louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04709874: Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder
Official title: Paravertebral Block Versus Suprascapular Block for Treatment of Frozen Shoulder: a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Shoulder
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 50
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: Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder.

Objectives: The primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. The primary outcome is pain measured through the Visual Analogue Scale (VAS) over a follow up period of 6 months.

Methods: This is a prospective randomized clinical trial that will be conducted between February 2021 and January 2022. Patients will be randomly allocated into two groups. Group I will receive paravertebral block guided by a nerve stimulator. Group II patients will receive suprascapular nerve block. Patients will be followed up at week 1, month 1, month 3 and month 6.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* presenting with frozen shoulder and were unresponsive to conservative therapy

Exclusion Criteria:

* Complete rotator cuff tear
* Osteoarthritis
* Calcified tendinitis
* History of shoulder joint injury
* Cervical radiculopathy
* Bleeding disorder
* Active infection
* Allergy to Bupivacaine
* Diabetes Mellitus

Primary outcomes:
measure: Pain score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Zoher Naja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06588374: Hemorrhoidectomy Only Versus Hemorrhoidectomy With Lateral Internal Sphincterotomy
Official title: The Effect of Lateral Internal Sphincterotomy During Hemorrhoidectomy ,a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hemorrhoidectomy alone versus hemorrhoidectomy with lateral internal sphincterotomy
Primary purpose: TREATMENT

Brief summary: The aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy.

Detailed description: Hemorrhoids arise from congestion of anal cushions and characteristically lie in the 3, 7 and 11 O clock positions (with the patient in lithotomy position) . The most common complication of open hemorrhoidectomy is postoperative pain caused by spasm of the internal sphincter . Lateral internal sphincterotomy is one good technique. It reduces pain by reducing spasm of internal anal sphincter which is the main cause of pain . The addition of lateral internal sphincterotomy to haemorrhoidectomy resulted in generally lower postoperative anal pressures . The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after lateral internal sphincterotomy . patients with recurrence of hemorrhoids, severe pain, prolonged constipation, or anyone with high sphincter tonicity in the digital rectal examination would be a candidate for manometric evaluation of anal canal pressure. These patients with high analcanal pressure confirmed with manometry might receive internal sphincterotomy plus hemorrhoid-ectomy .

Eligibility criteria: Inclusion Criteria:

1. Surgically fit according to ASA.
2. Cases with hemorrhoids Grade ll\& III \& IV.
3. Age between (18-60).

Exclusion Criteria:

1. Age less than 18 years old.
2. Complete rectal prolapse.
3. Grade I hemorrhoids.

Primary outcomes:
measure: Effect of Hemorrhoidectomy versus Hemorrhoidectomy with lateral internal sphincterotomy on post operative complications
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: ashraf A Helmy, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04939974: Probiotic in Autism
Official title: Evaluation of the Efficacy of Oral Probiotics Supplementation in Children With Autism Spectrum Disorders (ASDs): a Randomized Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One suitable probiotic packet will be administered to one group and placebo to another group of autism children and improvement in CARS will be monitored


Eligibility criteria: Inclusion Criteria:

1. All children diagnosed with Autistic Spectrum Disorders by DSM 5 criteria
2. Aged: 2-18 years.
3. Normal hearing (clinically or whenever required by Oto-acoustic emission / automated Brainstem evoked response audiometry)
4. Preferably patients from Delhi-NCR or ready to come for follow up -

Exclusion Criteria:

* On standard treatment and care for more than 12 weeks 2. Received in last 12 weeks or currently on any complementary and/or alternate therapy including dietary therapy 3. Associated chronic systemic illness 4. Known allergy to any component of probiotic supplement

Primary outcomes:
measure: change in childhood autism rating scale at 24 weeks as compared to baseline
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01511874: Efficacy and Safety Study of ELIGARD 22.5mg With Prostate Cancer
Official title: Non-comparative, Opened Multicenter Study to Assess the Efficacy and Safety of ELIGARD 22.5mg in the Treatment of Subjects With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: ELIGARD
Prostate cancer
Lead sponsor: HanAll BioPharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of ELIGARD 22.5mg in the treatment of subjects with prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Male of 20 years or above
* Subject with prostate cancer with TNM stage T2\~4NxMx
* Blood testosterone concentration ≥ 100ng/dl
* Bilirubin ≤ 1.5xULN, transaminase ≤ 2.5xULN
* WHO ECOG performance status ≤ 2
* Signed written informed consent

Exclusion Criteria:

* Hormone-Refractory Prostate cancer
* Brain metastasis
* Another primary malignant tumor except for prostate cancer
* Other conditions which in the opinion of the investigator preclude enrollment into the study

Primary outcomes:
measure: Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dl at 4 weeks after injection of ELIGARD 22.5mg
timeFrame: 4weeks
Secondary outcomes:
measure: Ratio of subjects whose blood testosterone concentration is maintained below 50ng/dL until 24weeks
timeFrame: 24weeks
measure: Ratio of subjects whose blood testosterone concentration exceed 50ng/dL until 24weeks
timeFrame: 24weeks
measure: Change in self assessment scale grade
timeFrame: 0,4, 8, 12, 24 weeks
measure: Ratio of subjects whose blood testosterone concentration is below 20ng/dL at 4weeks and 24weeks
timeFrame: 4, 24 weeks
measure: Change in ECOG performance status
timeFrame: 0,4,8,12, 24weeks
measure: Change in blood prostate-specific antigen
timeFrame: 0,4,8,12,24 weeks
measure: Change in QoL_EPIC grade
timeFrame: 0,12, 24weeks
measure: Change in penile length
timeFrame: screening, 12, 24weeks
measure: Change in testicular volume
timeFrame: screening, 12, 24weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
Study officials:
affiliation: Department of Urology,Yonsei University,College of Medicine, Gangnam Severance Hospital
name: Byung Ha Chung, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560274: A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.
Official title: An Open Label Study to Evaluate the Safety of NeoRecormon in the Treatment of Anemia in Patients With Chronic Hepatitis C Who Are Treated With Pegylated Interferon + Ribavirin Combination Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic hepatitis C;
* quantifiable serum HCV RNA;
* Pegylated interferon + ribavirin treatment started \<6 months before study;
* Hb \<10g/dL.

Exclusion Criteria:

* treatment with ESA during preceding 12 weeks;
* poorly controlled hypertension;
* history of cancer, except for basal cell cancer and cervical cancer in situ.

Primary outcomes:
measure: Blood pressure, pulse rate.
timeFrame: 6 and 12 months
measure: AEs, and laboratory parameters.
timeFrame: Throughout study
Secondary outcomes:
measure: Percentage of patients achieving correction of anemia
timeFrame: 3 months
measure: Percentage of patients not requiring blood transfusion
timeFrame: 12 months
measure: Course of Hb concentration
timeFrame: 12 months
measure: Percentage of patients maintaining initial ribavirin dose
timeFrame: 12 months
Other outcomes:
Locations:
city: Angers
country: France
city: Besancon
country: France
city: Caen
country: France
city: Chambray Les Tours
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Creteil
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Saint Laurent Du Var
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Vandoeuvre-les-nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05942274: SmartWatch ECG Evaluation Trial I
Official title: SmartWatch ECG Evaluation Trial I
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We propose to validate these smartwatch ECG functions to support FDA submissions
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.

Detailed description: 1. Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile.
2. Compare the ECG waveforms from the Smartwatch to the GE and KardiaMobile devices to demonstrate equivalence in terms of cross correlation (correlation coefficient \>.95) and RMS Difference (\<10 microvolts).
3. Compare the algorithmic determination from the Smartwatch ECG to those of the GE and KardiaMobile to demonstrate equivalence.

Eligibility criteria: Inclusion Criteria:

* Male or female \> 18 years of age.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
* Being seen in the OU Cardiac Electrophysiology Outpatient Clinic.

Exclusion Criteria:

* Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
* Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Primary outcomes:
measure: QRS amplitude
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stavros Stavrakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807274: Renal Function in Adults With Congenital Heart Disease.
Official title: Prospective Evaluation of Renal Function in Adults With Congenital Heart Disease.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiovascular Abnormalities
Kidney Failure
Keywords: Adult congenital heart disease
Heart failure
Renal failure
Proteinuria
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable adult patients with congenital heart disease

Brief summary: Impaired kidney function is associated with a poor outcome in patients with heart failure but it is not known of this is the case for patients who have been born with their heart condition (congenital heart disease). This study aims to investigate how frequently patients with congenital heart disease have kidney disease and whither this does have an impact on their outcome. The hypothesis is that kidney dysfunction will be common in these patients and may have an impact on long-term health and life-expectancy.

Detailed description: Renal dysfunction is a recognised independent prognosticator in patients with chronic heart failure. Indeed it has been suggested that the clinical impact of renal dysfunction may be greater than that of left ventricular ejection fraction per se.

The role of renal function has also been investigated in small sub-groups of patients with adult congenital heart disease (ACHD) for example peri-operatively. It is not however known if renal dysfunction has the same prevalence and significance as when present to patient with acquired heart failure. The hypothesis of the study is that renal dysfunction, both overt and sub-clinical, will be commonly detected in patients with congenital heart disease. The study proposes that renal dysfunction will be associated with hospitalisation for heart failure and fluid overload and will also identify patients at an increased risk of worsening clinical status.

Comparisons: Baseline renal function (creatinine, glomerular filtration rate by equation and clearance testing), quantification of urinalysis, baseline neurohormones. Follow-up data regarding clinical endpoints including new arrhythmia, functional deterioration, and hospitalisation.

Eligibility criteria: Inclusion Criteria:

* The ability to give informed consent
* Age \>18 years
* Congenital heart disease being treated as an outpatient

Exclusion criteria:

* Pregnancy
* Renal failure requiring renal-replacement therapy
* Known diabetes
* Shellfish, iodine, or significant drug allergy (sub-study only).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Adult Congenital Heart Disease Unit, Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Lorna Swan, MRCP MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985074: A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors
Official title: A Case Management Study Targeted to Reduce Health Care Utilization for Frequent Emergency Department Visitors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Focus is to Investigate Effect of a Case Management Interventions in Frequent Visitors to Emergency Departments
Keywords: case management, disease management, emergency
department
Lead sponsor: Health Navigator
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Ostergotland County Council, Sweden
name: Vastra Gotaland Region
name: Uppsala County Council, Sweden
name: Sormland County Council, Sweden
First posted: 2013-11-15
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to determine whether a nurse-managed telephone-based case-management intervention can reduce healthcare utilization and improve self-assessed health status in frequent emergency department users.

Detailed description: The study tests a nurse-run case-management intervention targeted towards frequent emergency department visitors. The aim is to reduce visits to emergency departments as well as to improve quality of life by facilitating coping mechanisms as well as redirecting these patients to more suitable health care facilities.

Eligibility criteria: Inclusion Criteria:

* Recent history of frequent visits to emergency department
* Anticipated sustained high visit frequency
* Living in one of five Swedish counties where trial is ongoing

Exclusion Criteria:

* Moribund patients
* Psychosis
* Severe hearing impairment or language difficulties
* Other factors that may make it impossible or impractical for a patient to participate in the study

Primary outcomes:
measure: Number of outpatient visits to medical doctor
timeFrame: During first two years of follow-up
measure: Number of hospitalizations
timeFrame: During first two years of follow-up
Secondary outcomes:
measure: Mortality
timeFrame: During first two years of follow-up
measure: Length of hospital stay
timeFrame: During first two years of follow-up
measure: Total health care costs
timeFrame: During first two years of follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Läns Landsting
Study officials:
affiliation: Health Navigator
name: Gsutaf Edgren, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
Clinical trial NCT00000274: Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics - 9
Official title: Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York State Psychiatric Institute
First posted: 1999-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of flupenthixol and haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Side effects
measure: Drug use
measure: Psychiatric symptoms
measure: Cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References: