louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02246881: A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
Official title: An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Von Willebrand Disease
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compare the first and second pharmacokinetic assessments on Optivate® (and recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and safety.


Eligibility criteria: Inclusion Criteria:

* Previously treated subjects with severe Haemophilia A (\<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.

Exclusion Criteria:

-

Primary outcomes:
measure: PK parameters for FVIII:C
timeFrame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Debinki 7, 80-211 Gdansk
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
city: Dr K Jaczewskiego 8, 20-090, Lublin
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
city: Pabianicka 62, 93-513 Lodz
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
city: Hills Road, Cambridge
country: United Kingdom
facility: Haemophilia Centre, Addenbrooke's Hospital
state: Cambridgeshire
city: Clifton Boulevard, Nottingham
country: United Kingdom
facility: Haemophilia Centre, University Hospital, Queens Medical Centre
city: Glossop Road, Sheffield
country: United Kingdom
facility: Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital
city: Manchester
country: United Kingdom
facility: Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary
city: Tremona Road, Southampton
country: United Kingdom
facility: Haemophilia Centre, Southampton General Hospital
Study officials:
References:
Clinical trial NCT01395381: Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition
Official title: Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kwashiorkor
Marasmus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
First posted: 2011-07-15
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.


Eligibility criteria: Inclusion Criteria:

* 12-59 months old
* Kwashiorkor and/or Marasmus
* Qualified for home-based therapeutic feeding with RUTF

Exclusion Criteria:

* Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF
* Unable to consume test-dose of RUTF in clinic
* Parent refusal to participate and return for follow-up

Primary outcomes:
measure: nutritional recovery
timeFrame: 12 weeks
measure: mortality
timeFrame: 12 weeks
Secondary outcomes:
measure: malnutrition relapse
timeFrame: 6 months
measure: height and weight gain
timeFrame: 6 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: St. Louis Nutrition Project
Study officials:
affiliation: University of Malawi
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malawi
name: Kenneth Maleta, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malawi
name: Indi Trehan, MD MPH DTM&H
role: STUDY_DIRECTOR
References:
Clinical trial NCT00420810: Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)
Official title: A Double-Blind, Placebo Controlled, Randomized, Cross-Over Polysomnographic Study of MK0928 15 mg in Adult Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Primary Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Primary Insomnia
* Patient is willing to stay overnight at a sleep laboratory for a total of 7 nights
* Patient is willing to avoid alcohol on PSG visits
* Patient will avoid napping during the course of the study
* Patient's bedtime is between 9pm and 1am

Exclusion Criteria:

* History of substance abuse, bipolar disorder or psychotic disorder
* Difficulty sleeping due to other medical condition
* History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome
* History of neoplastic malignancy within the last 5 years
* Positive alcohol breath test during the screening visits

Primary outcomes:
measure: Wake after sleep onset and Latency to persistent sleep
Secondary outcomes:
measure: Subjective total sleep time and subjective time to sleep onset
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01878110: Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania
Official title: Treatment Development Study of the COMB Model of Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Hair-Pulling Disorder
Keywords: Trichotillomania
Hair pulling
Behavior therapy
Lead sponsor: American University
Sponsor class: OTHER
Collaborators: name: Trichotillomania Learning Center
First posted: 2013-06-14
Enrollment: 16
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: This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM)

Exclusion Criteria:

* Current suicidality or severe depression
* Current psychosis
* Current alcohol or substance abuse
* Concurrent psychotherapy for TTM
* Psychotropic meds (for any disorder) that have not been stable for \>4 weeks

Primary outcomes:
measure: Massachusetts General Hospital Hairpulling Scale (MGH-HS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University
state: District of Columbia
Study officials:
References:
Clinical trial NCT01784510: Two or Six cm From Pylorus at Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Randomized controlled trial comparing between two technique of laparoscopic sleeve gastrectomy for treatment of morbid obesity. In the first technique the investigators started dissection of gastrocolic ligament 6 cm from pylorus and in the second one the distance was only 2 cm. The main primary outcome measure was weight loss.


Eligibility criteria: Inclusion Criteria:

* morbid obesity with body mass index more than 40 or 35 with at least one comorbidity

Exclusion Criteria:

* extreme of age less than 18 or over 65 years contraindications to laparoscopy

Primary outcomes:
measure: weight loss
timeFrame: 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gastroenterology Surgical Center
state: Dakahlia
Study officials:
References:
Clinical trial NCT00358410: An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
Official title: An Exploratory Study to Investigate the Effects of the NK1 Antagonist GW679769, 60 mg Once Daily for 4 Days, on Gastric Accommodation, Gastric Emptying and Gastric Distension-induced Perception and Discomfort in Adult Male and Female Patients With Functional Dyspepsia, in a Single Center, Placebo-controlled, Double-blind, Randomised, Two-period Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonulcer Dyspepsia
Keywords: Functional Dyspepsia
Barostat
Stomach
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was designed is to examine the idea that GW679769 has an effect on three of the pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to distension.

Detailed description: An exploratory study to investigate the effects of the NK1 antagonist GW679769, 120 mg once daily for 4 days, on gastric accommodation, gastric emptying and gastric distension-induced perception and discomfort in adult male and female patients with functional dyspepsia, in a single-centre, placebo-controlled, double-blind, randomised, two-period crossover study

Eligibility criteria: Inclusion criteria:

* Functional dyspepsia as diagnosed according to the Rome II criteria
* Must had a one month trial (full dose) of proton pump inhibitor treatment within the last 6 months, during a symptomatic period, that produced no lasting response, although this may not be required for those patients who have no symptoms of heartburn and do not present pain-predominant dyspepsia symptoms. Such decision will be left to the Principal Investigator's discretion.
* Patients who are non-smokers or smokers who smoke up to 20 cigarettes per day

Exclusion criteria:

* Active or history of peptic ulcer disorder
* History of major abdominal surgery
* History of underlying psychiatric illness, or current active psychiatric morbidity
* Pregnant or nursing women

Primary outcomes:
measure: To identify whether GW679769 has an effect on gastric accommodation to a meal, as measured by gastric barostat in male and female patients with FD. Meal induced fundus relaxation as measured by gastric barostat.
timeFrame: Three to Five Days
Secondary outcomes:
measure: Rate of gastric emptying as measured by dual breath test.Thresholds for perception and discomfort during gastric distension by gastric barostat.
timeFrame: Three to Five days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04976010: Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease
Official title: Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Cardiovascular Diseases
Microbial Colonization
Aging
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients treated at the Department of Pediatric Nephrology in Berlin (Charité), Hamburg (UKE) and Leipzig (KfH) will be recruited for this study.

Brief summary: Chronic kidney disease (CKD) is associated with an increased cardiovascular mortality. In particular children with early-onset CKD have a lifelong increased risk to suffer from cardiovascular disease (CVD). Therefore, children with CKD deserve our attention. The immune system in children with CKD is disturbed, exhibiting pro-inflammatory features. Therefore, we aim to learn more about the characteristics of the immune system in early-onset CKD. In this project PBMC of pediatric CKD patients and age-matched healthy controls will be analysed and compared using CITE-Seq as a multimodal scRNAseq phenotyping method. All patients will be clinically characterized to integrate cardiovascular and immunological data.


Eligibility criteria: Inclusion Criteria:

* matching to one of the following groups CKD G3-5: estimated eGFR according to Schwartz formula \<60ml/min\*1,73m2 (no ESKD) CKD G5 D: patients with ESKD treated with hemodialysis for at least 3 months normal kidney function: CKD G1 or no CKD with eGFR \> 90ml/min\*1,73m2
* informed consent to participate in this study

Exclusion Criteria:

* body weight of less than 15kg
* acute or chronic inflammatory diseases
* fever
* diabetes
* chronic liver disease
* inflammatory bowel disease or other gastrointestinal disorders (constipation, diarrhea, short bowel syndrome)
* antibiotic prophylaxis or treatment within four weeks prior to recruitment

Primary outcomes:
measure: Immunephenotyping of human PBMC
timeFrame: at recruitment
Secondary outcomes:
measure: Microbiome sequencing of fecal samples
timeFrame: at recruitment
measure: Targeted metabolomics of plasma samples
timeFrame: at recruitment
measure: Pulse wave velocity
timeFrame: at recruitment
measure: Carotid intima media thickness
timeFrame: at recruitment
measure: Echocardiography
timeFrame: at recruitment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Dominik Müller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06231810: Tracking a Tactile Signal Along the Nervous System
Official title: Tracking a Tactile Signal Along the Nervous System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Tactile Perception
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Quantify the flow of a tactile signal from the stimulus at the finger at the peripheral nervous system (PNS), to the central nervous system (CNS), and to cognitive perception at the brain in young adults (Aim 1) and individuals with and without stroke (Aim 2).


Eligibility criteria: Inclusion Criteria:

-right-hand dominance for participants who are neurotypical

For Aim 1:

-age range of 18-23

For Aim 2:

* participants who are neurotypical will be a similar age to the participants with stroke
* participants who are neurotypical will have no musculoskeletal and neurological conditions
* participants with stroke will have a single stroke incident resulting in a unilateral lesion (ischemic and hemorrhagic)
* participants with stroke will be in the chronic phase (\>1 year from stroke onset)
* participants with stroke will have an onset of stroke after the age of 18
* participants with stroke who meet the criteria of having the capacity to provide informed consent, regardless of aphasia

Exclusion Criteria:

* minors
* pregnant women
* prisoners
* adults not capable of consenting on their own behalf.

For Aim 2:

* participants with stroke who have used antispastic injections in the past six months
* participants with stroke who have a lesion in the brainstem and/or cerebellum
* participants with stroke who have a stroke arising due to brain surgery
* participants with stroke who have hemineglect

Primary outcomes:
measure: Conscious detection threshold
timeFrame: 30 minutes during the first session of a one session protocol
Secondary outcomes:
measure: Brain activation
timeFrame: 60 minutes during the first session of a one session protocol
Other outcomes:
measure: Peripheral nerve function
timeFrame: 30 minutes during the first session of a one session evaluation protocol
Locations:
city: Roanoke
country: United States
facility: Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Netta Gurari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02850510: Evaluating a Shortened Version of the Incredible Years (IY) Basic Programme in a Non-clinical Community Sample
Official title: Evaluating a Shortened Version of the Incredible Years Basic Programme in a Non-clinical Community Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting Behavior
Child Behavior Problems
Keywords: Harsh discipline
parental competence
positive parenting
Lead sponsor: Regional centre for children and youth mental health and welfare
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 189
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim of study:

To evaluate the effects of the shortened version of the Incredible Years (IY) Basic programme, the study which the parents were recruited to. A randomising experimental control between-group design was used with pre- and post-intervention measurements, and a one-year, four-year and ten-year follow-up. Children and families were randomized to either the shortened basic version (n = 89), or the control group (n = 97).


Eligibility criteria: Inclusion Criteria:

* No diagnosable behavior problems in child

Exclusion Criteria:

* Diagnosable behavior problems in child

Primary outcomes:
measure: Longitudinal change in ECBI scores
timeFrame: baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up
Secondary outcomes:
measure: Reasons for participation and help seeking behaviour
timeFrame: Four-year follow up
measure: Longitudinal change in PROC scores
timeFrame: baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up
measure: Longitudinal change in PSI scores
timeFrame: baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up
measure: Longitudinal change in PPI scores
timeFrame: baseline, 6-8 weeks after intervention, one-year follow up, four-year follow up, ten-year follow up
Other outcomes:
Locations:
Study officials:
affiliation: Arctic University of Norway
name: Charlotte Reedtz, Dr. Philos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reedtz C, Klest SK, Aalo NM, Rasmussen ID, Vitterso J. Results From an RCT on Brief Parent Training: Long Term Effects on Parental Quality of Life. Front Psychol. 2019 Feb 18;10:260. doi: 10.3389/fpsyg.2019.00260. eCollection 2019.
citation: Reedtz C, Klest S. Improved parenting maintained four years following a brief parent training intervention in a non-clinical sample. BMC Psychol. 2016 Aug 24;4(1):43. doi: 10.1186/s40359-016-0150-3.
Clinical trial NCT06322810: ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial
Official title: Comparison of Erector Spiane Plan Block (ESPB) Versus Pecto-intercostal Fascial Block(PIFB) for Analgesia and Respiratory Function Recovery in Cardiac Surgery: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia
Keywords: Erector spinae plane block
Pecto-intercostal plane block
Cardiac surgery
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\].

The main questions it aims to answer are:

* Does ESPB provide superior analgesia than PIFB
* Do patients who receive ESPB have better recovery outcomes

Detailed description: Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.

Eligibility criteria: Inclusion Criteria:

* Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.

Exclusion Criteria:

* 1. Emergency surgery 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before surgery.

Primary outcomes:
measure: 48hr opioid consumption
timeFrame: Day 2
Secondary outcomes:
measure: Postoperative static pain scores-Day 1
timeFrame: Day 1
measure: Postoperative static pain scores-Day 2
timeFrame: Day 2
measure: Postoperative dynamic pain scores-Day 1
timeFrame: Day 1
measure: Postoperative dynamic pain scores-Day 2
timeFrame: Day 2
measure: postoperative incentive spirometry volume (ml)-Day 1
timeFrame: Day 1
measure: postoperative incentive spirometry volume (ml)-Day 2
timeFrame: Day 2
measure: postoperative incentive spirometry volume (ml)-Day 3
timeFrame: Day 3
measure: QoL15 (pre-op)
timeFrame: Day 0
measure: QoL15 (POD3)
timeFrame: Day 3
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: