louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04947878: Development and Validation of an Orthopedic Visit Prompt List
Official title: Development and Validation of an Orthopedic Visit Prompt List
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Orthopedics
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to enroll. Randomization will be done through an Excel random number generator. The patients in the intervention group will review a prompt list before their visit. The research assistant will shadow the surgeon to count the amount of questions they ask during their visit. Patients in both groups will fill out a survey entailing demographics, the Decisional Conflict Scale, the JSPPE, the PAM score and a satisfaction scale at the end of the visit.
Primary purpose: TREATMENT

Brief summary: Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

Detailed description: Visiting a doctor with a musculoskeletal problem can be quite a daunting experience for patients. A visit question prompt list may help to empower patients and increase their role in active decision-making. Previous studies have shown that patient activation is correlated with a disability, pain intensity, and satisfaction with treatment. Perceived empathy is strongly associated with satisfaction among people with arm problems. A list that prompts patients to ask about things that matter to them, might improve their connection with the surgeon and their perceived empathy. The investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18+)
* Orthopedic visit

Exclusion Criteria:

* Patients who are illiterate.
* Patients who do not speak English.

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: Baseline
Secondary outcomes:
measure: Jefferson Scale of Patient's Perceptions of Physician Empathy
timeFrame: Baseline
measure: Patient Activation Measure-13
timeFrame: Baseline
measure: Satisfaction scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Austin
country: United States
facility: UT health Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06428071: Decompression Versus Heat and Decompression in Knee OA
Official title: Mechanical Knee Decompression With and Without Heating: Impact on Pain, Function, and Range of Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arm parallel randomized controlled trial
Primary purpose: TREATMENT

Brief summary: a randomized controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating.

Detailed description: Osteoarthritis (OA) is a progressive multifactorial joint disease characterized by chronic pain and functional disability due to the degeneration of the articular cartilage. The knee joint is the most vulnerable joint in the human body and occupies four-fifths of the burden of OA worldwide. Subjects having KOA demonstrate deferent clinical and radiological characteristics such as narrowed joint space, osteophytes around the articular surface, subchondral sclerosis, pain, limited range of motion (ROM), and declined functional status.

Except for the arthroplasty for the severely arthritic knee joint, there is no cure for the degeneration of joint cartilage. Medications, exercises, and physical agents can be used to address the associated pain, muscular tightness, weakness, and physical disability.

Interestingly, previous efforts that applied traction (decompression) on the arthritic knee joint demonstrated favorable results even on the thickness of the articular cartilage. However, these methods were mainly invasive surgical procedures that encountered disadvantages like the risk of infection and prolonged bedridden that might affect the general health of the patients

Eligibility criteria: Inclusion Criteria:

* Both sexes
* age between 45 to 60 years.
* Normal and or overweight categories of BMI 19-30 kg/m2
* Unilateral (grade 2 and 3) knee OA according to the Kellgren-Lawrence radiological rating scale

Exclusion Criteria:

* lower limb deformities as genu varum, valgus, flat foot
* leg length discrepancy
* previous trauma and or surgery to the knee joint
* Bone disease
* Inability to refrain from analgesic/anti-inflammatory medications for 6 weeks

Primary outcomes:
measure: pain intensity
timeFrame: at base line
measure: pain intensity
timeFrame: after the end of the treatment (after 6 weeks)
measure: active knee range of motion
timeFrame: at baseline
measure: active knee range of motion
timeFrame: after the end of the treatment (after 6 weeks)
measure: function
timeFrame: at baseline
measure: function
timeFrame: after the end of the treatment (after 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Hisham Hussein
Study officials:
References:
Clinical trial NCT01436578: Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)
Official title: Post Marketing Surveillance for General Drug Use to Assess the Safety and Efficacy Profile of NOXAFIL Oral Suspension in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 273
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants enrolled will be all who are treated with posaconazole oral suspension per the current local label by participating investigators during the pre-specified surveillance period.

Brief summary: This study will examine the safety and efficacy of posaconazole in general use in Korea.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* Treated with posaconazole oral suspension within current local label

Exclusion Criteria:

* Contraindication to posaconazole oral suspension according to current local label

Primary outcomes:
measure: Number of participants with Serious Adverse Experiences
timeFrame: During treatment and for 30 days following cessation of treatment
measure: Number of participants with drug-related adverse experiences
timeFrame: During treatment and for 30 days following cessation of treatment
measure: Number of participants with unexpected drug-related adverse experiences
timeFrame: During treatment and for 30 days following cessation of treatment
measure: Number of participants with Non-Serious Adverse Experiences
timeFrame: During treatment and for 30 days following cessation of treatment
measure: Number of Participants with Responses of Improved, Not Improved, and Worsened
timeFrame: After at least 14 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04455971: Orgasmic Meditation and Sleep Quality
Official title: A Naturalistic, Longitudinal, Observational Study of Associations Between Frequency of Orgasmic Meditation Practice, Occurrence of Female Physiological Orgasm and Sleep Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Lead sponsor: Institute of OM Foundation
Sponsor class: INDUSTRY
First posted: 2020-07-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The primary purpose of this study is to use an observational design to examine whether the practice of orgasmic meditation (OM) is associated with app-based measures of sleep quality. A secondary purpose of this study is to examine whether the occurrence of physiological orgasm during OM practice is associated with app-based measures of sleep quality. It is hypothesized that the practice of OM will have a positive impact on sleep quality.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old, males and females, no exclusion by race, ethnicity or sexual orientation
2. Experienced in OM practice ("experienced" defined as \>10 OM sessions in lifetime)
3. Currently practicing OM and participating in ≥1 OM session per week on average
4. Willingness to calibrate the Sleep Cycle app and use it for 30 continuous nights
5. Ability to charge phone by bed overnight during sleep
6. Ability to place phone near the bed, such as on a nightstand table overnight during sleep

Exclusion Criteria:

1. Inability to speak English

Primary outcomes:
measure: Correlation between sleep quality and occurrence and frequency of OM sessions during the prior day
timeFrame: 30 days
Secondary outcomes:
measure: Correlation between sleep duration and occurrence and frequency of OM sessions during the prior day
timeFrame: 30 days
measure: Correlation between time to fall asleep and occurrence and frequency of OM sessions during the prior day
timeFrame: 30 days
measure: Correlation between sleep regularity and occurrence and frequency of OM sessions during the prior day
timeFrame: 30 days
measure: Change in total sleep duration during nights following OM and nights following no OM
timeFrame: 30 days
measure: Change in time to fall asleep during nights following OM and nights following no OM
timeFrame: 30 days
measure: Change in sleep regularity during nights following OM and nights following no OM
timeFrame: 30 days
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Institute of OM Foundation
state: California
Study officials:
affiliation: Institute of OM Foundation
name: Charles Raison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01524471: Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Primary Esophageal Motility Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Achalasia
Keywords: Hypertensive LES
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.


Eligibility criteria: Inclusion Criteria:

* All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

* Patients will be excluded from this study with the followings -

  1. Pregnancy
  2. Informed consent not available
  3. Previous history of esophagectomy or mediastinal surgery
  4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow Investigations before and after POEM

Primary outcomes:
measure: Dysphagia score
Secondary outcomes:
measure: Improvement in LES pressure
measure: Eckhart score
measure: Operative time
measure: Length of myotomy
measure: Time to resume diet
measure: Morbidities
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT03621371: Cognitive-behavioral Therapy for Generalized Anxiety Disorder in Primary Care
Official title: Metacognitive Therapy and Intolerance of Uncertainty Therapy for Generalized Anxiety Disorder in Primary Care: Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2018-08-08
Enrollment: 64
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: The feasibilty and preliminary comparative effectiveness of two methods of cognitive-behavioral therapy - metacognitive therapy and intolerance of uncertainty therapy - for primary care patients with generalized anxiety disorder is investigated in a pilot study using a randomized controlled design. Purpose of the study is to examine the feasibility of a full-scale randomized controlled trial. Research questions primarily concern recruitment, measurement, and adherence.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of generalized anxiety disorder
* Age 18 years or above
* Being able to understand and speak Swedish without interpreter support

Exclusion Criteria:

* Psychosis, bipolar disorder, severe depressive symptoms, risk of suicid, substance use disorder, intellectual disability
* Simultaneous psychological treatment
* If pharmacological treatment, it needs to be stable prior to and during treatment

Primary outcomes:
measure: Penn State Worry Questionnaire - Measure of Symptom Change
timeFrame: Change from baseline symptoms at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Liljeholmen Primary Health Care Center
Study officials:
affiliation: Karolinska Institutet
name: Benjamin Bohman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06490471: Femom System Compared to the Standard of Care CTG
Official title: A Clinical Study Evaluating the Safety and Performance of the Femom System Compared to the Standard of Care CTG for Antepartum Fetal Monitoring.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy Related
Lead sponsor: Biorithm Pte Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with singleton gestation \> 32+0 weeks of pregnancy

Brief summary: The goal of this observational study is to evaluate the safety and performance of the femom system compared to the standard of care CTG for antepartum fetal monitoring in pregnant women with singleton gestation \> 32+0 weeks of pregnancy. The main questions it aims to answer are to assess the agreement between femom data collection (FHR, MHR, UA), and values measured via the standard of care used for prenatal monitoring (i.e. CTG). The secondary objective is to test concordance in clinical interpretability of femom traces and the standard of care CTG traces.

Participants will have the femom device and CTG attached to their abdomen. The femom device will be attached for about 30 minutes while they are wearing the device for the NST.


Eligibility criteria: Inclusion Criteria:

1. Female age between 18-50-year-old
2. Singleton pregnancy.
3. Should be at and above 32+0 weeks of pregnancy.
4. Able to speak and read English to understand and sign the Informed Consent.

Exclusion Criteria:

1. Participants with an intellectual or mental impairment.
2. Participants with a known allergy or hypersensitivity to ECG gel electrodes.
3. Known fetal cardiac or genetic abnormality.
4. Clinically unstable participants who require immediate medical care.
5. Participants with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
6. Participants with implantable electronic devices such as pacemaker or ICD.
7. Participants with medical skin condition in the abdominal area (such as wounds, cuts in the skin, skin rash, etc.)

Primary outcomes:
measure: FHR
timeFrame: From 32 weeks gestation to labour
measure: MHR
timeFrame: From 32 weeks gestation to labour
measure: PPA
timeFrame: From 32 weeks gestation to labour
Secondary outcomes:
measure: Femom NST vs NST
timeFrame: From 32 weeks gestation to labour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01376271: Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
Official title: Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Phobia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects diagnosed as having social anxiety disorder (SAD) are to be given paroxetine tablets according to the prescribing information

Brief summary: The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects who are diagnosed as having SAD
* Subjects who are expected to use paroxetine tablets for the first time

Exclusion Criteria:

* Subjects taking pimozide
* Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
* Subjects with hypersensitivity to paroxetine

Primary outcomes:
measure: The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03040271: Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.
Official title: Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: School-based intervention
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 2276
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.


Eligibility criteria: Inclusion Criteria:

* Schoolchildren
* Aged 9 to 11 years

Exclusion Criteria:

- no exclusion criteria

Primary outcomes:
measure: Change in knowledge score
timeFrame: One school year
measure: Change in dietary habits
timeFrame: One school year
measure: Change in self-efficacy score
timeFrame: One school year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: American University of Beirut Medical Center
name: Nahla Houalla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habib-Mourad C, Ghandour LA, Maliha C, Awada N, Dagher M, Hwalla N. Impact of a one-year school-based teacher-implemented nutrition and physical activity intervention: main findings and future recommendations. BMC Public Health. 2020 Feb 19;20(1):256. doi: 10.1186/s12889-020-8351-3.
Clinical trial NCT01820871: Self-Management Using Smartphone Application for Type2 DM in Real siTuation (SMART-DM)
Official title: A Pilot Study of Self Management Using Application for Chronic Disease Care in Real siTuation (SMART) - DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: T2DM
smartphone application
serum fasting glucose
HbA1c
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
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 effectiveness of smartphone application for management of type 2 diabetes mellitus (DM).

Type 2 DM is an almost incurable chronic disease and continuous management is important for long-term prognosis. However, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 DM.

Thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.


Eligibility criteria: Inclusion Criteria:

* Type 2 DM using oral hypoglycemic agent
* 6.5% \< HbA1c \< 10%
* systolic blood pressure \> 130 mmHg or diastolic blood pressure \> 80 mmHg
* BMI over 23.0
* 20 \< age \< 70
* smartphone user (android OS based)

Exclusion Criteria:

* Serum fasting glucose \> 250 mg/L or post prandial 2 hour serum glucose \> 350 mg/L
* systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
* Diabetes mellitus patient using insulin
* severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria)
* congestive heart failure (NYHA III-IV or left ventricular ejection fraction \< 30%)
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) over 3 times of upper normal limit
* Serum creatinine \> 1.5 mg/dL
* refusal to participate in the study
* drug addiction or alcohol addiction
* major psychiatric illness
* steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month
* changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month
* malignant cancer
* pregnancy

Primary outcomes:
measure: fasting serum glucose and HbA1c
timeFrame: 3months after enrollemnt (day 0-day 90)
Secondary outcomes:
measure: body weight and BMI
timeFrame: 3months after enrollemnt (day 0-day 90)
measure: Lipid profile
timeFrame: 3months after enrollment (day 0-90)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital
Study officials:
affiliation: Inje University
name: Jongha Park, MD
role: PRINCIPAL_INVESTIGATOR
References: