louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01927484: Hand OA AND Methotrexate Use
Official title: Methotrexate in Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Reduction in Pain
Reduction of Inflammation
Improvement in Function
Keywords: methotrexate,
osteoarthritis,
pain,
function,
synovitis
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 2
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is a common disabling condition, for which no effective therapy currently exists. Synovitis has been demonstrated in hand OA imaging. Synovial inflammation due to the release of cytokines is an important cause of pain. Methotrexate (MTX) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis.

The aim of the present study is to assess the efficacy of MTX in decreasing pain and inflammation in symptomatic hand OA.

Methods: One hundred and twenty patients with American College of Rheumatology (ACR) clinical and radiographic criteria of primary knee OA with hand pain, \[\>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization\] for \> 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. Patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. Pain will be assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment will be performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability will also be assessed. Synovitis will be detected by ultrasound imaging.


Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis
* persistent pain
* synovitis

Exclusion Criteria:

* rheumatoid arthritis
* gout and pseudogout
* traumatic arthritis
* other secondary arthritis
* renal disease
* liver disease

Primary outcomes:
measure: pain reduction
timeFrame: 28 weeks
Secondary outcomes:
measure: physical function improvement Functional assessment
timeFrame: 28 weeks
Other outcomes:
measure: safety and tolerability
timeFrame: 28 weeks
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00895284: A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy
Official title: Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hysterectomy
Keywords: robotic
laparoscopic surgical procedures
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-05-08
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500 procedures performed. Similar to the laparoscopic approach, small incisions are utilized with the robotic approach. Robotic instruments differ from laparoscopic instruments in that the tips of the instruments can rotate more like the human wrist. The instruments are attached to the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's console which is located 12 feet from the patient while the surgical assistant is at your bedside assisting in the procedure.

This study is being done to compare the procedure times and results after laparoscopic hysterectomies to laparoscopic hysterectomies performed with robotic assistance.


Eligibility criteria: Inclusion Criteria:

- All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited.

Exclusion Criteria:

- Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.

Primary outcomes:
measure: Total Procedure Time - Skin Incision to Skin Closure
timeFrame: At skin closure.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Rosanne Kho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01062984: Continuous Venovenous Hemofiltration Versus Continuous Venovenuous Hemodialysis
Official title: A Comparison of the Efficacy of Continuous Venovenous Hemofiltration Versus Continuous Venovenous Hemodialysis for Renal Replacement Therapy in Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Failure
Keywords: Renal Replacement Therapy
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: NxStage Medical
First posted: 2010-02-04
Enrollment: 11
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: Acute kidney injury is often treated with the use of continuous renal replacement therapy. Two commonly used treatments are continuous venvenous hemofiltration (CVVH)and continuous venovenous hemodialysis (CVVHD). CVVH uses convective clearance to remove toxins and solutes from the patients circulation, while CVVHD relies on diffusive clearance to remove these same toxins/solutes. This study will evaluate which of these two methods is more effective at clearing the body of waste/solutes.

We hypothesize that renal replacement therapy by either modality (hemodialysis or hemofiltration; CVVHD or CVVH, respectively) using a modern membrane and higher blood flow rates will be associated with similar clearances of both small and middle molecular weight solutes. We further believe that continuous renal replacement therapy using CVVHD will be associated with decreased clotting events and longer hemofilter survival, as well as improved resource utilization (i.e. nursing time, alarms, etc.).


Eligibility criteria: Inclusion Criteria:

* Age 18 or older and able to sign consent (or surrogate).
* Must have been referred to the inpatient Nephrology consult service for evaluation of acute kidney injury (AKI).
* Expected survival of at least 48 hours.

Exclusion Criteria:

* Hemoglobin \< 8 g/dl
* Serum potassium ≥6.5 milliequivalents per liter (mEq/L)
* Weight \> 120kg.

Primary outcomes:
measure: To compare the clearance of urea and creatinine by renal replacement therapy (RRT) using continuous venovenous hemofiltration versus continuous venovenous hemodialysis.
timeFrame: 48 hours
Secondary outcomes:
measure: To compare the clearance cystatin C and inflammatory cytokines (IL-6 and IL-10) by RRT using continuous venovenous hemofiltration versus continuous venovenous hemodialysis.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jay Koyner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
Clinical trial NCT03981484: REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
Official title: REPlaCE- Randomized Trial Evaluating the Use of Prothrombin Complex concEntrate to Improve Survival in Patients With Traumatic Coagulopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coagulopathy
Hemorrhage
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 280
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.


Eligibility criteria: Inclusion Criteria:

1. ≥15 years old
2. anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2

Exclusion Criteria:

1. Cardiopulmonary Resuscitation \> 5 minutes
2. Penetrating cranial injury or exposed brain matter
3. Anticoagulation treatment
4. Transfer patients
5. Known pregnancy
6. Prisoners

Primary outcomes:
measure: 24 Hour Mortality
timeFrame: 24 hours after enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Bellal Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06213584: Mulligan and Proprioceptive Neuromuscular Fasciliation Techiniques in Rotator Cuff Pathology
Official title: The Effectiveness of Mulligan and Proprioceptive Neuromuscular Fasciliation Techiniques in Rotator Cuff Pathology: A Randomized Controlled Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: rotator cuff injuries
mulligan mobilization
proprioceptive neuromuscular fascilitation
pain
functionality
quality of life
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of Mulligan Mobilization techniques, Mobilization with Movement (MWMs) and Proprioceptive Neuromuscular Facilitation (PNF) techniques, Hold-Relax Active Movement Technique, on pain, normal joint range of motion, proprioception, scapular dyskinesia and functional status in individuals with rotator cuff syndrome.

A total of 60 people were included in the study: 20 participants in the censervative rehabilitation group (Conservative Treatment), 20 participants in the Treatment A (Mulligan Mobilization Application) Group, and 20 participants in the Treatment B (PNF Application) Group. Individuals were treated for 5 days for 4 weeks. Pain before and after treatment with Visual Analog Scale; joint range of motion with goniometer; With proprioception Angle Repetition Test; Scapular dyskinesia with Lateral Scapular Slide Test; quality of life with SF-36; shoulder functionality was assessed with the Western Ontario Rotator Cuff Scale (WORC).


Eligibility criteria: Inclusion Criteria:

* between the ages of 25-75,
* diagnosed with rotator cuff syndrome,
* patients who did not have any obstacle to the evaluation parameters

Exclusion Criteria:

* having had shoulder surgery,
* presence of scoliosis,
* presence of cardiac pacemaker,
* history of recent myocardial infarction,
* presence of malignancy,
* corticosteroid treatment within the last 3 months

Primary outcomes:
measure: goniometer
timeFrame: 12 months
measure: visual analog scale
timeFrame: 12 months
measure: angle repetition test
timeFrame: 12 months
measure: lateral scapular glide test
timeFrame: 12 months
measure: Western Ontario Rotator Cuff Index
timeFrame: 12 months
measure: SF-36
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
affiliation: Okan University
name: Gamze AYDIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05659602: A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
Official title: A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in Participants Diagnosed With Asymptomatic or Mild COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Disease 2019(COVID-19)
Keywords: COVID-19
Treatment
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of asymptomatic or mild COVID-19.

Detailed description: During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive days, the efficacy and safety of HH-120 will be assessed throughout the study period based on viral clearance, clinical recovery, illness severity and adverse events.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old.
* Participants with mild COVID-19 with symptom onset≤5 days or asymptomatic COVID-19.
* Participants being able and willing to provide informed consent prior to any study-specific procedure.

Exclusion Criteria:

* Participants with moderate or severe COVID-19.
* Participants within the pregnancy or breastfeeding period or plan to be pregnant during the study period.
* Participants requiring oxygen treatment (such as non-invasive ventilation, invasive mechanical ventilation, ECMO, etc.).
* Participants with nasal disease that is inconvenient or intolerant of nasal spray administration, or cannot use the nasal spray treatment.
* Participants with comorbid Malignancy or with a history of malignancy.
* Participants with active or uncontrolled systemic autoimmune disease.
* Insufficient function of key organs.
* Other reasons considered by the investigator to be unsuitable for the trial.

Primary outcomes:
measure: Time to achieving SARS-CoV-2 clearance (defined as negative quantitative Real-Time polymerase chain reaction [qRT-PCR] tests taken on two consecutive days).
timeFrame: Up to 12 days
measure: Proportion of participants with SARS-CoV-2 clearance.
timeFrame: Up to 12 days
Secondary outcomes:
measure: Clinical recovery of COVID-19.
timeFrame: Up to 12 days
measure: Viral load.
timeFrame: Up to 12 days
measure: Adverse event.
timeFrame: Up to 12 days
Other outcomes:
measure: Proportion of the participants who have progression of COVID-19.
timeFrame: Up to 12 days
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT01811602: Gynecological Pelvic Floor Muscle Training
Official title: The Efficacy of Pelvic Floor Muscle Training in Gynecological Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: Training
Physiotherapy
Pelvic floor muscles
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: British Columbia Cancer Agency
First posted: 2013-03-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial pilot study to test the efficacy of a pelvic muscular training intervention led by a physiotherapist on urinary incontinence, quality of life and sexual health in women who report urinary urgency and incontinence following surgery and radiation treatment for gynecological cancer vs. usual care (a 1-page sheet on Kegel exercises).


Eligibility criteria: Inclusion Criteria:

- treated with surgery and adjuvant treatment, including radiation, for gynecological cancer within the last 3 years

Exclusion Criteria:

* stage IV cancer or stage III and IV cervical cancer
* radiation not part of treatment
* known spinal or long bone metastases diagnosis with a neuromuscular disorder that may impact pelvic floor muscle function
* urinary incontinence issues prior to cancer diagnosis
* scheduled or previous surgical treatment of incontinence
* fecal incontinence
* body mass index (BMI) \> 35
* use of medications to improve bladder function
* unable to complete questionnaires in English or unable to actively participate in physiotherapy treatment provided in English.

Primary outcomes:
measure: Urinary incontinence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Women's Health Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kristin Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426802: Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Official title: A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: metformin
vildagliptin
T2DM
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.


Eligibility criteria: Inclusion Criteria:

* Patients who sign the informed consent
* HbA1c in the range of \> 7 to ≤10.5% at Visit 1
* Ability to comply with all study requirements

Exclusion Criteria:

* Pregnant or lactating women
* Serious cardiovascular disorders
* Liver/renal disease or dysfunction
* Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
* Laboratories values abnormalities as defined by the protocol

Primary outcomes:
measure: Evaluate the safety and tolerability of vildagliptin 50 mg bid
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01858402: Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
Official title: The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Other Acute Postoperative Pain
Keywords: Pediatric spinal anesthesia, paracetamol, dipyrone
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 2
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.

Detailed description: The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery

Exclusion Criteria:

* increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs

Primary outcomes:
measure: Change from pain intensity until postoperative 6 hours
timeFrame: Pain intensity recorded until postoperative 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Caliskan E, Sener M, Kocum A, Ozyilkan NB, Ezer SS, Aribogan A. The efficacy of intravenous paracetamol versus dipyrone for postoperative analgesia after day-case lower abdominal surgery in children with spinal anesthesia: a prospective randomized double-blind placebo-controlled study. BMC Anesthesiol. 2013 Oct 22;13(1):34. doi: 10.1186/1471-2253-13-34.
Clinical trial NCT03565302: Beta2-adrenergic Agonism and Muscle Remodelling
Official title: Gender-specific Role of the beta2-adrenergic Stimulation With Short- or Long-acting Selective Agonist in Relation to Muscle Remodelling, Function, Performance, and Anti-doping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophy
Physiologic Hypertrophy
Physical Activity
Keywords: Proteome
VO2max
Muscle function
Exercise performance
Skeletal muscle
Doping
Anti-Doping
Enantiomeric analysis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping


Eligibility criteria: Inclusion Criteria:

* Healthy men and women, aged 18-45 years
* VO2max \>55 ml/kg/min for men and \>50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982)
* Body Mass Index (BMI) \< 26

Exclusion Criteria:

* Chronic user of beta2-agonist or allergy towards study drugs
* Serious adverse side effects of the used study drug
* Chronic disease that by the project physician would affect any of the outcomes of the study
* Smoker
* Chronic use of prescription medication (other than contraceptives for women)
* Pregnancy

Primary outcomes:
measure: Proteome enrichment
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Body composition
timeFrame: Baseline, 2 weeks, 4 weeks and 6 weeks
measure: Maximal oxygen consumption (VO2max)
timeFrame: Baseline, 2 weeks, 4 weeks and 6 weeks
Other outcomes:
measure: Drug exposure
timeFrame: Day 1-14 and day 49-56
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References: