louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00527085: 12-month Study of AMG 073 in Renal Osteodystrophy
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Osteodystrophy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 45
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: 4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.


Eligibility criteria: Inclusion Criteria:

* 18 years of age of greater
* Using effective contraceptive measures
* iPTH greater than or equal to 300 pg/mL
* Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
* Stable hemodialysis for 1 month prior to day 1

Exclusion Criteria:

* Any unstable medical condition
* Pregnant or nursing women Recent parathyroidectomy
* Change in Vitamin D therapy
* Recent MI, Seizure, Malignancy, GI Disorder
* Inability to swallow tablets

Primary outcomes:
measure: To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry
timeFrame: entire study
Secondary outcomes:
measure: To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations
timeFrame: entire study
measure: To evaluate the feasibility of measuring physical activity with accelerometry
timeFrame: entire study
measure: To evaluate the safety and tolerability of AMG 073 compared with placebo
timeFrame: entire study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Malluche HH, Monier-Faugere MC, Wang G, Fraza O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. Clin Nephrol. 2008 Apr;69(4):269-78. doi: 10.5414/cnp69269.
Clinical trial NCT06590285: Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation
Official title: Diagnostic Refinement and Educational Approaches in Managing Bone Marrow Transplantation (DREAM-BMT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GVHD
Bone Marrow Transplant Complications
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to standard of care monitoring or an educational intervention aimed at improving sleep and activity management during the transplantation process.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized, phase I/II, open-label study will investigate the efficacy and safety of an educational sleep intervention vs standard of care in adults undergoing alloHSCT. The randomization target in this pilot phase is 60 patients.

Detailed description: To facilitate rapid randomization and baseline collection of patient samples in the patient's home environment, screening activities and assessment of inclusion and exclusion criteria will begin once the patient is identified as transplant eligible at the bone marrow transplant meeting. The patient will subsequently be contacted by a study investigator to explain the study, including its potential benefits and risks.

Patients meeting all inclusion and exclusion criteria will be randomized 1:1 to receive either educational intervention or standard of care therapy.

Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18 or older at the time of study informed consent.
* Have plan to undergo alloHSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative and reduced intensity conditioning are eligible.
* Patients have access to digital device capable of downloading study app
* Patients able to read study documents and able to complete informed consent within the study app

Exclusion Criteria:

* Failed prior alloHSCT within the past 6 months

Primary outcomes:
measure: Objective Sleep Measurement
timeFrame: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT)
Secondary outcomes:
measure: Objective activity measurement
timeFrame: Continuous measurement throughout the study duration (from 2 weeks prior to alloHSCT to 100 days post-alloHSCT).
measure: Subjective sleep quality
timeFrame: Measurements will occur 12 days prior to alloHSCT, 10 days after alloHSCT and 60 days after alloHSCT
Other outcomes:
measure: Incidence of acute GVHD
timeFrame: Monitoring will occur from day of alloHSCT to 100 days post alloHSCT.
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
Study officials:
References:
Clinical trial NCT04905485: Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
Official title: Developing a Model to Better Predict Diabetes and/or Risk of Developing Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Type 2
Diabetes
Pre-diabetes
Keywords: Viome
Diabetes Type 2
Diabetes
Pre-diabetes
VPNP
Nutrition
Supplements
Precision
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 2912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants all received diet and supplement recommendations based on their microbiome results.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Participants who were previously Viome costumers who signed informed consent to participate and self reported type 2 diabetes or pre-diabetes were enrolled. They provided stool samples to VIOME and were provided with precision diet and supplement recommendations. The information obtained from this study is used to train a model to predict diabetes and/or risks of developing diabetes.


Eligibility criteria: Inclusion Criteria:

* Viome customer
* GI test collected at home using Viome test kit
* US citizen
* 18+ years old
* Is not participating in any other Viome study
* Must have answered the following on-boarding question with the indicated answer:

"Do you or did you ever have diabetes or prediabetes?"

* Signed and dated informed consent prior to any trial-specific procedures are performed
* Able to speak and read English
* Willing and able to follow the trial instructions

Exclusion Criteria:

* Unable/unwilling to complete the informed consent form and the questionnaires

Primary outcomes:
measure: Difference in VIOME's Type 2 diabetes risk score
timeFrame: ~3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Research Institute
state: Washington
Study officials:
affiliation: Viome
name: Guruduth Banavar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917785: Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abortion, Missed
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to examine the success rates of Karman curettage in completing the abortion after failed recurred treatment with Misoprostol for women with missed abortion.


Eligibility criteria: Inclusion Criteria:

* Healthy women diagnosed with missed abortion treated in Meir Medical Center.
* The abortion occured during the first trimester of pregnancy.
* Patients who chose drug therapy (Misoprostol), after retained products of conception were evident on ultrasound.

Exclusion Criteria:

* patients with mullarian abnormality (i.e. septal uterus, myoma etc.)
* patients with significant bleeding
* Endometrial wall (residua) greater than 20 mm.
* known or suspected infection
* known clotting defect
* women after cesarean section
* closed cervix

Primary outcomes:
measure: Completing the abortion
timeFrame: 1 month
Secondary outcomes:
measure: number of days of bleeding
timeFrame: 3 months
measure: pregnancy
timeFrame: 3 months
measure: Pain intensity
timeFrame: 3 months
measure: infection
timeFrame: 3 months
measure: number of sick days
timeFrame: 3 months
measure: number of days of abstinence from sexual intercourse
timeFrame: 3 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical center
Study officials:
affiliation: Meir Medical Center
name: Meir Pomeranz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pomeranz M, Goren Gepstein N, Ovadia M, Klein Z, Daykan Y, Schonman R, Arbib N. A novel method for office aspiration curettage in cases of retained products of conception: A randomized controlled trial. Acta Obstet Gynecol Scand. 2021 Nov;100(11):2076-2081. doi: 10.1111/aogs.14245. Epub 2021 Aug 31.
Clinical trial NCT03084185: Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .
Official title: Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Keywords: decompensation
deficit
metabolomics
portal hypertension
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with cirrhosis

Brief summary: This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients.

The duration of the study is 36 months and it provides a cohort of 200 patients.

Detailed description: At screening, patient will have taken blood samples and performed hepatic vein pressure gradient.

After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines.

In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of liver cirrhosis
* Aged between 18 and 75 years
* Obtaining written informed consent
* Absence of exclusion criteria

Exclusion Criteria:

* Diagnosis of hepatocellular carcinoma
* Presence of portal vein thrombosis
* HIV
* Liver transplantation

Primary outcomes:
measure: Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.
timeFrame: December 2018
Secondary outcomes:
measure: Finding of serum metabolomic features of cirrhotic patients.
timeFrame: December 2018
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Di Modena
state: MO
Study officials:
affiliation: University of Modena and Reggio Emilia
name: ERICA VILLA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366885: Vitamin D to Prevent Autism in Newborn Siblings
Official title: Study of Vitamin D to Prevent Autism in Newborn Siblings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autistic Disorder
Keywords: Autism
Pregnancy
Newborn siblings
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether by administering vitamin D to mothers who already have at least one child with autism and who are pregnant, that the vitamin D will prevent the recurrence of autism in the newborn sibling.

Detailed description: The incidence of autism is increasing. Also, women of childbearing age are increasingly found to be insufficient/deficient in vitamin D. Vitamin D is a neurohormone which is important for development of the child, especially of the child's brain. The primary source of vitamin D is from the sun through one's skin. People have been avoiding the sun because of skin cancer, because of increasing Television watching, computer viewing and wearing clothes that cover most of the body. This approach will study whether making the pregnant mother, whose child is at risk for autism because of a previous child with autism, replete with vitamin D will prevent that recurrence of autism in the newborn sibling.

Eligibility criteria: Inclusion Criteria:

* Pregnant mothers who have had at least one child with autism spectrum disorder

Exclusion Criteria:

* Child with autism must not be from a syndrome such as Fragile X syndrome, Retts Syndrome
* Mother must be before the third trimester

Primary outcomes:
measure: Number of Children Who Developed Autism
timeFrame: Child assessed at 3 years of age
Secondary outcomes:
measure: Number of Mothers Who Developed Side Effects From Vitamin D
timeFrame: During pregnancy and the 3 years of the child's development
Other outcomes:
Locations:
city: Oregon City
country: United States
facility: Evergreen Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ervin G. Stubbs, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cannell JJ. On the aetiology of autism. Acta Paediatr. 2010 Aug;99(8):1128-30. doi: 10.1111/j.1651-2227.2010.01883.x. Epub 2010 May 19. No abstract available.
Clinical trial NCT01853085: A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-05-14
Enrollment: 1830
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary open-angle glaucoma or ocular hypertension

Brief summary: The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma or ocular hypertension
* Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

Exclusion Criteria:

* None

Primary outcomes:
measure: Intraocular Pressure (IOP) in the Study Eye at Baseline
timeFrame: Baseline
measure: IOP in the Study Eye at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale
timeFrame: Baseline, 12 Weeks
measure: Patient Assessment of Tolerability on a 4-Point Scale
timeFrame: 12 Weeks
measure: Physician Assessment of Tolerability on a 4-Point Scale
timeFrame: 12 Weeks
measure: Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment
timeFrame: 12 Weeks
measure: Number of Patients Who Continue Treatment
timeFrame: 12 Weeks
measure: Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Wiesloch
country: Germany
state: Baden-Württemberg
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Pillunat LE, Eschstruth P, Hasemeyer S, Thelen U, Foja C, Leaback R, Pfennigsdorf S. Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice. Clin Ophthalmol. 2016 Sep 12;10:1759-65. doi: 10.2147/OPTH.S103084. eCollection 2016.
Clinical trial NCT03904485: Assessment of Myocardial Injury in Simultaneous Pancreas and Kidney Transplantation
Official title: Assessment of Myocardial Injury in Recipients of Simultaneous Pancreas and Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Simultaneous Pancreas-kidney Transplantation
Diabetic Cardiomyopathy
Keywords: SPK ,DCM,CMR
Lead sponsor: Tianjin First Central Hospital
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 25 patients with SPK who met the inclusion criteria and 25 patients with simple kidney transplantation for diabetic end-stage nephropathy were included by matching the onset time, gender, age, BMI and blood pressure of diabetes

Brief summary: Diabetic cardiomyopathy( DCM) is a major complication of diabetes and is a common cardiovascular complication independent of coronary artery disease and hypertension．Trial to assess of myocardial injury in recipients of simultaneous pancreas and kidney transplantation by nuclear magnetic T２ mapping technology.

Detailed description: 1. Evaluate the changes of myocardial injury before and after SPK by cardiac magnetic resonance imaging (CMR),
2. Evaluate the value of SPK in the repair of myocardial injury by comparing with the single renal transplant in recipients with diabetic nephropathy.

Eligibility criteria: Inclusion Criteria:

1. patients with type 2 diabetes were treated with SPK; 2.No definite history of cardiovascular diseases (such as congenital heart disease, coronary heart disease, cardiomyopathy or valvular heart disease, etc.); 3. Preoperative hemodialysis 4. No history of heart failure

Exclusion Criteria:

1. Contraindications in cardiac magnetic resonance imaging；2.poorly controlled hypertension；3.CMR examination revealed marked hypertrophy of the left ventricular myocardium

Primary outcomes:
measure: Assessment of myocardial injury
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin First central hospital
Study officials:
References:
citation: Messroghli DR, Radjenovic A, Kozerke S, Higgins DM, Sivananthan MU, Ridgway JP. Modified Look-Locker inversion recovery (MOLLI) for high-resolution T1 mapping of the heart. Magn Reson Med. 2004 Jul;52(1):141-6. doi: 10.1002/mrm.20110.
citation: Ding H, Fernandez-de-Manuel L, Schar M, Schuleri KH, Halperin H, He L, Zviman MM, Beinart R, Herzka DA. Three-dimensional whole-heart T2 mapping at 3T. Magn Reson Med. 2015 Sep;74(3):803-16. doi: 10.1002/mrm.25458. Epub 2014 Sep 19.
Clinical trial NCT01516385: Detection of Peripheral Blood Biomarkers in Intermediate Phase Spinal Cord Injury: Correlation With Neurological and Functional Outcomes, and Comparison to Other Central and Peripheral Neurological Conditions.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
biomarkers
rehabilitation
functional independence
prognosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients attmited for neuro-rehabilitation with spinal cord injury, stroke or Guillain-Barre syndrome

Brief summary: This research looks for markers in the blood of people with spinal cord injury that may be a sign of injury severity, or serve as a clue to the degree of recovery. Investigators would also like to compare the marker profile of these patient with that of other neurological conditions such as stroke and Guillain-Barre syndrome.

Patients participating in this trial will be those accepted to neuro-rehabilitation in Sheba medical center, Israel. They will join the trial at their arrival to the ward, no less than 2 week after the beginning of their condition, but no later than 3 months.

Patients will be examined by the research staff three times:

1. At arrival, the patients will be neurologically examined and their functional abilities will be assessed. Blood will be drawn and sent to the lab.
2. At 6 months after the beginning of the neurological condition the same will be repeated: the patients will be neurologically examined and their functional abilities will be assessed, and blood will be drawn and sent to the lab.
3. The final examination will take place 1 year after the beginning of the neurological condition. This time only the neurological and functional abilities will be assessed without blood tests.

The blood samples will be tested in the research lab. Then investigators shall compare the clinical findings with the laboratory findings, and see if any of the markers found reflect the injury severity or predict the recovery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of traumatic or non-traumatic Spinal cord injury, Guillain-barre syndrome or Stroke
* No more than 3 months after injury or disease onset
* Condition severe enough to necessitate hospital/day care unit
* Signed the informed consent form

Exclusion Criteria:

* Psychiatric or cognitive situations that may interfere with the trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: