louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03471741: Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer
Official title: Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Radiation Toxicity
Keywords: breast cancer
radiotherapy
cutaneous toxicity
subcutaneous toxicity
local control
IMRT
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 451
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From 2003, all women fullfilling the inclusion criteria were treated with MARA-2 scheme

Brief summary: To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

Detailed description: Patients treated conservatively with moderate-high risk breast cancer were treated with IMRT plus concomitant boost to surgical bed (up to a dose of 50 Gy to whole breast and 60 Gy to the tumor bed).

Aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (CG) of patients treated with 3D-conformal postoperative radiotherapy delivered with conventional fractionation.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed invasive breast cancer (pT1-4) with at least one of these characteristics: 3 or more metastatic axillary nodes, pre or peri-menopausal status, close resection margins
* breast conservative surgery

Exclusion Criteria:

* positive margins
* distant metastases

Primary outcomes:
measure: Incidence of treatment.related late adverse events
timeFrame: 5 years
Secondary outcomes:
measure: Local control
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macchia G, Cilla S, Buwenge M, Zamagni A, Ammendolia I, Zamagni C, Frezza GP, Valentini V, Deodato F, Morganti AG. Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I-II Trial. Breast Cancer (Dove Med Press). 2020 Nov 12;12:243-249. doi: 10.2147/BCTT.S261587. eCollection 2020.
Clinical trial NCT04168541: Glycemic Response in Persons With Type 2 Diabetes Mellitus
Official title: Plasma Glucose and Insulin Response to Six Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2019-11-19
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.


Eligibility criteria: Subject inclusion criteria

All subjects must comply with all the following inclusion criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial
* Patients with anemia

Primary outcomes:
measure: Area under the blood glucose curve (ACU 0-240 minutes)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
measure: Area under the insulin curves (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: Insulinogenic index [Change in Ins30/Change in Glu30]
timeFrame: [Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes]
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Orange County Research Center
name: Joel Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250341: Non-invasive Measures of Distal Lung Disease in Asthmatics
Official title: Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, single center study conducted in mild-to moderate asthmatics.

Detailed description: The study consists of 3 phases. There are 7 study visits.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Currently using SABA prn or a low-to-moderate persistent asthma

Exclusion Criteria:

* Tobacco use within 1 year or \>= 5 pack years

Primary outcomes:
measure: High resolution Cat Scans
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michelle Zeidler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03057041: Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration
Official title: Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Uterus
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2017-02-17
Enrollment: 107
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. The investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. The investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to the procedure.


Eligibility criteria: Inclusion Criteria:

* Seeking office based uterine aspiration
* Gestational age at 14 weeks or less
* Age 14 years or older with parental consent to participate in this research study if 14-17 years old
* Able to read, speak, and understand English
* Ability to understand materials and consent forms

Exclusion Criteria:

* Seeking medical abortion, operating room based surgical abortion, or operating room based miscarriage management
* Gestational age greater than 14 weeks
* Age less than 14 years old
* Inability to read, speak, and understand English
* Current incarceration
* Weight less than 40kg
* Self-reported or documentation of significant cardiopulmonary disease
* Self-reported or documentation of alcohol or substance dependence or abuse
* Contraindications, relative contraindication to fentanyl use

Primary outcomes:
measure: Pain during uterine aspiration
timeFrame: During uterine aspiration or immediately after uterine aspiration
Secondary outcomes:
measure: Patient satisfaction with procedural pain control
timeFrame: approximately 15 minutes after procedure ends
measure: Post-procedural pain
timeFrame: approximately 15 minutes after procedure end
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Women's Options Center
state: Hawaii
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
Study officials:
References:
Clinical trial NCT04536441: Ultra-brief Online Mindfulness-based Intervention During COVID-19 Movement Control Order
Official title: Effects of an Ultra-brief Online Mindfulness-based Intervention on Mental Health During the Coronavirus Disease (COVID-19) Outbreak in Malaysia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Psychological Security
Psychological Distress
Keywords: Mindfulness
Online Intervention
COVID-19
Movement Control Order
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
Collaborators: name: Sunway University
First posted: 2020-09-02
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The federal government of Malaysia implemented a nationwide Movement Control Order (MCO) to control the COVID-19 outbreak. The MCO, however, has been found to have a negative impact on people's mental wellbeing. Interventions that can improve mental health under restricted movement condition is urgently. The present study investigated the impact of a brief, online mindfulness-based intervention on mental health using two-arm randomized controlled trial design. A total of 161 participants self-reported their feeling, anxiety, psychological insecurity, and well-being at baseline (T1) and post-test (T2), while 61 of them answered the same set of measures and the fear of COVID-19 scale in a follow-up study two weeks later (T3).


Eligibility criteria: Inclusion Criteria:

* People residing in Malaysia during the Movement Control Order.

Exclusion Criteria:

* People who are unable to read or write in either Malay, English or Mandarin languages.

Primary outcomes:
measure: Changes of Subjective Unit of Distress
timeFrame: It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
measure: Changes of Anxiety Scores
timeFrame: It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
measure: Changes of Psychological Insecurity
timeFrame: It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
Secondary outcomes:
measure: Changes of General Well-being
timeFrame: It was being It was measured at pre-intervention, post-intervention (through intervention completion, on average 10 minutes), and 2-week follow up.
measure: Fear of COVID-19
timeFrame: It was being measured at 2-week follow up.
Other outcomes:
Locations:
city: Kampar
country: Malaysia
facility: Universiti Tunku Abdul Rahman
state: Perak
Study officials:
affiliation: Universiti Tunku Abdul Rahman
name: Kai-Shuen Pheh, MClinPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06265441: Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block Vs. Adductor Canal Block Alone
Official title: Comparison of IPACK Block with Adductor Canal Block Vs Adductor Canal Block Alone for Post Operative Analgesia Following Arthroscopic Knee Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries.

Detailed description: Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group A for Adductor canal block alone and odd numbers will be enrolled in group B for Adductor canal block and IPACK block.

Eligibility criteria: Inclusion Criteria:

* Physical status: ASA 1 or 2
* Age group: 21-40 years.
* No sex predilection.
* Patients undergoing arthroscopic knee surgery under spinal anesthesia.

Exclusion Criteria:

* Patient refusal
* Physical status: ASA III or above.
* Patients with contraindications for spinal anesthesia.
* Patients with history of drug allergies to study drugs.
* Evidence of local infection at site of injection.
* Neuromuscular pathology (example: - Multiple Sclerosis)

Primary outcomes:
measure: Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure.
timeFrame: 8 hours
Secondary outcomes:
measure: Total pethidine consumption
timeFrame: 24 hours
measure: The time till first analgesic requirement
timeFrame: as requested by patient
measure: The number of steps
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
affiliation: Anesthesia resident, Ain shams university
name: Mohamed Morsi, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01335841: Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis
Official title: Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Procedure, Unspecified
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: PRAXIM company
First posted: 2011-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.


Eligibility criteria: Inclusion Criteria:

* Patient aged over 18 years old
* Patient affiliated to social security or similarly regime
* Patient with a disease of the pelvic ring, with an indication of establishment of a screw sacro-iliac
* Patient with a disease of the spine, with an indication of establishment of pedicle implant

Exclusion Criteria:

* Intubated patient resuscitation
* Pregnant women and lactating mothers
* Adult unable to express their consent
* Ward of court or under guardianship
* Person under legal protection
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent

Primary outcomes:
measure: Reading number of trips extra-pedicular or extra bone in both groups on a postoperative TDM
timeFrame: two years
Secondary outcomes:
measure: measure radiation of the surgeon and the patient in the two groups
timeFrame: two years
measure: Show that the operative time is not increased significantly taking into account the learning curve and the benefit provided from a conventional 2-D amplifier
timeFrame: two years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Study officials:
affiliation: University Hospital, Grenoble
name: Philippe Merloz, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06027541: Young Patients With Early Breast Cancer
Official title: Prospective Research of Young Patients With Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Female
Keywords: young patients
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with breast cancer receiving operation in Peking Union Medical College Hospital

Brief summary: The prognosis of young patients with breast cancer is relatively poor. Chemotherapy damages ovarian function. Endocrine treatment for up to 10 years delays the childbearing time of patients. Treatment regimens in young breast cancer patients are still controversial in the following: 1. Exemption from chemotherapy based on gene prediction results; 2. Removing drugs that damage ovarian function from chemotherapy regimens; 3. Giving ovarian protection drugs during chemotherapy for patients with hormone receptor (HR)+; 4. The right time to get pregnant. In view of the above problems, the treatment scheme recommended in the guidelines cannot meet the personalized needs of young breast cancer patients. The project plans to establish a prognosis model for young patients with breast cancer, and provide the patients hierarchical and refined management, which is significant for prolonging survival time, improving quality of life, and protecting fertility. This project plans to observe the relationship between the characteristics of immune genes, pathological staging, molecular typing, treatment plans and prognosis in the cohort of young breast cancer patients, and establish a young breast cancer prognosis model and verify it. The project is expected to establish a prognosis model and provide a hierarchical and personalized precision treatment plan for young breast cancer patients, so as to prolong the survival time, improve the fertility rate, and improve the quality of life.


Eligibility criteria: Inclusion Criteria:

* patients with breast cancer received operation in Peking Union Medical College Hospital
* age ≤40 year old and ≥20 years old
* treatment regimen was made in Peking Union Medical College Hospital

Exclusion Criteria:

* patients without pathological information
* patients with metastasis
* patients with history of other malignant tumor (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma)
* patients with palliative resection of breast

Primary outcomes:
measure: 5-year disease free survival (DFS)
timeFrame: 5 year
Secondary outcomes:
measure: 5-year overall survival (OS)
timeFrame: 5-year
measure: 5-year recurrence
timeFrame: 5-year
measure: 5-year metastasis
timeFrame: 5-year
measure: the correlation between poor characteristics and survival
timeFrame: 5-year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03332641: Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Improvement of Blood Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.

Detailed description: This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Citron(Citrus Junos Siebold ex Tanaka) Peel Extract or a placebo group. Blood cholesterol profiles before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 19-75 years with Total cholesterol 200-239 mg/dL

Exclusion Criteria:

* Lipid lowering agent within past 6 months
* Severe cardiovascular disease(Mvodardial infarction, stroke, etc)
* Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, ect)
* Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
* Diabetes mellitus
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results
* Pregnancy or breast feeding
* Not Contraception(except: Surgery for female infertility)

Primary outcomes:
measure: Changes of Cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Lipid profile
timeFrame: 12 weeks
measure: Changes of Oxidized LDL
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
References: