cyrilzakka/clinical-trials huggingface dataset:
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease

Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study


Eligibility Criteria:
V.1. Patients

V.1.1. Diseases

Hematological malignancies confirmed histologically and not rapidly progressing:

* AML in CR;
* ALL in CR;
* CML unresponsive/intolerant to Imatinib but not in blast crisis;
* Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis;
* MDS with \< 5% blasts;
* Multiple myeloma;
* CLL;
* Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
* Hodgkin's disease.

V.1.2. Clinical situations

* Theoretical indication for a standard allo-transplant, but not feasible because:

  * Age \> 55 yrs;
  * Unacceptable end organ performance;
  * Patient's refusal.
* Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.

V.1.3. Other inclusion criteria

* Male or female; fertile female patients must use a reliable contraception method;
* Age \< 75 yrs.
* Informed consent given by patient or his/her guardian if of minor age.

V.1.4. Exclusion criteria

* Any condition not fulfilling inclusion criteria;
* HIV positive;
* Terminal organ failure, except for renal failure (dialysis acceptable);
* Uncontrolled infection, arrhythmia or hypertension;
* Previous radiation therapy precluding the use of 2 Gy TBI;
* HLA-identical donor.

V.2. PBSC donors

V.2.1. Inclusion criteria

* Related to the recipient (sibling, parent or child) or unrelated;
* Male or female;
* Weight \> 15 Kg (because of leukapheresis);
* Fulfills generally accepted criteria for allogeneic PBSC donation;
* Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.

V.2.2. Exclusion criteria

* Any condition not fulfilling inclusion criteria;
* HIV positive;
* Unable to undergo leukapheresis because of poor vein access or other reasons.

V.2.3. HLA matching

Related or unrelated donors who have 1-2 HLA mismatches, as either :

* One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
* One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
* Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
* One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
* One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1

V.3. Cord blood unit

Banked cord blood units will be used if they fulfill the following criteria:

* No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)
* \> 2.5 x 107 TNC/kg
* Standard validation by FACT/Netcord criteria.
The Protective Role of GABA Stimulation Before Ileostomy Closure

The goal of this clinical trial is to explore whether preoperative stimulation of the distal limb of the ileostomy loop with gamma aminobutyric acid (GABA) could effectively reduce the incidence of complications after ileostomy closure.

Participants will be divided into two groups. One group included patients treated with stimulation of the efferent loop with GABA prior to transit reconstruction surgery; the other control group was stimulated without giving any substance.

Researchers will compare incidence of complications such as postoperative ileus, diarrhea and other parameters such as time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay, etc.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age;
* body mass index (BMI) 18.5-28 kg/m2;
* having protective ileostomy after colorectal carcinoma surgery free of disease;
* with endoscopic and histological confirmation of diversion colitis;
* no oral antibiotics within 3 months;
* having signed the informed consent.

Exclusion Criteria:

* under 18 years of age;
* clinical history, and histological confirmation of inflammatory bowel disease with colorectal involvement;
* history of neoadjuvant or adjuvant chemoradiotherapy;
* other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
* serious perioperative complications such as anastomotic rupture after surgery;
* oral antibiotics within three months;
* participation in any other studies within the past 3 months.
Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation (LENEA)

The LENEA study is an international, prospective, open label, non-randomized multicenter clinical research study designed to assess the safety and effectiveness of the NANO LV lead system.


Eligibility Criteria:
Inclusion Criteria:

* Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s)
* Receiving a new implant OR undergoing an upgrade from an existing ICD or pacemaker implant with no prior implanted LV lead OR undergoing a new LV implant attempt consecutive to a recent LV lead placement failure not related to coronary sinus cannulation failure
* Patient receiving the PARADYM RF CRT or PARADYM RF CRT SONR devices
* Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

* Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
* Incessant Ventricular tachyarrhythmias;
* Unstable angina, or acute MI , CABG , or PTCA within the past 4 weeks;
* Correctable valvular disease that is the primary cause of heart failure;
* Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
* Patient who had previously a permanently implanted LV lead;
* Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or ICD devices should be removed prior to implant with the Paradym RF CRT-D or Paradym RF CRT SONR);
* Already included in another clinical study that could confound the results of this study;
* Life expectancy less than 1 year.
A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] in Cycle 1, then 1400 mg subcutaneous \[SC\] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Cluster of Differentiation 20-positive (CD20+) follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to World Health Organization (WHO) classification system
* Participants must have received and must have relapsed or been refractory to, one or more lines of adequate therapy prior to enrollment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2

Exclusion Criteria:

* Transformation to high-grade lymphoma
* Aggressive lymphoma (for example, mantle cell lymphoma \[MCL\])
* Presence or history of central nervous system (CNS) lymphomatous disease
* Other malignancy within 5 years prior to enrollment, except for curatively treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell skin cancer, or cervical carcinoma Stage 1B or less, breast cancer in situ or localized prostate cancer Stage T1c if treated with curative intent and relapse- and metastasis-free for at least 2 years prior to enrollment
* Inadequate hematological, hepatic or renal function
* Known human immunodeficiency virus (HIV) infection
* Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B or C)
* Pregnant or breastfeeding women
Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"

A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular
* Age ≥ 18 years
* Good general health (ASA score between \[1-2\])
* Sufficient bone volume and quality (with or without bone graft) to support the implant
* Non-opposition of the patient for the collection of his medical data as part of the study (delivery of a patient's sheet)

Exclusion Criteria:

1. Poor oral hygiene
2. Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
3. Infections and oral inflammation such as periodontitis, gingivitis
4. Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
5. Heavy smoker (\> 10 cigarettes / day)
6. Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
7. Patient on prolonged steroid therapy
8. Titanium / titanium alloy allergy
9. Alcohol or drug abuse
10. Pregnant woman (or likely to be pregnant); or breastfeeding
11. Difficulty of medical follow-up patients with geographical, social or psychological constraints
12. Persons deprived of liberty or guardianship
13. Involuntary / patient refusal to participate in the study
Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101

This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or nonpregnant females
* Age 18 to 65
* Sufficient submental fat for injections
* Signed informed consent

Exclusion Criteria:

* Prior interventions in the chin or neck area
* History or presence of drug or alcohol abuse
* Treatment with an investigational agent within 30 days before the dose
Clinical Evaluation of DAILIES TOTAL 1® Multifocal Compared to 1-Day Acuvue® Moist® Multifocal in a Japanese Population

The purpose of this clinical study is to evaluate DAILIES TOTAL1® Multifocal (DT1MF) contact lenses compared to 1-DAY ACUVUE® Moist® Multifocal (AMMF) contact lenses for investigator-graded lens centration in a Japanese population.

Subjects will be randomly assigned to one of two sequences of investigational product wear ((DT1MF→AMMF, AMMF→DT1MF). Each product will be worn in both eyes for at least 11 days.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent
* Habitually wear multifocal soft/ silicone hydrogel contact lenses
* Require a near spectacle ADD of +0.50 diopters (D) to +2.50D (inclusive)
* Correctable to 20/30 Snellen or 0.2 logarithm minimum angle of resolution (logMAR) or better in each eye at distance
* Willing to wear contact lenses and attend all study visits

Exclusion Criteria:

* Currently wearing DAILIES TOTAL 1® Multifocal or 1-DAY ACUVUE® Moist® Multifocal contact lenses
* Any eye condition that would make contact lens wear unadvisable
* Any use of medication that would make contact lens wear unadvisable
* Prior refractive surgery
Effect of Different Inspired Oxygen Concentrations on Intraoperative Recruitment Outcomes in Patients Undergoing Abdominal Surgery

This study intends to evaluate the effect of different inhaled oxygen concentrations on the effect of lung recruitment in patients undergoing abdominal surgery. During perioperative mechanical ventilation, higher FiO2 is usually given to prevent the occurrence of hypoxemia, but there are no conclusions about the setting of optimal FiO2 during surgery.

Dynamic pulmonary compliance enables real-time monitoring of alveolar changes and is used to assess pulmonary function in intraoperative patients. The value of compliance represents the number of air-containing alveoli; the more alveoli are trapped, the less air-containing tissue there is and the lower the compliance. Lung recruitment, as part of a lung-protective ventilation strategy, is effective in opening alveoli and improving oxygenation. This single-center, randomized controlled trial will explore the optimal inspired oxygen concentration that allows patients to benefit from lung recruitment and the duration of improvement in lung compliance after lung recruitment.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status classification: I or II.
* Adults aged 18 to 64 years, regardless of gender.
* BMI between 18 kg/m² and 25 kg/m².
* Patients undergoing elective abdominal surgery under general anesthesia.
* Patients with estimated operating time ≥1.5h and intraoperative bleeding ≤500ml.
* Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.

Exclusion Criteria:

* Previous thoracic surgery.
* Chest X-ray or CT suggestive of pneumothorax or alveoli.
* Lung disease: chronic bronchitis, asthma, moderate to severe obstructive ventilatory dysfunction.
* Preoperative pulse oxygen saturation (SpO2) \<90% on breathing air or SpO2 \<95% on oxygen.
* Contraindications to lung reanimation: high intracranial pressure, hypovolemic shock, right heart failure.
* Severe heart disease (New York Heart Association, NYHA class III or IV.
* Acute coronary syndrome or sustained ventricular tachyarrhythmia).
* Participation in other interventional studies or refusal of enrollment.
Risk Factors for Pressure Ulcers

Development of pressure ulcer (PU) is complex and multifactorial. The association of a constituted PU and of clinical / biological major elements is demonstrated and justifies. Prevention of PU is an important health priority, one that requires clear identification of risk factors.


Eligibility Criteria:
Inclusion Criteria:

* presenting with at least of a wound and confirmed diagnosis of PU, age≥18 years old, bedridden, not feeds only and without trophic and mental disorders.

Exclusion Criteria:

* paediatric study populations, age \> 90 years old, allergy to wound products, malignant origin
The Effect of Virtual Reality Glasses on Pain and Anxiety

In recent studies using virtual reality has been proposed as a non pharmacological methods for pain relief but until this time , its effects has not been assessed on pain and anxiety during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain and anxiety in Primiparity women during episiotomy repair.


Eligibility Criteria:
Inclusion Criteria:

* Iranian
* low risk pregnancy
* Apgar ≥ 7

Exclusion Criteria:

* vision or ear disorders
* History of motion sickness or headaches
* psychological disease or Addiction
* Prescribe narcotic or sedation 4hour prior to delivery.
The Family Talk Intervention When a Parent With Dependent Children or a Child is Severely Ill

The overall aim of this study is to evaluate the effects and the implementation process of the Family Talk Intervention (FTI) in clinical practice when a child or a parent of dependent children has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). During 2021, FTI will be implemented in several different care contexts including a children's hospital and a university hospital in Sweden. Social workers will be educated in using the FTI in their clinical work. This study has a pre-post effectiveness-implementation hybrid design using mixed method. Data collection will be made using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.

The Family Talk Intervention (FTI), also called Beardslee's Family Intervention is a manual-based complex intervention and involves families who have children aged 6-18 years. The core elements are to support the families in talking about illness-related subjects, support the parents in understanding the needs of their children and how to support them, and support the families in identifying their strengths and how best to use them.

The overall aim of this trial is to evaluate the effects and the implementation process of FTI in clinical practice when a parent or a child has a life-threatening/life-limiting illness (cancer, neurological diseases, etc.). More specifically, to examine the effects of FTI regarding family communication and psychosocial health among family members (Aim 1) and describe facilitating factors and barriers for implementing FTI in everyday clinical practice (Aim 2).

The FTI has previously been pilot-tested in the context of specialized palliative home care with promising results. In pilot-tests, an assigned interventionist was used for intervention delivery, while in this continued trial, social workers will deliver the intervention as a part of their clinical work.

This trial has a pre-post effectiveness-implementation hybrid design using mixed method. It will be placed at a children's hospital and at a university hospital in Sweden and conducted by all social workers working there (n=25). Education of social workers in working with FTI will take place during 2021 and families will be invited to the project from April 2022 and until power has been reached. Data will be collected using web-based questionnaires and interviews with families and social workers, and observations will be performed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Families that include a child with a life-threatening/life-limiting illness.
* 2-3 months should have passed since diagnosis or relapse.
* \<2 members of the family need to participate

Exclusion Criteria:

-
Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.

The position of the supraglottic airway is checked using a fiberoptic endoscope: The bronchoscope is placed at the opening of the laryngeal mask, and assessed using the following grading system: Grade 1: Vocal cords not visible. Grade 2: Vocal cords and anterior epiglottis visible. Grade 3: Vocal cords and posterior epiglottis visible. Grade 4: Only vocal cords visible.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I\~III, age 18\~65 y/o, BMI 18\~30kg/m2, elective surgery, surgery duration \< 2 hours, supine position, general anesthesia with laryngeal mask airway insertion

Exclusion Criteria:

* Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms
Facilitating Transition to Recommended PTSD Treatment

Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated as recommended posttraumatic stress disorder (PTSD) treatments. However, post-9/11 Veterans with PTSD rarely initiate CPT or PE, especially as an initial treatment. Little research has explored the combinations and sequences of psychosocial and medication treatments that Veterans receive ("treatment sequences"). One common and understudied treatment sequence begins with stabilization treatment, which is designed to prepare Veterans for CPT or PE. There is a significant research gap in understanding how treatment sequence affects initiation of CPT or PE. The proposed research is an innovative, mixed-methods approach to assessing the impact of variability in treatment sequence, including stabilization treatment, on initiation of CPT or PE and applying this knowledge by developing a health services intervention that facilitates timely transition to CPT or PE. Research aims can improve PTSD treatment by increasing initiation of and reducing disparities in CPT/PE.

Posttraumatic stress disorder (PTSD) is one of the most common mental health diagnoses among Veterans. Cognitive processing therapy (CPT) and prolonged exposure therapy (PE) were widely disseminated in the Veterans Health Administration (VHA) as recommended PTSD treatments. Despite these efforts, few post-9/11 Veterans diagnosed with PTSD initiate CPT or PE. In the small percentage of Veterans who receive these therapies, CPT and PE are rarely the first treatment a Veteran receives. A common treatment sequence identified in implementation research, begins with "stabilization treatment," combinations of psychosocial and medication treatments that prepare Veterans for CPT or PE. Despite consistently identifying stabilization treatment as a common VHA practice, little research has investigated this treatment sequence. A novel approach to solving existing limitations in PTSD treatment delivery involves developing an intervention that both acknowledges the ubiquitous presence and benefits of stabilization treatment, while facilitating timely transition from stabilization treatment to CPT or PE. This CDA-2 aims to improve delivery of PTSD services in the VHA. The proposed research aims are: (1) To qualitatively understand Veterans' and clinicians' perspectives on selecting stabilization treatments and how stabilization treatment serves as a barrier or facilitator of transition to CPT or PE; (2) To develop and conduct a randomized, pragmatic pilot trial of a brief, Veteran-centered intervention to support transition from stabilization treatment to CPT or PE; and (3) To identify sociodemographic disparities in treatment sequences and to determine how treatment sequences influence time to CPT or PE initiation across the VHA.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* Diagnosed with PTSD as part of an intake assessment at the San Francisco Veterans Affairs Medical Center.

Exclusion Criteria:

* Inability to provide informed consent
* Cognitive impairment that precludes comprehension of study materials
* Active psychosis
Video Exercise Mobile Application for People With Knee Osteoarthritis

The aim of our study is to realize an exercise training and follow-up system that individuals with knee OA can easily adapt.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
* Be qualified to use the mobile application and agree to use the application

Exclusion Criteria:

* Individuals with poor cognitive function or inadequate reading skills
* Individuals with neurological disorders that may affect mobility skills
* Individuals who have undergone knee joint surgery and individuals with traumatic injuries