louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04237233: Intense Monitoring Study on Tyvyt
Official title: Intense Monitoring Study on Sintilimab Injection (Tyvyt®)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Relapsed or Refractory Classical Hodgkin's Lymphoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 300
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: The main study population is target indication patients treated with Tyvyt® within the territory of China. If any new indication is approved during the implementation of the project, and there are no special requirements for the approval, the new indication patients using Tyvyt® will also be included in the study.

Brief summary: The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria:

Patients must be able to understand and voluntarily sign the informed consent form (ICF).

Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up.

Patients must have agreed to use Tyvyt® to treat the target indication.

Exclusion Criteria:

Patients refuse to be included in the study or refuse to cooperate.

Patients have participated in another interventional studies within 4 weeks prior to enrollment.

Primary outcomes:
measure: Incidence of known adverse drug reactions
timeFrame: During the actual Tyvyt treatment time.
measure: Occurrence of new adverse drug reactions
timeFrame: During the actual Tyvyt treatment time.
measure: Association, risk factors, severity and incidence of immune-related adverse drug reactions/events
timeFrame: During the actual Tyvyt treatment time.
measure: Association, risk factors, severity and incidence of serious adverse drug reactions
timeFrame: During the actual Tyvyt treatment time.
measure: Occurrence of adverse drug reactions in special population
timeFrame: During the actual Tyvyt treatment time.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: During the actual Tyvyt treatment time.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT05000333: Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff and on Their Professional Activity.
Official title: The Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff of the Hospital of Villeneuve Saint Georges and on Their Professional Activity. (SST-Covid Impact)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Work-related Illness
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care population (medical and paramedical) practicing at the Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges, having been reached by the Covid-19 during the first wave, between February 1st and June 30th 2020.

Brief summary: The aim of this research is to identify the consequences of the Covid-19 on the physical and psychological health of the nursing staff of the Intercommunal Hospital of Villeneuve-Saint-Georges and on their professional activity thanks to a self-questionnaire.

This anonymous self-questionnaire is intended for all the CHIV care workers who were infected by the coronavirus during the first wave and identified by the occupational health service.

Detailed description: The covid-19 pandemic has had an important impact in the world, in France, it has put our health system under tension. We know that a health crisis of this magnitude can induce psychological and physical disorders, particularly in exposed caregivers.

Systematic occupational medicine consultations of all medical and paramedical personnel, whether tenured or not, working at the Villeneuve Saint Georges Hospital (CHIV) who presented a Covid-19 between February 1 and June 30, 2020, allowed us to note the presence of multiple after-effects.

The present study evaluates the consequences of the disease on the physical and psychological health of these caregivers and on their professional activity.

Eligibility criteria: Inclusion Criteria:

1. Major patient
2. Part of the medical and paramedical staff working at the CHIV,
3. Having been reached by Covid-19 during the first wave, between February 1st and June 30th 2020.
4. Patient affiliated to a social security system

Exclusion Criteria:

* None

Primary outcomes:
measure: Physical and psychological health
timeFrame: up to 1 month
Secondary outcomes:
measure: Recognized occupational diseases
timeFrame: up to 1 month
measure: Days of sick leave
timeFrame: up to 1 month
measure: Reclassifications
timeFrame: up to 1 month
measure: workstation adjustments
timeFrame: up to 1 month
measure: Repercussions on the professional activity
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Villeneuve-Saint-Georges
country: France
facility: Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges
state: IDF
Study officials:
References:
Clinical trial NCT02547233: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
Official title: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)

Primary outcomes:
measure: Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
timeFrame: At Week 8
Secondary outcomes:
measure: Percentage of Participants With Partial Clearance (Multiple Imputation)
timeFrame: At Week 8
measure: Percentage of Participants With Partial Clearance (Multiple Imputation)
timeFrame: At Week 4
measure: Percent Reduction in AK Count in the Treatment Area Compared to Baseline
timeFrame: At Week 8
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
Study officials:
affiliation: Altman Dermatology Associates
name: Michael Bukhalo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04442633: Glutamine With Topical Corticosteroids for Lichen Planus Treatment
Official title: Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Penis Planus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

Detailed description: Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and intestinal epithelial cells involved in collagen production. It promotes protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

The aim of this study is to evaluate the effect of Glutamine combined with topical corticosteroid in the treatment of oral erosive LP.

Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists of patients treated with topical steroids plus antifungal (conventional therapy); Group 2 consists of patients treated with Glutamine combined with topical steroids plus antifungal.

Eligibility criteria: Inclusion Criteria:

1. Patients clinically and histopathologically diagnosed to be suffering from EOLP.
2. Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.
3. Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire
4. Males and Females with an age ranging from 30-60years

Exclusion Criteria:

1. Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.
2. Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
3. Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Primary outcomes:
measure: Change in oral lichen planus lesions severity
timeFrame: at baseline, 1 months and 3 months
Secondary outcomes:
measure: Change in pain level
timeFrame: at baseline, 1 months and 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Study officials:
References:
Clinical trial NCT01134133: Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
Official title: Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Hospital Acquired Pneumonia in Gurgling Patients
Lead sponsor: Bridgeport Hospital
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hospital inpatients who have gurgling sounds heard during speech or breathing have been observed to have a higher risk of hospital acquired pneumonia. Patients who gurgle and who consent to participation will be randomized to receive routine clinical management or management to include measures employed to reduce risks of aspiration, namely, 1. head of bed up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding predicated on formal evaluation), 3. prompting managing physicians to reduce sedating medications to minimal effective dose.


Eligibility criteria: Inclusion Criteria:

* Gurglers who consent to participate

Exclusion Criteria:

* Non-gurglers
* Patients presenting with pneumonia prior to identification with gurgling
* Patients receiving comfort-care-only

Primary outcomes:
measure: Hospital acquired pneumonia
timeFrame: 14 days (average)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07007533: A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects
Official title: An Open-label, Randomized, Single-dose, Crossover Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Adult
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: This study will compare and evaluate the safety, tolerability and pharmacokinetics between DA-5223 and DA-5223-R in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Adult male or female, 19 years to 55 years
* Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate

Exclusion Criteria:

* The subjects with acute illness
* The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
* The subjects hypersensitive to any of the Investigational Product components or other drug components
* The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
* The subjects who are pregnant or lactating

Primary outcomes:
measure: AUC0-24h
timeFrame: 0~12 hours
measure: Cmax
timeFrame: 0~12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Global Clinical Trials Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00602433: Hormone Changes in Women With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Receiving Erlotinib
Official title: Evaluation of Hormonal Changes in Women on Erlotinib Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Nonsmall Cell Lung Cancer
Keywords: advanced nonsmall cell lung cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects have advanced nonsmall cell lung cancer and have been taking erlotinib as part of anticancer therapy for at least 3 months.

Brief summary: Studying samples of blood in the laboratory from patients receiving erlotinib may help doctors learn more about the effects of erlotinib on hormone levels.

This clinical trial is looking at hormone changes in women with stage IIIB or stage IV non-small cell lung cancer receiving erlotinib.

Detailed description: Patients undergo a dermatology evaluation and complete the Polycystic Ovarian Syndrome (PCOS) research study questionnaire once. Blood samples are collected after an overnight fast. Samples are analyzed for circulating levels of total and bioavailable testosterone, dehydroepiandrosterone sulfate, and sex hormone binding globulin. Serum luteinizing hormone, follicle stimulating hormone, fasting glucose, and insulin levels are also assessed.

Eligibility criteria: * Histologically confirmed non-small cell lung cancer

  * Stage IIIB (effusion) or stage IV disease
* Must be receiving daily erlotinib hydrochloride for more than 3 months
* Must have hirsutism, acne, androgenic alopecia, amenorrhea, truncal weight gain, or other clinical phenotype associated with syndrome of androgen excess

Primary outcomes:
measure: Presence of hyperandrogenemia
timeFrame: One approximate 30 minute visit
Secondary outcomes:
measure: Dermatologic manifestations
timeFrame: One approximate 30 minute visit
measure: Changes in body habitus and patterns of hair loss
timeFrame: One approximate 30 minute visit
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Northwestern Medical Faculty Foundation
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jyoti D. Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02457533: Case Management - Active Telephone Support to Patients With COLD
Official title: Active Support to Patient With COLD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COLD
Lead sponsor: Region Sjælland
Sponsor class: OTHER
Collaborators: name: Health Navigator, Sweden
First posted: 2015-05-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate the effects of patient counseling by telephone on Quality of Life and the use of Health care system.

Detailed description: By analyzing patient data, patients with risk of high consumption of the Health system are identified.

These patients are invited to take part in the study. If the patient accept the invitation, oral and written information of the study is given. If the patient give informed consent to participate, the inclusion and exclusion criteria and the patient record are examined.

If the patient meet the criteria the patient is randomized to active treatment or control 1:1.

Patient in the Intervention Group have a in depth interview of Health and social status and possible interventions are planned. Following that, the patient is contacted by telephone on weekly intervals for 6 to 9 months.

Patients in both Groups fill out questionaire Short-Form Health Survey-36 (SF-36) and COPD Assessment Test (COPD) and the consumption of Health care is monitored.

Eligibility criteria: Inclusion Criteria:

* Patient living in The Zealand Region.
* A COLD-related contact with hospital with-in 6 months.
* Predicted to be in high risk of new hospital admission.

Exclusion Criteria:

* Dementia.
* Psychosis.
* Drug-addiction.
* Cancer with metastasis.
* Terminal illness.
* Language difficulties demanding translator.

Primary outcomes:
measure: Quality of Life questionnaire SF-36 (Short-Form Health Survey)
timeFrame: Participants will be followed an expected avarage of 6 months
Secondary outcomes:
measure: Analysis of patients use of Health Care system
timeFrame: 1 year
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Regional Research
Study officials:
affiliation: Region of Zealand
name: Knud Rasmussen, MD DMSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03009487: A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
Official title: A Multi-center, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hyperlipidemias
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 265
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blind, phase III clinical trial to evaluate the efficacy and safety of Olmesartan/Amlodipine/Rosuvastatin combination treatment in patients with concomitant hypertension and hyperlipidemia


Eligibility criteria: Inclusion Criteria:

* Age 20 to 80 years
* patients with hypertension and hyperlipidemias

Exclusion Criteria:

* orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* uncontrolled diabetes mellitus

Primary outcomes:
measure: the change of sitSBP based on baseline between Treatment arm and control 1 arm
timeFrame: 8 weeks
measure: the change of LDL-C based on baseline between Treatment arm and control2 arm
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university bundang hospital
Study officials:
References:
Clinical trial NCT01076387: Randomized Trial Comparing Robotic and Open Radical Cystectomy
Official title: A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: Bladder
Cystectomy
Robotic
Open Radical
10-016
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 124
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Scheduled for radical cystectomy at MSKCC

Exclusion Criteria:

* Prior pelvic or abdominal radiation therapy;
* Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon
* Any clinical contraindication for Trendelenburg positioning

Primary outcomes:
measure: To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.
timeFrame: intraoperative and 90-day postoperative period
Secondary outcomes:
measure: To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.
timeFrame: 2 years
measure: Intra-operative performance (surgical time, blood loss)
timeFrame: time from anesthesia induction to final skin closure
measure: Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.
timeFrame: 1.5 years
measure: Bladder cancer recurrence (local, upper tract and distant disease)
timeFrame: 2 years
measure: complications grade 2-5
timeFrame: 2 years
measure: complication grade 3-5
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Vincent Laudone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8.