cyrilzakka/clinical-trials huggingface dataset:
Healthy Student Initiative

This paper extends prior research by exploring how students with self-critical (SC) traits respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety sensitivity and mood changes during the school year as students attended MM tutorials ii) to study the relationship between self-criticism and MM-related benefits over time. This paper reports on participants' mood and anxiety sensitivity changes before, during, and after the MM program and the association between depressed mood and SC levels. Participants were trained in MM over two continuous semesters, with two specific hypotheses guiding evaluations:

1. Participants overall would report progressive improvements in psychological well-being as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of the MM program.
2. Elevations in self-critical personality traits would predict greater improvements in depressed mood, given the greater need to neutralize cognitive events related to negative moods.

A total of 71 undergraduate students in a large public university participated in weekly MM sessions through the Fall \& Winter semesters of the 2012/2013 academic year. Recruitment was facilitated through in-class announcements and poster and print advertisements. Online and paper surveys elicited self-report data (reflecting mental health profiles) at program initiation which served as baseline measures for the September-October study period, written informed consent was also obtained during this time. Inclusion criteria included: 1) currently enrolled (part-time-full-time); 2) computer access at the university or elsewhere and/or smartphone access Following a standard within-subjects design, participants were required to complete the psychological measures at 3 additional assessment periods; Time 2 (November-December), Time 3 (January-February), and Time 4 (March-April). To alleviate demands on the students partaking in weekly MM sessions, follow-up assessments were provided in paper and electronic form and completed autonomously. Study participants were given $50 cash payments for full study participation and the study met the ethical guidelines and received approval from the Human Participants Review Subcommittee of the university site where the study was conducted.

The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled (part-time-full-time) OR current staff members at university
* Computer access at the university or elsewhere and/or smartphone access

Exclusion Criteria:
Effect of Calcium + Vitamin D Supplementation on Weight Management in Very-low Calcium Consumers

The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.

Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(\<600mg/day).

The hypotheses to be tested are:

Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 25 years of age, generally healthy
* Habitual calcium intake below 600mg/d
* Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard)
* Stable body weight (body weight change less than 1kg two months before screening)
* Less than 3 times of 20min of physical exercise per week
* Signed written informed consent

Exclusion Criteria:

* Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment
* Pregnant or lactating woman
* Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization
* Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet)
* On special diets (i.e. vegetarian)
* Presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication)
* Participating in another clinical trial 6 months before randomization
* Unlikely to be compliant (i.e. alcohol, drug abuse)
* Refusal or inability to give informed consent to participate in the study
Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis

The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Both male and female patients will be selected.
3. Plantar fasciitis has been treated with conservative usual care for at least 8 weeks, including at least three of the following modalities

   1. RICE
   2. Corticosteroid injection
   3. Stretching exercises
   4. NSAIDs
   5. Orthotics
4. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
5. Patient understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
6. Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.

Exclusion Criteria:

1. Prior surgery at the site
2. Site that exhibits clinical signs and symptoms of infection
3. History of chronic plantar fasciitis of more than twelve months
4. Evidence of significant neurological disease of the feet
5. Non Ambulatory Patients
6. The presence of comorbidities that can be confused with or can exacerbate the condition including:

   * Calcaneal stress fracture
   * Nerve entrapment syndrome (baxter nerve syndrome or tarsal tunnel)
   * Plantar fascial rupture
   * Systemic disorders associated with enthesiopathy such as Gout, Reiters syndrome, rheumatoid arthritis, etc.
   * Achilles tendonitis
   * Fat pad atrophy
   * Fibromyalgia
7. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
8. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding Screening.
9. History of radiation at the site.
10. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
11. Study foot has been previously treated with tissue engineered materials such as PRP within the last 30 days.
12. Patients who are unable to understand the aims and objectives of the trial.
13. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
14. Pregnant or breast feeding. No pregnancy within the past 6 months.
15. Allergy to Gentamycin Streptomycin
Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes

The primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.

So, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes.

This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.

This is a prospective, open, non-controlled study with an individual benefit for the participant. This study is designed to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.

All 30 patients with type 1 diabetes attended a 4-day functional insulinotherapy class, taught by 2 nurses, 2 dieticians and 2 physicians. The participants were recruited among metabolically stable patients who had already been prescribed functional insulinotherapy.

To assess the impact of functional insulinotherapy on blood glucose variability, HbA1c will be measured at 0, 3 months and 6 months along with 4 blood glucose variability indicators: MAGE, ADRR, LI and LBGI.

This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress. Therefore, a measure of insulin antibodies by ELISA at baseline. At baseline and 6 months, LTE4, TXB2, 8-iso-PGF2alpha, anti-transglutaminase and anti-endomysium antibodies will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes with pump or multi-injection treatment and attending a functional insulinotherapy class
* Social Security membership or benefit from Social Security
* Informed consent, with a signed and approved form

Exclusion Criteria:

* Underage patient, major patient under guardianship or protected by the Law
* Pregnant, parturient or breastfeeding woman
* Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
* Antecedents of pathologies causing diabetes instability (coeliac disease, gastroparesis, non-balanced psychiatric pathology) and not optimally treated, acute pathology less than 3 months ago (infectious, cardio-vascular, metabolic), pregnancy
A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes

This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
* Otherwise fit and healthy
* Non smoker

Exclusion Criteria:

* Taking medication or supplements other than insulin to control diabetes.
* Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
* Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids
Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography

Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography (ERCP). Combination of sedatives and opioids is associated with increased morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative studies with PCS for ERCP are few. Therefore, the main objective of this randomized controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists during ERCP.


Eligibility Criteria:
Inclusion Criteria:

* Need for ERCP
* Able to speak and read swedish

Exclusion Criteria:

* Allergy to propofol
* Severe cardiopulmonary disease (ASA IV)
* Confusion or dementia
Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers

Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.

All groups will perform the same procedures twice weekly. Volunteers will be comfortable with the affected foot exposed. The diabetic foot ulcers (DFU) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. Diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the ImageJ program for follow-up throughout the intervention. The DFU will be ranked according to the Wagner Scale. Afterwards the volunteers will receive LLLT application and conventional treatment in the form of Helianthus Annuus oil dressing. Both therapist and participant will be instructed on precautions to be observed when using LLLT. Goggles will be provided prior to administration. The lower cylinder of the LASER probe will be placed perpendicular to the DFU, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. Once a week blood glucose levels will be obtained for patient screening. All data will be recorded until the end of the visits in a control form prepared.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus patients with diabetic foot ulcers;
* Patients aged 18 and over.

Exclusion Criteria:

* Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet;
* Patients with infected diabetic foot ulcers.
VOICE: Values and Options in Cancer Care

The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.

The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.

Eligibility Criteria:
Inclusion Criteria: Physicians

* Currently in clinical practice at participating institutions
* Oncologist that cares for patients with solid tumors
* Not planning to leave the practice during the next 6 months

Inclusion Criteria: Patients

* Currently a patient of an enrolled physician
* Age 21 years or older
* Diagnosis of advanced cancer
* Able to understand spoken English (study personnel will read materials to low literacy patients)

Inclusion Criteria: Caregivers

* Caregiver of a patient currently enrolled in the study
* Age 21 years or older
* Able to understand spoken English (study personnel will read materials to low literacy patients)

Exclusion Criteria: Physicians

* Non Physicians and physicians who are not oncologists
* Oncologists who exclusively care for patients with hematological malignancies
* Prior involvement in health-related coaching interventions

Exclusion Criteria: Patients

* Unable to complete orally-administered surveys in English
* Hospitalized or in hospice care at the time of recruitment
* Prior involvement in health-related coaching interventions
* Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma

Exclusion Criteria: Caregiver

Unable to complete orally-administered surveys in English
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Able to comprehend, sign, and date the written informed consent form
* English as primary language
* Undergoing a non-emergent EGD or colonoscopy
* Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure
* American Society of Anesthesiologists (ASA) Class I, II or III

Exclusion Criteria:

* Allergy or inability to tolerate study medications or components of study medications
* Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty
* Currently using a fentanyl patch
* History of diagnosed sleep apnea
* History of diagnosed gastroparesis
* Baseline oxygen saturation \< 90% (room air)
* Pregnant or nursing females
* Body mass index (BMI) ≥ 35
* Participation in a clinical trial within the past 30 days.
Radiographic Migration Analysis of the Insignia Hip Stem

The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.

This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.

The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty - Aged 21 years or older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
* Medical condition with less than 2 years life expectancy
* Overhanging pannus (direct anterior approach)
* Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
* Skin condition on the area of incision
* Multi-level lumbar spine fusion
* Ankylosing spondylolithesis
* Shortening osteotomy through the femur
Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children

Devices such as the GlucoWatch G2 Biographer (GW2B), which constantly measure blood sugar levels, may improve the treatment of Type 1 diabetes mellitus in children. This study evaluated the GW2B when used by children in their homes.

The proper role of the GW2B in the management of Type 1 diabetes in children has not been determined. As a prelude to a large-scale randomized clinical trial (RCT) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a GW2B versus standard care, the DirecNet Study Group conducted a pilot study to assess the feasibility of the protocol planned for the RCT and to collect data on changes in HbA1c, frequency of hypoglycemia, frequency of skin reactions, and quality of life after using the GW2B for three months.

Fifteen children and adolescents with Type 1 diabetes participated in this study. Each patient was provided with a personal computer for weekly downloading of the GW2B and for completion of questionnaires regarding hypoglycemia and GW2B use. Participants received study telephone calls after 1, 2, and 4 weeks and every 4 weeks thereafter to review their diabetes management. Participants had a follow-up visit at Week 29. The Continuous Glucose Monitoring System was inserted at this visit to assess hypoglycemia over three days. A follow-up visit was performed at Week 30 to measure HbA1c and administer psychosocial questionnaires.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of Type 1 diabetes
* Duration of diabetes \> 1 year
* Daily insulin therapy (pump or at least 2 injections/day)
* Stable insulin regimen; not expected to change administration modality within the next 3 months (e.g., injection user switching to pump)

Exclusion Criteria

* The presence of skin abnormalities or a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
* Prior use of a GWB prescribed for home use (Prior use of a GWB as part of a research study is allowable)
* The presence of any of the following diseases:

  * Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
  * Cystic fibrosis
  * Other major illness that in the judgment of the investigator might interfere with the completion of the protocol
  * Adequately treated thyroid disease and celiac disease do not exclude
* Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
* Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.