louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02104934: A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Official title: A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia in Total Knee Arthroplasty
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis of the knee, is a painful procedure and requires a multimodal analgesic approach. A method for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected around the knee joint.

Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been shown to result in minimal thigh weakness.

The investigators aim to study if the analgesia provided by ACB is superior to LIA while preserving quadriceps strength.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for primary TKA under single shot spinal anaesthesia, between ages 45-85 years old, American Society of Anesthesiologists (ASA) physical status 1 to 3 and BMI 18-35 kg/m2

Exclusion Criteria:

* Patients unable to give consent, inability to communicate/ cooperate, patients with regular consumption of strong opioids (morphine, oxycodone) or steroids, allergy to local anaesthetics or any drugs included in the study, patients with lower limb surgery in the preceding year, patients with pre-existing neurological deficits and patients who have contraindications for spinal anaesthesia.

Primary outcomes:
measure: Morphine consumption in the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Scores
timeFrame: 1, 6, 12, 24 hours; up to 48 hours postoperative
measure: Morphine Consumption
timeFrame: At 48 hours
measure: Postoperative Nausea and Vomiting
timeFrame: Up to 48 hours
measure: Sedation Scores
timeFrame: Up to 48 hours
measure: Quadriceps Strength
timeFrame: at 24 and 48 hours
Other outcomes:
measure: Presence of Complications
timeFrame: up to 48 hours
measure: Length of Hospital Stay
timeFrame: Up to 30 days
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yean Chin Lim, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04447534: Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19
Official title: Does Zinc Supplementation Enhance the Clinical Efficacy of Chloroquine/Hydroxychloroquine in Treatment of COVID-19?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 191
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: we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.

Detailed description: we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in enhancing chloroquine effect.

Eligibility criteria: Inclusion Criteria:

* Patients with positive COVID-19.

Exclusion Criteria:

* Contraindications or hypersensitivity to chloroquine.

Primary outcomes:
measure: Number of patients with improvement or mortality
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital, Assuit University, Ainshams University
Study officials:
affiliation: ass. Prof. Tropical Medicine
name: sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abd-Elsalam S, Soliman S, Esmail ES, Khalaf M, Mostafa EF, Medhat MA, Ahmed OA, El Ghafar MSA, Alboraie M, Hassany SM. Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial. Biol Trace Elem Res. 2021 Oct;199(10):3642-3646. doi: 10.1007/s12011-020-02512-1. Epub 2020 Nov 27.
Clinical trial NCT03485534: Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
Official title: Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
Collaborators: name: C&R Research, Inc.
First posted: 2018-04-02
Enrollment: 189
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomized, Parallel
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.

In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks

Detailed description: Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase.

The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
* HBeAg negative and HBeAb positive at screening

Exclusion Criteria:

* Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
* Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
* Significant renal, cardiovascular, pulmonary, or neurological disease
* currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion

Primary outcomes:
measure: HBV DNA inhibition
timeFrame: 48weeks
Secondary outcomes:
measure: viral suppression
timeFrame: 24weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Youngsuk Lim, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05806034: Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
Official title: Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Injury
MRI
Tractography
Keywords: ACL Injury
MRI
tractography
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.

The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old,
* Patient referred for non-enhanced knee MRI for traumatism.
* Affiliation to a social security program,

Exclusion Criteria:

* Person under guardianship or curators,
* Any contraindications to MRI

Primary outcomes:
measure: Anisotropy score after tractography MRI sequence
timeFrame: one day
measure: Correlation between anisotropy coefficient and ACL lesion state
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT06700434: Clinical Efficacy of In-office Bleaching With Different Concentrations of Hydrogen Peroxide
Official title: Clinical Evaluation of In-office Bleaching With Low, Medium, and High Concentrate Hydrogen Peroxide: A 6-month a Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Keywords: Hydrogen Peroxide
In-office bleaching
Randomized clinical trial
Tooth sensitivity
Whitening effectiveness
Quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 6-month a double-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Objective: The study evaluated the longevity, effectiveness, sensitivity and impact on the oral health-related quality of life of in-office dental bleaching using low, medium, and high concentrate hydrogen peroxide.

Material and Methods: Randomized, parallel, and double-blinded clinical trial was performed with 54 participants using18% hydrogen peroxide (HP), 20%HP, and 40%HP in-office bleaching agent. Tooth color was evaluated at baseline, after the 1st session bleaching, after the 2st session bleaching and 6 months (T5) after finishing the bleaching using spectrophotometer. Tooth sensitivity was measured with the Visual Analog Scale at baseline, immediately after bleaching, after 1 day, and after 7 days. The impact on quality of life was evaluated using the Oral Health Impact Profile (OHIP) questionnaire at baseline, and 6 months after bleaching.


Eligibility criteria: Inclusion Criteria:

* Women and men (at least 18 years old)
* People with good oral and general health
* People without periodontal disease
* Teeth without caries
* Teeth A3 or darker according to the VITA Easy Shade Guide (VITA Zanhnfabrik, BadSckingrn, Germany)

Exclusion Criteria:

* Having undergone teeth bleaching procedure in the last 2 years,
* People with tooth sensitivity,
* Use of fixed orthodontic appliances or prostheses on upper and/or lower anterior teeth,
* People with gingival recession,
* Discoloration due to parafunction, tetracycline or fluorosis,
* Smokers,
* Tooth fracture.

Primary outcomes:
measure: Tooth Shade evaluation
timeFrame: baseline, immediately after the first bleaching session, immediately after the second whitening session (7 days after the first bleaching), 180 days after the first bleaching session
Secondary outcomes:
measure: Tooth sensitivity evaluation
timeFrame: baseline, immediately after the first bleaching session, two hours later, and 7 days later.
Other outcomes:
measure: Impact of oral condition on quality of life
timeFrame: baseline and 180 days after bleaching
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Associate Prof
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Research assistant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06463834: A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Official title: A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

Detailed description: This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).

Eligibility criteria: Inclusion Criteria:

* ≥18 years old and ≤75 years old
* Esophageal squamous cell carcinoma diagnosed biopsy histopathology
* The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
* At least one measurable lesion
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Primary outcomes:
measure: Pathological complete response
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Major pathological response
timeFrame: 4 weeks after surgery
measure: Disease-free survival period
timeFrame: 3-year
measure: Incidence rate of adverse events
timeFrame: 3-year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT04996134: Domperidone Expanded Access Treatment Program
Official title: Domperidone Protocol - FDA Expanded Access Program
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Gastroparesis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-08-09
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

Detailed description: To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Age 12 and older
3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc\>470 milliseconds for females).
2. Hepatic dysfunction
3. Renal insufficiency
4. Clinically significant electrolyte disorders.
5. Gastrointestinal hemorrhage or obstruction
6. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
7. Pregnant or breast feeding female
8. Known allergy to domperidone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: Aurora BayCare Medical Center
name: John Bosco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883334: Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL
Official title: Efecto de la Isoprinosina en Pacientes Con infección Por VIH y Carga Viral Entre > 50 y < 200 Copias/mL de la Unidad de atención de PVV Del Hospital Enrique Garcés en Quito, Ecuador Durante el año 2019.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Universidad San Francisco de Quito
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old.
* Patients with a viral load (RNA of VIH) between \> 50 and \< 200 copies/mL after 24 weeks of antiviral therapy or after scheme change.
* Informed consent signature

Exclusion Criteria:

* Younger than 18 years old.
* No virologic failure or RNA of VIH \> 200 copies/mL.
* Presence of a serious opportunistic infection.
* Renal failure (including litiasis) or presence of gout.
* Pregnancy.

Primary outcomes:
measure: Viral load
timeFrame: Change from Baseline viral load at 3 months
Secondary outcomes:
measure: CD4+ count
timeFrame: Change from Baseline CD4+ count at 3 months
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Hospital Enrique Garces
Study officials:
affiliation: Universidad San Francisco de Quito
name: Enrique Teran, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00959634: Pharmacokinetic Study of ABT-126 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between 18 and 50 years of age
* If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
* If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration

Exclusion Criteria:

* Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
* History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
* Presence of any uncontrolled medical illness

Primary outcomes:
measure: Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)
timeFrame: One day before dosing through day of last dose and up to 6 days after last dose
measure: ABT-126 levels in blood (plasma)
timeFrame: First dose through last dose and up to 192 hours after last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Site Reference ID/Investigator# 22863
state: Texas
Study officials:
References: