louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04091191: Evaluation of a Nutraceutical for Endometriosis Pain Relief
Official title: A Single Center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of a Specialized Nutraceutical for Endometriosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Endometriosis
Lead sponsor: Metagenics Europe
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Based on the EHP-30 questionnaire, the pain score and general well-being of all patients will be assessed with and without taking a specialized nutraceutical. These patients will be taking continuous oral contraception, for 3 months before inclusion till at least end of the study or not taking any oral contraception at all during the study due to contraindication(s).


Eligibility criteria: Inclusion Criteria:

* Confirmed endometriosis and/or Positive NMR
* 18-49y
* Mean pain score \>6 on the assessment of pelvic pain (Visual analogue scale)
* Not eligible for surgery in the coming 3 months or had surgery \>3 months before inclusion in the study
* \>3 months intake of continue oral contraception (Oestrogen/Progesterone) before inclusion or no intake of oral contraception due to contraindication
* Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

* Planned surgery during study
* \<3 month intake of continue oral contraception (Oestrogen/Progesterone) before inclusion
* Chronic inflammatory disease (Chron's disease, Rheumatism,..)
* Pregnancy
* Bariatric surgery
* Malabsorption issues
* Allergy or hypersensitivity to the study product:
* Fish and products thereof: fish oil
* Soybeans and products thereof
* Alcohol or substance abuse
* Start of gonadorelin analogue (ex. Busereline, Gosereline, triptoreline) therapy in the past 6 months
* Intake of other food supplements, including omega 3 and omega 6
* Any other condition which in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Primary outcomes:
measure: Pain relief
timeFrame: 3 months
Secondary outcomes:
measure: Inflammation marker C-reactive protein (CRP)
timeFrame: 3 months
measure: General well-being
timeFrame: 3 months
measure: The need for analgesics
timeFrame: 3 months
Other outcomes:
Locations:
city: Mons
country: Belgium
facility: CHU Ambroise Paré de Mons
state: Hainout
Study officials:
affiliation: CHU Ambroise Paré de Mons
name: Yaacoub Salame, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094691: Haufen Diagnostic Biomarkers of BK Renal Disease
Official title: Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyoma Virus Nephropathy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2010-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of 'Haufen' with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrology) and more specifically to correlate 'Haufen' shedding with the histologically confirmed course of PVN.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Recipient of renal transplant
* Positive for polyoma virus
* Haufen cells present in urine
* Positive for polyoma virus nephropathy

Exclusion Criteria:

* anyone who does not meet the inclusion criteria

Primary outcomes:
measure: Correlate Haufen, urine and plasma data with the clinical presentation and - in selected cases - with renal biopsy findings.
timeFrame: The biopsy will be performed when urine is determined to be Haufen negative
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina-CH Dept of Pathology
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Volker Nickeleit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702091: Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, two-period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05800691: Predicting Factors for Mortality in Congenital Heart Disease Patients After Shunt Procedure in Developing Country.
Official title: Predicting Factors for Mortality in Patients After the Modified Blalock-Taussig Shunt Procedure in Developing Country: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cyanotic Congenital Heart Disease
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2023-04-05
Enrollment: 197
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this study is CHD pediatric patients with a previous history of BT shunt procedure

Brief summary: Blalock Taussig (BT) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. BT shunt remains a routinely performed procedure in developing countries before definitive surgery. However, evidence on predictors factors of mortality after this procedure is still scarce in Indonesia.


Eligibility criteria: Inclusion Criteria:

* All CHD pediatric patients with a previous history of BT shunt procedure.

Exclusion Criteria:

* Pediatric patients with incomplete medical records

Primary outcomes:
measure: In-Hospital Mortality
timeFrame: November 2020 - January 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Universitas Sumatera Utara
state: North Sumatera
Study officials:
References:
Clinical trial NCT00874991: Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables (An Intraoperative Study)
Official title: Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables. An Intraoperative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Cardiac deformation
Cardiopulmonary bypass
TEE
Cardiac Surgery
Left ventricular function
Pulmonary Artery catheter
Tissue Doppler
Left ventricular function in cardiac surgery
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery with general anesthesia.

Brief summary: The aim of this research is to apply cardiac tissue characterization in order to assess left ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The procedures to be used include a retrospective review of transesophageal images obtained during conventional intraoperative transesophageal echocardiography (TEE) for cardiac surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared with hemodynamic data obtained from a pulmonary artery catheter (PAC).

Detailed description: Patients included in this study are between the ages of 18 to 99 years of age, who presented to the operating room for cardiac surgery, and received both a pulmonary artery catheter and a routine intra-operative TEE. We will only be looking at patients whose TEE images were of good quality.

Subjects underwent cardiac surgery and received both a PAC and a routine TEE exam. We will review the data from the PAC, the images from the conventional TEE exam, and a secondary analysis with Tissue Doppler.

A potential benefit to society is a novel means for assessing left ventricular function. Our research will not benefit our subjects directly. There is no additional risk to our subjects beyond the insertion of the PAC and the TEE probe, which are routinely placed in our patients under-going cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Male or female patients \>18 years of age Patients scheduled for cardiac surgery and will receive both a pulmonary artery catheter and a routine intra-operative TEE

Exclusion Criteria:

* TEE images that are of poor quality

Primary outcomes:
measure: assess left ventricular function in cardiac patients pre and post cardiopulmonary bypass
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nikolaos Skubas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00300391: ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
Official title: ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Delirium
Keywords: Delirium
Mechanical ventilation
Intensive care
Haloperidol
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-03-08
Enrollment: 40
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 determine if treating delirious intensive care unit patients with haloperidol improves mortality.

Detailed description: Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized to haloperidol 5mg IV every 12 hours or placebo to determine if treatment with haloperidol improves short and long-term mortality.

Eligibility criteria: Inclusion Criteria:

* All adult (\>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require \>24 hours of mechanical ventilation

Exclusion Criteria:

* Baseline QTc \>480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.

Primary outcomes:
measure: 28-day All-cause Mortality
timeFrame: Daily
measure: 90-day All-cause Mortality
timeFrame: 90 Days from enrollment in study
Secondary outcomes:
measure: Duration of Mechanical Ventilation
timeFrame: daily
measure: ICU Length of Stay
timeFrame: Daily
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Eric B Milbrandt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milbrandt EB, Kersten A, Kong L, Weissfeld LA, Clermont G, Fink MP, Angus DC. Haloperidol use is associated with lower hospital mortality in mechanically ventilated patients. Crit Care Med. 2005 Jan;33(1):226-9; discussion 263-5. doi: 10.1097/01.ccm.0000150743.16005.9a.
Clinical trial NCT02098291: An Open, Single-center Study to Determine the Antibody Repsonse to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
Official title: Phase II, Open, Single-center Study to Determine the Antibody Response to Gastrimmune and Its Safety and Tolerability in Patients With Advanced Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 34
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 study was designed to determine the effect of jaundice on the ability of G17DT to generate antibodies before and after treatment of biliary obstruction due to advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with histological or cytological confirmation of pancreatic carcinoma who were not suitable for pancreatic tumour resection with curative intent
* Patients who had not received chemotherapy in the previous month and who would either not receive chemotherapy in the period of study or who would commence gemcitabine treatment in week 4 of the study
* Male or female patients over 18 years of age
* Patients with a life expectancy of at least 2 months
* Patients must have given written informed consent
* Patients with a Karnofsky Performance Status score of ≥ 50%
* Patients who would not receive chemotherapy in the period of the Extension Survival Study, except for concomitant gemcitabine ongoing at visit (for extension study)

Exclusion Criteria:

* History of other malignant disease except non-melanomatous skin carcinoma or in situ carcinoma of the uterine cervix
* Concomitant use or anticipated use in the period of the study of radiotherapy
* Chemotherapy in the previous month preceding screening, anticipated concomitant use of chemotherapy between screening and week 4 of the study or anticipated useof chemotherapeutic agents other than gemcitabine from week 4 for the period of the study
* Use in the past month or concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
* Females who were pregnant, planning to become pregnant or lactating
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during the study
* Haematological indicators:

Haemoglobin \<9.5g/dl White blood cell count \<3.5 x 109/l Platelets \<100 x 109/l

Primary outcomes:
measure: Pharmacodynamic
timeFrame: Up to week 16
Secondary outcomes:
measure: Patient Survival
timeFrame: Up to week 139
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Up to week 60
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06762691: Cranial Remolding Orthosis Registry
Official title: Cranial Remolding Orthosis Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Plagiocephaly
Brachycephaly
Asymmetric Head
Keywords: CRO
MyCRO
Cranial Helmet
Cranial Orthosis
Cranial Remolding Orthosis
Lead sponsor: Otto Bock HealthCare LP
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants who have been scanned and fitted with a cranial remolding orthosis

Brief summary: A registry of infants fitted with a cranial remolding orthosis.

Detailed description: The intention of the CRO registry is to gather real-world data of traditional and 3D-printed cranial remolding orthoses to compare outcomes.

Eligibility criteria: Inclusion Criteria:

* Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO
* Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry.
* Parent(s) or legal guardian(s) are willing to provide informed consent.

Exclusion Criteria:

* Patient is geographically inaccessible to comply and participate in the registry.

Primary outcomes:
measure: Asymmetry Index
timeFrame: Baseline to final follow up visit (est. 6 months)
Secondary outcomes:
measure: Orthosis Utilization
timeFrame: Baseline to final follow up visit (est. 6 months)
measure: QUEST 2.0
timeFrame: Final follow up visit (est. 6 months)
Other outcomes:
measure: Cranial Temperature
timeFrame: Baseline to final follow up visit (est. 6 months)
measure: Impact of delays on correction of asymmetry
timeFrame: Baseline to final follow up visit (est. 6 months)
measure: Duration of therapy
timeFrame: Baseline to final follow up visit (est. 6 months)
measure: Impact of torticollis on compliance
timeFrame: Baseline to final follow up visit (est. 6 months)
measure: Frequency of additional fittings
timeFrame: Baseline to final follow up visit (est. 6 months)
Locations:
city: Madison Heights
country: United States
facility: Wright & Filippis
state: Michigan
Study officials:
References:
Clinical trial NCT00646191: Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: Multicenter Extension Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 137
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: Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility criteria: Inclusion Criteria:

* Subject completed prior PS study

Exclusion Criteria:

* Subject has other active skin diseases
* Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
* Poorly controlled medical conditions
* History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
* History of cancer or lymphoproliferative disease
* History of active TB or listeriosis, or persistent chronic or active infections
* Known to have immune deficiency or is immunocompromised
* Clinically significant abnormal laboratory test results
* Erythrodermic psoriasis or generalized pustular psoriasis

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 12
measure: Adverse Events
timeFrame: Throughout Study Participation
Secondary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48
measure: DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS
timeFrame: Week 12, 24 and 48
measure: Physician's Global Assessment
timeFrame: Week 12, 16, 20, 24, 32, 40 and 48
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01595191: Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure
Official title: Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resting Energy Expenditure
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-05-09
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy preterm infants. Whether this finding is related to music per-se or to music by Mozart is unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE similar to that of Mozart music.


Eligibility criteria: Inclusion Criteria:

* Preterm infants at post menstrual age of 30-37 weeks who were appropriate for gestational age, clinically and thermally stable, gavage-fed, were eligible for recruitment.
* At the time of the study they were all tolerating full enteral feeding (150-160 cc/kg weight/day) without significant gastric residuals (\<5% of total feed), they were all growing steadily, and had no electrolyte imbalance.
* All infants who were recruited successfully passed a hearing screening test prior to discharge (otoacoustic emission and automated auditory brainstem response)

Exclusion Criteria:

* Infants with significant complications of prematurity such as intraventricular hemorrhage, periventricular leucomalacia, necrotizing enterocolitis, active apneas of prematurity, patent ductus arteriosus, active infection, electrolyte imbalance and major congenital anomalies.

Primary outcomes:
measure: Resting energy expenditure
timeFrame: 3 CONSECUTIVE DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Direcrotr, NICU
name: Dror Mandel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lubetzky R, Mimouni FB, Dollberg S, Reifen R, Ashbel G, Mandel D. Effect of music by Mozart on energy expenditure in growing preterm infants. Pediatrics. 2010 Jan;125(1):e24-8. doi: 10.1542/peds.2009-0990. Epub 2009 Dec 7.