louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03525860: Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
Official title: The Feasibility of Acupuncture Treatment in the Post-Operative Cardio-Thoracic Setting for Arrhythmias in Patients Undergoing Open Heart Surgery- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Operative Atrial Fibrillation
Acupuncture Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A feasibility study on the provision of acupuncture treatment in the hospital to 20 patients who have undergone open heart surgery procedures. The acupuncture treatments may begin as early as postoperative Day 2.

Detailed description: Primary Aim • Evaluate the feasibility of providing acupuncture in the hospital setting for 20 patients undergoing open heart surgery and subsequently develop arrhythmias.

Secondary Aims

• Evaluate the short-term effect of acupuncture including the effects on patient's arrhythmias, stress, anxiety, and pain measured by Electrocardiogram monitoring and Electrocardiography, VAS scores, and WIWI questionnaire for the patient.

Eligibility criteria: Inclusion Criteria:

1. Patients who have undergone CABG and/or cardiac valve operations.
2. Patients developing postoperative atrial fibrillation, and documented by ECG prior to acupuncture intervention, and treated with the common anti arrhythmic treatment of the department.
3. Patients moving to the step-down unit on postoperative day 2 or later.
4. Ability to provide informed consent.
5. Ability to speak English and complete all aspects of this trial.
6. At least 18 years of age.

Exclusion Criteria:

1. Patients with any other cardiac or non-cardiac concomitant procedures.
2. Patients with suspected sternal wound infection and/or with prolonged sternal wound dressing and wound- Vac-system application or open chest wound.
3. Patients with abnormal postoperative track staying in the intensive care unit for any clinical reason or hemodynamic compromise.
4. Patients with platelet count \<50,000
5. Patients in a severe immunocompromised state.
6. Pregnant women. All patients who meet the criteria will have their medical records reviewed to ensure they are not pregnant.

Primary outcomes:
measure: Acupuncture treatment in the hospital setting
timeFrame: 3 days post surgery
Secondary outcomes:
measure: Number of patients with recurrent atrial fibrillation
timeFrame: 3 consecutive days post-surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Chaim Leker Locker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05352360: Comparison of Pilates Exercises Verses Muscle Energy Techniques Along With Kinesio Taping in Non-Specific Low Back Pain
Official title: Comparison of Pilates Exercises Verses Muscle Energy Techniques Along With Kinesio Taping in Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilates Exercises With Kinesio Taping
Muscle Energy Techniques Along With Kinesio Taping
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will help to compare the effects of pilates Exercises with kinesiotaping and on other hand the effects of muscle energy technique with kinesiotaping for improving pain
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To Compare the effects of Pilates Excercises versus muscle energy technique along with kinesiotaping in non specific low back pain.

Detailed description: This study will help to compare the effects of pilates Exercises with kinesiotaping and on other hand the effects of muscle energy technique with kinesiotaping for improving pain, disability and Range of Motion in patient with non specific low back pain. By combining these interventions, time consumption for treatment and disability among community due to low back pain will be reduced. This treatment will be effective for participants for improving function, movement of joints and muscle to manage and treat low back pain. The combination of treatment will be more effective to relief non specific low back pain. The targeted population of 18-40 years old and most of them are having occupational related low back pain or due to bad posture, study will have an impact in improving and managing the low back pain in such population.

Eligibility criteria: Inclusion Criteria:

* Subjects of both genders should present with non-specific low back pain and between 18 and 40 years of age.(21)
* Could maintain their standing posture independently for _\>30s.
* Patient having enough physical autonomy to participate in the physical activities required by the study.
* The patient having a visual analog scale (VAS) score of equal to or \>3 will be included.(16).

Exclusion Criteria:

* A history of spinal surgery, compression fracture, spondylolisthesis, or sciatica, ongoing pregnancy, experiencing hypertension, cardiovascular disease, diabetes mellitus, liver disease, renal disease, rheumatoid arthritis, or other rheumatologically related pathologies (8).
* Those taking corticosteroids 2 weeks before recruitment.
* Hypersensitivity to the tape(6).

Primary outcomes:
measure: Pilates Exercises Verses Muscle Energy Techniques Along with Kinesio Taping
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudhary Muhammad Akram Teaching and research hospital, Jinnah Hospital Lahore and Mayo Hospital Lahore
state: Punjab
Study officials:
References:
Clinical trial NCT06331260: Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma
Official title: Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Transplantation
Hepatocellular Carcinoma
Alpha-Fetoprotein
Protein Induced by Vitamin K Absence or Antagonist-II
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shulan (Hangzhou) Hospital
First posted: 2024-03-26
Enrollment: 600
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: HCC patients who undergoing deceased donor liver transplantation for the first time.

Brief summary: As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
2. Patients undergoing deceased donor liver transplantation for the first time.

Exclusion Criteria:

(1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up, (5) taking warfarin at the time of LT biomarker measurements

Primary outcomes:
measure: Recurrence free survival rate
timeFrame: 2024.4.1-2028.4.1
measure: Overall survival rate
timeFrame: 2024.4.1-2028.4.1
measure: Tumor recurrence rate
timeFrame: 2024.4.1-2028.4.1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00547560: Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population
Official title: An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2007-10-22
Enrollment: 49
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women, greater than or equal to 65 years of age.
* Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight \>50 kg.

Exclusion Criteria:

n/a

Primary outcomes:
measure: The pharmacokinetic and pharmacodynamic profile for the elderly subjects.
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics (PK)
timeFrame: 6 months
measure: Pharmacodynamics (PD)
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03702660: Effect of GIP After a Meal in Patients With Type 2 Diabetes
Official title: Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2018-10-11
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.


Eligibility criteria: Inclusion Criteria:

* Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes
* HbA1c \< 75 mmol/mol
* BMI \> 27 kg/m2
* Stable weight (+/- 5%) during the last 3 months

Exclusion Criteria:

* Treatment with medicine or dietary supplements that cannot the paused for 12 hours
* More than 14 units of alcohol weekly or abuse of drugs
* Liver disease, estimated at plasma ALAT levels \> 3 x normal value or INR outside normal range
* Reduced kidney function (estimated at eGFR \< 60 ml/min/1,73 m2)
* Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)
* Low red blood cell count (hemoglobin \< 8.3 mmol/l
* Special diet or planned weight change during the trial period
* Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial

Primary outcomes:
measure: Glucagon
timeFrame: 8 weeks - 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Gentofte Hospital
Study officials:
affiliation: Center for Diabetes Research
name: Signe Stensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05782660: Cash Benefits and Reproductive/Perinatal Health
Official title: Cash Benefits and Reproductive/Perinatal Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Maternal Care Patterns
Pregnancy Related
Miscarriage
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2023-03-23
Enrollment: 3615
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the first two years of the COVID-19 pandemic, the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months. Using data from the Chelsea Eats program, the investigators propose to study the impact of the cash benefit on reproductive and perinatal health.


Eligibility criteria: Inclusion Criteria:

* Resident of Chelsea, Massachusetts
* Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income
* Childbearing age

Exclusion Criteria:

* See inclusion criteria

Primary outcomes:
measure: Pregnancy
timeFrame: 20 months
Secondary outcomes:
measure: Miscarriage
timeFrame: 20 months
measure: Abortion
timeFrame: 20 months
measure: Prenatal vitamin prescriptions prior to pregnancy
timeFrame: 10 months
measure: Contraception
timeFrame: 10 months
measure: Number and timing of prenatal visits before delivery
timeFrame: 20 months
measure: Composite of birth outcomes
timeFrame: 20 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital and Harvard Medical School
name: Sumit D Agarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01553760: The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Cataract
TRI-MICS
ACM
MICS
phacoemulsification
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal incision).

Detailed description: Three-port Micro Incision Cataract Surgery (Tri-MICS) is a technique suggested by Professor Assia. The idea (principle) behind the Tri-MICS technique is the use of a sleeveless phaco needle which is introduced via a tiny incision (1.1mm). An additional corneal incision is made for the introduction of a second surgical instrument, and a third for an ACM as an exclusive source for the infusion - this saves the need for an additional instrument. The ACM that will be used in this study (AVI New York) is a small metal tube with an external diameter of 1.1 mm, and an internal diameter of 0.9 mm and was developed specifically for this use. This type of ACM has been used in hundreds of surgeries and has been found to be both effective and safe.

This procedure has 4 clear advantages:

1. The implementation of three corneal incisions, 1.1 mm wide with an angle of approximately 120 degrees between them - neutrality regarding astigmatism versus the Biaxial-MICS.
2. This procedure does not require any special medical instruments, for example; new phaco instruments which are specifically adapted for the MICS approach at the cost of tens of thousands of dollars.
3. This procedure allows a free use of the surgeon's second hand.
4. A fixed intraocular infusion keeps the intraocular pressure (IOP) and anterior chamber volume constant and stable.

Eligibility criteria: Inclusion Criteria:

* Bilateral Cataract
* Ability to understand and sign on an inform consent form.
* whiling to undergo bilateral cataract surgery.

Exclusion Criteria:

* Mature Cataract
* PXF
* Uveitis
* Corneal Pathology
* Endothelial cell density\<1500 cells/mm
* Glaucoma
* Extreme Hyperopia / shallow anterior chamber
* Extreme Myopia
* s/p Ophthalmic Trauma / Surgery
* Allergy to Penicillin / IOD

Primary outcomes:
measure: Corneal temperature
timeFrame: up to 12 months
Secondary outcomes:
measure: Anterior chamber stability
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT03719560: Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
Official title: Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma

Detailed description: This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.

Eligibility criteria: Inclusion Criteria:

* New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens
* No central nervous system involvement on initial staging
* Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale)
* Renal function: creatinine clearance \>45 ml/min
* Not pregnant; agreeable to contraception
* Written informed consent
* High risk for central nervous system recurrence as determined by one of the following high-risk features:

  1. high central nervous system International Prognostic Index,
  2. testicular, breast, or uterine involvement,
  3. dual expresser or double/triple-hit status,
  4. HIV positive status, or
  5. Molecularly defined high-risk subtype.

Exclusion Criteria:

* pregancy
* unable to provide informed consent
* significant comorbidity in the investigator's judgement

Primary outcomes:
measure: Proportion with clinically significant toxicity
timeFrame: 1 year
Secondary outcomes:
measure: Cumulative incidence of central nervous system recurrence
timeFrame: 2 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Roxanne Wood
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Adam J Olszewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05757960: TMD-specific Physiotherapy in hEDS Patients Individuals With Hypermobile Ehlers-Danlos Syndrome
Official title: Effects of TMD-specific Physiotherapy in Individuals With Hypermobile Ehlers-Danlos Syndrome
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypermobile Ehlers-Danlos Syndrome
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: German Society of Craniomandibular Function and Disorders in the DGZMK.
First posted: 2023-03-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze the effects of strictly defined physiotherapy in patients temporomandibular dysfunction (TMD) and hypermobile Ehlers-Danlos Syndrome (hEDS). Patients will be clinically examined before starting physiotherapy and fill in the questionnaires. Subsequently, it will be followed up whether changes occur as a result of physiotherapy.

This study is a pilot study and is intended to be hypothesis generating in nature. Based on the resulting hypothesis, it will be verified by a study with a control group.


Eligibility criteria: Inclusion Criteria:

1. written consent to participate in the study
2. confirmed diagnosis of hEDS (based on the diagnostic criteria of the current classification of 2017).
3. pain in the area of the masticatory muscles and/or the temporomandibular joints
4. command of the German language, both spoken and written

Exclusion Criteria:

1. currently undergoing TMD-specific treatment (physiotherapy, pain therapy masticatory muscles and/or temporomandibular joint, orthopedic treatment, osteopathic treatment).
2. persons diagnosed with depression, anxiety or stress disorder
3. taking opiates
4. pregnant women
5. minors
6. persons with mental disability
7. persons who are not able to speak and write the German language
8. persons with legal representatives

Primary outcomes:
measure: Reduction of temporomandibular pain
timeFrame: Up to 3 months after the last physiotherapy intervention
Secondary outcomes:
measure: Effects on psychosocial impairment
timeFrame: Up to 3 months after the last physiotherapy intervention
measure: Effects on oral health-related quality of life (OHRQoL)
timeFrame: Up to 3 months after the last physiotherapy intervention
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department for Prosthodontics and Biomaterials, University Hospital Münster
Study officials:
affiliation: Department for Prosthodonctics and Biomaterials, University Hospital Münster
name: Ole Oelerich, Dr. med. dent.
role: PRINCIPAL_INVESTIGATOR
References: