louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05686889: Post-Hoc Enthusiasm and Wariness
Official title: Post-Hoc Enthusiasm and Wariness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The post-hoc fallacy (also termed the post-hoc-ergo-propter-hoc fallacy) has been recognized for centuries with endless relevance. The general concept in medical care is that patients who improve after a treatment are not necessary patients who improve because of a treatment. Modern medicine provides multiple opportunities to examine such pitfalls of judgment due to the prevailing uncertainty, incompleteness of our understanding pathogenic mechanisms, and natural tendency to connect treatments to outcomes. In this study, we will investigate whether judgments about vitamin supplementation might demonstrate the post-hoc fallacy.

Detailed description: We plan to conduct a brief survey of pharmacies portraying a patient in two slightly different versions. One version will portray the patient who feels better after starting a vitamin supplement whereas another version will portray the patient who feels unchanged after starting a vitamin supplement. The patients will be randomly assigned to participants and otherwise contain identical information. Judgments will be measured by eliciting participants recommendation about continuing the vitamin (Appendix_Script).

Eligibility criteria: Inclusion Criteria:

* Community pharmacist

Exclusion Criteria:

* Outside Ontario

Primary outcomes:
measure: Response variable in each survey is a binary recommendation whether to continue the vitamin supplement or discontinue the vitamin supplement
timeFrame: Short-term (less than 5 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Donald A Redelmeier, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03290989: Itch and Pain Characteristics in Skin Carcinomas
Official title: Itch and Pain Characteristics in Skin Carcinomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Carcinoma
Skin Cancer
Pruritus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From 1 April 2015 to 31 July 2015, all patients presenting with a skin lesion suspicious for carcinoma (BCC or SCC) at the Department of Dermatology of the Military Hospital in Brest were included in the study.

Brief summary: The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.


Eligibility criteria: Inclusion Criteria:

all patients with suspected skin carcinoma aged 18 years or more

Exclusion Criteria:

* age under 18 years,
* inability to complete the questionnaire because of cognitive impairment

Primary outcomes:
measure: Evaluate characteristics of pruritus in skin carcinomas
timeFrame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma)
measure: Evaluate characteristics of pruritus in skin carcinomas
timeFrame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
measure: Evaluate characteristics of pruritus in skin carcinomas
timeFrame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
measure: Evaluate characteristics of pain in skin carcinomas
timeFrame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
measure: Evaluate characteristics of in skin carcinomas
timeFrame: Day1 (when presenting at consultation with a skin lesion suspicious for carcinoma
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03389789: Newborn Cortical Response to Pain and Non Pharmacological Analgesia
Official title: Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: pain
infant
near-infrared spectroscopy
non pharmacological analgesia
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.


Eligibility criteria: Inclusion Criteria:

* Full term healthy infants, needing a heel-prick for metabolic screening;
* Informed consent obtained from parents.

Exclusion Criteria:

- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)

Primary outcomes:
measure: Cortical oxy-haemoglobin increase
timeFrame: During the procedure
Secondary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: During the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
name: Fabio Barbone, Prof
role: STUDY_CHAIR
affiliation: Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
name: Stefano Bembich, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bembich S, Cont G, Causin E, Paviotti G, Marzari P, Demarini S. Infant Analgesia With a Combination of Breast Milk, Glucose, or Maternal Holding. Pediatrics. 2018 Sep;142(3):e20173416. doi: 10.1542/peds.2017-3416.
Clinical trial NCT02317289: Assisted Device for Freezing in Parkinson Disease
Official title: Development of a Multimodal Controlled Device for Improvement and Monitoring of Freezing in Parkinsonian Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

Detailed description: Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients .This brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk is associated to a fall risk. Automatized FOG episode detection would allow systematic assessment of patient state and objective evaluation of the clinical effects of treatments. Techniques have been proposed in the literature to identify FOG episodes based on the frequency properties of inertial sensor signals. Our objective here is to adapt and extend these FOG detectors in order to include other associated gait pattern changes, like festination. The proposed approach is based on a single wireless inertial sensor placed on the patient's lower limbs. Based freezing detectors are not sufficient to detect all FOG and festination episodes. Stride length and cadence are valuable inputs to anticipate the occurrence of upcoming FOG events. The investigators have developed a solution based on a minimal number of embedded sensors and detection algorithms for future real-time applications. It is well known that auditory rhythmic stimulation or visuals marks on the ground would improve dramatically gait in patients with FOG. This sensibility to cueing leads some teams to develop some mobility aid devices rhythmic. Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

Eligibility criteria: Inclusion Criteria:

* troublesome freezing

Exclusion Criteria:

* dementia

Primary outcomes:
measure: fog score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui de Chauliac Hospital
Study officials:
affiliation: CHRU Montpellier
name: Christian GENY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05499689: Transcutaneous Pulsed Radiofrequency in Migraine
Official title: Comparison of Transcutaneous Pulsed Radiofrequency Therapy and Greater Occipital Nerve Block Efficiency in Migraine Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Disorders
Keywords: Transcutaneous pulsed radiofrequency
pulsed radiofrequency treatment
headache
GON block
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the investigator is to compare the efficacy of greater occipital nerve block and transcutaneous pulsed radiofrequency treatment in migraine.

Detailed description: Migraine is the second most common primary headache. Greater occipital nerve (GON) block is an effective method in the treatment of migraine. Transcutaneous pulsed radiofrequency (RF) therapy is used in the treatment of pain. However, its use in headaches is not widespread yet.

Investigator aimed to compare the efficacy of transcutaneous pulsed radiofrequency therapy applied through the GON trace and GON block therapy. A 60-patient study was designed. GON block was planned for 30 patients and transcutaneous pulsed RF was planned for 30 patients. The block will be applied once at the level of C2 vertebra with ultrasound.Transcutaneous pulsed RF will be applied twice, once a week, for 8 minutes.All patients will have pre-treatment migraine disability assessment score (MIDAS) scores filled. A headache diary will be provided to all patients. Frequency and severity of pain will be followed for 1 month. Pain intensity will be evaluated on the visual analog scale (VAS).

Investigator aimed to evaluate the efficacy of transcutaneous pulsed RF therapy, which is a noninvasive method, in migraine.

Eligibility criteria: Inclusion Criteria:

* Chronic Migraine

Exclusion Criteria:

* Other headaches will not accompany (tension-type headache, cluster...)
* Pregnancy

Primary outcomes:
measure: The Migraine Disability Assessment Test
timeFrame: Baseline
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazıt Teaching and Research Hospital
state: Altındğ
Study officials:
affiliation: Diskapi TRH
name: mehlika panpallı ateş
role: STUDY_CHAIR
affiliation: Diskapi TRH
name: ömer taylan akkaya
role: STUDY_DIRECTOR
affiliation: Diskapi TRH
name: Hüseyin Alp Alptekin
role: STUDY_CHAIR
References:
Clinical trial NCT06423989: Role of Immunoglobulin in Male Infertility
Official title: Role of Immunoglobulin in Male Infertility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Subfertility
Lead sponsor: Salma Kafeel Medical Centre
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: to investigate the role of IVIG in male infertility and to determine its benefits in term of semen parameters and assisted reproduction outcome


Eligibility criteria: Inclusion Criteria:

* male patients

Exclusion Criteria:

* female

Primary outcomes:
measure: Semen parameters percentage improvement
timeFrame: 6 month
measure: Sperm motility
timeFrame: 6 month
measure: Sperm morphology
timeFrame: 6 month
Secondary outcomes:
measure: Assisted Reproduction outcome measure
timeFrame: 12 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: SKMC
state: Capital
Study officials:
References:
Clinical trial NCT02793089: Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF
Official title: Retrospective Cohort Study of Increased Risk of Ectopic Pregnancy Associated With Marked Variation of Estradiol During the Early Luteal Phase and High Progesterone on hCG Day in IVF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectopic Pregnancy
Lead sponsor: IVI Vigo
Sponsor class: OTHER
Collaborators: name: Instituto Valenciano de Infertilidad, IVI VALENCIA
First posted: 2016-06-08
Enrollment: 578
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014.

Brief summary: This study evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF.

Detailed description: This is a retrospective cohort study of 578 patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014. Few studies have reported the relation between hormonal levels and ectopic pregnancy (EP) in IVF. Investigators describe EP incidence according to estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) or their variation between both days.

Eligibility criteria: Inclusion Criteria:

* Normal Fallopian tubes in HSG and /or laparoscopy
* Normal Uterus: Abscence of myomas and Müllerian anomalies .

Exclusion Criteria:

* Previous Ectopic Pregnancy .
* Recurrent Abortion .
* Tubal Factor : pelvic inflammatory disease, Hydrosalpinx
* Previous abdominal surgery (except laparoscopy) .
* Prior Peritonitis
* Smoking (at least 1 cigarette/day) .

Primary outcomes:
measure: Ectopic pregnancy rate
timeFrame: Up to 108 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IVI Vigo
name: Elkin Muñoz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.
citation: Paltieli Y, Eibschitz I, Ziskind G, Ohel G, Silbermann M, Weichselbaum A. High progesterone levels and ciliary dysfunction--a possible cause of ectopic pregnancy. J Assist Reprod Genet. 2000 Feb;17(2):103-6. doi: 10.1023/a:1009465900824.
citation: Cobo A, Bosch E, Alvarez C, de los Santos MJ, Pellicer A, Remohi J. Effect of a sharp serum oestradiol fall before HCG administration during ovarian stimulation in donors. Reprod Biomed Online. 2007 Aug;15(2):169-74. doi: 10.1016/s1472-6483(10)60705-5.
Clinical trial NCT04563689: Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
Official title: Efecto de un Enjuague Bucal Con Clorhexidina al 0.12% y Cloruro de Cetil Piridinio al 0.05% en la Carga Viral en Saliva en Pacientes COVID-19 + Hospitalizados o Que Esten Recibiendo Cuidado médico en Casa en Cali - 2020.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Dentaid SL
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized, double-blind, placebo-controlled pilot study to evalaute viral load in saliva of COVID19+ patients using quantitative PCR, before and after use of active or placebo rinses


Eligibility criteria: Inclusion Criteria:

1. Be positive for SARS-CoCV-2 real-time PCR test
2. SARS-CoV-2 patients positive, with home and/or hospitalized care.
3. Have a medical condition that allows them to perform a mouthwash for 1 minute.

Exclusion Criteria:

1. Pregnant.
2. People with impaired lung function who do not allow them to rinse.
3. Patients with antiviral treatment for Covid-19.
4. Patients with diseases that affect saliva, Sjogren's syndrome, and Systemic Lupus Erythematosus.
5. Any cause of immunosuppression (primary or secondary), including HIV.
6. Chronic kidney disease 3b or older, Coronary heart disease, Uncontrolled diabetes (Hb1Ac \>7), Uncontrolled high blood pressure, Uncontrolled thyroid disease, history of cancer less than 1 year

Primary outcomes:
measure: exploratory change in viral load
timeFrame: baseline (pre-rinse) and 15 min, 1 hour, 2 hours and 5 days after initial oral rinse
Secondary outcomes:
measure: number of patients who have decrease in viral load of SARS-CoV-2 in spontaneous saliva measured by quantitative PCR
timeFrame: 15 min, 1 hour, 2 hours and 5 days after initial oral rinse
measure: number of patients with adverse events during 5 days study duration
timeFrame: through study completion in day 5
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Escuela odontologia. Facultad de Salud Hospital del Valle
Study officials:
affiliation: Dentaid SL
name: Ruben Leon, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03752489: Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment
Official title: Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sepsis
Severe Sepsis
Septic Shock
Keywords: Dascena
machine learning
fluid administration
clustering algorithm
mortality
diagnostic
Lead sponsor: Dascena
Sponsor class: INDUSTRY
First posted: 2018-11-26
Enrollment: 51645
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a fluid treatment-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, reductions in in-hospital mortality.


Eligibility criteria: Inclusion Criteria:

* All adults above age 18 who are a member of one of the clinical subpopulations studied in this trial are eligible to participate in the study.

Exclusion Criteria:

* Under age 18

Primary outcomes:
measure: In-hospital SIRS-based mortality
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dascena, Inc.
name: Qingqing Mao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calvert J, Mao Q, Hoffman JL, Jay M, Desautels T, Mohamadlou H, Chettipally U, Das R. Using electronic health record collected clinical variables to predict medical intensive care unit mortality. Ann Med Surg (Lond). 2016 Sep 6;11:52-57. doi: 10.1016/j.amsu.2016.09.002. eCollection 2016 Nov.
citation: Shimabukuro DW, Barton CW, Feldman MD, Mataraso SJ, Das R. Effect of a machine learning-based severe sepsis prediction algorithm on patient survival and hospital length of stay: a randomised clinical trial. BMJ Open Respir Res. 2017 Nov 9;4(1):e000234. doi: 10.1136/bmjresp-2017-000234. eCollection 2017.
citation: Mao Q, Jay M, Hoffman JL, Calvert J, Barton C, Shimabukuro D, Shieh L, Chettipally U, Fletcher G, Kerem Y, Zhou Y, Das R. Multicentre validation of a sepsis prediction algorithm using only vital sign data in the emergency department, general ward and ICU. BMJ Open. 2018 Jan 26;8(1):e017833. doi: 10.1136/bmjopen-2017-017833.