louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01420809: Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
Official title: Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 1280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Brief summary: This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.

(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)


Eligibility criteria: Inclusion Criteria:

* Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb
timeFrame: 3 months
measure: Occurrence of adverse events of bleeding
timeFrame: 3 months
measure: Presence or absence of venous thromboembolism after treatment of fondaparinux
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06907407: Effect Of Different Diaphragmatic Myofascial Release Approaches On Low Back Pain And Quality Of Life Among Young Females With Irritable Bowel Syndrome
Official title: Effect Of Different Diaphragmatic Myofascial Release Approaches On Low Back Pain And Quality Of Life Among Young Females With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Diaphragmatic Myofascial Release
Low Back Pain
Irritable Bowel Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: diaphragmatic myofascial release and visceral mobilization
Primary purpose: TREATMENT

Brief summary: this study will be conducted to investigate the effect of different diaphragmatic myofascial release approaches on low back pain and quality of life among young females with irritable bowel syndrome

Detailed description: Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder linked to disruptions in autonomic nervous system regulation, gut inflammation, alterations in stool frequency, and visceral hypersensitivity. Irritable bowel syndrome (IBS) is a chronic condition affects 7 to 21% of the general population.The symptoms usually include abdominal cramping, discomfort or pain, bloating, loose or frequent stools and constipation.The diaphragm has a fundamental role in defining posture, its maintenance, and body position changes; dysfunction of the diaphragm is one of the recognized be causes of low back and sacroiliac joint pain. People with low back pain often experience early fatigue of the diaphragm muscle, altered and reduced excursion during respiration, and inadequate proprioceptive activation.

Eligibility criteria: Inclusion Criteria:

* Subjects with irritable bowel syndrome
* Young female subjects
* All patients will have low back pain.
* All subjects will be clinically and medically stable when attending the study

Exclusion Criteria:

* Lack of attention and cooperation
* History of cancer and any systemic disease
* Pregnancy
* History of any structural gastrointestinal pathology or surgery
* History of repeated inflammatory gastrointestinal pathology
* Diabetes mellitus and lactose intolerance.
* Abuse of laxative
* Depression
* Celiac disease
* Endocrine disorders as hypothyroidism and hyperthyroidism.
* Gastrinoma
* Recent/unhealed rib fracture
* History of any lumbar spine serious pathology ( tumor, infection fracture, osteoporosis , long term use of steroid, rheumatoid arthritis and surgery )

Primary outcomes:
measure: Lumbar spine mobility
timeFrame: up to four weeks
measure: low back disability
timeFrame: up to four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT01099007: Healthy Bodies, Healthy Hearts: A Physical Activity Intervention Trial
Official title: Phase II: Healthy Bodies, Hearts After Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Cardiovascular Disease
High Blood Pressure
Keywords: Women
Menopause
Cardiovascular Disease
Physical Activity
Weight Loss
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-04-06
Enrollment: 99
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. Participants will be randomly assigned to a group.


Eligibility criteria: Inclusion Criteria:

* Not currently exercising for at least 100 minutes per week
* Have a Body Mass Index (BMI) of 25 or greater
* Has a physician in one of the three participating practices

Exclusion Criteria:

* Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
Secondary outcomes:
measure: Increase physical activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01934907: Transfusion Reaction by Washed Red Blood Cell (RBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total hip replacement arthroplasty

Exclusion Criteria:

* Patients who do not agree with this clinical study.
* Patients who have a history of transfusion for recent 1 month.
* Patients who have rare blood types.

Primary outcomes:
measure: Complication by transfusion
timeFrame: Operation day and during postoperative 5 days
Secondary outcomes:
measure: Total units of RBC transfused.
timeFrame: On the operation day and during the postoperative 5 days
measure: Hemoglobin
timeFrame: 1 day before the operation day and postoperative 1 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT04962607: Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth
Official title: Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) Versus Formocresol as Dressing Agents in Pulpotomized Primary Molars
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulpotomies on Primary Molars
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem

Brief summary: The objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC).


Eligibility criteria: Inclusion Criteria:

* primary teeth which requires pulpotomy.

Exclusion Criteria:

* not healthy patients,
* teeth which requires pulpectomy.

Primary outcomes:
measure: Success rate of the primary molar pulpotomy
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT03683407: Effect of Chemotherapy on TMB in NSCLC
Official title: Effect of Platinum-based Chemotherapy on Tumor Mutation Burden in Patients With Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy Effect
Immunotherapy
Tumor Mutation Burden
PD-1/L1 Inhibitor
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced NSCLC without druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)

Brief summary: Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
* Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* Patient can not comply with research program requirements or follow-up;
* Patient will receive immunotherapy;

Primary outcomes:
measure: Tumor Mutation Burden Change
timeFrame: every 6 weeks up to progression disease
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01775007: A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
Official title: A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Measurement of the Elasticity of the Anterior Eye Segment
Keywords: Lens
Cornea
Presbyopia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis is that the instrument can measure the Brillouin light scattering spectra from the eye safely and effectively from human subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged 20-60
* No refractional abnormalities
* Clear enough cornea and media to permit imaging

Exclusion Criteria:

* Occludable narrow angles (without a patent peripheral iridotomy)
* Other ocular or systemic pathology, which precludes safe eye dilation
* LASIK eye surgery
* Allergies to the dilation medication
* Only one healthy eye
* Pregnant women or expected pregnancy within the timeframe of the study
* Do not or cannot understand the instructions for the imaging
* Restricted mobility

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity and accuracy of Brillouin modulus measurement.
timeFrame: at time of imaging session
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Seok-Hyun Yun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scarcelli G, Yun SH. In vivo Brillouin optical microscopy of the human eye. Opt Express. 2012 Apr 9;20(8):9197-202. doi: 10.1364/OE.20.009197.
Clinical trial NCT00033007: Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics - 1
Official title: Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Keywords: substance use disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 440
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.

Detailed description: The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics.

Eligibility criteria: Inclusion Criterea:

* New intake to a drug-free CTP
* Evidence of cocaine or methamphetamine use, any reported use in past 2 weeks or positive urine screen at study intake. For those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment

Exclusion Criteria:

* Unable to give informed consent (fails simple consent quiz)
* Answers yes to question: Are you in recovery from gambling? That is, have you stopped gambling because of previous problems with gambling?

Primary outcomes:
measure: ASI
measure: Cocaine use
measure: AIDS risk behavior
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: MATRIX/LA Addictions Research
state: California
city: Alamosa
country: United States
facility: Crossroads Managed Care Systems - Alamosa
state: Colorado
city: Littleton
country: United States
facility: Arapahoe/Douglas Mental Health Network
state: Colorado
city: Pueblo
country: United States
facility: Crossroads Managed Care Systems - Pueblo
state: Colorado
city: Trinidad
country: United States
facility: Crossroads Managed Care Systems - Trinidad
state: Colorado
city: Stamford
country: United States
facility: LMG Programs, Inc.
state: Connecticut
city: Baltimore
country: United States
facility: Harbel Prevention and Recovery Center
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson Intensive Sub. Abuse TP
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Center
state: South Carolina
city: Florence
country: United States
facility: Circle Park Behavioral Health Services - Florence
state: South Carolina
city: Florence
country: United States
facility: Circle Park Behavioral Health Services - Lake City
state: South Carolina
Study officials:
affiliation: Johns Hopkins University
name: Maxine Stitzer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06643507: Evaluation of the Modified VISTA Technique Using ALB-PRF vs CTG in the Treatment of Multiple Miller Class III Recessions
Official title: Clinical Evaluation of the Modified VISTA Technique (M-VISTA )Using Albumin-platelet Rich Fibrin (Alb-PRF) Versus Connective Tissue Graft (CTG)in the Treatment of Multiple Miler Class III RT2 Recessions A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Gingival Recession
Keywords: gingival recession, plastic surgery, soft tissue management
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: treatment of miller class III RT2 gingival recession using modified vista technique using connective tissue graft vs albumin PRF

Detailed description: treatment of gingival recession is an important element in the treatment of periodontitis this study covers clinical evaluation of using the modified VISTA technique with using Albumin-PRF VS connective tissue graft in the treatment of miller class III / RT2 for root coverage outcomes

Eligibility criteria: Inclusion Criteria:

* 18 years old good oral hygiene

Exclusion Criteria:

* smokers patients with poor oral hygiene

Primary outcomes:
measure: mean root coverage
timeFrame: 6 months
Secondary outcomes:
measure: the percentage of mean root coverage
timeFrame: 6 months
measure: the percentage of complete root coverage
timeFrame: 6 months
measure: recession depth
timeFrame: 6 months
measure: recession width
timeFrame: 6 months
measure: keratinized tissue width
timeFrame: 6 months
measure: clinical attachment level
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
affiliation: Cairo University
name: Enji EA Ahmed, BDS.MDS.PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Sarah SE Elbanna, BDS.MDS.PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02597907: Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
Official title: Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Detailed description: The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Study is performed during 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Non smoking, female patients, scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Patients with gastrointestinal disorder,
* Patients with allergies to any study medication,
* Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery

Primary outcomes:
measure: The Incidence of Postoperative Nausea and Vomiting
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06483607: Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Inguinal Hernia Surgeries
Official title: Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Inguinal Hernia Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: m-tapa
tap block
laparoscopic inguinal hernia
regional anesthesia
postoperative pain
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic inguinal hernia surgeries.

Detailed description: There will be three randomized groups: Group Control (no any block, n=30) Group M-TAPA (n=30), Group TAP (n=30). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed at the end of the surgery, before awakening the patients. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.

Eligibility criteria: Inclusion Criteria:

* Adult patients older than 18 years of age who will undergo laparoscopic inguinal hernia under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment

Primary outcomes:
measure: Comparing the numerical rating scale scores
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Comparing total tramadol consumption
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
name: Oğuz Gündoğdu
role: PRINCIPAL_INVESTIGATOR
References: