cyrilzakka/clinical-trials huggingface dataset:
Non-interventional Study on TEAM Conditioning in Patients With Lymphoma (TEAM)

Lymphoma is a malignant blood disease sensitive to chemotherapy. In case of relapse after first-line treatment, high-dose chemotherapy conditioning followed by autologous hematopoietic stem cell transplantation (auto-HSCT) improves patient survival and reduces the risk of relapse. Auto-HSCT may also be indicated in the first line in case of aggressive lymphoma at high risk of relapse. BEAM (Carmustine, Etoposide, Aracytine and Melphalan) is the more frequently used high-dose conditioning regimen. Nevertheless, Carmustine is no longer available in Europe.

The investigators have therefore chosen to replace Carmustine by Thiotepa and use the TEAM regimen as the new conditioning. Indeed, Thiotepa is approved by french national agency for the security of drugs (ANSM) for use as part of auto-HSCT conditioning regimen. The results of TEAM regimen in terms of efficacy and toxicity appear similar to those of BEAM. However, no study have been performed prospectively. Only small series and case reports have been reported.

If the study confirms the results of retrospective studies, conditioning by TEAM could become a new standard in auto-HSCT for the treatment of lymphoma.

This study is non-interventional, prospective with 3 centers.

All included patients will receive, according to standard practice and drug label in France, the following diagram:

1. Conditioning:

   * Thiotepa 8 mg / kg to J-6
   * Etoposide 100 mg / m² / 12 h for 4 days (J-5 to D-2)
   * Aracytine 200 mg / m² / 12 h for 4 days (J-5 to D-2)
   * Melphalan 140 mg / m² on day-1
2. Transfusion graft: the day D0 with autologous peripheral stem cell transplant
3. Care supports: Patients will be treated according to the usual procedures of centers participating in the study at the discretion of the investigator.
4. Follow-up of patients will not be changed by the study.

The main objective of the study is to evaluate the progression-free survival (PFS) of lymphoma patients treated with autologous stem cells after conditioning by TEAM

Secondary objectives are:

* To evaluate overall survival;
* To assess the response to treatment;
* to evaluate the incidence of relapse;
* to assess the toxic transplant related mortality;
* to study transplant-related morbidity (infections, nutritional and gastrointestinal toxicity, immune reconstitution).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years,
* lymphoma confirmed by biopsy
* first autologous haematopoietic stem cells transplantation after TEAM conditioning

Exclusion Criteria:

* VIH, HBV, and/or HCV seropositive
* Contraindication to autologous stem cell transplantation
Turkish Version of Computer Usage Proficiency Questionnaire

The Computer Proficiency Questionnaire (CPQ) assesses older individuals' computer and information technology skills. The questionnaire promotes digital inclusion by tailoring training packages to meet individual requirements. The CPQ serves as a continuous evaluation tool to track participants' progress in digital inclusion initiatives throughout time. The CPQ identifies unique problems that older persons have while utilizing digital technology, allowing for tailored solutions to overcome these barriers.

The adaptation of the elderly population to technology has increased rapidly with demographic changes and developments in the field of Gerontechnology, which supports successful aging by integrating technology into the daily lives of older individuals. Gerontechnology focuses on the development and application of communication and information technologies in order to increase the independence and social participation of older individuals.

Digital competence requires cognitive and technical skills that include processes such as finding, understanding, evaluating, creating and communicating digital information; it is of fundamental importance for the digital society. The Computer Use Competence Survey stands out as an assessment tool that measures the competence of older individuals in using computers and information technologies. This survey supports digital inclusion by contributing to the development of training programs tailored to individual needs. In addition, the Computer Use Competence Survey can be used as a continuous assessment tool to measure the progress of individuals participating in digital inclusion programs over time. Another strength of the Computer Use Competence Survey is that it can identify specific barriers that older individuals encounter when using digital technology and allows for special measures to be taken to overcome these barriers.

The aim of this study is to provide a reliable tool for assessing the digital competence of the elderly population in Turkey by performing the cross-cultural adaptation and content validation of the Computer Use Proficiency Questionnaire in Turkish.

Eligibility Criteria:
Inclusion Criteria:

* Being a native Turkish speaker,
* Having no reading and writing problems,
* Having a desktop or laptop computer,
* Agreeing to participate in the study

Exclusion Criteria:

-Individuals with neurological diseases such as cognitive impairment, Alzheimer's, dementia, etc. will be excluded from the study.
Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10\^6, 1.0×10\^6, or 1.5×10\^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged between 18 and 80;
2. Laboratory (RT-PCR, Gene Sequencing or Antibody) confirmed cases of severe COVID-19 pneumonia with mild to moderate ARDS (Berlin definition);
3. Patients are intubated;
4. Patients who voluntarily adhere to the research procedures and ensure good compliance during the research period;
5. Patients who fully understand the research nature of this study and sign written informed consent.

Exclusion Criteria:

1. Subjects who have received investigational drug (except for Remdesivir) for the treatment of COVID-19 within 30 days before screening;
2. Subjects who are pregnant, breastfeeding or whose urinary pregnancy test is positive before participation in the study; subjects who are pregnant, breastfeeding, have a birth plan, or are unwillingness to use contraception during the study period and within 12 months of infusion; except for subjects who have sterilization surgery or menopause during the study period;
3. Within 3 days before screening/randomization, subjects who have used high-dose corticosteroids that is equivalent to methylprednisolone \>240 mg/day or irregular use of systemic corticosteroids to treat other diseases that could affect the efficacy evaluated by the investigator;
4. Subjects receiving extracorporeal membrane oxygenation (ECMO) support.
5. Subjects who are allergic to low-molecular-weight heparin calcium or human albumin;
6. Subjects with ongoing malignant tumors.
Assessment of the Therapeutic Utility of hMG-HP

To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-38 years
* Body mass index (BMI) between 18 and 30
* Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
* Testosterona, FSH (follicle-stimulating hormone) LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
* No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion Criteria:

* Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
* Data suggestive of possible ovarian failure
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy
Microbiome in Head and Neck Squamous Cell Carcinoma

This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

HNSCCis a lethal cancer with a 5-year survival rate below 50%. Although smoking, alcohol intake, and human papillomavirus (HPV) infection are linked to HNSCC, only a small proportion of individuals exposed to these factors develop cancer and not all cases progress. Thus, additional environmental or host factors must contribute to HNSCC. The Study Team and others have observed significant oral dysbiosis in human HNSCC cases, both before and after treatment. This study aims to determine whether dysbiosis actively contributes to HNSCC and if so, the underlying molecular mechanisms.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects equal to or above the age of 18.
2. Patients who are seen and evaluated by a provider within the adult Otolaryngology clinic at the University of Colorado Health.
3. Patients that present with a diagnosis of OSCC.
4. An equal number of age-matched patients who are visiting the clinic for reasons other than OSCC diagnoses, as the control group.
5. Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

1. Subjects under the age of 18 or over the age of 100
2. Subjects unwilling to particiapte
Wound Infection Alexis Wound Retractor

The purpose of this study is to determine whether the incidence of surgical site wound infection will be reduced in open appendectomy patients through the use of the Alexis® wound retractor.

Aim: This is a randomized comparison of open appendectomy using metal retractors and open appendectomy using the Alexis® wound retractor in patients with simple and complicated appendicitis. The study is designed in order to minimize bias by standardizing the two procedures and blinding patients and nurses during the preoperative and postoperative period.

After obtaining informed consent, or informed assent of minors, subjects will be randomized to either of two groups: one groups will undergo a standard open appendectomy using traditional metal retractors. The second group will undergo an open appendectomy with the use of the Alexis® wound retractor.

Pre-operative antibiotic Zosyn will be given prior to skin incision. Skin prep will be betadine, duraprep or gel prep. After entering the peritoneal cavity, the Alexis® retractor will be introduced and used to maintain retraction for the duration of surgery.

In simple appendicitis, the patient will receive one dose of antibiotics six hours after surgery. The patient will not receive oral antibiotics at discharge. In complicated appendicitis, the patient will be given Zosyn until afebrile for 24 hours and a normal white blood cell count. The patient will be discharged on oral antibiotics.

Follow up will occur between the 14th and 21st post operative day. At the test of cure visit, the wound will be checked for erythema, drainage, or opening. It will be assessed whether the subject received any further medical attention or received medications since discharge.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of appendicitis
* Open appendectomy
* Ability to attend follow-up visit
Effects of Inpatient Pulmonary Rehabilitation on Frailty in Patients After Lung-Transplantation

Frailty is closely linked to the success of lung transplantations (LTx) (1,2). Studies have shown that frailty causes a diminished physical performance in candidates for LTx and an increased 30 day rate of re-hospitalization after surgery. Furthermore, frailty is associated with a higher one-year-mortality rate after LTx in frail compared to non-frail patients (1,3,4).

Some evidence that frailty in LTx-candidates can be decreased by a suitable rehabilitation program suggests that improving the frailty status in post-LTx patients can be a further strategy to contribute to an overall success in LTx. However, at the moment these possible benefits are not investigated yet. Therefore the aim of this study is to observe the effect of a three-week inpatient rehabilitation on frailty in patients after LTx.

Rationale:

Frailty is a complex clinical syndrome describing a loss of physical and/or cognitive functionality which leads to a decreased resistance to stressors such as operations or illness. It is associated with increased number of falls, exacerbations, adverse health outcomes and a higher mortality (7-10).

Frail LTx-candidates have a higher risk of being delisted before transplantation, adverse transplantation outcomes and a higher one-year-mortality compared to non-frail candidates. However, studies show that frailty can be decreased by physical training (11-13). A recent prospective cohort study in the UK observed a significant decrease of frailty in patients with COPD participating at an inpatient rehabilitation program (5). Singer et al. (USA) could detect a significant decrease of frailty by a homebased training for LTx-candidates (6).

Aim of this study is to investigate the effects of a three-week inpatient rehabilitation program on physical frailty (measured by Short Physical Performance Battery) in patients after LTx. Additionally, other functional measures as well as the cognitive, social and psychological state will be assessed in order to better understand the complex syndrome of frailty and the effects of rehabilitation.

Design:

This study is a prospective observational trial. The number of 30 participants is based on a sample size calculation. Assessments will take place in the beginning of rehabilitation program and at discharge.

Eligibility Criteria:
Inclusion Criteria:

* Participation in an inpatient pulmonary rehabilitation programme (Schön Klinik BGL, Germany)
* Patient after Lung Transplant (\< 1 year)
* Indication: COPD or ILD
* written informed consent

Exclusion Criteria:

* Non compliance at assessments
* Re-Transplantation
Real-Time fMRI Feedback Effects on Pain Perception

The purpose of this study is to determine whether real-time functional magnetic resonance imaging may be a viable treatment for chronic pain in the future.

Twenty-four healthy volunteers will undergo a series of four fMRI scanning sessions wherein thermal pain stimuli will be used to elicit activation of the pain neuro-matrix. All participants will undergo thermal pain threshold testing before and after fMRI scan. Participants will also rate the painfulness and unpleasantness of the thermal stimuli applied before fMRI and after fMRI. All participants will be given prompts to apply a set of cognitive pain-control strategies. Half of the participants will receive real-time fMRI feedback of activity in the Right Anterior Cingulate Cortex (rACC) and the other half will receive real-time fMRI feedback of activity in the Prefrontal Cortex (PFC). It is hypothesized that those receiving real-time feedback of brain activity thought to be involved with analgesic effects will demonstrate greater analgesia associated with the application of the cognitive control techniques after fMRI paradigm (decreased pain intensity and unpleasantness ratings and increased thermal pain thresholds) than those who are not given feedback before fMRI paradigm.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ages 18-65

Exclusion Criteria:

* Clinical depression
* Anxiety
* Substance dependence or chronic pain
* Ferrous metal implants
* Cardiac pacemakers or other implanted medical devices that might be adversely impacted by the MRI scanner magnetic field
Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge

This study aims to evaluate masticatory efficiency of the zero-degree teeth complete denture in treatment of edentulous patients of severely resorbed ridge.Patients will be crossed over to be treated with zero-degree teeth complete denture and anatomic teeth complete denture. For each patient, the masticatory efficiency and electromyography with different denture will be recorded and analysis.


Eligibility Criteria:
Inclusion Criteria:

* complete edentulism for at least three months class Ⅳ ridge

Exclusion Criteria:

* neuromuscular dysfunction, psychiatric disorder,
Aerosol Particle From EGD in Patients With and Without Head Box in COVID-19 Era

According to preexisting data, it has revealed the fundamental role that aerosols play in the transmission of the COVID-19 virus. Esophagogastroduodenoscopy (EGD), producing particle smaller than 5 microns, was regarded as 'aerosol-generating procedures' (AGPs) associated with an increased risk of transmission of respiratory pathogens to healthcare workers. The strategies aim to reduce spreading of aerosol during the procedure should be beneficial. Using an acrylic box to cover the head of a patient undergoing an endoscopy seems to reduce aerosol scatter and reduce the spread of respiratory pathogens. At present, there are no high-quality studies that provide quantitative data on the use of head box to reduce aerosol generation.

Pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) affected globally clinical practice including temporary postponement of elective endoscopic procedures in GI office activity and has caused an unprecedent concern in personal protection against the airborne virus. Whitin 2.5 years since the outbreak in mid-December 2019, COVID-19 had infected over 182 million people and killed more than 3.9 million across 210 countries worldwide. (Ref. https://www.who.int/emergencies/diseases/novel-coronavirus-2019).

According to preexisting data, it has revealed the fundamental role that aerosols play in the transmission of the COVID-19 virus. Previously, in the medical community attempted to find strategies to minimize risk of respiratory transmission to HCPs during pandemic such as wearing either standard or full personal protective equipment (PPE), including do-it-yourself devices and gadgets are the necessary substitutes to protect them from aerosolization. However, there has been no published study evaluating the efficacy or real benefit of these tools in preventing aerosolization during EGD quantitatively.

Esophagogastroduodenoscopy (EGD), producing particle smaller than 5 microns, was regarded as 'aerosol-generating procedures' (AGPs) associated with an increased risk of transmission of respiratory pathogens to healthcare workers. The strategies aim to reduce spreading of aerosol during the procedure should be beneficial.

Using an acrylic box to cover the head of a patient undergoing an endoscopy seems to reduce aerosol scatter and reduce the spread of respiratory pathogens. At present, there are no high-quality studies that provide quantitative data on the use of head box to reduce aerosol generation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who indicated in upper gastrointestinal endoscopy and undergoing endoscopy at Excellence Center For GI Endoscopy, King Chulalongkorn Memorial Hospital, Thailand
* Age of 18 years or more

Exclusion Criteria:

* Patients with a high risk of conscious sedation who need an anesthetist
* Patients with refusal to participate in clinical research
* Patients who cannot make medical decisions on their own
* Patients who underwent therapeutic endoscopy
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients

The aim of this study is to examine the effect of Self-acupressure application on fatigue and sleep quality in epilepsy patients.

Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in our body in order to ensure the continuation and balance of the energy in our body.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Volunteering to participate in the research
* Having the ability to use technological tools
* Not having a verbal communication disability (hearing and speaking)
* Not having a diagnosed psychiatric disorder
* Having a scale score of \>5 on the Piper Fatigue Scale
* A score of \>5 on the Pittsburgh Sleep Quality Scale
Timing of Influenza Vaccination in Patients With Heart Failure

Heart failure (HF) is one of the most common causes of hospital admission in Canada and costs the Canadian healthcare system over $1 billion annually. Influenza vaccination is an inexpensive strategy to prevent influenza infections and reduce an important trigger for HF decompensation and hospital readmission. Yet, the optimal timing of vaccine administration remains unclear. When patients with HF are admitted to the hospital with an acute decompensation in advance of, or during, the 'flu season', this can be an ideal time to administer the vaccine. However, patients with acute HF decompensation have significant inflammatory injury, and may have substantially impaired immune responses; thus vaccine administration while admitted during an acute decompensated HF episode may not lead to high anti-influenza antibody titres. A more effective strategy can be to vaccinate after the decompensation has resolved, when patients are more stable. The FLU-HF randomized trial will determine whether administering the influenza vaccine to patients admitted in-hospital with an acute HF decompensation or waiting until they have stabilized as an out-patient leads to an improved anti-influenza response.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Admitted in hospital with primary diagnosis of acute HF
* Prior diagnosis of chronic HF \> 3 months prior to admission
* Not on inotropes, mechanical support, or IV diuretics for 24 hours
* Able to follow-up within the MUHC HF clinic as per schedule
* agree to receive influenza vaccination

Exclusion Criteria:

* Any person who does not meet the above criteria and/or who refuses to participate
* Already received this seasons influenza vaccination
* Known allergy to influenza vaccination or components of the influenza vaccination
* Unlikely to survive to discharge as per admitting physician
* Prior organ transplant
* Undergoing chemotherapy for active malignancy
* Currently randomized in another clinical study