cyrilzakka/clinical-trials huggingface dataset:
SimpleC Wellness Platform With Social Robot Interaction

This implementation study will be conducted to test a Socially-Assistive Robot (SAR) system for residents in an Assisted Living environment. The goal of the SAR system is to enhance social engagement and connectedness. The system engages residents via robot-facilitated activities such as trivia and reminder and is integrated with the SimpleC Wellness Platform.

This is a 3-week mixed-method study to assess the installation procedure, assess user first impressions, develop training, assess user materials, and identify any barriers and concerns during implementation. New features and design will be validated.

Research questions include:

* How should the SAR system be introduced to the users and their environment?
* What are facilitators and barriers to implementation?
* Will users accept the SAR system in their environment?
* What are facilitators and barriers to SAR system acceptance?
* What are the desired parameters that the SAR system should have?

  * What social behaviors do users expect?
  * What tasks would be acceptable that the SAR system tablet do?
  * How should the SAR system's perception, competence, and awareness be presented to users?
  * What is most valuable to users and why?
* If the answer depends, then what does it depend on (user, task, environment)?

Sample: Thirty individuals will participate: 10 residents, 10 family, and 10 staff. Enrollment will stop when reaching saturation.

Procedure: The research will follow established procedures for recruitment, screening, and assessment. Participants will provide informed consent, which will be followed by a baseline assessment. Participants will be screened to ascertain inclusion and exclusion criteria. Residents and Senior Housing Community will receive the new SAR system, which includes a virtual robot and physical social robot. At the beginning of the study, enrolled residents will receive a tablet with a personalized profile, wellness programs, and virtual robot using the standard SimpleC enrollment process. Installation will be followed by training. Residents and family will be invited to personalize residents' profile and programming. One social robot will be implement for the whole community. Participants will engage with the SAR system as they are willing. All staff, residents, and family will be invited to use the SAR system, independent of study participation status. At the end of the study, assessments will be administered, which is followed by a brief interview.

Eligibility Criteria:
Inclusion Criteria:

* All: Fluent in English
* Resident: 50 years and older
* Resident: lives in Assisted Living Community
* Resident: MMSE score of 13 or higher
* Family member: 18 years and older
* Family member: family or friend of resident
* Family member: no diagnosis of dementia or related disorder
* Staff: 18 years and older
* Staff: works for the Senior Housing Community

Exclusion Criteria:

* All: pregnant
* Resident: Expecting to move during the study
* Resident: Both legally deaf and blind
Antimicrobial Efficacy of Biogenic Gold Nano Particle From Pelargonium Graveolens Leaves Extract Mouthwash for Children

The study is randomized controlled trial ... The null hypothesis of the present study is that there is no antibacterial efficacy of gold nanoparticles of pelargonium graveolens mouthwash against Streptococcus mutans and Candida Albicans . Meanwhile the alternative hypothesis of the present study is that gold nanoparticles of pelargonium graveolens mouthwash have antimicrobial activity against Streptococcus mutans and Candida Albicans .

This is double blind study will be conducted among male patients with mild to moderate gingivitis . Those patients aged between (7-14 ) years old who attended the second specialized dental health center in Baquba city/ Diyala governorate/ Iraq. patients will be randomly assigned to one of two study groups the first group is Gold Nano particle from Pelargonium Graveolens Mouthwash , the second Chlorhexidine. by using 15ml of it for one minute two times daily for three weeks. In this study a clinical parameters as ( plaque index, gingival index and calculus index ) were assessed at the base line (before mouthwash use), and then assessed three times at one week interval after the base line assessment through the period of mouthwash use. On the other hand, microbiological aspect were assessed for those patients before and three weeks after the use of Gold Nano particle from Pelargonium Graveolens Mouthwash and Chlorhexidine . After three weeks the mean of plaque, gingival, and culculs indices are significantly reduced after the use of Biogenic Gold Nano particle from Pelargonium Graveolens Leaves Extract Mouthwash.

Eligibility Criteria:
Inclusion Criteria:

* The study sample will include a group if children aged (7-14) years, with mild to moderate crowding, attending the specialist dental center in Diyala city.
* Patients with mild to moderate gingivitis as a base line (for standardization).
* Healthy child without any oral ulceration or systemic medical condition.
* Cooperative child.
* Patient did not take any antibiotics or anti-fungal for at least 4 weeks prior to sampling procedure.
* Children are healthy without any systemic disease .
* From the same geographical area ( Diyala Governorate ).

Exclusion Criteria:

* Children outside specified age.
* Children with systemic disease or on medication.
* Children on a daily fluoride or other therapeutic regimen were excluded from the study.
* Children 's parents who are smokers (passive smoking ) to reduce the confounding factors.
* No more than one child per family to be allowed into the study.
* Children who their parents refuse to participate in the study.
Efficacy of a VR Paradigm to Reduce Fear of Heights in a Clinical and Subclinical Population With Fear of Heights

Investigation of the effectiveness and acceptability and usability of a VR height exposure App in individuals with fear of heights.

The study will be conducted as a randomized controlled between subject trial. The study consists of two study phases. In study phase 1 the experimental group takes part in three VR exposure sessions (duration 20min each), whereas the control group takes part in three virtual tours (duration 20min each). All VR sessions and assessments of outcomes will be conducted on one study day for each participant.

In study phase 2 the experimental group will participate in a home training, spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive any treatment (untreated comparison group). Assessment of outcomes will be conducted 3-5 weeks after completion of home trainings.

Group 1 (experimental group) consists of individuals with clinical and subclinical fear of heights, that will receive a three-session VR exposure (study phase 1) and take part in a 2-week treatment period with the same VR scenarios (study phase 2). Group 2 (control group) consists of individuals with clinical and subclinical fear of heights that will not receive any active treatment, but will participate in fear-unrelated tasks in study phase 1 or receive no treatment at all (study phase 2).

This design allows a direct comparison and therefore an estimation of the effectiveness of the VR exposure therapy. Before and after the virtual exposure/tours participants will undergo an in vivo BAT to assess the effects of the VR exposure therapy.

80 participants between 18 and 60 years with clinical or subclinical fear of heights will take part in the study. Two to three months after having finished study phase 1 the participants will be contacted again and asked to take part in study phase 2. All participants undergo a third in vivo BAT during study phase 2. The BAT will take place 3-5 weeks after completion of the home training.

Eligibility Criteria:
Inclusion Criteria:

* Clinical fear of heights (DSM-V) or subclinical fear of heights (fulfilment of DSM-C criteria A-E and G, but not F: distress/impairment)
* Physically healthy
* Aged between 18-60
* Fluent in German

Exclusion Criteria:

* Depression (BDI-II \> 8)
* Suicidal ideation (BDI-II item 9 \> 0)
* Concurrent psychotherapy or pharmacotherapy
* Previous therapy for height phobia
* Parallel participation in another study
* Pregnancy (will be excluded with a pregnancy test during screening)
* Chronic medication intake (except oral contraceptives)
* Alcohol and medication intake before visit (less than 12 h)
* Cannabis or other psychoactive substances (including benzodiazepines) intake before visit (less than 5 days)
* Sleep-inducing drugs (incl. antihistamines) intake before visit (less than five days)
* Restricted 3D sight
Imaging the Neuroimmune System in PTSD

In this study, individuals with and without post-traumatic stress disorder (PTSD) will undergo one positron emission tomography (PET) scan using the radiotracer \[11C\]PBR28, which binds to the 18kDa translocator protein (TSPO). A subset of individuals who complete the first PET \[11C\]PBR28 scan will be invited to complete an inflammatory challenge and second PET \[11C\]PBR28 scan. Approximately 3 hours prior to the second \[11C\]PBR28 PET scan, lipopolysaccharide (LPS; endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral biomarker levels will be assayed periodically throughout the experimental session.

Specific aims: 1) Determine if individuals with PTSD exhibit neuroimmune system disruption relative to well-matched comparators at baseline. 2) Determine if individuals with PTSD exhibit a disrupted neuroimmune response after a classical immune stimulus relative to well-matched comparators. 3) Determine if LPS differentially alters cognitive function, subjective response, or physiological markers in individuals with PTSD compared to well-matched comparators.

Hypothesis: Individuals with PTSD will exhibit a suppressed neuroimmune system at baseline and an attenuated neuroimmune response following LPS challenge, relative to matched trauma controls.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged 18-55 years
2. Subjects with PTSD will have a primary, current diagnosis of PTSD according to DSM-V criteria (i.e., CAPS-5 ascertained diagnosis)
3. Able to read and write English and to provide voluntary, written informed consent

Exclusion Criteria:

1. Current medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology including COPD, anemia, uncontrolled daily asthma or asthma requiring the use of an inhaler more than 1x/week with an ACT score below 20. \[We will not exclude individuals taking SSRIs and TRIs due to high prevalence of use within the PTSD population and due to evidence suggesting no effect of these drug classes on endotoxin response\].
2. Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder
3. Current or regular use of over-the-counter medication that may affect the immune system
4. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD
5. Contraindications to MRI such as claustrophobia or metal in their body
6. Individuals who are classified as "low binders" for the rs6971 polymorphism (\<10% of the population)
Pneumatic Leg Compression and Norepinephrine Requirements in Patients Having Non-cardiac Surgery: a Pilot Monocentric Prospective Randomized Interventional Clinical Trial

The PLANE trial is a randomized, single-center trial investigating whether pneumatic leg compression reduces the amount of norepinephrine needed to keep MAP above 65mmHg compared to routine care without PLC in patients having non-cardiac surgery under general anesthesia


Eligibility Criteria:
Inclusion Criteria:

Consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia that is expected to last ≥60 minutes

Exclusion Criteria:

Patients with the following exclusion criteria:

* Surgery in which pneumatic calve compression is indicated according to ERAS guidelines
* Surgery which interferes with the installation or correct function of PLC
* Sepsis (according to current Sepsis-3 definition)
* Pregnancy
* Congestive heart failure NYHA III/IV
* American Society of Anesthesiologists (ASA) physical status classification V or VI
* Interference of PLC and patient positioning (e.g.; extreme Trendelenburg positioning, lithotomy positioning)
* Contraindications for the use of PLC according to the German guideline13 (e.g., extensive thrombophlebitis, thrombosis or suspected thrombosis of the lower limbs, erysipelas, acute phlegmon, limb compartment syndrome, severe uncontrolled arterial hypertension, lymphatic drainage disorder proximal to PLC, extensive open soft tissue trauma, autoimmune blistering skin conditions such as IgA bullous dermatosis or bullous pemphigoid)
The Effect of Z-338 in Subjects With Functional Dyspepsia

Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound


Eligibility Criteria:
Inclusion Criteria:

* Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
* Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.

Exclusion Criteria:

* Subjects that heartburn should be the most bothersome symptom
* Subjects presenting with primary complaints relieved by stool movements (IBS)
* Subjects with diabetes by treatment
* Subjects that heartburn should be more than moderate
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

The primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a real-world clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Distant metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)
* Prescribed and currently (at enrollment) being treated with abiraterone acetate and prednisone (AA + P) for the treatment of Castration-resistant metastatic prostate cancer (mCRPC) according to the local product label
* Having received a minimum 1 cycle of AA + P (4 weeks), and maximum 4 consecutive cycles of AA + P (16 weeks ) prior to study enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 at enrollment

Exclusion Criteria:

* Participants who have received and terminated abiraterone acetate treatment for prostate cancer (PCa) in the past
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device less than or equal to (\<=) 30 days before the start of the study or the first data collection time point
* Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the abiraterone acetate treatment in mCRPC
* Known brain metastases
* Pathological finding consistent with small cell carcinoma of the prostate
Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty

The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.

The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Total or partial tear of the Anterior Cruciate Ligament

Exclusion Criteria:

* Patient refusal
Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria

Cholinergic Urticaria (CholU) is as a subtype of CIndU caused by an increase in the core body temperature, such as to activate the sweating reflex. It can occur in response to physical exercise, hot bathing and/or emotional stress. Clinically it appears as pinpointing and highly pruritic wheals with surrounding erythema, CholU can be accompanied by severe symptoms such as angioedema, respiratory symptoms or anaphylaxi CholU is frequently associated with atopic dermatitis (AD) The JAK-STAT is a mast cell (MC) signaling pathway activated downstream of IgE and IL-3 with important roles in MC homeostasis via regulation of proliferation, survival, and release of mediators. JAK-STAT activation is associated with polarization toward Th2, B cell isotype switching to IgE production, and IgE-dependent degranulation and cytokine release .

Because both IL-4 and IL-13 use the IL-4Rα as a receptor component, these cytokines activate any common signaling pathways. Both of these cytokines use Janus kinases (JAKs) to initiate signaling and activate signal transducer and activator of transcription-6 (STAT6), which is a transcription factor required for many of their biologic functions.

The non-receptor protein tyrosine kinases JAK1 and JAK3 associate with the IL-4Rα and γC, respectively. The binding of IL-4 to its receptor induces the transphosphorylation of JAK1 and JAK3, an event that activates these kinases and thereby initiates the early events of signal transduction .


Eligibility Criteria:
Inclusion Criteria:

* The study will include 45 adult patients complaining of CholU as well as 45 healthy controls.

Exclusion Criteria:

* Patients with one or more of the following criteria will be excluded:

  * Pregnancy and lactation.
  * Patients with systemic diseases especially those with autoimmune diseases and infections.
  * Patients with skin diseases.
  * Patients on medications such as: antibiotics, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, combined oral contraceptives.
  * Patient refusal
Evaluation of an HIV Outreach Program

This study evaluates outreach to HIV-infected people living in unstable housing in New York City who are new to CitiWide Harm Reduction. One hundred and fifty people are interviewed every 6 months, and their medical records are reviewed every 6 months for a total of 18 months. The study examines how outreach, case management, housing, drug use, mental health, and quality of life are related to people's ability to get into and stay in medical care.

The study is a prospective cohort study in which 150 newly enrolled HIV-infected participants of CitiWide Harm Reduction are followed for 18 months to assess HIV-related health outcomes. Data elements include (1) face-to-face interviews focusing on housing, HIV disease severity, utilization of health care services, utilization of non-medical services, substance use, mental health, and quality of life; (2) medical chart information focusing on CD4 count, viral load, and HIV primary care visits; and (3) outreach services. The study hypothesis is that involvement with CitiWide Harm Reduction will improve HIV-related health care utilization and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected, living in one of 15 single room occupancy hotels served by CitiWide Harm Reduction, new to CitiWide Harm Reduction, at least 18 years of age, English or Spanish speaking

Exclusion Criteria:

* HIV-negative
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children

To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

To evaluate patient acceptance of a new MiraLax dose formulation in children currently treated with polyethylene glycol 3350 powder for treatment of constipation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female constipated outpatients between the ages of 4 and 16
2. Currently taking a dose of less than or equal to 17g of PEG 3350 powder that has been consistent for at least 4 weeks
3. Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
4. Are otherwise in good health, as judged by a physical examination
5. If female and of childbearing potential, patient must be using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study
6. In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

1. Patients with heme positive stool at baseline exam
2. Patients who are impacted at baseline exam
3. Patients that are not receiving PEG 3350
4. Patients on PEG 3350 that continue to have problems
5. Patients with known or suspected perforation or obstruction
6. Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
7. Patients with a known history of organic cause for their constipation.
8. Patients currently using medications known to cause constipation. These include Opiates, antidepressants, SSRI's, antimotility agents and anticholinergics.
9. Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
10. Female patients of childbearing potential who refuse a pregnancy test
11. Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
12. Patients with known allergy to PEG or PEG containing medications
13. Patients who, within the past 30 days have participated in an investigational clinical study
Acceptance and Commitment Therapy (ACT) for Anxious Cancer Survivors

This randomized clinical trial compares group acceptance and commitment therapy (ACT) to usual care for cancer survivors experiencing anxiety following the end of cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Adults in the Greater Boulder/ Denver, Colorado area who had cancer and completed primary cancer treatment (surgery, chemotherapy, and/or radiation) within the previous 18 months
2. For solid tumor cancers: Show no current evidence of disease for solid-tumor cancers (of any cancer type or initial stage). For lymphoproliferative disorders such as chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma: In remission or asymptomatic after initial treatment and are followed with active surveillance.
3. Screen positive for anxiety symptoms on the study screener
4. Able to speak, read, and write English fluently
5. Willing and able to participate in an ACT group once a week for 7 weeks
6. Willing and able to complete online questionnaires and phone interviews at designated assessment points

Exclusion Criteria:

1. Current moderate to high suicide risk
2. History of chronic untreated trauma (unrelated to their cancer)
3. Psychiatric hospitalization or suicide attempt in the past 5 years