louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01187264: Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis
Official title: Efficacy and Safety of Methotrexate in 2 Fixed Doses of 10mg or 25mg Orally Once Weekly in Patients With Severe Plaque Type Psoriasis: a Prospective, Randomized, Double Blind, Dose Ranging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2010-08-24
Enrollment: 100
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: In this study the investigators intend to compare the efficacy and safety of two fixed doses of once weekly oral methotrexate in a prospective randomized double blind manner in patients with severe plaque type psoriasis.


Eligibility criteria: Inclusion Criteria:

* Patients with plaque-type psoriasis having more than 10% body surface area involvement (severe psoriasis).20
* Patients of either sex with age between 18-65 years.
* Females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment and negative pregnancy test 2 weeks before starting of treatment and at day 2 or 3 of a normal menstrual cycle.
* Males who were willing to maintain contraception during and 3 months after completion/stopping of treatment.

Exclusion Criteria:

* Pregnant or lactating women.
* Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness.
* Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP \>1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
* history of excessive alcohol consumption.
* Severe anemia, leucopenia or thrombocytopenia.
* Active infectious disease or immune system deficiency including AIDS.
* history of intolerance/hypersensitivity to methotrexate.
* history of phototherapy in past 6 months.
* Patients who had received any systemic treatment for psoriasis in the past 4 weeks and topical treatment in the past 2 weeks.
* Body mass index (BMI) \> 30 kg/m2.

Primary outcomes:
measure: change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: time to achieve PASI 75
timeFrame: 12 weeks or earlier
measure: number of patients achieving PASI 90 and 100
timeFrame: 12 weeks or earlier
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
state: U.T
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: C V KRISHNA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: SUNIL DOGRA, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01542164: Calcium Intake and Fat Excretion
Official title: Calcium Intake and Fat Excretion - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fat Excretion
Energy Excretion
Keywords: Calcium intake
Fat excretion
Energy excretion
Gut micro flora
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Arla Foods
name: The Danish Dairy Research Foundation, Denmark
First posted: 2012-03-02
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Copenhagen and Sjælland

Brief summary: The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.

Detailed description: Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles.

The aim of this study is to examined for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight

Eligibility criteria: Inclusion Criteria:

* age between 18 - 50 years
* healthy
* weight stable within 4 months prior to the inclusion

Exclusion Criteria:

* pregnant or lactating
* uses cholesterol lowering drugs
* on diet
* suffering from, now or previously, any gastrointestinal diseases
* elite athletes
* participation in other concomitant trial

Primary outcomes:
measure: Total fat and energy excretion
timeFrame: 5 days
Secondary outcomes:
measure: p-vitamin D
timeFrame: 1 day
measure: p-PTH
timeFrame: 1 day
measure: Selected genetic variations
timeFrame: 1 day
measure: Blood lipids and cholesterol
timeFrame: 1 day
measure: calcium excretion
timeFrame: 2 days
measure: Gut micro flora
timeFrame: 1 day
measure: NMR-spectroscopy based metabonomics profiling of urin
timeFrame: 1 day
measure: blood pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: Frederiksberg, Copenhagen
country: Denmark
facility: Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Study officials:
affiliation: Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
name: Lesli H. Larsen, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03072290: Corticosteroid Injection in Carpal Tunnel Syndrome
Official title: Comparison of Different Dose of Steroid Injection in Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-03-07
Enrollment: 56
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 compare the effectiveness of different dose of ultrasound guided steroid injection in patient with carpal tunnel syndrome, by using clinical and electrophysiological parameters in evlauation

Detailed description: This is a prospective, single-blinded randomized controlled study to determine the efficacy of low dose corticosteroid in patient with CTS. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection with different dosage of triamcinolone acetonide (Shincort) mixed, 1ml 10mg (10mg/ml) or 1ml 40mg (40mg/ml) with 1 ml of 2% lidocaine hydrochloride. The follow up at 6 and 12 weeks includes Boston Carpal Tunnel Questionnaire, nerve conductive study and VAS pain score.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of CTS
* The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

* presence of thenar atrophy
* existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
* prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery
* history of distal radius fracture
* pregnancy or lactation
* regular use of systemic NSAIDs ,corticosteroids or diuretics
* known allergy to corticosteroids and local anesthetics.
* impaired cognitive function

Primary outcomes:
measure: Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).
timeFrame: at 6, 12 weeks
Secondary outcomes:
measure: Change from Baseline in Median nerve distal motor latency
timeFrame: at 6, 12 weeks
measure: Change from Baseline in sensory nerve conduction velocity
timeFrame: at 6, 12 weeks
measure: Change from Baseline in compound muscle action potential amplitude (CMAP)
timeFrame: at 6, 12 weeks
measure: Change from Baseline in self-reported pain intensity
timeFrame: at 6, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei veteran general hospital
Study officials:
References:
citation: Hsu PC, Liao KK, Lin KP, Chiu JW, Wu PY, Chou CL, Wang NY, Wang JC. Comparison of Corticosteroid Injection Dosages in Mild to Moderate Idiopathic Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Nov;101(11):1857-1864. doi: 10.1016/j.apmr.2020.06.018. Epub 2020 Jul 16.
Clinical trial NCT04367090: Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
Official title: An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-29
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.

The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.


Eligibility criteria: Inclusion Criteria:

1. HER2 positive recurrent or metastasis breast cancer.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Adequate organ function.
4. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

1. Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
3. Assessed by the investigator to be unable receive systemic chemotherapy.
4. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
5. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Primary outcomes:
measure: Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel
timeFrame: Approximately 2 months
measure: Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
timeFrame: Approximately 2 months
Secondary outcomes:
measure: ORR
timeFrame: Approximately 17 months
measure: AEs+SAEs
timeFrame: Approximately 17 months
measure: λz
timeFrame: Approximately 6 months
measure: The incidence of≥3 grade diarrhea with different treatment
timeFrame: Approximately 17 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01565590: Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
Official title: Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: aneurysmal subarachnoid hemorrhage
dexmedetomidine
cytokines
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 4
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 research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.


Eligibility criteria: Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage
* World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
* Surgical intervention with clip or coil
* Placement of cerebrospinal fluid drain (lumbar or ventricular)
* Mechanically ventilated at start of infusion

Exclusion Criteria:

* Hemodynamic instability (SBP \< 100, HR \<60, or on continuous infusion of catecholamines) at screening
* Heart failure class III or IV (New York Heart Association)
* Renal failure (RIFLE classification - see table below)
* Liver failure (serum protein \< 3 g/dL and total bilirubin \> 5 mg/dL)
* Known or suspected brain death
* Pregnancy
* Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery
* Allergy to dexmedetomidine
* Prisoners

Primary outcomes:
measure: Changes between serum and CSF cytokines over 48 hours
timeFrame: 0, 24 and 48 hours
Secondary outcomes:
measure: Sedative and analgesic medication requirements
timeFrame: 2 weeks
measure: Sedation scores (RASS and CAM-ICU)
timeFrame: 2 weeks
measure: ICU length of stay
timeFrame: 2 weeks
measure: Hospital length of stay
timeFrame: 2 weeks
measure: Glasgow Outcome Scores Extended (GOSE) at discharge
timeFrame: 2 weeks
measure: Incidence of delayed cerebral ischemia (DCI)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06033690: Intervention in the Surgical Treatment of Obesity
Official title: Intervention Beyond Multidisciplinarity in the Surgical Treatment of Obesity Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: obesity
bariatric surgery
food guide
interdisciplinarity
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The worldwide prevalence of obesity reaching epidemic levels, and directly associated with several non-communicable chronic diseases, being considered the sixth leading cause of death in the world. In Brazil, estimated that one third of the population is overweight. Currently, bariatric surgery the fastest and most effective method to control the disease. However, most patients do not follow the postoperative follow-up protocol, causing weight regain. Intervention in the literature that goes beyond multidisciplinary and can prevent weight relapse. The develop and apply an interdisciplinary manual, based on the guidelines of the Food Guide for the Brazilian Population, as a support in the prophylactic treatment of weight relapse patients and bariatric surgery

Detailed description: The objective of this randomized clinical study is to compare the eating behavior of obese participants who underwent the dietary guide after bariatric surgery treatment. The main questions are:

* Can an interdisciplinary intervention through a dietary guide promote a change in eating behavior in participants undergoing surgical treatment for obesity?
* Participants will participate in consultations and receive a food guidance guide and lectures with guidance.
* Researchers will compare intervention and control groups to see if there will be changes in eating behavior

Eligibility criteria: Inclusion criteria:

Referred for bariatric surgery Having or not comorbidity associated with obesity.

Exclusion criteria:

not signing the informed consent form.

Primary outcomes:
measure: behavior
timeFrame: 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Izabele Vian
state: Rio Grande Do Sul
Study officials:
affiliation: Cardiology Institute
name: Izabele Vian
role: STUDY_DIRECTOR
References:
Clinical trial NCT05504590: Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection
Official title: Comparison of Tuohy Needle and Quincke Needle on the Incidence of Intravascular Injection During Caudal Epidural Injection Under Ultrasound Guidance: Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caudal Epidural Block
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 230
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.


Eligibility criteria: Inclusion Criteria:

1. A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
2. When NRS of back and/or radiating pain is 4 or more
3. Patients over 19 years of age

Exclusion Criteria:

1. Malignancy
2. Systemic infection
3. Bleeding tendency
4. Contrast Allergy
5. Pregnant women
6. If you cannot read or agree to the consent form
7. If you cannot sign the consent form yourself

Primary outcomes:
measure: incidence of intravascular injection
timeFrame: 1 minute after finishing caudal epidural block
Secondary outcomes:
measure: time required to complete caudal epidural block
timeFrame: Baseline, 1 second after the completion of caudal epidural block
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT06424990: Balance Training With TENS for Spastic Diplegic Cerebral Palsy
Official title: Biodex Balance Training With Transcutaneous Electrical Nerve Stimulation for Children With Spastic Diplegia: A Double-blinded, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegic Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with spastic diplegic Cerebral Palsy (CP) often show motor impairment due to a number of deficits; including poor muscle control, weakness, spasticity and reduced range of motion in the extremities. All these factors affect the ability of children with CP to maintain balance and walk which are the primary rehabilitation concerns of parents and clinicians. The Balance Trainer provides a safe balance environment and assists with muscle activation of ankle and hip joints, and it is hypothesized that to promote spasticity inhibition, the use of TENS may decrease hyper-excitability, modulate reciprocal inhibition, and increase presynaptic inhibition. To the best of the authors' knowledge, the current study is the first research to investigate the effect of using Biodex balance training with TENS in improving children with spastic diplegia.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of spastic diplegia cerebral palsy.
* Age from 10 to 12 years.
* Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
* Level II motor function according to the Growth Motor Function Classification System.
* Able to understand and follow instructions.
* Their heights are more than 100 cm and weights are more than 20 Kg which are the lower limits of height and weight needed by the Biodex stability system.

Exclusion Criteria:

* Epilepsy.
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
* Structural or fixed soft tissue deformities of the lower extremities.
* Neurological or orthopedic surgery in the past 12 months.
* Botox injection in the lower extremities in the past 6 months.
* Fracture, sprain, or strain injury of the lower extremities in the past 6 months.

Primary outcomes:
measure: hip adductor spasticity
timeFrame: change from base line at 4 weeks.
measure: spatio-temporal gait parameters
timeFrame: change from base line at 4 weeks.
measure: balance assessment
timeFrame: change from base line at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References: