louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00493155: A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.
Official title: "An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-06-28
Enrollment: 48
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: This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* cancer not amenable to curative treatment (ie advanced and/or metastatic);
* measurable or evaluable disease;
* adequate cardiac, hepatic and renal function.

Exclusion Criteria:

* patients with known CNS metastases;
* serious cardiovascular illness or other medical conditions;
* prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment;
* inability to swallow oral medications, or impaired gastrointestinal absorption.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: Throughout study
Secondary outcomes:
measure: AEs, laboratory parameters
timeFrame: Throughout study
measure: Plasma levels of R1530
timeFrame: Throughout study
measure: Tumor assessments
timeFrame: Every 2 cycles of treatment
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02271555: The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy
Official title: Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Haemodynamic Rebound
Keywords: electroconvulsive therapy
sevoflurane
remifentanil
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression

Detailed description: Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.

Eligibility criteria: Inclusion Criteria:

* Major depressive patients

Exclusion Criteria:

* younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.

Primary outcomes:
measure: The effects of remifentanil on the heart rate after electroconvulsive therapy
timeFrame: 20 minute
Secondary outcomes:
measure: Seizure duration
timeFrame: 20 minute
measure: The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy
timeFrame: 20 minute
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medical Center
Study officials:
affiliation: İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation
name: Feray Erdil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nishikawa K, Higuchi M, Kawagishi T, Shimodate Y, Yamakage M. Effect of divided supplementation of remifentanil on seizure duration and hemodynamic responses during electroconvulsive therapy under propofol anesthesia. J Anesth. 2011 Feb;25(1):29-33. doi: 10.1007/s00540-010-1049-4. Epub 2010 Nov 30.
Clinical trial NCT00034255: Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
Official title: Single Dose and 34-Day Tolerance Study of INGAP Peptide in Insulin Deficient Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: GMP Endotherapeutics
Sponsor class: INDUSTRY
First posted: 2002-04-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of intramuscular INGAP Peptide given for the first time in humans as a potential treatment for diabetes.


Eligibility criteria: Inclusion Criteria:

Patients meeting all of the following inclusion criteria at screening can be considered for admission to the study.

Stage 1 and Stage 2:

1. Male and female patients with, type 1 diabetes mellitus that are 18 through 70 years of age, or type 2 diabetes mellitus that are 30 through 70 years of age.
2. Patients who are insulin deficient and are diagnosed with type 1 or type 2 diabetes mellitus, and are currently well managed with insulin, with or without metformin.
3. Patients who have been on stable doses of insulin treatment for 90 days prior to study randomization.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria at screening will not be enrolled in the study:

1. Patients with a history of any clinically significant retinopathy, symptomatic autonomic neuropathy, unstable angina, or kidney problems.
2. Patients with an uncontrolled or untreated significant pulmonary, neurological condition, or cardiovascular disease, including hypertension, congestive heart failure, angina, or peripheral vascular disease.
3. Patients who have received any investigational product within 30 days of admission into the study.
4. Patients with a history or clinical evidence of multiple organ autoimmune disorders.
5. Patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
6. Patients who are lactating and breastfeeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VASDHS Medical Center
state: California
city: Washington
country: United States
facility: MedStar Research Institute - Clinical Research Center
state: District of Columbia
city: Durham
country: United States
facility: UNC Diabetes, Endocrinology, Metabolism Clinic
state: North Carolina
city: San Antonio
country: United States
facility: Texas Diabetes Institute
state: Texas
Study officials:
References:
Clinical trial NCT02675855: GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
Official title: A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Ulcer, Diabetic
Keywords: Grafix
Lead sponsor: Osiris Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.


Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 Diabetes
* Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks)
* Index ulcer located below the malleoli on the plantar or dorsal surface of the foot
* Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule
* Adequate circulation to the foot (documented by ABI or TBI)

Exclusion Criteria:

* Gangrene present on affected foot
* Index ulcer is over a Charcot deformity
* Patient is receiving dialysis
* Patient has 2 or more previous amputations
* Patient has HbA1c \>12% or random blood sugar \>450 mg/dl
* Chronic oral steroid use
* Use of IV corticosteroid, immunosuppressive, or cytotoxic agents
* IV antibiotics
* Another ulcer within 5cm of the Index ulcer
* Cellulitis, evidence of infection, or osteomyelitis

Primary outcomes:
measure: Complete closure of index wound
timeFrame: Up to Day 56
Secondary outcomes:
measure: Time to wound closure
timeFrame: Up to Day 56
measure: Proportion of patients that achieve a 50% reduction or greater in wound size
timeFrame: Day 28
measure: Number of product applications
timeFrame: Up to Day 56
measure: Number of Adverse Events
timeFrame: Up to Day 56
measure: Number of patients with worsening of wound by ≥50% increase in size
timeFrame: Up to Day 56
Other outcomes:
Locations:
city: Arizona
country: United States
state: Arizona
city: California City
country: United States
state: California
city: New Mexico
country: United States
state: New Mexico
Study officials:
affiliation: Director, Clinical Affairs
name: Sharron McCulloch
role: STUDY_DIRECTOR
References:
Clinical trial NCT05087355: Health Status Prior and Post Infection With Influenza or COVID 19: a Population Based Retrospective Analysis of 2016-2021
Official title: Health Status Prior and Post Infection With Influenza or COVID 19: a Population Based Retrospective Analysis of 2016-2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid 19
Influenza
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Landesklinikum Sankt Polten
name: Sicknessfund Burgenland (BGKK)
name: A.ö. Krankenhaus St. Josef Braunau GmbH
First posted: 2021-10-21
Enrollment: 440000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with or after Covid-19 or influenza between 2016-2021 in Austria will be included in this study

Brief summary: The overall project aim is to study outcomes after COVID-19 and influenza hospitalisation from 2016 - 2021 by retrieving data from the main social security carriers in Austria for the years 2010-2018


Eligibility criteria: Inclusion Criteria:

* Patients with SARS
* Patients with Covid-19
* Patients after Covid-19
* Patients with influenza

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall Mortality
timeFrame: 5 years
measure: age distribution
timeFrame: 5 years
measure: risk profile
timeFrame: 5 years
measure: newly diagnosed diseases
timeFrame: 5 years
measure: newly prescribed medication
timeFrame: 5 years
measure: duration of hospitalisation or unemployability
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04135950: Prospective Registry of Anterior Cruciate Ligament Reconstructions
Official title: Prospective Registry of Predictors and Comorbid Injuries Associated with Anterior Cruciate Ligament Reconstructions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anterior Cruciate Ligament Tear
Meniscal Tear
Cartilage Injury
Bone Bruising
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at our institution who are having ACL surgery by one of 4 fellowship-trained surgeons will be included in this registry.

Brief summary: The purpose of the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (ACL) in the knee among patients who are undergoing surgical reconstruction. This study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. The surgeon documents patient information on standard data forms including risk factors and surgical findings.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing ACL surgery

Exclusion Criteria:

* Previous surgery on the affected knee
* Posterior cruciate ligament injuries
* Grade 2 lateral collateral ligament or medial collateral ligament injuries

Primary outcomes:
measure: additional injury
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UBMD Orthopaedics and Sports Medicine
state: New York
Study officials:
References:
Clinical trial NCT01361750: The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy
Official title: The Effects of Gastric Tube on the Quality of Life and Nutritional Status After Ivor-Lewis Esophagectomy: A Randomized Control Trial and Physiological Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oesophageal Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with Ivor-Lewis esopagectomy in a 12-month follow-up period.


Eligibility criteria: Inclusion Criteria:

* esophageal cancer (squamous and adenocarcinoma subtypes)
* eligble for Ivor-Lowis esophagectomy
* expected survival time longer than 12 months

Exclusion Criteria:

* palliative resection(non-R0)
* anastomosis leak
* jejunum or colon transversum interponate

Primary outcomes:
measure: change of nutritional status and quality of life before and after operation
timeFrame: before operation (baseline), 1 month, 6 month and 12 month after operation
Secondary outcomes:
measure: change of serum markers and tissue inflammatory status before and after operation
timeFrame: before operation (baseline), 1 month, 6 month and 12 month after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University School of Oncology
state: Beijing
Study officials:
affiliation: Peking University Health Science Center
name: Yue Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232150: Does Midazolam Cause Effective Anterograde Amnesia in Orthopedic Surgeries?
Official title: Midazolam's Anterograde Amnesia Efficacy in Noisy Orthopedic Surgery: Does Midazolam Cause Effective Anterograde Amnesia in Noisy Orthopedic Surgeries?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Orthopedic Surgery
Keywords: Midazolam
Orthopedic surgery
total knee replacement
total hip replacement
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Abdelkarim S. Aloweidi
First posted: 2020-01-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Overall, 116 patients were enrolled, out of which 20 were excluded before start of study for the following reasons: contraindication for spinal anesthesia (n=10), preoperative administration of sedative agent (n=3), refusal to be enrolled in study (n=4), a patient with neurological disorder (Schizophrenia), a blind patient, and a deaf patient. Of the 96 patients included, 33 were enrolled in group C, 32 in group S; however, 2 patients requested a deeper level of sedation so an added dose of midazolam and fentanyl were given thus excluding them from study, and 31 patients in group R.
Primary purpose: PREVENTION

Brief summary: Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Detailed description: Spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.The use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. The main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. The aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving Midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Eligibility criteria: Inclusion Criteria:

* patients undergoing total knee or total hip replacement.
* ASA I, II, or III.
* patients undergoing spinal anesthesia.

Exclusion Criteria:

* patient refusal.
* \<24 hours sedative administration.
* patient with hearing impairment.
* neurological or memory disorder.
* abnormal kidney function tests.
* any contraindication for spinal anesthesia.

Primary outcomes:
measure: Postoperative recall of auditory stimuli and intraoperative noise
timeFrame: 4 months
measure: Postoperative recall of visual stimuli
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT01633450: Zinc Absorption From Biofortified Rice
Official title: Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2012-07-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.


Eligibility criteria: Inclusion Criteria:

* Male or female of 18 to 45 years old
* Body Mass Index in the range of 19 to 25
* No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

* Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
* Long-term medication during the whole study (except for contraceptives)
* Pregnancy
* Lactation
* Intention to become pregnant during the course of the study
* Lack of safe contraception
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study

Primary outcomes:
measure: Fractional absorption of zinc
timeFrame: 33 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
Study officials:
References:
citation: Brnic M, Wegmuller R, Melse-Boonstra A, Stomph T, Zeder C, Tay FM, Hurrell RF. Zinc Absorption by Adults Is Similar from Intrinsically Labeled Zinc-Biofortified Rice and from Rice Fortified with Labeled Zinc Sulfate. J Nutr. 2016 Jan;146(1):76-80. doi: 10.3945/jn.115.213421. Epub 2015 Dec 16.