louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01162967: Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
Official title: PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chagas Disease
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Tropical Medicine and International Health Unit Drassanes. Barcelona
name: International Health Unit Metropolitana Nord. Santa Coloma.
First posted: 2010-07-15
Enrollment: 78
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 investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.


Eligibility criteria: Inclusion Criteria:

* Consenting patients with serological evidence of Chagas infection and positive PCR real time

Exclusion Criteria:

-

Primary outcomes:
measure: Parasitological cure measured by a real time PCR in blood sample
timeFrame: 12 months after starting treatment
Secondary outcomes:
measure: Parasitological cure measured by real time PCR in blood sample
timeFrame: End of treatment, weeks 8, 16, 24 and 40 after treatment
measure: Safety and tolerability of both drugs
timeFrame: First 2 months
Other outcomes:
Locations:
city: Santa Coloma
country: Spain
facility: International Health Unit Metropolitana Nord
state: Barcelona
city: Barcelona
country: Spain
facility: Infectious Disease Department Vall d'Hebron Hospital
city: Barcelona
country: Spain
facility: International Health Unit Drassanes
Study officials:
affiliation: Infectious Disease Department Vall d'Hebron Hospital
name: Molina Israel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Disease Department Vall d'Hebron Hospital
name: Pahisssa Albert, MD Ph
role: STUDY_CHAIR
affiliation: International Health Unit Drassanes
name: Gomez Jordi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Health Unit Metropolitana Nord
name: Valerio Lluis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122.
Clinical trial NCT06723067: A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants
Official title: More Time More Milk - Wearable, Wireless Breast Pumps to Increase Accessibility of Milk Expression for NICU Mothers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: premature birth
lactation
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.

Detailed description: Randomized, controlled crossover study design. Non-blinded. Mother of infants born at or below 29+6 weeks of gestation will be eligible once their infant is 28 or more days old. Mothers will be provided with a wearable, wireless breast pump in addition to their usual hospital grade pump. Wireless pumps can be used while cuddling their baby, driving too and from the hospital, caring for other children, etc.

Eligibility criteria: Inclusion Criteria:

* Mother of infant born at 29+6 weeks or below
* Mother still pumping at 4 weeks since birth

Exclusion Criteria:

* Current use of mothers own wearable pump

Primary outcomes:
measure: Number of pumping sessions per day
timeFrame: 7 days
Secondary outcomes:
measure: Volume of milk pumped per day
timeFrame: 7 days
measure: Percentage of required volume pumped
timeFrame: 7 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ascension Seton Medical Center
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Alan Groves
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05498467: The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
Official title: The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: A Randomized Controlled Trial With Anakinra vs. Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Contact Dermatitis
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy


Eligibility criteria: Inclusion Criteria:

* Aged at least eighteen years old.
* Able to provide written informed consent.
* Have a medical diagnosis of nickel allergy with at least a +2 reaction on the
* ICDRG scoring system when challenged with nickel.
* Fitzpatrick skin type 1-4.
* Able to speak and understand Danish.

Exclusion Criteria:

* Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0.
* Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0.
* Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
* Dermatitis and/or infection.
* Recent (3 months or less) administration of a live virus vaccine.
* Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating.
* Taking part in any other intervention study.
* Has any other condition which would, in the Investigator's opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use).
* Presence of any condition or use of any medication which precludes the use of the study drug.
* Allergy to any of the ingredients in the drug.

Primary outcomes:
measure: Clinical Reaction
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References:
Clinical trial NCT04925167: Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO
Official title: Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.


Eligibility criteria: Inclusion Criteria:

* age older than 18 years old; received V-V ECMO because of sevever respiratory failure

Exclusion Criteria:

* anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.

Primary outcomes:
measure: incidence of ECMO related thrombotic events
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bing Sun
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Bing Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05577767: Does Longitudinal Nursing Follow-up Improve Smoking Cessation in Patients Referred for COPD Screening
Official title: Does Longitudinal Nursing Follow-up Improve Smoking Cessation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Screening
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COPD
Nurse's Role
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 233
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: Smoking patients screened for COPD between 35 years old 65 years old

Brief summary: a monocentric study to evaluate the efficacy of a longitudinal nursing follow up in smoking cessation in patients screened for Chronic obstructive pulmonary disease (COPD).

Detailed description: The challenges to limit the occurrence of COPD are early detection, the fight against smoking and smoking and addictions (e.g. Cannabis), as well as the fight against environmental exposures.

we proposed to evaluate if a longitudinal nursing follow-up at 3 months, 6 months and one year, in patients coming to screening for COPD.

Cessation of respiratory toxics is the most effective intervention in stopping the progression of COPD.

Eligibility criteria: Inclusion Criteria:

* Smoking patients screened for COPD between 35 years old 65 years old
* Read, write and understand the French language
* Patient affiliated to a social security system
* Written and signed informed consent

Exclusion Criteria:

* Patients with a diagnosis of respiratory diseases
* Patients receiving inhaled respiratory therapy
* Persons unable to perform spirometry
* Pregnant women
* Refusal to participate in research
* Patient under guardianship, deprived of liberty, safeguard of justice

Primary outcomes:
measure: number of cigarettes or other toxic substances
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Valence
country: France
facility: Ch Valence
state: Drome
Study officials:
affiliation: CH VALENCE
name: Gilles RIVAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04227067: TENS for Back Pain Emergency Department
Official title: The Use of TENS for the Treatment of Back Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: TENS, back pain, ibuprofen
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 80
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: In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.

Detailed description: Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their pain.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 years or greater
* Able to consent
* Back pain of less than 2 weeks duration
* Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)

Exclusion Criteria:

* Pregnant patients
* Minors
* Prisoners
* Neurological deficits

Primary outcomes:
measure: Pain severity
timeFrame: 30 minutes after application of TENS unit
Secondary outcomes:
measure: Use of rescue medications
timeFrame: 30 minutes after application of the TENS unit
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University
name: Adam Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192567: Open Label Study of DS-5573a
Official title: Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Malignant Tumors
Keywords: Advanced solid malignant tumor
phase 1
oncology
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status(PS) of 0 or 1

Exclusion Criteria:

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.

* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.

Primary outcomes:
measure: Number of subjects experiencing dose limiting toxicities
timeFrame: Day 1 through Day 28
measure: Number of subjects experiencing adverse events
timeFrame: Day 1 through 45 days after last dose
measure: Pharmacokinetic profile of DS-5573a
timeFrame: Cycle 1 - Day 1 through Cycle 8 - Day 1
Secondary outcomes:
measure: Incidence of human anti-human antibodies (HAHA) against DS-5573a
timeFrame: Cycle 1 - Day 1 through Cycle 1 - Day 15.
measure: Assessment of tumor response to DS-5573a using RECIST ver1.1.
timeFrame: week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90
measure: Assessment of DS-5573a-related biomarkers in blood and tumor
timeFrame: Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
Study officials:
affiliation: National Cancer Center Hospital
name: Kenji Tamura, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586804: Postural Sway at Menstrual Cyclus
Official title: Comparison of Postural Sway Responses at Menstrual Cyclus in Women With and Without Dysmenorrheal Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Women's Health: Endometriosis
Keywords: menstrual
postural sway
dual task
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with and without pain at menstrual cycles

Brief summary: The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.

Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.

Detailed description: The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.

Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated with the same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.

Results will be compared for menstrual cycles and well-being day in women with and without pain at menstrual cycles.

Eligibility criteria: Inclusion Criteria:

* Have dysmenorrheal syndrome
* Have menstrual cycle without pain

Exclusion Criteria:

* Have another health problem (systemic, neurologic, orthopedic or psychiatric)

Primary outcomes:
measure: Change of Postural sway score
timeFrame: First evaluation: at first minute. Second evauation: Change baseline postural sway score at 15th minutes. Third evaluation: Change baseline postural sway score at 30th minutes.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00765804: Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
Official title: Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Iontophoresis
Ophthalmic Delivery
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 89
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.

Detailed description: The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.

Eligibility criteria: Inclusion Criteria:

* Have a reported history of dry eye in each eye
* Be at least 12 years of age
* Demonstrate a response when exposed to the Controlled Adverse Environment model

Exclusion Criteria:

* Have contraindications to the use of the test articles
* Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
* Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
* Be current contact lens wearers or wear contacts during the study

Primary outcomes:
measure: Sign: Corneal fluorescein staining after CAE exposure at Visit 5
timeFrame: Visit 5 (Day 7 ± 2 Days)
measure: Symptom: Ocular discomfort during CAE exposure at Visit 5
timeFrame: Visit 5 (Day 7 ± 2 Days)
Secondary outcomes:
measure: Sign: Fluorescein staining at each visit over 3 weeks
timeFrame: 7 visits / 3 weeks
measure: Symptom: Ocular discomfort pre and post CAE
timeFrame: Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ophthalmic Research Associates
state: Massachusetts
city: North Andover
country: United States
facility: Ophthalmic Research Associates
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: