louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06718998: A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity
Official title: Evaluation of Different Dose Escalation Regimens for NNC0519-0130 in Participants With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.


Eligibility criteria: Inclusion criteria:

* Female of non-childbearing potential, or male.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered to be otherwise healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria:

* Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percentage (48 millimoles per mole \[mmol/mol\]) at screening.
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Primary outcomes:
measure: Number of Adverse Events (AEs)
timeFrame: From randomisation (week 0) to week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Clinical Trials Unit / Center for Medical Research
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05103098: Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
Official title: Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Miscarriage
Keywords: miscarriage
sublingual
misoprostol
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a double-blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.

Detailed description: the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.

Eligibility criteria: Inclusion Criteria:

* All women above 18 years of age
* Less than 12 weeks of gestation.
* Pregnancy is confirmed by pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
* respiratory illnesses, recent liver disease, or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* Failed medical or surgical evacuation before the presentation.
* Known allergy to misoprostol.

Primary outcomes:
measure: Completeness of abortion
timeFrame: 7 days
Secondary outcomes:
measure: Successful medical abortion
timeFrame: 7 days
measure: amount of calculated blood loss following treatment
timeFrame: 7 days
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT06318598: Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Official title: Dissezione Fenotipica Guidata da Biomarcatori Della Sclerosi Laterale Amiotrofica/Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza
name: Ospedale San Raffaele
First posted: 2024-03-19
Enrollment: 200
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: Consecutive cohort of incident patients from three Italian ALS Centers

Brief summary: The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:

* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?
* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?

Participants will undergo:

* neurological evaluation
* neurophysiological evaluation
* neuropsychological evaluation
* whole exome sequencing
* biomarker measurement in CSF and plasma


Eligibility criteria: Inclusion Criteria:

* diagnosis of ALS or other motor neuron disease
* residence near the study centers

Exclusion Criteria:

* refusal to participate to the study
* unable/unwilling to perform follow-up visits

Primary outcomes:
measure: genetic screening
timeFrame: baseline (at diagnosis)
measure: biomarker assessment
timeFrame: baseline (at diagnosis), at 6 months, at 1 year
Secondary outcomes:
measure: clinical assessment
timeFrame: baseline (at diagnosis), at 6 months, at 1 year
measure: neuropsychological assessment
timeFrame: baseline (at diagnosis), at 1 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: MI
city: Milano
country: Italy
facility: Ospedale San Luca
state: MI
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
state: TO
Study officials:
References:
Clinical trial NCT00729898: Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes
Official title: Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 243
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: Study population type 2 diabetes strated on NovoMix® 30

Brief summary: This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.


Eligibility criteria: Inclusion Criteria:

* Any patient with diabetes type 2 diabetes
* Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
* Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months

Primary outcomes:
measure: Incidence of serious adverse drug reactions, including major hypoglycaemic events
timeFrame: after 12 and 26 weeks
Secondary outcomes:
measure: Number of all hypoglycaemic events
timeFrame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks
measure: Number of all adverse drug reactions
timeFrame: after 12 and 26 weeks
measure: HbA1c
timeFrame: at 12 and 26 weeks
measure: Variability in fasting plasma glucose (FPG) values and average FPG levels
timeFrame: at visits at 12 and 26 weeks
measure: Weight changes
timeFrame: at visits at 12 and 26 weeks
Other outcomes:
Locations:
city: Rud
country: Norway
facility: Novo Nordisk Investigational Site
city: Farsta
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05326698: Evoked Potential Response to Full-endoscopic Cervical Foraminotomy
Official title: Evoked Potential Response to Full-endoscopic Cervical Foraminotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Foraminal Stenosis
Keywords: Evoked Potential
Endoscopy
Irrigation pressure
Dorsal columns
Lead sponsor: Centre Hospitalier Régional de la Citadelle
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 patients will undergo endoscopic surgery on February 22 and 23, 2022 for a cervical foraminotomy to treat foraminal stenosis responsible for recalcitrant cervicobrachial pain. These surgeries will be performed with pre-, per- and post-operative recording of motor and sensory evoked potentials.

Brief summary: Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy


Eligibility criteria: Inclusion Criteria:

1. Cervical radiculopathy due to foraminal stenosis
2. Age \> 18 years
3. Radicular arm pain that were refractory to optimal medical therapy for a minimum of 3 months.
4. Persistent pain despite 3 types of pharmacological treatments (paracetamol, non-steroidal anti-inflammatory drugs, opioids, antidepressant medications, and anticonvulsant medications, etc.).
5. Intact Llemniscal pathways must remain at least partially intact

Exclusion Criteria:

1. History of coagulation disorders; Lupus erythematosus; diabetic neuropathy; rheumatoid arthritis; Morbus Bechterew; Active malignancy; immune deficiency
2. Presence of myelopathy
3. Addiction to drugs, alcohol (5 units/day) and/or medications

Primary outcomes:
measure: Influence of the endoscopic irrigation pressure on somatosensory evoked potentials.
timeFrame: Through surgery completion, from electrodes placement until their removal. An average of two hours.
measure: Influence of the endoscopic irrigation pressure on motor evoked potentials.
timeFrame: Through surgery completion, from electrodes placement until their removal. An average of two hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHR Citadelle
Study officials:
References:
Clinical trial NCT03111498: Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries
Official title: Technical Skills Training Programme for Conducting Vacuum Assisted Deliveries - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training VAD
Keywords: Vacuum assisted delivery
technical skills
training
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: video-recorded vacuum procedure on a special VAD-training phantom in a randomized setting: (1) theory-based training programme (2) practice-based training programme (one-to-one teaching).

Video-recorded vacuum procedure on the VAD- training phantom before randomization, directly after training programme, 4-8 weeks after training programme in order to determine retention of skills.
Primary purpose: OTHER

Brief summary: Training is very important for acquisition and maintenance of obstetric skills. As a one-to-one practical teaching needs time and personal resources, the investigators want to prove the benefit and necessity of the one-to-one training program compared to a theory-based training program in conducting vacuum assisted deliveries (VAD).

The aim of this study is to prove that a practice-based training program (one-to- one teaching) leads to better training results compared to a theory-based training program in conducting VAD.


Eligibility criteria: Inclusion Criteria:

* employees of the Department of Obstetrics and Gynaecology
* oral and written informed consent

Exclusion Criteria:

* no oral and written informed consent

Primary outcomes:
measure: technical skills in conducting VAD
timeFrame: one day (day 0)
Secondary outcomes:
measure: Retention of skills conducting VAD
timeFrame: 4-8 weeks after day 0
measure: trainees' satisfaction
timeFrame: 4-8 weeks after day 0
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. Obstetrics and Gynaecology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Julian Marschalek, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01195805: The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables
Official title: The Effect of Amiloride and Spironolactone on Renovascular and Cardiovascular Variables in Patients With Essential Hypertension in a Doubleblinded, Randomized, Placebo-controlled, Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Keywords: Blood pressure, PWV, HRV, PWV, potassium
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators wish to study the effect of retaining potassium. The participants have essential hypertension. The test substances are Amiloride, Spironolactone and placebo. The participants will ingest tablets for 28 days before being examined. We will perform a 24 hours urine collection, 24-hours bloodpressure measurement, blood and urine samples and we also examine the patient using a SphygmoCor.

Detailed description: Purpose of the study is to examine the effect of amiloride and spironolactone on

1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),
2. Pulsewave velocity, augmentation index central bloodpressure,
3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and
4. Ambulatory bloodpressure

Eligibility criteria: Inclusion Criteria:

* hypertension,
* BMI 18,5-30,
* non-smoker

Exclusion Criteria:

* Smoking
* Not using contraceptives
* Other illnesses
* Drug or alcohol abuse

Primary outcomes:
measure: Bloodpressure
timeFrame: 24-hours and examination
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Departments of medical research and medicine
Study officials:
affiliation: Departments of medical research and medicine
name: Solveig K Matthesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611805: Japanese Phase I of GSK1605786
Official title: A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn's Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-06-05
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese as
* Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity -Male between 20 and 55 years of age inclusive, at the time of signing the informed consent.
* Body weight =\>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive).

Exclusion Criteria:

- Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)

Primary outcomes:
measure: Plasma concentration
timeFrame: up to 72h post dose
Secondary outcomes:
measure: Adverse envents
timeFrame: up to 72h post dose
measure: Vital signe
timeFrame: up to 72h post dose
measure: Clinical laboratory
timeFrame: up to 72h post dose
measure: 12 lead ECG
timeFrame: up to 72h post dose
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05632705: Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis
Official title: A Randomised Trial to Evaluate the Efficacy and Feasibility of a Closing Pack to Reduce the Rate of Surgical Site Infection Following Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Postpartum Sepsis
Lead sponsor: University of Pretoria
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised trial
Primary purpose: PREVENTION

Brief summary: Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis

Detailed description: Pregnant patients meeting the inclusion criteria undergoing elective or emergency caesarean section will be eligible for recruitment. Patients will be randomised into two arms. In the control arm sheath and skin closure will be performed with the instruments used to perform the caesarean section, as per the current standard of care. In the intervention arm, after suturing the uterine incision and obtaining hemostasis and before commencing closure of the sheath and skin, the surgical team (obstetrician, assistant and scrub sister) will don clean sterile gloves, open clean sterile linen to drape on top of the existing linen and open a pack of clean sterile instruments to close the sheath and skin.

Eligibility criteria: Inclusion Criteria:

* women 18 years and older willing and able to provide consent

Exclusion Criteria:

* women who are not able or willing to provide consent patients with existing maternal infection

Primary outcomes:
measure: Efficacy to reduce surgical site infections within seven days
timeFrame: Seven days post-operatively
Secondary outcomes:
measure: Efficacy to reduce postpartum endometritis within seven days
timeFrame: Seven days post-operatively
measure: Feasibility of using a closure pack
timeFrame: At the time of caesarean section
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Kalafong Provincial Tertiary Hospital
state: Gauteng Province
Study officials:
References:
Clinical trial NCT06052605: Healthy Aging in People With Epilepsy Program
Official title: Healthy Aging in People With Epilepsy Program (HAP-E): Closing the Gap in Epilepsy Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to develop and test an educational program about dementia in older adults living with epilepsy. The main questions it aims to answer are:

1. Can providing education on healthy aging, chronic disease management, dementia, and modifiable lifestyle dementia risk factors improve dementia knowledge and health literacy among older adults with epilepsy?
2. Can aging related education and resources improve quality of life among older adults with epilepsy?

Participants will:

* Complete a 12-week group educational program.
* Complete pre- and post-program evaluation.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of epilepsy made by a neurologist, epileptologist, or internist/family medicine physician
* Proficiency in English

Exclusion Criteria:

* Dementia

Primary outcomes:
measure: Dementia Knowledge
timeFrame: Pre and Post intervention (3 months)
measure: Health literacy
timeFrame: Pre and Post intervention (3 months)
measure: Health Related Quality of life
timeFrame: Pre and Post intervention (3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of Califonia, San Diego
state: California
Study officials:
References: