louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01124500: Transdermal Methylphenidate for Cancer-Related Fatigue
Official title: Efficacy and Safety of Transdermal Methylphenidate for Cancer-Related Fatigue
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: methylphenidate
transdermal patch
placebo
fatigue
10-020
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects, good and/or bad, of the Methylphenidate patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue caused by cancer or by cancer treatment. The Methylphenidate patch contains a medication that is known to increase alertness and wakefulness. Oral methylphenidate has been used in the past to treat cancer related fatigue and is often used to treat unusual sleepiness. But this is the first time that the patch form is offered to try treating cancer fatigue in patients who cannot always swallow tablets.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of head and neck cancer who underwent combined modality treatment with curative intent
* Has not undergone cancer treatment in the last 4 weeks
* Is 21 years of age or older
* Fatigue scale score of 4 or higher
* Is able to understand English, through written and verbal communication
* In the judgment of the consenting professional, is able to provide informed consent
* Physically able to present for follow-up appointments at outpatient Radiation Oncology or Pain \& Palliative Care clinics
* Probable life expectancy of more than 6 months

Exclusion Criteria:

* Pulmonary or cardiovascular failure, seizure disorder, sleep disorder, mental impairment, psychiatric disorder, or pregnancy
* Has known sensitivity or allergies to methylphenidate
* Receiving concurrent treatment with a psychostimulant
* Hospitalized patients
* Evidence of impaired hepatic or renal function (hyperbilirubinemia, greater than two fold elevation of transaminases; \>40mg/dl BUN or \>1.5mg/dl Cr )
* Anemia ( hemoglobin \<10mg/dl)

Primary outcomes:
measure: To investigate the efficacy of sustained-release, transdermal methylphenidate compared to a placebo.
timeFrame: for 10 days
measure: To evaluate the possible side effects of a methylphenidate patch.
timeFrame: for 10 days
Secondary outcomes:
measure: To evaluate the feasibility of accelerometry-based objective outcome measures to assess improved activity levels and energy expenditure of cancer patients.
timeFrame: for 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Natalie Moryl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05632900: COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS - A PROSPECTIVE RANDOMISED CONTROLLED STUDY.
Official title: COMPARISON OF OUTCOMES OF BI-FLANGED METAL STENT ALONE VERSUS BI-FLANGED METAL STENT WITH CO-AXIAL PLASTIC STENT FOR DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ENDOSCOPIC ULTRASONOGRAPHY
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 76
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: Endoscopic ultrasound guided drainage of WON with metal stent is the mainstay of WON management.

But there are few complications related to BFMS , like bleeding due to vessel erosion, stent clogging , stent migration .

This study is to assess, whether placing an anchoring DPS through the BFMS will decrease adverse events or not.

There are only 2 retrospective studies till date ,comparing LAMS with coaxial stent vs LAMS alone.

one study showed no significant decrease in adverse events , one study showed decrease in adverse events when DPS with LAMS .

But there has been no prospective RCT to assess the utility of DPS to date

Detailed description: Inclusion Criteria: -

1. Symptomatic Walled-off pancreatic necrosis (WON)
2. Eligible for EUS guided BFMS placement
3. Signed informed consent .
4. Age \>18 Years

Exclusion Criteria: -

1. Types of pancreatic collections other than WON .
2. Drainage with stents other than BFMS
3. Previous attempts at drainage of WON
4. Coagulopathy (INR\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable.
5. Pregnancy
6. Not willing to give informed consent

Eligibility criteria: Inclusion Criteria:

1. Symptomatic Walled-off pancreatic necrosis (WON)
2. Eligible for EUS guided BFMS placement
3. Signed informed consent .
4. Age \>18 Years

Exclusion Criteria:

1. Types of pancreatic collections other than WON .
2. Drainage with stents other than BFMS
3. Previous attempts at drainage of WON
4. Coagulopathy (INR\>1.5) or thrombocytopenia(plc \<50000/cmm)- not correctable.
5. Pregnancy
6. Not willing to give informed consent

Primary outcomes:
measure: Adverse evens rates associated with both the groups ( stent clogging and stent migration, bleeding).
timeFrame: 4 weeks
Secondary outcomes:
measure: re-intervention rates
timeFrame: 4 weeks
measure: Technical success rate
timeFrame: 4 weeks
measure: Clinical success rate
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Dr Rajesh Gupta
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Rajesh Dr Gupta, MBBS MD DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04810000: The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication
Official title: The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematoma
Arthroplasty Complications
Keywords: Tourniquet
Intra articular Hematoma
Total Knee Replacement
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 113
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the study was conducted in University hospital in the Capital city , the patients were from all around the country - Jordan - , as the hospital is as tertiary hospital most of the patients were above 60 , mostly female

Brief summary: The study , observe the effect of releasing the Tourniquet in total knee replacement surgery before closure in comparison with releasing it after wound closure

The effect was assessed by Hb drop post operative and Hematoma formation ( measured by ultrasound ) as well as the wound complication

Detailed description: The study is conducted in tertiary university hospital as a referral hospital for joint arthroplasty , the patients was informed about the study and consent was taken , the same operator , same theater and the same prosthesis company as well as the same radiologist during the study period.

the patient randomly assigned to either group A (Tourniquet release before closure of the wound and hemostasis ensured ) , or a group B ( Tourniquet release after wound closure )

post operative Hb drop was studied between the groups , and each patient underwent ultrasound measurement of the intraarticular hematoma . The wound complication between the groups was also studied .

Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthrosis

Exclusion Criteria:

* Rheumatoid arthritis
* post traumatic arthritis
* revision knee replacement
* patients on anticoagulant/antiplatelet except acetylsalicylic acid 80-100 mg

Primary outcomes:
measure: Hemoglobin(HG) drop
timeFrame: ( pre-operative and post-operative day 2)
measure: Intra articular Hematoma formation
timeFrame: day three post operative hematoma formation
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
affiliation: Jordan University Hospital
name: Yazan S Hammad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02848300: Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia
Official title: Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Androgenetic Alopecia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).

Detailed description: Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia

Eligibility criteria: Inclusion Criteria:

-Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.

Exclusion Criteria:

* Patients with uncontrolled systemic disease
* History of significant cardiovascular disease
* Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders)
* Patients who have received hair transplants or have had scalp reductions
* Abnormal bone biomarker laboratory results.

Primary outcomes:
measure: Drug Concentration in Skin Biopsy Samples
timeFrame: Day 14
measure: Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch, LLC
state: Texas
Study officials:
affiliation: Allergan
name: Danielle McGeeney
role: STUDY_DIRECTOR
References:
Clinical trial NCT01742000: Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
Official title: Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Keywords: postmenopause
phytoestrogen
atherosclerosis
intima-media thickness
Lead sponsor: Institute for Atherosclerosis Research, Russia
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Women at least 5 years after menopause
* Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
* The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
* The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
* The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion

Exclusion Criteria:

* Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion
* Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)
* Personal history or diagnostic of following diseases:

  1. Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
  2. Pulmonary thromboembolism
  3. Chronic heart failure IIa-III
  4. Uncontrolled arterial hypertension (systolic blood pressure \> 145 mmHg, diastolic blood pressure \> 95 mmHg under hypotensive therapy)
  5. Malignancy
  6. Chronic renal failure II-III
  7. Chronic hepatic failure II-III
  8. Liver cirrhosis
  9. Individual intolerance of Karinat or major side effects

Primary outcomes:
measure: B-mode ultrasound of carotid arteries
timeFrame: up to 2 years
Secondary outcomes:
measure: Measure of serum atherogenicity
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00882700: To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
Official title: A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fasting State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SFBC Anapharm
name: Richard Larouche, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01199900: Single Dose Study Of PF-04171327 And Prednisone On Carbohydrate Metabolism
Official title: An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy People
Glucocorticoids
Prednisone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of a single dose of PF-04171327 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test


Eligibility criteria: Inclusion Criteria:

* BMI 17.5 to 30.5 kg/m2 and total body weight \>50 kg

Exclusion Criteria:

* Fasting glucose above the limits of the reference range for healthy individuals
* "No treatment" Oral Glucose Tolerance Test (OGTT) indicative of impaired fasting glucose or impaired glucose tolerance
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Primary outcomes:
measure: Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide
timeFrame: 4 hours
Secondary outcomes:
measure: Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma c-peptide
timeFrame: 3 days
measure: Safety: adverse events, vital sign measurements, physical examination
timeFrame: 3 days
measure: Pharmacokinetics: sparse plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK)
timeFrame: 3 days
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06498700: Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries
Official title: Intraoperative Subanesthetic Ketamine Versus Dexmedetomidine Infusion for Prevention of Post-traumatic Stress Disorder After Traumatic Brain Surgeries: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Subanesthetic Ketamine Dexmedetomidin
Keywords: Ketamine, Dexmedetomidine ,Post-traumatic Stress Disorder , traumatic Brain surgeries
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-07-12
Enrollment: 52
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: Prevention of Post-traumatic Stress Disorder after traumatic Brain surgeries by using either subanesthetic ketamine or dexmedetomidine infusion.

Detailed description: after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (K group and D group). Using computer generated randomization table; each group consists of 26 patients: K group (n=26): Patient will receive with 0.5 mg/kg/h ketamine infusion. D group (n=26): Patient will receive 0.1 ug/kg/h dexmedetomidine infusion.

Eligibility criteria: Inclusion Criteria:

Aged 18-60 years old.Body mass index of less than or equal 35.American Society of I and II.Duration of surgery not more than 3 hours.

Exclusion Criteria:

Known hypersensitivity to dexmedetomidine or ketamine. Hemorrhagic shock decompensation.History of alcohol or drug abuse.History of neurologic or psychiatric diseases Advanced renal ,liver or cardiovascular disorders.

Primary outcomes:
measure: (PTSD)
timeFrame: 6 months
Secondary outcomes:
measure: VAS
timeFrame: (24 hours, 48 hours, and 1 month)
measure: postoperative delirium
timeFrame: twice daily for 3 days
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine,Zagazig University
state: El Sharkia
Study officials:
affiliation: Zagazig University
name: marwa M Medhat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03497000: Effects of OCTA-guided PDT in Acute CSC
Official title: Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Serous Chorioretinopathy
Tomography, Optical Coherence
Keywords: optical coherence tomography angiography
central serous chorioretinopathy
photodynamic therapy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2018-04-12
Enrollment: 23
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: OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.


Eligibility criteria: Inclusion Criteria:

* Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
* Presence of SRF and/or serous pigment epithelial detachment on OCT
* Presence of abnormal dilated choroidal vasculature in ICGA

Exclusion Criteria:

* Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
* Any disease that may affect the quality of imaging (quality of OCTA images \< 6), such as cataract, high myopia or nystagmus
* History of ocular surgeries including retinal laser
* Pregnancy
* Any uncontrolled systemic disease
* Any condition rendering patients intolerable to image acquisition

Primary outcomes:
measure: Number of patients with subretinal fluid resolution on OCT after PDT of two groups
timeFrame: 3 months
Secondary outcomes:
measure: Number of patients with leakage point resolution on FFA after PDT of two groups
timeFrame: 3 months
measure: Number of recurrent CSC after PDT of two groups
timeFrame: 3 months
measure: BCVA (best corrected visual acuity) at every follow-up of two groups
timeFrame: 1 month, 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Mingwei Zhao, M.D
role: STUDY_DIRECTOR
References:
citation: Hu J, Qu J, Li M, Sun G, Piao Z, Liang Z, Yao Y, Sadda S, Zhao M. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY-GUIDED PHOTODYNAMIC THERAPY FOR ACUTE CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2021 Jan 1;41(1):189-198. doi: 10.1097/IAE.0000000000002795.