louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04614259: Perioperative Pain Management for Cleft Lip in Children
Official title: Perioperative Pain Management for Cleft Lip Repair in Children, Bilateral Infraorbital Nerve Block Versus Conventional Methods( Combined IV Fentanyl With Peri Incisional Infiltration). A Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perioperative Complication Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Single blind prospective randomized comparative study. 76 children between 6 months and 3 years with cleft lip will be divided in two groups. 38 children group C conventional group and 38 children group S infraorbital nerve block group.


Eligibility criteria: Inclusion Criteria:

* good physical condition.
* Age 6 months to 3 years.
* Scheduled to undergo operations for cleft lip repair. Genders eligible for study are both .

Exclusion Criteria:

* Children posted for combined procedures like congenital heart correction with palatoplasty .
* Parents refusal .
* Bleeding disorders( platelets count \< 100.000 , international ratio \>1.5).
* Skin lesions or wounds at site of needle insertion .
* Co-morbidities as congenital heart disease , lung pathology or central nervous system
* Known hypersensitivity to local anesthetics or opioids .

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 huors
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pain terms: a list with definitions and notes on usage. Recommended by the IASP Subcommittee on Taxonomy. Pain. 1979 Jun;6(3):249. No abstract available.
citation: Lee SJ, Ralston HJ, Drey EA, Partridge JC, Rosen MA. Fetal pain: a systematic multidisciplinary review of the evidence. JAMA. 2005 Aug 24;294(8):947-54. doi: 10.1001/jama.294.8.947.
citation: Tremlett M. Anaesthesia for cleft lip and palate surgery. Curr Anaesth Crit Care. 2004;15:309-16.
citation: Doyle E, Hudson I. Anesthesia for primary repair of cleft lip and cleft palate: a review of 244 procedures. Paediatr Anaesth 1992; 2: 139-145.
citation: Takemura H, Yasumoto K, Toi T, Hosoyamada A. Correlation of cleft type with incidence of perioperative respiratory complications in infants with cleft lip and palate. Paediatr Anaesth. 2002 Sep;12(7):585-8. doi: 10.1046/j.1460-9592.2002.00906.x.
Clinical trial NCT03293459: Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt.
Official title: Influence of Shunt Occlusion on Organ Functions in Hyperammonemic Patients With Cirrhosis Having Porto-systemic Shunt. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The spontaneous Porto-systemic shunt is occluded by intervention procedures like Balloon Occluded Retrograde Transvenous Obliteration (BRTO), Plug-assisted Retrograde Transvenous Obliteration (PARTO) and shunt occlusion procedures resulting in diversion of blood flow towards the portal circulation and in turn the liver. According to this investigator hypothesized that shunt occlusion improves liver volume and function along with beneficial effect on other organ systems by decreasing ammonia and improving hepatopetal flow. All patients with cirrhosis having large shunt(\>10mm) and raised ammonia levels and will be randomized to receive standard medical treatment and those receiving shunt occlusion procedures. Investigator will assess organ functions and liver regenerative potential pre and post (after 3 to 15 months) procedure.


Eligibility criteria: Inclusion Criteria:

* Informed consent to participate in the study
* Age 18 to 70 years
* Cirrhotic patients with large shunts (\>10mm) and hyperammonemia (arterial ammonia \>1.5 x N)

Exclusion Criteria:

* Intractable ascites
* Hepatocellular Carcinoma
* Portal Vein Thrombosis or splenic vein thrombosis
* High risk esophageal varices
* Pregnant and lactation
* Significant heart or respiratory failure
* Active gastrointestinal bleeding
* Refusal to participate in study

Primary outcomes:
measure: Increase in liver volume by CT Volumetry.
timeFrame: 3 to 15 months
Secondary outcomes:
measure: Reduction in MELD (Model for End Stage Liver Disease) in both groups
timeFrame: 3 to 15 months
measure: Improvement in T Score
timeFrame: 3 to 15 months
measure: Reduction in Plasma ammonia levels in both groups
timeFrame: 3 to 15 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences
name: Dr Amar Mukund, MD
role: STUDY_DIRECTOR
References:
citation: Mukund A, Choudhury SP, Tripathy TP, Ananthashayana VH, Jagdish RK, Arora V, Singh SP, Mishra AK, Sarin SK. Influence of shunt occlusion on liver volume and functions in hyperammonemic cirrhosis patients having large porto-systemic shunts: a randomized control trial. Hepatol Int. 2023 Feb;17(1):150-158. doi: 10.1007/s12072-022-10418-4. Epub 2022 Sep 12.
Clinical trial NCT05823259: The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes
Official title: The Impact of a Widely Accessible Respiratory Muscle Training Program Integrated with Patient Education Utilizing a Hybrid Telehealth Platform on Patient-Reported Constipation Outcome Scores: a Call to Treat Beyond the Pelvic Floor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Constipation - Functional
Dyssynergia
Keywords: Pelvic floor dysfunction
Dyssynergic defecation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Physical Therapy Association
First posted: 2023-04-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study will be to determine if a respiratory muscle training program that includes both inspiratory muscle training (IMT) and expiratory muscle training (EMT), targeted at improving respiratory muscle performance-based measures combined with patient education about breathing on the toilet will improve patient satisfaction scores in individuals with chronic constipation (CC).


Eligibility criteria: Inclusion Criteria:

* Adults \>18 years of age
* Complaint of CC and associated symptoms
* Willing and able to sign an informed consent
* The ability to comply with study guidelines
* Report two or more of the following: straining during more than 25% of defecations, lumpy or hard stools more than 25% of defecations, sensations of incomplete bowel evacuation more than 25% of defecations, manual maneuvers to facilitate more than 25% of defecations, sensation of anorectal obstruction/blockage more than 25% of defecations, and fewer than 3 small bowel movements per week.

Exclusion Criteria:

* Rectal prolapse greater than grade 2
* Pregnancy
* Cognitive impairments
* Currently receiving physical therapy treatment for conditions associated with pelvic floor muscle dysfunction
* Recent surgery within the past 3 months without clearance from a medical doctor
* Medication usage that would interfere with their ability to exercise safely
* Individuals recovering from a confirmed eating disorder
* Recent unexplained weight loss \>10lbs within one month.

Primary outcomes:
measure: Change In Patient Assessment of Constipation Symptoms (PAC-SYM)
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Change In Maximal Inspiratory Pressure (PImax)
timeFrame: Baseline and 8 weeks
measure: Change In Maximal Expiratory Pressure (PEmax)
timeFrame: Baseline and 8 weeks
measure: Change in Hospital Depression and Anxiety Scale (HADS)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lawrence Cahalin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06182059: Persistent Post Surgical Pain After Total Knee Arthroplasty
Official title: Enhanced Recovery After Surgery and Total Knee Replacement: A Prospective, Randomized Study on the Rule of Peripheral Nerve Blocks on Persistent Postoperative Pain Six Months After Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthropathy
Keywords: knee arthroplasty
acute postoperative pain
persistent post surgical pain
regional anesthesia
Lead sponsor: Policlinico di Monza SpA
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergone total knee replacement are randomized to receive a "fast track" regional anesthesia protocol or a "traditional" regional anesthesia continuous infusion by both a femoral and sciatic catheter to assess if this latter technique may reduce persistent postoperative pain six months after surgery

Detailed description: Patients undergone to primary total knee replacement with spinal anesthesia are randomized to receive a continuous adductor canal block infusion + an ipack block or a continuous femoral nerve block + a continuous sciatic nerve block just at the end of surgery. Both group will receive a multimodal analgesia with paracetamol, ketorolac, desametasone and morphine as a rescue.

Eligibility criteria: Inclusion Criteria:

* primary total knee replacement with a written informed consent

Exclusion Criteria:

* Allergy to local anesthetics or any drugs involve in the study
* Controindication to regional anesthesia
* chronic use of opioids
* BMI \> 35 kg m2

Primary outcomes:
measure: Persistent post surgical pain
timeFrame: 0-6-month
Secondary outcomes:
measure: acute postoperative pain
timeFrame: 0-72 hours
measure: Morphine requirement
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Policlinico di Monza SPA
state: Monza Brianza
Study officials:
References:
Clinical trial NCT04493359: Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19
Official title: Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Covid19
Angiotensin II Receptor Antagonist Adverse Reaction
Keywords: covid19
ace inhibitors
ace2
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 18
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: The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during in-hospital stay or switch the therapy to other antihypertensive classes.

Detailed description: Patients eligible for the study, after signing informed consent will be randomized 1:1 for maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy for other classes according to a pre-specified protocol.

Patients are going to be followed during hospital stay for evaluation of clinical endpoints. Also blood and urine samples will be acquired for evaluation of renin-angiotensin system activation.

Eligibility criteria: Inclusion Criteria:

* Hypertension in use of renin-angiotensin system inhibitors
* Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical presentation and chest CT.
* Symptoms onset \< 96h
* Need for hospitalization

Exclusion Criteria:

* Heart failure
* Previous cerebrovascular disease
* Previous myocardial infarction
* Blood pressure \> 180 x 100 mmHg
* Need for 3 or more anti-hypertensive classes
* Use os spironolactone
* Severe pulmonary disease
* Contraindication for using other anti-hypertensive classes (calcium channel blockers, hydralazine, diuretics or nitrates)

Primary outcomes:
measure: Need for ICU or mortality
timeFrame: 30 days
Secondary outcomes:
measure: High sensitivity troponin levels and covid-19 severity
timeFrame: 30 days
measure: ACE-2 activity and disease severity
timeFrame: 30 days
measure: ACE-2 activity with different Renin-angiotensin system inhibitors
timeFrame: 30 days
measure: Blood control and acute renal failure
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - Incor HCFMUSP
state: SP
Study officials:
References:
Clinical trial NCT02046759: A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
Official title: A Comparative Study of an Integrated Pharmaceutical Care Plan and a Routine Care in Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to compare the effect of asthma care by clinical pharmacist intervention versus routine care on asthma control.


Eligibility criteria: Inclusion Criteria:

* patient with clinical diagnosis of bronchial asthma
* responsible for administering their own asthma medications.

Exclusion Criteria:

* patients who were not responsible for administering their own asthma medications.
* patients with cognitive defects, other pulmonary disease e.g. Chronic Obstructive Pulmonary Disease (COPD), experiencing illness with asthma-like symptoms e.g. Congestive Heart Failure, evidence of fixed airway obstruction
* patients unavailable for 2-month follow-up.
* patients who did not provide written informed consent.

Primary outcomes:
measure: Asthma Control Questionnaire
timeFrame: at baseline & after 2 months of therapy
Secondary outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1%)
timeFrame: at baseline & after 2 months of therapy
measure: Rescue Medication SABA (number of puffs used most days)
timeFrame: at baseline & after 2 months of therapy
measure: Inhaled Corticosteroid Use (number of puffs used/day)
timeFrame: at baseline & after 2 months of therapy
measure: Number of courses of systemic steroid used
timeFrame: During 2 months of therapy
measure: Number of ER visits/ Hospitalization
timeFrame: During 2 months of therapy
Other outcomes:
measure: Assessment of Inhalation Technique
timeFrame: at baseline and after 2 months of therapy
measure: Patient Adherence to Therapy
timeFrame: 2 months of therapy
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Ahram Canadian University
name: Rana R Farrag
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01195259: Malignancy Meta Analysis for BRL49653
Official title: A Meta Analysis of Malignancy Serious Adverse Events in the ADOPT, 49653/048, and RECORD, 49653/231, Studies, Comparing Metformin With Rosiglitazone.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone
ADOPT
metformin
malignancy
RECORD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5135 subjects with type 2 diabetes mellitus from the intention to treat (ITT) populations of 2 randomised, controlled studies (2576 metformin/2559 rosiglitazone)

Brief summary: Observational analyses of data from population registeries have suggested that metformin may be associated with a decreased prevalence of malignancy. The ADOPT and RECORD studies both contain groups of subjects randomly allocated to metformin and rosiglitazone. This meta-analysis combines malignancy serious adverse events from ADOPT and RECORD in order to compare their incidence on metformin with that on rosiglitazone.

Detailed description: The objective of this meta-analysis is to compare the incidence of malignancy (excluding non-melanomatous skin cancers) reported as serious adverse events in the ADOPT and RECORD studies between subjects randomly allocated to treatment with metformin with those allocated to rosiglitazone.

Eligibility criteria: Subjects from ADOPT that are included in this meta-analysis (those in the metformin or rosiglitazone groups) had the dose of their study medication increased to a maximum of 2g (metformin) or 8mg (rosiglitazone) if their fasting plasma glucose was greater than 140mg/dl.

Subjects from RECORD that are included in this meta-analsyis entered the RECORD study taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride). They were randomly allocated to metformin or rosiglitazone in a 1:1 ration to use as add-on treatment to the background of sulfonylurea. These subjects had the dose of their study medication increased to a maximum of 2.55g (metformin) or 8mg (rosiglitazone) if their HbA1c was greater than 7.0%.

Primary outcomes:
measure: Time to first occurrence of a serious adverse event of malignancy (excluding non-melanomatous skin cancers)
timeFrame: ADOPT approximately 4 years duration, RECORD approximately 5.5 years duration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Home PD, Kahn SE, Jones NP, Noronha D, Beck-Nielsen H, Viberti G; ADOPT Study Group; RECORD Steering Committee. Experience of malignancies with oral glucose-lowering drugs in the randomised controlled ADOPT (A Diabetes Outcome Progression Trial) and RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes) clinical trials. Diabetologia. 2010 Sep;53(9):1838-45. doi: 10.1007/s00125-010-1804-y. Epub 2010 Jun 8.
Clinical trial NCT01897259: Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
Official title: Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tennis Elbow
Lateral Epicondylitis
Keywords: tennis elbow
lateral epicondylitis
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 200
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: This is a prospective study where patients with lateral epicondylitis (tennis elbow) will be randomized into one of 4 possible treatments. The purpose is to individually examine the efficacy of each treatment, and determine if one treatment method is more effective than another. The four treatments are: corticosteriod injections, prolotherapy, NSAIDs (non-steroidal anti-inflammatory drugs) combined with physical therapy, and a placebo.


Eligibility criteria: Inclusion Criteria:

* pain over the lateral epicondyle (via palpation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for less than six-months duration prior to enrollment
* conservative treatment of tennis elbow is recommended as standard of care treatment
* over the age of 18 and under the age of 65
* ability to give informed consent

Exclusion Criteria:

* treatment by a health care profession (MD, physicians assistnat, therapist, or nurse practitioner) within the previous 6 months for tennis elbow
* congenital deformities, tendon ruptures, or fractures of the elbow within the previous 12 months
* immobility casts or splints within the last 6 months for tennis elbow
* co-existing elbow diagnosis (i.e. osteoarthritis or instability)
* pregnant women, women trying to get pregnant, or breastfeeding women
* under the age of 18 or over the age of 65

Primary outcomes:
measure: Symptom Severity in pre intervention assessments
timeFrame: 12 months
measure: Symptom severity in post-intervention assessments
timeFrame: 12 months
Secondary outcomes:
measure: Functional status score pre-intervention
timeFrame: 12 months
measure: Functional status score severity- post intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine M. Kleinert Institute of Hand and Microsurgery
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute for Hand and Microsurgery
name: Tuna Ozyurekoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04757259: Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
Official title: An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia
Non-hodgkin's Lymphoma
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This expanded access program will provide continued access to cerdulatinib to eligible participants who experienced clinical benefit from cerdulatinib in Study 13-601 (NCT01994382) and who otherwise meet the eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Participant has completed Portola Study 13-601 and wishes to continue treatment with cerdulatinib.
* In the opinion of the Investigator, the potential benefit to the participant of continuing to receive cerdulatinib outweighs the risks.
* Female participants of childbearing potential and male participants must agree to continue to abstain from sexual intercourse or to remain on an effective method of contraception during treatment and for 90 days following the last dose of protocol therapy (examples of effective methods of contraception include oral contraceptives or double barrier methods, such as condom plus spermicide or condom plus diaphragm).
* Participant must be willing to give written informed consent and be able to adhere to dose and visit schedules.

Exclusion Criteria:

* Participant requires chronic treatment with a strong CYP3A4 inhibitor or inducer.
* Participant has a known hypersensitivity to any of the components of cerdulatinib.
* Participant is female and is breast-feeding, pregnant, or intends to become pregnant.
* Participant is participating in any therapeutic clinical study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: