louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04275427: The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
Official title: The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the efficacy of laser acupuncture on osteoarthritis (OA) knee patients by magnetic resonance imaging (MRI), clinical evaluation and movement analysis.

Detailed description: The Kellgren-Lawrence (KL) grading scheme for OA knee

Patient selecting flow Age: 20-70 year old Grade II-III knee OA Exlusion: Trauma history/ Space claustrophobia /Severe chronic disease/ Malignancy Pregnancy Study Cases 40 Randomize Pre-treatment MRI (to evaluate grade of OA knee/ the T2 signal of the cartilage), MRS (baseline glutamate), Movement analysis(sit to stand), Maximum strength ratio of Quadriceps/Hamstring WOMAC Post-treatment evaluation laser therapy Modality: LA-400 Treatment protocol of low level laser

* 40mW, 50Hz, 808nm (invisible light) , 15min
* The effect of laser acupuncture is dose dependent Effect of Laser Therapy on Chronic Osteoarthritis of the Knee in Older SubjectsJ Lasers Med Sci. 2016 Spring; 7(2): 112-119
* 830nm is an effective form of treatment for chronic knee pain caused by knee osteoarthritis. Low Level Laser Therapy for chronic knee joint pain patientsLaser Ther.

  2014 Dec 27; 23(4): 273-277
* Duration: 2 weeks Frequency: 3 times/week
* Control group: no treatment Acupuncture point: EX- LE-5, EX-EL 2, SP10

Eligibility criteria: Inclusion Criteria:

* Kellgren-Lawrence grade II \~ III

Exclusion Criteria:

* Trauma history/ Space claustrophobia/ Severe chronic disease/Malignancy Pregnancy

Primary outcomes:
measure: difference on MRI post- versus pre- treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Improve stability on movement analysis
timeFrame: 2 weeks
Other outcomes:
measure: decreased WOMAC score
timeFrame: 2 weeks
Locations:
city: Taipei
country: Taiwan
facility: ShinKongHospital
Study officials:
References:
Clinical trial NCT02278627: Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement
Official title: Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Surgery
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: During fthe first postoperative days, physiotherapists supported patients with knee replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes movements of the leg in active and non active motions, without any help and with an arthromotor, and involves walking rehabilitation.

The investigators would like to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might have a positive impact on time recovery of joint range, on postoperative oedema resorbtion and on patient's pain during rehabilitation classes.

French National Authority for Health specifies there is not a single study assessing massage effects on knee replacement, according to current bibliography.

The investigators purpose is the establishment of a prospective, controlled, randomised trial referred as a "superiority" trial. A total of 98 patients divided in 2 parallel groups will be created.

The study will be in an open-label manner for both patient and physiotherapist involved in walk rehabilitation but will be conducted as a blinded study for the investigating physiotherapist.

Inclusion period will be 17 months and the following period will be 6 weeks.


Eligibility criteria: Inclusion Criteria:

* At least 18-years-old patients.
* Men and women operated for a knee replacement.
* Patients affiliated to a social security system and having given their informed consent write.

Exclusion Criteria:

* Patients operated on Fridays
* Patients presenting contraindications to the administration of a treatment by héparine
* Patients affected by insane pathology or by confusion.
* Patients participating in another medical research
* Pregnant and breast-feeding women and without effective contraception.
* Patients under guardianship or guardianship.

Primary outcomes:
measure: To measure the joint range at day 7 after operation
timeFrame: 2 days (Day 0 and Day 7)
Secondary outcomes:
measure: To measure the oedema at day 7 after operation
timeFrame: 2 days (Day 0 and Day 7)
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
References:
Clinical trial NCT00779727: Post-Cesarean Wound Drainage is Not Necessary in Women at Increased Risk of Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pregnancy
Hemorrhage
Keywords: women
increased
risk
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-10-24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial assessing the benefit of cesarean wound drainage in pregnant women at increased risk of hemorrhage. The pregnant women at increased risk of hemorrhage were randomised in two groups. In one group 2 wound drainages were placed during the cesarean section, in the other group none. Outcome measures were difference between preoperative and postoperative hemoglobin, postoperative fever, cumulative opiate dose adjusted to body weight, length of stay and operation time. It is postulated that the pregnant women with increased risk of hemorrhage do not profit from the routine placement of wound drainages.

* Trial with surgical intervention


Eligibility criteria: Inclusion criteria:

* All pregnant women with increased risk of hemorrhage carrying singleton pregnancies, who had to undergo cesarean section.

Exclusion criteria:

* Twin-pregnancies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT05354427: Retrospective Evaluation of Commercial Spacers in Prostate Cancer Patients
Official title: Evaluation of Commercially Available Implantable Spacers, in Prostate Cancer Patients Undergoing Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: BioProtect
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 175
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate Cancer

Brief summary: Assessment of efficacy and safety of implantable spacers when used to reduce the radiation dose delivered to the organs at risk in prostate cancer patients undergoing radiotherapy.

Detailed description: Multi-center, retrospective, observational study for assessment of rectal dose reduction following implantation of the BioProtect Balloon Implant System

Eligibility criteria: Inclusion Criteria:

- Males at least 18 years of age, who have undergone radiation therapy with implantable spacers

Exclusion Criteria:

* Patients whose clinical and pathological data are not available.
* Patients have been histologically diagnosed with invasive adenocarcinoma that is extracapsular with posterior extension

Primary outcomes:
measure: Evaluation of Rectal radiation Dose
timeFrame: 1 month
Secondary outcomes:
measure: Prostate to rectum spacing
timeFrame: 1 month
Other outcomes:
measure: Incidence of adverse events throughout the treatment course and follow up period
timeFrame: 3 months
Locations:
city: Warsaw
country: Poland
facility: Institute of Maria Skłodowska, Curie (MCMCC)
city: Porto
country: Portugal
facility: Cuf Porto institution
Study officials:
References:
Clinical trial NCT04042727: Controlling Rapid Atrial Fibrillation With Dexmedetomidine
Official title: Controlling Rapid Atrial Fibrillation With Dexmedetomidine (C-RAD) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Rapid Atrial Fibrillation
Heart Rate Control
Keywords: Dexmedetomidine
Critical Care
Atrial Fibrillation
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to receive either Dexmedetomidine or Placebo in addition to Standard of Care. Investigational pharmacy will be primarily responsible for randomization.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of Dexmedetomidine (DEX), on heart rate control in patients with rapid atrial fibrillation (AF) through a pragmatic, randomized, double blinded study comparing the addition of Dex or placebo to standard of care (SOC) treatment.

Detailed description: Dexmedetomidine is a commonly used sedative/anxiolytic agent in the ICU with sympatholytic properties that can cause a decrease in heart rate. Eligible patients will be randomized into one of two groups: SOC plus Dex arm or SOC plus placebo (normal saline) arm. Study drug infusion will be administered at an infusion rate of 1μg/kg/hr via IV, and will not include a loading dose. Four 6-second telemetry rhythm strips will be collected per hour, starting one hour prior to study drug infusion, during the eight hour infusion period, and two hours post infusion cessation). Degree of heart rate control and time to heart rate control for both groups will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Adult patients in a SBU Hospital ICU with rapid-AF (with ventricular rates \>100 bpm).
* Patient screening will be conducted prior to patient or LAR consent.

Exclusion Criteria:

* Patients age \<18yrs;
* Anticipated ICU stay \<11hrs;
* Permanently paced heart rhythm;
* Known 2nd or 3rd degree heart block;
* Junctional rhythms;
* Known pregnancy;
* Known allergy to Dexmedetomidine;
* Receiving Dexmedetomidine prior to study onset;
* Non-intubated patients w/ Glasgow Coma Scale \<8;
* Weight \>400lbs (protocol dosing restriction);
* Untreated, symptomatic hypotension (SBP\<90mmHg);
* Received amiodarone, lidocaine, or mexiletine w/in 4hrs prior to consent.

Primary outcomes:
measure: Mean Systolic Blood Pressure
timeFrame: During Study Drug Infusion Period
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University
name: Andreas Kalogeropoulos, MD MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02354027: The Drug-drug Interaction of SHR3824 and Metformin
Official title: Drug Interaction Study of Henagliflozin and Metformin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SHR3824 metformin drug-drug interaction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.

Detailed description: This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 kg/m2.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SHR3824 or metformin or any of the excipients of the formulation of SHR3824 or metformin

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SHR3824.
timeFrame: At protocol-specified times up to Day 9.
measure: The area under the plasma concentration-time curve (AUC) of SHR3824.
timeFrame: At protocol-specified times up to Day 9.
measure: The maximum plasma concentration (Cmax) of metformin.
timeFrame: At protocol-specified times up to Day 9.
measure: The area under the plasma concentration-time curve (AUC) of metformin
timeFrame: At protocol-specified times up to Day 9.
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability.
timeFrame: Up tp day 9.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01767727: Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Official title: Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Finger Injuries
Soft Tissue Injuries
Keywords: surgical flap;
dorsal branch of the digital artery
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2013-01-14
Enrollment: 12
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multiple finger defects are common in hand trauma and result in functional disability. These injuries are often complex and severe, and thus reconstructive alternatives are limited. In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects. At the final follow-up, we would evaluate the efficacy of this technique.

Detailed description: At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing. The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer. The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme. The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).

Eligibility criteria: Inclusion Criteria:

1. a patient who had separate soft tissue defects in different fingers in same hand;
2. the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
3. local tissue near the defect is uninjured; and
4. a patient between 15 and 60 years of age.

Exclusion Criteria:

1. concomitant injuries to local tissue around the defect that precluded its use as donor site;
2. a defect \< 1.5 cm and ≥ 3.5 cm in length;
3. a finger degloving injury;
4. the defect of the thumb.

Primary outcomes:
measure: static two-point discrimination
timeFrame: postoperative 18-24 months
Secondary outcomes:
measure: Cold intolerance of the injured finger
timeFrame: Postoperative 18-24 months
Other outcomes:
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Hu HT, Chen WH, Liu WC, Hang QW. [Fingertip reconstruction using a volar flap based on the transverse palmar branch of the digital artery]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2005 Sep;21(5):353-5. Chinese.
citation: Al-Qattan MM. Technical modifications and extended applications of the distally based adipofascial flap for dorsal digital defects. Ann Plast Surg. 2004 Feb;52(2):168-73. doi: 10.1097/01.sap.0000101954.16674.99.
Clinical trial NCT00296127: Study of Celecoxib Bioavailability in Healthy Subjects
Official title: A Relative Bioavailability Study Of Celecoxib Administered As Capsule Contents Sprinkled On Applesauce In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the bioavailability of celecoxib administered as capsule contents sprinkled onto applesauce relative to intact capsule


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects

Exclusion Criteria:

* Standard criteria for healthy volunteer studies

Primary outcomes:
measure: Relative bioavailability of celecoxib administered as capsule contents sprinkled onto applesauce relative intact capsule after a single dose
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04172727: Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Section
Official title: Subarachnoid Block With Ultrasound-Guided Transversalis Fascia Plane Block for Cesarean Sections: A Randomized Placebo-Controlled Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caesarean Section
Pain, Acute
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain management is critical for the fulfillment of the maternal duties. The transversalis fascia plane (TFP) block provides adequate postoperative analgesia in the T12 and L1 dermatomes. The aim of this study was to investigate the effect of the TFP block on postoperative opioid consumption and pain scores in patients undergoing cesarean section (CS) under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 45
* American Society of Anesthesiologists (ASA) physical score I or II

Exclusion Criteria:

* Patients who received general anesthesia
* hypersensitivity to the agents to be used
* body mass index (BMI) greater than 35 kg/m2
* coagulopathy
* local infections
* opioid addiction
* pregnancy-related hypertension or diabetes mellitus

Primary outcomes:
measure: opioid consumption
timeFrame: Postoperative first 24hour
Secondary outcomes:
measure: pain scores
timeFrame: postoperative 0-24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ali Ahıskalıoğlu
Study officials:
References:
citation: Serifsoy TE, Tulgar S, Selvi O, Senturk O, Ilter E, Peker BH, Ozer Z. Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2020 Feb;59:56-60. doi: 10.1016/j.jclinane.2019.06.025. Epub 2019 Jun 27.
citation: Hebbard PD. Transversalis fascia plane block, a novel ultrasound-guided abdominal wall nerve block. Can J Anaesth. 2009 Aug;56(8):618-20. doi: 10.1007/s12630-009-9110-1. Epub 2009 Jun 4. No abstract available.
citation: Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.
Clinical trial NCT02695927: Rehabilitation Glasses for the Treatment of Hemispatial Neglect
Official title: Rehabilitation Glasses for the Treatment of Hemispatial Neglect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemispatial Neglect
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.
Primary purpose: TREATMENT

Brief summary: This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere.

Detailed description: Hemispatial neglect is the inability or failure to attend and respond to the left side of space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain injury frequently suffer neglect and will ignore all information located in the left side of space. Currently there is no effective rehabilitation technique to treat neglect and many of these patients have severe long-term disability. The goal of this project is to determine whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial neglect.

Eligibility criteria: Inclusion Criteria:

* Presence of hemispatial neglect as defined by Behavioral Inattention Test score of 129 or worse (maximum score 146).

Exclusion Criteria:

* Presence of aphasia at time of testing,
* Recent seizures
* Major psychiatric illness
* Prior unrelated neurological disease

Primary outcomes:
measure: Improvement of patient's hemispatial neglect scores
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.