louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01104480: Tocilizumab for Relapsing Polychondritis
Official title: Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Relapsing Polychondritis
Keywords: Relapsing Polychondritis
Unremitting
Inflammation
IL6
Lead sponsor: McMaster Children's Hospital
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 0
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study for one patient with severe relapsing polychondritis which has been unresponsive to other more conventional medications including prednisone, methotrexate, anakinra and TNF inhibitors. Tolerability, and efficacy of the drug, Tocilizumab will be monitored by clinical assessment and bloodwork.


Eligibility criteria: Inclusion Criteria:

* A single patient with unremitting inflammatory relapsing polychondritis

Exclusion Criteria:

* As this is a study in a single patient, there are no exclusions

Primary outcomes:
measure: Efficacy of Tocilizumab
timeFrame: 2 years
Secondary outcomes:
measure: Safety of Tocilizumab
timeFrame: 2 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University and Children's Hospital
name: Maggie Larché, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01168180: Traditional Thai Massage and Scapulocostal Syndrome
Official title: Efficacy of Traditional Thai Massage on Patients With Scapulocostal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scapulocostal Syndrome
Keywords: Traditional Thai Massage
Scapulocostal Syndrome
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of traditional Thai massage on pain intensity, pressure pain threshold, muscle tension, anxiety, cervical range of motion, patient satisfaction and side effects in the treatment of scapulocostal syndrome.


Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Age between 18 - 50 years old
3. The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition.
4. The participants will be able to follow instructions.
5. Good communication and cooperation.

Exclusion Criteria:

1. A history of the following diseases or disorders:

   * Rotator cuff disease
   * Cervical radiculopathy
   * Degenerative shoulder joint disease
   * Shoulder stiffness
2. Contraindications of traditional Thai massage

   * Contagious skin disease
   * Injury or inflammation of muscle
   * Bone fracture and/or joint dislocation
   * Open wound
   * Uncontrolled hypertension
   * Drug and/or alcohol intoxication

Primary outcomes:
measure: Pain intensity (Visual analog scale)
timeFrame: 4 months
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: 4 months
measure: Muscle tension (Visual analog scale)
timeFrame: 4 months
measure: State Anxiety Inventory
timeFrame: 4 months
measure: patient satisfaction
timeFrame: 3 weeks
measure: Side effects
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Faculty of Associated Medical Sciences, Khon Kaen University
state: Khon Kaen
city: Muang
country: Thailand
facility: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University
state: Khon Kaen
Study officials:
References:
Clinical trial NCT00212680: Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
Official title: Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Supraventricular Tachyarrythmia
Keywords: ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.


Eligibility criteria: Inclusion Criteria:

1. 20-80 years old
2. Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher)
3. Within 7 days postoperatively
4. Other inclusion criteria as specified in the protocol

Exclusion Criteria:

1. Acute myocardial infarction (within 1 month after onset)
2. Severe heart failure (New York Heart Association functional class III or higher)
3. Atrioventricular block (grade II or higher),or sick sinus syndrome
4. Other exclusion criteria as specified in the protocol

Primary outcomes:
measure: Percentage of patients achieving 20% reduction in heart rate at each dose
Secondary outcomes:
measure: Heart Rate, Blood pressure and 12-lead ECG
Other outcomes:
Locations:
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
Clinical trial NCT04466280: Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19
Official title: Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVID-19 Disease in Healthcare Providers at Baqiyatallah Hospital in Tehran
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 180 people from the medical staff and high-risk people in Baqiyatallah Hospital, who are in close contact with patients, will enter the study. Participants will be divided into two intervention groups and one control group. The control group will use the full protective equipment assigned to the treatment staff. In addition to protective equipment, the first intervention team will receive a daily diet of 200 mg hydroxychloroquine tablets. The second intervention team, while observing and using the complete protective equipment, will place a thin layer of Mucodentol gel in the vestibular area of the mouth daily, every 6 to 8 hours.

At the beginning of the treatment, qualified people will participate in the study while recording demographic and clinical information, PCR test will be performed, and if they have negative PCR, they will be in one of the 3 study groups. During the study, if the symptoms of the disease occur in each of the participants, the test will be taken again. If the test is positive, the person will withdraw from the study, and the patient's information will be recorded. Finally, the people present in the study will be tested for PCR, and the results of the disease and the side effects of the drugs will be compared.


Eligibility criteria: Inclusion Criteria:

* Negative PCR testing through throat swabs
* Signing Conscious Consent

Exclusion Criteria:

* History of ocular complications and visual disturbances
* Sensitivity to plant compounds in the product

Primary outcomes:
measure: PCR test
timeFrame: up to 1 month
Secondary outcomes:
measure: Laboratory Treatment Response
timeFrame: up to 1 month
measure: drug reactions Adverse
timeFrame: up to 1 month
measure: Allergic drug
timeFrame: up to 1 month
measure: Radiological Treatment Response
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
References:
Clinical trial NCT00897780: Combined Biofeedback With Virtual Reality in the Treatment of Pediatric Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Headache
Keywords: Headache
Pediatric
Virtual Reality
Biofeedback
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of the study is to examine the effect of combined treatments (biofeedback with virtual reality) for pediatric chronic headache.

Detailed description: Chronic headache is a common symptom in children. Pharmacologic treatment has only a limited productivity and several known adverse reactions. Despite the frequency and chronicity of pediatric headache, validated treatment paradigms are currently inadequate.

Biofeedback is a medical treatment in which physiologic markers like heart rate, breathing rate, EMG, EEG, or electrodermal activity are measured and displayed back to the patient. The patient can then attempt to modulate physiology to achieve a certain feedback goal,such as slowing heart or breath rate, or relaxing certain muscles. Numerous psychophysiologic studies have been conducted that examine the effect of biofeedback alone on physiology as well as various clinical conditions. Clinical trials for chronic headaches have found that biofeedback was more effective in the treatment of headache when compared to pure drug therapy.

A number of recent distraction interventions for acute pain in children and adolescents have employed virtual reality technology in conjunction with either a passive distraction stimulus, such as a movie, or an interactive distraction activity, such as a computer game. However, the actual benefit of VR technology over and above the benefits of the distracting stimulus that is experienced through the VR equipment has not been adequately tested in children.

The objective of this study is to combine virtual reality with biofeedback in order to increase the effectivity of both techniques in decreasing chronic headache frequency and pain degree in the pediatric population.

Eligibility criteria: Inclusion Criteria:

* 9-18 years old children suffering from chronic headache diagnosed by pediatric neurologist
* Exclusion of Other disorders causing chronic headache

Exclusion Criteria:

* Children younger than 9 years or olde than 18.
* Children who do not fulfill headache criteria as described in the International Headache Society
* Children who were not examined by a certified pediatric neurologist

Primary outcomes:
measure: Improvement in headache frequency and pain degree among participants
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00408980: is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?
Official title: is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breastfeeding
Keywords: diet
breast milk fat
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.

Detailed description: The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk. specifically, we will test the following hypotheses:1) at constant caloric intake, 2 high fat (40% fat, 45% CHO) diets ( margarine e nriched versus butter enriched) lead to higher fat and caloric content of human milk than the low fat diet (5% fat, 80% CHO); and 2) All 3 groups will have strikingly different milk fatty acid profiles (mirroring the dietary fatty acid profile).

Eligibility criteria: Inclusion Criteria:

* breast feeding women
* healthy
* on no medications

Exclusion Criteria:

* women on medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem
name: Weinstadt Morya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490880: Neoadjuvant Chemo (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer
Official title: The Evaluation of Efficacy and Toxicity of Combined Treatment: Neoadjuvant Chemotherapy (Gemcitabine and Cisplatin) With Radical Cystectomy or Radiotherapy in Patients With Bladder Cancer Stage T2b-T3 NO/Nx M0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 2
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 purpose of this study is to evaluate efficacy of gemcitabine and cisplatin combined with either radical cystectomy or radiotherapy in the treatment of bladder cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven urothelial carcinoma of the urinary bladder in stage T2b-T3, N0/Nx, M0.
* Patients must have measurable disease. Response assessment will be evaluated according to RECIST criteria. Measurable lesions with clearly defined margins will be evaluated by X-Ray, Transvesical Ultrasound, CT-Scan or MRI, cystoscopy.
* Lesions serving as measurable disease must have the longest diameter of greater than or equal to 20 mm as measured with conventional techniques or greater than or equal 10 mm with spiral CT scan. Lesions measured by physical examination must have a longest diameter of greater than or equal 20 mm.

Exclusion Criteria:

* Patients with prior or concomitant malignant diseases (other than appropriately treated basal cell carcinoma of the skin or carcinoma of the cervix)
* PSA greater than 5.0 ng/mL
* Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.

Primary outcomes:
measure: To evaluate efficacy
Secondary outcomes:
measure: To evaluate pathological complete responses
measure: To evaluate progression free survival
measure: To evaluate overall survival
measure: To evaluate time to disease progression
measure: To evaluate safety
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00800280: Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Generalized Anxiety Disorder
Keywords: cimetidine, PD 0332334, organic cation transporter, OCT2, pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Detailed description: Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Eligibility criteria: Inclusion Criteria:

* healthy
* male or female adults

Exclusion Criteria:

* Current or history of clinically significant medical illness
* Smokers
* Illicit drug use

Primary outcomes:
measure: PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)
timeFrame: 4 to 6 days
measure: PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
timeFrame: 4 to 6 days
measure: Half-life (t1/2) of PD 0332334
timeFrame: 4 to 6 days
measure: Maximum plasma concentration (Cmax) of PD 0332334
timeFrame: 4 to 6 days
Secondary outcomes:
measure: Evaluate the incidence, duration and severity of adverse events
timeFrame: 4 to 6 days
measure: Evaluate the discontinuation due to adverse events
timeFrame: 4 to 6 days
measure: Clinical safety labs
timeFrame: 4 to 6 days
measure: ECG
timeFrame: 4 to 6 days
measure: Vital signs
timeFrame: 4 to 6 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02356380: The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
Official title: The Effects of Thoracic Spine Mobilizations in Individuals With Neck Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Chatham University
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol.

Detailed description: The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine treatments: grade 1-4 as performed by Cleland et. al. and grade 1-4 mobilization to the thoracic spine as selected by the Physical Therapist for cervical spine pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007) If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Theapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Comission of Accredicdation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.

Eligibility criteria: Inclusion Criteria:

* Patients with Neck Pain
* Ages 18 - 60

Exclusion Criteria:

* Red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004), cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action

The inclusion and exclusion above represent a conservative approach based on combining criteria of recent studies in published review articles. (Cross, 2011; Walser, 2009

Primary outcomes:
measure: Neck Pain
timeFrame: 2 weeks
measure: Neck Disability Index
timeFrame: 2 weeks
measure: Global Rating of Change
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Chatham University
state: Pennsylvania
Study officials:
References: