cyrilzakka/clinical-trials huggingface dataset:
Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress

This trial studies how well self-administered meditation therapy works in improving anxiety and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a mind-body approach that uses a variety of techniques, such as deep breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility of having patients self-administer meditation recordings using a portable, computer-based program during a 2-week period.

SECONDARY OBJECTIVES:

I. Assess the effect of self-administered meditation on anxiety, depression and other symptoms that are part of the Edmonton Symptom Assessment Scale (ESAS) questionnaire.

II. Evaluate participant satisfaction with the meditation delivery and tracking program.

III. Examine the association between the frequency of practice (number of sessions a day) and choice of length of practice (5, 10, or 15 minute sessions) and anxiety, depression and other patient reported outcomes.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (MEDITATION): Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes once daily (QD) for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.

GROUP II (WAITLIST CONTROL): Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients at MD Anderson with a cancer history who are either undergoing active treatment or who have completed treatment for their cancer
* Must understand and read English, sign a written informed consent, and follow protocol requirements
* Willing to come to MD Anderson Main Campus (Texas Medical Center) for enrollment
* Patient self-reported ESAS psychological scale score (sum of anxiety and depression scores) between 4 and 11 (and/or) individual anxiety or depression score between 4 and 7 on a 0 to 10 numeric scale, where 10 is the worst possible
* If on medication for anxiety, stable dose of medications for management of anxiety symptoms for at least six weeks prior to enrollment with no plans to change meditations in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable

Exclusion Criteria:

* Diagnosis of a formal thought disorder (e.g., schizophrenia)
* Known history of a neurological and/or psychological disorder that in the physician's opinion may interfere with the patient's ability to cooperate with study procedures
Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

The purpose of this study is the investigation of biomechanical properties of the cornea using computer-aided data analysis. Currently, it is known that keratoconus and glaucoma are ocular disease that are associated with biomechanical alterations of the cornea. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. In glaucoma, the information about corneal alterations serves in two ways, first, correct measurement of intra ocular pressure (IOP); second, early diagnosis of suspects before visual field defects are detectable.

Especially, the Corvis ST is an air-puff tonometer that measures intraocular pressure, corneal thickness (CCT) as well as dynamic corneal response (DCR) parameters. Most of the DCR parameters are affected by IOP and CCT: Therefore, algorithm are needed to determine parameters without impact of IOP and CCT that are describe the biomechanical properties of the cornea.

In this study, an eye twin based on finite element modeling is used to measure advanced properties of corneal biomechanics. Raw data of Corvis ST measurement are exported from the device and imported into the model. The outcome of these calculations are merged together and are compared to further clinical findings (e. g. corneal topography and tomography, axial eye length).

Further information were obtained:

Age, sex, refraction, family history, known duration of disease, previous ocular surgery, systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.

Eligibility Criteria:
Inclusion Criteria:

* corneal ectasia (keratoconus) or ectasia suspect
* glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect

Exclusion Criteria:

* age under 18 years
* pregnancy
Study of Single Doses of SBT115301 in Healthy Participants

This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.


Eligibility Criteria:
Inclusion Criteria:

* Males or females not of childbearing potential
* Healthy participants based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests
* Use of highly effective methods of contraception (sexually active males with partners of childbearing potential)
* Up-to-date vaccinations for coronavirus disease (COVID-19) and influenza

Exclusion Criteria:

* Chronic or acute illness
* History of drug or alcohol abuse or positive drug or alcohol screening results
* Clinically significant ECG abnormality
* Received attenuated live vaccine within 1 month or COVID-19 vaccine within 2 weeks prior to study, or anticipated vaccination during study period
Cross-Training and Locomotor Abilities in Cerebral Palsy

The purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy.

Thirty children with spastic unilateral cerebral palsy were recruited from different rehabilitation centers. They were assigned randomly into two groups. Children in the control group (A) were engaged in a selected physical therapy program while those in the experimental group (B) received cross-training program followed by application of the same selected physical therapy program received by group (A). The treatment programs were conducted five times per week for six successive weeks. Measurements obtained included active ankle dorsiflexion range of motion (AROM), and the speed of walking obtained by 10-meter walking test. These measures were recorded two times: pre- and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Spasticity grade 1 to 1+, according to the Modified Ashworth Scale.
* Can stand and walk autonomously.
* Able to follow verbal commands and instructions.

Exclusion Criteria:

* Fixed musculoskeletal deformities
* significant cognitive disorders
* significant perceptual disorders
* significant auditory disorders
* significant visual disorders
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* Indication for a total knee replacement with a mobile-bearing UC or PS inlay
* Written informed consent for participating at the clinical study
* Willingness and mental ability to participate at the long-term follow-up examinations

Exclusion Criteria:

* Patient age \< 18 and \> 80 years
* Pregnancy
* High risk patients (ASA class \>3)
Molecular Biology of Polycythemia and Thrombocytosis

Our study is designed to characterize the clinical picture and genetic pattern of Polycythemia and Thrombocytosis. The purpose of this project is to find a gene and its mutation that causes these disorders. When this is accomplished, new therapies to control and eventually cure the disorder can be designed.

Our hypothesis is that genes and their mutation are causative of certain types of polycythemia and thrombocytosis. These will be sought for by genetic and cell biology means. The purpose of the study is to identify the molecular defect of these disorders.

5-7 teaspoons of peripheral blood will be drawn on all study subjects. After DNA is obtained, linkage analysis and/or mutation analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with an elevated hemoglobin concentration (\>18 in males and \>16 in females)
2. Subjects with an elevated platelet count (\>450,000)

Exclusion Criteria:

1. Subjects who have a known acquired cause of polycythemia and thrombocytosis
2. Subjects with heart disease, left to right heart shunt or severe pulmonary disease
Plasma Appearance of Xanthohumol in Healthy Adults

The aim of this study is to investigate the rate and extend of the plasma appearance of native Xanthohumol and Xanthohumol integrated into micelles in healthy men and women. Therefore, participants consume capsules with either 86 or 172 mg of native Xanthohumol or Xanthohumol integrated into micelles. In an observation period of 24 hours, Xanthohumol and its major metabolites are analyzed in plasma.

In a crossover design, 6 healthy young men and 6 healthy young women participate in 4 Xanthohumol interventions with either 86 or 172 mg native or micellar solubilized Xanthohumol. During an observation period of 24 hours, Xanthohumol and its major metabolites Isoxanthohumol, 8- and 6-Prenylnaringenin are analyzed in plasma. Each intervention will be separated by a wash-out period of 14 days. Typical plasmakinetic analyses (Cmax, tmax, AUC, t1/2, bioavailability) will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18,5 - 24,9 kg/m2
* metabolically healthy
* written consent

Exclusion Criteria:

* smoking
* low or high blood pressure
* dyslipidemia
* insulin resistance or diabetes mellitus type 1 or type 2
* gastrointestinal diseases (e.g. food intolerances or allergies)
* liver, kidney and/or thyroid diseases
* hepatitis B or C, HIV Infection
* chronic inflammatory diseases
* disordered eating
* psychological diseases
* alcohol and/or drug abuse
* veganism or unbalanced diets
* use of medication
* pregnancy or lactating
* participation in another intervention study
The Effects of a Standardized Management Plan on Children With Critical Asthma

A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome.

A Standardized Clinical Assessment Management Plan (SCAMP) has been developed and implemented at Boston Children Hospital to decrease variations in clinical practice in critical asthma therapies for children. However the effects of the Critical Asthma SCAMP on the clinical outcomes in children with critical asthma are unknown. This study will assess the effectiveness of the SCAMP by comparing retrospective data from medical records in children with critical asthma to prospective clinical PPSQ SCAMP outcome data obtained during the QA process of the SCAMP. The primary aim is to determine whether a Critical Asthma SCAMP can improve clinical outcome. There are three specific pathways in the Critical Asthma SCAMP. The primary outcome measure is the length of intensive care length of stay (defined as time to every 2 hr intermittent albuterol nebulization) for all three pathways. The secondary aim is to validate a clinical asthma score to direct critical asthma therapies. To achieve this goal we will determine the relationships of the driver(s) of the SCAMP which includes Boston Children Hospital (BCH) Asthma Severity Score \[HASS\] and non-invasive measures of pCO2 to standard measures of severity of asthma (blood gases and peak flow measurements).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients 2 years and older requiring critical asthma therapies including continuous albuterol nebulization
Green Tea Extract for Endometriosis Treatment

The purpose of the study is to evaluate the efficacy and safety of green tea in endometriosis.

Women with endometrioma will be randomised into either the experimental group or the placebo comparator group in a 1:1 ratio. The subjects will be given SUNPHENON EGCg or placebo for 3 months prior to their planned surgery.

Eligibility Criteria:
Inclusion Criteria:

* Complaints of pelvic pain, dysmenorrhoea and/or dyspareunia ≥ 6 months; and
* Verbal pain rating scale \> 4/10 and visual analogue pain scale \> 4cm; and
* Ultrasound confirmed endometrioma with or without fibroid and adenomyoma; and
* Planned surgery treatment within 4-6 months

Exclusion Criteria:

* Age \< 20 years beyond or \>40 year behind the active reproductive age; or
* BMI \<18.5 kg/m2 as underweight or \>25 kg/m2 as overweight; or
* Chronic pelvic pain or low back pain due to other medical conditions, e.g. urological disorders and orthopaedic disorders; or
* Secondary dysmenorrhoea due to gynaecological conditions other than endometriosis, e.g. pelvic inflammatory diseases, genitourinary infections, gynaecological tumours, etc.; or
* Primary dysmenorrhoea without any underlying disease identified; or
* Ultrasound suggested polycystic ovary, haemorrhagic ovarian cyst, ovarian dermoid cyst, cystic neoplasm, tubo-ovarian abscess or other ovarian pathologies in the same ovary; or
* Chronic medical conditions under long-term medications; or
* Endometriosis under active medication in past 1 month; or
* History of herbal medicine intake in past 1 month
Interest of Performing Two 6-minute Walk Tests at the End of a Pulmonary Rehabilitation Program, in COPD Patients.

In pulmonary rehabilitation, the 6-Minute Walk Test (6MWT) is essential to assess the effects of the program on patients' health. Current guidelines don't recommend to perform two 6MWT at the end of pulmonary rehabilitation. However, a more recent study shows that two 6MWT should be performed at the end of the program to accurately and reliably assess patients' capacities.

The aim of this study is to compare the results of two tests performed at the end of the program by COPD patients to find out whether there is a benefit of performing two 6MWT at the end of pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with stage 2 to 4 (A to D) COPD
* Admitted to pulmonary rehabilitation unit of CH des Pays de Morlaix (CHPM)
* To follow a pulmonary rehabilitation program (4 weeks)
* Patient aged 18 or over
* Patient able to formulate his non-opposition to participate in the study

Exclusion Criteria:

* Contraindication to perform the 6-Minute Walk Test
* Patient under legal protection
* Refusal of participation
Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

The aim of the study is to investigate the confounding factors of chronic endometritis and therapeutic benefits of antibodies targeting plasma cells in women with reproductive failure.

Eligible women, based on the inclusion and exclusion criteria, will be recruited from the IVF and/ or miscarriage clinic in the Prince of Wales Hospital/ CUHK medical centre (CUMC). Endometrial sampling (ES) will alternatively be conducted during mid-luteal phase. In natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the Luteinizing Hormone (LH) surge. The ES will be obtained precisely 7 days after LH surge. In artificial cycles, 6mg estradiol will be given daily orally from day 2 of the menstrual cycle for 14+/-1-2 days. Transvaginal ultrasound will be performed on day 14 of the estrogen therapy to assess the endometrial thickness and to exclude ovarian activity. If endometrial thickness is ≥8 mm, plasma progesterone level is \< 4nmol/L, progesterone will be commenced using either Endometrin (Ferring, Saint-Prex, Switzerland) 100 mg TDS vaginally. ES will be obtained using a Pipelle sampler as an outpatient procedure. The ES will be obtained precisely 5 days after progesterone supplementation.

Immunohistochemical staining will be used to determine plasma cells by using a mouse antihuman monoclonal primary anti-CD138 antibody and anti-CD38 antibody. The total number of plasma cell present in the stroma of the entire specimen will be determined and expressed as plasma cell count per unit area of the specimen. If CE is present, antibiotics will be given following the guideline from the Hospital Authority (HA). Then ES will be taken again to be re-examined by histology and microbiology.

Eligibility Criteria:
Inclusion criteria:

1. Age 20-45 years;
2. Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation12; or
3. Women who failed to conceive after unprotected intercourse for one year; or
4. Women who failed failure to achieve a clinical pregnancy after two consecutive cycles of IVF, ICSI or frozen embryo replacement cycles where the cumulative number of transferred embryos is no less than four for day-2 embryos and no less than 2 for day-5 embryos (blastocysts), with all embryos being of good quality.

Exclusion criteria

1. Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural);
2. Untreated hydrosalpinx;
3. History of antiphospholipid syndrome;
4. Known clinical autoimmune disease;
5. Undergoing immunotherapy;
6. Abnormal thyroid function;
7. Abnormal karyotyping.
8. Those with active pelvic inflammatory disease or suspicion of infection etc.
Linear Source Registry for Prostate Cancer

Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.

This registry is being conducted to provide long term analysis on the use of the linear Civastring source for prostate cancer. Prospective data collection will record and demonstrate biochemical response rates. Long term side effects and adverse events will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Plans to remain in care of enrolling physician for 5 years
* \> 5 years life expectancy
* Signed informed consent
* Enrolled within 6 weeks of implant or within 365 days of prior implant

Exclusion Criteria:

* Not willing or able to comply with protocol visit schedule
A Randomized Controlled Trial Evaluating an Online Intervention in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years

A non-blinded two-arm parallel randomized controlled trial will be conducted. Inclusion criteria are: 1) aged ≥65 years, 2) having Hong Kong ID, 3) Chinese speaking, 4) willing to be followed up by telephone, 5) having a smartphone, and 6) have not received SIV for the incoming flu season. Exclusion criteria include: 1) cognitive impairment, blindness or deafness, 2) not able to communicate with others effectively, and 3) with known contradictions of SIV (allergic to previous SIV, diagnosed/suspected egg allergy, with bleeding disorder or on warfarin). A total of 396 participants will be randomly assigned to either the intervention group (n=198) or the control group (n=198). Intervention group will watch an online health promotion video tailored to their current stage of change related to SIV uptake once every two weeks for four times (at week 0, 2, 4, and 6).

Participants in the control group will watch a same online video providing general advices related to SIV at week 0, 2, 4, and 6. All participants will be followed up by telephone 3 and 6 months after the baseline survey.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥65 years,
* Having Hong Kong ID
* Chinese speaking
* Willing to be followed up by telephone
* Having a smartphone
* Have not received seasonal influenza vaccination for the incoming flu season

Exclusion Criteria:

* Cognitive impairment, blindness or deafness,
* Not able to communicate with others effectively
* With known contradictions of seasonal influenza vaccination listed by the Centre for Health Protection (allergic to previous SIV, diagnosed/suspected egg allergy, with bleeding disorder or on warfarin)
Racial Discrimination, Pain, and the Buffering Influences of Acknowledgment

Black young adults (aged 18-30; N = 92) were racially included (i.e., received the ball an equal number of times) or excluded (i.e., received the ball only once) by other White players in a ball-tossing computer game called Cyberball; White experimenters acknowledged the exclusion for half of the excluded participants. Participants completed a cold-pressor task twice to measure pain sensitivity (threshold, tolerance, and unpleasantness): immediately prior, and after the Cyberball (and acknowledgment) manipulation. Participants also completed a post-manipulation survey examining the psychological effects of racial exclusion and acknowledgment (i.e., psychological needs satisfaction, negative affect, control).


Eligibility Criteria:
Inclusion Criteria:

* Participants identify as Black/African American
* Age 18-30

Exclusion Criteria:

* Past 30-day persistent pain
* Cardiovascular or circulatory disorders
* Diabetes
* Current pregnancy
* Open sores/frostbite on nondominant hand