louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02121951: Quadratus Lumborum Block for Percutaneous Nephrostomy
Official title: Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Nephrostomy; Complications
Upper Urinary Tract Dilatation and Obstruction
Regional Anesthesia Morbidity
Adverse Anesthesia Outcome
Keywords: Percutaneous Nephrostomy
Quadtatus Lumborum Block
Cancer
Monitored Anaesthesia Care
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 0
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: Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.

Detailed description: Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\\analgesia to a minimum.

Eligibility criteria: Inclusion Criteria:

1. ASA grade III and IV patients,
2. Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy

Exclusion Criteria:

1. Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3.
2. Untreated urinary tract infection;
3. Pre-operative haemoglobin \<10 gm/dl,
4. Severely co morbid patients
5. Non-dilated renal collecting system
6. Patient refusal to consent for the procedure.

Primary outcomes:
measure: Analgesia
timeFrame: 4 hours
Secondary outcomes:
measure: Respiratory Depression
timeFrame: 4 hours
measure: Sedation
timeFrame: 4 hours
measure: Cardiovascular stability
timeFrame: 4 hours
measure: Patient Satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
state: Old Cairo
Study officials:
affiliation: National Cancer Institute, Egypt
name: Dina N Abbas, M D
role: STUDY_DIRECTOR
affiliation: National Cancer Institute, Egypt
name: Ghada M Bashandy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Egypt
name: Wael Darwish, M D
role: STUDY_CHAIR
References:
citation: Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
citation: Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.
Clinical trial NCT02852551: Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
Official title: A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: PharmAkea, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
* body weight of 50 to 100 kg, inclusive
* subjects must be in good health

Exclusion Criteria:

* male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
* female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
* history of, any clinically significant major disorder
* clinically significant allergic condition
* significant history of alcoholism or drug/chemical abuse
* use of any tobacco or nicotine-containing products
* clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
* positive urine drugs of abuse screen or alcohol breath test

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: one to seven days
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: one to seven days
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: one to seven days
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: one to seven days
measure: Terminal elimination half-life (t½)
timeFrame: one to seven days
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit Ltd.
Study officials:
affiliation: PharmAkea, Inc.
name: Kevin Holme, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00506051: ZD6474(Vandetanib) + Alimta Combo Study
Official title: A Phase I, Open-Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With Pemetrexed (Alimta) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Prior Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Non-Small Cell Lung
Lung Cancer
Keywords: Non-small cell lung cancer
lung cancer
alimta
vandetanib
phase 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 21
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 main purpose of this trial is to look to see if adding ZD6474 (100 mg or 300mg tablets) to Alimta chemotherapy in patients with non-small cell lung cancer is safe and will help control their symptoms and disease better than the chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Confirmed advanced or metastatic non-small cell lung cancer
* Failure of first-line chemotherapy
* 1 or more measurable lesion by RECIST

Exclusion Criteria:

* Previous chemotherapy or radiotherapy within 4 weeks
* Significant cardiac events, arrythmias or other cardiac conditions
* Unacceptable laboratory measurements

Primary outcomes:
measure: To establish the safety & tolerability of ZD6474 when administered in combination w/Pemetrexed (Alimta) to patients w/locally advanced or metastatic NSCLC after failure of prior chemo, by assessment of AEs, vital signs, lab, ECG and physical exam.
timeFrame: assessed at each visit
Secondary outcomes:
measure: To investigate the pharmacokinetics of ZD6474 and Pemetrexed when given in combination to patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy, by assessment of appropriate pharmacokinetic (PK) parameters.
timeFrame: assessed at each visit
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: de Boer R, Humblet Y, Wolf J, Nogova L, Ruffert K, Milenkova T, Smith R, Godwood A, Vansteenkiste J. An open-label study of vandetanib with pemetrexed in patients with previously treated non-small-cell lung cancer. Ann Oncol. 2009 Mar;20(3):486-91. doi: 10.1093/annonc/mdn674. Epub 2008 Dec 16.
Clinical trial NCT01946451: Gene Expression in Patients With Epiretinal Membranes
Official title: Gene Expression and Their Correlations in Patients With Idiopathic and Secondary Epiretinal Membranes in Proliferative Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proliferative Diabetic Retinopathy
Keywords: idiopathic epiretinal membranes
secondary epiretinal membranes
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2013-09-19
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population description:

The blood and ERM samples were obtained from patients treated in the Department of Ophthalmology, University Hospital No. 5, Medical University of Silesia, Katowice, Poland.

All subjects underwent a complete ophthalmic examination: best corrected visual acuity (BCVA), tonometry, slit lamp examination of anterior and posterior segment, optical coherence tomography (OCT) of the central retina.

Brief summary: The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.


Eligibility criteria: Inclusion Criteria:

* Caucasian race,
* both males and females,
* aged ≥ 55 years,
* suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR).
* Presence of ERM was proven in optical coherence tomography (OCT) examination.

Exclusion criteria:

* aged \< 55 years,
* systemic connective tissue disease,
* active inflammatory process

Primary outcomes:
measure: Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy.
timeFrame: The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Medical University of Silesia
Study officials:
References:
Clinical trial NCT06285851: A Novel Iron Supplement for Athletes: Phase I
Official title: Pilot Study for a Novel Iron-Based Supplement for Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Diarrhea
Cramp, Abdominal
Bleeding Gastric
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Lallemand Bio-Ingredients
First posted: 2024-02-29
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study is a pilot trial to assess the tolerability of a novel iron supplement prior to conducting a clinical trial on the efficacy of the developed novel iron supplement on iron status and performance.

Detailed description: Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the tolerability of the developed supplement and any associated symptoms before conducting a clinical trial on this product. Participants will consume 40mg of elemental iron every second day for 14 days. Participants will complete a daily survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms. Additionally, participants will complete a more thorough survey of gastrointestinal symptoms at baseline, the mid-point, and the end of the study.

Eligibility criteria: Inclusion Criteria:

* cis-gendered female 18-25years old
* BMI \<25 kg/m2
* engaging in moderate to vigorous physical activity for ≥3 hours per week

Exclusion Criteria:

* gastrointestinal issues (e.g. Irritable bowel disease/syndrome)
* chronic illnesses
* prescription medication (including oral contraceptives)
* allergies to supplement ingredients
* iron supplementation in the last 3 months

Primary outcomes:
measure: GI Symptoms
timeFrame: Daily for 14 days
measure: Gastrointestinal symptoms
timeFrame: Weekly for 14 days
Secondary outcomes:
measure: Supplement Tolerability and Preferences Questionnaire
timeFrame: 14 days
measure: Recovery
timeFrame: 14 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jane Shearer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05319951: Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Official title: Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Donation
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2022-04-11
Enrollment: 6250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation

Detailed description: Vasovagal reaction is the most common type of blood donation reaction. The main cause of this reaction is the decrease of blood volume. Therefore, fluid supplement before blood donation has been proved to be effective in preventing the vagal reaction after blood donation. It was proved that isotonic (sugar \& salt) drink intake before blood donation had a significant effect on reducing vasovagal reaction.

However, in 2002, WHO recommended the new reduced osmolarity rehydration formula with better taste. Oral Rehydration Salt 3 has been produced according to WHO formula with standard ingredient and easy to prepare. In addition, in Guangdong culture, sugar water is regarded as a tonic, more easily accepted. So, the aim of our study was to compare the effects of 500 ml water with Oral Rehydration Salt 3, white granulated sugar and conventional recommended water intake prior to blood donation on blood donation reaction after whole blood donation, in order to understand the effect of different liquid supplement on blood donation reaction and the willingness of blood donation again.

Eligibility criteria: Inclusion Criteria:All blood donors donated whole blood in Guangzhou Blood Center during study.

-

Exclusion Criteria:Blood donors who were deferral by blood screening result and other situations.

-

Primary outcomes:
measure: vasovagal reaction rate
timeFrame: 1-3days
Secondary outcomes:
measure: rate of willingness to donate blood again
timeFrame: 3days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
affiliation: Guangzhou Blood Center
name: Guiyun Xie, MPH
role: STUDY_CHAIR
affiliation: Guangzhou Blood Center
name: Jinyan Chen, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Blood Center
name: Shijie Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT00236951: Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Official title: A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
Cancer
Chemotherapy
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

Detailed description: This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Eligibility criteria: Inclusion Criteria:

* Histological Diagnosis of Cancer
* Hgb \</= 10
* Ongoing or Planned Chemotherapy
* Body Weight \>50kg
* Free of Active Infection
* Karnofsky Status 60% to 100%

Exclusion Criteria:

* Active infection
* Use of Multivitamins with iron within one week of entry
* Myelophthisic bone marrow involvement by tumor except hematologic malignancy
* Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
* Use of any IV iron products within two months of study entry
* Blood Transfusions
* Hypoplastic bone marrow failure state
* Acute Leukemia
* Myeloproliferative syndrome
* Uncontrolled hypertension

Primary outcomes:
measure: Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
timeFrame: During Stage 2 (week 9 through week 21)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02189551: Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Stroke Gait Training
Lead sponsor: Cereneo AG
Sponsor class: INDUSTRY
Collaborators: name: Swiss Commission for Technology and Innovation
name: Swiss Federal Institute of Technology
name: Hocoma AG
name: University of Zurich
First posted: 2014-07-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective).

Primary study endpoints will be a significantly higher rated patient comfort and or patient satisfaction using the new versions, compared with the established Lokomat. Furthermore, muscle activity and kinematic movement patterns will be expected to show more involved muscle groups and a walking pattern involving more degrees of freedom during use of the new version compared with the established Lokomat.

Exploratory endpoints will be a significantly stronger involvement of muscles needed for balance, more physiological walking patterns and more change on the lateral positioning of the feet due to training with the new version, compared with the established Lokomat.


Eligibility criteria: Inclusion Criteria:

* Lower extremity weakness due to stroke
* minor functional impairment (MRC \< 5)
* ability and willingness to participate

Exclusion Criteria:

* severe spasticity of the lower extremities
* severe dementia
* severe depression
* any other contraindications against Lokomat training
* body weight \> 135 kg

Primary outcomes:
measure: Lateral hip movement
timeFrame: 30 min training during day 1 (next session after inclusion)
Secondary outcomes:
measure: Patient satisfaction
timeFrame: day 2 and 3
measure: Patient motivation
timeFrame: day 2 and 3
Other outcomes:
Locations:
city: Vitznau
country: Switzerland
facility: Cereneo, Center For Rehabilitation and Neurology
state: LU
Study officials:
References:
Clinical trial NCT02976051: DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC
Official title: DAHANCA 33: Functional Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Head and Neck Cancer
Radiotherapy
Hypoxic Radioresistance
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
First posted: 2016-11-29
Enrollment: 60
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: Aim: To improve curability of radiotherapy in HNSCC patients identified by hypoxic FAZA-PET scanning

Detailed description: Prospective phase II study aiming to improve the outcome in hypoxic resistent patients identified by FAZA-PET.

Inclusion:

Patients must fulfill the following:

Positive hypoxic FAZA-PET Scanning (as described in DAHANCA 24 - see citation) Stage III-IV, Squamous cell carcinoma of the larynx, pharynx or oral cavity (HPVneg (oropharynx) Indication for hyperfractionated accelerated radiotherapy with concommitant cis-platin and nimorazole

Eligibility criteria: Inclusion Criteria:

* Stage III-IV larynx, pharynx, oral cavity
* Hypoxic FAZA-PET positive
* Indication for primary radio-chemotherapy
* Informed consent

Exclusion Criteria:

* HPV positive oropharynx cancer
* Primary surgery

Primary outcomes:
measure: Loco-regional failure
timeFrame: Year 3
Secondary outcomes:
measure: Overall survival
timeFrame: Year 3
measure: Acute radiation related morbidity
timeFrame: Month 3
measure: Late radiation related morbidity
timeFrame: Year 3
measure: Disease-specific death
timeFrame: Year 3
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Experimental Clinical Oncology, Aarhus University Hospital
Study officials:
References:
citation: Mortensen LS, Johansen J, Kallehauge J, Primdahl H, Busk M, Lassen P, Alsner J, Sorensen BS, Toustrup K, Jakobsen S, Petersen J, Petersen H, Theil J, Nordsmark M, Overgaard J. FAZA PET/CT hypoxia imaging in patients with squamous cell carcinoma of the head and neck treated with radiotherapy: results from the DAHANCA 24 trial. Radiother Oncol. 2012 Oct;105(1):14-20. doi: 10.1016/j.radonc.2012.09.015. Epub 2012 Oct 16.