cyrilzakka/clinical-trials huggingface dataset:
Effects of Bariatric Surgery on Different Compositions of Trunk Fat and Mechanisms

This is a prospective, single-center, observational study to explore effects of bariatric surgery on different compositions of trunk fat and mechanisms.

This is a prospective, single-center, observational study to explore effects of bariatric surgery on different compositions of trunk fat and mechanisms. The primary outcome is effects of bariatric surgery on different compositions of trunk fat evaluated with MRI for patients pending bariatric surgery before and 3 months after surgery. The secondary outcome is the associations of trunk fat reduction with improvement in metabolism indicators. Before patients are enrolled in this observational study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the study. Patients who meet the conditions of the study will be required to sign an informed consent form.

Eligibility Criteria:
Inclusion Criteria:

* BMI of \>27.5 kg/m2 with T2DM;
* BMI of \>32.5 kg/m2 with or without metabolic syndrome;
* Age 18-65 years old;
* T2DM duration \< 15 years.

Exclusion Criteria:

* Previous history of pancreatitis or pancreatic surgery;
* Serious T2DM complications or organic diseases;
* Alcohol addiction;
* Uncontrolled mental illness.
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle

OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH) and sex steroid secretion in normal and hypogonadal children.

II. Examine the acute effects of sex steroids on the sleep-entrained patterns of GnRH secretion in pubertal children and normal adults, either by stimulation of endogenous production with pulsatile injection or by intravenous infusion of GnRH.

III. Examine the role of endogenous opioids by means of opioid receptor blockade in the sex steroid regulation of GnRH secretion in pubertal children and normal adults.

PROTOCOL OUTLINE: This project involves several clinical protocols that study the regulation and role of pulsatile gonadotropin-releasing hormone (GnRH) secretion.

Studies include dynamic and repeated stimulation tests of pulsatile GnRH; plasma luteinizing hormone, follicular-stimulating hormone, testosterone (T), estradiol (E2), and GnRH measurements at cyclic and episodic intervals; and evaluation of adrenal androgen patterns.

Circadian rhythms of GnRH secretion are monitored during sleep and awake hours. Growth hormone secretory patterns and responses to provocative stimuli are studied as clinically indicated.

Selected participants undergo an assessment of pituitary responsiveness following T, E2, and/or naloxone infusions. The suppressive effects of E2 are also studied during the early follicular phase of the menstrual cycle.

Endocrinologically normal children and normal adult men and women are also studied.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Suspected or proven hypothalamic-pituitary-gonadal dysfunction, i.e.: Significant short stature and possible hypopituitarism Delayed adolescence Precocious puberty Isolated growth hormone deficiency (IGHD)Primary hypogonadism
* Women are also studied, including those with the following disorders: Infertility Oligo- or amenorrhea Hirsutism

--Patient Characteristics--

* Age: 7 to 16 (18 to 35 for women and volunteers)
* Other: No pregnant or nursing women No prisoners Not in neuropsychiatric institute or other facility for mental illness
Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study

The objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current pulmonary embolism risk stratification score using the sPESI score refined by the use of cardiac biomarkers and right ventricular dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pulmonary embolism according to clinical algorithm, confirmed by thoracic angioscan or ventilation perfusion (V/P) scan,
* Non-serious pulmonary embolism, not requiring intensive care (thrombectomy or fibrinolysis not considered).
* sPESI score ≥ 1 \[or = 0 with elevated troponin or presence of markers of VD dysfunction, or = 0 with need for hospitalization due to comorbidities unrelated to PE (social isolation, comprehension disorders, intercurrent infection, chronic renal failure, advanced cancer...)
* Patients with no contraindications to chair lift testing (no O2 at the time of testing).
* Effective anticoagulation for at least 1 hour.

Exclusion Criteria:

* sPESI score = 0 with outpatient referral.
* Diagnostic confirmation of Pulmonia Embolism by thoracic angioscan or scintigraphy more than 24h after suspicion of diagnosis.
* Hospitalization \> 24h after introduction of anticoagulation, with subsequent confirmation by scintigraphy.
* Any sign of serious Pulmonia Embolism, requiring hospitalization in an intensive care unit.
* Asymptomatic Pulmonia Embolism discovered by chance
Effectiveness of Prolonged Use of IUD/Implant for Contraception

This study will evaluate LNG-IUD and Etonogestrel (ENG) Implant users who are willing to use their contraception beyond the end of the FDA-approved duration. ENG Implant users will also be offered to participate in an arm of the study that will randomize them to either keeping their implant in or having it removed and replaced with a new implant. Participants will be followed for up to three years.

This prospective cohort study will evaluate 675 LNG-IUD users and 675 Etonogestrel (ENG) Implant users who are within 6 months of expiration or beyond the end of the FDA-approved duration. Participants will be contacted via telephone and either scheduled to enroll in person or be mailed the consent form before participation in the EPIC study. After the signed consent form is obtained, participants will also be asked to complete a brief telephone or in-person questionnaire on sociodemographic, medical and reproductive history, sexual and contraceptive history, history of unintended pregnancy and substance abuse. During the informed consent process, implant users will also be offered to participate in an arm of the study that will randomize them (if they consent) to either keeping their subdermal implant in or have it removed and replaced with a new subdermal implant. The randomized control trial subset allows us to compare effectiveness to that of a new implant.

It also allows us to assess "other contraceptive use" (e.g. condom use) in both groups.

Participants will also be asked if they are interested in providing a blood sample for analysis of etonogestrel assay levels at baseline enrollment and annually. If Follow-up phone interviews will occur every 6 months for 36 months beyond the expiration of their method. The investigators will attempt to validate all pregnancy outcomes with medical chart reviews.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-45
* Within 6 months of expiration or beyond the end of the FDA-approved duration of use of the levonorgestrel intrauterine device (LNG-IUD = 5 years) OR the etonogestrel-releasing subdermal implant (ENG implant = 3 years)
* Able to consent in English or Spanish.
* Not pregnant at the time of enrollment

Exclusion Criteria:

* Have history of female sterilization procedure
* Desire for conception in the next 12 months
* Not sexually active with a male partner
Gait and Functional Improvement in Total Knee Arthroplasty With the Use of Verasense for Soft Tissue Balancing

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe:

* Pain medication use
* Swelling
* Muscle strength and girth
* Gait efficiency
* Patient satisfaction
* Activity levels, functional return (i.e., back to work, resume normal activities)
* Patient perception of a balanced knee


Eligibility Criteria:
Inclusion Criteria:

* Subject must be a candidate for a primary PCL retaining total knee arthroplasty
* Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis
* Subject is between the age of 45 - 80 years
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

* Prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
* Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
Computer-assisted Total Knee Arthroplasty (TKA) With Zimmer LPS Flex Knee System

To determine clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. This study will provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.

The objective of this study is to determine the clinical outcomes and biomechanical gait performance of patients who receive the Zimmer Legacy® LPS Flex Knee system using a computer-assisted surgical technique. Pre and post-operative clinical and gait variables will be compared within the computer-assisted group. These same comparisons will also be made between the computer-assisted surgical group and a conventional surgical group who receive the same knee implant. This study will further provide evidence as to whether there are differences between the two surgical procedures with respect to complications such as infection and dislocations, rate and level of functional recovery, blood loss, operating time, degree of radiographic correction and quality and duration of post-operative pain and stiffness.

Eligibility Criteria:
Inclusion Criteria:

* age 50-80

  * undergoing primary total knee arthroplasty
  * femoral tibial varus \< 7 degrees
  * no previous joint infections
  * anteriorcruciate ligament intact
  * clinically significant patellofemoral or osteoarthritic degeneration

Exclusion Criteria:

* active articular infections
* significant concurrent ipsilateral hip osteoarthritis
* chronic pain syndrome requiring medications for control
* history of chemical addiction
* significant spinal stenosis, chronic back pain, sciatica
* patients who are unlikely to comply with, participate in or return for follow-up visits as described in the protocol
* osteomyelitis, septicemia or other infections that may spread to other areas of the body
* highly communicable diseases, immuno-compromising conditions and/or that may limit follow-up (eg. AIDS, active tuberculosis, venereal disease, active hepatitis, neoplastic disease)
* diabetic neuropathy
* skeletal immaturity
* decreased mental comprehension and literacy
* pregnancy
Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment

Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial.

There is still inconclusive evidence about the orthodontics treatment duration and interappointment interval.

Patients with moderate to severe crowding will be divided randomly into two groups (Group A and Group B). Group A includes patients with an interval of 3 weeks between their appointments while Group B includes the patients with an interval of 6 weeks between their appointments.

1. To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 3rd week
2. To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 6th week
3. To compare the difference between the two modalities in percentage

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16-30
* Little's irregularity index from 5mm to 12mm
* Healthy periodontium
* No systemic disease
* Patients giving consent for inclusion

Exclusion Criteria:

* Little's irregularity index less than 5mm and more than 12mm
* Blocked out incisors needing push coil
* Ankylosed teeth
* Active periodontal disease
* Systemic bone disease
* Non-compliant patients
* Patients with frequent breakages
Pancreatic Islet Function, Insulin Sensitivity, and Chronic Complications in Pre-Diabetes

We, the investigators at National Taiwan University Hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine the association between insulin sensitivity and islet functions.

We, the investigators at National Taiwan University Hospital, want to compare patients' islet cell function, insulin sensitivity and risk of chronic complications with normal subjects. Moreover, we want to examine whether they are at a higher risk of having metabolic syndrome and to answer whether we should screen the phenotypes of metabolic syndrome in impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) patients. Then, we want to examine the association between insulin sensitivity and islet functions.

Eligibility Criteria:
Inclusion Criteria:

* Fasting glucose 100-125 mg/dl OR oral glucose tolerance test (OGTT) 2 hour glucose 140-199 mg/dl
* Diabetes mellitus

Exclusion Criteria:

* Pregnancy
* Children \< 18 years old
An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)

This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically confirmed CRC with metastatic lesion
* Participants having initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to bevacizumab SmPC
* Participants who previously received a minimum 9 cycles of 5-FU-based or a minimum 6 cycles of capecitabine-based induction doublet chemotherapy (i.e. 5-FU or capecitabine + oxaliplatin or irinotecan) plus bevacizumab
* Disease evaluation showed stable disease, partial response, or complete response according to RECIST within one month

Exclusion Criteria:

* Contraindication to receive bevacizumab according to the bevacizumab SmPC
* Participants who received more than 10 cycles of 5-FU-based or more than 7 cycles of capecitabine-based induction doublet chemotherapy plus bevacizumab
* Pregnant or lactating women
TQ-PAL Development and Validation

Taste problems are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. There is no validated tool to assess taste disturbances and their impact on patients with advanced cancer. This study will develop and validate a novel assessment tool to assess taste disturbances and their impact on patients with advanced cancer.

Patients with advanced cancer often develop taste disturbances. A recent literature review reported a median prevalence of 55%, with prevalence ranging from 27-93%. Studies have shown taste disturbance is usually a persistent symptom, is often 'moderate-to-severe' in intensity, and is often associated with significant distress. Taste disturbance may have a major impact on the experience and pleasure associated with eating and drinking. Taste disturbance may have a major impact on nutritional intake. It may be associated with low mood / depression, social isolation, and an impaired quality of life.

The aforementioned literature review identified, importantly, that the terminology used in the published literature varied, which may have had an effect on the results obtained, especially prevalence statistics. The review identified the need for "development/validation studies of a taste-specific assessment tool for this group of patients - there is a need for a tool that not only assesses the problem but can also assess the response to treatment for the problem, utilising patient reported outcome measures."

Eligibility Criteria:
Inclusion Criteria:

18 years of age Diagnosis of locally advanced or metastatic cancer Referred to palliative care/oncology services Taste problems rated 'moderate' or worse over previous 2-week period Good understanding of English

Exclusion Criteria:

Cognitive impairment (unable to provide consent / complete questionnaire) Taste problems precedes cancer diagnosis. Head and neck surgery Head and neck radiotherapy Salivary gland disorders (e.g., Sjogren's Syndrome) In the 'Deteriorating' or 'Terminal' Phase of illness
Efficacy and Safety of MC2-25 Cream & Vehicle in Women With Vulvar Lichen Sclerosus (VLS)

The purpose of this study is to explore the efficacy and safety of MC2-25 cream and MC2-25 vehicle in women with vulvar lichen schelosus (VLS).

In this study, subjects who fulfil all inclusion and exclusion criteria are enrolled.

Eligible subjects will be randomized in a 1:1 ratio to MC2-25 cream or MC2-25 vehicle, respectively.

The subjects will apply the assigned investigational medicinal product (IMP) daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women, of any race or ethnicity, who are ≥18 years of age at the time of screening.
* Able to understand the trial and willing to comply with trial requirements.
* Has provided written informed consent.
* Clinical diagnosis of VLS.
* Presence of at least one of the following signs of VLS: Hyperkeratosis and/or Sclerosis.
* First symptoms of VLS noticed by the patient at least 6 months before baseline.
* At least four WI-NRS scores available in the diary for calculation of the average WI-NRS at the baseline visit.
* At least moderate itch defined as average WI-NRS ≥4 at the Baseline visit.
* Women must be of either of non-childbearing potential or childbearing potential with a negativ urine pregnancy test at baseline.
* Women of childbearing potential must agree to use a highly effective method of contraception.

Exclusion Criteria:

* Pregnant, breast feeding, or planning to become pregnant during the trial.
* Any (other than VLS) ongoing localized or systemic disease involving the vulvar region.
* Ongoing symptomatic Urinary Tract Infection.
* Ongoing or prior diagnosis of any genitoanal malignancy or pre-malignancy.
* Any kind of ongoing cancer prior to the Baseline visit.
* Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with the assessment of efficacy in this trial.
* Known history of allergic reaction to any ingredients in MC2-25 cream or MC2-25 vehicle.
* Start of a new or change of existing non-biologic systemic treatment, within 21 days prior to the Baseline visit.
* Start of a new or change of existing biologic systemic treatment, within 3 months or 5 half-lives (whichever is longest) prior to the Baseline visit.
* Start of a new or change of existing systemic or intravaginal treatment with estrogen containing products, within 21 days prior to the Baseline visit.
* Start of new or change of menstrual care routines within 21 days prior to the Baseline visit.
* Use of emollients on the vulvar region within 3 days prior to the Baseline visit.
* Use of any topical treatment on the vulvar region, within 14 days prior to the Baseline visit.
* Use of any light therapy on the vulvar region, within 28 days prior to the Baseline visit.
* Received a non-marketed or blinded drug within 28 days or 5 half-lives (whichever is longer) prior to the Baseline visit.
* If in the opinion of the investigator, the patient is unlikely to comply with the clinical trial protocol.
* If previously randomized in this trial.
The Effectiveness of Conversational AI Service (chatbot) Utilization on Vaccine Confidence

The primary objective of this study is to develop and evaluate a conversational AI service (chatbot) on social media platforms to obtain accurate and up-to-date vaccine information, and assess the impact of chatbot usage on users' vaccine confidence and acceptance in Hong Kong, Singapore, and Thailand.

The investigators will focus on vulnerable seniors and/or children from Hong Kong, Singapore and Thailand who have refused or delayed COVID-19 vaccination. Participants will be recruited by an online panel to meet the target quota by age and sex. Participants will then be randomly assigned to the intervention group and the control group. For both intervention and control groups, evaluation questionnaires will be given out to the study participants asking questions about their demographics, including age, sex, educational level, employment status and household income levels. Participants will then answer questions regarding COVID-19 vaccine confidence, including the effectiveness and safety of vaccines, and the motivations of the policymakers who decided on the needed vaccines. Participants will be asked about COVID-19 vaccine acceptance including the intention to receive COVID-19 vaccines, make plans to receive COVID-19 vaccines, and receive at least one dose of COVID-19 vaccines. The intervention group will then be asked to use the chatbot developed by the research team for up to two weeks. The chatbot is developed under the RE-AIM framework for formative, impact, and process evaluation of the intervention. The control group will have no exposure to the chatbot.

The chatbot will be supported with data from 1) social listening analytics for monitoring local real-time discourses in the digital space on COVID-19 vaccine hesitancy and misinformation, and 2) formative, baseline, and endpoint evaluation, which will generate evidence for development and improvement/refinement.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong adult residents (English or Chinese users) with (a) unvaccinated senior parents/grandparents aged 60 (including those who received first dose after the announcement of the COVID passport on 4th of January) or (b) unvaccinated children aged below 18.
* Thailand adult residents (Thai users) with (a) unvaccinated senior parents/grandparents aged 60 or above or (b) unvaccinated children aged below 18.
* Singapore adult residents (English or Chinese users) with unvaccinated children aged between 5 to 11 years old.

Exclusion Criteria:

* People who do not meet the inclusion criteria.