louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03327259: A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms
Official title: A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is literature to support both the need for and efficacy of brief interventions for depressive symptoms, particularly among college students.Brief behavioral activation interventions (BATD) have gained recognition as efficacious treatments for depression; yet a recent study evidenced a substantial (39%) non-response rate (Kuyken et al., 2017). In accordance with behavioral models of depression, the treatment involves increasing activity and positive experience, to break the negative reinforcement cycle maintaining depressed mood. Thus, strategies that may facilitate increasing activity may improve BATD outcomes. The objective of the current study is to examine whether briefly practicing a target activity during an activity planning session (modified single session of BATD) increases the likelihood of completing the activity during the upcoming week. We hypothesized that guided activity practice may improve self-efficacy within session and activity completion in the upcoming week. We further aim to explore whether activity completion mediates depressive symptom change.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* University of Texas at Austin students currently enrolled in Introductory Psychology (PSY 301)
* Score \>14 on Beck Depression Inventory during both pre-screening and baseline screen
* Avoidance rating \>59 and Distress rating \>39 on at least one item of the Avoidance Screen.

Exclusion Criteria:

* Initiated psychotherapy or psychotropic medication in past 6 weeks
* Recent change (past 6 weeks) in psychotropic medication
* Current or past psychosis or mania

Primary outcomes:
measure: Percent Activity Completion Between Conditions
timeFrame: Daily for 7 days
measure: Change in Self-Efficacy in Response to Therapist Guided Activity Practice
timeFrame: Baseline
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline and 1 week follow-up
measure: Experiential Avoidance and Psychological Flexibility
timeFrame: Baseline and 1 week follow-up
measure: Multidimensional Experiential Avoidance
timeFrame: Baseline and 1 week follow-up
Other outcomes:
measure: Behavioral Activation
timeFrame: Baseline and 1 week follow-up
measure: Distress Intolerance
timeFrame: Baseline and 1 week follow-up
measure: Anxiety Sensitivity and Distress Intolerance
timeFrame: Baseline and 1 week follow-up
measure: Anxiety Symptoms
timeFrame: Baseline and 1 week follow-up
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT03541759: Pain Management After Elective Shoulder Surgery
Official title: Pain Management After Elective Shoulder Surgery: A Randomized Quantitative Study Comparing Hydromorphone With Piritramide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Elective shoulder surgery, hydromorphone, piritramide
Lead sponsor: AUVA Traumazentrum Vienna Site UKH Meidling
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain management plays an important role in elective shoulder surgery. The aim of this randomized quantitative study is to compare two frequently used postoperative pain regimes (hydromorphone versus piritramide) regarding onset and duration after the effectiveness of the single-shot interscalene block has diminished.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing elective shoulder surgery with a single-shot interscalene plexus brachialis block in addition to general anesthesia
* patients aged 18-99 years
* patients being capable of giving an informed consent to participation in this study

Exclusion Criteria:

* patients aged below 18 years
* patients with decompensated liver, heart or renal insufficiency
* patients with any kind of lung disease
* patients with a chronic pain syndrome
* patients with a previous pain medication with more than 3 drugs over more than 3 months

Primary outcomes:
measure: Pain management after elective shoulder surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Austrian Workers Compensation Board Trauma Center Vienna Meidling
Study officials:
affiliation: Trauma Center Vienna Meidling
name: Heinz Steltzer, MD, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT02162459: Strength-enhancing Effect of Whey Protein Supplementation Following Resistance Exercise in Adolescent Males
Official title: Strength-enhancing Effect of Whey Protein Supplementation Following Resistance Exercise in Adolescent Males
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Adolescent
supplements
strength
whey protein
bench press strength
squat strength
Lead sponsor: Olympia Eye Clinic
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 18
Sex: MALE
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male high school athletes

Brief summary: This study investigates the strength gains associated with resistance training in a group of 18 male high school athletes consuming either a whey protein supplement or chocolate milk following their exercise.


Eligibility criteria: Inclusion Criteria:

* member of Bellarmine Preparatory School boys sports team
* Must be willing to consume a post-exercise beverage

Exclusion Criteria:

* allergy to either beverage

Primary outcomes:
measure: bench press strength
timeFrame: 8 weeks
Secondary outcomes:
measure: squat strength
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Bellarmine Preparatory School
state: Washington
Study officials:
affiliation: Olympia Eye Clinic
name: Rodger D Bodoia, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06338059: Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
Official title: Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema:Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vitamin D Deficiency
B12 Deficiency Vitamin
Lipedema
Keywords: Vitamin D, B12 Deficiency Vitamin,Lipedema,Pain
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lipedema patients

Brief summary: Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema.

Detailed description: In this cross sectional study 200 lipedema patients will beincluded. According to painDETECT questionnaire scores of cases with lipedema patients will be divided into two groups;An overall score of \> 13 likely or possible neuropathic pain (group 1) and \<13 unlikely NP (group 2). Patients' age, gender, comorbid diseases and laboratory values (25 OH vitamin D and vitamin B12 levels) will be recorded.

Eligibility criteria: Inclusion Criteria:

* The patients diagnosed byan experienced physical medicine and rehabilitation specialist for the diagnosis of lipedema

Exclusion Criteria:

* individuals who did not have 25(OH)D and B12 values in the past 6 months,
* those with a history of gastrectomy or bypass surgery,
* those consuming a vegetarian diet, those with lymphedema or chronic venous insufficiency, endocrine diseases, rheumatic diseases, malignancy, neurological diseases, and musculoskeletaldiseases that can be related to lower extremity neuropathic or nociceptivepain.

Primary outcomes:
measure: Vitamin B12 Level
timeFrame: 1 day
measure: 25 OH Vitamin D Level
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gulcan Ozturk
Study officials:
References:
citation: Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
citation: Kiraly SJ, Kiraly MA, Hawe RD, Makhani N. Vitamin D as a neuroactive substance: review. ScientificWorldJournal. 2006 Jan 26;6:125-39. doi: 10.1100/tsw.2006.25.
citation: Gharibpoor F, Ghavidel-Parsa B, Sattari N, Bidari A, Nejatifar F, Montazeri A. Effect of vitamin B12 on the symptom severity and psychological profile of fibromyalgia patients; a prospective pre-post study. BMC Rheumatol. 2022 Sep 1;6(1):51. doi: 10.1186/s41927-022-00282-y.
Clinical trial NCT02289859: Undermining During Cutaneous Wound Closure
Official title: Undermining During Cutaneous Wound Closure: a Randomized Split Wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Closure Techniques
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining.

Detailed description: The purpose of this study is to determine whether undermining during cutaneous surgery improves scar cosmesis compared to wound closure without undermining. Our aims are to compare outcomes using a split wound model, where half the wound is undermined and the other half is not. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wound undermining will result in cosmetically superior wound outcomes.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Incarceration
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
* Wounds with diameter \> 3 cm
* Wounds unable to be fully closed without undermining

Primary outcomes:
measure: Assessment of Scar on the Patient and Observer Scar Assessment Scale
timeFrame: 3 months
Secondary outcomes:
measure: Measurement of Scar Width
timeFrame: 3 months
measure: Assessment of Complications
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joo J, Pourang A, Tchanque-Fossuo CN, Armstrong AW, Tartar DM, King TH, Sivamani RK, Eisen DB. Undermining during cutaneous wound closure for wounds less than 3 cm in diameter: a randomized split wound comparative effectiveness trial. Arch Dermatol Res. 2022 Sep;314(7):697-703. doi: 10.1007/s00403-021-02280-5. Epub 2021 Sep 21.
Clinical trial NCT01972100: Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance
Official title: Use of Low-level Laser Therapy (808nm) to Muscle Fatigue Resistance: a Randomized Double-blind Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Low-level laser therapy
Muscle fatigue resistance
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio Grande do Norte
First posted: 2013-10-30
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study hypothesis is a improved muscle fatigue resistance induced by low-level laser therapy applied between sets of intense exercises.


Eligibility criteria: Inclusion Criteria:

* healthy males
* physically active
* aged between 18-28 years old

Exclusion Criteria:

* smoker
* under medicine
* lower limb lesions limiting the flexion-extension of the knee joint

Primary outcomes:
measure: Maximum repetitions
timeFrame: 1 week
Secondary outcomes:
measure: Median Frequency
timeFrame: 1 week
Other outcomes:
Locations:
city: Rio Grande do Norte
country: Brazil
facility: Federal Univesity of Rio Grande do Norte
state: Natal
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Cleber Ferraresi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Wouber Hérickson de Brito Vieira, PhD
role: STUDY_DIRECTOR
References:
citation: Felismino AS, Costa EC, Aoki MS, Ferraresi C, de Araujo Moura Lemos TM, de Brito Vieira WH. Effect of low-level laser therapy (808 nm) on markers of muscle damage: a randomized double-blind placebo-controlled trial. Lasers Med Sci. 2014 May;29(3):933-8. doi: 10.1007/s10103-013-1430-2. Epub 2013 Sep 5.
citation: Ferraresi C, Hamblin MR, Parizotto NA. Low-level laser (light) therapy (LLLT) on muscle tissue: performance, fatigue and repair benefited by the power of light. Photonics Lasers Med. 2012 Nov 1;1(4):267-286. doi: 10.1515/plm-2012-0032.
citation: Vieira WH, Ferraresi C, Perez SE, Baldissera V, Parizotto NA. Effects of low-level laser therapy (808 nm) on isokinetic muscle performance of young women submitted to endurance training: a randomized controlled clinical trial. Lasers Med Sci. 2012 Mar;27(2):497-504. doi: 10.1007/s10103-011-0984-0. Epub 2011 Aug 26.
citation: Ferraresi C, de Brito Oliveira T, de Oliveira Zafalon L, de Menezes Reiff RB, Baldissera V, de Andrade Perez SE, Matheucci Junior E, Parizotto NA. Effects of low level laser therapy (808 nm) on physical strength training in humans. Lasers Med Sci. 2011 May;26(3):349-58. doi: 10.1007/s10103-010-0855-0. Epub 2010 Nov 18.
Clinical trial NCT06929000: A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients
Official title: A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adjustable Headrests
Ventilation Function
Obese Patients
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to observe the effect of adjustable headrests on ventilation function in overweight and obese patients through clinical experiments, and to explore the impact on the incidence of hypoxemia during painless curettage in overweight and obese patients.

Participants will be randomly allocated to three groups: the supine head-straight position group(Group A), the supine head-lateral position group(Group B), and the adjustable headrest group(Group C). These three groups of patients underwent painless curettage surgery in the daytime operating room and the occurrence of hypoxemia will be observed.


Eligibility criteria: Inclusion Criteria:

* patients who choose to have painless surgical abortion
* Body mass index greater than 24
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent

Exclusion Criteria:

* Abnormal lung function or respiratory system diseases
* Airway obstruction or respiratory malformation
* cervical spondylosis
* psychiatric disorders

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: 1,2 and 3 minutes after anesthesia induction
measure: Respiratory rate and oxygen saturation
timeFrame: The time of entering the daytime operating room, intraoperative period., 1 minute after the patient wakes up
Secondary outcomes:
measure: Heart rate and blood pressure
timeFrame: The time of entering the daytime operating room, intraoperative period, 1 minute after the patient wakes up
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li NaLi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983500: Patient Reported Outcomes Registry in Patient With Cancer Cachexia
Official title: Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Pancreatic Cancer
NSCLC, Metastatic
Keywords: Patient Reported Outcome (PRO)
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharma Europe Ltd.
First posted: 2016-12-06
Enrollment: 253
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: Adult patients diagnosed with locally advanced and unresectable or metastatic NSCLC (UICC Stage IIIB/IV) or locally advanced and unresectable or metastatic pancreatic cancer (UICC stage III/IV) at start of their first-line palliative systemic treatment.

Brief summary: Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.

Detailed description: The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.

Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.

These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV
* Start of the first line palliative systemic treatment
* Ability to read and understand German
* Written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of patients with loss of > 5 % body weight
timeFrame: 18 months
Secondary outcomes:
measure: Number of underweight patients
timeFrame: 12 months
measure: General health-related quality of life assessment
timeFrame: 12 months
measure: Fatigue assessment
timeFrame: 12 months
measure: Cachexia assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over Germany
Study officials:
affiliation: Medical practise for oncology
name: Manfred Welslau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139100: Evaluation of Antibacterial Soap for Treatment of Lymphedema in a Filariasis-Endemic Area
Official title: Evaluation of Antibacterial Soap for Treatment of Lymphedema and Elephantiasis in an Area Endemic for Lymphatic Filariasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Cellulitis
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Procter and Gamble
name: Ste. Croix Hospital, Leogane, Haiti
First posted: 2005-08-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Introduction. Lymphatic filariasis is a devastating mosquito-transmitted parasitic disease that causes lymphedema or elephantiasis of the leg in 15 million persons, the majority of whom are women. In these persons, frequent bacterial infections ("acute attacks") of the legs adversely affect physical health, economic well-being, and quality of life. Prevention of bacterial infections through hygiene and skin care can result in significant improvements in lymphedema and patient well-being.

Methods. To determine the extent to which antibacterial soap can help reduce the incidence of acute bacterial infections of the lower limbs in persons with filarial lymphedema, 200 patients of the Ste. Croix Hospital lymphedema treatment clinic in Leogane, Haiti randomly assigned to receive either antibacterial (Safeguard) or placebo (Camay) soap and acute attacks monitored monthly for 12 months. Both groups received specific instructions on washing and skin care.


Eligibility criteria: Inclusion Criteria:

Patients eligible for participation include those who are currently enrolled in the lymphedema treatment program in Leogane who 1) have been trained in the techniques of self-care, 2) who live in a 10-km radius of the hospital, and 3) for whom we have adequate data on incidence of acute bacterial infections, risk factors for infection, and ability to comply with the treatment protocol (particularly hygiene).

-

Exclusion Criteria: Don't meet inclusion criteria.

-

Primary outcomes:
measure: Incidence of bacterial "acute attacks", assessed monthly.
measure: Reported or observed severity of these acute attacks.
measure: Duration of acute attacks.
Secondary outcomes:
measure: Process measures
measure: Number of bars of soap used per patient per month.
measure: Demonstrated knowledge and ability to wash leg appropriately during home visits.
measure: Reported patient satisfaction with soap.
measure: Reported frequency of leg washing.
Other outcomes:
Locations:
city: Leogane
country: Haiti
facility: Hopital Ste. Croix
Study officials:
affiliation: CDC/NCID/DPD
name: David G Addiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Addiss DG, Michel MC, Michelus A, Radday J, Billhimer W, Louis-Charles J, Roberts JM, Kramp K, Dahl BA, Keswick B. Evaluation of antibacterial soap in the management of lymphoedema in Leogane, Haiti. Trans R Soc Trop Med Hyg. 2011 Jan;105(1):58-60. doi: 10.1016/j.trstmh.2010.08.011. Epub 2010 Sep 17.