louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05031286: Differences in Pain Processing Between Men and Women
Official title: Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Sensitisation
Keywords: central sensitisation
central sensitization
nociception
withdrawal reflex
heat pain
secondary hyperalgesia
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Many chronic pain conditions show clear differences between between men and women, such as reported pain intensities or treatment effects, with chronic pain conditions being generally more frequent in women. Yet, the underlying mechanisms causing these differences are poorly understood. Central sensitization (CS) is considered one important mechanism in pain patients which differs between female and male patients. The central hypothesis is that already in the healthy population CS processes are more pronounced in women than in men.


Eligibility criteria: Inclusion Criteria:

* good general health
* able to give informed consent

Exclusion Criteria:

* pain complaints for more than two consecutive days over the past three months
* any major medical or psychiatric condition (e.g. heart disease, major depressive disorder)
* any chronic pain condition
* inability to follow study instructions
* consumption of stimulants, drugs, or analgesics within the past 24 hours
* scar tissue or generally reduced sensitivity in the designated testing site areas

Primary outcomes:
measure: Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline
timeFrame: 10-20 minutes before intervention (baseline) and 20-30 minutes after intervention
measure: Changes to the nociceptive withdrawal reflex (NWR) after intervention w.r.t. baseline
timeFrame: 5-10 minutes before intervention (baseline) and 30-35 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist Campus
Study officials:
affiliation: Department of Chiropractic Medicine, Balgrist University Hospital, University of Zurich
name: Petra Schweinhardt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01306786: Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication
Official title: Five Days Quadruple and Clarithromycin Containing Triple Therapy as Empirical First and Second-Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

Detailed description: Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Eligibility criteria: Inclusion Criteria:

* patients with H. pylori infection
* did not receive H. pylori eradication therapy before

Exclusion Criteria:

* patients who have received previous H. pylori eradication therapy
* co-morbidity of liver cirrhosis
* co-morbidity of renal failure
* co-morbidity of alcoholism
* co-morbidity of malignancy
* received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months
* patients with known allergy to the medications used
* patients with a history of previous gastrointestinal diseases or gastric surgery
* pregnancy

Primary outcomes:
measure: H pylori eradication
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 10 weeks outpatient follow-up
Other outcomes:
Locations:
city: Hong Kong SAR
country: Hong Kong
facility: The University of Hong Kong, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Ivan F Hung, MD MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130386: Motivational Interviewing to Address Freshman Weight Gain
Official title: Motivational Interviewing to Address Freshman Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivational Interviewing
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assigned to either motivational interviewing or e-education.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect of Motivational Interviewing and e-health education on body composition and psychological outcomes. After baseline testing, participants will be randomly assigned to a motivational interviewing or e-health education group for a 10-week intervention. Variables of interest include: body composition, physical activity, food consumption and self-determination theory constructs.


Eligibility criteria: Inclusion Criteria:

1. Classified as a college freshman and 18 years of age.
2. Low risk for medical complications from exercise (as determined by physical activity readiness questionnaire (PARQ+).
3. Neither currently engaging in exercise nor consistently exercising over the last three months (2 days per week or less).
4. Be considered overweight based on BMI (BMI at or above 25)
5. Not pregnant.

Exclusion Criteria:

* Those that do not meet inclusion criteria.

Primary outcomes:
measure: changes in fat mass
timeFrame: 12 and 28 weeks
measure: Changes in lean mass
timeFrame: 12 and 28 weeks
measure: Physical Activity
timeFrame: 12 and 28 weeks
measure: Changes in the number of servings of Fruit and Vegetables
timeFrame: 12 and 28 weeks
measure: Changes in Autonomous motivation
timeFrame: 12 and 28 weeks
Secondary outcomes:
measure: Experience with MI
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Auburn
country: United States
facility: School of Kinesiology
state: Alabama
Study officials:
References:
Clinical trial NCT01384786: The Incidence of Thyroid Cancer in 4474 Patients Treated for Hyperthyroidism or Goiter
Official title: The Incidence of Thyroid Cancer in 4474 Patients Treated for Hyperthyroidism or Goiter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperthyreosis and Goiter
Thyroid Cancer
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 4474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Radioiodine treated patients

Brief summary: Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan before they are treated with radioiodine for their thyroid disease. Because the investigators do not get a histologically/final diagnosis the investigators want to make sure, that the patients treated do not have a thyroid cancer when treated.

The investigators have found that thyroid cancer is not overlooked.


Eligibility criteria: Inclusion Criteria:

* all patients treated with radioiodine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: herlev Hospital
Study officials:
affiliation: Herlev Hospital, Copenhagen, Denmark
name: Anders Vej-Hansen
role: STUDY_CHAIR
References:
Clinical trial NCT02449486: Ropivacaine After Sternotomy
Official title: Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Requirement of postoperative pain medication
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.

Detailed description: A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.

Eligibility criteria: Inclusion Criteria:

* Elective CABG or heart valve surgery patients

Exclusion Criteria:

* Psychic disorders
* Sleep apnea syndrome
* Diabetes mellitus (insulin dependent)
* Obesity, body mass index (BMI) ≥ 35
* Cardiac insufficiency, ejection fraction (EF) ≤ 30

Primary outcomes:
measure: Postoperative oxycodone consumption
timeFrame: 48 postoperative hours
Secondary outcomes:
measure: Pain measured with Visual Analog Scale
timeFrame: 48 postoperative hours
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University hospital
Study officials:
affiliation: Kuopio University Hospital
name: Pasi K Lahtinen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02970786: Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Neuroendocrine Carcinoma
Breast Cancer
Ovarian Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

Detailed description: The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E\[c(RGDyK)\]2. In addition, the quantitative uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
* Capable of understanding and giving full informed consent

Exclusion Criteria:

* Pregnancy
* Lactation
* Obesity (weight above 140 kg)
* Claustrophobia

Primary outcomes:
measure: Biodistribution
timeFrame: 2 hours
measure: Dosimetry
timeFrame: 2 hours
measure: Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.
timeFrame: 48 hours
Secondary outcomes:
measure: Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue
timeFrame: 2 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
References:
Clinical trial NCT01144286: Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Official title: Multi-center, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study to Compare the Therapeutic Efficacy, Safety, and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate Pessaries in the Treatment of VVC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvovaginal Candidiasis
Keywords: VVC
candidiasis
vaginal candidiasis
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2010-06-15
Enrollment: 229
Sex: FEMALE
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: In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).


Eligibility criteria: Inclusion Criteria:

* Women aged between 18 to 65 years of age who have signed the informed consent.
* Not pregnant, not nursing.
* No indication of other vulvovaginitis or genital infections
* Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
* Negative wet mount results for T. vaginalis and clue cells.
* Exclusion Criteria:
* Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
* Hypersensitivity to imidazole products administered topically.
* Any other medical condition which in the opinion of the investigator could interfere with study conduct.

Primary outcomes:
measure: Dose-response of Clinical and Mycological (Global) Therapeutic Response
timeFrame: day 26 ± 4 days
Secondary outcomes:
measure: Dose-response of Clinical and Mycological (Global)Therapeutic Response
timeFrame: Day 8 ± 2 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ferrer Internacional S.A.
Study officials:
References:
Clinical trial NCT02253186: Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
Official title: Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.


Eligibility criteria: Inclusion Criteria:

* Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
* Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
* Lymphoedema with evident pitting sign (assessed as ++ or +++)
* Requiring compression therapy for, at least, the next 3 months.
* Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
* Signed informed consent prior to any study-mandated procedure.
* Not under any administrative or legal supervision.
* Covered by a health insurance system

Exclusion Criteria:

* Stage I lymphoedema
* Active cellulitis
* Lymphoedema associated with active cancer needing acute chemotherapy
* Motor and sensitive neurological deficiency
* Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
* Patient participating in any other clinical study
* Unlikely to be followed up to 3 months with clinical assessment

Primary outcomes:
measure: Change in excess arm volume
timeFrame: between Day 0 and Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires
Study officials:
affiliation: University Hospital, Montpellier
name: Isabelle Quere, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05178186: Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer
Official title: Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer: an International Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Carcinoma
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 22974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The impact of the COVID-19 pandemic has heavily influenced routine medical care. In the first months of the pandemic, healthcare authorities restricted medical care to emergency procedures, postponing elective surgical activity. Conversely, screening programmes and planned examinations have been temporarily suspended or delayed. Gradually, elective surgery and clinical activities have resumed, thanks to the weakening of the pandemic, to a better organization of the healthcare systems and to the diffusion of COVID-19 vaccines.

In the present study, we aim to evaluate the impact of the COVID-19 pandemic on surgery for thyroid carcinoma. Particularly, we aim to investigate whether the delay in operations, screening programmes, and planned examinations for patients under follow-up after thyroid surgery have led to an increased number of aggressive tumours.

To evaluate this aspect, we aim to compare the patients who had undergone thyroidectomy for thyroid cancer before the COVID-19 pandemic (from February 2019 to February 2020), during the first phase of the pandemic (from March 2020 to September 2020), and after the first phase of the COVID-19 pandemic (from October 2020 to October 2021).


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone thyroidectomy with preoperative diagnosis of thyroid cancer (cytological diagnosis, including Bethesda III, IV, IV or VI class, or high suspicion of thyroid carcinoma based on clinical and/or ultrasonographic features) during the study period (from February 2019 to October 2021)
* Patients who underwent reoperative neck surgery for local recurrence of thyroid carcinoma during the study period (from February 2019 to October 2021)

Exclusion Criteria:

* Age \< 18 yo
* Incidental diagnosis of thyroid carcinoma

Primary outcomes:
measure: Incidence of aggressive thyroid cancers
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: AOU Cagliari
state: CA
Study officials:
References:
Clinical trial NCT02888522: Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML
Official title: Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AML
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 60
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: Acute myeloid leukemia

Brief summary: Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.

The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.


Eligibility criteria: Inclusion Criteria:

* Acute myeloid leukemia
* Allogeneic stem cell transplantation (related or unrelated)

Exclusion Criteria:

* Age under 18 years
* Cord blood transplantation

Primary outcomes:
measure: Percentage of recipient chimerism
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of relapse at 1 year
timeFrame: Relapse rate at 1 year
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
References: