louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01536613: Post Marketing Surveillance Study of Biphasic Insulin Aspart 30
Official title: NovoMix® 30 FlexPen, Post Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 5346
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with diabetes who did not have indications that are contraindicated in the product insert

Brief summary: This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.


Eligibility criteria: Inclusion Criteria:

* Subjects with diabetes who did not have indications that are contraindicated in the product insert

Primary outcomes:
measure: Change in body weight
Secondary outcomes:
measure: Change in fasting plasma glucose (FPG)
measure: Change in HbA1c (glycosylated haemoglobin)
measure: Occurrence of adverse events (non-serious and serious)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04934813: Alveolar Ridge Preservation Techniques After Tooth Extraction
Official title: Clinical Evaluation of Different Alveolar Ridge Preservation Techniques After Tooth Extraction: a Single- Center, Triple Blinded Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.

Detailed description: Thrirty-six patients were randomly assigned in four treatment groups: A) freeze-dried bone allograft (FDBA) covered with collagen sponge (CS), B) FDBA covered with free gingival graft (FGG), C) demineralized bovine bone mineral xenograft (DBBM) covered with FGG and D) FGG without socket grafting. Clinical measurements were performed immediately after tooth extraction and 4 months later. The related outcomes pertained to both vertical and horizontal assessment of bone loss

Eligibility criteria: Inclusion Criteria:

* systematically healthy patients
* non-smokers
* no use of antibiotics for the last 3 months
* presence of a non-restorable single-rooted tooth in the maxilla.

Exclusion Criteria:

* Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction

Primary outcomes:
measure: Vertical dimensional alterations of the alveolar ridge, after tooth extraction.
timeFrame: 4 months
measure: Horizontal dimensional alterations of the alveolar ridge, after tooth extraction.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University
state: Αττική
Study officials:
References:
Clinical trial NCT01595113: Safety Study of Clinical Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction
Official title: A Follow-up Observational Study of Safety of Clinical Trial Conducted With Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-05-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects agreed to participate in this follow-up observational study among the subjects (80 patients:40-test group, 40-control group) who participated in the previously conducted clinical trial.

Brief summary: The purpose of this study is to evaluate the safety of the previously conducted clinical trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial infarction. This is a follow-up observational study and targeting the subjects who participated in the previously conducted clinical trial.

Detailed description: The safety evaluation in this clinical trial is performed with variables, such as occurrence and severity of adverse events, clinical laboratory tests, vital signs, physical examination, cardiac events, and cancer.

Eligibility criteria: Inclusion Criteria:

* Patients who have elapsed for more than 2 years after onset of acute myocardial infarction among the patients who had received cell transplant therapy or drug treatment at least once in test and control group on the previously conducted clinical trial.
* Subjects agreed to participate in this follow-up study and signed the consent form.

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Min-Soo Ahn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569113: Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
Official title: A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergency Contraception
Keywords: ella
ellaOne
quickstart
contraception
combined oral pill
microgynon
Lead sponsor: HRA Pharma
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.


Eligibility criteria: Inclusion Criteria:

* Healthy women aged 18-35 years old
* BMI \< 30 Kg/m2
* Not at risk of pregnancy
* No use of progesterone-only-pill for 3 months before start of treatment cycle
* No use of implant hormonal contraception for 3 months before start of treatment cycle
* No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
* No use of depo provera for 12 months before start of treatment cycle
* Able to give informed consent.

Primary outcomes:
measure: Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).
timeFrame: Day 1 to day 21 of intake of microgynon 30
Secondary outcomes:
measure: Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo.
timeFrame: Day 1 to day 21 of intake of microgynon 30
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Dinox
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Edinburgh
country: United Kingdom
facility: Chalmers Sexual Health Clinic
state: Scotland
Study officials:
affiliation: Chalmers Sexual Health Clinic
name: Sharon Cameron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cameron ST, Berger C, Michie L, Klipping C, Gemzell-Danielsson K. The effects on ovarian activity of ulipristal acetate when 'quickstarting' a combined oral contraceptive pill: a prospective, randomized, double-blind parallel-arm, placebo-controlled study. Hum Reprod. 2015 Jul;30(7):1566-72. doi: 10.1093/humrep/dev115. Epub 2015 May 20.
Clinical trial NCT03993613: Apotransferrin in Patients With β-thalassemia
Official title: Efficacy and Safety of Human Apotransferrin in Patients With β-thalassemia Intermedia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: β-thalassemia Intermedia
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 10
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 aim of the trial is to study the effect of apotransferrin administration in patients suffering from β-thalassemia intermedia in order to restore the erythropoiesis as reflected by enhanced haemoglobin levels or reduced transfusion dependency.


Eligibility criteria: Inclusion Criteria:

* Non-transfusion dependent β-thalassemia intermedia, defined as patients with microcytic anaemia in combination with an elevated HbA2 (\>2.5%) and a haemoglobin of \<6.2 mmol/L, or transfusion dependent β-thalassemia treated with a regular transfusion schedule.
* Age above≥ 17 years.
* Adequate renal and hepatic function tests
* WHO performance 0, 1 or 2.
* Signed informed consent.

Exclusion Criteria:

* Known with allergic reactions against human plasma or plasma products.
* Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease).
* Cardiac dysfunction as defined by: myocardial infarction within the last 6 months of study entry, unstable angina, or unstable cardiac arrhythmias.
* Pregnant or lactating females.
* Known with IgA deficiency with anti-IgA antibodies

Primary outcomes:
measure: Erythropoiesis
timeFrame: 17 weeks
Secondary outcomes:
measure: Change from baseline in serum iron
timeFrame: 17 weeks
measure: Change from baseline in change plasma levels of advanced glycation end products
timeFrame: 17 weeks
measure: Change in spleen size
timeFrame: at baseline and at 16 weeks
measure: Change from baseline in reticulocyte count
timeFrame: 17 weeks
measure: Change from baseline in erythropoietin levels
timeFrame: 17 weeks
measure: Ctrough
timeFrame: predose and postdose 5 minutes, 2 hours and 1, 4, 7, 14 days
measure: Cmin
timeFrame: predose and postdose 5 minutes, 2 hours and 1, 4, 7, 14 days
measure: tmax
timeFrame: predose and postdose 5 minutes, 2 hours and 1, 4, 7, 14 days
measure: Cmax
timeFrame: predose and postdose 5 minutes, 2 hours and 1, 4, 7, 14 days
measure: AUCτ
timeFrame: predose and postdose 5 minutes, 2 hours and 1, 4, 7, 14 days
measure: Ctrough
timeFrame: predose
measure: Adverse events
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Academic Medical Centre
state: Noord-Holland
Study officials:
affiliation: Academic Medical Centre
name: Bart Biemond, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683513: Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients
Official title: Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
PCOS
Keywords: OHSS
mataphase II oocytes (MII)
good quality embryo's
pregnancy
Lead sponsor: AZ Jan Palfijn Gent
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouw Hospital
First posted: 2012-09-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* ICSI patients below 38 years
* 1, 2 and 3e IVF cycle
* Body Mass Index (BMI) less than 32
* PCOS patients

Exclusion Criteria:

* endocrinal diseases or problems

Primary outcomes:
measure: MII oocytes
timeFrame: patients will be followed during the stimulation with an average of 10 days
measure: 2 Pro Nuclei (2PN) fertilization
timeFrame: 24h after ICSI
Secondary outcomes:
measure: implantation rate
timeFrame: 12 weeks
measure: OHSS
timeFrame: one month with oocyte retrieval in the middle
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Jan Palfijn
state: Oost-vlaanderen
Study officials:
affiliation: IVF Centrum Jan Palfijn Gent
name: Wim Decleer, gynecologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664013: The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
Official title: The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Botulinum Toxin
Quality of Life
Cervical Dystonia
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2012-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients


Eligibility criteria: Inclusion Criteria:

* aged ≥ 18 years to 75 years
* Subjects requiring treatment for a clinical diagnosis of cervical dystonia
* Willing to provide written informed consent before any study-related procedures.

Exclusion Criteria:

* Patients with pure anterocollis
* Patients with an anaphlyactic response history to botulinum toxin type A.
* Patients who have been treated with botulinum toxin type A within 3 month.
* Females who are pregnant, planning pregnancy, unable to use contraception or lactating.
* Any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.

Primary outcomes:
measure: To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.
timeFrame: 6 weeks
Secondary outcomes:
measure: To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)
timeFrame: 6 weeks
measure: To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Roongroj Bhidayasiri
state: Bangkok
Study officials:
References:
Clinical trial NCT05354713: NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers (BE)
Official title: An Clinical Trial to Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Detailed description: Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Primary outcomes:
measure: NVP-1805's Pharmacokinetics of plasma
timeFrame: 0hours - 72hours
measure: Pharmacokinetics of plasma
timeFrame: 0hours - 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospita
Study officials:
affiliation: H Plus Yangji Hospital
name: Jaewoo Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149213: Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Official title: An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder
follow-up
relapse
remission
transcranial direct current stimulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse.

Detailed description: Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for depression treatment. The purpose of the present study is to determine whether tDCS is also an effective strategy for sustaining remission.

We will enroll patients who presented remission using tDCS from our previous study and offer them to tDCS every other week for three months, than once a month for another three months. We will address whether tDCS prevents relapse by assessing depression scores once a month, using a time-to-event analysis.

The importance of the present study is to determine whether tDCS is able to sustain remission during long-term follow-up of depressed patients.

Eligibility criteria: Inclusion criteria:

Patients from previous studies (ID:USP-HU-001 and ID:USP-HU-002) who:

* received tDCS and responded.
* received tDCS + sertraline and responded.
* received sertraline or placebo and did not respond, and thereafter received tDCS during the cross-over phase and responded.

Exclusion criteria:

Patients from previous studies who:

* received tDCS and did not respond.
* received tDCS + sertraline and did not respond.
* received sertraline or placebo and responded.
* did not respond during the crossover phase.
* do not wish to participate in the present study.

Primary outcomes:
measure: Relapse from depression
timeFrame: Week 4
measure: Relapse from depression
timeFrame: Week 8
measure: Relapse from depression
timeFrame: Week 12
measure: Relapse from depression
timeFrame: Week 16
measure: Relapse from depression
timeFrame: Week 20
measure: Relapse from depression
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Andre R Brunoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05891613: A Study of Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride Post Breast Reduction
Official title: Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride for Postoperative Analgesia After Breast Reduction Surgery: a Prospective, Single Blind, Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Reduction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.

Detailed description: This is a prospective, multi-surgeon, single blind, non-randomized, controlled trial with breasts allocated to two parallel groups: A mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride will be used on one side (Treatment side) as local infiltration, and plain 0.25% Bupivacaine Hydrochloride will be used in the control arm. Each breast will serve as the control for the other. The study is designed to evaluate early postoperative pain control of each of the products up to 72 hours postoperatively. These treatments are standard of care in clinical practice.

Eligibility criteria: Inclusion Criteria

- Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

Exclusion Criteria

* Inability to provide informed consent
* Medical or surgical history precluding breast reduction
* History of significant chronic pain requiring daily use of opioid or nonopioid analgesics
* Pregnancy
* Concomitant non-breast surgical procedure
* Previous chest wall irradiation
* Previous breast implant, breast reduction or breast lift surgery
* Known allergy to bupivacaine or liposomal bupivacaine
* Liver or kidney dysfunction
* Use of antiplatelet or anticoagulation therapy.

Primary outcomes:
measure: Pain Scores in the first 72 hours post-operatively following breast reduction
timeFrame: 72 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Basel Sharaf, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References: