cyrilzakka/clinical-trials huggingface dataset:
Highlighting the Benefits of Therapeutic Gardens in Alzheimer's Disease by 18F-FDG Cerebral PET /CT

The Alzheimer's Plan 2008-2012 allowed the installation of therapeutic gardens for the structures welcoming patients with Alzheimer's disease (AD) . The physical, psychological and social benefits are the improvement of the state of health and overall well-being.

There is a positive role in social interactions for patients with AD who can walk in the therapeutic gardens. Indeed, this promotes meetings with caregives and other people.

Using the garden decreases the stress level in patients (Ulrich). The therapeutic garden named "art, memory and life" in NANCY is based on art, nature and regional culture.

This garden can break with the "artificial" framework of care services often perceived as stressful.

In the garden, people walk around and have an experience that could improve self-image perception.

A clinical study with 2 groups of AD patients hospitalized in UCC or Cognitive Behavioral Unit took place in Nancy. The evaluation of the QCS (questionnaire on self-awareness) was carried out at the beginning and at the end of the study,

* a group of patients went into the garden: the QCS score increased
* a group of patients did not go to the garden (they remained in UCC): the QCS score decreased


Eligibility Criteria:
Inclusion Criteria:

* Patient with AD in the mild to moderate stage, followed at the memory and resource center (CMRR) (MMS 15-23) and having had a 18F-FDG PET-CT (Positon emission tomography) scan in routine care having a companion for the duration of the study .
* Patient with a neuropsychological assessment (MOCA, DO80, BREF, HAD) of less than 3 months. (If the last neuropsychological assessment dates from more than 3 months, these tests are carried out in routine care during the consultation was proposed and the consent obtained)
* Symptomatic treatment of AD (anticholinesterase or memantine) if prescribed, at a stable dose for 1 month, stable psychotropic treatment for 1 month
* Person affiliated with a social security scheme or beneficiary of such a scheme.
* Patient over 18 years old.
* Person received complete information on the organization of the research and having signed their informed consent.

Exclusion Criteria:

* Patient who did not have biomarkers identified by lumbar puncture
* Patient unable to perform a cerebral 18F-FDG PET-CT scan (lying position for more than 20 minutes)
* Patient unable to follow the therapeutic program of the garden.
* Woman of childbearing age whitout effective contraception.
* Pregnant woman or nursing mother.
* Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric treatment under articles L. 3212-1 and L. 3213-1
A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters

The primary aim of this study is to investigate the feasibility, acceptability, and preliminary efficacy of an adapted Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention in improving sleep in a firefighter population.

After being informed about the study and potential risks, participants will be randomized to the intervention group (group to receive CBT-I) or the no-intervention control group. All participants in the study will complete three assessment visits; one prior to the start of the intervention, one immediately following the 6-week intervention, and one 3-months post-intervention. The intervention group will engage in 6-weeks of CBT-I training aimed at targeting sleep and sleep-related concerns faced as a result of occupational considerations.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* full-time professional firefighter
* At least 18 years of age
* A global Pittsburgh Sleep Quality Index score ≥ 5 (Grandner et al., 2006)
* Be willing and able to participate in all study activities including pre-, post-, and 3-month follow up assessments and 6-weeks of the CBT-I intervention
* Agree to random assignment to one of two conditions (treatment or control group)
* Have access to an email account
* Be willing to wear the Fitbit Inspire HR device throughout the duration of the intervention and for two weeks following completion of the 6-week intervention

Exclusion Criteria:

* Endorsement of prior involvement in formal CBT-I interventions
* Unwillingness to give written informed consent
Study of the Molecular Genetics of Menstrual Migraine

The investigators hypothesize that genes that play a role in menstrual migraine can be identified using a well characterised migraine population and a comprehensive genome-wide association scan approach.

The aim of the study is to identify genes, genetic regions, and the effect of hormones on expression profiles in women with menstrual migraine compared to a control population with no personal or first-degree family history of migraine.

In this case control study, saliva samples will be taken from 300 cases and 300 controls for DNA analysis. Blood samples from 30 cases and 30 controls will be taken during the follicular phase as well as the luteal phase of the menstrual cycle for ribonucleic acid (RNA) analysis.


Eligibility Criteria:
Inclusion Criteria:

All cases and controls must:

* Be over 18 years
* Caucasian
* Provide written, informed consent
* Clearly understand and be able to comply with all the trial procedures, as required
* Not have taken part in trials of any investigational products within the previous 4 weeks

DNA Study:

* Cases must have at least a 12-month current or past history of menstrual migraine

RNA Study:

* Cases must have at least a 12-month current history of menstrual migraine
* Cases must have kept at least three months of headache diary data in advance of visit in order to confirm diagnosis
* Controls must still be having menstrual periods

Exclusion Criteria:

DNA Study:

* Cases and controls must not have smoked, chewed gum or consumed any food or drink in the 30 minutes prior to sample collection

RNA Study:

* Cases and controls will not be eligible for participation if they have:

  * Polycystic ovarian syndrome;
  * Taken any hormones or drugs in the previous three months that may affect normal hormone activity (e.g., hormonal contraceptives, hormone replacement therapy, dietary supplements such as isoflavones);
  * Donated or lost a significant amount of blood (\> 550 mL) within the previous 12 weeks
  * Additionally, controls must not have a personal or family history in any first-degree relative of current or past migraine
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC

The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer

Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.

Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib

Eligibility Criteria:
Inclusion Criteria:

* Signed the informed consent.
* Female aged ≥18 years old.
* Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer.
* No more than 2-line chemotherapy failed at the stage of recurrence and metastasis .
* Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment
* At least one measuring lesion that confirmed by RECIST v1.1 standard.
* The patients can swallow pills.
* Have a life expectancy of at least 12 weeks.
* The functions of vital organs meet protocal requirements.

Exclusion Criteria:

* Subjects had any history of active autoimmune disease .
* Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors.
* Subjects have untreated central nervous system metastasis.
* History of hypertension and antihypertensive medications are not well controlled.
* Some clinical symptoms or diseases of the heart that are not well controlled.
* History of immunodeficiency including HIV-positive.
* Subjects had active infections.
Robot-Assisted or Laparoscopic Resection for Gastric Subepithelial Tumor With Hand-Sewn Repair, a Case Series

There are a lot of surgical techniques in minimally-invasive surgery to remove gastric subepithelium tumor. Surgical approach depend on location and size of tumor. Usefully used Endostapler to cut stomach include lesion. For tumors in difficult locations some surgeons prefer laparoscopic and endoscopic cooperation or use the intragastric port technique to identify and remove the mass. But in complex procedures, gastotomy and hand sawn to identify and remove gastric subepithelium tumor is a simple technique and easy to apply. This study demonstrates the safety and effectiveness of this technique.

: A retrospective chart review was made of all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018. Surgical outcomes and complication of gastotomy and hand-sewn repair were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* all patients who presented with gastric subepithelial tumor and underwent laparoscopic or robotic resection at Ramathibodi Hospital during 2012-2018.

Exclusion Criteria:

* conversion to open surgery
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Males 18-64 years of age
* Mild or mild to moderate ED (defined as \>15 and \<21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
* History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
* Stable, heterosexual relationship for more than six months

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy.
Regional Differences in Human Immunodeficiency Virus (HIV) Testing

This retrospective observational study aims at the examination of regional differences in the procedure of referral for serological HIV testing between eastern (new) and western (old) German federal states.

Increasing incidence of HIV infections urges early recognition and timely introduction of therapy. Regional differences in referral approach and patient behavior are presumably associated with considerable delays in infection recognition and therapy onset. Comparison of records of new cases which were diagnosed in 2014 in several eastern federal states and a major western German city is expected to disclose whether the regionally preferred type of the primary care institution affects the time point of first diagnosis and the elapsed time since the emergence of the infection, as assessed by Cluster of Differentiation 4 positive (CD4+) lymphocyte counts and manifestation of clinical symptoms of immune deficiency.

Eligibility Criteria:
Inclusion Criteria:

* first-time HIV seropositivity

Exclusion Criteria:

* N/A
Differences in Trends Malignant Germ Cell Tumors in Males and Females: A SEER Population-based Study

Differences in 30-year Trends in Incidence and Survival for Malignant Germ Cell Tumors in Males and Females.

Differences in 30-year Trends in Incidence and Survival for Malignant Germ Cell Tumors in Males and Females: A SEER Population-based Study.

Eligibility Criteria:
Inclusion Criteria:

* Survival for Malignant Germ Cell Tumors in Males and Females.
Effect of Dietary Fat When Eaten With Fructose Versus Glucose

This study is designed to test the effects on liver fat of varying fat intake in the presence of fructose or glucose. We hypothesize that higher dietary fat when eaten with fructose as compared to glucose will increase the amount of hepatic lipid as measured by magnetic resonance spectroscopy.

After 2 screening visits including an exercise test, DEXA and CT scan, qualifiers begin a 7 day diet with 20% fat, 65% carbohydrate (with 20% glucose) and 15 % protein. Participants consume 2 meals per day at PBRC with lunch and weekend meals packed to go. Following a test day, participants are randomized to one of 3 diet assignments and then test again:

1)20% fat, 65% carbohydrate (with 20% glucose beverage), 15% protein 2)40% fat, 45% carbohydrate (with 20% glucose beverage), 15% protein 3)40% fat, 45% carbohydrate (with 20% fructose beverage), 15% protein On Day 7 and again 14 days later participants have labs, an oral Glucose tolerance test, hepatic and intramuscular lipid measures by MRS, vital signs and waist measurement.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 35 kg/m2 inclusive
* At least one of the following:

  1. Impaired fasting glucose between 100-125 mg/dl inclusive
  2. HDL below 40 mg/dl for men or below 50 mg/dl for females
  3. Triglycerides between 150 mg/dl and 400 mg/dl inclusive
  4. Blood pressure above or equal to 135 / 85 mm Hg
* Waist circumference \>94cm (37 inches) for men or \>80cm for women
* Mainly Healthy

Exclusion Criteria:

* Unable or unlikely to eat study foods and only foods provided by PRBC
* Taking routine medications except birth control pills
* Smoke, Abuse drugs,or Alcohol
* Pregnant or breastfeeding, irregular menstrual cycles, Post-menopausal,or PCOS
* Diabetes, heart, lung, liver, blood, or Kidney disease
Effect of Air-stacking on Peak Cough Flow in Patients With Acute Cervical or High Thoracic Spinal Cord Injury

Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of these respiratory complications needs to begin immediately after injury. To achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. Manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. The emphasis should therefore be on expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted cough the PCF can be increased sufficiently. The aim of this study is to compare the effect of two different air-stacking techniques on PCF, air-stacking on a respirator versus air-stacking with a manual resuscitator.


Eligibility Criteria:
Inclusion Criteria:

* acute cervical or high thoracic spinal cord injury admitted to the ICU

Exclusion Criteria:

* substantial abdominal or thoracic injury
* substantial brain damage
* intubated or tracheostomized patients
* not able to cooperate
* pregnant women
Personalized Prediction of Persistent Postsurgical Pain

P5 is planned as a prospective observational study, collecting evidence-based perioperative data on patient history and demographics, physical function, cognitive measures, psychological, and biological markers associated with increased pain susceptibility, and psychophysical measures of pain processing.

The study will use daily ecologic momentary assessment (EMA) of physical and emotional parameters, and collect data on perioperative events.

Follow up will occur 3 months and 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-75 who are candidates for major surgery (expected surgery duration \>1 hour, and expected overnight admission to the hospital)
* Access to a smartphone

Exclusion Criteria:

* Participants who do not speak English
Intravenous Paricalcitol in Chronic Hemodialysis Patients

This study aims to provide intravenous paritcalcitol treatment for the sick and poor hemodialysis patients with severe secondary hyperparathyroidism (SHPT) resistant to existing vitamin D analogs therapy or with hypercalcemia precluding the use of existing vitamin D analogs.

The study aims to evaluate the effect of paricalcitol on control of SHPT, biochemical parameters of chronic kidney disease-mineral bone disease, cardiac parameters, vascular calcification and stiffness parameters and nutrition status in patients receiving chronic hemodialysis treatment.

This is a 2-year single-arm intervention study of which intravenous paricalcitol will be provided as a second-line treatment to 30 chronic hemodialysis patients with severe SHPT (defined as intact parathyroid hormone \[iPTH\] ≥ 800pg/mL) resistant to existing vitamin D analogs treatment (including rocaltrol and alfacalcidol) or with hypercalcemia (defined as serum calcium ≥2.56mmol/L) precluding the use of existing vitamin D analogs.

The study aims to evaluate the control of SHPT, various biochemical parameters of chronic kidney disease-mineral bone disease, left ventricular mass and volumes, vascular calcification and stiffness parameters, handgrip strength and serum albumin with the use of intravenous paricalcitol in patients receiving chronic hemodialysis treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients with severe SHPT (defined as iPTH ≥ 800pg/mL) resistant to rocaltrol or alfacalcidol (defined as iPTH not controlled in the range between 2 - 9 times of lab upper limit reference).
* Chronic hemodialysis patients with severe SHPT and at the same time hypercalcemia (defined as serum calcium ≥2.56mmol/L) but still \< 2.8mmol/L precluding the use of rocaltrol or alfacalcidol but still feasible to use paricalcitol.

Exclusion Criteria:

* Patients with metastatic malignancy,
* Patients with extremely poor general condition (eg. bedbound) and expected lifespan is below 6 months
Internet Based Screening and Stepped Care for Cancer Patients With Anxiety and Depression Symptoms

The aim is to evaluate the effects of Internet based Stepped Care on anxiety, depression and health related quality of life in cancer patients with anxiety and depression symptoms, compared to Standard Care, and to evaluate the health-economic effects of the intervention. The investigators also want to examine the development of anxiety and depression symptoms and health related quality of life in cancer patients without initial symptoms.

The primary hypothesis is that Internet based Stepped Care (I-SC) is more effective in relieving anxiety and depression symptoms in cancer patients, compared to Standard Care (SC). Secondary hypotheses are that less anxiety and depression symptoms also means improved health related quality of life and that I SC is cost-effective or at least cost neutral compared to standard care.

The IT-platform Carebase.se is developed within U-CARE. The platform will be used for delivering of interventions and for collection of all patient reported outcomes. Patients with anxiety or depression symptoms according to the Hospital Anxiety and Depression Scale will be randomized to I SC or SC. Patients with no initial anxiety or depression symptoms will be included in descriptive studies. All patients, in the randomized controlled trial and the descriptive study will followed up during 24 months

I-SC comprises interactive support (Step 1) and Cognitive Behavioral Therapy (CBT; Step 2). Step 1 starts directly after randomization and extends over a 24 months period. Step one comprises web-based patient education including psycho-education and easy interventions strategies employed in CBT. Step 1 also includes a FAQ, a discussion board for patients and a personal diary. Project staff (nurses) is responsible for the FAQ and to moderate the discussion board. The nurses will be supervised by a CBT psychologist. They can also turn to other experts in the project group for advices about how to answer patients' questions.

Patients with remaining anxiety or depression symptoms at 1, 4 or 7 months after randomization will be offered Step 2. Step 2 comprise conventional Internet based CBT for common psychological concerns. The participants' chooses to work with modules that correspond to prioritized concerns, e.g. anxiety or depression. The CBT is structured and manualized and include conventional treatment methods with homework and weekly contacts with the psychologist. Step 2 extends over a 10-week period.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Breast- Colorectal- or Prostate cancer or recurrent Colorectal cancer within 3 months form diagnoses

Exclusion Criteria:

* inability to communicate in Swedish
* Karnovsky performance status \< 40
* short expected survival (\< 6 month)
* cognitive disability (e.g. dementia or psychosis)
* severe depression or suicide risk
Promoting Physical Activity in Rural Communities

The purpose of the study is to test a multilevel intervention's impact on increasing physical activity among rural residents. It is expected that participants who participate in more of the intervention (e.g., all levels) will increase their physical activity more than the control group and individuals who participate in less of the intervention (e.g., one level of the intervention).

The study will test the independent and moderating effects of a multilevel intervention and the community environment on physical activity among rural residents. The multilevel intervention consists of community, interpersonal, and intrapersonal aspects. The community level intervention consists of community events. The interpersonal level intervention consists of walking group formation. The intrapersonal level intervention consists of cues provided by short message service messages (i.e., text messaging). A dose response relationship is expected in the intervention communities.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18+)
* No cognitive impairments
* Able to physically active
* Willing to complete telephone survey at three time points
* Located in targeted communities in southeast Missouri

Exclusion Criteria:

* Participants not located in targeted communities