louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01865318: Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
Official title: A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-30
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

Exclusion Criteria:

* History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
* Participation in any other trials involving investigational products within 3 months preceding the start of dosing

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: 0-24 hours after dosing
Secondary outcomes:
measure: Maximum glucose infusion rate (GIRmax)
timeFrame: 0-24 hours after dosing
measure: Time to maximum glucose infusion rate (tGIRmax)
timeFrame: 0-24 hours after dosing
measure: Area under the serum insulin degludec curve
timeFrame: 0-96 hours after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06926218: This Study is to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of HSK47388 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HSK47388 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Keywords: HSK47388, Phase I
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388


Eligibility criteria: Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
3. Able and willing to attend the necessary visits to the study site

Exclusion Criteria:

1. Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
2. Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
3. Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE
timeFrame: 7 days after single dose
Secondary outcomes:
measure: Cmax
timeFrame: Predose up to Day 5 postdose
measure: Tmax
timeFrame: Predose up to Day 5 postdose
measure: AUC
timeFrame: Predose up to Day 5 postdose
measure: t1/2
timeFrame: Predose up to Day 5 postdose
measure: CL/F
timeFrame: Predose up to Day 5 postdose
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
Study officials:
References:
Clinical trial NCT02225418: Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy
Official title: Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cholecystitis
Pain
Keywords: Laparoscopic
Cholecystectomy
Postoperative
Pain
Quadratus lumborum
Ultrasound
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2014-08-26
Enrollment: 0
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 TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.

The trial will compare active TQL block versus placebo TQL block after said operation.

The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.


Eligibility criteria: Inclusion Criteria:

* scheduled for elective laparoscopic cholecystectomy
* received oral and written information about the trial
* American Society of Anaethesiologists (ASA) classification 1-3
* NRS score \> 3 upon arrival at the PACU area

Exclusion Criteria:

* Cannot cooperate
* Does not speak or understand Danish
* Allergy towards drugs used in the trial
* Large daily consumption of opioids
* Known alcohol og medicin abuse
* Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
* Pregnancy

Primary outcomes:
measure: Pain score in sitting position
timeFrame: 1 hour
Secondary outcomes:
measure: Pain score at rest
timeFrame: 15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
measure: Pain score at sitting position
timeFrame: 15 min 30 min 2 hour 3 hour 4 hour 5 hour
measure: Total opioid consumption in PACU area
timeFrame: On average 3 hours
measure: Opioid side effects (nausea, vomiting)
timeFrame: On average 3 hours
measure: Length of stay in PACU area
timeFrame: On average 3 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Copenhagen University Hospital Bispebjerg
name: Jens Børglum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05621018: "Maze Out": A Serious Game to Improve Self-efficacy and Mutual Understanding in Eating Disorders.
Official title: A Randomized Controlled Trial of "Maze Out": A Serious Game to Improve Self-efficacy, Mutual Understanding and Improved Family Functioning in People With Eating Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Keywords: serious games
coproduction
bulimia nervosa
anorexia nervosa
mHealth
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 143
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: Eating Disorders (EDs) are mental disorders with long recovery time and high mortality. Despite the importance and extensive research in the field, an effective treatment for EDs has yet to be found.

In co-production with ED patients, clinicians, and technology experts a Serious Game called "Maze out" was developed and initially evaluated through a feasibility study. Maze out is an innovative first player tool focusing on improving self-efficacy, mutual understanding, and family functioning in adults with EDs.

The game has been evaluated through a usability study. Study findings demonstrate that patients found Maze out easy to use, meaningful and fun.

The usability study was thus a first step in developing and testing an evidence-based intervention to be implemented in the treatment repertoire of adolescents and adults with EDs.

The present study is a Randomized Controlled Trial, whereby the investigators will explore the effectiveness of Maze out as an additional treatment to Treatment as Usual (TAU)


Eligibility criteria: Inclusion Criteria:

* All sexes aged 18+
* Diagnosis of anorexia nervosa, bulimia nervosa, other eating disorders and eating disorders unspecified (ICD-10 codes: F.50.0-F.50.9)
* Receiving treatment from one of psychiatry centers in the Mental Health Services of Region South Denmark, or in Endocrinology Services specialized in ED of Region South Denmark; or living in a mental health care institution in Region of Southern Denmark.

Exclusion Criteria:

• No Danish speaker

Primary outcomes:
measure: Self-Efficacy
timeFrame: at baseline, 8 weeks and 15 weeks
Secondary outcomes:
measure: perceived help received from staff
timeFrame: baseline and after 15 weeks
measure: feelings of ineffectiveness and self-image
timeFrame: baseline and after 15 weeks
measure: interpersonal and intrapsychic interactions
timeFrame: baseline, 8 weeks, 15 weeks
measure: family function
timeFrame: baseline, 8 weeks, 15 weeks
measure: mental health literacy
timeFrame: baseline, 15 weeks
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Maria Mercedes Guala
Study officials:
References:
Clinical trial NCT01953718: A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation
Official title: A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University

Brief summary: The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).

Detailed description: In this observational study, we will retrospectively analyze the one-year follow-up data of 27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University in the years 2008-2012. The data, including parameter settings and severity of motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, was collected during the patients' annual visit to the hospital for reprogramming. A correlation analysis will be conducted to investigate the relationship between change of a specific parameter and the subsequent change of motor scores.

Eligibility criteria: Inclusion Criteria:

* PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012

Exclusion Criteria:

* Simultaneous participation in another clinical trial
* Dementia (Mini Mental State Examination \< 26)
* Removal of DBS electrodes
* Loss to follow-up

Primary outcomes:
measure: Change of parameters (voltage, pulse width, frequency) during follow-up
timeFrame: at 12 months
measure: Change of UPDRS Part III score and the relation to parameters
timeFrame: at 12 months
measure: Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters
timeFrame: at 12 months
Secondary outcomes:
measure: Change of daily levodopa equivalent dosage (LED) during follow-up
timeFrame: at 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01146418: Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031)
Official title: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Reproductive Techniques, Assisted
Follicle Stimulating Hormone, Human
Fertilization In Vitro
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 307
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).


Eligibility criteria: Inclusion Criteria:

* Participant must have provided written informed consent for the trial.
* Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.

Primary outcomes:
measure: Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
timeFrame: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
Secondary outcomes:
measure: Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
timeFrame: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Boostanfar R, Gates D, Guan Y, Gordon K, McCrary Sisk C, Stegmann BJ. Efficacy and safety of frozen-thawed embryo transfer in women aged 35 to 42 years from the PURSUE randomized clinical trial. Fertil Steril. 2016 Aug;106(2):300-305.e5. doi: 10.1016/j.fertnstert.2016.03.041. Epub 2016 Apr 16.
Clinical trial NCT01523418: Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
Official title: Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prophylaxis, Thromboembolism, Venous
Total Knee Replacement
Total Hip Replacement
Keywords: Xarelto
Thromboembolism, Venous
Orthopedic surgery
Factor Xa inhibitor
Observational study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective TKR / THR

Brief summary: The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex, undergoing elective THR/TKR, in whom, Rivaroxaban is given for thromboprophylaxis
* Patients willing to give a written informed consent

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information
* Patients on UFH / LMWH therapy, fondaparinux and vitamin K antagonists are not eligible.
* Patients with history of hypersensitivity to active ingredients or excipient :cellulose microcrystalline, croscarmellose sodium, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

Primary outcomes:
measure: Safety related variables are bleeding events reported as major or non-major adverse events
timeFrame: 3 months after the day of surgery
measure: Symptomatic thromboembolic events (Deep vein thrombosis, Pulmonary embolism) reported as adverse events
timeFrame: 3 months after the day of surgery
measure: All cause mortality
timeFrame: 3 months after the day of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06563518: Clinical Study of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste.
Official title: The Clinical Investigation of Toothpaste Containing Zinc Lactate as Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in Thailand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gingivitis
Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this six-month clinical research study is to evaluate the clinical efficacy of two dentifrices - Toothpaste containing zinc lactate and Colgate Cavity Protection Toothpaste in reducing gingivitis and dental plaque in adults.


Eligibility criteria: Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects.

Primary outcomes:
measure: Gingivitis Assessment
timeFrame: baseline, 3 months and 6 months
measure: Plaque Assessment
timeFrame: baseline, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Mahidol University
state: Bangkok
Study officials:
affiliation: Managing Director of Dental Research Center
name: Terdphong Triratana
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02614118: Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain
Official title: Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irreversible Pulpitis
Keywords: Endodontic treatment
non steroid
pain
pre medication
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 66
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: PREVENTION

Brief summary: The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Detailed description: The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers with age ranged 18-65, non smoking or any medicine consumption, non pregnant or break feeding who haven't received any analgesic during 24 hours before the treatment, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before the treatment. All patients will receive a standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) with no need to take analgesic during 6, 12, 24 and 48 hours intervals following the treatment. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Eligibility criteria: Inclusion Criteria:

* Patients with age ranged 18-65
* without systemic diseases
* without any medicine consumption
* non smoking
* non pregnant
* non breast feeding
* with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment
* without any medicine consumption or analgesic and sedation who understand and sign the VAS and consent forms.

Exclusion Criteria:

-

Primary outcomes:
measure: Pain rate change based on visual analog scale(VAS) form
timeFrame: 6,12,24,and 48 hour intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Dental Branch, AZad UMS
Study officials:
affiliation: Associate Professor
name: Nahid Mohammadzadeh Akhlaghi, DDS,MDS
role: PRINCIPAL_INVESTIGATOR
References: