cyrilzakka/clinical-trials huggingface dataset:
Senior Peer Alliance for Rural Research On Wellness

Dr. Brooke Hollister, Ph.D. from the department of Social and Behavioral Sciences at the University of California, San Francisco is conducting a study comparing two types of interventions for treating depression in rural older adults.

If you are eligible to participate in the study after completing the screening assessment, and if you choose to continue on, we will randomize you (like a flip of a coin) to receive either 12 weeks of case management combined with problem solving therapy (CM-PST) with a social worker or 12 weeks of self-guided problem solving therapy (SG-PST) with support from a senior peer counselor.

As part of your participation in the study you will participate in three 1.5 hour assessment interviews of psychological and neuropsychological functioning (similar to your screening assessment) prior to your first week of treatment (baseline), two weeks after your final session (week 14), and three months after your final session (week 24). Additionally, you will participate in three shorter assessment interviews of psychological functioning, which will be conducted at weeks 3 and 6. These assessments will take approximately 30-45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Residence in rural Tuolumne, Calaveras, San Joaquin or Stanislaus Counties;
* Diagnosis: Major depression, unipolar (by SCID ascertained DSM-IV criteria);
* Severity of depression: A PHQ-9\>10 or a 24-Item HDRS\>19;
* Need for social services: CANE score\> 2, i.e. at least one unmet need;

Exclusion Criteria:

* Psychotic depression by SCID-IV, i.e., presence of delusions;
* High suicide risk, i.e. intent or plan to attempt suicide in near future;
* Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression;
* Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV);
* History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (including bipolar disorder, hypomania, and dysthymia);
* Dementia: MMSE below 24 or clinical diagnosis of dementia by DSM-IV;
* Acute/severe medical illness (delirium, metastatic cancer, de-compensated cardiac, liver or kidney failure, stroke or myocardial infarction) 3 months prior to entry; or use of drugs causing depression, (steroids, reserpine, alphamethyl-dopa, tamoxiphen, vincristine);
* Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance (walking with a cane is not an exclusion criterion)
* Inability to speak English;
* Aphasia interfering with communication;
Biomarker Breast Pap Test

This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.


Eligibility Criteria:
Inclusion Criteria:

* Any female subject aged 18 years or older

Exclusion Criteria:

* none
Qigong and Social Isolation: Mental Health Benefits

The objective of the study is to understand if Qigong may be useful in controlling the psychological state of participants in relative social isolation (during Covid-19 governmental imposed isolation procedures) The sessions are conducted live by the internet by a professional instructor-therapist with the duration of 2 months and a regular minimum of 2 sessions a week.

The study's objective is to understand if Qigong may be helpful on the psychological state control of the participants in a relative state of isolation imposed by the government on the fight against Covid-19.

Data is gathered via the Mental Health Inventory (MHI) adapted to the Portuguese population to assess quantitative mental health scores and a simple structured interview to assess qualitative mental health benefits of Chikung (Qigong).

Qigong was the chosen technique to be studied as an intervention. Qigong is a Traditional Chinese Medicine therapeutic tool that has been studied for its several health benefits. As a traditional vegetative biofeedback therapy, Qigong can be useful for the maintenance of mental health of people with several conditions such as anxiety and depression, autism spectrum disorder and even conditions related to behavioral control.

* Group 1 was composed of Qigong practitioners (for at least 3 months).
* Group 2 was composed of participants who would receive the Qigong intervention (never practiced Qigong).
* Group 3 was composed of control participants (who would not receive the intervention).

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Physical or mental disabilities or conditions that may aggravate when performing semi-supervised physical activity
Exercise-induced Hypoalgesia in Patients With Knee Osteoarthritis

The main objective of this study is to evaluate the differences in the phenomenon of exercise-induced hypoalgesia in patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with severe knee OA (according to the clinical and radiographic criteria of the American College of Rheumatology Guidelines)

Exclusion Criteria:

* pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities),
* undergone another hip or knee joint replacement in the previous year
* any medical condition in which exercise was contraindicated
Impact of the Kaligo Solution on Learning to Write in Children Aged 6 to 11 With Handwriting Disorders : KALIGO+

Writing is a fundamental skill, crucial to a child's success at school and the development of independence. Around 30% of children present difficulties in learning to write, and for some of them (10%), these difficulties persist for a long time. Adapted learning can improve their handwriting. Initial studies into the use of new technologies (tablets, virtual reality headsets) have shown that they can help children learn to write. Attractive to children, these interfaces make it possible to apply new paradigms (e.g. enrichment of feedback \[sonification\], variation of writing media) that have proved effective, mainly with children with 'typical' development. The Kaligo+ solution is based on the latest scientific advances to offer an innovative approach to learning to write, particularly for children with significant difficulties in this area. This study proposes to test the benefits of the Kaligo+ solution on 15 children with writing difficulties.

The main objective of this pilot study is to demonstrate improved writing performance following use of the Kaligo+ solution in children aged 6 to 11 with writing difficulties, using a Single Case Experimental Design (SCED) methodology.


Eligibility Criteria:
Inclusion Criteria:

* Children with writing difficulties (who may or may not be receiving care in this area)
* Age: 6 - 11 years
* Score \> 1 standard deviation on the BHK deterioration score

Exclusion Criteria:

* Contraindication to the use of the tablet or virtual reality
* Moderate, severe or profound intellectual disability (Total Intelligence Quotient below 55 on an intellectual efficiency scale such as WISC-V or K-ABC-II).
A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease
* Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
* Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
* Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion Criteria:

* Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
* Diagnosis of ulcerative colitis (UC) or indeterminate colitis
* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
* Suspected or diagnosed intra-abdominal or perianal abscess at screening
* Current stoma or need for colostomy or ileostomy
* Previous small bowel resection with a combined resected length of \>100 cm or previous colonic resection of \> 2 segments
* Surgical bowel resection within 3 months before screening
* Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
* Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study
* Subjects who meet the protocol criteria for important laboratory exclusion criteria
Osteogenic Effects in Human Mesenchymal Stem Cells Enhanced by Wnt Signaling

The first year purpose:

The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Our previous work is investigating the viral (Adv-BMP-2) administration for the development of a model to generate bones for possible use in clinical settings; the non-viral and viral administrations will be compared for best osteogenesis effects.

The first year purpose:

The best concentration of canonical Wnt3a will be investigated in promoting the osteoblastogenesis of human mesenchymal stem cells.

Eligibility Criteria:
Inclusion Criteria:

* age above 10 years old
* The patients require surgery ner iliac or abdomen areas

Exclusion Criteria:

* age below 10 years old
Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer

The purpose of this research study is to understand if a mobile app is useful to assist young adult female survivors of childhood cancer in the self-management of survivorship-related needs.

Survivorship related needs include managing lingering symptoms from treatment, how to keep a healthy lifestyle, social and medical issues, as well as other needs. The mobile health app that will be used in this study is the Health Storylines TM app developed by Self Care Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is how long the study will be conducted. The use of the Health Storylines TM app in this study is investigational.

Participation in this study starts with setting up a study specific profile on the app and entering information including email address, age, ethnicity/race, cancer diagnosis, as well as other optional information for the profile (example health goals or current health conditions). Participants will then be prompted by the app to complete three questionnaires about their ability to self-manage their survivorship-related needs, their perception of their survivorship-related illness symptoms and perceived health related quality of life. They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9 month intervals of using the app. It will take about 20 minutes to complete the questionnaires at each measurement time. The only additional information that will be reported from the app for the study is the amount of time and features of programs accessed during the study period.

Eligibility Criteria:
Inclusion criteria are females who:

* Have been diagnosed with cancer before the age of 18 years
* Are between the ages 18 to 30 years
* Have been off treatment for at least six months
* Have a personal smart device to use for the app

Exclusion Criteria:

- None
A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China

major objective This multicenter, prospective cohort study aims at evaluating the predictive value of microbiome ,proteomics and serum markers in preeclampsia. secondary objective to evaluate the value of microbiome,proteomics and serum markers in assessing pregnancy outcome (complications during pregnancy and delivery, delivery) and neonatal prognosis.

The volunteers will be recruited from the gestational women who come to the hospital before 14 weeks of gestation. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. Then,urines ,serums and salivas as well as vaginal swabs and feces will be taken from each volunteer at gestational ages 11-14, 22-28, 32-34 weeks and delivery period .In delivery period,we will take placentas, cord bloods, amniotic fluids if it is possible. They will be followed up to two years after the child delivery (6 weeks,6 months,1 years and 2years after the child delivery) and do the same sampling who have preeclampsia during gestation. The salivas, vaginal swabs,placentas, amniotic fluids and feces will be to perform 16S rRNA(ribosomal ribonucleic acid) gene sequencing microecology assessment, Body fluid samples will be to perform peptidomics by MALDI-TOF(Matrix-Assisted Laser Desorption/ Ionization Time of Flight ) and metabonomics by mass spectrometer, combinations of mean arterial pressure (MAP), uterine artery pulsatile index , serum placental growth factor (PlGF) to estimate the patient-specific risk of pre-eclampsia (PE) .

Eligibility Criteria:
Inclusion Criteria:

* Aged \>=18 years;
* Pregnancy woman;
* With a singleton pregnancy;
* Volunteer and receive regular antenatal examinations in the research centers;
* Volunteer to sign a written informed consent.

Exclusion Criteria:

* Concurrent with hypertension, diabetes, liver and kidney diseases, hematonosis and other serious diseases of pre-pregnancy women, including patients requiring long-term medication for primary diseases;
* With history of preeclampsia;
* Tumor patients concurrent with serious infection requiring long-term drug treatment;
* Pregnant women conceiving through in vitro fertilization;
* Multiple pregnancies;
* Patients with clear indications of medical pregnancy termination during early pregnancy;
* Any medical or non-medical conditions deemed inappropriate for study participation according to the investigator.
Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring in Patients With Hip Fracture

Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per 100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory complications during and after surgery partly explain this high morbidity and mortality. Most patients are frail and with multicomorbidity. Goal-Directed Hemodynamic Therapy (GDT) based on noninvasive continuous monitoring of blood pressure, heart rate, oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index can reduce perioperative complications and improve survival. The objective of our study is to assess the efficacy of a goal-directed hemodynamic therapy in reducing perioperative complications. Patients and Methods: non-randomized intervention study with a historical control and 1-year follow-up. Patients older than 64 years with non-traumatic hip fracture requiring surgical intervention. In the control group standard care was performed based on non-invasive, intermittent arterial pressure measurement, obtained every 5 minutes, continuous heart rate, and oxygen saturation. In the intervention group GDT based on noninvasive monitoring will be performed. The main outcome will be the percentage of patients with perioperative complications. Secondary outcomes: LOS and survival at 12 months of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Hip fracture that require surgical treatment
* Agree to participate and sign informed consent

Exclusion Criteria:

* Pathological or traffic related fractures
* Anesthetic contraindication for surgery
* Refractures
* Contraindication for hemodynamic monitoring
* Physiocal less than 30 after 7 minutes
* Psychomotor agitation that prevents hemodynamic monitoring
Short Effects of a Rehabilitation Session on Gait in Patients With CNS

The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,

1. muscle strengthening of the lower limbs and
2. effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥ 18 years receiving a motor rehabilitation in the service
* Hemiplegia after stroke or paraplegia incomplete ASIA C or D or multiple sclerosis (EPSS \<5).
* Walking with or without technical assistance
* Patients who received and signed information and informed consent
* Patient who received physiotherapy session for rehabilitation of the lower limbs
* Patients able to perform the entire study

Exclusion Criteria:

* Patient with safety measure
* Pregnant women, breastfeeding
* Patient who has received botulinum toxin injection of in the lower limbs between 3 weeks and 2 months prior to inclusion in the study
* Bilateral Brain damage, cerebellar syndrome, apraxia, severe aphasia
* Orthopedic complications preventing walking
* Patients who participated in a clinical study within 3 months prior to inclusion • No affiliation to a social security scheme (beneficiary or assignee)
Flexible Tip Bougie Vs Tube with Stylet for Intubation with a Videolaryngoscopy in ICU (VIDEOL-FLEXTIP)

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications . Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although two meta-analysis showed that videolaryngoscopy improves visualization of the glottis and the first-attempt success, other two meta-analysis reported that videolaryngoscopy didn´t improve first-attempt success rate. The reason may be that although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea .

Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.

The purpose of this prospective randomized study is to compare successful intubation on the first attempt wuth the new flexible tip bougie versus endotracheal tube with stylet during intubation with videolaryngoscopy of critically ill adults in ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the intensive care unit (ICU) and require mechanical ventilation through a tracheal tube.
* Adult (age ≥ 18 years)
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Refusal of study participation or to pursue the study by the patient
* Pregnancy
Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors

The purpose of this study is to determine the concurrent validity of a newly developed pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator in the stimulation of muscle proprioceptors.


Eligibility Criteria:
Inclusion criteria for healthy individuals:

* Age: 20-45 years old
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, pelvis or lower quadrant
* One of the following conditions: Parkinson, MS, Stroke with sequels....
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Ankle problems
* Smoking
Ultrasound and Endometrial Hyperplasia

The investigators hypothesize that endometrial thickness will be a significant predictor of endometrial hyperplasia in a postmenopausal female population with metabolic syndrome: diabetes and/or insulin resistance, hypertension, and obesity.

The objective is to identify the utility of ultrasound as a screening test for endometrial hyperplasia and cancer in an "at risk" cohort. Endometrial carcinoma is an understudied cancer. This study will provide benefit regardless of its outcome, because it will be the first prospectively designed screening trial in an asymptomatic population.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal obese subjects, who have diabetes or a prediabetic state, or hypertension

Exclusion Criteria:

* Women who have had a hysterectomy