louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00653107: Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only
Official title: Palliation of Dysphagia in Patients With Advanced Cancer of the Oesophagus by Comparing Stent Followed by 3 Courses of Brachytherapy With 3 Courses of Brachytherapy Only. A Randomised Phase III Study (PACO)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Esophageal Neoplasm
Keywords: Palliation
Cancer oesophagus
Stent
Brachytherapy
Randomized
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
name: Norwegian Foundation for Health and Rehabilitation
First posted: 2008-04-04
Enrollment: 41
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: We wish to improve the swallowing function of patients with advanced cancer of the oesophagus, by carrying out a randomised clinical study in which we compare primary stenting followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3.

The aim of the study is to investigate whether patients who receive a stent followed by brachytherapy have a better swallowing function without more pain at week +2,compared to patients who receive brachytherapy alone.


Eligibility criteria: Inclusion Criteria:

Patients must fulfill all the following criteria:

1. Histologically or cytologically verified carcinoma of the oesophagus
2. Reduced ability to swallow solid food, minimum grade 1 (see page 16)
3. Age ≥ 18 years
4. Ability to understand and answer (with or without help) the study questionnaires
5. Written informed consent received
6. A Completed questionnaire received from the patient
7. One of the following criteria must be fulfilled:

   1. Advanced disease and WHO performance status ≥2
   2. Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
   3. Advanced disease and WHO performance status 0-1 and patient's preference
   4. Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
   5. Local disease and WHO performance status ≥2 and patient's preference

Exclusion Criteria:

1. Oesophageal stent already inserted
2. Endoscopic procedures not tolerated
3. Cannot have (additional) radiation therapy
4. Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)

Primary outcomes:
measure: Dysphagia measured with the dysphagia grading scale at week +2 after start of treatment. Pain at rest measured with ESAS at week +2 after start of treatment.
timeFrame: 8 years
Secondary outcomes:
measure: Health related quality of life
timeFrame: 8 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Radiumhospitalet
Study officials:
affiliation: Radiumhospitalet. Rikshospitalet HF
name: Kristin Bjordal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00547807: Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: Randomised Controlled Trial
Official title: Non-Nutritive Sucking and Swaddling for Pain Relief in Term Neonates: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Pain, neonate, nursing care
Lead sponsor: Sociedade Hospital Samaritano
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non pharmacological approaches are important in pain control in neonates, specially in term healthy neonates. Non-nutritive sucking and swaddling are considered effective strategies for pain control in these population, but the effect in their association are not clear until now. The hypothesis of the study is that association between non-nutritive sucking and swaddling reduces pain scores resulting from venepuncture compared to non-nutritive sucking alone.


Eligibility criteria: Inclusion Criteria:

* Term healthy neonates

Exclusion Criteria:

* NICU admission

Primary outcomes:
measure: pain score
timeFrame: pre painfull procedure
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sociedade Hospital Samaritano
state: SP
Study officials:
affiliation: Sociedade Hospital Samaritano
name: Mariana Bueno, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: Sociedade Hospital Samaritano
name: Edna A Bussotti, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Sociedade Hospital Samaritano
name: Andréia Silva, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01106807: Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne
Official title: Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.


Eligibility criteria: Inclusion Criteria:

* subject has a clinical diagnosis of acne vulgaris with facial involvement
* the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria:

* subject has a severe acne form or secondary acne form
* the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
* the subject has a known allergy or sensitivity to any of the components of the study products
* subject is not willing to respect wash-out periods for topical and/or systemic treatments

Primary outcomes:
measure: Total acne lesion count
timeFrame: 6 weeks
measure: Percent change of acne lesion count
timeFrame: 6 weeks
Secondary outcomes:
measure: Lesion counts- Inflammatory
timeFrame: 6 weeks
measure: Lesion count- non-inflammatory
timeFrame: 6 weeks
measure: Lesion counts- Inflammatory
timeFrame: 6 weeks
measure: Lesion count- non-inflammatory
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceuticals
state: Arkansas
city: Louisville
country: United States
facility: Dermatology Specialist PSC
state: Kentucky
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Rochelle Park
country: United States
facility: TKL Research
state: New Jersey
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Fargo
country: United States
facility: Cetero
state: North Dakota
city: Austin
country: United States
facility: Derm Research, Inc
state: Texas
city: Bryan
country: United States
facility: J & S Studies
state: Texas
city: Lynchburg
country: United States
facility: Education and Research Foundation, Inc
state: Virginia
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06774807: Blocking of the Gut Hormone Receptor for Glucagon-like Peptide 2 (GLP-2) by the GLP-2 Receptor Antagonist GLP-2(3-33)
Official title: Antagonist of the Glucagon-like Peptide 2 (GLP-2) Receptor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Glucagon-Like Peptide 2
GLP-2
GLP-2 (3-33)
GLP-2 (1-33)
Gastrointestinal Blood Flow
Superior Mesenteric Artery
Portal Vein
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2025-01-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, placebo-controlled, single-blinded, crossover-study
Primary purpose: BASIC_SCIENCE

Brief summary: This project will describe the role of physiological levels of GLP-2 in regulating the blood flow to the intestines and the effect of the antagonist GLP-2(3-33) in blocking these effects of GLP-2.

Detailed description: Ten healthy participants will meet fasting and attend four randomized experimental days of MRI-scans of the abdomen. Each day will include subcutaneous injections of GLP-2 or saline and intravenous infusion of either the GLP-2 (3-33) antagonist or saline. The infusion start at timepoint -20, while the subcutaneous injection is given to timepoint 0 and the participant will lay in the scanner in one hour after injection. Eight MR-scans are done repeatedly to measure the blood flow in larger abdominal vessels and four blood samples are taken during the experimental day for analysis of GLP-2(1-33), GLP-2(3-33) and bone markers.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* BMI 19-28 kg/m2

Exclusion Criteria:

* Chronic illness that affects the cardiovascular system or gastrointestinal tract
* Treatment with medicine or supplements that cannot be paused for 12 hours
* Intake of above 14 alcoholic drinks per week or substance abuse
* Liver enzymes (ALAT) above 2 times normal values
* Decreased kidney function (eGFR below 90 or creatinine levels over reference value)
* Low blood percentage (hemoglobin below reference value)
* Any condition or disease that the persons responsible for the study find would interfere with the participation of the study.

Primary outcomes:
measure: SMA blood flow
timeFrame: 85 minutes
Secondary outcomes:
measure: PVblood flow
timeFrame: 85 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT04698707: Role of Supermicrosurgical LVA for Lower Limb Lymphedema
Official title: The Role of Supermicrosurgical Lymphaticovenous Anastomosis for Lower Limb Lymphedema - A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 131
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were enrolled.

Brief summary: Vascularized lymph node flap transfer (VLNT) was believed to be the treatment of choice for moderate-to-severe lymphedema. Recent publications have supported the use of supermicrosurgical lymphaticovenous anastomosis (LVA) for treating severe lymphedema. This study hypothesizes whether LVA can be performed on post-VLNT patients seeking further improvement.


Eligibility criteria: Inclusion Criteria:

* From November 2014 to January 2019
* Lower limb lymphedema patients

Exclusion Criteria:

* Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.

Primary outcomes:
measure: Magnetic resonance volumetry
timeFrame: 6 months after LVA
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05563207: Application of Health Education Path of Traditional Chinese Medicine Nursin
Official title: Shijiazhuang Pingan Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
health education
traditional Chinese medicine nursing
Lead sponsor: Shijiazhuang Pingan Hospital
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 37
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To explore the effect of traditional Chinese medicine (TCM) health education standard path on the treatment of patients with acute myeloid leukemia (AML). A total of 60 patients with acute myeloid leukemia in Shijiazhuang Ping An Hospital were selected and divided into control group (n=30) and observation group (n=30) according to the time of admission. Both groups received the same chemotherapy, the control group received routine nursing, and the observation group received TCM health education standard path intervention. The scores of Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Spitzer Quality of Life Index (QLI), awareness of TCM health education standard path content and nursing satisfaction were compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* patients admitted to the hospital for the first time during the observation period
* patients who met the diagnostic criteria for AML
* patients with stable disease, clear consciousness, fluent speech, and normal communication
* patients who volunteered to participate in the research

Exclusion Criteria:

* patients who were repeatedly admitted to hospital during the investigation period
* patients with hospitalization time ≤3 days
* patients whose condition changed after admission and could not continue to cooperate with the investigation
* patients who asked to withdraw during the observation period.

Primary outcomes:
measure: Self-rating anxiety scale
timeFrame: 3 months of intervention
measure: self-rating depression scale
timeFrame: 3 months of intervention
measure: Quality of Life Index
timeFrame: 3 months of intervention
measure: Self-made questionnaires to compare the awareness of traditional Chinese medicine health education standard path content
timeFrame: 3 months of intervention
measure: Self-made questionnaires to compare nursing satisfaction
timeFrame: 3 months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Shijiazhuang Pingan Hospital
state: Hebei
Study officials:
References:
Clinical trial NCT02843607: Combination of Cryosurgery and NK Immunotherapy for Advanced Kidney Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Renal Cell Cancer
Keywords: Kidney Cancer
Cryosurgery
NK Immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced kidney cancer.

Detailed description: By enrolling patients with kidney cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced kidney cancer.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Guifeng Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06718907: Mitigating Response to Stressors in Pregnant Women
Official title: Mitigating Response to Stressors in the Pregnant Woman
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: stressors, chronic stress, pregnancy, stress regulation, stress management
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.

Detailed description: Maternal stress-induced complications are correlated with gestational hypertension, infant low birth weight, and developmental disruption. Various social determinants of health are contributors to stress in pregnant women; factors such as socioeconomic status, education, access to prenatal care, and neighborhood conditions are some of the most identified psychosocial causes of prenatal stress. Further, chronic psychosocial stress is identified as a significant contributor to biophysiological damages such as accelerated telomere shortening in the mother as well as the offspring. Using a public health approach, this research study proposes to gather evidence to assess how response to stress is modulated and how it is captured in and affects pregnant women, with history of prolonged exposure to harmful stressors. More relevant to this study, individuals who have repeated exposure to stressors have poorly managed response to stress and display frequent elevated heart rates due to biological and physiological disruptions. Evidence from the literature suggests that having a support system and utilizing stress management techniques moderate and buffer the effects of stress on physiological measures while facilitating emotional recovery.

Eligibility criteria: Inclusion Criteria: in 24 weeks gestation or more

* between 21 and 37 years of age

Exclusion Criteria:

* in less than 24 weeks gestation
* high risk pregnancies

Primary outcomes:
measure: Stress level change
timeFrame: 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Davie
country: United States
facility: Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Gesulla Cavanaugh, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05381207: Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers
Official title: Impact Of Montelukast On Allergic Rhinitis And Its Inflammatory Makers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Allergic Rhinitis
Keywords: Montelukast
Allergic Rhinitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the efficacy of Montelukast as an adjunct to INCS in patients with allergic rhinitis.

Detailed description: Allergic rhinitis (AR) is a non-infectious inflammatory disease occurring in nasal mucosa with nasal itching, nasal congestion, rhinorrhea, and sneezing as its main clinical symptoms, which are induced by immunoglobulin E-mediated chemical mediators with the participation of various immunologically competent cells and cytokines after allergen exposure. (1) According to statistics, AR affects 10% to 25% of the global population. (2).

AR could be investigated by skin prick test, A blood test to check for the immunoglobulin E (IgE) antibody, and Total blood eosinophil count. (3) Current guidelines suggest that Intranasal corticosteroids should be used as the first line of treatment (4).

Surgical care may be indicated for comorbid or complicating conditions such as chronic sinusitis and nasal polyps. (5) Many studies have proven that the abnormality of inflammatory factors such as(TNF-α, IL-6, and IL-12)are closely related to the pathogenesis of AR. (6)these inflammatory factors participate in the regulation of immune response through media leucocyte chemotaxis and activate, so elevate of levels of these 3 factors can reflect the aggravation of inflammatory markers in the patient with AR. (7) Montelukast is belonging to the leukotriene receptor antagonists with the effect of inhibiting the expression of cysteinyl leukotriene involved in the pathogen of AR. Thus, the inhibition of the inflammatory marker can effectively reduce airway inflammatory response, nasal mucosal edema, and inflammatory exudation etiologically \[8\].

Eligibility criteria: Inclusion Criteria:

Adult patients (aged 18 years and over) with AR. Clinical diagnosis of Allergic Rhinits Must be able to swallow tablets

Exclusion Criteria:

Bronchial Asthma patients. Patients already on Antihistamine combined treatment Patients who are allergic to this medication Advanced liver or kidney diseases.

Primary outcomes:
measure: Nasal symptoms
timeFrame: 3 monthes
measure: laboratory findings
timeFrame: 3 months
measure: Quality of life symptoms
timeFrame: 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: