louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04728113: Early Integration of Supportive Care for Metastatic Uveal Melanoma Patients (EarlyTogether)
Official title: Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveal Melanoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM.

Supportive care in patients with metastatic Uveal Melanoma (UM)

Detailed description: Before the start of the study, medical oncologists and supportive care physicians from both the sites will attend Communication Skills Training (CST) workshops provided by an expert team in the field. The training sessions will focus on practicing the required communication skills needed in consultations.

The randomization will assign patients, with a 1:2 ratio, to "Introduction of supportive care when medically needed" (Arm A: Control Group) or "Initial concomitant management by the oncologist and the supportive care team" (Arm B: Early Together Group).

Selected and validated questionnaires will be filled at baseline, 6 and 12 months by the patients before the consultation, in the 2 groups.

Eligibility criteria: Inclusion Criteria:

1. adult patients with metastatic UM;
2. no surgery or loco-regional treatment of metastases in a curative intent;
3. systemic treatment planned or started since less than 2 months;
4. ECOG PS 0-1;
5. no uncontrolled symptoms;
6. liver function tests in normal range or ≤ grade 2;
7. signed informed consent;
8. able to fill the questionnaires.

Exclusion Criteria:

1. patient\<18 years old;
2. patient condition requiring supportive care before any systemic specific treatment for metastases;
3. acute psychopathological disorder incompatible with the study;
4. prior medical condition incompatible with the study.

Primary outcomes:
measure: 34 items - Supportive Care Needs Survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: PIPERNO NEUMAN Sophie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650813: Adapting the FACETS Program to Sickle Cell Disease
Official title: Adapting the FACETS Fatigue Management Program to Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue Symptom
Sickle Cell Disease
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
name: University Grenoble Alps
name: Paris Nanterre University
First posted: 2024-10-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Adaptation of a fatigue management program combining the principles of cognitive-behavioral therapy and energy conservation strategies (FACETS program) for a population of adult patients with sickle cell disease (Drépa-FACETS program).


Eligibility criteria: Inclusion Criteria:

* Participant having freely given his oral agreement.
* Participant with a major sickle cell syndrome, regardless of genotype (e.g. SS, SC, Sbeta).
* Participant with a sufficient command of spoken and written French to take the assessments, complete the questionnaires, follow the program sessions and carry out the home exercises.

Exclusion Criteria:

* Participant with one or more severe psychiatric pathologies (e.g. severe depression, psychosis) that could interfere with the conduct of the study, in particular the primary and secondary endpoints.
* Participants with another chronic pathology causing fatigue.
* Participants in vaso-occlusive crisis (VOC) or hospitalization.
* Participant under legal protection (guardianship, curatorship, safeguard of justice, deprived of liberty).

Primary outcomes:
measure: Feasibility of the FACETS program for adult sickle-cell patients
timeFrame: From the enrollment to the end of the protocol visits (10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Paris Nanterre University
name: Marie-Claire GAY, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00249613: Gender-Responsive Treatment for Women Offenders - 1
Official title: Gender-Responsive Treatment for Women Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse Problem
Keywords: gender-responsive substance abuse treatment
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 291
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether substance abuse treatment designed specifically for drug-dependent women offenders provides better outcomes than standard drug court treatment (mixed-gender programs).

Detailed description: In this five-year study, a total of 300 women entering court-referred treatment throughout Los Angeles County and who agree to participate in the study will be randomly assigned to a women-focused or to a mixed-gender outpatient treatment program. The study will assess the impact of women-focused substance abuse treatment using outcome measures including recidivism, substance abuse and relapse, and social adjustment (e.g., employment, parenting behaviors, psychological improvement, and HIV risk reduction behaviors), compared to the impact of traditional mixed-gender programs. Assessments will occur at baseline and at 1 month, 12 months, and 24 months after admission.

Eligibility criteria: Inclusion Criteria:

* Drug court participant
* At least eighteen (18) years old
* Have had no more than three prior non-violent, non-drug felony convictions
* Do not have a current charge of driving under the influence of alcohol or drugs or a charge of sale or transportation of drugs

Exclusion Criteria:

* Not capable of giving informed consent

Primary outcomes:
measure: Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment
timeFrame: baseline and 1-year follow-up
measure: Predictors of Criminal Activity at 12 Months Post Intake
timeFrame: 12 Months
measure: Any Substance Use Past 30 Days
timeFrame: 12 Months
Secondary outcomes:
measure: Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model
timeFrame: 12 month post intake
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michael Prendergast, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prendergast ML, Messina NP, Hall EA, Warda US. The relative effectiveness of women-only and mixed-gender treatment for substance-abusing women. J Subst Abuse Treat. 2011 Jun;40(4):336-48. doi: 10.1016/j.jsat.2010.12.001. Epub 2011 Feb 11.
Clinical trial NCT03289013: Assessement of the Peal Force Needed to Peel New Adhesives From the Skin
Official title: A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study investigates the adhesion of new adhesives to the skin.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the investigation

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have dermatological problems in the abdominal area (assessed by investigator)

Primary outcomes:
measure: Swelling of the adhesive
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of preclinical department
name: Lene Feldskov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00286013: Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
Official title: Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced and Unresectable, But Non-metastatic Pancreatic Adenocarcinoma or Cholangiocarcinoma
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma


Eligibility criteria: Inclusion Criteria:

* Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease
* WHO performance status of 0 or 1
* Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed
* Maximum delay after surgery: 8 weeks
* No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ
* Adequate bon marrow reserve
* No previous chemotherapy or radiotherapy
* Expected survival \> 6 months

Exclusion Criteria:

* Active infection
* Metastatic disease
* Inadequate liver function after derivative surgery
* Inadequate renal function
* Pregnancy, breast feeding
* Use of any other investigational agent in the month before enrollment
* Patients with grade 2 or more neuropathy

Primary outcomes:
measure: Feasibility
measure: Tolerance
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
city: Brussels
country: Belgium
facility: Jules Bordet Institute
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Luik
country: Belgium
facility: CHU Sart-Tilman
Study officials:
affiliation: University Hospital, Ghent
name: Marc Peeters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02810613: Leiden University Medical Center Mini Donor Bank
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malaria
Schistosoma Mansoni
Schistosoma Haematobium
Diabetes
Asthma
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy human volunteers

Brief summary: (Bio)medical research, particularly immunological, metabolic, transcriptional or biological assays, occasionally require the use of fresh blood (peripheral mononuclear cells) or urine. In order to comply with international guidelines for Good Clinical Practice, the investigators propose to establish a Mini Donor Bank to be able to obtain fresh blood or urine from voluntary donors. Recruitment of volunteers will be a continuous process. Volunteers will consent to occasional blood- or urine donation.


Eligibility criteria: Inclusion Criteria:

1. Subject is aged ≥ 18 and ≤ 65 years and in good health.
2. Subject has adequate understanding of the procedures of the study.
3. Subject is able to communicate well with the investigator.
4. Subject has signed informed consent.
5. Subject refrains from donation to the Sanquin blood bank.

Exclusion Criteria:

1. Previous vasovagal collapse during venepuncture.
2. For female participants: pregnancy or lactation.
3. Presence of any chronic systemic condition, which could compromise the health of the volunteer when performing venepuncture or interfere with the interpretation of immunological or metabolic test results.
4. Chronic use of immunosuppressive drugs.
5. Total blood volume donated exceeding \>500 mL in the past 4 months.

Primary outcomes:
measure: A collection of samples for the purpose of (bio)medical laboratory assays including immunological, metabolic, transcriptional or biological analyses.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06975813: Magnesium Sulfate and Trigger Points
Official title: Efficacy of Isolated Masseter Versus Masseter- Sternocleidomastoid Trigger Points Injection by Magnesium Sulfate for Myofacial Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Myofascial Pain Syndrome
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 30
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 patients will be randomly assigned to one of the two groups according to the treatment method: group I (masseter group) and group II (masseter \&sternocleidomastoid group) where each patient will be injected 0.5ml in each trigger point (TrPs) of magnesium sulphate according to the treatment group by the same operator. The treatment method for TrPs will be the primary predictor variable. Patients will be examined at the following intervals: during diagnosis, 1-month, 3-months, and 6-months post-injection. The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever


Eligibility criteria: Inclusion Criteria:

* definite diagnosis of myofascial pain
* presence of one or more unilateral or bilateral trigger points in the masseter muscle and sternocleidomastoid muscle;
* no history of any invasive procedures of the related masseter muscle.

Exclusion Criteria:

* any painful conditions (other than myofascial trigger points) affecting the orofacial region
* any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy);
* pregnancy and lactation

Primary outcomes:
measure: muscle pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05508113: Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder
Official title: Effects of Ozone Autohemotherapy on Patients With Post-ischemic Stroke Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-ischemic Stroke Insomnia
Keywords: Ischemic stroke
Insomnia
Ozone Autohemotherapy
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to observe the efficacy and safety of ozonated autohemotherapy in patients of post-ischemic stroke insomnia and to explore its mechanism of action.


Eligibility criteria: Inclusion Criteria:

* meet the diagnostic criteria for ischemic stroke; Insomnia quality index (ISI) score \> 7 points

Exclusion Criteria:

* acute ischemic stroke; associated with failure of important organs or malignant tumor; patients with worsening condition, new cerebral infarction or secondary cerebral hemorrhage; with comprehension or cognitive impairment, unable to fully understand the scale and unable to cooperate with treatment

Primary outcomes:
measure: Insomnia severity index
timeFrame: 2 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 2 weeks
Secondary outcomes:
measure: brain-derived neurotrophic factor (BDNF)
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Sekerdag E, Solaroglu I, Gursoy-Ozdemir Y. Cell Death Mechanisms in Stroke and Novel Molecular and Cellular Treatment Options. Curr Neuropharmacol. 2018;16(9):1396-1415. doi: 10.2174/1570159X16666180302115544.
citation: Masan J, Sramka M, Rabarova D. The possibilities of using the effects of ozone therapy in neurology. Neuro Endocrinol Lett. 2021 Mar;42(1):13-21.
citation: Kadir K, Syam Y, Yusuf S, Zainuddin M. Ozone Therapy on Reduction of Bacterial Colonies and Acceleration of Diabetic Foot Ulcer Healing. Home Healthc Now. 2020 Jul/Aug;38(4):215-220. doi: 10.1097/NHH.0000000000000889.
citation: Martinez-Sanchez G, Delgado-Roche L, Diaz-Batista A, Perez-Davison G, Re L. Effects of ozone therapy on haemostatic and oxidative stress index in coronary artery disease. Eur J Pharmacol. 2012 Sep 15;691(1-3):156-62. doi: 10.1016/j.ejphar.2012.07.010. Epub 2012 Jul 13.
Clinical trial NCT01155713: Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors
Official title: A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
Cancer
Tumors
Keywords: Neoplasms
Cancer
Tumors
Administration, oral
Capsules
CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258,
Bioavailability,
Food
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.


Eligibility criteria: Inclusion Criteria:

* Patients with an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists
* World Health Organization (WHO) performance status ≤ 2
* Patient must meet protocol-specified laboratory values

Exclusion Criteria:

* Patients with brain cancer
* Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Patients who have not recovered from previous anti-cancer therapies
* Female patients who are pregnant, breast feeding, or not willing to use an effective method of birth control

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules)
timeFrame: relative bioavailability (9 days)
measure: Determine the effect of food on the bioavailability of TKI258
timeFrame: food effect (22 days)
Secondary outcomes:
measure: Characterize the safety and tolerability of TKI258, including acute and chronic toxicities.
timeFrame: Up to 28 days after the last dose of study drug
measure: Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors.
timeFrame: Every 8 weeks until progression of disease
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
state: Arizona
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute Sarah Cannon Research Instit
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06186713: Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function
Official title: Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function (STIMULATE): A Single-center, Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Pulmonary Hypertension
Keywords: Acute Myocardial Infarction
Pulmonary Hypertension
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 4784
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study included patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.

Brief summary: Pulmonary hypertension (PH) has a negative effect on acute myocardial infarction (AMI) patients and appears to be closely associated with reduced left ventricular function. However, its impact on AMI patients with reduced left ventricular function remains unclear. This retrospective study included AMI patients with reduced left ventricular function to investigate the prognostic value of PH in this specific type of patient. Meanwhile, a nomogram would be established basing on the identified independent risk factors, hoping to provide a novel risk stratification for them.


Eligibility criteria: Inclusion Criteria:

* The patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.

Exclusion Criteria:

* Myocardial infarction complicated by cardiac rupture.
* Significant pre-existing heart failure.
* Other comorbidities such as malignancy that may significantly affect prognosis.
* Incomplete clinical data.

Primary outcomes:
measure: The incidence of all-cause death
timeFrame: 1-year after the AMI.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: