cyrilzakka/clinical-trials huggingface dataset:
Animal-assisted Interventions in Health Promotion for Elderly With Dementia

The overall research aim of this study is to investigate changes in measures related to the risk of falls among elderly with dementia participating in animal-assisted interventions. Also relatives' experience of own and the elderly's situation during and after the intervention will be examined. The design will be a prospective and cluster randomized multicenter trial, but mixed-methods will be used to target different outcomes. The study population will be elderly (age above 65) at day care centers diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or animal-assisted therapy two times a week for 12 weeks in groups of 4-6 participants. Control groups will receive treatment as usual. Research questions:

1. Is there an effect in use of ordinary and optional medication among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?
2. Is there an effect on social interaction, quality of life, activeness and wellbeing among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?
3. Is there an effect on balance among elderly persons with dementia at day care centers participating in animal-assisted therapy compared to animal-assisted activity or a control group?
4. Do relatives of elderly persons with dementia at day care centers experience a change in their own and the elderly's situation after the intervention compared with before the intervention started?


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.

Exclusion Criteria:

* Fear of dogs, dog allergy or need of wheel chair
Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome

During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.

Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs.

Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults.

The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs.

Patients will be randomly assigned to one of two groups:

FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers

VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.

Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.

In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
* BMI \< 35 kg/m2
* Age ≥ 18 years
* Expected duration of surgery \> 60 min
* Expected duration of anesthesia \> 90 min

Exclusion Criteria:

* COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
* uncontrolled asthma
* NYHA 3+4, CCS 3+4
* previous thoracic surgery
* ARDS (Berlin definition)
* documented pulmonary arterial hypertension \> 40 mmHg syst
* documented or suspected neuromuscular disease (thymoma, myasthenia)
* planned mechanical ventilation after surgery
* bilateral procedures
* lung separation with other method than DLT (eg diff. airway, trachestomy)
* surgery in prone position
* persistent hemodynamic instability, intractable shock
* intracranial injury or tumor
* enrollment in other interventional study or refusal of informed consent
* pregnancy (excluded by anamnesis and/or laboratory analysis)
Prospective Investigation of Intra-Articular Tranexamic Acid Use in Elective Hip Arthroplasty

Tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) is an antifibrinolytic substance that chemically belongs to the group of e-carboxylic acids. TXA is a synthetic amino acid derivative of lysine that competitively inhibits the activation of plasminogen to the serine protease, plasmin. TXA is a competitive inhibitor of tissue plasminogen activator, blocking the lysine-binding sites of plasminogen, resulting in inhibition of plasminogen activation and fibrin binding to plasminogen and therefore impairment of fibrinolysis.

Due to its antifibrinolytic effect (reduction of bleeding), TXA has been recently an increasing interest in orthopaedics, especially in elective major joint replacements.

The total hip arthroplasties (ΤΗΑ) are associated with perioperative blood losses exceeding 500 mL. Blood loss volumes are dependent on the chosen surgical approach and technique. Some patients that undergo elective hip replacement receive at least one blood unit in postoperative care. Heterotopic ossification is also a common complication after THA, presented as bone in soft tissue where bone normally does not appear. TXA reduces postoperative blood losses and consequently leads to less frequent blood transfusions. This has an impact on the economic burden for the health care system. Increased blood loss could lead to longer length of stay at the hospital and the connected economic consequences. TXA further reduces the incidence of heterotopic ossification after elective THA.

Objectives:

The aim of this study is to prospectively evaluate postoperative blood losses, hemoglobin decline and associated blood transfusion, heterotopic ossification and other parameters in patients with intraarticular application of Tranexamic acid during THA.


Eligibility Criteria:
Inclusion Criteria:

* Elective hip replacement

Exclusion Criteria:

* Traumatic hip replacement indication
Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks

The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.

This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Patients in whom regional anesthesia is contradicted
Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.

This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
* Aged 18-65 years (inclusive), no gender restriction;
* A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
* First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (\<0.05IU/ml), HBV DNA undetectable (HBV DNA\<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
* Agreement to undergo two liver biopsies during the study;
* Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.

Exclusion Criteria:

* Lactating women;
* Evidence of acute severe liver injury: such as ALT \> 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
* Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
* Evidence of hepatocellular carcinoma;
* Prothrombin time (PT) or INR \> ULN;
* Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.
Molecular Genetic and Pathological Studies of Anal Tumors

Study the Genetics of Anal Cancer

To determine the status of previously identified anal cancer molecular markers and any correlations with outcome as well as to discover new molecular biomarkers through correlating molecular data with clinical outcome. Study of tissue samples and cells from biopsies of your lesion and blood sample. We hope to learn the role genes and proteins may play in the development of anal cancer. Experiments will be performed using this tissue and blood, include analysis of DNA, analysis of RNA expression levels, analysis of protein levels of important gene products, and development of tissue culture cell lines.

Eligibility Criteria:
Inclusion Criteria:Inclusion Criteria:

* Patients with anal tumors
* Undergoing surgery for elective colon and rectal surgery Exclusion Criteria:No other patients other than adult patients with anal cancer or high risk for anal cancer refered to Stanford will be enrolled to the study. No Children will be included to the study
Etiology and Incidence Assessment of Radiographically-confirmed Community Acquired Pneumonia (CAP)

This is an epidemiological study to investigate the etiology of radiographically-confirmed community-acquired pneumonia (CAP) in adults aged ≥18 years. The main objective is to determine the proportion of which cases that is due to Streptococcus pneumoniae and the corresponding incidence and serotype distribution. The study will utilize a serotype-specific urinary antigen detection (UAD) assay.


Eligibility Criteria:
The Pneumonia Group

Inclusion Criteria:

* Age ≥ 18 years.
* Present to a study healthcare facility where treating physician clinically suspects CAP with the presence of two or more of the following signs and symptoms: Fever, Hypothermia, Chills or rigors, Pleuritic chest pain, Cough, Sputum production, Dyspnea, Tachypnea, Malaise, Abnormal auscultatory findings suggestive of pneumonia.
* Has radiographic finding that is consistent with pneumonia.
* Able and willing to provide urine sample.
* Signed and dated informed consent

Exclusion Criteria:

* Transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility.
* Hospital acquired pneumonia.
* Subjects who are investigational staff members and their family members, and site staff members otherwise supervised by the investigator.
* Previous enrollment in this study within the previous 30 days.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.

The Control Group

Inclusion Criteria:

* Signed and dated informed consent.
* Age ≥ 18 years.
* Able and willing to provide urine sample.

Exclusion Criteria:

* Subjects who are investigational staff members or relatives of those staff member or subjects who are Pfizer employees directly involved in the conduct of the study.
* Subjects with suspicion of CAP or any other respiratory infectious disease, as well as evidence of or documented concomitant infectious disease.
* Subjects residing in any long-term care facilities.
* Subjects with known bronchial obstruction or history of post-obstructive pneumonia. Chronic obstructive pulmonary disease (COPD) is permissible, provided there has no been an exacerbation with 3 months prior to enrollment.
* Subjects with primary lung cancer or another malignancy metastatic to the lungs.
* Subjects with fever.
* Subjects with significant immunosuppressive disease such as AIDS, leukemia, etc.
* Subjects with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPV) administration within the past 30 days.
Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics

Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.


Eligibility Criteria:
Inclusion Criteria:

1. MRI Diagnosis of TCSCI
2. Clinic Diagnosis of TCSCI
3. The injury site must be in cervical spinal cord
4. MRI images of T2WI must be collected within 48 hours after injury
5. Complete and available imaging data, clinical data, including MRI, sex, age

Exclusion Criteria:

1. Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
2. The quality of MRI images is insufficient or there are serious motion artifacts
Hernia Prevention in Stomas

Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.

The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a life expectancy of at least one year
* Temporary stoma formation
* Signed informed consent
* Elective surgery
* Clean-contaminated abdomen

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) score IV or above
* Incapacitated adult or no signed informed consent
* Emergency procedure
* Contaminated or infected abdomen
* Residual intraperitoneal mesh
* Already injured part of the abdominal wall where the stoma will be sited
* Contraindication to laparoscopy
* Longterm use of corticosteroids and other immunosuppressive agents
* Current antibiotic therapy
* One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy
Nicotine Skin Patch in Treating Patients With Kaposi's Sarcoma

RATIONALE: Nicotine may stimulate the immune system to kill Kaposi's sarcoma cells.

PURPOSE: This phase II trial is studying the side effects and how well the nicotine skin patch works in treating patients with Kaposi's sarcoma.

OBJECTIVES:

* Evaluate the toxicity and efficacy of transdermal nicotine applied to lesions in patients with classic Kaposi's Sarcoma.

OUTLINE: This is a double-blind, placebo-controlled study.

Patients apply a nicotine dermal patch to a selected lesion and a placebo patch to the other lesion, replacing the same type of fresh patch every other day, during the first 2 weeks, increasing the nicotine dose in week 3 and again in week 5 for a total of 15 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven classic Kaposi's sarcoma (KS)
* At least 2 KS lesions that can be measured (minimum diameter 0.5 cm to maximum diameter 3 cm) and located on body sites (leg, arm, torso, dorsum of foot or hand) to which a patch can be applied

  * A third measurable lesion (if available) of the same size can be located on any body site
* KS lesions must be separated by at least 8.0 cm at their centers and 6.0 cm at closest edges
* Patient must be a nonsmoker

  * No smoking, chewing, or other use of tobacco within the past year

PATIENT CHARACTERISTICS:

* HIV antibody negative
* Willing to shower or bathe no more than every other day
* No life-threatening conditions
* Not pregnant
* Fertile patients must use effective contraception
* Chronic conditions (e.g., hypertension or diabetes) must be stable and well controlled
* No history of HIV/AIDS, unstable angina pectoris, or claudication
* ECOG performance status 0-1

PRIOR CONCURRENT THERAPY:

* No prior biopsy of the selected KS lesion(s) within the past 90 days
* No prior systemic therapy for KS within the past 90 days
* No concurrent systemic or local conventional treatment for KS
* No prior use of a nicotine product within the past year
* No prior surgery, chemotherapy, biologic therapy, or radiotherapy within the past 90 days
* No prior organ allograft
Eyecontrol coMmunication Platform for dEliRium manaGemEnt in Intensive Care Units (EMERGE)

The purpose of this research is to investigate whether addition of the EyeControl-Pro platform as an adjunct to standard guideline-based intensive care unit management of critically ill patients is effective in reducing delirium incidence and severity.

This is a prospective, binational, single-blind, multicenter, randomized control trial, conducted according to international good clinical practice (GCP) ethical and quality standards. Critically ill, mechanically ventilated patients aged \>=50 years with Richmond Agitation Sedation Scale (RASS) score of -3 to +1 (at time of screening) who are anticipated to require ventilation for \>=24 hours will be eligible for recruitment. The study will be conducted simultaneously at Beth Israel Deaconess Medical Center (BIDMC) Boston, USA, Assuta Ashdod Medical Center (Ashdod, Israel) and Rabin Medical Center (Petah Tikvah, Israel) with BIDMC contributing up to 50% of the total enrollment. Participants will be randomized to either a) sham device or b) active intervention arm (details described below). Legally appointed representatives, patients and caregiver teams will be administered an optional questionnaire to assess their experience with the study device at the conclusion of the study protocol. Study subjects will be administered the telephone-Montreal Cognitive Assessment (t-MoCA); total score of 22 - missing 8 points present in Montreal Cognitive Assessment (MoCA) pertaining to drawing/executive function not feasible over phone) or MoCA (if still in-hospital; assessed out of total score of 30) and Hospital Anxiety and Depression Scale (HADS) questionnaire 30 days post-randomization. Hebrew versions of these questionnaires will be used at Israeli sites.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients aged \>=50 years
* RASS score of -3 to +1 and
* Anticipated to require \>=24 hours of mechanical ventilation

Exclusion Criteria:

* Not expected to survive \>=24 hours
* Have limitations in care (Do Not Resuscitate, or comfort-focused care orders)
* Receiving paralytic neuromuscular blocking agent (NMBA) infusion or anticipated need for NMBA use
* Have advanced dementia or cognitive impairment including post-concussive syndrome.
* Have acute or subacute neurological disorders.
* Have severe uncorrected psychiatric disorders.
* Have uncorrected hearing or visual impairment.
* Acute or subacute neurological disorder hindering communication or ability to participate in CAM ICU assessments
* Enrolled in a clinical trial which prohibits co-enrollment.
* Incarcerated
* Have no identified legally appointed representative (LAR)
* Are unable to communicate in the predominant local language (English at US site and English/Hebrew/Arabic/Russian in Israel)
* Refusal of treating clinical team.
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers

This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.


Eligibility Criteria:
Inclusion Criteria:

* Age greater of 18 years and less than 45
* Weight ≥50 kg,body mass index of 19\~26 kg/m2
* Signed ICF

Exclusion Criteria:

* active autoimmune disease
* uncontrolled concurrent illness
* Smoking
* Drugs
* positive serology for HIV, Hepatitis B or C,Syphilis
* Pregnancy or breastfeeding
Phase II Trial With Metronomic, Capecitabine Plus Oral Vinorelbine for Metastatic Breast Cancer

The study hypothesis is that metronomic treatment is more efficient than standard treatment.

Purpose: In an open-label randomized phase II trial, patients with metastatic Human Epidermal Growth Factor Receptor 2-negative breast cancer with normal organ function sant WHO performance status \< 3 are randomized to receive either capecitabine (day 1-14) plus vinorelbine oral (day 1 and 8) or capecitabine (day 1-14) plus vinorelbine oral metronomic (3 days a week).

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic Human Epidermal Growth Factor Receptor2-Negative breast cancer
* WHO performance status \< 3

Exclusion Criteria:

* Former treatment with Capecitabine or Vinorelbine
* Patients who have received more than one line of chemotherapy for metastatic disease
* Brain metastases
* Malabsorption syndrome
* Abnormal organ function
* pregnant or lactating women