louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02332642: Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy
Official title: Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immuno-monitoring
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic melanoma patients (AJCC stage IV)

Brief summary: This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.


Eligibility criteria: Inclusion Criteria:

* histologically defined metastatic melanoma patients (AJCC stage IV)
* aged 18 to 80 years
* at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy

Exclusion Criteria:

* therapy-naive patients
* any contra-indications for (specific) systemic chemotherapy

Primary outcomes:
measure: Immuno-monitoring
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Christoffer Gebhardt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsmedizin Mannheim
name: Jochen Utikal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06153342: A Study of TL-925 for the Treatment of Allergic Conjunctivitis
Official title: A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2 Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Keywords: TL-925
Phase II
Lead sponsor: Telios Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-01
Enrollment: 70
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: In this prospective Phase 2, single-center, randomized, double-masked, placebo-controlled study, approximately 70 subjects with allergic conjunctivitis will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 years or older
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
* Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
* Calculated best-corrected visual activity of 0.7 LogMAR or better
* Positive bilateral CAC reaction

Exclusion Criteria:

* Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
* Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
* Any ongoing ocular infection (bacterial, viral or fungal)

Primary outcomes:
measure: Ocular itching
timeFrame: 3, 5 and 7 minutes after CAC
measure: Conjunctival redness
timeFrame: 7, 15 and 20 minutes after CAC
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT02856542: Real-life Evaluation of the Daivobet® Gel Applicator
Official title: Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: Psoriasis vulgaris, scalp, topical, applicator, device
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 1560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with psoriasis vulgaris affecting the scalp who are prescribed scalp treatment with Daivobet® gel Applicator.

Representativeness is ensured through random sampling of investigators to be invited to participate from a country wide list of dermatologists and general practitioners, with adjustment for regional distribution. Investigators include their first three patients meeting the study criteria.

Brief summary: This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator

Exclusion Criteria:

* Indication not within the approved labelling in France
* Contraindication for treatment with calcipotriol or betamethasone dipropionate
* Informed consent to participate in the study has not been obtained

Primary outcomes:
measure: Morisky Medication Adherence Scale-8
timeFrame: 2 weeks
measure: Morisky Medication Adherence Scale-8
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient opinion on Applicator usability
timeFrame: 4 weeks
measure: Patient overall satisfaction
timeFrame: 4 weeks
measure: Patient Global Impression of Improvement
timeFrame: 2 weeks
measure: Patient Global Impression of Improvement
timeFrame: 4 weeks
measure: Investigator's opinion on the properties of the Applicator
timeFrame: Baseline
Other outcomes:
Locations:
city: Charenton le Pont
country: France
facility: Cabinet de Dermatologie, Dr. Mathilde Kemula
Study officials:
affiliation: Cabinet de Dermatologie, Dr. Mathilde Kemula
name: Mathilde Kemula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Practice, 356 Rue de Charles de Gaulle, 91400 Orsay
name: Frederic Bonnier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint Joseph, 26 Boulevard de Louvain, Marseille
name: Nathalie Quiles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
Clinical trial NCT02716142: Rectal Misoprostol Versus Sublingual Misoprostol Prior to Myomectomy
Official title: Rectal Misoprostol Versus Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding During Myomectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of the study is To compare the effectiveness of rectally administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before myomectomy to decrease blood loss during and after the operation.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Primary outcomes:
measure: Mean amount of blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: Change of hemoglobin level
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05496842: Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation
Official title: Veränderungen ausgewählter Funktions- Und Teilhabebezogener Merkmale Bei Post-COVID-Patient*Innen in Folge Einer Pneumologischen Phase II Rehabilitation [Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-COVID-19
Lead sponsor: Pensionsversicherungsanstalt
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 779
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Regular patients with post-COVID-19 Syndrome in inpatient rehabilitation.

Brief summary: The aim of this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Subsequently, the extent to which selected function- and participation-related parameters change following a pneumological phase II rehabilitation in this group of patients is investigated. Furthermore, the extent of these possible changes will be compared between post-COVID patients who received respiratory muscle training and post-COVID patients who did not receive respiratory muscle training. Patients were not randomized but assigned to conditions based on medical criteria (e.g., initial respiratory muscle strength).

The present project provides insight into participation- and function-related characteristics of a relatively new patient population, enables the observation of changes in these following pneumological phase II rehabilitation and provides differentiated insights into the course of health-related parameters for specific subgroups (respiratory muscle training vs. no respiratory muscle training).


Eligibility criteria: Inclusion Criteria:

The study participants were regular patients in a rehabilitation centre. The data basis consists of secondary data collected during routine operation.

Exclusion Criteria:

-

Primary outcomes:
measure: 6-minute walk test
timeFrame: 3 weeks of inpatient rehabilitation
measure: European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)
timeFrame: 3 weeks of inpatient rehabilitation
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: 3 weeks of inpatient rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Weyer
country: Austria
facility: Rehabilitationszentrum Weyer
state: Upper Austria
Study officials:
affiliation: Pensionsversicherungsanstalt
name: David Felder, Mag.
role: STUDY_CHAIR
References:
Clinical trial NCT04313842: A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED
Official title: A Clinical Study to Explore the Feasibility of AVATAMED in Predicting the Cilnical Response to Temozolomide in Glioblastoma Patients, a Single-center, Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: among histologically confirmed glioblastoma patients, patients with samples which passed the QC screening process of in vitro drug screening experiment will be finally enrolled.

Brief summary: This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.

Detailed description: Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled.

Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.

Eligibility criteria: Inclusion Criteria:

1. written informed consent
2. histologically confirmed glioblastoma patients who will take TMZ treatment
3. KPS \>70
4. adequte end-organ function
5. prior major surgery \> 4 weeks (prior minor surgery \> 1weeks)
6. prior standard concurrent chemo-radiation therapy \> 4 weeks
7. prior radiation therapy (including stereotactic radiosurgery) \> 12 weeks

Exclusion Criteria:

1. contraindication to TMZ
2. prior anti-cancer therapy except standard of care (\*standard of care includes surgery, Stupp regimen, and radiotherapy)
3. uncontrolled systemic medical illness
4. pregnancy

Primary outcomes:
measure: 6 month PFS rate
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Professor
name: Doo-sik Kong, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02991742: Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients (IDPC Trial)
Official title: Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients After Diagnostic and Therapeutic Cardiac Catheterization (IDPC Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Failure
Keywords: nephropathy
catheterization
contrast media
ioxaglate
iodixanol
high risk
prevention
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 2262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary angiography or percutaneous interventions will be eligible for the trial if they have at least 1 risk factor for contrast-induced acute kidney injury

Brief summary: Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.

Detailed description: Contrast-induced acute kidney injury represents a serious complication of procedures requiring administration of iodinated contrast media and is associated with the need for dialysis, prolonged hospitalization, increased costs, and mortality.

Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than low-osmolar contrast media in high-risk patients.

The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients between 48 and 96 hours after procedures that use contrast.

Eligibility criteria: Inclusion Criteria:

At least one of the following criteria

* Aged more than 70 years-old
* Chronic renal failure
* Diabetes mellitus
* Congestive heart failure - left ventricular ejection fraction \< 0.50
* Shock or intra-aortic ballon pump use
* Urgency or emergency procedures

Exclusion Criteria:

* Patients in dialysis
* Allergy to iodine
* Patient refusal to informed consent

Primary outcomes:
measure: Contrast-induced nephropathy incidence
timeFrame: Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization
Secondary outcomes:
measure: Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization
timeFrame: 30 days
measure: The individual components of the combined outcome (total mortality or dialysis indication)
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03195842: Audio-Recorded Discharge Instructions for LEP Parents
Official title: Impact of Audio-Recorded Discharge Instructions on Confidence and Comprehension Among Limited English Proficient Parents: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Limited English Proficiency
Disparities
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 83
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this pilot study, limited English proficient (LEP) parents of children at Seattle Children's Hospital for day surgery will be randomized to usual discharge care or usual discharge plus language-concordant, audio-recorded instructions via recordable card. these cards are similar to recordable greeting cards, and can record up to 180 seconds of information. They can be played back over 100 times. We will follow-up with families 2-7 days later to assess satisfaction and comprehension of discharge instructions.


Eligibility criteria: Inclusion Criteria:

* Limited English proficient (LEP) parents of day surgery patients at Seattle Children's Hospital (main campus) who prefer one of the following languages for care: Spanish, Somali, Russian, Ukrainian, Vietnamese, Mandarin, or Cantonese. Eligible parents are those receiving condition-specific discharge instructions about one or more of the following: a new medication, wound care, diet advancement, return precautions, or more than 1 follow-up appointment

Exclusion Criteria:

* Child being kept overnight at hospital following surgery

Primary outcomes:
measure: Comprehension of discharge instructions
timeFrame: 2-7 days after discharge
Secondary outcomes:
measure: Confidence in caring for the child post-discharge
timeFrame: 2-7 days after discharge
measure: Satisfaction with card
timeFrame: 2-7 days after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05849142: Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
Official title: Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Oropharynx Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 0
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: The purpose of this research is to determine whether it is feasible to treat patients with Human Papilloma Virus positive (HPV-positive) oropharyngeal tumors on a specialized treatment machine (MRIdian linear accelerator \[Linac\]), which utilizes magnetic resonance imaging (MRI) for radiation planning and delivery.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed new diagnosis of HPV-positive OPC \[i.e. Base of tongue, tonsil, soft palate, vallecula, and posterior pharyngeal wall\]
* American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
* Members of all races and ethnic backgrounds
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
* Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.

Exclusion Criteria:

* Prior surgery, chemotherapy, or radiation treatment for head and neck cancer
* Prior history of cancer other than non-melanomatous skin cancer
* Distant metastases (cM1) or (pM1) disease)
* Evidence of a compromised airway
* Medical contraindications to MRIs
* Unable to tolerate MRIs without sedation
* Pregnant patients
* Breastfeeding patients
* Eastern Cooperative Oncology Group (ECOG) performance status \>1

Primary outcomes:
measure: Percent difference between initial reference plan and adaptive weekly RT plan
timeFrame: Up to 6 months
measure: Evaluation of deformable imaging registration
timeFrame: Up to 6 months
Secondary outcomes:
measure: Treatment times recorded in minutes
timeFrame: Up to 6 months
measure: Patient-reported Quality of Life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30)
timeFrame: Up to 1 year
measure: Patient-reported Quality of Life as measured by the European Organization for Research and Treatment Head & Neck 43
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: The University of Miami Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Stuart Samuels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: