louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04785573: The Effect of Mastiha Oil in Metabolic Syndrome
Official title: The Effect of Mastiha Oil in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 94
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Over 90 compounds have been identified in Mastiha oil, with monoterpenes exhibiting favorable effects in regulating mechanisms of oxidative stress and inflammation. The aim of this study is to determine the effect of Mastiha oil in adults with Metabolic Syndrome. 90 participants will be allocated to two groups, (45 in intervention group and 45 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.

The effects of the intervention will be evaluated via clinical and laboratory markers.


Eligibility criteria: Inclusion Criteria:

* 30 years \< Age \< 75 years
* Metabolic Syndrome cardiometabolic parameters
* A stable weight for ≥ 3 months pre-intervention
* An unchanged treatment regimen for ≥ 6 months pre-intervention

Exclusion Criteria:

* Hepatotoxic Medication
* Untreated Diabetes Mellitus
* Dysthyroidism, hypopituitarism, Cushing syndrome / disease
* Pregnancy, lactation
* Psychiatric or mental disorder
* Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, anti-, pre- or pro-biotics within 3 months pre-intervention

Primary outcomes:
measure: Change in blood total cholesterol
timeFrame: 3 months
measure: Change in insulin sensitivity
timeFrame: 3 months
measure: Change in blood triglycerides
timeFrame: 3 months
measure: Change in blood LDL
timeFrame: 3 months
Secondary outcomes:
measure: Change in blood CRP
timeFrame: 3 months
measure: Change in blood MPO
timeFrame: 3 months
measure: Change in blood IL-6
timeFrame: 3 months
measure: Change in blood antioxidant potential
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
state: Attica
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
References:
Clinical trial NCT05426473: Differences in Quality of Life After Thoracic Outlet Syndrome Surgery
Official title: Differences in Quality of Life After Thoracic Outlet Syndrome Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Outlet Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-06-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Quality of life evaluation after thoracic outlet surgery with Quick-DASH and SF-36 forms


Eligibility criteria: Inclusion Criteria:

* thoracic outel syndrome surgery scheduled in the vascular and thoracic surgery department of Angers ; age \> 18 y ; french language understood

Exclusion Criteria:

* denied of consent

Primary outcomes:
measure: Change from QuickDASH form results before surgery at 6 weeks after surgery
timeFrame: Results before surgery and at 6 weeks after surgery are compared
Secondary outcomes:
measure: Change from SF-36 form results before surgery at 6 weeks after surgery
timeFrame: Results before surgery and at 6 weeks after surgery are compared
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT00040573: Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
Official title: A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioma
Brain Neoplasm
Keywords: Brain neoplasm
Clinical trial, phase I/II
Lead sponsor: TransMolecular
Sponsor class: INDUSTRY
First posted: 2002-07-02
Enrollment: 18
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: This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

Detailed description: This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.

Eligibility criteria: * Patient must have given informed consent
* Patient must have histologically confirmed supratentorial malignant glioma
* Patients must have recovered from toxicity of prior therapy
* Patients must be eligble for resection of the recurrent tumor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: TransMolecular
name: Diana M Hablitz, MSNCRNP
role: STUDY_DIRECTOR
References:
Clinical trial NCT02498873: Linear Running Periodization x Nonlinear
Official title: Linear Running Periodization x Nonlinear: a Cross Effect of Five Months Controlled Running on VO2Max and Critical Power Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: VO2Max
Physical Conditioning
Aerobic Exercise
Performance
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In a competitive scenario, trainers and coaches seek to improve the performance of their athletes organizing macrocycles (year), mesocycles (months), and microcycles (weeks) training aimed at a specific moment of a competition. The organization variables, mainly the intensity of exercise in a training routine can stimulate important physiological pathways and uphold superior gains to VO2max, leading to a peak aerobic performance. However, due to lack of evidence, and the difficulty of control on a large scale, the effects of the intensity organization over a mesocycle periodization are still poorly investigated.

Detailed description: The objective of this study is compare two intensity blocks organization a) linear progression intensity (LP) and b) randomized or not intensity linaer (NLP) over five months running training, and a crossover design between subjects, on gains in VO2max, peak velocity (Vpeak) and critical power (CP). Furthermore, the relationship between the gains obtained with the training and the amount of exercise will be established. In our case all dependent variables will increase after training, with no significant differences between the two strategies on dependent variables.

Eligibility criteria: Inclusion Criteria:

* Minimum standards of physical activity proposed by the ACSM
* 18-45 years
* No metabolic or cardiovascular events
* No use ergogenic resources

Exclusion Criteria:

* Sedentary
* Diagnosis of cardiac, pulmonary or diabetes type I or II
* No injuries

Primary outcomes:
measure: VO2Max
timeFrame: 0 - 2 month; 1 month (wash out); 3 - 5 month
Secondary outcomes:
measure: Critical Power
timeFrame: 0 - 2 month; 1 month (wash out); 3 - 5 month
measure: Peak Velocity
timeFrame: 0 - 2 month; 1 month (wash out); 3 - 5 month
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Sérgio Machado, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05709873: Narcolepsy Nightmare Study
Official title: Behavioral Treatment of Narcolepsy-Related Nightmares
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy
Narcolepsy Type 1
Narcolepsy With Cataplexy
Narcolepsy Type 2
Narcolepsy Without Cataplexy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 7
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 goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:

* Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares?
* Does adding targeted dream control (TDC) to IRT make it more effective?

Participants will be randomized to one of two treatment groups and will be asked to:

* Complete a daily log of sleep symptoms for up to 13 weeks.
* Attend 7 sessions of treatment.
* Complete questionnaires before and after treatment.
* Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).


Eligibility criteria: Inclusion Criteria (all participants):

* Diagnosis of narcolepsy
* Age 18 or older
* Speak English
* Live in the United States
* Receiving standard medical care for narcolepsy
* Sleep and psychiatric medications stable for at least 3 months
* Nightmare frequency of ≥3 times per week
* Nightmare Disorder Index score indicates probable nightmare disorder

Inclusion Criteria (Chicago area participants):

* Able to attend a study appointment in Evanston, IL
* Able and willing to not take wake-promoting medications on day of lab visit

Exclusion Criteria:

* History of a neurological disorder that might alter EEG
* Currently engaged in sleep- or trauma-focused psychotherapy
* Previous behavioral treatment for nightmares
* Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
* Untreated sleep apnea (AHI ≥ 5)

Primary outcomes:
measure: Daily diary
timeFrame: Duration of study (11-13 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jennifer Mundt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05964673: Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women
Official title: Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal Women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dry eye disease (DED) is a growing public health concern affecting quality of life and visual function, with a significant socio-economic impact. It is more prevalent in the females and is being specifically in the menopausal and postmenopausal age group.

Bioptron light therapy is efficient in the elimination of allergic reactions, signs and symptoms of dry eye improving capillary circulation, immunity stimulation, relieving pain and establishing balance of tissue electromagnetic field

Detailed description: Around 60 postmenopausal women will be randomly divided into two equal groups, they all complain from dry eye symptoms, ranging from mild/normal to moderate and severe.

Group(A): will receive patient education program for four weeks. Group(B): will receive patient education program and bioptron light therapy for four weeks

Eligibility criteria: Inclusion Criteria:

* All participants are postmenopausal women.
* Their age above 50 years old
* All participants aren't on any systematic therapy.

Exclusion Criteria:

* • Injuries and previous surgical treatment of eyes

  * All patients with diagnosis of chronic blepharitis, meibominitis or any other eye infections
  * Participants with autoimmune diseases such as Sjögren's syndrome (SS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)
  * Diabetic participants will be excluded.
  * Smokers will be excluded from the study.
  * The use of Hormone Replacement Therapy

Primary outcomes:
measure: Dry Eye-Related Quality-Of-Life Score (DEQS)
timeFrame: Dry Eye-Related Quality-Of-Life Score will be measured at baseline, and it will be measured again after four weeks
measure: Tear Breakup Time (TBUT)
timeFrame: Tear Breakup Time will be measured at baseline, and it will be measured again after four weeks
Secondary outcomes:
measure: Schirmer's test
timeFrame: Schirmer's test will be measured at baseline, and after four weeks
Other outcomes:
Locations:
city: Cairo,
country: Egypt
facility: Cairo University
Study officials:
affiliation: giza, Egypt, 12511
name: Sara Ahmed, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04295473: Reduced Port Laparoscopic Gastrectomy for Gastric Cancer
Official title: Comparison the Short and Long-term Outcome of Patients With Gastric Cancer Who Underwent Reduced Port Laparoscopic Gastrectomy With Patients Underwent Traditional Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic
Gastrectomy
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy

Detailed description: Reduced port laparoscopic gastrectomy has been adopted in clinical. The safety and outcome of reduced port laparoscopic gastrectomy has not been systematically evaluated. The investigators designed a comparative study, which sought to compare the short and long-term outcome of patients with gastric cancer who underwent reduced port gastrectomy with patients underwent traditional laparoscopic gastrectomy. The short-term outcome include surgical complications, postoperative morbidity, postoperative nutrition. The long-term outcome mainly include long-term survival.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. Adequate organ function.

Exclusion Criteria:

1. Patients had distant metastasis.
2. oesophageal invasion of more than 3 cm.
3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
4. Previous chemotherapy or radiation therapy for any other malignancies.

Primary outcomes:
measure: 5-year survival rate
timeFrame: 5 years
measure: 3-year survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Postoperative morbidity rate
timeFrame: 6 months
measure: Malnutrition rate
timeFrame: 6 months
measure: Quality of life in PGSAS-45 scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
affiliation: Nanchong Central Hospital
name: Yunhong Tian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00672373: Extract of Ginkgo Biloba and Tardive Dyskinesia
Official title: A Double-Blind, Randomised, Parallel-Group Comparison of Extract of Ginkgo Biloba(EGB-761) Versus Placebo as Add-on Medication in Patients With Established Tardive Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tardive Dyskinesia
Schizophrenia
Keywords: Tardive Dyskinesia
Schizophrenia
Extract of Gingko Biloba
Lead sponsor: Beijing HuiLongGuan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2008-05-06
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in the treatment on Tardive dyskinesia

Detailed description: Tardive dyskinesia(TD) is a common complication of conventional antipsychotic treatment in subjects with schizophrenia. There is no established treatment for TD patients.This disorder remains a significant clinical problem for both patients and physicians for the foreseeable future.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 60yrs
* Meeting Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition(DSM-IV) criteria for schizophrenia or schizo-affective disorder
* Abnormal Involuntary Movement Scale (AIMS) score ≥2.
* Patients from whom informed, written consent is obtained.
* Patients who have been on a fixed dose of antipsychotic medication for at least 4 weeks prior to trial entry.

Exclusion Criteria:

* Significant neurological disorder other than TD
* Substance abuse
* Significant other medical illness
* Psychiatric disorder not stabilised
* Pregnancy or lactation
* Take antioxidants(such as Vitamin C)

Primary outcomes:
measure: Change in the scores of Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline, 6th and 12th week
Secondary outcomes:
measure: Change in PANSS
timeFrame: Baseline, 6th and 12th week
measure: Change in Simpson-Angus Rating Scales for EPS
timeFrame: Baseline, 6th and 12th
measure: Change in cognitive function
timeFrame: Baseline and 12th week
measure: Change in Udvalg for Kliniske Undersøgelser (UKU) Side Effect Rating Scale
timeFrame: Baseline, 6th and 12th week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hui-Long-Guan Hospital
Study officials:
affiliation: Beijing HuiLongGuan Hospital
name: Yunlong Tan, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of mental health, Peking University
name: Dongfeng Zhou, Professor
role: STUDY_CHAIR
References:
citation: Zhang WF, Tan YL, Zhang XY, Chan RC, Wu HR, Zhou DF. Extract of Ginkgo biloba treatment for tardive dyskinesia in schizophrenia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 May;72(5):615-21. doi: 10.4088/JCP.09m05125yel. Epub 2010 Sep 21.
Clinical trial NCT02608073: A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer
Official title: A Multi-Center Phase II Trial of Capecitabine (Xeloda) in Combination With Cisplatin as First Line Chemotherapy in Patients With Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults 18 to 75 years of age
* Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
* Ability to swallow and retain oral medication

Exclusion Criteria:

* Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
* Clinically significant cardiac disease
* History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
* Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study

Primary outcomes:
measure: Overall response rate
timeFrame: up to 28 days after the last intake of study treatment (up to approximately 5 years)
Secondary outcomes:
measure: Overall survival
timeFrame: Up to approximately 18 months
measure: Time to disease progression
timeFrame: Up to approximately 18 months
measure: Duration of response
timeFrame: Up to approximately 18 months
measure: Complete response rate
timeFrame: Up to approximately 18 months
measure: Incidence of adverse events
timeFrame: Up to approximately 7 months
measure: Quality of life according to Visual Analog Scale (VAS) score
timeFrame: Up to approximately 6 months
measure: Treatment convenience/satisfaction according to VAS score
timeFrame: Up to approximately 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Jogjakarta
country: Indonesia
city: Kuala Lumpur
country: Malaysia
city: Kueishan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: