cyrilzakka/clinical-trials huggingface dataset:
Building Resiliency Among Caregivers of Curvivors and Metavivors

The main purpose of this research study is to assess the feasibility and participants' satisfaction of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) and compare this treatment with SMART-3RP versus referral to a group-based, online support group to see which is better for improving resilience and decreasing distress of participants with cancer and their caregivers.

The name of the study intervention involved in this study is:

Smart-3RP (virtual, mind-body group treatment program).

This pilot, randomized controlled trial assesses the feasibility, acceptability, and efficacy of the Stress Management and Resiliency - Relaxation Response Resiliency Program (SMART-3RP) for improving resiliency and decreasing distress among caregivers and cancer survivors compared to enhanced usual care.

Participants will be randomly assigned into one of the study groups: Smart-3RP versus referral to a group-based, online support group. Randomization means that a participant is placed into a group by chance.

Participation in this study is expected to last about 180 days.

It is expected about 96 people made up of 48 patients and 48 caregivers will take part in this research study.

The National Institutes of Health (NIH) is supporting this research by providing funding.

Eligibility Criteria:
Inclusion Criteria for Patients:

* English speaking adult patients with cancer (18 years or older)
* Treated at MGH, who are either within approximately:

  * 3 months to 3 years after completing potentially curative therapy for cancer diagnosis including surgery, radiation, and/or chemotherapy or other novel therapies (e.g., immunotherapy, biological therapy). Patients can be on long- term maintenance hormonal or biological therapy at the time of enrollment.
  * 6 months to 3 years after diagnosis of metastatic disease with an expected prognosis of \>1 year as confirmed by the treating oncology clinician
* Able to identify a caregiver (i.e., spouse/partner or patient-identified family member or friend) who is willing to participate in the study

Exclusion Criteria for Patients:

* Prognosis less than one year as determined by the treating oncology clinician
* Active psychiatric or cognitive comorbidity that prohibits the capacity to provide informed consent as determined by the treating oncology clinician
* Patients without a caregiver who is willing to participate

Inclusion Criteria for Caregivers:

* Adult caregiver (age 18 years or older).
* Identified by the patient as the spouse/partner or family member/friend.
Neuromuscular Electrical Stimulation in Patients With COVID19 Associated Pneumonia

Neuromuscular electrical stimulation (NMES) has been considered as a promising approach for the early rehabilitation of patients in and/or after the intensive care unit (ICU). Aim of this study is to evaluate the NMES effect on physical function of COVID-19 patients.

This prospective, randomized, controlled, parallel-group, single-blind trial will include 80 patients who had undergone mechanical or non-invasive ventilation following pneumonia-induced respiratory failure. Patients are randomized to a control group (routine physical therapy for 3 weeks) or a NMES group (routine physical therapy plus NMES of quadriceps and gastrocnemius muscles for 3 weeks). The primary outcome is physical performance assessed through the Short Physical Performance Battery (SPPB). Secondary outcomes include independence level, perceived fatigue, muscle strength, rectus femoris thickness, and walking performance. The SPBB and walking performance will be assessed once (after the 3-week intervention period), while all other outcomes will be assessed twice (before and after the intervention).

NMES is a simple and non-invasive technique for muscle strengthening that is usually well tolerated, does not produce adverse effects, requires no or little cooperation from patients and is quite inexpensive. Therefore, proving the effectiveness of NMES therapy for physical and muscle function in COVID-19 patients could support its systematic incorporation in post-ICU rehabilitation protocols of patients presenting with post-intensive care syndrome.

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* respiratory (PaO2/FiO2 ratio \> 180 mmHg) and hemodynamic stability for at least two days after withdrawal of mechanical ventilation and neuromuscular blocking agents

Exclusion Criteria:

* pregnancy
* known or suspected malignancy in the lower limbs
* body mass index equal or greater than 35 kg/m2
* conditions preventing NMES treatment (e.g., deep vein thrombosis, skin lesions, rhabdomyolysis)
* conditions preventing the outcome assessment (e.g., amputation or inability to transfer independently from bed to chair before hospital admission)
* presence of an implanted cardiac pacemaker or defibrillator
Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question\[s\] it aims to answer are:

* Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU
* Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics

If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.

The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent antibiotic-associated diarrhea (AAD) in the PICU.

Design:

Prospective randomized, double-blind, placebo-controlled trial

Setting:

15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile, Alabama.

Patients:

Pediatric patients ≤ 17 years and required antibiotic therapy ≥ 72hrs were randomized to receive placebo or control (lactobacillus GG). Exclusion criteria included but was not limited to antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative therapy, immunocompromise, and GI disorders.

Interventions:

Treatment with LGG (30 x 109 CFU) or a matching placebo capsule was administered twice daily, initiated within 24 hours of starting antibiotic therapy and continued for the duration of therapy.

Measurements:

Diarrhea was defined as stools \>200 mL or 200 g per day in a patient over 10 kg and \> 20 mL/kg/day or \> 20 g/kg/day in a patient \< 10 kg or 3 or more loose stools in 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to PICU
* Requiring \> 72 hrs of antibiotic therapy
* \< 17 years
* Able to administer oral LGG or placebo

Exclusion Criteria:

* Antibiotics 48 hours prior to hospital admission
* Probiotic use within 7 days of admission
* Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
* Laxative therapy at time of admission or 48 hours prior to admission
* HIV with CD4 \< 250
* Established immunologic deficiencies (ANC \< 100)
* Chronic steroid therapy ( \> 10 days)
* GI disorders including intussusception, lower bowel disease, bowel resection, irritable bowel syndrome, ulcerative colitis, or Crohn's disease
* Status post-surgical patients with antibiotic prophylaxis (\< 72 hours duration)
* NPO
Sildenafil for Secondary Pulmonary Hypertension Due to Valvular Disease

The purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with sildenafil in patients with persistent moderate or severe pulmonary hypertension (PH) after a heart valve intervention.

Phase IV, prospective, multicenter, randomized, double-blind, placebo-controlled, academically funded clinical trial, with 6 months follow-up. A total of 354 patients will be recruited. Inclusion criteria are: 1) successful surgical or percutaneous repair of a cardiac valve at least one year before screening and 2) persistent moderate or severe PH, and 3) absence of any residual significant valvular lesion. Patients will be randomized 1:1 to received sildenafil 40 mg t.i.d. or placebo. The primary endpoint is a clinical composite score combining: all-cause mortality, hospital admission for heart failure, World Health Organization (WHO) functional class, and the patient global assessment score. Additional clinical and mechanistic secondary end-points are defined.

Eligibility Criteria:
Inclusion Criteria:

* Age at the date of selection ≥ 18 years
* Mean pulmonary pressure ≥ 30 mmHg, measured by a Swan-Ganz catheter placed in the pulmonary artery
* Heart valve intervention: surgical or percutaneous replacement, repair or dilatation performed at least one year before inclusion
* Stable clinical condition for at least one month, without hospital admissions for heart failure, and on appropriate and stable doses of conventional cardiovascular medications

Exclusion Criteria:

* Requiring or likely to require the following medications: organic nitrates, alpha-blocker therapy, potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, cimetidine, HIV protease inhibitors such ritonavir and saquinavir) Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
* Patients with resting hypotension, with systolic blood pressure \< 90 mmHg
* Patients with retinitis pigmentosa
* Anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia)
* Severe renal impairment with creatinine clearance \< 30 ml/min
* Significant hepatic dysfunction
* Prosthesis or valvular dysfunction with hemodynamic repercussion.
* Pregnant or breast-feeding women
* Patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent
* Life expectancy less than 2 years due to non-cardiac disease
Clinical Intervention Psychosis and Addiction

The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* Addiction
* Written statement of agreement
* Majority

Exclusion Criteria:

* Acute psychosis
* Further neuropsychiatric disorder
Perioperative Sitagliptin Medication for Reduction of the Inflammatory Response Associated With Cardiopulmonary Bypass

Sitagliptin is an inhibitor of the enzyme dipeptidylpeptidase-4 (DPP-4) and represents an established drug in type 2 diabetes mellitus treatment. However, Sitagliptin may also have several antiinflammatory properties. Within this study the investigators examine the effects of perioperative Sitagliptin intake on the inflammatory response after cardiopulmonary bypass.

Sitagliptin is an inhibitor of the enzyme dipeptidylpeptidase-4 (DPP-4) and represents an established drug in type 2 diabetes mellitus treatment. However, Sitagliptin may also have several antiinflammatory properties. For example, it is known that DPP-4-inhibition prevents procalcitonin from being cleaved to a truncated form that lacks 2 amino acids. As the investigators described recently, truncated procalcitonin targets the CRLR-RAMP1-receptor on vascular endothelium and induces VE-cadherin-phosphorylation which leads to leakage of fluids and proteins from vessels. Furthermore, many other immunoregulatory targets such as substance p, CXCL10 or NF-kB have been reported to be modified by DPP-4. Therefore, it can be assumed that Sitagliptin possibly represents a powerful drug in inflammatory circumstances.

The aim of this study is to prove possible antiinflammatory properties by conducting an observational trial in cardiac surgery patients. All patients undergo cardiac surgery with the use of cardiopulmonary bypass (CBP) which is known to trigger a systemic inflammatory response syndrome (SIRS). Group 1 suffers from diabetes mellitus type two and regularly takes Sitagliptin which is continued perioperatively. Group 2 also suffers from diabetes mellitus type 2 but does not take Sitagliptin. Group 3 has no diabetes mellitus but also undergoes cardiac surgery. To determine the effect of Sitagliptin under inflammatory conditions deep immune phenotyping and a cytokine assay is performed from blood withdrawals 24h after surgery. Moreover, the sublingual microcirculation is measured two times after the operation.

Taking all measurements of the cellular immune system, the humoral immune system and the vasculature into account it should be possible to define the immunoregulatory effects of Sitagliptin treatment more properly.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients undergoing cardiac surgery with use of CBP and...
* Diabetes mellitus type 2 with Sitagliptin treatment or,
* Diabetes mellitus type 2 without Sitagliptin treatmet or,
* No diabetes mellitus
* Written informed consent

Exclusion Criteria:

* Diabetes mellitus type 1
* Treatment with another DPP4-inhibitor
* Treatment with GLP-1-analoga
* Emergency surgery
* Chronic or acute infection
* Pregnancy
* Participation in an interventional study trial within last 3 months
* Relationship to study investigators
Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.

In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.

To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (\~3 patients consented / month).

Eligibility Criteria:
INCLUSION CRITERIA:

Candidates for this registry must meet ALL of the following criteria:

* Patient is \> 18 years of age
* Patient has failed attempts at non-operative conservative therapy
* Patient has participated in the informed consent process and signed an IRB approved informed consent
* Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee

EXCLUSION CRITERIA:

Candidates will be excluded from the evaluation if ANY of the following apply:

* Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee
* Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture
* Evidence of active or suspected (systemic or local) infection at time of surgery
* Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)
* Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus
* Patients with neuromuscular or neurosensory deficit
* Women who are pregnant
* Prisoner or transient
* Recent history of known narcotic abuse
* Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires
Study Comparing Whole Breast Radiotherapy With a Daily Versus a Weekly Tumor

All patients (with Stages 0-II breast cancer) will receive an accelerated three week regimen of prone whole breast radiotherapy. The study intends to test the hypothesis that a weekly boost to the tumor bed, delivered on Friday, before the weekend break, is as well tolerated as the daily boost during accelerated prone radiotherapy.

Arm 1 is a concomitant boost protocol over three weeks which has previously been evaluated in over 500 patients (NYU 03-30 and NYU 05-181) and has shown excellent tolerance, and results. Arm 2 evaluates a Weekend Boost Dose (WBD) regimen which may have a radiobiological advantage by counteracting tumor repopulation which can occur over the weekend break. At the time of registration in the study, patients will be randomized to either treatment arm and stratified according to pre or post-menopausal status and on previous chemotherapy received or not.

Eligibility Criteria:
Inclusion Criteria:

* Pre or post-menopausal women with stage 0,I, and II breast cancer
* Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
* Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (DCIS and Tumors \<5mm do not require nodal assessment)
* At least 2 weeks from last chemotherapy
* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast
* More than 3 involved nodes identified at axillary staging, requiring adjuvant axillary radiation
* Active connective tissue disorders, such as lupus or scleroderma
* Prior or concurrent malignancy other than basal or squamous cell skin cancer or carcinoma in-situ of the cervix, unless disease-free \>3 years
* Pregnant or lactating women
Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE)

Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).

Abstract Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).

Material and Methods: A total sample of thirty CBCT of patients presented with constricted maxilla with mean age of 14±3Y was randomized in to three groups. Group 1 CH, group 2 HH and group 3 MSE.

CBCT records were taken before(T1) and after six months (T2) of RME; the Airway was segmented and quantified using software (version 5.3.4.39USA).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering maxillary collapse with a skeletal background
* Patients with unilateral or bilateral posterior crossbite.
* Patients with reduced or average anterior face height.
* Patients with no periodontal disease.
* Patients with good oral hygiene and general health.
* No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
* Patients with erupted maxillary permanent first molars and premolars.
* Patients with no previous orthodontic treatment.

Exclusion Criteria:

* previous treatment
* syndromes
* cleft lip and palate
A BHI to Increase Hope Level and Stress Level of Parents With a CMC

Being a parent of a child with medical complexity (CMC) poses an enormous stress because these CMC have a multisystem disease, a severe neurologic condition or cancer which may result in premature death. Parents may feel challenged, lacking in confidence and high level of stress when managing their daily caregiving activities and child's new symptom. Literature suggested that hope is believed to be the central agent in facilitating positive psychological change when parents are facing difficulties and feeling stress. Brief Hope Intervention (BHI) is an alternative method considered to be feasible in improving parental hope level meanwhile, decreasing their stress level associated with daily caregiving activities. The purpose of BHI is to help these parents to develop workable goals, and concentrate on problem solving skill along with achievable planned actions in order to terminate the stressors associated from the caregiving activities.

This proposed pilot randomized controlled trial will test the feasibility and preliminary effect of the BHI in term of increasing the level of hope meanwhile decreasing the stress level of parents with a CMC. Eligibility, recruitment rates, and attrition rates will be collected in percentage to evaluate the feasibility of the study. Content analysis will be adopted to analysis the qualitative feedback on the acceptability of BHI from the parents. A repeated-measures, two-group design will be used to evaluate the preliminary effects between intervention and wait-listed control groups by comparing Brief Hope Intervention and wait-listed control groups receiving usual community care for 64 randomly selected parents over a 1-month follow-up. The outcome measures include parental hope and stress level. They will be measured before intervention, immediately after intervention and one-month after intervention.

With positive outcomes found in this study, this intervention will be implemented in a larger scale to improve local psychological health service for parents with a CMC.


Eligibility Criteria:
Inclusion Criteria:

Parents of a CMC will be recruited via the special schools for the children with physical disabilities. The eligible criteria for parents are

1. one of the parent of a child with medical complexity aged 5-18,
2. able to communicate in Chinese and read Chinese,
3. willing to participate in face-to-face activities and a telephone follow-up,
4. alert and oriented, able to sustain approximately 1 hour of attention and interaction, and
5. able to be reached by phone.

Exclusion Criteria:

Parents are

1. a reported mental health disorder,
2. inability to communicate in Cantonese,
3. engaging in other Hope Therapy related to stress relief and hope enhancement, and
4. severe hearing deficit that prevented them from engaging in phone communication.
T Cell Function in Chronic Idiopathic Urticaria

Chronic idiopathic urticaria (CIU) is a common form of chronic urticaria in which the cause is not detected after intensive clinical and laboratory investigation.In view of the current data, it was suggested that at least part of the patients with CIU have an autoimmune process.This study is designed to investigate the mechanisms involved in the regulation and activation of the immune cells in patients with CIU and corelate them with disease activity


Eligibility Criteria:
Inclusion Criteria:

* age above 18
* chronic urticaria

Exclusion Criteria:

* age below 18
* pregnancy
* other severe chronic diseases
Busulfan and Fludarabine as Conditioning for Allogeneic Stem Cell Transplantation: a Pharmacokinetic Study

A study of pharmacokinetics of daily intravenous busulfan

A study of pharmacokinetics of daily intravenous busulfan

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing transplantation

Exclusion Criteria:

-