louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01281592: A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
Official title: Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumours
Lead sponsor: Aptose Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 36
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 is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy.
3. Meet laboratory parameter requirements at study entry.

Exclusion Criteria:

1. Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.
2. A hematologic malignancy.
3. A history of brain or other central nervous system metastases.
4. Have a presence of a significant infection.
5. Clinically significant autoimmune disease.
6. Uncontrolled intercurrent illness.
7. With iron or copper overload syndromes.
8. Pregnancy or breast feeding.

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.
timeFrame: 8 weeks
Secondary outcomes:
measure: To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Cercek, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Jennifer Wheler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03845192: Oxygen Reserve Index for Kids
Official title: Application and Validation of the New Oxygen Reserve Index in Infants < 2 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 107
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In infants less than two years old the new Oxygen Reserve Index (ORI) will be measured during general anaesthesia. It will evaluated if and how ORI-monitoring gives earlier warning of hypoxaemia than conventional oxygen saturation measurement.

Detailed description: The Oxygen Reserve Index (ORI) is a new development in multiple wavelength pulse oximetry, reflecting the arterial partial oxygen pressure (PaO2) continuously and non-invasively by an index. In contrast to established standard oxygen saturation (SpO2) measurements, ORI detects a drop of PaO2 until the threshold of 100 mmHg. During anaesthesia induction-associated apnoeic periods ORI may detect a drop of PaO2 early enough for the anaesthesiologist to interrupt the intubation procedure and re-start oxygenation. In contrast, due to the flat upper part of the oxyhaemoglobin dissociation curve, SpO2 stays at values above 90% until PaO2 falls below 60mmHg. At this point, SpO2 drops rapidly and a pro- longed hypoxic dip is the consequence. To avoid this potentially harmful hypoxic dip, continuous monitoring of PaO2 using ORI would be advantageous during anaesthesia induction phase.

This clinical study aims to evaluate the time benefit between alarm of hypoxaemia by the ORI-monitoring and the start of the dropping of oxygen saturation. Pre-set and pre-described ORI-alarms will be checked for their utility and a new ORI-alarm will be defined that is potentially more useful. As secondary endpoints the study examines the correlation of ORI with PO2, the influence of patient or measurement characteristics on the correlation of ORI with PO2 and the influence of the measurement site on ORI-measurement.

Eligibility criteria: Inclusion Criteria:

* small infants \< 2 years scheduled for elective surgery with general anaesthesia.

Exclusion Criteria:

* emergency procedures, lack of informed consent of legal guardian

Primary outcomes:
measure: time in seconds between ORI-dropping and dropping of SpO2
timeFrame: during general anaesthesia of the infant
Secondary outcomes:
measure: correlation of ORI and PO2
timeFrame: during general anaesthesia of the infant
measure: influence of patient or measurement characteristics on the correlation of ORI and PO2
timeFrame: during general anaesthesia of the infant
measure: influence of measurement site on the correlation or ORI with PO2 and the influence of the measurement site on ORI measurement
timeFrame: during general anaesthesia of the infant
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenbert University Centre
Study officials:
References:
Clinical trial NCT02329392: Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Circulation During On-pump Cardiac Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patinets \> 20 years old who are scheduled for elective on-pump cardiac surgery

Brief summary: This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.


Eligibility criteria: Inclusion Criteria:

* age \> 20 yrs, scheduled for elective on-pump cardiac surgery

Exclusion Criteria:

* known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate \> 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate

Primary outcomes:
measure: Assessment of skin perfusion pressure
timeFrame: From post induction to 6 hours
Secondary outcomes:
measure: Assessment of arterial lactate level
timeFrame: From post induction to 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04820192: Craniosacral Therapy for Concussion Symptoms
Official title: Effects of CranioSacral Therapy Upon Symptoms of Post-Acute Concussion and Post-Concussion Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Concussion Syndrome
Lead sponsor: Special Therapies, Inc.
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 67
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ten year retrospective chart review of patients who received craniosacral therapy addressing symptoms post concussion

Brief summary: This study investigated the utilization of CranioSacral Therapy (CST) in patients with Post-Concussion Syndrome (PCS) and capture patient-reported perceptions of their lived experiences of treatment effect upon their symptoms. The first part part was a 10 year chart review of patients who sought out CST to capture data from the medical records. The second part was an anonymous post treatment survey.


Eligibility criteria: Inclusion Criteria:

* Charts were extracted from a group of 212 of patients with a history of concussion to a final chart review size of 67. These patients had specifically sought of CST to address symptoms of Post Concussion Syndrome.

Exclusion Criteria:

* Was determined for the 2nd part of study: Post Treatment Outcome Survey. Final group size of 47 excluded those under age 14 and those with confounding medical or personal issues or involved in litigation.

Primary outcomes:
measure: Patient-directed Utilization of CST
timeFrame: Through study completion. 1 year - study is now completed
Secondary outcomes:
measure: Demographic information
timeFrame: 3 months
measure: Post-treatment Patient-reported Outcome Survey
timeFrame: Through study completion. 1 year - study is now completed
Other outcomes:
Locations:
city: Waukesha
country: United States
facility: Special Therapies, Inc.
state: Wisconsin
Study officials:
affiliation: Special Therapies, Inc.
name: Susan Kratz, OTR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581892: Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion
Official title: Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Long Bone Nonunion
Keywords: bone nonunion
bone marrow
mononuclear
fracture
Lead sponsor: Hospital Universitario Central de Asturias
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 7
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: The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.

Detailed description: In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.

Eligibility criteria: Inclusion Criteria:

* diagnosed long bone nonunion
* age from 18 years old

Exclusion Criteria:

* active infection
* cancer patients
* concomitant serious illness
* pregnant women
* evidences of mental illness
* previous alcohol or drug dependences
* previous malignant disease during last 5 years, except for basal carcinoma

Primary outcomes:
measure: Absence of adverse effects during timeframe as infections or complications related with the intervention
timeFrame: Six months
Secondary outcomes:
measure: Improvement and union of the bone
timeFrame: One year
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
Study officials:
affiliation: Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa
name: Jesus Otero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez-Bances I, Perez-Basterrechea M, Perez-Lopez S, Nunez Batalla D, Fernandez Rodriguez MA, Alvarez-Viejo M, Ferrero-Gutierrez A, Menendez-Menendez Y, Garcia-Gala JM, Escudero D, Paz Aparicio J, Carnero Lopez S, Lopez Fernandez P, Gonzalez Suarez D, Otero Hernandez J. Repair of long-bone pseudoarthrosis with autologous bone marrow mononuclear cells combined with allogenic bone graft. Cytotherapy. 2013 May;15(5):571-7. doi: 10.1016/j.jcyt.2013.01.004. Epub 2013 Feb 14.
Clinical trial NCT06783192: A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
Official title: A Study to Assess the Effects of Single Oral Doses of MK-8527 on the Single-Dose Pharmacokinetics of an Oral Contraceptive (Levonorgestrel and Ethinyl Estradiol) in Healthy Adult Postmenopausal or Oophorectomized Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV)
HIV Pre-Exposure Prophylaxis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.


Eligibility criteria: Inclusion Criteria:

* is in good overall health
* assigned female at birth

Exclusion Criteria:

* has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
* has a history of cancer (malignancy)

Primary outcomes:
measure: Area under the curve from dosing to infinity (AUC0-∞) of LNG alone and with MK-8527
timeFrame: Up to ~96 hours postdose
measure: Maximum plasma concentration (Cmax) of LNG alone and with MK-8527
timeFrame: Up to ~96 hours postdose
measure: Time to Cmax (Tmax) of LNG alone and with MK-8527
timeFrame: Up to ~96 hours postdose
measure: Apparent half-life (t½) of LNG alone and with MK-8527
timeFrame: Up to ~96 hours postdose
measure: AUC0-∞ of EE alone and with MK-8527
timeFrame: Up to ~72 hours postdose
measure: Tmax of EE alone and with MK-8527
timeFrame: Up to ~72 hours postdose
Secondary outcomes:
measure: Percentage of participants with ≥1 adverse event (AE)
timeFrame: Up to ~28 days
measure: Percentage of participants discontinuing from study therapy due to AE
timeFrame: Up to ~28 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC-Early Phase (Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00384592: PPI Sequencing Study
Official title: A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastro-Oesophageal Reflux Disease
Keywords: heartburn
reflux
proton pump inhibitor
GERD
GORD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 100
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: The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.


Eligibility criteria: Inclusion Criteria:

* Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
* Informed consent
* Over 18 years of age

Exclusion Criteria:

* Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study;
* More than 1 other course of PPI treatment in the previous 12 month;
* Previous use of esomeprazole;
* Presence of alarm symptoms.

Primary outcomes:
measure: The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily
Secondary outcomes:
measure: Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry
measure: Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires
Other outcomes:
Locations:
city: Allerton
country: United Kingdom
facility: Research Site
city: Ashford
country: United Kingdom
facility: Research Site
city: Atherstone
country: United Kingdom
facility: Research Site
city: Ayrshire
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research SIte
city: Coventry
country: United Kingdom
facility: Research Site
city: Fowey
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research SIte
city: Hamilton
country: United Kingdom
facility: Research Site
city: Motherwell
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Warminster
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Rhiannon Rowsell, MD
role: STUDY_DIRECTOR
affiliation: UCL
name: Roger Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04834492: The Results of Total Hip Arthroplasty in Crowe Type 4 Hips.
Official title: At Least 10-Year Results of Cementless Ceramic-On-Ceramic Total Hip Arthroplasty Performed With Transverse Subtrochanteric Osteotomy in Crowe Type 4 Hips.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Results of Total Hip Arthroplasty in Crowe Type 4 Dysplastic Hips
Keywords: Developmental dysplasia of the hip, total hip arthroplasty, transverse subtrochanteric shortening osteotomy, ceramic on ceramic, cementless.
Lead sponsor: Private Ortopedia Hospital, Seyhan Adana
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Crowe type 4 developmental dysplasia of the hip patient

Brief summary: Total hip arthroplasty (THA) performed for developmental dysplasia of the hip (DDH) is a technically difficult procedure with a high complication rate, especially in the presence of completely dislocated hips. This study aimed to evaluate the results of at least 10 years of follow-up results of cementless, ceramic-on-ceramic (CoC) total hip arthroplasty performed with transverse subtrochanteric osteotomy in Crowe type 4 hips.

Detailed description: We reviewed retrospectively 67 hips of 50 patients which underwent CoC, cementless THA with transverse subtrochanteric osteotomy between 2008 and 2011. Clinical and radiological data of the hips were examined. Clinical results were evaluated using the Harris Hip Score (HHS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility criteria: Inclusion Criteria:

Crowe type 4 developmental dysplasia of the hip

Exclusion Criteria:

Primary Coxarthrosis

Primary outcomes:
measure: Clinical results
timeFrame: minimum 10 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Private Ortopedia Hospital
state: Seyhan
Study officials:
References:
Clinical trial NCT02006992: Growth of Infants Fed Hydrolysate Formulas
Official title: Growth of Infants Fed Hydrolysate Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 195
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.


Eligibility criteria: Inclusion Criteria:

* Infants in good health.
* Singleton, term birth with a gestational age of 37 to 42 weeks.
* Birth weight of 2500 g (5 lb 8 oz) or greater.
* Between 0 and 9 days of age at enrollment.
* Not receiving vitamin or mineral supplements.

Exclusion Criteria:

- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.

Primary outcomes:
measure: Weight
timeFrame: Study day 1 to 112 days of age
Secondary outcomes:
measure: Length
timeFrame: Study day 1 to 112 days of age
measure: Head Circumference
timeFrame: Study day 1 to 112 days of age
measure: Study Formula Intake
timeFrame: Enrollment to 112 days of age
measure: Incidence of Spit Up
timeFrame: Enrollment to 112 days of age
measure: Stool Pattern
timeFrame: Enrollment to 112 days of age
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Aurora
country: United States
facility: Dreyer Medical Center
state: Illinois
city: Evansville
country: United States
facility: PediaResearch, LLC
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa Hospitals and Clinics
state: Iowa
city: Bardstown
country: United States
facility: Kentucky Pediatric Research
state: Kentucky
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Chapel Hill
country: United States
facility: NC Children's & Young Adults' Clinical Research Foundation
state: North Carolina
city: Sellersville
country: United States
facility: GrandView Medical Research
state: Pennsylvania
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, RD, PhD
role: STUDY_CHAIR
References: