louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02027090: High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease
Official title: High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology);
* Pretreated with at least 1 platinum-based chemotherapy;
* No previous targeted treatment such as gefitinib, erlotinib;
* With a measurable disease(longest diameters \>=10mm with Spiral computed tomography (CT)and \>=20mm with conventional CT) according to RECIST Criteria;
* WHO performance status(PS)\<= 2;
* Adequate organ functions;
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib;
* Patients with metastatic brain tumors with symptoms;
* Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab;
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 months
Secondary outcomes:
measure: Overall survival
timeFrame: 18 months
measure: Response rate assessed using the RECIST criteria
timeFrame: 2 months
measure: The number of patients who suffered adverse events
timeFrame: 30 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Shun Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010490: Outcomes of Phacoemulsification With Torsional Ultrasound
Official title: A Randomised Trial of Torsional Ultrasound Versus Longitudinal Ultrasound During Phacoemulsification of Age-related Cataracts: Comparison of Intra-operative Performance and Impact on Post-operative Endothelium Integrity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: PACHYMETRY
CELL LOSS
SAFETY
EFFICACY
PHACOEMULSIFICATION
Intraoperative complications
CLOCK TIME
FLUID USED
CORNEAL THICKNESS
ENDOTHELIUM CELL LOSS
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2009-11-10
Enrollment: 360
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery and at post-operative day 1, 1 month and 3 months.

Detailed description: Introduced in mid 2006, torsional ultrasound (OZil, Infiniti Vision System, Alcon Laboratories, Texas, USA) uses rotational oscillations at ultrasonic frequencies to emulsify cataractous lens material in a seamless cutting motion from a tip that oscillates laterally. The side-to-side movement of the phaco tip produces minimal repulsion of lens material from the phaco tip resulting in improved followability. Clinically this translates into more effective lens removal with torsional phaco in comparison to the conventional ultrasound mode.to test this in a clinical scenario we undertook this study.

Eligibility criteria: Inclusion Criteria:

* patients 55 years and older with a senile cataract grades 1 to 5 nuclear sclerosis based on Emery's classification,
* endothelial cell density \> 1500 cells/mm2,
* anterior chamber depth \> 2.4 mm, and
* a dilated pupil \> 7 mm.

Exclusion Criteria:

* eyes with pseudoexfoliation,
* mature, traumatic, or complicated cataracts,
* history of previous intra-ocular surgery, glaucoma, uveitis, and
* patients who were unable to comply with follow-up examinations.

Primary outcomes:
measure: Intra-operative complications, surgical clock time in minutes (SCT), fluid volume in ml(FV), and central corneal thickness in µm (CCT) on day 1 and months 1 and 3, and endothelial cell density (ECD) at 3 months.
timeFrame: 3 months post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Raghudeep eye clinic
state: Gujarat
Study officials:
affiliation: Iladevi Cataract and IOL Research Center
name: shetal m raj, ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu Y, Zeng M, Liu X, Luo L, Yuan Z, Xia Y, Zeng Y. Torsional mode versus conventional ultrasound mode phacoemulsification: randomized comparative clinical study. J Cataract Refract Surg. 2007 Feb;33(2):287-92. doi: 10.1016/j.jcrs.2006.10.044.
Clinical trial NCT03173690: Medicines Reconciliation at an Intensive Care Unit
Official title: Medicines Reconciliation at an Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medicines Reconciliation
Intensive Care Unit
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Hospital Pharmacy Enterprise, South Eastern Norway
First posted: 2017-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The included patients are randomized to either intervention or control group. The intervention group receives medicines reconciliation at the intensive care unit. The control group receive standard pharmaceutical care, which now does not include medicines reconciliation. After the patients are transferred to care at the ward, medicines reconciliation is performed for all patients.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the effect of performing medicines reconciliation on patients admitted to an intensive care unit. Half of the patients will receive a medicines reconciliation at the intensive care unit. The other half will not. All included patients will receive medicines reconciliation after transfer to the ward.

Detailed description: Transfer of patients from one level of care to another is known to increase the risk of medication errors. Medication reconciliation is an accepted intervention to increase the knowledge on the patients medication use, thus reducing the risk of avoidable medication errors. For patients in the intensive care unit treatment of the imminent threat is obviously the most important. Nevertheless, knowledge about previous medications are important.

Eligibility criteria: Inclusion Criteria:

* belonging to the hospitals intake area
* written informed concent by the patient or his/her next to kin

Exclusion Criteria:

* Patients without next to kin
* Not Norwegian speaking, in need of a translator
* medication reconciliation performed earlier
* Patients with Guillain-Barre or Myasthenia Gravis, due to long expectancy of stay
* Short life expectancy, decided in cooperation with the physician

Primary outcomes:
measure: Number of patients with at least one discrepancy between medications listed on hospital chart and medications used at home before hospital admittance
timeFrame: Medicines reconciliation is performed at randomisation and within 48 hours after transmission to the ward, assessed up to 28 days after randomisation
Secondary outcomes:
measure: Retrospective evaluation on the clinical relevance of the observed medical discrepancies
timeFrame: Retrospectively, based on the information gathered from the day of randomisation up until 28 days after randomisation
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus university Hospital
state: Akershus
Study officials:
affiliation: Hospital Pharmacy Enterprise, South Eastern Norway
name: Silje E Oernes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05941390: Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures
Official title: Using Virtual Reality (VR) Technology in Gynecological Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Virtual Reality
Anxiety
Pain
Lead sponsor: Assuta Ashdod Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.

After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.

Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.


Eligibility criteria: Inclusion Criteria:

* ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
* amniocintesis -single tone,gestional age 16-24 week,
* hysteroscopy-women age 18-60 , diagnostic procedure,

Exclusion Criteria:

* ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
* amniocintesis- Known fetal malformations, amnionitis
* hysteroscopy-pregnancy, PID

Primary outcomes:
measure: stress cortisol saliva level
timeFrame: up to 5 minutes after the procedure
Secondary outcomes:
measure: pain levels
timeFrame: up to 5 minutes after
measure: anxiety levels
timeFrame: up to 5 minutes after
Other outcomes:
Locations:
Study officials:
affiliation: Assuta Ashdod
name: Noa glick fishman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koyyalamudi V, Sidhu G, Cornett EM, Nguyen V, Labrie-Brown C, Fox CJ, Kaye AD. New Labor Pain Treatment Options. Curr Pain Headache Rep. 2016 Feb;20(2):11. doi: 10.1007/s11916-016-0543-2.
citation: Woolf CJ. What is this thing called pain? J Clin Invest. 2010 Nov;120(11):3742-4. doi: 10.1172/JCI45178. Epub 2010 Nov 1.
citation: Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.
citation: Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021 Aug;38(S 01):e167-e172. doi: 10.1055/s-0040-1708851. Epub 2020 Jun 2.
Clinical trial NCT05678764: Evaluation of a Conversational Information Collection Tool to Access Talk Therapy
Official title: Evaluation of a Conversational Information Collection Tool to Access Talk Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health Issue
Lead sponsor: Limbic Limited
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 300000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who refer to the talk therapy services that use the conversational information collection tool.

Brief summary: This is an observational study evaluating a conversational information collection tool to access talk therapy.

The patient outcome data will be compared between people who refer to talk therapy via the conversational information collection tool and people who refer using other means.


Eligibility criteria: Inclusion Criteria:

* Participant meets minimum age requirements for the talk therapy service Participant's registered GP is within the talk therapy service's CCG catchment area

Exclusion Criteria:

* Participants who are in crisis (defined by requiring urgent care or being at an urgent risk of harm)

Primary outcomes:
measure: Change from baseline depression score to after treatment
timeFrame: The definition of reliable and clinically significant improvement is based on a comparison of pre-treatment (at time of referral, on the day of consenting) and post-treatment (assessed at point of discharge, an average of 5 months) clinical score.
measure: Change from baseline anxiety score to after treatment
timeFrame: The definition of reliable and clinically significant improvement is based on a comparison of pre-treatment (at time of referral, on the day of consenting) and post-treatment (assessed at point of discharge, an average of 5 months) clinical score
measure: Clinical assessment times
timeFrame: This measure will be available after the clinical assessment (up to average of 1 month from consenting).
Secondary outcomes:
measure: Waiting times
timeFrame: This measure will be available after the clinical assessment (up to average of 1 month from consenting).
measure: Referral Dropout Rates
timeFrame: During Information Collection Tool interaction (day 1)
measure: Assessment Dropout Rates
timeFrame: At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)
measure: Treatment Dropout Rates
timeFrame: At time point of treatment termination using standard IAPT definitions (assessed up to 3 months)
Other outcomes:
Locations:
city: Epping
country: United Kingdom
facility: Essex Partnership University NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03688490: Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms
Official title: Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Disorder
Keywords: aquagenic pruritus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for myeloproliferative neoplasms in our Institution (Brest University Hospital)

Brief summary: Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.

Detailed description: Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.

Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus.

Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

Eligibility criteria: Inclusion Criteria:

* patients followed with myeloproliferative neoplasms
* suffering from aquagenic pruritus

Exclusion Criteria:

* Unable to fulfil the questionnaire
* No written informed consent

Primary outcomes:
measure: Intensity of the pruritus
timeFrame: 15 days
Secondary outcomes:
measure: Duration of the pruritus
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Hématologie Clinique-Institut de Cancéro-Hématologie
name: IANOTTO Jean-Christophe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carre JL, Misery L, Ianotto JC. Clinical characteristics of aquagenic pruritus in patients with myeloproliferative neoplasms. Br J Dermatol. 2017 Jan;176(1):255-258. doi: 10.1111/bjd.14809. Epub 2016 Dec 22. No abstract available.
Clinical trial NCT06561490: Placental Thickness And Volume Nomogram In Normal Singleton Pregnancies Between 11th And 18th Week Gestational Age
Official title: Placental Thickness And Volume Nomogram In Normal Singleton Pregnancies Between 11th And 18th Week Gestational Age
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Placental Volume
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse

Brief summary: Measurement of placental thickness and volume has a great importance in predicting adverse outcome specially in combination with other markers.

In order to determine abnormalities in placental thickness and volume, we should have a normal range of values and this can be achieved by a nomogram


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse

Exclusion Criteria:

* Maternal Diseases Fetal anomalies Placenta previa, placental anomalies and poor visualization of the placenta Multiple pregnancies Unreliable gestational age

Primary outcomes:
measure: placental thickness
timeFrame: 6 months
measure: placental volume
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Karthikeyan T, Subramaniam RK, Johnson W, Prabhu K. Placental thickness & its correlation to gestational age & foetal growth parameters- a cross sectional ultrasonographic study. J Clin Diagn Res. 2012 Dec;6(10):1732-5. doi: 10.7860/JCDR/2012/4867.2652. Epub 2012 Dec 15.
citation: Wolfson RN, Zador IE, Halvorsen P, Andrews B, Sokol RJ. Biparietal diameter in premature rupture of membranes: errors in estimating gestational age. J Clin Ultrasound. 1983 Sep;11(7):371-4. doi: 10.1002/jcu.1870110705.
Clinical trial NCT00225290: Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
Official title: Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: Phase III
Hepatocellular Carcinoma
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 230
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.


Eligibility criteria: Inclusion Criteria:

1. Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
2. The diagnosis of HCC should be established either by cyto/histology
3. Patients must be \> 20 years of age.
4. ECOG score \< 2.
5. Signed informed consent.
6. Female patients at child-bearing age must have negative pregnancy test.

Exclusion Criteria:

1. Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
2. Patients with advanced second primary malignancy are not eligible.
3. Patients with active infection are not eligible.
4. Patients with pregnancy or breast-feeding are not eligible.
5. Patients with brain metastases are not eligible.

Primary outcomes:
measure: overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taiwan Cooperative Oncology Group
Study officials:
affiliation: Division of Cancer Research, National Health Research Institute Ward 191
name: Li-Tzong Chen, M.D Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305290: Upper GI Outcomes Following EMR
Official title: Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoma, Villous
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have Upper Gastrointestinal Tract adenomas which are amendable to Endoscopic Mucosal Resection

Brief summary: The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER) of superficial lesions of the Upper Gastrointestinal Tract(UGIT)

Detailed description: Endoscopic resection (ER) of superficial lesions of the upper gastrointestinal tract is a safe and effective surgery-sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the UGIT.

Eligibility criteria: Inclusion Criteria:

* UGIT lesion \> 10mm
* Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
* Aged 18 years or older

Exclusion Criteria:

* Lesion less than 10mm
* Gastric lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
* Aged younger than 18 years

Primary outcomes:
measure: Observed procedural data
timeFrame: 14 days
Secondary outcomes:
measure: Analysis of the costs of this procedure compared to previous treatments
timeFrame: 14 days
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Endoscopy Unit
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael J Bourke, MBBS
role: PRINCIPAL_INVESTIGATOR
References: