louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00284518: Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-02-01
Enrollment: 380
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.


Eligibility criteria: Inclusion Criteria:

* Lower urinary tract symptoms due to benign prostatic hyperplasia
* Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

* Previous prostate surgery
* Previous or current diagnosis of prostate cancer
* Use of other medications for the treatment of prostatic hyperplasia
* Urinary tract infection

Primary outcomes:
measure: Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
timeFrame: Baseline, Week 72
measure: Change From Baseline in Peak Urine Flow Rate
timeFrame: Baseline, Week 12, Week 72
measure: Change From Baseline in Total Prostate Volume
timeFrame: Baseline, Week 12, Week 72
measure: Change From Baseline in Transitional Zone Prostate Volume
timeFrame: Baseline, Week 12, Week 72
measure: Change From Baseline in Post-Void Residual
timeFrame: Baseline, Week 2, Week 12, Week 72
Other outcomes:
measure: Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
timeFrame: Baseline, Week 12, Week 72
Locations:
city: Murdoch
country: Australia
city: Vienna
country: Austria
city: Victoria
country: Canada
state: British Columbia
city: Olomouc
country: Czech Republic
city: Paris Cedex 13
country: France
city: Braunschweig
country: Germany
city: Perugia
country: Italy
city: Seoul
country: Korea, Republic of
city: Martin
country: Slovakia
city: Taipei
country: Taiwan
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.
Clinical trial NCT03620318: Individual Patient Compassionate Use of Crenolanib
Official title: Compassionate Use of Crenolanib for Cancers With Platelet Derived Growth Factor Receptor Alpha (PDGFRa) Mutations, PDGFRa Amplifications or Fms-like Tyrosine Kinase 3 (FLT3) Mutations
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: FLT3-ITD Mutation
FLT3/TKD Mutation
PDGFR-Alpha D842V
PDGFRA Gene Amplification
Keywords: Compassionate use
Lead sponsor: Arog Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Compassionate use of crenolanib for patients with serious life-threatening illness that have exhausted all available therapies used to treat the disease, with no other viable therapy options, who is not eligible for clinical trials. This program is designed to evaluate the requests on a patient by patient basis.

Patients must have documented evidence of a point mutation in position 842 in platelet derived growth factor receptor alpha (PDGFRA-D842V) or amplification of PDGFRA or internal tandem duplication within the FMS-like tyrosine kinase 3 (FLT3-ITD) or point mutations within the tyrosine kinase domain (TKD) of FLT3 (FLT3-TKD)

Detailed description: This program is being offered on a patient by patient basis while phase 3 studies with crenolanib are ongoing.

Institutional Review Board-/Independent Ethics Committee approval must be granted before, The experimental intervention will be administered over 28-day cycles. Compassionate use of crenolanib will be limited such that it does not interfere with the supply need for phase 3 studies.

There must be adequate understanding of the indication for the requested use.

Eligibility criteria: Inclusion Criteria:

* Subject must have a serious life threatening cancer with FLT3/PDGFRa mutation or PDGFRa amplification who has exhausted all other treatment options
* Subject and their partner (if adults) must use 2 forms of contraception during study and for 3 months following last dose of study drug

Exclusion Criteria:

* Subject is eligible for enrollment in an ongoing clinical trial
* Subject has any condition which, in the investigator's opinion makes the subject unsuitable for participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
Study officials:
References:
Clinical trial NCT04792918: Characterization of Intestinal Microbiota Stability in Preterm Born Neonates
Official title: Intestinal Microbiome Strain-level Stability in NEC/ or LOS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotising Enterocolitis
Late-Onset Neonatal Sepsis
Lead sponsor: ETH Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: University Children's Hospital, Zurich
First posted: 2021-03-11
Enrollment: 81
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is represented by infants born at gestational age below 32 weeks (very preterm born infants) or with a birthweight below 1500g (very low birthweight infants). It is estimated that approximately 100 infants will be enrolled during the study period. As the aim is to study stability of the premature microbiota within individual patients, the study design precludes the need of control groups.

Brief summary: Study around very-low birthweight preterm infants at high risk of developing necrotizing enterocolitis (NEC) or late-onset sepsis (LOS). Collection of stool and other biological samples to assess the strain-level stability of gastrointestinal microbiota in these preterm infants who may or may not develop NEC/LOS.

Detailed description: This study aims to collect biological samples (stool, stomach fluid, and blood) from preterm infants at risk of developing NEC or LOS; as well as environmental samples from infants' hospital surroundings (swabs, air), nutritional intake (formula, breastmilk) and samples from their family members (faeces, vaginal swab).

The main focus of the study is to assess strain-level stability of gastrointestinal microbiota in these infants and potentially assess the source of disease-causing microbiota species/strains.

Eligibility criteria: Inclusion Criteria:

-Preterm infants with a gestational age \< 32 weeks or a birthweight \< 1500g and their family members

Exclusion Criteria:

* Intestinal atresia
* Live born infants referred to from other hospitals later than 3 days after birth

Primary outcomes:
measure: Strain-level stability
timeFrame: 24 months
Secondary outcomes:
measure: Source of bacterial species/strains
timeFrame: 24 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zürich
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
References:
Clinical trial NCT04440618: Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy
Official title: Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea-hypopnea
Oropharyngeal Cancer
Keywords: combined chemoradiotherapy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Disease-free patients treated for locally advanced oropharyngeal cancer for over 6 months by radio-chemotherapy.

Brief summary: The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years old
* Performance Status 0-2
* Squamous cell carcinoma of the oropharynx treated with concomitant chemoradiotherapy
* Treatment termination time greater than 6 months at inclusion
* Tumor classification (American Joint Committee on Cancer 8th) T2-T4 N0-N3
* Patient in complete remission at inclusion
* patient's consent's obtained after information

Exclusion Criteria:

* Previous treatment for upper aerodigestive tract cancer
* Incomplete radiotherapyTreatment
* Neurological pathology wich may affect the functions of the upper aerodigestive tract
* Pregnant or breastfeeding woman
* Unweaned alcoholism
* Tracheotomized patient at the time of the study
* Patient under protection: subjects with guardianship or under law protection
* No health insurance coverage

Primary outcomes:
measure: Prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy.
timeFrame: Day 28
Secondary outcomes:
measure: Severity of OSAHS as a function of the post-therapeutic delay.
timeFrame: Day 28
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT03537118: Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures
Official title: Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Myocardial Ischemia
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 621
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.

Detailed description: Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.

Eligibility criteria: Inclusion Criteria:

1. Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned.
2. Planned femoral access

Exclusion Criteria:

1. Age ≤ 18 years
2. STEMI
3. Absence of palpable femoral pulse

Primary outcomes:
measure: Incidence of major vascular complications
timeFrame: up to 30 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: Sanjit S Jolly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Tej Sheth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: Jose Winter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jolly SS, AlRashidi S, d'Entremont MA, Alansari O, Brochu B, Heenan L, Skuriat E, Tyrwhitt J, Raco M, Tsang M, Valettas N, Velianou JL, Sheth T, Sibbald M, Mehta SR, Pinilla-Echeverri N, Schwalm JD, Natarajan MK, Kelly A, Akl E, Tawadros S, Camargo M, Faidi W, Bauer J, Moxham R, Nkurunziza J, Dutra G, Winter J. Routine Ultrasonography Guidance for Femoral Vascular Access for Cardiac Procedures: The UNIVERSAL Randomized Clinical Trial. JAMA Cardiol. 2022 Nov 1;7(11):1110-1118. doi: 10.1001/jamacardio.2022.3399.
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.
Clinical trial NCT04111718: The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
Official title: The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: ArthroBiologix Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 158
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether outcomes for patients receiving intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis are influenced by observation of the preparatory steps to the procedure. The viewing of the steps involved in the administration of PRP may increase the effectiveness of the treatment in comparison to patients who have not observed the preparatory steps.


Eligibility criteria: Inclusion Criteria:

* Adult men or women ages 50-80 years
* Diagnosis of symptomatic osteoarthritis of the knee based on clinical and radiographic criteria
* Provision of informed consent

Exclusion Criteria:

* Patients with inflammatory osteoarthritis
* Open wounds or sores over the knee joint
* Patients that will likely have problems, in the judgement of the investigators, with maintaining follow-up

Primary outcomes:
measure: VAS Pain
timeFrame: 12 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 12 weeks
measure: Range of motion
timeFrame: 12 weeks
measure: Short Form 12 (SF-12) Functional outcome assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: ArthroBiologix
state: Ontario
Study officials:
affiliation: McMaster University
name: Moin Khan, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03988218: Perception and Representation of Internal Body in Anorexia Nervosa
Official title: Perception and Representation of Internal Body in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Body awareness
Interoceptive awareness
Anorexia Nervosa
Adolescent
Body image
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study focuses on representations of the interior of the body and interoceptive awareness in women with anorexia nervosa in comparison with women without eating disorders.


Eligibility criteria: Inclusion Criteria:

* Anorexia Nervosa according to DSM-5
* aged above than 14
* BMI between 14 and 18.5 for adults or less than the reference age by age for minors

Exclusion Criteria:

* Unable to understand the tests, poor understanding of the French language
* Mental retardation
* Severe psychiatric comorbidity (bipolar disorder, schizophrenia)
* Lesion or pathology of the upper limbs
* Pregnancy
* Absence of social protection
* Hospitalization under duress

Primary outcomes:
measure: drawing
timeFrame: At inclusion
Secondary outcomes:
measure: IAI
timeFrame: At inclusion
measure: Time
timeFrame: At inclusion
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
Study officials:
References:
Clinical trial NCT01897818: Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 20
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: ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.


Eligibility criteria: Inclusion Criteria:

* age \>= 18
* have a diagnosis of ALS suspected, possible, probable with EMG
* be able to follow the study process and to comply with the schedule of visits upon entry into the study
* understand the purpose of the study
* expressing P300 wave in the conditions of the study

Exclusion Criteria:

* have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
* have a significant history of photosensitive epilepsy
* have a history of allergy to the gel used for the electrodes
* Major protected by law (guardianship, curators)
* have uncorrectable visual disorders
* not being able to maintain a sitting position and focus on a computer screen for more than 30 min.

Primary outcomes:
measure: the full achievement of "copy spelling" and "free spelling" tests session 1
timeFrame: 14 days after inclusion
measure: the full achievement of "copy spelling" and "free spelling" tests session 2
timeFrame: 28 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital de l'Archet I
Study officials:
References:
Clinical trial NCT05761418: Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy
Official title: Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myoma;Uterus
Keywords: Uterine leiomyoma
misoprostol
dinoprostone
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

Detailed description: Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.

Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital

Eligibility criteria: Inclusion Criteria:

* Age 30-50 years
* all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.

Exclusion Criteria:

* contraindications to dinoprostone or misoprostol,
* active PID,
* history of pelvic/ ovarian endometriosis,
* females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.

Primary outcomes:
measure: Blood loss
timeFrame: all time of the myomectomy operation
Secondary outcomes:
measure: change hemoglobin levels
timeFrame: within 1 week before operation and 24 hours after operation
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00190918: A Trial for Patients With Gestational Trophoblastic Disease
Official title: A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trophoblastic Neoplasms
Uterine Neoplasms
Hydatidiform Mole
Choriocarcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Gynecologic Oncology Group
First posted: 2005-09-19
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.


Eligibility criteria: Inclusion Criteria:

* Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)
* WHO score 2-6 (re-evaluated at the time of relapse
* Histologically confirmed complete or partial moles on initial evacuation
* Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
* All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
* Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
* Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy.

Exclusion Criteria:

* Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).
* Patients with more than 8 metastatic lesions identified
* Patients with metastases to liver, spleen, brain, kidney or GI tract

Primary outcomes:
measure: To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Secondary outcomes:
measure: To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group 215-854-0770
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: David Miller, MD
role: STUDY_CHAIR
References: