louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04186455: Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study
Official title: Comparison of Pro Seal and Baska-mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Calculi
Keywords: baska-mask
proseal
urs
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations.

Detailed description: The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS operations were enrolled in this prospective randomized clinical study. The demographic and airway characteristics of patients preoperatively and lam insertion times, nasogastric insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care unit.

Eligibility criteria: Inclusion Criteria:18-65 years of age

* undergoing elective urs operations
* bmı\<35
* ASA I-II

Exclusion Criteria:\<18 years of age

* bmı\>35
* ASA III-IV

Primary outcomes:
measure: insertion time
timeFrame: 20 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
References:
Clinical trial NCT05604755: Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT
Official title: Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prophylactic HQP1351 Therapy
Third Generation TKI
Keywords: CML
ph+ ALL
HQP1351
Prophylactic therapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Guangdong Second Provincial General Hospital
First posted: 2022-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.


Eligibility criteria: Inclusion Criteria:

1. Patient age of 18-65 years
2. Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants
3. Survival \> 30 days post-transplants
4. Laboratory parameters as defined below:

   Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN
5. Ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

1. Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants
2. Survival \<30 days post-transplants
3. MRD positive on day +30 post-transplants
4. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
5. Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: Disease Free Survival（DFS）
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 2 years
measure: Relapse rate
timeFrame: 2 years
measure: Adverse effects of TKI therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Department of Hematology, Nanfang Hospital, Southern Medical University,
Study officials:
References:
Clinical trial NCT01953055: SABR Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Official title: Phase II Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation for Patients With High Risk Prostate Cancer (SATURN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: stereotactic ablative radiotherapy
androgen deprivation therapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current treatment options for high risk localized prostate cancer include radical prostatectomy +/- postoperative radiotherapy, radical radiotherapy with androgen deprivation therapy. Evidence has emerged that prostate cancer has a low α/β ratio in the range of 1-3 Gy. Even with high risk tumors, prostate cancer is hypothesized to have a greater sensitivity to large fraction sizes and high dose per fraction radiotherapy theoretically allows for biological dose escalation with fewer visits and no additional toxicity. Therefore, we hope to determine the toxicity, quality of life, biochemical and pathological control of SBRT for high risk prostate cancer incorporating ENI.


Eligibility criteria: Inclusion Criteria:

* informed consent obtained
* men \> 18 years of age
* histologically confirmed prostate adenocarcinoma (centrally reviewed)
* high risk prostate cancer, defined as at least one of clinical stage T3 or Gleason 8-10, or PSA \> 20ng/mL

Exclusion Criteria:

* prior pelvic radiotherapy
* anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* diagnosis of bleeding diathesis
* large prostate (\>90cm3) on imaging at time of gold seed insertion
* no evidence of castrate resistance (defined as PSA \< 3ng/mL while testosterone is \< 0.7nmol/L
* definitive regional or distant metastatic disease on staging investigations

Primary outcomes:
measure: Acute GU and GI toxicities
timeFrame: Baseline to 3 months post treatment
Secondary outcomes:
measure: Late GU and GI toxicities
timeFrame: > 6 months post treatment
measure: Quality of Life (QoL)
timeFrame: 5 years
measure: Biochemical control
timeFrame: 5 years
measure: Disease free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre/Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre/University of Toronto
name: Andrew Loblaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966355: Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
Official title: RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Variceal Bleeding, Cirrhosis
Keywords: Cirrhosis, Esophagus Disorders, Varicose Veins
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 1034
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Detailed description: In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.

Eligibility criteria: Inclusion Criteria:

* liver cirrhosis
* age between 16 and 75 years
* Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment
* Patients whose systolic blood pressure \<100 mmHg or pulse rate \>100/min at the enrollment
* Patients who were not performed endoscopic or pharmacologic therapy for varices
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Positive anti-HIV Ab
* A history of severe side-effects or contraindications to study drugs
* Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure \>170 mmHg or diastolic pressure \>100 mmHg)
* Chronic renal failure
* Hepatocellular carcinoma with protal vein thrombosis
* Coexisting malignancy except hepatocellular carcinoma

Primary outcomes:
measure: 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
timeFrame: 5 days after enrollment
Secondary outcomes:
measure: Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects
timeFrame: 5 days after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University
name: Soon Ho Um, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01797055: Apotransferrin in Atransferrinemia
Official title: Dose Escalating Study to Evaluate Pharmacokinetics, Efficacy and Safety of Apotransferrin in Atransferrinemia Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Congenital Atransferrinemia
Keywords: transferrin
anemia
iron overload
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atransferrinemia is a very rare disorder, which is caused by a deficiency of the protein transferrin. No regular treatment is available for these patients. The objective of this study is to investigate the pharmacokinetics, efficacy and safety of Apotransferrin replacement therapy in atransferrinemia patients.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of atransferrinemia, defined as serum levels of transferrin below 40 mg/dl
* Informed consent

Exclusion Criteria:

* Known with allergic reactions against human plasma or plasma products
* Having detectable anti-immunoglobulin A antibodies

Primary outcomes:
measure: Hemoglobin
timeFrame: 10 year
measure: pharmacokinetics of transferrin
timeFrame: first infusion and year 3
measure: iron overload in organs
timeFrame: 10 years
Secondary outcomes:
measure: Iron overload
timeFrame: 10 years
measure: Hematocrit
timeFrame: 10 years
measure: Erythrocytes
timeFrame: 10 years
Other outcomes:
measure: transferrin levels
timeFrame: 10 years
measure: adverse drug reactions
timeFrame: 10 years
Locations:
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
city: Monza
country: Italy
facility: AO San Gerardo
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
Study officials:
affiliation: Vall d'Hebron, Spain
name: Cristina R Diaz de Heredia Rubio, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: klinikum Aschaffenburg, Germany
name: Katja Moser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO San Gerardo Monza, Italy
name: Raffaella Mariani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO San Gerardo Monza, Italy
name: Alberto Piperno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03866655: Evaluating a Digital Tool for Supporting Breast Cancer Patients
Official title: Evaluating a Digital Tool for Supporting Breast Cancer Patients: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Digital
eHealth
Supportive Care
Patient Activation
Resource Utilisation
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Innovate UK
First posted: 2019-03-07
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective randomised controlled trial that aims to understand the impact of the OWise breast cancer digital tool in newly diagnosed breast cancer patients. Half the patients will receive the digital tool and half the patients will receive standard information. The study will look at the impact of the digital tool on patient activation, health related quality of life (HRQoL), health status, psychological distress, NHS resource utilisation and health care costs.


Eligibility criteria: Inclusion Criteria:

* female
* adult (age 18 years or over)
* newly diagnosed
* early breast cancer
* first primary cancer diagnosis
* under treatment at one of the participating sites.

Exclusion Criteria:

* have started anti-cancer treatment
* private patients
* unable to read or write in English
* significant cognitive impairment
* poor mental health
* do not have access to the internet
* confirmed metastatic disease

Primary outcomes:
measure: Comparison of the change in patient activation (validated questionnaire: Patient Activation Measure (PAM-13) Survey)
timeFrame: 3 months after diagnosis (primary objective); 6 months and 1 year (secondary objective)
Secondary outcomes:
measure: Comparison of the change in health status (validated questionnaire: EuroQol 5-Dimension 5-Level (EQ-5D-5L) Survey)
timeFrame: 3 months, 6 months and 1 year after diagnosis
measure: Comparison of the change in health related quality of life (validated questionnaire: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core30 (EORTC-QLQ-C30 version 3) Survey)
timeFrame: 3 months, 6 months and 1 year after diagnosis
measure: Comparison of the change in psychological distress (validated questionnaire: HADS)
timeFrame: 3 months, 6 months and 1 year after diagnosis
measure: Resource Utilisation
timeFrame: 1 year
measure: Health care costs
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Institute of Cancer Research, United Kingdom
name: Olga Husson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lidington E, McGrath SE, Noble J, Stanway S, Lucas A, Mohammed K, van der Graaf W, Husson O. Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT). Trials. 2020 Jan 15;21(1):86. doi: 10.1186/s13063-019-3971-6.
Clinical trial NCT03007355: Peripheral Perfusion Index (PPI) as Monitor During Deliberate Hypotensive Anesthesia
Official title: The Use of Peripheral Perfusion Index as a Predictor for Patient's Response to Deliberate Hypotension During Functional Endoscopic Sinus Surgery A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monitoring During Deliberate Hypotensive Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult male or females, aged between 18-50 years, ASA class I ans II

Brief summary: Hypotensive anesthesia is effective in reducing the intraoperative blood loss. The risk of hypoperfusion of vital organs continues to be a concern. An adequate monitoring of tissue perfusion and oxygenation is crucial issue. Peripheral Perfusion Index (PPI) as a noninvasive new monitoring, can reflect the peripheral perfusion dynamics.

This study is designed to explore the behaviour and trend of PPI during nitroglycerine induced deliberate hypotensive anesthesia in adult patients undergoing functional endoscopic sinus surgery (FESS).


Eligibility criteria: Inclusion Criteria:

* Patients, aged from 18-50 years, ASA physical status I and II, undergoing functional endoscopic sinus surgery (FESS) under deliberate hypotensive anesthesia

Exclusion Criteria:

* Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation defects, renal or hepatic insufficiency, and hypersensitivity to the study drugs will be excluded from the study. Patients receiving vasoactive drugs or beta blockers will be also excluded from the study.

Primary outcomes:
measure: correlation between PPI and T1
timeFrame: start of nitroglyceirn infusion till target arterial pressure is reached up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04039555: Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)
Official title: Clinical Study to Compare the Efficacy of 1 Series of 2 Treatment Sessions With Erbium-Yag Laser or CO2RE Intimate Laser vs Sham (Sham Treatment) for Vulvovaginal Atrophy (Dryness and / or Dyspareunia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Atrophy
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 136
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial compares the efficacy of two different laser treatments for vaginal atrophy symptoms between them and with sham treatment. Patients will be randomized to one of the two lasers or sham treatment.

Detailed description: Patients over 45 years of age with one or more AVV symptoms who wish to participate in the study will be included, 2 laser sessions spaced one of another 4-6 weeks, and final tracking visit 4-6 weeks of the last laser session.

Each patient shall be randomly assigned an arm of tto, with laser CO2, or laser Erbium, or sham group

Eligibility criteria: Inclusion Criteria:

* Women older than 45 years with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity.

Exclusion Criteria:

* Hormone treatment in the last three months for vulvovaginal atrophy
* Treatment with vaginal moisturizers in the last week for vulvovaginal atrophy
* Laser treatment in the last 12 months.
* Acute and recurrent infections of the urinary tract in the last 3 months.
* Acute genital infections
* Vaginal prolapse
* Alterations in the area to be treated, such as lacerations, abrasions or ulcers (time of resolution at medical discretion)
* Chronic decompensated noncommunicable diseases
* Women who are pregnant or have given birth in the last 3 months

Primary outcomes:
measure: Comparation of 1 series of 2 treatment sessions with Erbium-Yag or intimate CO2RE vs Sham for the symptoms of vulvovaginal atrophy
timeFrame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
Secondary outcomes:
measure: Differences between CO2RE and Erbium-Yag
timeFrame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
measure: Changes in the Vulvar and Vaginal Health Index (VVHI)
timeFrame: Visit 1(Day 0), visit 2(5 +/-1 weeks), visit 3(10 +/-1 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
References:
Clinical trial NCT02501655: Analysis of Deposition With Nebulizers Membrane
Official title: ANALYSIS OF DEPOSITION RADIOAEROSOL NEBULIZERS MEMBRANE IN HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Mesh nebulizers (MN) have lower residual volume and increased inhaled dose compared to jet nebulizers (JN) per in vitro and animal models. The aim of this study was to compare radioaerosol deposition using MN and JN in healthy subjects, using 2-D planar scintigraphy. METHODS: A randomized trial in 6 normal subjects (4 female, 2 male) inhaled 99mTc-DTPA with an activity of 1 mCi with the normal saline to a total dose of 4 mL with JN (Misty Max, Air Life, Yorba Linda, USA) oxygen flow of 8 L / min and 1.5 mL with MN (Aeroneb Solo with Ultra adapter; Aerogen Galway, Ireland). Scintigraphy was used to determine distribution of deposition and mass balance between compartments.


Eligibility criteria: Inclusion Criteria:

* The study inclusion critera was healthy adults of both sexes, between 18 to 65 years, without history of lung disease or smoking, with forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) greater or equal to 80% of predicted values (Pereira et al., 1992), ability to follow and retain verbal commands while able and willing to provide signed consent to participate in this study.

Exclusion Criteria:

* Participants were excluded if they have been diagnosed with a lung disease, current smoker, unable to understand and follow the procedures and pregnant or unable to tolerate nebulization.

Primary outcomes:
measure: radioaerosol deposition index into the lungs
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Hospital das Clínicas de Pernambuco
state: Pernambuco
Study officials:
affiliation: UFPE
name: Luciana Alcoforado
role: PRINCIPAL_INVESTIGATOR
References: