cyrilzakka/clinical-trials huggingface dataset:
Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

The investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA
* Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases
* Age 18 years or older
* Able to provide verbal consent

Exclusion Criteria:

* Definite contraindication for BMA
* History of, or current evidence of osteonecrosis of the jaw
* Radiotherapy or surgery to the bone planned within 4 weeks after randomization
* Current hypercalcemia defined as corrected serum calcium of \> 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)
Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD

The aim of this randomized, controlled crossover designed study is to compare the outcomes of receiving autologous, adult stem cells versus placebo among participants with chronic obstructive pulmonary disease (COPD). The study is limited to self-funded participants with a diagnosis of COPD. The study, along with others at the Lung Institute, have received full review and approval of an Institutional Review Board.

The purpose of the Lung Institute is to collect, minimally process, and administer a person's own stem cells and/or platelet rich plasma and deliver the product back to the patient same-day through an intravenous catheter. This study is limited to patients diagnosed with chronic obstructive pulmonary disease (COPD) and is a double-blinded prospective, cohort trial using cross-over methodology. The aim of this study is to determine if stem cell therapy is better than placebo among a group of patients with COPD.

50 participants will be recruited for each arm of the study.

Cohort A will receive three days of cell therapy using the venous procedure (three consecutive days of blood harvest, cell separation and cell application). Cohort A will return in three months and receive three consecutive days of placebo.

Cohort B will receive three consecutive days of placebo. Cohort B will return in three months and receive three consecutive days of cell therapy using the venous procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of Lung Institute who determines final eligibility for inclusion. Patients must be diagnosed with chronic obstructive pulmonary disease (COPD) and be able to travel to the Dallas clinic location.

Exclusion Criteria:

* Patients who are unable to provide informed consent, pregnant patients, prisoners, non-English speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. Patients without a documented COPD diagnosis are excluded.
Prospective Study of Patients With Thrombocytopenia Following HSCT

Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

Isolated thrombocytopenia is a frequent and severe complication of hematopoietic stem cell transplantation (HSCT). It often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT, including thrombopoietin, interleukin-11, immunoglobulin, methylprednisolone and rituximab, are frequently unsatisfactory in platelet recovery. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Thrombopoietin (TPO) is a cytokine that drives thrombopoiesis by stimulating the differentiation of stem cells into megakaryocytes and promoting megakaryocyte proliferation and polyploidization. Decitabine was approved for the treatment of myelodysplastic syndrome (MDS) as a DNA methylation inhibitors. Studies in vitro show that decitabine enhances platelet release and megakaryocyte maturation. Here, the investigators performed a prospective clinical trial, in order to investigate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

Eligibility Criteria:
Inclusion Criteria:

1. Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;
2. Neutrophil and hemoglobin were well recovered;
3. Full donor chimerism was achieved;
4. No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;

Exclusion Criteria:

1. Patients with malignancy relapse;
2. Active infections;
3. Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health criteria;
4. Severe organ damage;
5. Thrombosis requiring treatment;
6. Received decitabine following the current transplantation.
Effects of Limicol on LDL-cholesterol

The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* About 18 to 55 years (inclusive)
* Subject has a stable weight for at least three months before the start of the study
* Subject able and willing to comply with the protocol and agreeing to give their consent in writing
* Subject affiliated with a social security scheme
* Subject willing to be included in the national register of volunteers who lend themselves to biomedical research
Adherence and Clinical Correlates in Persons With HIV on TAF

This is an observational, 48-week, prospective study of PWH treated with TAF in which the investigators will compare TFV-DP concentrations in DBS in virologically suppressed vs. non-suppressed individuals and evaluate the utility of TFV-DP in DBS to predict future viremia. To accomplish this, the investigators will approach PWH currently taking TAF (which is being prescribed by a primary care physician) and who present to the clinic for regular HIV care and HIV VL assessment. Participants will complete up to 3 visits (at least 2 weeks apart) during the 48-week study follow-up period.

Antiretroviral (ARV) drug exposure is directly linked to individual host factors, including age, weight, diet, and genetics. However, the main factor influencing long-term drug exposure is drug adherence. Adherence is a strong predictor of HIV treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. There is no gold-standard measure to monitor ARV exposure and adherence that has been implemented in clinical practice. Tenofovir diphosphate (TFV-DP), the phosphorylated anabolite of tenofovir (TFV), has distinct pharmacological characteristics that make it an ideal candidate for drug adherence and exposure monitoring. The long half-life of TFV-DP (\~17 days) in red blood cells (RBC), which are abundant in dried blood spots (DBS) are properties that make it well suited for monitoring average TFV exposure over time both from tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). TFV-DP in DBS in persons with HIV (PWH) on TDF has been associated with viral suppression and is predictive of future viremia, even in patient who are virologically-suppressed. However, data on TFV-DP in DBS from TAF are lacking. To address this gap, this study will assess the association of TFV-DP in DBS from PWH on TAF with clinically-relevant virologic outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Females or males with HIV (≥18 years), able to give informed consent and comply with study procedures who are having a blood draw as part of their regular clinical care.
2. Being prescribed TAF-based ART \>= 3 months.

Exclusion Criteria:

1. For females, active pregnancy or intent to become pregnant.
A Study to Learn About the Safety of BESPONSA Injection in Pediatric Patients With Acute Lymphocytic Leukemia.

The purpose of this study is to learn about the safety of BESPONSA for pediatric patients. .

BESPONSA is approved for treatment of relapsed or refractory CD22-positive acute lymphocytic leukemia for pediatric patients. A type of leukemia (blood cancer) that comes on quickly and is fast growing. In acute lymphocytic leukemia, there are too many lymphoblasts (early-stage white blood cells) in the blood and bone marrow. Also called ALL.

The registration criteria for this study are:

* Never used BESPONSA before
* \<18 years at the start of treatment with BESPONSA

All patients in this study will receive BESPONSA according to the prescriptions.

Patients will be followed up as follow.

* Treatment phase: From the day of treatment initiation (Day 1) to Day 28 post-treatment to collect information on safety (e.g., adverse events).
* Follow-up phase: From Day 29 post-treatment to Week 52 to collect information on VOD/SOS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with relapsed or refractory CD22-positive ALL
2. Patients who have never used BESPONSA before
3. Patients aged \<18 years at the start of treatment with BESPONSA

Exclusion Criteria:

* None
Induced Pluripotent Stem Cells for Niemann Pick Disease

Establishment of individualized human cellular disease models based on induced pluripotent stem cells that reflect the broad heterogeneous phenotypic spectrum of Niemann Pick disease

Niemann-Pick disease type C (NPC) is a lipid storage disease that can present in infants, children, or adults. Neonates can present with ascites and severe liver disease from infiltration of the liver and/or respiratory failure from infiltration of the lungs. Other infants, without liver or pulmonary disease, have hypotonia and developmental delay. The classic presentation occurs in mid-to-late childhood with the insidious onset of ataxia, vertical supranuclear gaze palsy, and dementia. Dystonia and seizures are common. Dysarthria and dysphagia eventually become disabling, making oral feeding impossible; death usually occurs in the late second or third decade from aspiration pneumonia. Adults are more likely to present with dementia or psychiatric symptoms. The diagnosis of NPC is confirmed by biochemical testing that demonstrates impaired cholesterol esterification and positive filipin staining in cultured fibroblasts. Biochemical testing for carrier status is unreliable. Most individuals with NPC have NPC1, caused by mutations in the NPC1 gene; fewer than 20 individuals have been diagnosed with NPC2, caused by mutations in the NPC2 gene. Molecular genetic testing of the NPC1 genes detects disease-causing mutations in approximately 94% of individuals with NPC. Such testing is available clinically.

NPC is inherited in an autosomal recessive manner. The phenotype (i.e., age of onset and severity of symptoms) usually runs true in families. Carrier testing for at-risk relatives and prenatal testing for pregnancies at increased risk are possible when the two disease-causing mutations have been identified in the family.

Though NPC is a pan-ethnic disorder, the prevalence of this autosomal-recessive disorder is elevated in countries with a higher frequency of consanguinity.

Therefore, the goal of the study to prepare a cell culture from patients affected with Niemann Pick disease in order to identify novel pathways and proteins involved in disease progression that allow for an earlier diagnosis (i.e. before symptom onset) and that are suitable targets for an individualized therapeutic approach able to address not only the hepatic form, but also the neurologic form of the disease, which is less responsive to the current therapeutic approaches.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent will be obtained from the patient or the parents before any study related procedures
* Patients of both genders older than 6 months and younger than 80 years
* The patient has a diagnosis of Niemann Pick disease

Exclusion Criteria:

* No Informed consent from the patient or the parents before any study related procedures
* Patients of both genders younger than 6 months or older than 80 years
* No diagnosis of Niemann Pick disease
Patient Empowerment Study

The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics System can impact patient health-related quality of life. Health-related quality of life will be measured by both the generic 36-item Short-Form Health Survey (SF-36) questionnaire and the ulcer-specific Diabetic Foot Ulcer Scale Short Form (DFS-SF) questionnaire.

There is emerging evidence that diabetic foot complications greatly affect the quality of life of patients and cause people a significant burden to life. A diabetic foot ulcer (DFU) is associated with deterioration the physical, mental and social life quality. Given the detrimental effect foot ulcers have on patients, it is essential that quality of life metrics be evaluated among DFU patients. To what degree can diabetic foot ulcers affect the quality of life of patients? What are the facilitators and barriers to an improved quality of life?

To gain insight into these questions Podimetrics researchers will be conducting a longitudinal study among patients suffering with a DFU. The general purpose of the study is to evaluate the current quality of life of DFU patients from the subject perspective in various domains including physical functioning, general health perception, psychological, social functioning, vitality and role limitations. The study will also explore the relationships between HRQoL and usage of the Podimetrics System. Improved understanding of patients' subjective evaluation of their quality of life, and the role of the Podimetrics System, will help clinicians provide better care for these patients.

A cohort of DFU patients will be recruited upon providing informed consent. Participant lifestyle and ulcer status information is collected by a background survey. HRQoL is assessed at baseline, 6 month and 12 month using questionnaires. The investigators intend to use two types of questionnaires for HRQoL evaluation in this study: one generic questionnaire, SF-36, which addresses general quality of life issues, and one specific questionnaire, DFS-SF, which addresses issues specific to diabetic foot diseases, such as ulcer severity and impact of ulcer care.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old (by verbal history from the participant)
* Have history of one or more foot ulcers in the lower extremities (by verbal history from the participant)
* Have been prescribed the Podimetrics RTM System in the last 30 days
* Not be pregnant (by verbal history from the participant)
* Be mentally lucid
* Be able to read and write English
* Provide informed consent

Exclusion Criteria:

* Be younger than 18 years old
* Unable to understand English
* Unable to complete questionnaires due to visual or upper extremity impairments
* Unable to provide consent
* Other issues that, at the discretion of the investigator, renders the subject ineligible for participation
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients

The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
* (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value \< 140/90mmHg at Week 0)
* (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
* (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C \< 250 mg/dL, and TG \< 400 mg/dL at Week -2
* Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
* (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value \< 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
* (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
* (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C \< 250 mg/dL, and TG \< 400 mg/dL at Week -2

Exclusion Criteria:

* Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure \< 140mmHg and diastolic blood pressure \< 90 mmHg.
* Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated
Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial

In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?

The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with healthy systemic condition (Mazzotti et al., 2023).
2. Age from 20-50 years old
3. Patients must be free of any systemic disease which could influence the surgical procedure.
4. Tooth involved in the esthetic zone.
5. Sufficient hard and soft tissue volume in vertical and buccolingual direction
6. Natural teeth adjacent to the involved tooth will be required to be free from infection.
7. Controlled oral hygiene.
8. Indication for tooth extraction included (Degidi et al., 2012);

   * Endodontic failures
   * Untreatable caries
   * Non- restorable teeth
   * Vertical root fracture
   * Remaining roots

Exclusion Criteria:

- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

5.Presence of acute dento-alveolar infection.
Evaluation of a Probiotic On Anxiety and Stress in Healthy Adults Sensible to Daily Stress

The purpose of the the study is to determine if PROBIOSTICK® decrease stress and anxiety of people sensible to daily stress.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian healthy men or women
* Age 30-60 years
* Hospital anxiety and depression score equal or below 12 and above 4
* Standard safety biology

Exclusion Criteria:

* HAD A results above 12 and below 4
* HAD D results above 12
* Neurologic or psychiatric pathology
* Consumption of psychotropic
* High level of caffeine consumption
* Any important chronic pathology
* Drugs wich impairs concentration, anxiety and stress
Breathlessness Relieved by Employing Medical Air to be Titrated by Hospitalized Patients to Improve Inpatient Experience

The BREATHE-easy is a randomized control trial assessing the efficacy of the novel PneumoCool device to alleviate subjective shortness of breath. The PneumoCool device is a disposable, bladeless, highly portable device that uses medical-grade air that confers many advantages in a hospital setting.

This will be randomized control trial (RCT) for patients admitted to the Ohio State University Wexner Medical Center, ROSS and James Cancer Hospital. Patients will be screened to assess eligibility. The study team will use a 2-group (intervention vs. control) RCT design. On meeting inclusion criteria, completed informed consent will be obtained. After informed consent, subjects will be randomized to receive either the PneumoCool device or usual therapy. PneumoCool setup will be done by the study team. This study will be unblinded, since blinding is not feasible in this device study. Conventional therapy will include the patients usual care and any palliation for patients' symptoms ordered by the primary team, including bedside fan if the patient requests. Patients will be queried for their symptoms at the time of enrollment, at time 0 (start of first arm of trial) and 8 hours for the primary outcome. Patient will be followed throughout their hospital stay until discharge. Data will be collected from the electronic medical record. Patient and Provider satisfaction will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Dyspnea (Borg Scale \> 3)
* Admitted to University hospital, ROSS or James Cancer Hospital with expected length of stay \> 24 hours
* Age 18 years or more

Exclusion Criteria:

* Delirium (assessed by CAMICU) or dementia or brain injury precluding ability to consent and or respond to outcome scales
* Prisoner status
* Continuous mechanical ventilation
* Patients with motor disability with inability to maneuver the device