louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03203941: ACT for CP Individual Patient Expanded Access IND Protocol
Official title: Autologous Cell Therapies for Cerebral Palsy-Chronic (ACT for CP) Individual Patient Expanded Access IND Protocol
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cerebral Palsy
Keywords: Autologous Cord Blood Stem Cells
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-06-29
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Individual patient expanded access protocol for a child with cerebral palsy (CP) who has autologous umbilical cord blood available and who is ineligible to participate in other stem cell studies for children with CP.

Detailed description: This protocol is part of an FDA Individual Patient Expanded Access IND submitted at the request of the parents of a child with cerebral palsy (CP) who is ineligible to participate in other stem cell studies. For this child, there are no other treatment options.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth, McGovern Medical School at Houston
name: Charles S Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05251441: The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
Official title: The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Milk Fortifier Supplements
Premature
Keywords: Breast Milk Fortifier
Nutrition
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 160
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and breast milk enrichment will be started when 100 ml/kg/day enteral feeding is reached in the other group. In the study, the babies in these two groups will be compared by making early (nutrition characteristics and premature morbidity) and long-term follow-ups. In this study, a 30% reduction in the transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. In our study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.


Eligibility criteria: Inclusion Criteria:

* Preterm babies born weighing less than 1500 grams

Exclusion Criteria:

* Babies with congenital anomalies
* Infants who develop necrotizing enterocolitis or spontaneous intestinal perforation before starting a breast milk fortifier
* Babies lost before reaching 50 cc/kg enteral nutrition
* Babies who are not breastfed

Primary outcomes:
measure: The effect of time to start breast milk fortifiers on full enteral feeding day.
timeFrame: 1 year
Secondary outcomes:
measure: Weight gain rate (grams/day)
timeFrame: 1 year
measure: Duration of parenteral nutrition (days)
timeFrame: 1 year
measure: Time to discharge (days)
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
References:
citation: Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.
citation: Basu S, Upadhyay J, Singh P, Kumar M. Early versus late fortification of breast milk in preterm infants: a systematic review and meta-analysis. Eur J Pediatr. 2020 Jul;179(7):1057-1068. doi: 10.1007/s00431-020-03677-6. Epub 2020 May 27.
citation: Maas C, Wiechers C, Bernhard W, Poets CF, Franz AR. Early feeding of fortified breast milk and in-hospital-growth in very premature infants: a retrospective cohort analysis. BMC Pediatr. 2013 Nov 4;13:178. doi: 10.1186/1471-2431-13-178.
Clinical trial NCT00605241: A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
Official title: A Randomized, Double-bind, Placebo Controlled, Two-way Cross-over Study to Assess the Effects of a Single Dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Dependence
Keywords: pharmacodynamics,
pharmacokinetics,
tolerability,
Safety,
single dose,
placebo,
Nicotine reward
GSK598809
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-01-31
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.


Eligibility criteria: Inclusion Criteria:

* Healthy male smokers aged 18-65 with a desire to quit smoking.
* Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
* Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.

Exclusion Criteria:

* Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
* History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
* History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
* History of cardiac or pulmonary disease/abnormalities.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: through 24 hours
Secondary outcomes:
measure: Stroop test
timeFrame: through 10 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Mugnaini M, Iavarone L, Cavallini P, Griffante C, Oliosi B, Savoia C, Beaver J, Rabiner EA, Micheli F, Heidbreder C, Andorn A, Merlo Pich E, Bani M. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach. Neuropsychopharmacology. 2013 Jan;38(2):302-12. doi: 10.1038/npp.2012.171. Epub 2012 Sep 12.
Clinical trial NCT00316641: The Clinical Evaluation of Efficacy of Lipid-Lowing Tea on Hyperlipidemia Patients' Lipid Profiles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2006-04-21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients


Eligibility criteria: Inclusion Criteria:

* Patient aged 20-65 years;either sex
* Patient diagnosed with hyperlipidemia(fasting levels of TC\>=200mg/dL),or TG\>=200mg/dL but \<400mg/dL,or LDL-C\>=130mg/dL)
* Patient who has signed the informed consent form

Exclusion Criteria:

* Patient with pregnancy (or child bearing potential),or in lactation
* Patient with any lipid regulating agents within 4 weeks prior to study period
* Patient currently taking concomitant medications, such as oral contraceptives, or any medical treatment capable of interfering with lipid metabolism(eg thiazides, β-blockers, cyclosporins, itraconazole erythromycin,and danazol)
* Patient with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, primary biliary cirrhosis.
* Patient with liver dysfunction (SGOT or SGPT\>2x ULN)
* Patient with renal insufficiency (serum creatinine\>1.3mg/dL)
* Patient with myocardial infarction,cerebrovascular disease,or major operations within 6 months prior to the study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital,Taichung,Taiwan
name: Chia-I Tsai, V.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06244641: New Relapse Model in Psychiatry
Official title: Creation of a Visualization Tool With Integrated Clinical Data to Support Clinical Intervention and Empowerment of Inpatients in Psychiatry : Basis for the Development of a Predictive Model of Relapse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: clustering
relapse
feedback-measurment-system
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2024-02-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are :

* Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ?
* Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster?
* Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ?

Participants will :

* Complete auto-questionnaires
* Pass hetero-evaluations
* Undergo an electrophysiological battery


Eligibility criteria: Inclusion Criteria:

* To suffer from AUD
* To be hospitalized
* To speak French fluently
* To be able to give their consent (medically and legally).

Exclusion Criteria:

* To suffer from severe perceptive disabilities (auditory, visual)
* To suffer from severe cognitive impairment

Primary outcomes:
measure: Relapse or abstinence after detoxification
timeFrame: Throughout the entire study, approximately during 48 months
Secondary outcomes:
measure: Satisfaction of the feedback-measurment-system for clinicians and patients
timeFrame: Throughout the entire study, approximately during 48 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Université catholique de Louvain (Wallonia)
name: Philippe de Timary, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02620241: Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR).
Official title: Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-oesophageal Reflux
Keywords: gastro-oesophageal reflux
intrapulmonary percussive ventilation
positioning
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a stable upright position during 20 min. This is an addendum to the previous study with record number clinical trials.gov NCT02124863


Eligibility criteria: Inclusion Criteria:

* Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR)

Exclusion Criteria:

* : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Primary outcomes:
measure: number of reflux episodes
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZBrussel
state: Brussels
Study officials:
References:
Clinical trial NCT00350441: Does Sildenafil Protect Against Pulmonary Related Complications Following Cardiopulmonary Bypass?
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study of the Pre-Operative Effect of Sildenafil Citrate on Pulmonary Related Complications Following Cardiopulmonary Bypass in Children Undergoing Cardiac Surgical Repair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiopulmonary Bypass
Keywords: Sildenafil Citrate
Cardiopulmonary bypass
Open heart surgery
Lead sponsor: NHS Greater Glasgow Yorkhill Division
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury associated with cardiopulmonary bypass in children undergoing corrective surgical repair of congenital heart disease.


Eligibility criteria: Inclusion Criteria:

Paediatric patients undergoing open heart surgery utilising cardiopulmonary bypass to correct acyanotic congenital heart disease.

Age \> 3 months Parents that show a good understanding of their child's condition and are happy for their child to participate in the study.

Exclusion Criteria:

Patients with known organ dysfunction prior to surgery (pulmonary, renal or hepatic) Communication barrier resulting in poor basic comprehension of the proposed study (e.g. language barrier) Patients with cyanotic heart disease Patients undergoing heart surgery without the use of cardiopulmonary bypass Patients who do not tolerate oral Sildenafil (e.g. Vomiting) or whose surgery is subsequently cancelled.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Strathclyde
Study officials:
affiliation: Royal Hospital for Sick Children
name: Tony Vassalos, MB Ch B
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02018341: The Homeogenomic Trial
Official title: A Randomized Double-blind Placebo Controlled Homeopathic Pathogenetic Trial (HPT) on Healthy Volunteers Proving XX in the Potency of 30C, "The Homeogenomic Trial"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: Assessment of biologic activity of a homeopathic remedy
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 0
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: BASIC_SCIENCE

Brief summary: A randomized double-blind placebo controlled homeopathic pathogenetic trial (HPT) will be carried out on 30 healthy adult volunteers. The remedy used for the proving will be administered in a potency of 30C. The remedy being used is a common homeopathic remedy commercially available in the US, but the exact remedy is not disclosed to participants.The purpose of the proving is twofold: 1) to determine if there is a difference in symptoms between those receiving an active versus placebo medicine, and 2) to see if there is a difference in gene expression between those who receive the homeopathic remedy or placebo. It is hypothesized that participants receiving the active medication will have more symptoms characteristic of the remedy and have specific patterns of gene expression in whole blood that are different from those in placebo recipients. Participants will record symptoms in a diary for 3 days prior to administration of study medications, during 3 day of its administration and for 3 days following completion of the study medication. Blood will be drawn for gene expression studies on the day that the study medication is started and again after taking the study medication for approximately 48 hours. An additional, optional blood draw for possible future analysis of gene expression will be done at the end of the study period.


Eligibility criteria: Inclusion Criteria:

* Read and Speak English

Exclusion Criteria:

* Acute illness in last 7 days
* Chronic illness requiring daily medication
* Use of homeopathic remedy within 4 weeks
* Use of homeopathic remedy of 200C potency in past 2 months
* Women who are pregnant or breastfeeding an infant

Primary outcomes:
measure: Characteristic symptoms
timeFrame: 6 days
measure: gene expression
timeFrame: 2 days
Secondary outcomes:
measure: gene expression in sensitive provers
timeFrame: 2 days
Other outcomes:
Locations:
city: Kenmore
country: United States
facility: Bastyr University
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292941: Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Official title: Clinical Study Evaluating Safety of a New Catheter for Urinary Intermittent Catheter in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Spinal Cord Injury
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate discomfort of a new coating and catheter material compared to SpeediCath (SC)

Detailed description: Intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction.

Coloplast have developed a new intermittent catheters. In this investigation this new test catheter will be compared with SpeediCat by assessing discomfort and pain associated with catheterization of healthy men. The reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort.

55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. They are recruited through advertisements on the website www.forsoegsperson.dk.

Eligibility criteria: Inclusion Criteria:

* • ≥18 years

  * Male
  * Signed informed consent
  * Negative urine stix (erythrocytes, leucocytes and nitrite)

Exclusion Criteria:

* • Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Primary outcomes:
measure: Discomfort during catheterisation measured by VAS-scale (0-10)
timeFrame: 10 measurements in an 11 week period. 10 min after each catheterisation
Secondary outcomes:
measure: Safety
timeFrame: During the investigation 11 Weeks per subject
measure: Discomfort during urination post catheterisation
timeFrame: 10 measurements in an 11 week period. 10 min after each catheterisation
measure: Haematuria
timeFrame: 10 measurements in an 11 week period. 10 min after each catheterisation
measure: Handling during insertion, withdrawal
timeFrame: 10 measurements in an 11 week period. 10 min after each catheterisation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Coloplast A/S
name: Susanne Gürtler, CTM
role: STUDY_DIRECTOR
References:
Clinical trial NCT01216241: Daptomycin Versus Placebo in Patients With Neutropenia and Fever
Official title: A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Febrile Neutropenia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2010-10-07
Enrollment: 36
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 purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.

Detailed description: To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. The five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.

Eligibility criteria: Inclusion Criteria:

1. Patients in the above categories who are currently undergoing chemotherapy.
2. Patients at least 18 of age.
3. Patient expected to reach an absolute granulocyte count of \<100 cells/mm3
4. Patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures \> 38o on at least two occasions before study drug is administered.

Exclusion Criteria:

1. Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic.
2. Patients undergoing auto-transplantation, for the same reason as above.
3. Patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis.
4. Patients who have received daptomycin in the two weeks prior to enrollment.
5. Patients with concomitant use of vancomycin.
6. Patients with creatinine clearance \< 30 ml/min or CPK \> 3x normal
7. Patients with significant hepatic dysfunction, defined as baseline liver function tests \> 5x above normal.
8. Patients with known allergy to daptomycin.
9. Patients previously in this study.
10. Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
11. Patients previously enrolled in this study.

Primary outcomes:
measure: Percentage of Afebrile Neutropenic Subjects
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Robert F Betts, MD
role: PRINCIPAL_INVESTIGATOR
References: