louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04992494: Treatment for Migraine and Mood (Team-M)
Official title: Treatment for Migraine and Mood (Team-M): A Pilot Trial of a Mindfulness-based Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Depression
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-08-05
Enrollment: 27
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: The researchers propose a two-arm pilot study of telephone and video delivered Mindfulness-based Cognitive Therapy (MBCT-T and MBCT-V) in people with migraine and depressive symptoms.

Detailed description: This study aims to set the stage for a future definitive large-scale Phase III trial in patients with migraine and depressive symptoms. This first phase is aimed at fidelity optimization of MBCT-T and MBCT-V in people with migraine (defined by the International Classification of Headache Disorders - 3) and depressive symptoms (defined by empirical cut-offs on the Patient Health Questionnaire - 9).

Eligibility criteria: Inclusion Criteria:

* Currently meets ICHD-3 criteria for migraine using the Structured Diagnostic Interview for Headache
* Self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria
* Score between 5-14 on the PHQ-9
* Age ≥ 18
* Ability to read and speak English
* Capacity to consent

Exclusion Criteria:

* Meeting ICHD-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the Structure Diagnostic Interview for Headache
* Changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin A, anti-calcitonin gene related peptide treatment) within 3 months of intake
* Comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the MBCT intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities
* Prior history of engaging in formal mindfulness-based interventions including: MBSR, MBCT, Acceptance and Commitment therapy, Dialectical Behavior Therapy
* Current meditation practice \>3x/week

Primary outcomes:
measure: Treatment Session Adherence Rate
timeFrame: Week 8
measure: Average Client Satisfaction Questionnaire Score (CSQ-8)
timeFrame: Week 8
measure: Mean Score on MBCT-T/V Adherence & Competence Scales (MBCT-TACS)
timeFrame: Week 8
measure: Homework Assignment Completion Rate
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Amanda Shallcross, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507894: Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke.
Official title: Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: rehabilitation
exercise
stroke
adherence
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be stroke survivors who have completed a conventional rehabilitation program. They will be recruited from Hospital-Consorci Sanitari de Terrassa (Barcelona, Spain) over a period of six months.

Brief summary: The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.

Detailed description: This is a 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. The aim of the MERP is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. The mobile app technology complements the MERP in order to achieve long term adherence to healthy physical activity.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke
* age ≥18;
* Functional Ambulation Classification (FAC) ≥3
* Barthel Index ≥45

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Examination ≤24)
* Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
* Alcohol or other toxic substances abuse
* Decompensated psychiatric disorders that prevented from following a group session

Primary outcomes:
measure: Adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Gait speed
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Montserrat Grau-Pellicer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
Clinical trial NCT00737594: Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Official title: A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Portal Hypertension
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo Pharmaceuticals, Inc.
First posted: 2008-08-19
Enrollment: 9
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: The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.


Eligibility criteria: Inclusion Criteria:

* Patient is \>= 18 years of age.
* Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
* Patient has clinical diagnosis of cirrhosis.
* Patient has undergone variceal banding.

Exclusion Criteria:

* Patient has a Child-Pugh score \>12.
* Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
* Variceal banding procedure was performed within 1 month of the screening visit.
* Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
* Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
* Patient has hepatocellular carcinoma that is being medically treated or is advanced.
* Patient has impaired renal function (i.e., serum creatinine concentration \>1.8 mg/dl)
* Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
* Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.

Primary outcomes:
measure: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03572894: Comparison of PVI and RPVI
Official title: Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous; Return (Anomaly)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing closed-chest surgery in the supine position under general anaesthesia.

Brief summary: Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Low or intermediate risk surgery or noninvasive procedures in the supine position
* General anaesthesia and volume-controlled mechanical ventilation.

Exclusion Criteria:

* Non sinus heart rhythm
* Left Ventricular Ejection Fraction \< 50%
* Documented right ventricle failure
* Lack of patient consent
* Pregnancy
* Minor patient or under tutorship
* Presence of spontaneous ventilatory movements (attested by a real respiratory rate higher than the set respiratory rate)
* Report HR / RR \<3.6 (HR: heart rate, RR: respiratory rate)
* Open chest surgery
* Laparoscopic surgery
* Vital or lateral decubitus surgery

Primary outcomes:
measure: Evaluation of the diagnostic characteristics of RPVI in comparison to PVI
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03760094: Role of Color Doppler Ultrasound in Lymphadenopathy
Official title: Role of Color Doppler Ultrasound in Differentiation Between Benign and Malignant Lymphadenopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymph Node Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes Accurate lymph node characterization is important for a wide number of clinical situations, including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis itself (cancer, lymphoma, or inflammatory nodes)

Detailed description: Various ultrasound criteria that can help in differentiation of benign and malignant lymph nodes have been well described in literature. On Gray scale ultrasound imaging, the benign enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On the other hand, the malignant lymph nodes are round with short to long axis ratio \>0.5 and show loss of echogenic hilum, while the Color and Power Doppler features documented for the diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale ultrasound findings are equivocal. However, it can neither replace histopathology nor can eliminate the need for biopsy

Eligibility criteria: Inclusion Criteria:

* clinically enlarged lymph nodes

Exclusion Criteria:

* previous medical treatment or radiotherapy
* previous biopsy

Primary outcomes:
measure: The percentage of patients with benign lymphadenopathy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05569694: Movement-Based Pelvic Health Education for Women in Underserved Communities
Official title: Pelvic Health Education for Women in Underserved Communities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Pelvic Pain
Keywords: Women's health
Community education
Underserved population
Lead sponsor: Arkansas Colleges of Health Education
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* female-identifying
* ability to speak English or provide own translator
* ability to complete the questionnaires
* clearance from physician if pregnant
* access to internet

Exclusion Criteria:

-Experiencing pelvic pain and/or pregnant and does not have physician clearance to participate

Primary outcomes:
measure: Knowledge Acquisition
timeFrame: 1 month
Secondary outcomes:
measure: Exercise Adherence
timeFrame: 1 month
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Arkansas Colleges of Health Education
state: Arkansas
Study officials:
References:
Clinical trial NCT05283694: A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
Official title: A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.

Exclusion Criteria:

* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 140 Days
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: Up to 140 Days
measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt)
timeFrame: Up to 140 Days
measure: AUC from time 0 to infinity (AUCinf)
timeFrame: Up to 140 Days
measure: Terminal phase elimination rate constant (β)
timeFrame: Up to 140 Days
measure: Terminal phase elimination half-life (t1/2).
timeFrame: Up to 140 Days
measure: Number of Anti-drug antibody (ADA) Titers
timeFrame: Up to 140 Days
measure: Number of Participants with Adverse Events
timeFrame: Up to 140 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 165737
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02177994: Antibiotic Prophylaxis for Elective Cesarean Section
Official title: Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection of Cesarian Section Wound Following Delivery
Keywords: Elective Cesarean Section
Antibiotic prophylaxis
Timing of Antibiotic prophylaxis
post cesarean section infection
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 328
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.

Detailed description: comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective cesarean section with Gestational age 37 weeks or more

Exclusion Criteria:

1. Fever greater than 38°C or maternal sepsis.
2. Cephalosporin allergy.
3. Exposure to any antibiotic agent within 1week before delivery.
4. Patents having premature rupture of membranes and acute chorioamnionitis.
5. Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).

3) Morbid obesity (BMI\>30)

Primary outcomes:
measure: The primary outcome is the rate of post cesarean section surgical site infection.
timeFrame: administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days
Secondary outcomes:
measure: other post cesarean section maternal and neonatal infection
timeFrame: follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Antibiotic Prophylaxis for Elective Cesarean Section
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Amr AH Helmy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05334394: The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Official title: The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lumbal Disc Herniation
Imbalance
Keywords: Balance
Chronic Low Back Pain
Exercise
Lumbal Disc Herniation
Manual Therapy
Mulligan Mobilization
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was aimed to investigate the effectiveness of mulligan mobilization technique on balance, pain and functionality in patients with chronic low back pain and to compare it with exercise.37 patients aged between 18-65 who applied to Fındıkzade Medipol Hospital were included in the study. The individuals participating in the study were divided into two groups, 18 control and 19 mulligan groups, according to the randomization table. The intervention was performed 3 times a week for 4 weeks. Conventional physiotherapy and exercise program accompanied by a physiotherapist were applied to the control group, and conventional physiotherapy and mulligan mobilization technique were applied to the mulligan group. Conventional physiotherapy methods included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS), and hotpack. The patients were evaluated with TecnoBody Static Balance Device, algometer, electrogoniometer, visual analog scale, Oswestry Low Back Pain Disability Questionnaire before and after the treatment.


Eligibility criteria: Inclusion Criteria:

* Experiencing non-specific chronic low back pain for more than 3 months
* The diagnosis has been confirmed by the Health Board Report
* Be over 18 years old
* Be younger than 65 years old
* Pain of at least 2 severity according to VAS
* Voluntarily agree to participate in the study

Exclusion Criteria:

* Previous lumbar trauma or operation
* Long-term use of corticosteroids
* Cancer
* Pregnancy
* Osteoporosis
* Systemic Diseases
* Spinal Deformities
* Lumbal Stenosis
* Ankylozone Spondylitis
* Spondylolisthesis
* Spinal Deformities
* Lumbal Stenosis

Primary outcomes:
measure: TecnoBody Static Balance Device Measurements
timeFrame: 5 Minutes
measure: Pressure Pain-Threshold Measurements with Algometer
timeFrame: 5 Minutes
measure: Electrogoniometer
timeFrame: 5 Minutes
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 1 Minutes
measure: Oswestry Disability Index
timeFrame: 10 Minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fındıkzade Medipol Hospital
state: Fındıkzade
Study officials:
affiliation: Medipol University
name: Kübra Bali, Licenced
role: PRINCIPAL_INVESTIGATOR
References: