recurrent intractable abdominal pain, pancreatic exocrine insufficiency and endocrine dysfunction. Very few studies had evaluated the quality of life in CP, and even a fewer have assessed the mental status in these patients.

In the current study, we proposed to evaluate the the relationship between pain, quality of life and depression status in two large independent cohorts of patients with CP. We also proposed to evaluate the brain metabolites in the right and left anterior cingulate cortex, basal ganglia, hippocampus and prefrontal cortex using magnetic resonance spectroscopy. We further proposed to evaluate the pasta metabolites and look for associations with the mental state. Finally, we proposed to evaluate how CP related education of the patients could impact on their mental status and response to interventions on pain.


Eligibility criteria: A. Inclusion Criteria:

* Age 18-60yrs
* Both genders
* Documented CP for at least 3 years
* Capable and willing to provide informed consent

B. Exclusion Criteria:

* Acute exacerbation of pancreatitis
* Pancreatic malignancy
* On anti-depressant and antipsychotic medications
* Concomitant psychiatric illness (other than depression)
* Pancreatic malignancy
* Major co-morbidities
* Pregnancy and lactation

Primary outcomes:
measure: Improvement in depression scores
timeFrame: 3 months
measure: Improvement in Quality of life parameters
timeFrame: 3 months
measure: Change in brain metabolite profiles
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Andhra Pradesh
Study officials:
References:
Clinical trial NCT02721004: Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis
Official title: Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
RoActemra
Tocilizumab
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-28
Enrollment: 592
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with rheumatoid arthritis will be enrolled in this trial.

Brief summary: This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.


Eligibility criteria: Inclusion Criteria:

- Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion Criteria:

- No specific exclusion criteria were specified for this non-interventional trial

Primary outcomes:
measure: Disease Activity Score Based on 28-joints Count (DAS28)
timeFrame: Month 12
measure: Simplified Disease Activity Index (SDAI) Score
timeFrame: Month 12
measure: Clinical Disease Activity Index (CDAI) Score
timeFrame: Month 12
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) Response
timeFrame: Month 12
measure: Tender Joint Count (TJC)
timeFrame: Month 12
measure: Swollen Joint Count (SJC)
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants with any Adverse Event (AE)
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Bludenz
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01631604: Gait Characteristics Following a Fall
Official title: Quantification of Gait Parameters and Muscle Activation Patterns Following a Fall
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Impairments
Orthopaedic Injuries
Neurological Conditions
Keywords: risk of falling
gait patterns
muscle activity
fall prevention
motor impairment
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-06-29
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to quantify the safety degree of the patient's gait, to detect the reason for the fall and quantify the biomechanical parameters related to fall. This study also aims to evaluate the effect of different rehabilitation treatments and their effect on the risk of falling.

Detailed description: In this study, patients suffering from motor disabilities as a result of orthopedic or neurologic impairments will be tested at the gait and motion laboratory. Each patient will be secured with a ceiling-mounted safety harness and will walk on the path wearing passive light-reflecting markers and surface electrodes. High-speed cameras will record the subject's movements and the markers will be tracked to produce data of joint angles, velocities and accelerations. Dynamic EMG will be recorded from various muscles.

During the examination, the gait of the subjects will be disturb by either (i) a visual or sound signal that requires the subject to stop immediately, or (ii) walking different terrains, or (iii) tying a string to the foot and pulling it shortly to induce a trip.

Eligibility criteria: Inclusion Criteria:

* Individuals suffering from gait impairment following injury to the central or peripheral nervous system, as well as following orthopedic injuries. The subjects will be able to understand and independently sign a consent form.

Exclusion Criteria:

* Subjects who are unable to understand and independently sign a consent form
* Subjects who are wheelchair bound.
* Pregnant women.

Primary outcomes:
measure: Gait kinematics
Secondary outcomes:
measure: Muscle activation patterns
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT03142204: [18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy
Official title: Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG (VisAcT), a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Cancer Patients Who Have Received or Are Expected to Receive Immunotherapy and/or Radiation Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cancer
Lead sponsor: CellSight Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: UCSF Imaging Center at China Basin
First posted: 2017-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a Phase 1 study is to visualize biodistribution of a PET tracer called \[18F\]F-AraG (VisAcT) in cancer patients expected to undergo immunotherapy and/or radiation therapy.

Detailed description: This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation dosimetry of the Positron Emission Tomography \[18F\]FAraG (VisAcT) in cancer patients selected for immunotherapy and/or radiation therapy. Each patient may have up to two \[ 18F\]FAraG PET imaging sessions, a baseline scan and a post start of immunotherapy scan. For each imaging session, patients will receive a single injection of \[18F\]FAraG and undergo a whole-body PET scans an hour after injection of the tracer. Following each imaging session, the patient will be called within 72 hours to note any side effects.

Optional - Blood samples may be collected at up to 9 time points post-injection to analyze whole-blood/plasma time activity of \[18F\]FAraG in addition an urine sample may be collected post scan.

Eligibility criteria: Inclusion Criteria:

* Cancer patients with identified tumor mass
* Cancer patients expected to undergo immunotherapy and/or radiation therapy

Exclusion Criteria:

* Under the age of 18
* Pregnant women
* Women who are breastfeeding
* Individuals with known or suspected substance abuse
* Individuals unable or unwilling to comply with the study procedures

Primary outcomes:
measure: Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy
timeFrame: Up to 6 weeks before immunotherapy is administered
measure: Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy
timeFrame: Up to 12 weeks after start of immunotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Imaging Center at China Basin
state: California
Study officials:
affiliation: UCSF Department of Radiology & Biomedical Imaging
name: Robert R Flavell, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06154304: BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma
Official title: To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Bronchial Asthma
Lead sponsor: Cipla Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Detailed description: This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Eligibility criteria: Inclusion Criteria:

1. Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)
2. Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC

   a. If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is \<80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)
3. Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC
4. Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.

Exclusion Criteria:

1. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.

-

Primary outcomes:
measure: Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Medford
country: United States
facility: Velocity CLinical Research
state: Oregon
Study officials:
affiliation: Velocity Clinical Research
name: Sarah Smiley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01463904: Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Official title: Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Diabetes
Keywords: Morbid obesity
duodenal switch
diabetes
decrease in cardiac risk
remission of T2DM
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbid obesity patients and patients with obesity and T2DM

Brief summary: Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified duodenal switch. It is performed on morbid obese patients and severe T2DM patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a remission of T2DM. A lower complication rate than for duodenal switch is expected.

Detailed description: A sleeve gastrectomy over a wide bougie is performed. Then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum.

The preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30 with T2DM or BMI \> 40

Exclusion Criteria:

* Oncologic patients, alcoholic patients, mentally retarded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
References:
Clinical trial NCT05464004: Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy
Official title: Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Problem
Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effects of Nintendo Wii balance board in combination with conventional physical therapy in children with CP
Primary purpose: TREATMENT

Brief summary: I wan to check the effects of Nintendo Wii balance board therapy in children with CP.

Detailed description: Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional physical therapy.

Eligibility criteria: Inclusion Criteria:

* children with age of 7-14 years. No history of falls. children able to stand independently. delays in gait development.

Exclusion Criteria:

* Children with hemiplegic CP. Comorbidities. children with lower limb contractures. hearing disorders. children with epilepsy.

Primary outcomes:
measure: Effects of Nintendo Wii balance board in children with CP
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rising Sun Institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajiha Shahid, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
citation: Gage JR, Novacheck TF. An update on the treatment of gait problems in cerebral palsy. J Pediatr Orthop B. 2001 Oct;10(4):265-74.
citation: Woollacott MH, Shumway-Cook A. Postural dysfunction during standing and walking in children with cerebral palsy: what are the underlying problems and what new therapies might improve balance? Neural Plast. 2005;12(2-3):211-9; discussion 263-72. doi: 10.1155/NP.2005.211.
citation: Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
Clinical trial NCT03133104: Repeat Antenatal Corticosteroids
Official title: Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antenatal Corticosteroids
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 182
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women preterm premature rupture of membranes All ethnic backgrounds

Brief summary: This study will review records of women who broke their water early who received a repeat course of antenatal steroids.

Detailed description: Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight.

Current guidelines recommend two doses of ANCS administered 24 hours apart as a single "course." A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM.

One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately.

The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.

Eligibility criteria: Inclusion Criteria:

* pregnant women with preterm premature rupture of membranes

Exclusion Criteria:

* Women who did not have preterm premature rupture of membranes

Primary outcomes:
measure: Infant outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Cara Buskmiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00399204: Comparison of Cardiovascular Outcomes of Pioglitazone and Metformin in Type 2 Diabetes Patients
Official title: A Randomised Pilot Study to Compare the Effect of Pioglitazone and Metformin on Cardiovascular Morbidity and Mortality in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Council of Scientific and Industrial Research, India
First posted: 2006-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to see if there is any significant difference in the cardiovascular outcomes in type 2 diabetes patients who are treated with pioglitazone or Metformin


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed (less than six months since diagnosis and not controlled on dietary modifications) type 2 diabetic patients of both sexes aged 25-60 years.
2. Ready to give written informed consent

Exclusion Criteria:

1. Presence of ketonuria
2. Severe concurrent, infection or illness
3. History of hypersensitivity to any study drug
4. Impaired renal function
5. Pulmonary insufficiency with hypoxemia
6. Severe hepatic disease
7. Congestive heart failure
8. History of myocardial infarction or angina(stable/unstable)
9. History of alcohol or drug abuse
10. Pregnant or lactating women -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Promila Pandhi
role: STUDY_CHAIR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Nusrat Shafiq, MD,DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Anil Bhansali, MD,DM
role: STUDY_DIRECTOR
References: