louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06765486: Exercise-Induced Hypoalgesia Differences Between Upper and Lower Limbs Resistance Training Interventions
Official title: Exercise-Induced Hypoalgesia Differences at Proximal and Distal Regions After Applying a Lower Limb Resistance Training or an Upper Limb Resistance Training Protocol: A Randomized Controlled Trial in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Local Hypoalgesia
Distal Hypoalgesia
Resistance Training
Pressure Pain Thresholds
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb resistance training intervention, another using an upper limb resistance training, and a control group. The exercise protocol involves 3 sets of 5 repetitions of resistance exercises (brachial biceps curl and leg extensions). Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow, comparing exercise interventions with the control group. Additionally, a secondary objective is to compare the lower limb and upper limb resistance training groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological, or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 12 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on dominant quadriceps and dominant brachial biceps
timeFrame: before, immediately after intervention, and 30 minutes after intervention.
Secondary outcomes:
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Physical Activity Readiness Questionnaire (PAR-Q)
timeFrame: before intervention (up 5 minutes)
measure: Fatigue Assessment Scale (FAS)
timeFrame: before intervention (up 5 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT06097286: A Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane (EOIP) Block and Erector Spinae Plane (ESP) Block for Postoperative Analgesia in Upper Abdominal Surgeries
Official title: A Comparative Study Between Ultrasound Guided External Oblique Intercostal Plane (EOIP) Block and Erector Spinae Plane (ESP) Block for Postoperative Analgesia in Upper Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Upper abdominal incisions, such as the oblique subcostal laparotomy, can cause severe pain and can lead to significant respiratory impairment.

Erector spinae plane (ESP) block is the deposition of local anaesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.

External oblique intercostal plane (EOIP) block is a newly described block at which local anaesthetic (LA) is deposited in the interfascial plane deep to external oblique muscle at the sixth intercostal space. It provides blockade of the thoracoabdominal nerves at the level of T6 to T10.

In this study, the investigators compare between ultrasound (US) guided external oblique intercostal plane block and erector spinae plane block, in providing postoperative analgesia for upper abdominal surgeries


Eligibility criteria: Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status (ASA) I and II.
* Both sex.
* 20 to 60 years old patients.
* upper abdominal surgeries.

Exclusion Criteria:

* Refusal of the patient to consent.
* Patients with ASA status III or IV
* Patients with bleeding disorders and coagulopathy (INR≥1.6 \& PTT≥50 sec).
* Infection at the injection site.
* Allergy to local anesthetics.
* Patients with ages less than 20 or more than 60
* Patients with pre-existing myopathy or neuropathy.
* Patients with chronic pain syndromes.
* Patients with history of long acting opioids or steroids preoperatively.

Primary outcomes:
measure: amount of total 24 hour pethidine consumption (mg) .
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: visual analogue scale (VAS) at rest and movement.
timeFrame: 24 hours postoperatively
measure: mean arterial blood pressure (MAP)
timeFrame: 24 hours postoperatively
measure: heart rate (HR)
timeFrame: 24 hours postoperatively
measure: incidence of postoperative complications (nausea and vomiting)
timeFrame: 24 hours postoperatively
measure: time to start mobilization
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01206686: The Effect of Time-Slot Scheduling on Flu Vaccination Rates
Official title: Effect of Time-Slot Scheduling on Flu Vaccination Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Influenza
Keywords: seasonal influenza
behavioral economics
nudge
implementations intentions
vaccination
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Yale University
name: Stanford University
First posted: 2010-09-22
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this project is to see if encouraging an individual to privately choose in advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood that he or she will become vaccinated.

Detailed description: Influenza causes 36,000 U.S. deaths per year, but influenza immunization rates average just 28%. Behavioral "nudges" may increase the effectiveness of immunization reminder mailers at little or no added cost. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. We study whether adding a planning prompt to a vaccination reminder mailer increases immunization rates.

Eligibility criteria: Inclusion Criteria:

* seasonal influenza vaccine indications according to the CDC
* employees of partner corporations executing study

Exclusion Criteria:

* none

Primary outcomes:
measure: Receipt of seasonal influenza vaccination
timeFrame: up to 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04247386: Mizone vs Water for Bowel Preparation.
Official title: The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation
Keywords: bowel preparation quality
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 270
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: DIAGNOSTIC

Brief summary: In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000) and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in subjects undergoing colonoscopy.


Eligibility criteria: Inclusion Criteria:

Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.

Exclusion Criteria:

1. Patients with constipation;
2. Patients with congestive heart failure;
3. Patients with a history of kidney disease;
4. Patients with a history of poor intestinal preparation;
5. Pregnant / lactating women;
6. Patients without informed consent;
7. Allergic or intolerant to any research drug;
8. Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;
9. Patients with a history of inflammatory bowel disease;
10. Significant electrolyte anomalies, including phosphorus, sodium, potassium, calcium, chloride and magnesium;
11. History of colorectal resection；
12. Patients with diabetes.

Primary outcomes:
measure: Quality of Bowel Preparation
timeFrame: 1 Day of colonoscopy
Secondary outcomes:
measure: Adverse event rate
timeFrame: 3 days
measure: patient tolerability of bowel preparation
timeFrame: 1 Day of colonoscopy
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo No. 1 Hospital
state: Zhejiang
Study officials:
References:
citation: Zhang Z, Gao H, Yuan X, Liu C, Bao Z, Yu S, Xie H, Wang W, Xie J, Xu L. The efficacy and tolerability of sports drink versus water in bowel preparations: a randomised controlled study. Trials. 2022 Aug 26;23(1):709. doi: 10.1186/s13063-022-06658-2.
Clinical trial NCT01841086: Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation
Official title: A Randomized, Open-label, Single Dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Sarpogrelate HCl CR Tablets Compared With Sarpogrelate HCl IR Tablets in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.


Eligibility criteria: Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Sarpogrelate HCl or other antiplatelets

Primary outcomes:
measure: Cmax
timeFrame: 24h
measure: AUCt
timeFrame: 24h
Secondary outcomes:
measure: tmax, t1/2
timeFrame: 24h
measure: AUC0-∞
timeFrame: 24h
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Huh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04959786: MANS-NRIZ Trial for COVID-19 Treatment : Extension Study
Official title: Effect of a Combination of Nitazoxanide, Ribavirin and Ivermectin Plus Zinc Supplement on the Clearance of COVID-19: Extension Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID-19 Pneumonia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 100
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: This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.

Detailed description: This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years

  * Laboratory-confirmed SARS-CoV- 2 infection
  * Hospitalized patients
* need reservoir mask for oxygen support
* need HFNC for oxygen support

Exclusion Criteria:

* Mechanical ventilations for oxygen support
* Inability to take oral medications
* Pregnancy or breastfeeding

Primary outcomes:
measure: Stabilization of oxygen
timeFrame: 28 days
measure: In-hospital and 28-day mortality
timeFrame: 28 day
Secondary outcomes:
measure: Negative conversion of SARS-CoV- 2 by Day 28
timeFrame: 28 day
measure: Time to clinical improvement
timeFrame: 28 day
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Select A State Or Province
Study officials:
References:
Clinical trial NCT03953586: Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix
Official title: Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tubal Patency
Keywords: laparoscopy
hysteroscopy,
tubal patency,
bubble test,
peristalsis
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women with a history of HSG

Brief summary: Tubal patency testing is essential for infertility evaluation. Standard tests are hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble suction test was described in apparently normal tubes. However, the efficacy of bubble suction test in abnormal tubes like hydrosalpnix has not been studied.

Detailed description: Nowadays, hysteroscopy is extensively used for fertility assessment. In a previous study, it is recommended to add hysteroscopy to the routine infertility work-up to achieve a better assessment of infertility cases.

In 2016, hysteroscopy as a predictor test of tubal patency and tubal peristalsis was introduced. It is concluded that hysteroscopic bubble suction test is a good initial screening test for tubal patency nearly comparable to HSG and DL. It should be attempted in every case of OH prior to referral for more invasive HSG or laparoscopic chromopertubation test.

Thereafter, some authors tried the same idea of bubble suction test and were over-enthusiastic with this test and considered it superior to hysterosalpingography (HSG) in detection of tubal patency in infertile women. They wrongly described HSG as a historic tool despite being recommended as a basic infertility test by many organizations. Some authors criticized the results of these studies and underestimated their clinical implication. One of the objections were lack of differentiation between normal tubes and damaged or narrowed but still patent tubes.

Aim of the work:

To test whether bubble suction test and osteal peristalsis are preserved or lost in cases with hydrosalpnix.

Design: A prospective double blinded randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion Criteria:

* No HSG

Primary outcomes:
measure: percentage of positive tests in both pathologic and healthy tubes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health University Hospital
Study officials:
References:
Clinical trial NCT03742986: Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Official title: Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Nivolumab
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC

Detailed description: The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive

Exclusion Criteria:

* Clinical or radiologic evidence of distant metastases
* Malignancy that progressed within the last five years.
* Cardiac disease (history of and/or active disease)
* HIV positive
* Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0
* Allogeneic stem cell or solid organ transplantation
* Autoimmune disease where in the opinion of the Investigator would preclude the use of immunotherapy
* Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonitis
* Tuberculosis
* Pregnancy or lactation
* Treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Treatment with systemic immunosuppressive medications
* Cardiopulmonary dysfunction
* Clinically significant history of liver disease, including cirrhosis, autoimmune hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C
* Subject is pregnant or nursing
* Known hypersensitivity to the components of the study drugs(s)

Primary outcomes:
measure: Number of Participants Who Had a Pathological Complete Response (pCR)
timeFrame: up to 16 weeks
measure: Number of Participants Who Had a Pathological Complete Response (pCR)
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Maryann Kwa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557686: Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study
Official title: Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Leukemia
Keywords: Cancer Related fatigue
Quality of Life
Psychosocial Intervention
Rehabilitation
Physical Fitness
Physical Activity
Exercise Therapy
Exercise
Hematologic
Hematological
Leukemia, Myeloid, Acute
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Leukemia
Lead sponsor: Universitetshospitalernes Center for Sygepleje
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: Lundbeck Foundation
First posted: 2012-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
* Normal EKG, blood pressure and pulse
* Signed informed written consent

Exclusion Criteria:

* Medical reason that contraindicates physical activity
* Patients diagnosed with a symptomatic cardiac disease within the last three months.
* Documented bone metastasis
* Dementia, psychotic
* Cannot write or read Danish
* Patients unable to carry out baseline tests

Primary outcomes:
measure: Feasibility - adherence rates
timeFrame: Adherence to the intervention components from baseline to 6 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: baseline to 6 weeks
measure: 6MWD
timeFrame: Change from baseline in 6MWD at 6 weeks
measure: Attrition
timeFrame: Withdrawal from the project from baseline to 6 weeks
measure: Timed chair stand
timeFrame: Change from baseline in timed chair stand at 6 weeks
measure: Timed bicep curl
timeFrame: Change from baseline in timed bicep curl at 6 weeks
measure: FACT-Anemia
timeFrame: Change from baseline in FACT-An at 6 weeks
measure: HADS
timeFrame: Change from baseline in HADS at 6 weeks
measure: SF36
timeFrame: Change from baseline in SF36 at 6 weeks
measure: MDSAI
timeFrame: Change from baseline over time (1,2,3,4,5,6 weeks)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Copenhagen University Hospital at Herlev
name: Mary Jarden, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: