louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03765996: Effectiveness of Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema
Official title: Effectiveness of Kinesio® Taping on Anastomotic Regions in Patients With Breast Cancer-Related Lymphoedema: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Compression Bandages
Manual Lymphatic Drainage
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 36
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: One of the most common conservative treatments of lymphoedema is Complex Decongestive Physiotherapy (CDP). The bandage is one of the most important components of the treatment process. The multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. However, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which showed that KT was an effective for patients with BCRL, it was applied on both the affected arm and anastomosis. One of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. This significant effect could also be seen by applying KT only to the anastomosis. In literature, however, there is no evidence to support this theory. So the aim of this study is to determine the effectiveness of KT which was applied to anastomotic regions along with CDP in the management of BCRL.


Eligibility criteria: Inclusion Criteria:

* Patients who had unilateral BCRL and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema.

Exclusion Criteria:

* Patients with paralysis on part of the affected arm,
* Patients who had undergone CDP more than once within six months,
* Patients who had an active infection,
* Patients who had a skin disease.

Primary outcomes:
measure: Change of the Limb Volume, (Last Value of the Follow-up - Baseline Value)
timeFrame: At baseline and at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. İsmail Atabek Physical Therapy and Rehabilitation Center
Study officials:
affiliation: European University of Lefke
name: Gülbin Ergin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Didem Karadibak, Prof.
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Tuğba Yavuzşen, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00482196: To Study Different Levels of MK0493 for Safety, Efficacy, and Tolerability in Obese Patients (0493-017)(COMPLETED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 173
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study different doses of MK0493 for safety, efficacy and tolerability in obese patients.


Eligibility criteria: Inclusion Criteria:

* Patient is between 21 and 65 years of age

Exclusion Criteria:

* HIV positive as determined by medical history
* Patient is pregnant, lactating or plans to become pregnant
* Patient has undergone surgical treatment for obesity
* Patient has undergone a surgical procedure within 4 weeks prior to Visit 1 or plans to undergo a surgical procedure during the study
* Patient plans to consume more than 2 glasses of grapefruit juice per day during the study
* Patient has participated in another clinical study (involving an investigational drug) within 3 months prior to restudy screening

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Krishna R, Gumbiner B, Stevens C, Musser B, Mallick M, Suryawanshi S, Maganti L, Zhu H, Han TH, Scherer L, Simpson B, Cosgrove D, Gottesdiener K, Amatruda J, Rolls BJ, Blundell J, Bray GA, Fujioka K, Heymsfield SB, Wagner JA, Herman GA. Potent and selective agonism of the melanocortin receptor 4 with MK-0493 does not induce weight loss in obese human subjects: energy intake predicts lack of weight loss efficacy. Clin Pharmacol Ther. 2009 Dec;86(6):659-66. doi: 10.1038/clpt.2009.167. Epub 2009 Sep 9.
Clinical trial NCT02824796: Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach
Official title: Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2016-07-07
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a new parent training protocol for children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the comorbidities.


Eligibility criteria: Inclusion Criteria:

* Parents to children 6-12 with ADHD symptoms according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V)
* The child was diagnosed in the past as ADHD by MD

Exclusion Criteria:

* Parents with psychotic symptoms or suicidality
* Parents with active manic episode
* Parents with substance dependence
* Parents with autism spectrum disorder

Primary outcomes:
measure: Change from baseline in parent-teacher-rated ADHD symptoms
timeFrame: baseline, 12 weeks, 25 weeks, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Dropout rate
timeFrame: baseline, 12 weeks, 25 weeks
measure: Change from baseline in parent-teacher-rated Comorbidities symptoms
timeFrame: baseline, 25 weeks, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Mental Health Children and Adolescent Clinic, Maccabi Health Services
Study officials:
References:
citation: Lee PC, Niew WI, Yang HJ, Chen VC, Lin KC. A meta-analysis of behavioral parent training for children with attention deficit hyperactivity disorder. Res Dev Disabil. 2012 Nov-Dec;33(6):2040-9. doi: 10.1016/j.ridd.2012.05.011. Epub 2012 Jun 29.
citation: Solan M, Brunstein Klomek A, Ankori G, Bloch A, Apter A, Plishty S. Impact of a New Parent Behavioral-Schema Training on Children with ADHD: A Pragmatic Control Trial. J Atten Disord. 2021 Dec;25(14):2048-2059. doi: 10.1177/1087054720959711. Epub 2020 Sep 30.
Clinical trial NCT05631496: Validity and Reliability of Turkish Version of Marx Activity Rating Scale
Official title: Validity and Reliability of the Turkish Marx Activity Rating Scale for Knee Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Disease
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who have knee disorders such as traumatic mensical and ligament injuries,fractures,patellofemoral pain syndrome and/or mild osteoarthritis.

Brief summary: The aim of the study is to investigate Turkish validity and reliability of Marx Activity Rating Scale for patients with knee disorders.

Detailed description: The aim of the study is to investigate Turkish validity and reliability of Marx Activity Rating Scale for patients with knee disorders.The study will include 30 patients with different types of knee disorders such as traumatic meniscal and ligament injuries,fractures,osteoarthtiris and patellofemoral joint pain.This study will conduct at Palmer\&Still Physiotherapy Clinic.The original English form will be translated into Turkish according to guidelines.Subjects will complete translated Marx Activity Rating Scale,International Knee Documentation Committee (IKDC) subjective knee form and EuroQol EQ5D.Re-testing will be obtained after 1 month.

Eligibility criteria: Inclusion Criteria:

Older than 18 years can read and write Turkish have knee disorders such as traumatic mensical and ligament injuries,fractures,patellofemoral pain syndrome and/or mild osteoarthritis

Exclusion Criteria:

Individuals with multiple ligament injuries, large osteochondral fractures, large focal cartilage defects requiring surgery, malignancy, and advanced osteoarthritis.

Primary outcomes:
measure: Marx Activity Rating Scale (MARS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Palmer and Still Physiotherapy Clinic
state: Ataşehir
Study officials:
affiliation: Yeditepe University
name: Elif Tuğçe Çil
role: STUDY_DIRECTOR
References:
Clinical trial NCT01458496: Health Coaching to Effect Lifestyle Behaviour Change
Official title: Health Coaching to Effect Lifestyle Behaviour Change: A Randomized Trial of Individuals With Pre-disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Prehypertension
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-10-24
Enrollment: 219
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes) but without pre-existing cardiovascular disease will effectively help participants change their lifestyle behaviour and prevent or delay onset of cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Age 40-60 years
* Last recorded fasting blood glucose between 6.0 abd 6.9 mmol/L
* Last recorded blood pressure between 130-139 mmHG systolic and/or85-89 mmHG diastolic

Exclusion Criteria:

* Diagnosis of diabetes on the chart
* Diagnosis of hypertension on the chart
* taking an anti-diabetic medication
* taking an antihypertensive medication

Primary outcomes:
measure: Change from baseline in lifestyle behaviours as measured by the Simple Lifestyle Indicator Questionnaire
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline in Self-efficacy
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline in score on the Framingham-based Global Risk Assessment
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline in blood pressure as measured by the BpTRU device
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline in fasting blood glucose and HbA1c as measured by the Cholestech Analyser
timeFrame: baseline, 6 months, 12 months
measure: Change from baseline in health related quality of life
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University of Newfoundland
name: Marshall Godwin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05390996: Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods
Official title: Implant Stability Changes In Dental Implants Installed By Osseodensification and Conventional Methods: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant Stability
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of Osseodensification on implant stability during the healing period The objective of this study is to compare between dental implant stability after osteotomy site preparation using osseodensification technique and conventional drilling technique immediately after implant installation (primary stability) , 6 week after the insertion of implant and 12 weeks later (secondary stability)


Eligibility criteria: Inclusion Criteria:

1. medically fit patients ≥ 18 years of age including both genders
2. alveolar ridges of sufficient vertical and horizontal dimensions
3. bone density less than 850 Hounsfield units (HU) which corresponds to D3-D5 bone density according to Misch bone classification based on preoperative CBCT findings

Exclusion Criteria:

1. Patients with high bone density (more than 850 HU which corresponds to D1 and D2 according to Misch classification are not suitable for osseodensification.
2. Patient with severe buccal plate undercut or concavity
3. Active infection or inflammation in the implant zone
4. Presence of any uncontrolled systemic diseases.
5. Any patient need advance treatment such as sinus lifting and bone augmentation.

Primary outcomes:
measure: primary stability
timeFrame: 0 day (baseline)
measure: stability at the dip period
timeFrame: 6 week post surgery
measure: secondary stability
timeFrame: 12 week post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad University
state: Babalmatham
Study officials:
affiliation: University of Bagh
name: Salwan Y Bede, BDS,FIMBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05592496: Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
Official title: Bilateral Retromuscular Rectus Sheath Block Catheters Usage for Early Postoperative Analgesia After Laparotomic Gastrectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Riga East Clinical University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Latvia
First posted: 2022-10-24
Enrollment: 100
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: In early postoperative period, the occurrence of severe pain after open major upper GI surgery is a significant issue. The study is aimed to access the efficiency of rectus sheet block with continuous bupivacaine infusion catheters into retromuscular space in providing an effective pain relief, decreasing opioid consumption and enhancing postoperative recovery.

Detailed description: This prospective randomised case-control experimental study is being conducted in Riga East University Hospital (Latvia). Patients with total or subtotal open gastrectomy were divided into two groups - half patients in the Block group and half patients in the Control group. In the Block group and control group, retromuscular catheters in the m. rectus abdominis sheath is going to be placed before fascia closure. Catheters will be placed under the direct supervision of a surgeon throughout the operation wound on both sides of the incision.

After surgery patients in the Block group will receive continuous 0.125% (10-12 mg/h) bupivacaine infusion through rectus sheath catheters for 72 h. Additionaly ketorolac or trimeperidine infusion will be performed if VAS of pains more than 30mm. If pains continue, additional opioids will be performed.

Patients in the Control group received 0,9% NaCl solution 72 hours by using the same "easy pump" system, and ketorolac or trimeperidine injection if necessery Pain intensity will be assessed in both groups using 0-100 mm Visual Analog Scale (VAS) at 24, 48 and 72 hour intervals after surgery at rest and during movement (by asking the patient to bend legs). Postoperative complications, hospital stay, comorbidities, the time taken to start walking after the surgery, bowel movements (time until first stool) were all examined.

Eligibility criteria: Inclusion Criteria:

* Open Laparotomy and gastrectomy

Exclusion Criteria:

* acute surgery

Primary outcomes:
measure: Pain scores
timeFrame: 3 days
measure: Opioid usage after surgery
timeFrame: 3 days
Secondary outcomes:
measure: Peri-operative analgesic use
timeFrame: 4 days
measure: TIme to diet and mobilisation
timeFrame: likely 5 days
measure: Time to discharge
timeFrame: approximately 7 days
measure: Postoperative complications
timeFrame: approximately 14 days
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Igors Ivanovs
city: Riga
country: Latvia
facility: Riga East Clinical University hospital
Study officials:
References:
Clinical trial NCT01060696: Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women
Official title: Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: Infertility
Saline infusion sonohysterography
Pain
Hyoscine
Mefenamic acid
women
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2010-02-02
Enrollment: 138
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.


Eligibility criteria: Inclusion Criteria:

* infertility female
* no history of HSG or Hysteroscopy

Exclusion Criteria:

* vaginal or pelvic infection
* abnormal Pap smear
* contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies

Primary outcomes:
measure: Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography
timeFrame: Before, during and after the procedure
Secondary outcomes:
measure: Patients satisfaction during saline infusion sonohysterography
timeFrame: After the procedure
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital Mahidol university
Study officials:
name: Singpetch Suksompong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03343496: Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation
Official title: Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Trachea
Intubation
Keywords: Awake fiberoptic intubation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The trial will be performed at Zhongshan Hospital, Fudan University in Shanghai, China.

Brief summary: Awake fibreoptic intubation (AFOI) is a classic and standard method for some special patients which is also difficult for anesthesiologists to learn and master. The procedure is sometimes hard and often takes about 20-30 min. Most of patients have a strong sense of discomfort. Investigators conducted the research to study the simplification and feasibility of AFOI.

Detailed description: Many studies have studied the sedative drugs and regional anesthesia related to awake intubation. However, several problems of AFOI are existing including long operation time, patients' strong discomfort, coughing and resistance. And, to investigators' knowledge, there was a lack of a fixed procedure for the implementation of AFOI. Investigators conducted the research and aimed to study the simplification and feasibility of a new AFOI method based on years of clinical theory, practice and experience.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists' physical status I-II patients
2. Aged 18-75 years
3. Mallampati Grade I-II
4. Body Mass Index 18.5-28 kg·m-2

Exclusion Criteria:

1. Allergic to the drugs involved in the study
2. Neck mass or infection
3. Drug or alcohol abuse
4. Pregnant

Primary outcomes:
measure: The average total time of Awake Fiberoptic Orotracheal Intubation (AFOI)
timeFrame: End of the AFOI
measure: The rate of one-time intubation success.
timeFrame: End of the AFOI
Secondary outcomes:
measure: Systolic blood pressure, SBP (mmHg)
timeFrame: During the AFOI
measure: Diastolic blood pressure, DBP (mmHg)
timeFrame: During the AFOI
measure: Heart rate, HR (bpm)
timeFrame: During the AFOI
measure: Rate of amnesia of the intubation
timeFrame: On the first postoperative day
measure: Ramsay sedation scale
timeFrame: During the AFOI
measure: Patients' satisfaction
timeFrame: On the first postoperative day
measure: Unexpected coughing
timeFrame: During the AFOI
measure: Relative complications
timeFrame: End of the surgery and the first postoperative day
measure: Vocal cord movement
timeFrame: During the AFOI
measure: Hypoxic episode
timeFrame: During the AFOI
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan University
state: Shanghai
Study officials:
References: