louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03840096: Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty
Official title: Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
Collaborators: name: BREG, Inc
First posted: 2019-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.


Eligibility criteria: Inclusion Criteria:

1. Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel)
2. Individuals who are at least 55 years of age
3. Individuals with a body mass index (BMI) \<45
4. Must be able and willing to complete all study assessments and to be followed for the full course of the study.
5. Must be able to read, write and follow instructions in English.
6. Must be able and willing to provide informed consent.
7. Must be willing and able to attend the pre-op assessment

Exclusion Criteria:

1. Individuals with a history of any underlying neurological conditions
2. Individuals with a history of stroke
3. Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
4. Individuals with physical conditions which would make them unable to perform study procedures
5. Pregnant women or inadequate precautions to prevent pregnancy
6. Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.
7. Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis)?
8. Individuals with muscle diseases (i.e. muscular dystrophy)
9. Visible skin injury or disease on their legs
10. Principal investigator for this study, or member of study staff

Primary outcomes:
measure: Patient Acceptable Symptoms State (PASS)
timeFrame: 52 weeks post op
Secondary outcomes:
measure: Knee Osteoarthritis Outcome Score-JR (KOOS-JR)
timeFrame: 6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op
measure: Number of Participant Physical Therapy Visits
timeFrame: 3 ,6, 12, 52 week post op
measure: Range of motion
timeFrame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
measure: Strength
timeFrame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
Other outcomes:
Locations:
city: Greenville
country: United States
facility: ATI Physical Therapy
state: South Carolina
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
state: South Carolina
Study officials:
References:
Clinical trial NCT02120196: Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Official title: Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spontaneous Bacterial Peritonitis
Ascites
Liver Cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2014-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effectiveness of rifaximin versus norfloxacin for secondary prevention of spontaneous bacterial peritonitis in patients with liver cirrhosis and ascites.

Detailed description: This study will be carried out on 100 patients with liver cirrhosis and ascites who will be enrolled from Tanta University, Tropical Medicine Department in the period between January 2014 to 6 months. The selected patients will be randomly assigned to receive 400 mg of norfloxacin daily or 1200 mg of rifaximin daily and will be classified into two groups :

Group 1 : 50 patients will be treated with 1200 mg of rifaximin daily. Group 2 : 50 patients will be treated with 400 mg of norfloxacin daily.

Eligibility criteria: Inclusion Criteria:

* Previous episode of SBP
* Total protein in the ascitic fluid below or equal to 1.5 g/dL

Exclusion Criteria:

* Allergy to quinolones
* Antibiotic therapy in the 2 weeks preceding inclusion
* Recent ( within the previous 2 weeks) episode of digestive hemorrhage
* Hepatocellular carcinoma or other neoplasias able to shorten life expectancy
* Pregnant and lactating women

Primary outcomes:
measure: Number of participants with recurrence of SBP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: TUH
name: Asem A Elfert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01527396: Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer
Official title: Multi-center Prospective Observational Study for the Validation of Preoperative Low-risk Criteria for Lymph Node Metastasis in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Keywords: endometrial cancer
lymph node metastasis
lymphadenectomy
risk criteria
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Korean Gynecologic Oncology Group
First posted: 2012-02-07
Enrollment: 529
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endometrial cancer patients who undergo surgery including systemic lymph node dissection

Brief summary: The purpose of this study is to evaluate the efficacy of low risk criteria for lymph node metastasis, that was determined by KGOG-2014 retrospective study, in women with endometrial cancer.

Detailed description: The Korean Gynecologic Oncology Group (KGOG) undertook a multi-center retrospective study to develop a preoperative prediction model for lymph node metastasis in endometrial cancer (KGOG-2014). This retrospective multi-center study showed that the accurate identification of a low-risk group for lymph node metastasis among the patients with endometrial cancer can be achieved with the new criteria using preoperative MRI and serum CA-125 assay. In this study, serum CA125 levels and three MRI parameters (deep myometrial invasion, lymph node enlargement, and extension beyond uterine corpus) were found to be independent risk factors for nodal metastasis. Based on the success of KGOG-2014, Korean Gynecologic Oncology Group initiated this prospective, multi-center observational study to validate our prior prediction model.

Eligibility criteria: Inclusion Criteria:

* Patients with a histologic diagnosis of endometrial cancer before surgical staging.
* Patients with a preoperative magnetic resonance imaging (MRI) and serum CA-125 within 4 weeks from surgical staging.
* Patients who underwent adequate systemic lymph node dissection during surgical staging.

Exclusion Criteria:

* Patients with a histologic feature suggesting sarcoma or squamous cell carcinoma

Primary outcomes:
measure: Sensitivity/Specificity
timeFrame: 2014-12-31
measure: Negative predictive value
timeFrame: 2014-12-31
measure: Diagnostic odds ratio
timeFrame: 2014-12-31
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korean Gynecologic Oncology Group
state: Kangnam-gu
Study officials:
affiliation: National Cancer Center, Korea
name: Sokbom Kang
role: STUDY_CHAIR
References:
Clinical trial NCT04413396: German Register of Outpatient Parenteral Antibiotic Therapy
Official title: German Register of Outpatient Parenteral Antibiotic Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implementation of OPAT in Germany
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults getting OPAT in one of the participating study sites

Brief summary: Many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. Affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell.

Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. For these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. For the hospitals a reduced inpatient health care means a clear reduction of costs.

The aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there.

If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated OPAT could become an important therapy option with many advantages for certain patients.


Eligibility criteria: Inclusion Criteria:

* patients who get OPAT

Exclusion Criteria:

* patients who don't get OPAT

Primary outcomes:
measure: Number of Patients with effective OPAT
timeFrame: 12 weeks
measure: Number of Patients With Treatment-Related Adverse Events
timeFrame: 12 weeks
measure: Number of Hospitals being able to apply OPAT
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: Head of Outpatient Department in ID, University Hospital of Cologne
name: Clara Lehmann, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06900296: ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)
Official title: ImmuNe ParameTERs to Predict Immunotherapy REsponse and Toxicity (INTERPRET)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: immunotherapy treatment
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana Institute of Personalized Medicine
First posted: 2025-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with cancer and initiating immunotherapy treatment

Brief summary: This is a prospective observational study that will collect blood samples at 1-10 timepoints related to initiation of immunotherapy. The study may collect samples before the start of immunotherapy and/or at clinically significant timepoints during immunotherapy treatment.

Detailed description: The long-term goal of this research is to identify immunologic and other blood-borne markers of immunotherapy efficacy and toxicity. The objective of this proposal is to identify associations between immunologic parameters and other blood-borne markers with treatment response, irAE development, or relevant biomarkers of both outcomes.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent.
2. Have a diagnosis of cancer and initiating therapy with single agent or combination therapy that includes an immunotherapy (see Appendix 16.1 for list of immunotherapy classes).
3. Ability to provide written informed consent and HIPAA authorization.

Exclusion Criteria:

1. Not meeting any of the previously described inclusion criteria.

Primary outcomes:
measure: Quantification of plasma concentrations
timeFrame: through study completion (i.e. up to 12 months)
measure: Profiling of immune cells
timeFrame: through study completion (i.e. up to 12 months)
Secondary outcomes:
measure: Assessment of genomic variants
timeFrame: through study completion (i.e. up to 12 months)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Tyler Shugg, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03732716: Sarcopenia and Orthostatic Hypotension
Official title: The Relationship Between Sarcopenia and Orthostatic Hypotension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthostatic Hypotension
Sarcopenia
Keywords: blood pressure
elderly
sarcopenia
fall
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients ( 75 or older) with and without sarcopenia

Brief summary: Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Patients 75 years or older

Exclusion Criteria:

* Pace-maker
* End stage renal insufficiency
* End stage malignancy
* Dehydration
* Severe anemia ( Hgb \< 8 gr/dl)
* Acute infection
* Marked edema
* Neurodegenerative disease

Primary outcomes:
measure: Change in blood pressure
timeFrame: 0-3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şişli Hamidiye Etfal Education and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Education and Research Hospital
name: Kadriye Orta Kılıçkesmez, Prof
role: STUDY_DIRECTOR
References:
citation: Hashimoto Y, Kaji A, Sakai R, Hamaguchi M, Okada H, Ushigome E, Asano M, Yamazaki M, Fukui M. Sarcopenia is associated with blood pressure variability in older patients with type 2 diabetes: A cross-sectional study of the KAMOGAWA-DM cohort study. Geriatr Gerontol Int. 2018 Sep;18(9):1345-1349. doi: 10.1111/ggi.13487. Epub 2018 Jul 24.
Clinical trial NCT00433316: Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy
Official title: Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopic Surgical Procedures
Keywords: ropivacaine
laparoscopy
intraperitoneal
nebulization
pain
local analgesic
gynecology
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2007-02-09
Enrollment: 40
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: In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy.
* The patient is not participating in other medical study at present or in the last 30 days.
* The patient signed on an informed consent.
* Age 18 years and above.
* ASA (American Society of Anesthesiologists) physical status grade 1- 2.

Exclusion Criteria:

* Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol.
* The patient is participating in other medical experiment at present or in the last 30 days.
* Acute Pelvic Inflammatory Disease.
* Coumadin or Aspirin treatment.
* ASA physical status grade 3-4.
* Age \< 18 years.
* Significant arrythmias
* Analgesic treatment for chronic pain

Primary outcomes:
measure: VAS score
timeFrame: early post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: the Carmel Medical Center Ambulatory Gynecoendoscopic Unit
Study officials:
affiliation: Carmel Medical Center, Haifa, Israel
name: Yuval Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Medical Center, Haifa, Israel
name: Reuven Pizov, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06435416: Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
Official title: Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Off-pump Coronary Artery by Pass Surgery
Keywords: Prognostic Nutritional Index (PNI)
Off-pump coronary artery bypass (OPCAB),
Coronary artery bypass graft surgery (CABG)
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 983
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing off-pump coronary artery bypass surgery

Brief summary: This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.


Eligibility criteria: Inclusion Criteria:

• Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery

Exclusion Criteria:

* Patients without PNI value between 1 and 3 days after surgery
* Patients without PNI value between 20 and 60 days after surgery

Primary outcomes:
measure: one-year mortality
timeFrame: one-year mortality after surgery
Secondary outcomes:
measure: Overall mortality
timeFrame: Up to the last follow-up
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severnace Hospital
state: GangnamGu
Study officials:
References:
Clinical trial NCT03037216: Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans
Official title: Investigation of Exercise Training-Induced Myokines and Adipolkines in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Exercise
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo
First posted: 2017-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to find out whether exercise training leads to changes in the blood that are produced by exercised muscles and if these changes produce new hormones that affect the body's regulation of sugar and body weight.


Eligibility criteria: Inclusion Criteria:

- Age between 18-35. Body mass index (BMI) must be ≥18.5 and ≤27 kg/m2. HbA1c values ≤5.7%

Exclusion Criteria:

* Age \<18 and \>50
* HbA1c ≥ 5.7%; heart or lung disease
* acute systemic infection accompanied by fever, body aches, or swollen lymph glands
* BMI \> 27 kg/m2
* current dieting or weight loss efforts
* current pregnancy or breastfeeding
* known history of HIV/AIDS; cancer
* biochemical evidence of renal or hepatic dysfunction; renal or liver disease demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis
* recent blood donation
* clinical history of stroke
* hypertension (systolic \> 140 mmHg or diastolic \> 90 mmHg)
* type 1 or 2 diabetes; inability to exercise at 50% of predicted heart rate (HR) reserve at baseline
* Participants taking beta-blockers Participants who screen positive for The American Heart Association's contraindications to exercise testing

Primary outcomes:
measure: Changes in circulating proteins in the blood.
timeFrame: Baseline vs. Post 10 Week Training.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Laurie J Goodyear, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01566916: Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2012-03-29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.


Eligibility criteria: Inclusion Criteria:

* Patient signed an IRB, study specific informed patient consent
* Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation
* Patient has primary diagnosis of non-inflammatory degenerative joint disease.
* Patient is a candidate for primary cementless total hip replacement
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 40 Kg/m2
* Patient has an active or suspected infection at the time of device implantation
* Patient is immunologically suppressed.
* Patient requires revision surgery of a previously implanted total hip replacement
* Patient has a known sensitivity to device materials

Primary outcomes:
measure: Survivorship of Bone Preservation Tri-Lock femoral stem
timeFrame: 2 years post-op
Secondary outcomes:
measure: TUG (timed up and go) Score
timeFrame: 6 weeks post-op
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References: