louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04188561: Comparative Study Between Intra Articular Injection of Hyaluronic Acid (HA) With Platelet Rich Plasma (PRP) Versus Genicular Nerve Thermal Radiation in Management of Pain in Knee Osteoarthritis
Official title: Comparative Study Between Intra Articular Injection of Hyaluronic Acid (HA) With Platelet Rich Plasma (PRP) Versus Genicular Nerve Thermal Radiation in Management of Pain in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2019-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This Prospective randomized study was conducted on (100) knees with mild to moderate osteoarthritis and scheduled for Intra articular injection or Genicular nerve radiofrequency at Tanta University Hospital (Intra articular injection was done in pain clinic and Radiofrequency was done in operating room
Primary purpose: TREATMENT

Brief summary: Intraarticular injection (IAI) of Platelet rich plasma (PRP) with Hyaluronic acid (HA) Versus Radiofrequency (RF) of genicular nerve for pain reduction of of knee osteoarthritis , Improving daily activity and reduction analgesia requirements

Detailed description: In this study the investigators to comparing between the effect of Intra articular injection of hyaluronic acid (HA) with platelet rich plasma (PRP) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis.

Knee assessment and pain score recorded according to Visual Analogue Scale (VAS) after one week, one month, three months, six months following intraarticular injection and radiation.

All analgesics stopped and only (Arcoxia "etoricoxib" 60 mg, 90 mg) was taken after the procedure, total day dose and frequency will be reported, other analgesics taken by the patient is reported also.

Improvement of daily activities and clinical examination for the studied knees is observed.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate Knee osteoarthritis.
* Body mass index: 24 - 42 kg/m2

Exclusion Criteria:

* Coagulopathy.
* Acute local or systemic infections with knee effusion Previous knee surgery (relative Contraindication).

Primary outcomes:
measure: Pain Measurment via Visual analogue score
timeFrame: Measured throuout 6 months follow up session
Secondary outcomes:
measure: Analgesic requirements Comparison
timeFrame: Throuout 6 months follow up session
measure: Improvement of daily activities between 2 groups
timeFrame: Throuout 6 months follow up session
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
References:
Clinical trial NCT02086461: Pylorus Dysfunction After Esophagectomy and Gastric Tube Reconstruction. Effect of Pneumatic Pylorus Dilatation During Hospital Stay, Surgical Complications During in Hospital Stay
Official title: Pylorus Dysfunction After Esophagectomy. Effect of Pneumatic Dilatation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophagectomy
No Signs of Cancer Recurrence
Delayed Gastric Emptying
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University Hospital
name: Sahlgrenska University Hospital
name: Region Örebro County
name: Uppsala University Hospital
name: University Hospital, Linkoeping
First posted: 2014-03-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delayed emptying of the gastric tube after esophagectomy is a frequent and durable problem. No treatment is currently available. It can be hypothesized that incomplete relaxation of the pyloric sphincter may be a significant contributing factor. Pneumatic dilatation may therefore be a potentially effective treatment.

Detailed description: Patients surviving one year after esophagectomy are sent questionnaires to pick up symptoms suggestive of delayed gastric emptying.Those fulfilling predefined criteria for delayed gastric emptying will be invited to the study. The study design is sham controlled single blind with a follow up extending to twelve months post treatment.

Eligibility criteria: Inclusion Criteria:

* Previous esophagectomy and gastric tube reconstruction.
* Symptoms suggestive of delayed gastric emptying.
* signed informed consent

Exclusion Criteria:

* Signs of recurrent cancer disease
* no symptoms suggestive of delayed gastric emptying.
* unwillingness to participate

Primary outcomes:
measure: Symptoms suggestive of delayed gastric emptying
timeFrame: 3-12 months after treatment
Secondary outcomes:
measure: Quality of Life
timeFrame: 3-12 months after treatment.
measure: Delayed gastric emptying
timeFrame: 3, 6 and 12 months after treatment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, Gastrocentrum
name: Jon Tsai, ass professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081661: Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA
Official title: The Effects of Mental Imagery on Postural Control Following Anterior Cruciate Ligament Plasty - a Pilot Study of Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: ACL plasty
anterior cruciate ligament
motor imagery
postural control
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 23
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 aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty.

Detailed description: Primary and secondary outcomes will be measured twice at the hospital, a first time six weeks after the beginning of the intervention and a second time eight weeks after the four weeks of the intervention.

Twelves home-based motor imagery sessions will occur in four weeks, three times a week, to activate. The training sessions will last between 15 and 20 minutes. During each training session, the participant will note on his/her own "Tracking sheet" how long they listened to the audio and their comments. The "Tracking sheet" will document whether or not the patient has participated in each of the twelve sessions.

In parallel, a control group will follow a placebo programme according to the same formalities.

Twenty-three participants (min.) will take part in this study.

Eligibility criteria: Inclusion Criteria:

* men and women of legal age
* to be capable of discernment
* to have a telephone number or email address to communicate with the investigators, to have a device with internet access to access the mental imagery programs.
* to have had an ACL surgery performed by the Doctor Siegrist within the last three days using the Hamstrings Tendon Graft or the Kenneth Jones method.

Exclusion Criteria:

* not having a good spoken knowledge of the French language
* recurrence of ACL injury in the same knee
* meniscal sutures
* associated fractures
* pre-existing balance problems (tested at recruitment)
* pre-existing neurological problems diagnosed by a doctor.

Primary outcomes:
measure: Recruitment rate
timeFrame: 26 Weeks
measure: Enrolment rate
timeFrame: 38 Weeks
Secondary outcomes:
measure: Dynamic postural control
timeFrame: 12 Weeks
measure: Static postural control
timeFrame: 12 Weeks
measure: Changes in the functional capacities of the operated knee
timeFrame: 12 Weeks
measure: Mental representation ability
timeFrame: 6 Weeks
measure: Use of Electrotherapy
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Marielle.Pirlet
Study officials:
affiliation: HES-SO Valais-Wallis
name: Marielle Pirlet, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03247361: High-intensity vs. Low-intensity Inspiratory Muscle Training in Patients With Heart Failure
Official title: The Addition of High-intensity vs. Low-intensity Inspiratory Muscle Training to Combined Aerobic and Resistance Exercise in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure; Rehabilitation
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 90
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: It is well-known that muscle weakness and deconditioning play an important role in low exercise capacity of patients with HF. Interestingly, not only peripheral muscles are impaired, but also respiratory muscles. Studies have shown that patients with HF may have, in addition to decreasing maximal inspiratory muscle strength and endurance, metabolic and structural impairments in diaphragm fibers. Moreover, exercise capacity and weakness of inspiratory muscles have been associated with low quality of life and poor prognosis, which make the addition of inspiratory muscle training (IMT) reasonable in cardiovascular rehabilitation.The specifications of the loads to be imposed during IMT is the main factor determining the outcome. Studies of IMT have highlighted the need for a fixed inspiratory workload during exercise. Thus, purpose of this report was to perform a randomized clinical trial of the effects of addition of high-intensity vs. low-intensity IMT to combined aerobic and resistance Exercise in patients with heart failure.


Eligibility criteria: Inclusion Criteria:

* The target population consists of adults patients aged ≥ 18 years with heart failure and New York Heart Association (NYHA) class I-III.

Exclusion Criteria:

* Unstable angina;
* coronary revascularization;
* Decompensated heart failure functional class IV (NYHA);
* Recent transplant or hospitalization (6 months \<);
* Chronic Obstructive Pulmonary Disease;
* Neuromuscular, Orthopedic, Neurologic and Neoplastic Diseases;
* Recent myocardial infarction or cardiac surgery (less than 6 months);
* Atrial Fibrillation.

Primary outcomes:
measure: Aerobic Capacity
timeFrame: 10 weeks
measure: Health-Related Quality of Life: MLHFQ
timeFrame: 10 weeks
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 10 weeks
measure: Disability
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Mansueto Gomes Neto
state: BA
Study officials:
affiliation: Federal University of Bahia
name: Mansueto Gomes-Neto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06553261: Anastomotic Leakage in Right Colectomy
Official title: Open Versus Laparoscopic Right Colectomy: Does the Initial Approach Impact on Management and Outcome in Anastomotic Leakage? A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anastomotic Leak
Lead sponsor: Barmherzige Brüder Vienna
Sponsor class: OTHER
Collaborators: name: Barmherzige Brüder Salzburg
name: Kepler University Hospital
name: University of Salzburg
name: Hospital Barmherzige Schwestern Vienna
name: Medical University of Vienna
name: University Hospital, Saarland
name: Sigmund Freud PrivatUniversitat
First posted: 2024-08-14
Enrollment: 3446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with benign or malignant diseases in the right colon.

Brief summary: Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.


Eligibility criteria: Inclusion Criteria:

* Patients with benign or malignant diseases in the right portion of the colon.
* elective surgery

Exclusion Criteria:

* emergent surgery

Primary outcomes:
measure: Clinical outcome
timeFrame: 2010-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
Study officials:
affiliation: Krankenhaus der Barmherzigen Brüder Vienna
name: Bernhard Dauser, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04422561: Prophylactic Ivermectin in COVID-19 Contacts
Official title: Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-06-09
Enrollment: 340
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of COVID -19


Eligibility criteria: Inclusion Criteria:

family contact of confirmed COVID-19 case

Exclusion Criteria:

* refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin

Primary outcomes:
measure: Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
timeFrame: within 14 days after enrollement
Secondary outcomes:
measure: Development of COVID
timeFrame: within 14 days after enrollement
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
References:
Clinical trial NCT04729361: CGH-array in Prenatal Diagnosis of Isolated Severe and Early Intra-uterine Growth Restriction
Official title: CGH-array in Prenatal Diagnosis of Isolated Severe and Early Intra-uterine Growth Restriction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IUGR
Prenatal Disorder
Genetic Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: fetus with an isolated intra-uterine growth restriction (IUGR) severe (bellow the third percentile on CFEF curves) and early (between 21 and 24 gestational weeks).

Brief summary: According to french recommandations for IUGR management we have to propose a CGH-array analysis if the IUGR is severe (bellow the 3rd percentile) and early (in the second trimester). However there is no data to support this point of view.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* fetus with an isolated intra-uterine growth restriction (IUGR) severe (bellow the third percentile on CFEF curves) and early (between 21 and 24 gestational weeks).

Exclusion Criteria:

* associated IUGR (with other abnormalities during prenatal screening)

Primary outcomes:
measure: rate of abnormal CGH-array in the groupe "severe and early" UGR
timeFrame: one-time (at the time of the analysis)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06185361: Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.
Official title: Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nocturnal Enuresis
Enuresis
Enuresis, Nocturnal
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 7 years
2. Severe enuresis with at least (50%) seven wet nights out of 14
3. Failed treatment
4. The enuresis alarm was either ineffective or considered impractical due to the family circumstances.

Exclusion Criteria:

1. Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
2. Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder.
3. Untreated constipation
4. Contraindications to fluoxetine or desmopressin treatment

Primary outcomes:
measure: The children will be non-responders, partial responders, or full responders to therapy
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of medicine, Fayoum University
Study officials:
References:
Clinical trial NCT05469061: Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC
Official title: The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC，A Single-arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Locally Advanced Carcinoma
Keywords: Drug: Tislelizumab
Chemotherapy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 75 years;
2. Understand the research procedure and content, and voluntarily sign written informed consent;
3. Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging.
4. Esophageal surgery experts believe that patients with potentially resectable esophageal cancer
5. No blood transfusion was received 3 months before enrollment;
6. ECOG PS score: 0-1.

Exclusion Criteria:

* Patients meeting any of the following criteria are not eligible for inclusion:

  1. Women who are pregnant or breastfeeding;
  2. previous or concurrent malignancy;
  3. Participated in clinical trials of other drugs within four weeks;
  4. Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc.
  5. Patients with hypersensitivity to human or mouse monoclonal antibodies;
  6. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
  7. According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.

Primary outcomes:
measure: Incidence of translational treatment AE
timeFrame: up to 2 years
measure: MPR
timeFrame: up to 2 years
measure: pCR
timeFrame: up to 2 years
Secondary outcomes:
measure: R0 resection rate
timeFrame: up to 2 years
measure: Disease-free Survival，DFS
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00653861: Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Keywords: Aesthetic correction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.

Detailed description: Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.

Eligibility criteria: Inclusion Criteria:

* Be male or female, 18 years of age or older
* Desire correction of moderate to severe nasolabial folds (NLFs)
* Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score

Exclusion Criteria:

* Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
* Begin use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or are planning to begin use of such products during the study.
* Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
* Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
* Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
* Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area

Primary outcomes:
measure: Procedural Pain Score
timeFrame: 1 day
Secondary outcomes:
measure: Comparative Pain
timeFrame: 1 day
measure: Nasolabial Fold (NLF) Severity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mt. Kisco
country: United States
state: New York
Study officials:
References:
citation: Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.