louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05957211: Improving Drop Instillation Comfort of a Cyclosporine A Solution
Official title: Improving Drop Instillation Comfort of a Cyclosporine A Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Keywords: dry eye disease
cyclosporine
eye drop
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2023-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine A that help with reducing inflammation. The newest eye drop containing cyclosporine A is called Cequa (Sun Pharma, Canada). Unfortunately, nearly a quarter of (24.2%) of patients using Cequa have reported some form of discomfort (burning and stinging) when instilling the drops. This potentially discourages patients from continuing the eye drop, which prevents their dry eye disease from being managed effectively. This study is trying to determine if refrigerating the eye drops would allow the drops to feel more comfortable when they are instilled in the eye.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.
* Ocular Surface Disease Index score \>= 23.
* Strip meniscometry \< 5 mm.

Exclusion Criteria:

* Contact lens wearers.
* Have corneal neuropathic or neurotrophic disease.
* Have an ocular or medical condition or taking medications that could confound a study outcome.
* Currently pregnant or breastfeeding (cyclosporine is a FDA pregnancy Category C drug).
* Have an ocular or medical condition for which Cequa is contraindicated (e.g., allergy to cyclosporine or other ingredients in Cequacurrent eye infection, cancer or precancerous condition in or around the eyes).
* Have an allergy to fluorescein.

Primary outcomes:
measure: Ocular discomfort score. A subjective questionnaire that queries participants' ocular discomfort. The instrument ranges from 0 (no discomfort) to 10 (maximum discomfort).
timeFrame: Within 10 minutes of drop instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
References:
Clinical trial NCT06362811: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies
Official title: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Pain, Acute
Keywords: Rectal Biopsy
Sacral Erector Spinae Block
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.

Detailed description: Rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. Post-operative pain can persist for longer than a day and requires analgesics. This study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing only rectal biopsy
* ASA class I-II

Exclusion Criteria:

* ASA class III or more
* Coagulation disorders
* Sacral or spinal anatomical abnormalities
* Infection around the block site
* Local anesthesia allergy

Primary outcomes:
measure: Postoperative pain scores
timeFrame: Postoperative 30th minute, 1st hour, 2nd hour, 4th hour, 6th hour, 12th hour and 24th hour
measure: Analgesia requirement
timeFrame: Post operative 24 hours
Secondary outcomes:
measure: Complications
timeFrame: Post-operative 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayse C Tutuncu, MD
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Pinar Kendigelen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piraccini E, Taddei S. Sacral multifidus plane block: The correct name for sacral erector spinae plane block. J Clin Anesth. 2020 Aug;63:109754. doi: 10.1016/j.jclinane.2020.109754. Epub 2020 Feb 28. No abstract available.
citation: Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available.
citation: Oksuz G, Arslan M, Bilal B, Gisi G, Yavuz C. Ultrasound guided sacral erector spinae block for postoperative analgesia in pediatric anoplasty surgeries. J Clin Anesth. 2020 Mar;60:88. doi: 10.1016/j.jclinane.2019.08.006. Epub 2019 Sep 3. No abstract available.
Clinical trial NCT06280911: The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy
Official title: The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy on The First Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Augmentation
Induction
Labor
Stimulation, Self
Keywords: Augmentation
Date fruit
Induction
Labor
Nipple Stimulation
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed to be randomly controlled.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.

The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014.

Detailed description: The study was designed to be randomly controlled. Block randomization method was used to determine the experimental and control groups. Randomization was done by a biostatistician outside the researcher. 198 pregnant women were randomly assigned to the date fruit, nipple and control groups. From the 37th gestational age to the onset of labor, 6 date fruits were consumed per day by the date fruit group and the nipple stimulation was applied 6 minutes per day for the nipple group. No intervention was made for the control group. For the collection of research data, "Structured Information Form" and "Wijma Birth Expectancy / Experience Scale Version" were used.

Eligibility criteria: Inclusion Criteria:

* Women who nulliparous at the 37th gestational age, have singleton pregnancy, have the BMI is less than 25 kg/m2, planning to have a normal vaginal delivery, have vertex presentation, a volunteer to participate in the study, no smoking in pregnancy and have moderate birth fear according to W-DEQ were included in the study.

Exclusion Criteria:

* Women who have risk pregnancy (such as preterm labor risk, preeclampsia eclampsia, premature rupture of membranes, placenta previa, gestational diabetes, fetal anomaly and chronic diseases) were excluded in the study.

Primary outcomes:
measure: The spontaneous onset of labor
timeFrame: From the 37th gestational age to the labor
measure: Induction and augmentation of labor
timeFrame: From the 37th gestational age to the labor
Secondary outcomes:
measure: Mode of delivery
timeFrame: From the 37th gestational age to the birth
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
Study officials:
affiliation: Atlas University
name: Gülay Rathfisch, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03175211: Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 456906 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses.

The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing


Eligibility criteria: Inclusion criteria

* Healthy male according to the assessment of the Investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (incl.)
* Body Mass Index (BMI) of 20.0 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria

* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
* Further exclusion criteria apply

Primary outcomes:
measure: [N (%)] of subjects with drug-related adverse events.
timeFrame: Up to 672 hours
Secondary outcomes:
measure: AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)
timeFrame: up to 168 hours
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 672 hours
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT04542811: Acupuncture In Migraine Without Aura Patients
Official title: Acupuncture For Preventing Of Attack Frequency And Improving Disability In Migraine Without Aura Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Acupuncture
Keywords: migraine
acupuncture
MIDAS
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 84
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to investigate the effect of acupuncture treatment on attack frequency, pain intensity, and disability in migraine without aura patients who receive prophylaxis treatment.

Detailed description: Acupuncture is a Traditional Chinese Medicine method that has been used for 3000 years to control symptoms, treat illnesses, and relieve pain. Acupuncture is widely used in many countries today as a complementary therapy, especially in cases of chronic pain. Migraine is one of the diseases in which acupuncture treatment is commonly used. Studies conducted so far have focused more on the effect of acupuncture on pain intensity in patients with migraine. Data comparing the impact of acupuncture on both the attack frequency and disability in migraine are relatively scarce.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with migraine according to IHS (International Headache Association)
* Receiving migraine prophylaxis treatment
* Having more than four attacks per month/more than one attack per week
* Not having received acupuncture treatment before.

Exclusion Criteria:

* Being diagnosed with migraine with aura/secondary headache
* Having received acupuncture treatment for any reason within the last year
* Not giving consent for acupuncture treatment
* Having a fear of needles.

Primary outcomes:
measure: Monthly attack frequency
timeFrame: 3 months
measure: Duration of attacks
timeFrame: 3 months
measure: Pain severity
timeFrame: 3 months
Secondary outcomes:
measure: Disability
timeFrame: 3 months
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Rabia Rukiye Akinci
Study officials:
affiliation: Ataturk University
name: Yasemin Çayır
role: STUDY_DIRECTOR
References:
Clinical trial NCT05580211: Neuromodulation for Schizophrenia
Official title: The Clinical and Functional Imaging Effects of Non-invasive Neuromodulation on Illness Awareness in Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: neuromodulation
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
Collaborators: name: Centre for Addiction and Mental Health
First posted: 2022-10-14
Enrollment: 34
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: Our proposed study employs a novel approach to determine the clinical and functional imaging effects of brainstem neuromodulation, with an investigational study device, on illness awareness in schizophrenia - a significant contributor to medication non-adherence and poor treatment outcomes, and arguably the most treatment resistant manifestation of the disorder.

The study device under investigation provides a safe and non-invasive method of brainstem stimulation that will be used in conjunction with a neuroimaging biomarker to measure brain changes associated with treatment and illness awareness.


Eligibility criteria: Inclusion Criteria:

1. Male or female inpatients or outpatients ≥ 18 years of age
2. Having a DSM-V diagnosis of schizophrenia or schizoaffective disorder
3. Voluntary and capable of consenting to participation in the research study
4. Fluent in English
5. Moderate-to-severe lack of illness awareness ≤7 on the VAGUS-SR, which corresponds to a rating of ≥3 on PANSS G12 Insight and Judgment item
6. On a stable dose of antipsychotic and other concomitant medications for at least 2 months, and unlikely to undergo changes in dose during the study

Exclusion Criteria:

1. Unwilling or unable to consent to the study
2. Use of hearing aids or cochlear implants, chronic tinnitus, temporomandibular joint disease
3. Had eye surgery within the previous three (3) months
4. Ear surgery within 6 months prior to entering the study
5. Active ear infection or perforated tympanic membrane
6. Diagnosis of vestibular dysfunction
7. Unstable medical illness or any concomitant major medical or neurological illness, including a history of cardiovascular disease and seizures
8. Acute suicidal and/or homicidal ideation
9. Formal thought disorder rating ≥4 on PANSS item P2
10. DSM-V substance dependence (except caffeine and nicotine) within one month prior to entering the study
11. Positive urine drug screen at the screening visit
12. Metal implants or a pacemaker that would preclude the MRI scan
13. Pregnancy

Primary outcomes:
measure: Illness Awareness
timeFrame: 4 weeks from baseline to end of treatment
Secondary outcomes:
measure: Examine changes in brain network activity
timeFrame: 4 weeks from baseline to end of treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References:
Clinical trial NCT02357511: Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor
Official title: Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: sensitivity
specificity
novel blood pressure monitor
Saturation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

Detailed description: A novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. Monitor captures also saturation and ECG, which are compared to traditional monitoring.

Eligibility criteria: Inclusion Criteria:

* subjected to operative treatment with the need for invasive blood pressure measurement
* spontaneous ventilation
* able to give informed consent

Exclusion Criteria:

* denial by patient
* pacemaker

Primary outcomes:
measure: Relationship between invasive and noninvasive blood pressure measurement
timeFrame: 2 hours of continuous measurement at PACU
Secondary outcomes:
measure: Relationship between study monitor Sp02 measurement and current sp02 measurement
timeFrame: 2 hours of continuous measurement at PACU
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00306111: Pegfilgrastim vs. Filgrastim - Comparison of Mobilized Blood Stem Cells in Patients With Non Hodgkin-lymphoma
Official title: Pegfilgrastim Versus Filgrastim - Intraindividual Comparison of Quantity and Quality of Mobilized Peripheral Blood Stem Cells in Patients With Non Hodgkin-lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Keywords: stem cell transplantation
stem cell mobilization
high-dose therapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2006-03-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the ability of pegfilgrastim vs. filgrastim to mobilize peripheral blood stem cells in patients with Non Hodgkin-lymphoma in an intraindividual study

Detailed description: Patients with Non Hodgkin-lymphoma undergoing stem cell mobilization for planned high-dose therapy will be treated with two cycles of chemotherapy (etoposide, ifosfamide, cisplatin, epirubicin), either followed by daily administration of filgrastim (first cycle) or pegfilgrastim (once after the second cycle). The number of circulating cluster of differentiation 34+ cells, colony-forming units and primitive progenitors will be analyzed at corresponding time points. Peripheral blood stem cells will be collected after the second cycle of chemotherapy by leukapheresis. After the second cycle, high-dose therapy with peripheral blood stem cell support will be administered (the protocol will be chosen according to the diagnosis, including total body irradiation-containing regimens).

Eligibility criteria: Inclusion Criteria:

* histological diagnosis of non-Hodgkin lymphoma
* planned high-dose therapy with autologous stem cell transplantation
* WHO performance status 0-2
* written consent

Exclusion Criteria:

* allergy against (peg)filgrastim
* life expectancy \<3 months
* other malignant diseases within the last 5 years
* cardial insufficiency (\>= New York Heart Association II°)
* uncontrolled infection
* pregnancy, lactation
* central nervous system lymphoma
* Karnofsky score \<70%

Primary outcomes:
measure: Hematopoietic recovery after autologous stem cell transplantation
timeFrame: 1-3 weeks after transplantation, follow up every 3 months (up to 2 years)
Secondary outcomes:
measure: Intraindividual comparison of quantity/quality of circulating stem cells
timeFrame: before and during 3 weeks after conventional chemotherapy
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Dept. of Medicine 2, University of Tuebingen
state: BW
Study officials:
affiliation: University of Tuebingen, Dept. of Medicine 2
name: Robert Mohle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02631811: Early Palliative Care in Patient With Acute Leukaemia
Official title: Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukaemia in Relapse
Keywords: acute leukaemia
supportive / palliative care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion.
* Patients in whom a curative strategy (transplant) is not considered.
* patients older that 75 years at the diagnosis
* informed signed consent

Exclusion Criteria:

* unable to answer the questionnaire
* psychiatric disorders other than depression
* persons under guardianship

Primary outcomes:
measure: mesure of quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: measure of symptoms intensity
timeFrame: 12 weeks
measure: measure of depression
timeFrame: 12 weeks
measure: measure of anxiety
timeFrame: 12 weeks
measure: measure of the quality of the end of life
timeFrame: up to 9 months
measure: overall survival
timeFrame: 9 months
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre Hospitalier LYON SUD
Study officials:
References: