louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01699100: Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design
Official title: Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Offloading Technique: Insoles With Peg Assist Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Keywords: offloading
plantar pressure
insole
foot ulcer
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidance of peg removal.

Detailed description: The investigators tested the effect of plantar pressure reduction in four conditions:

1. insole of the original shoe
2. peg assist insole but the pegs are not yet removed
3. peg assist insole and the pegs were removed
4. condition3. plus arch support to the insole

Eligibility criteria: Inclusion Criteria:

* previously diagnosed type 2 diabetes with neuropathic foot were recruited from the outpatient endocrinology and metabolism division of Taichung Veterans General Hospital in central Taiwan

Exclusion Criteria:

* The exclusion criteria were history of lower extremities amputation, major foot deformities, presence of active plantar foot wound or ulcer, and difficulty walking more than 100 m.

Primary outcomes:
measure: plantar pressure of region of interest
timeFrame: 30 minutes
Secondary outcomes:
measure: Plantar pressure of non-region of interest
timeFrame: 30 minutes
Other outcomes:
measure: plantar pressure of midfoot area
timeFrame: 30 minutes
Locations:
Study officials:
affiliation: Taichung Verterans General Hospital
name: Tung-Liang Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05383300: Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy
Official title: Investigating the Effect of Oxytocin and the Neurochemistry of Antisocial Personality Disorder and Psychopathy Using Neuroimaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antisocial Personality Disorder
Keywords: Oxytocin; Psychopathy; Violent Offenders; Social Processing
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Father Flanagan's Boys' Home
First posted: 2022-05-20
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-binded placebo-controlled crossover trial
Primary purpose: OTHER

Brief summary: A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy

Detailed description: Using a double-blinded, placebo controlled design, we explored similarities and differences in i) an important component of empathic processing (neural response to facial emotional expressions) and ii) decision-making in violent men with ASPD+/-Psychopathy, compared to healthy non-offenders (NO; n= 21 across studies), with placebo and after acute application of intranasal oxytocin, using functional Magnetic Resonance Imaging (fMRI).

Eligibility criteria: Inclusion Criteria:

* Male
* Aged 18-60
* IQ greater than 70 as defined by the Wechsler Abbreviated Scale of Intelligence (WASI-II).

Violent offenders:

Offenders with convictions for violent crimes (murder, rape, attempted murder, grievous and actual bodily harm) who met DSM-5 criteria for antisocial personality disorder (Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5 PD) Psychopathy or non-psychopathy subgroup based on Psychopathy Checklist- Revised (PCL-R; (Hare, 2003))- score of 25 as the threshold for psychopathy in this English population.

Healthy non-offenders:

Non-offenders with no personality disorder

Exclusion criteria:

* history of major mental disorders (bipolar 1, bipolar 2, major depression or psychotic disorders)
* self-reported neurological disorders
* head injury resulting in loss of consciousness for 1 hour or longer
* severe visual or hearing impairments
* contraindications to MRI

Primary outcomes:
measure: Within-group effect of oxytocin on nerual modulation of fear
timeFrame: 10 minutes
Secondary outcomes:
measure: Baseline neural modulation of morphed fearful faces
timeFrame: 10 minutes
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Insititue of Psychiarty, Psychology and Neuroscience
state: Nottinghamshire
Study officials:
affiliation: King's College London
name: Nigel Blackwood, MB MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01095900: Comparison of Botulinum Toxin and Sphincterotomy in the Treatment of Chronic Anal Fissure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain after treatment
healing of fissure after treatment
continence scores after treatment
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This trial included consecutive adult patients presenting with symptomatic chronic anal fissure in which conservative treatment had failed.

Brief summary: Intra-sphincteric injection of botulinum toxin seems to be a reliable option causing temporary alleviation of sphincter spasm and allowing the fissure to heal. study is to compare the outcome of surgical sphincterotomy and botulinum toxin injection treatments in patients with uncomplicated chronic anal fissure.

Detailed description: consecutive patients with uncomplicated chronic anal fissure who had failed conservative treatment were randomized to receive either intra-sphincteric injection of botulinum toxin (BT) or lateral internal sphincterotomy (LIS). Postoperative pain relief, healing of fissure, continence scores and fissure relapse during 18 weeks of follow up was the outcomes assessed.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of chronic anal fissure was based on evidence of circumscribed ulcer at anal canal with indurations at the edges and exposure of the horizontal fibers of the internal anal sphincter at its floor.

Exclusion Criteria:

* Anal fissure that had been operated on before, complicated fissure with cicatricial deformation, large sentinel pile, associated hemorrhoids, suspected inflammatory bowel disease, or malignancy.

Primary outcomes:
measure: Postoperative pain relief, healing of fissure, continence scores
timeFrame: 18 weeks
Secondary outcomes:
measure: fissure relapse
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of General Surgery-Theodore Bilharz Research Institute ,
Study officials:
References:
Clinical trial NCT05427552: Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study
Official title: Exploring the Cortical Hemodynamic Response of Excitatory Brain Stimulation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Theta-Burst stimulation (iTBS)
Functional near-infrared spectroscopy (fNIRS)
Concurrent TMS/fNIRS
Prefrontal hemodynamic response
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Healthy volunteers will receive iTBS three times with three different intensities separated by one week to investigate the prefrontal hemodynamic response to different stimulation intensities.
Primary purpose: BASIC_SCIENCE

Brief summary: Intermittent theta-burst stimulation (iTBS) is a promising treatment for major depressive disorder. However, fewer than 50% of patients show sufficient response. Therefore, the optimal treatment protocol is worth investigating. Recent studies show that the relationship between stimulation intensity and prefrontal hemodynamic response is not linear but in an inverse U-shape by exploring the hemodynamic changes before and after iTBS. Concurrent transcranial magnetic stimulation (TMS)/functional near-infrared spectroscopy (fNIRS) setup allows the investigators to observe the prefrontal hemodynamic response during stimulation.

The aim of this study is to investigate the effects of different intensities on brain activity during and after the stimulation using fNIRS.

Detailed description: Please refer to the full proposal

Eligibility criteria: Inclusion Criteria:

* Right-handed

Exclusion Criteria:

* history of epilepsy, seizures, or convulsions
* current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
* current or past diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
* with metal implants, such as a cochlear implant, neurostimulator, or cardiac pacemaker

Primary outcomes:
measure: Oxygenated hemoglobin (HbO) change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 3 months
Secondary outcomes:
measure: Deoxygenated hemoglobin (HbR) Change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 3 months
measure: Oxygen saturation change compared to baseline
timeFrame: During and post TBS-fNIRS measurement, up to 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Georg S Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002152: A Study of WF 10 IV Solution in Patients With Advanced HIV Disease
Official title: Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of WF 10 IV Solution ( TCDO ) in the Management of Patients With Advanced HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give WF 10 (TCDO) to patients with advanced HIV disease who cannot or will not take zidovudine, didanosine, zalcitabine, or stavudine. This study also examines how TCDO affects the levels of HIV in the body. TCDO is a solution delivered through a vein.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Approved drugs at a stabilized dose except those specifically excluded.
* Aerosolized pentamidine (300 mg) once a month for PCP prophylaxis.

Patients must have:

* HIV positivity.
* Absolute CD4 count \< 200 cells/mm3.
* Intolerance to or refusal to take AZT, ddI, ddC, or d4T.
* No active opportunistic infection requiring ongoing therapy.
* Life expectancy at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Neoplasm other than basal cell carcinoma of the skin.
* Clinically significant cardiac disease.
* Anemia.

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapy.
* Corticosteroids.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Any antiretroviral agent.
* Interferon.
* Systemic therapy with biologic response modifiers, corticosteroids, cytotoxic chemotherapy, or neutropenic or nephrotoxic drugs.

Excluded within 30 days prior to study entry:

* Investigational drugs.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

* Radiation therapy. Active drug or alcohol abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Nashville Health Management Foundation / Vanderbilt Univ
state: Tennessee
Study officials:
References:
citation: Kahn JO, McGrath MS, Ching OM, Kuhne FW. A single center, phase 2 study evaluating the effects of WF10. Int Conf AIDS. 1998;12:349 (abstract no 22423)
citation: Busch HW, Christensen S, Reichelt D, Jahn S, Zidek W. Treatment of HIV-infected patients with advanced symptomatic disease with WF10 solution (TCDO). Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no PB0245)
citation: Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kuhne FW. Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS. Infection. 1998 Jul-Aug;26(4):202-7. doi: 10.1007/BF02962364.
Clinical trial NCT03602352: A Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period
Official title: A Cohort Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adhesive Small Bowel Obstruction
Keywords: Cohort
Surgery
Adhesive Small Bowel Obstruction
Cost
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery due to adhesive small bowel obstructions during the time period 2007-2012.

Brief summary: A cohort study of the cost for patients operated for adhesive small bowel obstruction (SBO) during a five-year period

Detailed description: It is a population-based cohort study of the costs for patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two Swedish neighboring regions. Patients were identified by a broad search of operation and International Classification of Diseases (ICD) codes. Data regarding surgery and complications has been analyzed in a previous study (Clinical trials no NCT0353459)

The costs for hospital stay, radiology, Intensive Care Unit (ICU)-care, operation for the index SBO care event were calculated. The cost for revisit, sick leave and recurrent SBO during follow-up were calculated. Patients were followed to 31st January 2017, last medical note or death.

Eligibility criteria: Inclusion Criteria:

* Above18 years of age
* Surgery for adhesive surgical bowel obstruction (SBO)

Exclusion Criteria:

• Surgery for SBO of other etiology than adhesions

Primary outcomes:
measure: Cost for primary hospital admission in patients who underwent SBO surgery during 2007-2012
timeFrame: 2007-2012
Secondary outcomes:
measure: Cost for further hospital admissions, surgery and outpatient visits during follow-up
timeFrame: 2007-2012
measure: Potential cost-reduction with prophylactic treatment calculating with different prophylactic efficacy levels
timeFrame: 2007-2012
Other outcomes:
Locations:
Study officials:
affiliation: Region Uppsala
name: Urban Karlbom, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00514852: Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-08-10
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear


Eligibility criteria: Inclusion Criteria:

* Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Use of systemic medications affecting dry eye
* Pregnancy or planning a pregnancy
* Contact lens wear

Primary outcomes:
measure: Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
timeFrame: Change from baseline at Day 30
Secondary outcomes:
measure: Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
timeFrame: Change from baseline at Day 30
measure: Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
timeFrame: Change from baseline at Day 30
measure: Patient Acceptability Score (Dryness) at Day 30
timeFrame: Day 30
measure: Patient Acceptability Score (Vision) at Day 30
timeFrame: Day 30
measure: Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
timeFrame: Change from baseline at Day 30
measure: Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
timeFrame: Change from baseline at Day 30
measure: Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
timeFrame: Change from baseline at Day 30
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00197652: Botswana Diarrheal Diseases Study
Official title: Botswana Diarrheal Diseases Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Prevention of Mother-Infant HIV Transmission
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Botswana Ministry of Health
First posted: 2005-09-20
Enrollment: 1350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The goals of this study are to:

1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.

   * analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.
   * comparison to rates among infants born to HIV uninfected mothers.
2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.


Eligibility criteria: Inclusion Criteria:

* Subject is able to provide independent informed consent.
* Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.
* Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.

For HIV-infected subjects:

* Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.

Exclusion Criteria:

* Subject cannot provide legal independent informed consent.

Primary outcomes:
measure: OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Roger Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shapiro RL, Smeaton L, Lockman S, Thior I, Rossenkhan R, Wester C, Stevens L, Moffat C, Arimi P, Ndase P, Asmelash A, Leidner J, Novitsky V, Makhema J, Essex M. Risk factors for early and late transmission of HIV via breast-feeding among infants born to HIV-infected women in a randomized clinical trial in Botswana. J Infect Dis. 2009 Feb 1;199(3):414-8. doi: 10.1086/596034.
citation: Shapiro RL, Lockman S, Kim S, Smeaton L, Rahkola JT, Thior I, Wester C, Moffat C, Arimi P, Ndase P, Asmelash A, Stevens L, Montano M, Makhema J, Essex M, Janoff EN. Infant morbidity, mortality, and breast milk immunologic profiles among breast-feeding HIV-infected and HIV-uninfected women in Botswana. J Infect Dis. 2007 Aug 15;196(4):562-9. doi: 10.1086/519847. Epub 2007 Jul 9.
Clinical trial NCT02908152: Curcumin Supplement in Nonalcoholic Fatty Liver Patients
Official title: The Effect of Curcumin Supplement on Metabolic Factors and Hepatic Fibrosis in Nonalcoholic Fatty Liver Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Nonalcoholic Fatty Liver
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
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 investigate the effects of curcumin supplement on metabolic factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes. Subjects will participate in 3 month, two group, randomized intervention, where one group (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare differences in outcomes between the two groups.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with type 2 diabetes based on ADA definition or who only take oral antidiabetic drug;
* CAP score \>263.

Exclusion Criteria:

* Taking any kind of antibiotics two weeks before recruitment;
* History of alcohol consumption;
* pregnancy or lactation;
* Professional athletes;
* Other liver disease (viral/etc);
* High dose synthetic estrogens, methotrexate, amiodarone, steroids, chloroquine, immunosuppressive drugs;
* A history of Cardiovascular disease;
* Renal disease, Celiac disease, Cirrhosis;
* History of Upper GI surgery;
* A history of hypothyroidism or Cushing's syndrome;
* History of drug dependence;
* Body mass index (BMI) ≥35 kg/m2;
* A restrictive diet or weight change ≥ 5 kg during the 3months prior to study;
* Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study;
* Use of weight loss medications.

Primary outcomes:
measure: Hepatic steatosis
timeFrame: [12 weeks]
Secondary outcomes:
measure: Glucose
timeFrame: [12 weeks]
measure: HBA1C
timeFrame: [12 weeks]
measure: ALT
timeFrame: [12 weeks]
measure: AST
timeFrame: [12 weeks]
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI
Study officials:
References: