louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03093571: Auricular Stimulation vs. Relaxation for Pre-exam Anxiety
Official title: Auricular Acupuncture vs. Progressive Muscle Relaxation in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Title of the study: Auricular acupuncture (AA) vs. progressive muscle relaxation for pre-exam anxiety - a randomised crossover study

Study period: 04 / 2015 - 07 / 2015

Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care, University Medicine of Greifswald

Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle relaxation and vs. no intervention in students, passing the oral exams in anatomy at the University of Greifswald

Design: Prospective randomised crossover trial

Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Progressive muscle relaxation

Number of volunteers: N = 30

Healthy medical students at the University of Greifswald Participants of the oral anatomy exams in spring/summer 2015 Without previous anxiolytic, sedative and analgesic medication No pregnancy or lactating Informed consent

Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase


Eligibility criteria: Inclusion Criteria:

1. Medical students at the University of Greifswald
2. Going to take part in oral exams of human anatomy
3. Participants without previous anxiolytic medication
4. Ability to understand and perform PMR
5. Written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Pregnant or lactating women
4. Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
5. Participants who are unable to understand the consent form
6. History of psychiatric disease

Primary outcomes:
measure: Intensity of anxiety
timeFrame: 2 days
Secondary outcomes:
measure: Salivary alpha-amylase
timeFrame: 1 day
measure: heart rate
timeFrame: 1 day
measure: blood pressure
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Medicine of Greifswald
name: Catharina Klausenitz, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06483971: Comparison of Oral Isotretinoin vs Ancomparison of Oral Isotretinoin vs Antibiotics on Corneal Thickness With AV
Official title: Comparison of Oral Isotretinoin Versus Ancomparison of Oral Isotretinoin Versus Antibiotics on Corneal Thickness in Patients With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cornea
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of Oral Isotretinoin versus comparison of Oral Isotretinoin versus Antibiotics on Corneal Thickness in Patients with Acne Vulgaris

Detailed description: Acne is the most common skin disease requiring attention of health practitioners. It is a self-limiting disease of the pilosebaceous unit, which can lead to devastating and frustrating scars and pigmentary alterations.

Eligibility criteria: Inclusion Criteria:

* Patients of either gender shall be enrolled for this study.
* Acne vulgaris patients taking oral isotretinoin and oral antibiotics shall be included.

Exclusion Criteria:

* Patients with any ocular pathology shall be excluded.
* Patients with any systemic pathology other than acne vulgaris shall be excluded.
* Patients with history of contact lens wear, previous refractive surgery or injury shall be excluded.

Primary outcomes:
measure: Optical Coherence Tomography (OCT)
timeFrame: 12 Months
measure: Snellen Chart
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shalamar Hospital Mughalpura
state: Punjab
Study officials:
References:
Clinical trial NCT02257671: Oral Contraceptives and Economic Behaviour
Official title: The Influence of Oral Contraceptives on Mood, Sexuality and Economic Behavior
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Contraception
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2014-10-06
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood, sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400 healthy women will be randomized to OC or placebo for a period of three months. Before and at the end of treatment, mood and sexuality will be assessed by validated instruments. At the end of treatment, each woman will participate in behavioral experiments testing self-confidence, risk taking and altruism. The current project could fill the gap of ignorance about causal effects of OCs on mood, sexuality and behavior. The results might improve current practice as regards information about OCs, choice of hormonal contraceptive, regimen and duration of use. As a consequence, this could lead to reduced discontinuation rate, fewer unintended pregnancies and abortions. The project will contribute to an overall improvement in women's reproductive health.


Eligibility criteria: Inclusion Criteria:

* Healthy young women, aged 18-35 years, BMI 19-30

Exclusion Criteria:

* Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and estrogen/gestagen therapy the last three months

Primary outcomes:
measure: economic behaviour
timeFrame: 11 weeks
measure: sexual behaviour
timeFrame: baseline to 11 weeks
measure: mood
timeFrame: baseline to 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Obstetrics and Gynecology, Karolinska University Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
name: Angelica L Hirschberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06805071: Decisional Regret in Open Partial Horizontal Laryngectomy
Official title: Decisional Regret in Open Partial Horizontal Laryngectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Laryngeal Squamous Cell Carcinoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 100
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 with laryngeal squamous cell carcinoma of any stage amenable of organ preservation surgery.

Brief summary: Prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with Open Horizontal partial Laryngectomy


Eligibility criteria: Inclusion Criteria:

* SCC larynx treated with OPEN PARTIAL HORIZONTAL LARYNGECTOMY

Exclusion Criteria:

* Previous surgical treatment of the larynx
* Previous CT-RT of the head and neck district

Primary outcomes:
measure: Decisional Regret Scale
timeFrame: From the surgery to the enrollment time (6 months post-treatment)
Secondary outcomes:
measure: DASS-21 Questionnaire
timeFrame: From the surgery to the enrollment time (6 months post-treatment)
measure: Chicago Priority Scale
timeFrame: From the surgery to the enrollment time (6 months post-treatment)
measure: VHI-10
timeFrame: From 6 Months after surgery until the end of the study
measure: MD Anderson Dysphagia Inventory
timeFrame: From 6 Months after surgery until the end of the study
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Matteo Fermi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02166671: Immune Response to Hepatitis B Virus Booster Vaccination After 20-23 Years
Official title: Humoral and Cellular Immune Responses to a Hepatitis B Vaccine Booster 20-23 Years After Neonatal Immunization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatitis B Vaccination
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the humoral and cellular immune responses to a hepatitis B vaccine booster in healthy adults which received a full course of neonatal hepatitis B vaccination 20-23 years ago.


Eligibility criteria: Inclusion Criteria:

* healthy adults 20-25 years old

Exclusion Criteria:

* Hepatitis B surface antigen (+)
* Hepatitis B core antibody (+)
* any history of liver disorders including hepatitis
* HIV Ag or Ab(+)

Primary outcomes:
measure: change of HBsAb titer
timeFrame: 28 days after HBV booster vaccination
Secondary outcomes:
measure: HBsAg-specific cell mediated immunity
timeFrame: 28 days after HBV booster vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05121571: The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
Official title: The Efficacy and Safety of Retreatment With Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib for Patients Who Showed Transarterial Chemoembolization-resistant: a Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
TACE failure
Sorafenib
Hepatic arterial infusion chemotherapy
Oxaliplatin, fluorouracil, and leucovorin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
* TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
* Without extrahepatic metastasis
* The following laboratory parameters:

Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Known history of HIV
* History of organ allograft
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Serious non-healing wound, ulcer, or bone fracture
* Evidence of bleeding diathesis.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug

Primary outcomes:
measure: Progression free survival
timeFrame: 12 months
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 30 days
measure: overall survival
timeFrame: 24 months
measure: tumor response
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06655571: What Technique for Caudal Block in Children: Conventional or Ultrasound-guided
Official title: What Technique for Caudal Block in Children: Conventional or Ultrasound-guided
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Compare Ultrasound-guided Caudal Block to the Conventional Technique Based on Anatomical Landmarks
Keywords: caudal block - children - ultrasound - conventional method
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 94
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E)
Primary purpose: OTHER

Brief summary: The goal of our study is to compare ultrasound-guided caudal block to the conventional technique based on anatomical landmarks.

Detailed description: The primary endpoint was the success rate of each technique. We also collected the time taken for each technique, the number of punctures, and the incidence of complications (subcutaneous infiltration, intravascular injection).

Children were randomized to receive a caudal block based on anatomical landmarks (group C) or ultrasound-guided (group E) at a dose of 1 ml/kg of 0.25% bupivacaine, not exceeding 20 ml.

Eligibility criteria: Inclusion Criteria:

* children aged between 6 months and 6 years, ASA 1 , underwent elective surgery

Exclusion Criteria:

* severe systemic diseases, previous neurological or spinal disorders, coagulation abnormalities, allergies toward LAs, local infection at the block site

Primary outcomes:
measure: Success rate of block
timeFrame: during surgery
Secondary outcomes:
measure: block performing time
timeFrame: perioperative
measure: number of needle puncture
timeFrame: during procedure
measure: complication rates
timeFrame: during procedure
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Bechir Hamza hospital
Study officials:
References:
Clinical trial NCT00804271: Memantine and Validation of a New Alzheimer's Disease Scale
Official title: Open Label, Single-Arm, Multi-Centre, Study to Validate a New Alzheimer's Disease Scale in Patients With DAT, Treated With Memantine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 487
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To validate a new Alzheimer's Disease scale against other rating tools in subjects with dementia of Alzheimer's type, treated with memantine.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of Alzheimer's type.
* Signed informed consent prior to the initiation of any study specific procedures.
* Sight and hearing (a hearing aid is permitted) are sufficiently good to allow the undertaking of study-related procedures and psychometric tests.

Exclusion Criteria:

* Evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
* Intake of any medication that is contra-indicated in combination with memantine.
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to ingredients of memantine or lactose.
* Known or suspected history of alcoholism or drug abuse within the past 2 years.
* Current or previous treatment with memantine or participation in an investigational study with memantine.

Primary outcomes:
measure: Validation of new scale regarding content, reliability and responsiveness for DAT symptoms
timeFrame: at post baseline visit
Secondary outcomes:
measure: Assessment of treatment response and correlation of new scale against ADAScog, SIB, NPI, DAD.
timeFrame: at a post baseline visit
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Clinic Gustav Carus
state: Saxony
Study officials:
affiliation: University Clinic Gustav Carus Dresden, Germany
name: Vjera Holthoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holthoff V, Ferris S, Gauthier S, Ihl R, Robert P, Winblad B, Sternberg K, Tennigkeit F; ROSA Study Group. Memantine effects measured with the Relevant Outcome Scale for Alzheimer's disease in an open-label, single-arm, multicenter clinical study. Int J Geriatr Psychiatry. 2013 Feb;28(2):164-72. doi: 10.1002/gps.3805. Epub 2012 Apr 11.
citation: Holthoff VA, Ferris S, Ihl R, Robert P, Winblad B, Gauthier S, Sternberg K, Tennigkeit F. Validation of the relevant outcome scale for Alzheimer's disease: a novel multidomain assessment for daily medical practice. Alzheimers Res Ther. 2011 Jul 6;3(5):27. doi: 10.1186/alzrt89.
Clinical trial NCT00067171: Telephone Enhancement Procedure for Continuing Care - 1
Official title: Telephone Enhancement Procedure (TELE) for Continuing Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Keywords: behavioral intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-08-13
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: The purpose of this study is to test a feasibility study of a telephone enhancement procedure (TELE) to improve participation in continuing care activities.


Eligibility criteria: Inclusion Criteria:

* Residential substance abuse treatment patients who reside within the pre-specified catchment area who complete continuing care plans prior to discharge.
* Voluntary admit to residential treatment center; substance abuse or dependence; reside in targeted counties; and may be reached by telephone.

Primary outcomes:
measure: Treatment compliance, drug and alcohol astinence
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: James Gilmore Jr. Treatment Center
state: Michigan
city: Black Mountain
country: United States
facility: Julian F. Keith
state: North Carolina
city: Greenville
country: United States
facility: Walter B. Jones, ADATC
state: North Carolina
city: Columbia
country: United States
facility: Morris Village Alcohol & Drug Treatment Center
state: South Carolina
Study officials:
affiliation: Duke University
name: Robert Hubbard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03189771: Effect of Occlusal Reduction on Post-operative Pain
Official title: Effect of Occlusal Reduction on Post-operative Pain in Patients With Irreversible Pulpitis and Symptomatic Apical Periodontitis Treated in a Single-visit: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluate Occlusal Reduction on Post-operative Pain
Teeth With Symptomatic Irreversible Pulpitis
Apical Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: effect of occlusal reduction on post-operative pain is evaluated after single visit root canal treatment in upper and lower molar teeth in patients with sypmtomatic irreversible pulpitis and apical periondontis


Eligibility criteria: Inclusion Criteria:

1. Patient's age between 20-50 years with no sex predilection.
2. Medically free patients.
3. Patients suffering from symptomatic irreversible pulpitis with symptomatic apical periodontitis in maxillary and mandibular molars with:

   * Preoperative pain.
   * Vital pulp.
   * Sensitivity to percussion.
   * Occlusal contact with the opposing teeth.
   * Normal periapical radiographic appearance or slight widening in the periodontal membrane space.

Exclusion Criteria:

1. Pregnant females.
2. Patients having a significant systemic disorder.
3. Patients who had administered analgesics or antibiotics during the last 12 hours preoperatively.
4. Patients having bruxism or clenching.
5. Teeth having :

   * No occlusal contact.
   * No sensitivity to percussion.
   * Association with swelling or fistulous tract.
   * Acute or chronic peri-apical abscess.
   * Greater than grade I mobility.
   * Pocket depth greater than 5mm.
   * No possible restorability.
   * Previous endodontic treatment

Primary outcomes:
measure: pre-operative pain before single visit root canal treatment by NRS (numerical rating scale)
timeFrame: Baseline
measure: post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
timeFrame: after treatment by 6 hours
measure: post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
timeFrame: after treatment by 12 hours
measure: post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
timeFrame: after treatment by 24 hours
measure: post-operative pain after single visit root canal treatment by NRS (numerical rating scale)
timeFrame: after treatment by 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: