louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02149771: Combination Treatment for Advanced Liver Cancer
Official title: Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Hepatic Portal Vein Tumor Invasion
Keywords: hepatocellular carcinoma
portal vein tumor thrombosis
stents
chemoembolization
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
First posted: 2014-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.


Eligibility criteria: Inclusion Criteria:

* (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
* (2) Child-Pugh classification grade A or B；
* （3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

Exclusion Criteria:

* advanced liver disease (bilirubin levels \>3 mg/dL, ASTor ALT \>5 × upper limit of normal)；
* Tumor invade the Inferior Vena Cava, extrahepatic spread;
* contraindications for doxorubicin or oxaliplatin chemotherapy;
* any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
* renal failure,cardiac ejection fraction \<50 %) or end-stage disease；
* patients who were not capable of cooperation during the procedure.

Primary outcomes:
measure: Median survival time
timeFrame: 2 years
Secondary outcomes:
measure: Time to Disease Progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Interventional Radiology, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Interventional Radiology, Zhongshan Hospital, Fudan University
name: Zhinping Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Interventional Radiology, Zhongshan Hospital, Fudan University
name: Jianjun Luo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02928809: Effect of Low-level Laser Prior to the Induction of Fatigue
Official title: Effect of Low-level Laser Administered to the Masseter and Anteriortemporal Muscles Prior to the Induction of Fatigue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: temporomandibular joint
temporomandibular disorder
muscle fatigue
low-level laser therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to perform an evaluation of the effect of LLLT on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without TMD.

Detailed description: Male and female individuals aged 18 to 23 years will be evaluated. The Research Diagnostic Criteria for Temporomandibular Disorders will be applied for the determination of the presence or absence of temporomandibular disorder. Each group (with and without temporomandibular disorder) will then be randomly allocated into a control group and experimental group submitted to pre-fatigue low-level laser therapy. Before and after the induction of fatigue, all volunteers will be evaluated with regard to the range of mandibular movement, bite force, sensitivity to palpation of the muscles evaluated and muscle fatigue. Low-level laser therapy will be administered to the masseter and anterior temporal muscles prior to the induction of fatigue, which will be induced with the use of chewing gum. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to establish the associations of the categorical variables. Pearson correlation coefficients will be calculated for the analysis of the correlation of the continuous variables.

Eligibility criteria: Inclusion Criteria:

* Male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study.

Exclusion Criteria:

* Individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.

Primary outcomes:
measure: Change on Bite Force
timeFrame: 6 minutes
Secondary outcomes:
measure: Change on range of mandibular movements
timeFrame: 6 minutes
Other outcomes:
measure: Change on pain upon palpation
timeFrame: 6 minutes
measure: Muscle fatigue
timeFrame: 6 minutes
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Camila HL Godoy, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04683809: Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis
Official title: The Effect of Telerehabilitation on Quality of Life, Anxiety and Depression Levels in Children With Cystic Fibrosis and Their Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Keywords: anxiety
depression
cystic fibrosis
caregiver
telerehabilitation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with cystic fibrosis aged 6-13 will be recruited and randomized into two groups: one will receive telerehabilitation sessions including postural, breathing and high-intensity interval training exercises and one will be subject to routine follow up. Exercise program will be applied three days a week for three months. Children will be assessed by pulmonary function tests, cystic fibrosis quality of life questionnaire, six minute walking test and anxiety and depression scale in children, while caregivers will be assessed by Beck depression scale and situational anxiety inventory.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed cystic fibrosis

Exclusion Criteria:

* Current pulmonary exacerbation
* Musculoskeletal problems hinder exercising
* No internet access
* Patients and parents do not consent to intervention

Primary outcomes:
measure: Cystic fibrosis quality of life questtionaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02324309: BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance
Official title: A Single-blind Crossover Study of the Pharmacokinetic and Postprandial Glucose Dynamics of BIOD-531 Compared to Humulin® R U-500 and Humalog® Mix75/25™ in Subjects With Type 2 DM Who Are Treated With ≥ 150 Units of Insulin Per Day
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is designed to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500 in patients with diabetes and severe insulin resistance.


Eligibility criteria: Inclusion Criteria:

* BMI \> 25 kg/m2
* Diabetes Mellitus using ≥ 150 units of insulin or insulin analog per day and/or ≥ 100 units of insulin or insulin analog at a single dosing session for at least 1 month prior to screening
* HbA1c \< 10.0%

Exclusion Criteria:

* History of bariatric surgery
* Corticosteroid therapy
* Significant cardiovascular or other major organ disease
* Females who are breast feeding or pregnant
* A sexually active person not using adequate contraceptive methods

Primary outcomes:
measure: Post-breakfast glucose exposure (AUC)
timeFrame: 0-330 minutes
Secondary outcomes:
measure: Speed of insulin absorption (Times to 50%, 90%, maximal insulin concentrations)
timeFrame: 0-330 and 660-1020 minutes
measure: Insulin exposure (AUC)
timeFrame: 0-1440 minutes
measure: Maximal insulin concentration
timeFrame: 0-330 and 660-1020 minutes
measure: Post-lunch and post-dinner glucose exposures (AUC)
timeFrame: 330-660 and 660-1020 minutes
measure: Injection site toleration (VAS and severity scales)
timeFrame: 30 and 690 minutes
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research, Inc. (PICR)
state: California
Study officials:
affiliation: Profil Institute for Clinical Research, Inc.
name: Laurie Han-Conrad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149409: Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure
Official title: Omega-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Severe Chronic Heart Failure:Effects On Endothelial Function, Left Ventricular Remodelling, Natriuretic Peptide Levels, And Exercise Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Heart Failure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2005-09-08
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: To investigate whether n3-fatty acids have beneficial effects in chronic heart failure as regards circulatory function.


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure of non-ischemic origin
* Age ≥18 years
* NYHA functional class III-IV
* LVEF \< 35 %
* Optimized heart failure therapy
* plasma NT-BNP \>2000pg/ml

Exclusion Criteria:

* Current treatment with Omacor or other fish oil products
* Known hypersensitivity to the study drug
* Ischemic cardiomyopathy
* Uncorrected significant valvular heart disease
* Heart failure due to congenital heart disease
* Restrictive cardiomyopathy
* Alcoholic heart disease
* Acute myocarditis
* Continuous i.v. therapy for heart failure
* Mechanical assist device
* Life expectancy \<1 year due to non-cardiac causes
* Inability to perform bicycle testing
* Women of childbearing potential not practicing a save contraception method
* Current participation in another intervention study
* Participation in another study with an intervention within the last 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rudolf Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moertl D, Hammer A, Steiner S, Hutuleac R, Vonbank K, Berger R. Dose-dependent effects of omega-3-polyunsaturated fatty acids on systolic left ventricular function, endothelial function, and markers of inflammation in chronic heart failure of nonischemic origin: a double-blind, placebo-controlled, 3-arm study. Am Heart J. 2011 May;161(5):915.e1-9. doi: 10.1016/j.ahj.2011.02.011.
Clinical trial NCT02295709: Cervical Transforaminal Injection of Steroids Guided by Ultrasound
Official title: Cervical Transforaminal Injection of Steroids Guided by Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: ultrasound
cervical Transformational Epidural Steroid Injection
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical radicular pain resistant to conservation therapy, by which steroids can be delivered into anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel or not, many serious neurological complications caused by inadvertent intra-arterial injection have been reported2. Here, the investigators will introduce a novel cervical TFESI guided by ultrasound, which incidence of inadvertent vessel injury or injection might be lower than those guided by fluoroscopy.


Eligibility criteria: Inclusion Criteria:

* evidence of a cervical radiculopathy involving 1 spinal nerve of at least 1 month's duration refractory to medical treatment
* symptoms of cervical pain radiating to the upper limb
* and signs of altered sensations, ab- normal reflexes, or motor weakness caused by degenerative spondylosis and/or disk herniation as documented at CT or MR imaging and a current mean pain VAS score of six.

Exclusion criteria:

* evidence of vertebral fracture, tumor, or infection of the cervical spine
* treatment with cervical corticosteroid injections within the past 3 months
* coagulopathy
* allergy to iodinated contrast media.

Primary outcomes:
measure: change of pain severity rated on a Visual Analog Scale (VAS)
timeFrame: 1 day before, 1day after, 1week after and 4 weeks after the intervention
Secondary outcomes:
measure: change of neck actives rated on Neck Disability Index (NDI)
timeFrame: 1 day before, 1day after, 1week after and 4 weeks after the intervention
measure: change of medication use rated on Medication Quantitative Scale (MQS)
timeFrame: 1 day before, 1day after, 1week after and 4 weeks after the intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005309: Prospective Study of HIV Infection in Hemophiliacs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
HIV Infections
Blood Disease
Hemophilia A
Hepatitis, Viral, Human
Blood Transfusion
Cytomegalovirus Infections
Lead sponsor: Bloodworks
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine mechanisms of individual differences in the progression of HIV infection in hemophiliacs.

Detailed description: BACKGROUND:

In the late 1980s, hemophiliacs were transfused with a variety of blood products, including large amounts of cryoprecipitate. In comparison to other cohorts, hemophiliacs are CMV(-), resulting in a comparison group for the study of this virus as a potential cofactor. In contrast, non A, non-B hepatitis is common in comparison to other cohorts, and preliminary data prior to 1990 suggested that this chronic disease predisposes to more rapid progression of HIV infection.

DESIGN NARRATIVE:

Disease-free survival rates were determined in HIV-infected hemophiliacs. The effects of co-factors such as intensive transfusion, concomitant cytomegalovirus or chronic NANB hepatitis infection were ascertained. Host-virus interaction was assessed through the use of plasma cultures, specific antibody titers, and markers of immune changes detected by flow cytometry and immune function assays. The immunology of asymptomatic stable infection was investigated. The safety of volunteer donor blood products was determined in seronegative patients exposed to over 50,000 donors yearly and the risk of sexual transmission of HIV to spouses of seropositive patients was monitored.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bloodworks
name: George Gjerset
References:
Clinical trial NCT06462209: Effects of Ladder Training Versus Plyometric
Official title: Effects of Ladder Training Versus Plyometric Training Program on Agility , Speed and Power in Female Cricket Players
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sports Physical Therapy
Keywords: agility, cricket , ladder training , plyometric
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine the effects of ladder training versus plyometric training program on agility, speed and power in domestic female cricket players. Plyometric training program and ladder training program consider effective training methods for players for development of speed, agility and power.

Detailed description: Cricket is a well-known, particularly created team sport that is played on an international scale and involves a group of eleven players. Because both baseball and cricket are played on open fields, they are comparable sports. Cricket was first thought to be a game played only by men.1, 2 However, a few years ago, the globe became aware of the female cricket game because it was becoming more and more popular worldwide. It's a game that requires both physical components and a substantial level of technical understanding. Plyometric and ladder training programmes are thought to be efficient ways to help athletes gain strength, speed, and agility. Players will be selected for this randomised clinical study by use of successive sampling. The players will be split into two groups, 1 and 2, with Group 1 receiving ladder training and Group 2 receiving plyometric training. Each group will receive three 60-minute sessions per week for eight weeks. The vertical leap test, the agility t test, and the 30-dash test will be used to examine patients before and after the trial. Software from SPSS 25 version will be used to analyse the data.

Eligibility criteria: Inclusion Criteria:

* • Age ranging from 18-25year.

  * Player with minimum 1- year experience of cricket Only female cricket players.

Exclusion Criteria:

* • Any cardiopulmonary problem. Lower extremity injuries of last 6 months(fractures, ligament ruptures)

  * Players who were unable to complete ladder and plyometric training.

Primary outcomes:
measure: vertical jump test
timeFrame: 4 week
measure: 30 dash test
timeFrame: 4 week
measure: T test
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muzna Munir, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young WB, McDowell MH, Scarlett BJ. Specificity of sprint and agility training methods. J Strength Cond Res. 2001 Aug;15(3):315-9.
Clinical trial NCT01463709: Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
Official title: Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Basal Cell Carcinomas
Keywords: basal cell carcinoma
Basal Cell Nevus Syndrome
Electric Field
Nanosecond pulse
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)

Detailed description: The purpose of this study is to determine if low energy, non-thermal, 100 ns pulses can ablate BCCs. The investigators consider this a non-significant risk study because our PulseCure system only applies 0.4 watts to the skin compared to the 40 watts applied by the currently used electrosurgical unit to remove skin lesions, the Hyfrecator. Since the PulseCure applies 1/100 of the energy and does not even heat the skin significantly, it represents a non-significant risk to the patient. Our study will provide the first data on the response of BCCs to these 100 ns pulses. The investigators will first treat three BCCs on BCNS patients with different pulse numbers to determine the pulse number needed to ablate. Once the investigators have the optimal pulse number, the investigators will use it to treat 20 normal patients with sporadic BCCs on their trunks. This should provide sufficient data to conclude whether or not nsPEF can ablate BCCs on normal individuals.

Eligibility criteria: Inclusion Criteria:

1. Study subjects must have had diagnosed at least one BCCon their trunk
2. The subject is from 18-75 years of age, inclusive.
3. The subject must sign and date all informed consent statements.

Exclusion Criteria:

1. The subject is exhibiting signs of a bacterial or viral infection, including fever.
2. The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
3. The subject has a pace maker or other electronic device implanted

Primary outcomes:
measure: Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.
timeFrame: One year
Secondary outcomes:
measure: Determine the efficacy of the PulseCure pulse generator using the optimal pulse number.
timeFrame: one year
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital Research Center Oakland
state: California
Study officials:
affiliation: Children's Hospital Research Institute
name: Ervin E Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References: