louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03766477: Aspects Associated With Sleep Quality
Official title: Aspects Associated With Bruxism and Sleep Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Bruxism
Keywords: Sleep bruxism
Sleep
Sleep hygiene
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults (aged 20 to 60 years) and elderly (aged \> 60 years) who had undergone PSG at the Pelotas Sleep Institute (ISP), a private medical out patients clinic, from January to December 2019, will be invited to participate in the study.

Eligibility criteria includ adequate cognitive capacity to understand and answer the questionnaire. Written consent will be given by all participants who agreed to participate in the study.

Brief summary: Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson).

Detailed description: This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between 19 and 60 years old will be submitted to polysomnography from January to December 2019. The questionnaires will be applied before the polysomnography, and the APP will be used together with the polysomnography. The data will be tabulated and a descriptive statistical analysis performed. Specific statistical tests will be determined after preliminary analysis of the data (α = 0.05).

Eligibility criteria: Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
* Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion Criteria:

• Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.

Primary outcomes:
measure: Data Collect on Sleep Quality with ISQP quastionario.
timeFrame: 4 months after study start
measure: Data Collect on Sleep Quality with the APP
timeFrame: 4 months after study start
measure: Data Collect on Sleep Quality with polysomnography exam
timeFrame: 4 months after study start
Secondary outcomes:
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Noéli Boscato
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Noéli Boscato
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Noéli Boscato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05930977: Outcomes of Thyroid Auto Transplantation Following Total Thyroidectomy in Benign Thyroid Disorders Protocol
Official title: Outcomes of Thyroid Auto Transplantation Following Total Thyroidectomy in Benign Thyroid Disorders Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Diseases
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with benign multi nodular goiter

Brief summary: the study aimed at evaluating efficacy of auto-transplantation of thyroid tissue after total thyroidectomy in benign thyroid disorders to keep the patient euthyroid with no need for life long hormone replacement therapy.

Detailed description: This study will be a prospective study which will be conducted at Sohag University Hospital after approval of the protocol the study population include . Adult patients with goiters are seen in the general surgery outpatient clinic The study included thirty studied cases presented in the outpatient clinic with benign thyroid disorders for whom total thyroidectomy was performed

Eligibility criteria: Inclusion Criteria:

* Patients proved to have benign thyroid disorders operable and candidate for total thyroidectomy Adult patients who agreed and consented to do the procedure.

Exclusion Criteria:

* Patients with high suspicion of malignancy , unfit and refused the procedure

Primary outcomes:
measure: Thyroid function following thyroid auto transplantation after total thyroidectomy
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT01471977: Treatment Adherence of Tuberculosis Medicines
Official title: Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Gambat Institute of Medical Sciences
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 1280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: It was hypothesized that tuberculosis patients receiving multiple interventions like educations, counseling and default tracing along with DOTS were more likely to adhere to tuberculosis treatment as compared to few interventions or DOTS only.


Eligibility criteria: Inclusion Criteria:

* adult patient
* \> 18years
* either sex
* diagnosed to have tuberculosis through chest x ray or sputum microscopy
* eligible to participate in the study

Exclusion Criteria:

Primary outcomes:
measure: Proportion of patients cured
timeFrame: 8 months
measure: Proportion of patients completed treatment
timeFrame: 8 months
measure: Proportion of patients died
timeFrame: 8 months
measure: proportion of patients defaulted
timeFrame: 8 months
measure: proportion of patients with treatment failure
timeFrame: 8 months
measure: proportion of patients transferred out
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Khairpur
country: Pakistan
facility: Basic Medical Unit of Taluka Gambat
state: Sindh
Study officials:
affiliation: GIMS
name: Nisar Sheikh, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03032445: Beer for Endurance Exercise Recovery
Official title: Potential Impacts of Beer on Post-Race Ultramarathon Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Keywords: Body Water/physiology
Hyponatremia/etiology
Physical Exertion/physiology
Running/physiology
Sodium/blood
Ethanol
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are eligible, based on inclusion criteria, to participate in this research study that is seeking to determine whether supplementation of beer (alcohol) immediately following a long distance ultramarathon race can positively impact exercise-associated hyponatremia \[EAH\].


Eligibility criteria: Inclusion Criteria:

* Completed informed consent
* Ability to read and speak English language
* Age 21 years or older
* Not considered a vulnerable population, such as pregnant (by history) or cognitively impaired.
* Able to tolerate needle exposure for blood draw
* Willing to drink alcoholic or nonalcoholic beer
* Willing not to eat or drink other than the study fluid during 1 hour study period
* Participating in 100 mile or 50 mile race
* To participate in the controlled part of the study the individual must have fully completed either the 100 mile or the 50 mile race.

Exclusion Criteria:

* Under age 21 years
* Vulnerable population, such as pregnant (by history) or cognitively impaired
* Subjects who are alcohol-naive (i.e first exposure to alcohol)
* Subjects with known familial and/or genetic backgrounds at higher risk for the development of alcohol dependence
* Subjects should not be seeking treatment for alcohol or drug abuse
* Subjects who are in general high risk for abuse such as those completing or participating in alcohol or drug abuse programs
* Subjects who have had a sustained period of abstinence, with history of heavy drinking problems, while living in the community

Primary outcomes:
measure: Changes in sodium level pre and post intervention
timeFrame: One hour
Secondary outcomes:
measure: Measurement of urine output
timeFrame: One hour
measure: Number of participants with abnormal laboratory values
timeFrame: One hour
measure: Level of cognition
timeFrame: Within one month of intervention
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: SUNY Upstate Medicial University
name: Jeremy Joslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03861845: Impact of Pillboxes on Medical Adherence
Official title: Impact of Pillboxes on Medical Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Medication Adherence
Keywords: Assistive Technology
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 15
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 study uses an experimental design to test the impact of different types of pillboxes on medication adherence. Participants in this study will randomized to receive one of the three pillbox interventions: 1) A standard seven day a week, one-dose per day pillbox with training 2) an off-the-shelf pillbox that was purchased specifically for the individual's needs with training and education, or 3) a customized 3D printed pillbox that was designed and manufactured specifically to the individual's needs with training and education. Participants will have three visits with the research team to collect baseline data, receive the pillbox, and collect follow up data.

Risks to the study include loss of time, boredom, invasion of privacy, and medication errors. The investigators have taken precautions to mitigate these risks. This study will improve understanding of medication adherence and potentially help us better address poor medication adherence which needlessly causes morbidity, mortality, and costs over $300 million in unnecessary healthcare costs each year.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* speak English
* be prescribed to take two or more medications per day, and manage their own medications.

Exclusion Criteria:

* have a significant cognitive impairment
* unwilling to use a novel pillbox
* unable to meet with the research team

Primary outcomes:
measure: Medication Adherence at 1 Month
timeFrame: 1 month
measure: Satisfaction With Pillbox at 1 Month
timeFrame: 1 month
Secondary outcomes:
measure: Number of Participants Who Completed the Study
timeFrame: 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Jaclyn Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02334345: Skin Protection During Radiotherapy in Patients With Breast Cancer
Official title: Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

Detailed description: Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.

Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* Patients with breast cancer for which a treatment by radiotherapy is planned
* No concomitant chemotherapy
* Signed informed consent

Exclusion Criteria:

* Cutaneous neoplasia radiotherapy
* Total mastectomy
* Bilateral breast cancer
* Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
* Pregnant, breast-feeding woman

Primary outcomes:
measure: Average of the radiation dermatitis intensity
timeFrame: at 3 months
Secondary outcomes:
measure: Clinical grade of dermatitis
timeFrame: at 3 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU LIMOGES - Radiothérapie
Study officials:
affiliation: CHU LIMOGES
name: Pierre CLAVRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06054945: Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Official title: Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block in Knee Arthroplasty Patients Under Spinal Anesthesia: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Pain Management
Acute Pain
Keywords: analgesia
IPACK
SIFIB
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: data of patients underwent total knee arthroplasty under spinal anesthesia between 01.01.2023 and 01.09.2023

Brief summary: In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block to this regimen, and the aim of this retrospective study is to determine whether the addition of the IPACK block enhances the quality of analgesia.

Knee arthroplasty, also known as knee joint replacement surgery, is a common procedure performed to alleviate pain and improve joint function in patients with knee osteoarthritis or other knee-related conditions. Postoperative pain management is crucial for patient comfort and overall recovery.

In this study, we aimed to compare the two techniques mentioned earlier, namely the SIFIB (Suprainguinal Fascia Iliaca Block) and the SIFIB+IPACK, by examining the data of patients who underwent knee arthroplasty under spinal anesthesia at our clinic between January 1, 2023, and September 1, 2023.


Eligibility criteria: Inclusion Criteria:

* Patients meeting the following criteria and whose postoperative follow-up forms were completed in full were included in the study
* Patients underwent total knee arthroplasty (TKA)
* ASA class I to III.
* operated under spinal anesthesia
* patient controlled analjgesia device was used for analgesia

Exclusion Criteria:

Patients whose data were inaccessible or had incomplete follow-up forms were excluded from the study to ensure the accuracy and reliability of our analysis.

* PCA device problems in follow up in 24 hours
* anesthesia plans were converted to general anesthesia
* spinal anesthesia failure
* peripheral blocks used other than protocol

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: NRS scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: Hatice Kusderci, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04976647: A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
Official title: A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Non-small-cell Lung Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 156
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 purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
* EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
* Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Has a life expectancy of greater than 12 weeks
* Has adequate organ function

Exclusion Criteria:

* Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
* Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
* EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
* Has had other active malignancies within 5 years or at the same time
* Has uncontrolled pleural effusion、pericardial effusion or ascites

Primary outcomes:
measure: Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC
timeFrame: Up to 5 years
measure: Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Adverse Events (AE)
timeFrame: Up to 5 years
measure: Duration of Response (DOR) per RECIST 1.1 assessed by IRRC
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01742247: Assessment of Needs of Moisturizers After Various Laser Treatments
Official title: Phase 4 Study of Assessment of Needs of Moisturizers After Various Laser Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatologic Disorders
Injury Due to Laser
Keywords: Moisturizer, laser
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessment of needs of moisturizers after various laser treatments

Detailed description: The investigators would like to assess of needs of moisturizers after various laser treatment

: by investigating the changes in the skin barrier function after fractional carbon dioxide laser and fractional Er:Glass laser in mice and human skin

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age without any dermatologic diseases

Exclusion Criteria:

* Taking other known dermatologic disease
* Others who are shown pigmented lesion on treated-area
* Who have allergy or history of hypersensitivity reaction to moisturizers
* Who have other definitive cutaneous findings

Primary outcomes:
measure: Clinical assessment of erythema, transepidermal water loss
timeFrame: 2weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of dermatology, Pusan National University Hospital
Study officials:
affiliation: Pusna National University Hospital
name: Byung-Soo Kim, Ph.D.
role: STUDY_CHAIR
References: