louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00593801: Erythropoietin Treatment in Extremely Low Birth Weight Infants
Official title: Multicentre, Blinded, Randomised, Controlled Study on the Efficacy and Safety of Early or Late Epoetin Beta Treatment in Premature Infants (500- 999g Birth Weight)for Prevention or Treatment of Anaemia of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Low Birth Weight
Anemia
Keywords: extremely low birth weight infants
transfusion need
erythropoietin
trace elements
antioxidant enzymes
reduction of the transfusion need by EPO treatment
trace elements and antioxidant enzymes in blood
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
name: University Hospital Tuebingen
name: Children's Hospital at the Bult Hannover, Germany
name: University Hospital, Aachen
name: University of Zurich
name: Children's Hospital Koeln, Germany
name: Université Catholique de Louvain
name: Children's Hospital Dortmund, Germany
name: Hopital Antoine Beclere
name: Hôpital Edouard Herriot
name: Olga Hospital Stuttgart, Germany
name: University Hospital, Strasbourg, France
First posted: 2008-01-15
Enrollment: 219
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.

The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too.

Study population: 219 patient randomized into 3 groups

Detailed description: Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.

The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.

Eligibility criteria: Inclusion Criteria:

* Extremely low birth weight infants

Exclusion Criteria:

* Cyanotic heart disease
* Major congenital malformation requiring surgery
* Gestational age \> 30 weeks
* Administration of an investigational drug during pregnancy
* Lack of parental consent

Primary outcomes:
measure: transfusion need
timeFrame: 9 weeks
Secondary outcomes:
measure: concentrations of trace elements and antioxidant enzymes in the blood
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dept of Neonatolgy Charité University Medicine Berlin
Study officials:
affiliation: Charité Berlin, University Medicine
name: Michael Obladen, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03239301: Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
Official title: Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury Cervical
Lead sponsor: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted training of forearm and hand functions in spinal cord injury patients Setting: Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty patients were allocated into robotic and control groups. Both groups received conventional rehabilitation program for four weeks. Moreover, robotic group received robotic rehabilitation program tailored to the patient five times a week (each session of 30 min).

Baseline data and post-intervention data was compared.


Eligibility criteria: Inclusion Criteria:

* Ages between 18-50
* Cervical Level of Spinal Cord Injury

Exclusion Criteria:

* Severe upper extremity contractures in the joints
* Intensive spasticity (Ashworth 3-4)
* Shoulder pain that causes exercise intolerance

Primary outcomes:
measure: Functional Independence Measure
timeFrame: Four weeks
measure: Spinal Cord Independence Measure III
timeFrame: Four weeks
measure: Short Form-36
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi
city: Ankara
country: Turkey
facility: Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital
Study officials:
References:
Clinical trial NCT06133101: Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Official title: Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: NAFLD
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective parallel arm randomized controlled study
Primary purpose: TREATMENT

Brief summary: A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.


Eligibility criteria: Inclusion Criteria:

* Children with overweight/obesity
* Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF \>10%
* Known NAFLD or elevated ALT for sex (\>22 for females and \>26 for males)

Exclusion Criteria:

* MRI-PDFF \<10%
* Baseline habitual (\>3 days per week) consumption of soy foods
* Allergy to soy or cow's milk protein
* Inability to undergo MRI
* Recent (past 8 weeks) antibiotic exposure
* Treatment for existing endocrine disorders

Primary outcomes:
measure: Change in liver disease severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])
timeFrame: 12 weeks
measure: Change in gamma glutamyl-transferase levels (GGT)
timeFrame: 12 weeks
measure: Change in alkaline phosphatase (ALP)
timeFrame: 12 weeks
measure: Change in fasting triglycerides
timeFrame: 12 weeks
measure: Change in total cholesterol (TC)
timeFrame: 12 weeks
measure: Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels
timeFrame: 12 weeks
measure: Change in glucose
timeFrame: 12 weeks
measure: Change in insulin
timeFrame: 12 weeks
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: 12 weeks
measure: Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels
timeFrame: 12 weeks
measure: Change in thyroid function (TSH and Free T4)
timeFrame: 12 weeks
measure: Change in estradiol
timeFrame: 12 weeks
measure: Change in serum metabolome and lipidome
timeFrame: 12 weeks
measure: Change in systolic and diastolic blood pressure
timeFrame: 12 weeks
measure: Change in equol production status
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT06078501: MisOpRostol Effect on Second Trimester Abortion Blood Loss
Official title: Misoprostol Effect on Second Trimester Abortion Blood Loss
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Blood Loss, Surgical
Second Trimester Abortion
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although serious complications from second trimester abortion are rare hemorrhage is the most common cause of procedural abortion related morbidity and mortality. Misoprostol is a prostaglandin E1 analogue that is used by 75% of clinicians prior to procedural abortion for the purpose of cervical preparation. Misoprostol is also known to decrease blood loss in first trimester abortion and is used to treat postpartum hemorrhage, however the effect of preprocedural misoprostol on procedural blood loss is not well described.

We will conduct a double blinded placebo-controlled gestational age stratified superiority trial of those undergoing procedural abortion between 18 and 23 weeks gestation at Stanford Health care. Participants will be randomized to either 400mcg buccal misoprostol or placebo on the day of the procedure. A quantified blood loss (QBL) will be measured during the procedure and participants will complete a survey to assess symptoms. Our primary outcome is quantified blood loss. Secondary outcomes include clinical interventions to manage excess bleeding, total procedure time, provider reported experience, patient reported experience.


Eligibility criteria: Inclusion Criteria:

* Pregnant people, 18 years of age or older; intrauterine pregnancy between 18/0-23/6 weeks of gestational age (by ultrasound dating performed prior to same day of enrollment visit) consented for an induced abortion; English or Spanish speaking, able to consent for a research study, literate in English or Spanish.

Exclusion Criteria:

* known coagulopathy, suspected morbidly adherent placenta spectrum, multiple gestation, current infection, ruptured membranes, or fetal demise at time of enrollment.

Primary outcomes:
measure: quantified blood loss
timeFrame: day of procedure (approximately 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
Study officials:
References:
Clinical trial NCT02468401: Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Official title: The Efficacy of a New Protocol for Preventing Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Disease, Chronic
Ischemic Heart Disease
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: There is a pressing need to find effective strategies for the prevention of contrast induced nephropathy in patients with advanced renal dysfunction. The current study was designed to assess the efficacy of a new protocol for preventing contrast induced nephropathy in patients with advanced renal dysfunction undergoing coronary interventions


Eligibility criteria: Inclusion Criteria:

Patients with estimated glomerular filtration rate\<45ml/min undergoing coronary angiography due to one of the following indications in accordance with the 2014 guidelines:

1. Elective coronary angiography due to symptoms suggestive for angina with a positive non-invasive ischemia assessment of ≥10% of left ventricle.
2. Non ST-elevation acute coronary syndrome with a GRACE score\>110

Exclusion Criteria:

* Patients on dialysis or those planned for dialysis in the next 3 months.
* Patients with ST-elevation myocardial infarction
* No symptoms or signs of heart failure
* Treatment with IV diuretics during the 48 hours prior to enrolment
* Patients with acute renal failure (Creatinine raise of at least 0.3mg/dl from )baseline
* Patients post coronary artery bypass surgery

Primary outcomes:
measure: Changes in glomerular filtration rate following coronary angiography or intervention
timeFrame: 24 and 48 hours post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
citation: Rozenbaum Z, Benchetrit S, Rozenbaum E, Neumark E, Mosseri M, Pereg D. Ultra-Low Contrast Volume for Patients with Advanced Chronic Kidney Disease Undergoing Coronary Procedures. Nephron. 2018;138(4):296-302. doi: 10.1159/000485648. Epub 2018 Jan 24.
Clinical trial NCT00193401: Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
Official title: Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Institutional Review Board TriStar Nashville Market
First posted: 2005-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens

Detailed description: Upon determination of eligibility, all patients will be receive:

* Topotecan

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Biopsy-proven small cell lung cancer, extensive stage disease
* Age \> 65 years
* No previous chemotherapy or radiation therapy.
* Measurable or evaluable disease.
* Adequate bone marrow, liver and kidney function.
* Must be \> 4 weeks from previous major surgery
* Must give written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Meningeal involvement
* Serious active infections
* Serious underlying medical conditions
* Other active neoplasms

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Median survival
measure: 1 year and 2 year survival
measure: Overall toxicity
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Anthony Greco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096601: A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients
Official title: A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Motor fluctuations
levodopa pharmacokinetics
levodopa and carbidopa solution
continuous subcutaneous delivery
Lead sponsor: NeuroDerm Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2014-03-26
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label randomized study to evaluate the Safety, Tolerability, and PK of Low and High single doses of ND0612 (i.e. LD/CD ratio 60/7.5 mg/mL and 60/14 mg/mL), as well as the combination with oral Entacapone (concomitant catechol-O-methyl transferase \[COMT\] inhibitor) in PD subjects with well-defined morning "OFF" and a good response to LD. Exploratory efficacy parameters were collected (early evidence of effectiveness as part of Phase 1).

Detailed description: PD subjects were randomized in Low or High LD dose study group in 1:1 ratio. Each patient received singe doses ND0612 over 3 days: Day 1. LD/CD 60/7.5 mg/mL, Day 2. LD/CD 60/14 mg, and Day 3. LD/CD 60/14 mg/mL with Entacapone.

Eligibility criteria: Inclusion Criteria:

1. Male and female PD patients of any race aged 30 to 80 years
2. PD diagnosis consistent with the UK PD Society Brain Bank criteria.
3. Stable doses of anti PD drugs for at least 30 days
4. PD patients with well-defined morning "OFF" and a good response to LD
5. MMSE score \> 26
6. No clinically significant medical, psychiatric or laboratory abnormalities

Exclusion Criteria:

1. Atypical or secondary Parkinsonism.
2. Acute psychosis or hallucinations.
3. Subjects treated with neuroleptics
4. History of melanoma or significant skin disorders.
5. Prior neurosurgical procedure for PD.
6. Patients with a history of drug abuse or alcoholism
7. Clinically significant ECG abnormalities.
8. Renal or liver dysfunction
9. Subjects who have participated in another clinical study within 30 days

Primary outcomes:
measure: Adverse events frequency
timeFrame: Up to 6 weeks
measure: LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax.
timeFrame: Days 1, 2, 3 and 4
measure: Tolerability: Number of patients who discontinued due to adverse events
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT01869101: Prospective Observational Study Assessing Treatment and Outcomes of Patients With Prediabetes
Official title: A Multicenter, 26-Week, Prospective Observational Study in Adult Patients With Prediabetes Assessing Patient Treatment and Outcomes in Community-Based Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediabetes
Keywords: Prediabetes
Diabetes prevention
Lead sponsor: Tethys Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: U.S.-based primary care practices

Brief summary: The purpose of this observational study is to assess the treatment and outcomes of patients with prediabetes in community-based clinical practices.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Diagnosis of prediabetes based on hemoglobin A1C and/or fasting plasma glucose
* Established patient of Principal Investigator's clinical practice
* BMI greater than or equal to 25 kg/m2
* Physically able to participate in a diabetes prevention program

Exclusion Criteria:

* Has prior diagnosis of diabetes
* Is pregnant or is planning to become pregnant in the next 6 months
* Is currently taking a medication prescribed for diabetes prevention
* Is currently enrolled in a formal diabetes prevention or weight loss program

Primary outcomes:
measure: Diabetes prevention treatment decisions by physician
timeFrame: 6 months
Secondary outcomes:
measure: Subject initiation and persistence with diabetes prevention interventions
timeFrame: 6 months
Other outcomes:
measure: fasting glucose
timeFrame: 6 months
measure: Hemoglobin A1C
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Body weight
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
Locations:
Study officials:
affiliation: Tethys Bioscience
name: Juan P. Frias, M.D.
role: STUDY_DIRECTOR
affiliation: Indiana University School of Medicine
name: David G Marrero, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03703401: The Role of Hydrosalpinx in Recurrent Miscarriage
Official title: The Role of Hydrosalpinx in Recurrent Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion, Spontaneous
Miscarriage, Recurrent
Hydrosalpinx
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: Tommy's
First posted: 2018-10-12
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have suffered from 2 or more pregnancy losses

Brief summary: Miscarriage affects one in five pregnancies and little progress has been made in understanding and treating this distressing condition. C. trachomatis is the most common sexually transmitted infection in the UK. C. trachomatis infection can have serious health consequences, including fallopian tube damage. Untreated C. trachomatis infection and tubal damage have been associated with miscarriage and adverse pregnancy outcomes such as preterm birth, low birth weight and stillbirth. A cohort study is needed to establish the prevalence of tubal disease in women with recurrent miscarriages. HyCoSy will be performed to identify tubal disease and establish the magnitude of the problem in the recurrent miscarriage population. The prognosis of tubal disease on miscarriage and other obstetric outcomes, and the role of medical interventions such as tubal surgery (to treat hydrosalpinx) on reducing miscarriage and adverse obstetric outcomes will also be studied.

Objectives

1. Establish the prevalence of hydrosalpinx in the recurrent miscarriage population.
2. Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx.
3. Explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.


Eligibility criteria: Inclusion Criteria:

* Age 18-45
* Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages
* Ability to give informed consent

Exclusion Criteria:

* Allergy to contrast media used for Hysterosalpingo-contrast-sonogram
* Allergy to sonographic gel used for ultrasound scanning
* Anatomical anomaly meaning transvaginal ultrasound scan not possible
* Stenosed/occluded cervix meaning contrast media unable to be introduced via cervix
* Inability to give informed consent
* Pregnant at the time of recruitment
* Declined recruitment

Primary outcomes:
measure: Hydrosalpinx
timeFrame: 12 months
Secondary outcomes:
measure: Miscarriage
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
state: West Midands
Study officials:
References: