cyrilzakka/clinical-trials huggingface dataset:
Risedronate in Osteopenic Postmenopausal Women

The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).

The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:

* Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
* 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and
* Bone turnover markers (BTMs) of:

  * fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
  * serum aminoterminal propeptide of type 1 procollagen (PINP); and
  * urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) \< 30 kg/m²

Exclusion Criteria:

* Clinical or radiological evidence of osteoporosis
* Severe renal impairment
* Serum 5-hydroxy vitamin D level \< 15 ng/ml
* History of recent primary hyperparathyroidism or recent thyroid disorder
* History of any generalized bone disease
* Current use of glucocorticoids, estrogens, progestins, calcium supplements \> 1 g/day, vitamin D supplements \> 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for \> 1 month at any time within the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient admission for cardiac diagnosis
* Positive depression evaluation (PHQ-2\>2, PHQ-9\>9)
* Ability to provide informed consent

Exclusion Criteria:

* Active suicidal ideation
* Bipolar disorder, psychotic disorder, active substance use disorder
A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The main purpose of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The study is expected to last approximately 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
* Have received prior CLL/SLL treatment
* Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
* Have received a covalent BTK inhibitor
* Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
* Capable of swallowing oral study medication.
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

Exclusion Criteria:

* Have received prior treatment with a BTK degrader and a noncovalent BTK inhibitor
* Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor
* Have known or suspected Richter's transformation
* Have known or suspected history of central nervous system involvement by CLL/SLL
* Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:

  * nonmelanoma skin cancer or lentigo maligna melanoma
  * cervical carcinoma in situ
  * localized prostate cancer undergoing active surveillance, and
  * localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy
Would You be Happy to be Contacted About Research?

The aim of this study is to re-examine the proportion of primary care patients that would be happy to be contacted about research of relevance to them. This study will examine the utility of SMS messages sent to patients by their general practice, with a link URL to an online questionnaire containing five research questions.

Since the onset of the COVID-19 pandemic in 2019, the NIHR has played a critical role in the fight against this new disease with the delivery of COVID-19 research studies. Taking part in COVID-19 research is vital to enable effective treatments to be identified, evidenced and made available to NHS patients as quickly as possible. Over 100,000 UK participants have now enrolled in COVID-19 urgent public health research supported by the NIHR.

Keele Clinical Trials Unit (CTU) quickly implemented online data collection methodologies during 2020, in order to continue with recruitment of and retention of research participants and in response to the national lockdown and tiered systems implemented for protection of the population during the pandemic. There is now opportunity, to re-evaluate the proportion of primary care patients that would be happy to be contacted about research of relevance and also to assess the utility of online technologies, in particular SMS text messaging and an online survey platform, in the collection of the research data.

The specific research objectives of this study are:

1. To examine patient response rates to an invitation to complete an online Keele Health Survey questionnaire, delivered by SMS message from their general practice,
2. To examine the difference in patient response rates to the invitation to participate in the research study with and without a precursor test message (SMS).
3. To estimate the number of patients that would be happy to be contacted about future research studies relevant to their health.
4. To explore any demographic variances in completion responses.
5. To estimate research question completion rate feasibility, for future use of SMS messages containing a link URL to an online Keele Health Survey questionnaire to collect research data.

Eligibility Criteria:
Inclusion Criteria:

* Age - 18 years or over
* Mobile telephone number must be registered at general practice (doctor's surgery)

Exclusion Criteria:

* Anyone under the age of 18
* Anyone who does not have their mobile phone number registered with their general practice (doctor's surgery)
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction

Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast reconstruction are becoming more and more popular.But the reconstruction caused greater trauma and more severe postoperative pain.ESPB is a new nerve block method which thought to reduce pain after thoracic and breast surgery.However, there are few studies on radical mastectomy combined breast reconstruction. So, this randomized controlled study is conducted to explore its impact on postoperative pain and thus provide more data guidance for clinical.

Patients: 100 breast cancer patients who are planned radical mastectomy combined breast reconstruction Intervention: General anesthesia + erector spinae plane block Control ： General anesthesia Outcome: NRS(Numerical rating scale) of postoperative pain at the sixth hour Study:RCT

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for an radical mastectomy and implant reconstruction surgery
* Patients with American Society of Anesthesiologists (ASA) physical status I-II,
* aged 18-70 years

Exclusion Criteria:

* coagulation disorders,
* known allergy to study drugs,
* obesity (body mass index \> 35 kg/m2),
* infection at the injection site,
* chronic opioid consumption, and an inability to use patient-controlled analgesia (PCA) device,
* patient refuse
Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease

Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.

A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease. (REFLECT-1)

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of probable Alzheimer's Disease (AD).
* MMSE score 10 to 23
* Has not taken an approved AD therapy in last 30 days.
* No previous hypersensitivity/intolerance to AChEIs
* Have a regular caregiver.

Exclusion criteria:

* Diagnosis of vascular dementia.
* Type I or secondary diabetes mellitus.
* Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
* History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
* History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair

The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.


Eligibility Criteria:
Inclusion Criteria:

Maternal Inclusion Criteria:

1. Singleton pregnancy
2. Gestational age at screening is 19 to 25 5/7 weeks and gestational age at surgery is 22 to 25 6/7 weeks
3. Maternal age: 18 years and older
4. Body mass index ≤45 kg/m2 (pre-pregnancy)
5. No preterm birth risk factors (short cervix \<20 mm or a history of previous preterm delivery)
6. No previous uterine incision in the active uterine segment
7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful

Fetal Inclusion Criteria:

1. Spina bifida defect between T1 to S1 vertebral levels
2. Chiari II malformation
3. No evidence of kyphosis (curved spine)
4. No major life-threatening fetal anomaly unrelated to spina bifida
5. Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\].

Exclusion Criteria:

Maternal Exclusion Criteria:

1. Non-resident of the United States
2. Multifetal pregnancy
3. Poorly controlled insulin-dependent pregestational diabetes
4. Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes
5. Current or planned cerclage or documented history of an incompetent cervix
6. Placenta previa or placental abruption
7. Short cervix of \< 20 mm
8. Obesity as defined by a body mass index of \> 45 kg/m2
9. Previous spontaneous singleton delivery prior to 37 weeks
10. Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia
11. HIV or Hepatitis-B positive status
12. Known Hepatitis-C positivity
13. Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery
14. Other medical conditions which are contraindication to surgery or general anesthesia
15. Patient does not have a support person
16. Inability to comply with the travel and follow-up requirements of the trial
17. Patient does not meet psychosocial standardized assessment criteria
18. Participation in this or another intervention study that influences maternal and fetal morbidity and mortality
19. Maternal hypertension
20. Zika virus positivity
21. Allergy/history of drug reaction to Amphotericin B

Fetal exclusion criteria:

1. Major fetal anomaly not related to spina bifida
2. Kyphosis in the fetus of 30 degrees or more
3. Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints
The ConnectedCancerCare Pilot Study (CCC)

This study is an NCI-funded, randomized control pilot trial to evaluate: (1) the feasibility and acceptability of a web-based, personalized navigation tool (ConnectedCancerCare) and (2) explore whether the tool improves delivery of team-based survivorship care for women who have recently finished primary breast cancer treatment.

This study is a randomized control pilot trial involving 60 women newly diagnosed with early-stage breast cancer who are finishing primary treatment. Participants will be randomized either to the intervention arm (CCC website that provides information on team-based follow-up care for both cancer surveillance and preventive care) or the control arm (static online survivorship care plan template, adapted from the ASCO breast cancer survivorship template). The feasibility and acceptability of the tool and correlations with patient-reported outcomes will be assessed 3 months following the completion of a baseline survey via an online follow-up survey.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with early Stage (0-IIB) breast cancer
* Must be a patient of a University of Michigan Breast Cancer Oncologist
* Must be completing primary cancer treatment and transitioning into survivorship
* Must be able to speak, read and write in English
* Must have access and the ability to use the internet

Exclusion Criteria:

* Diagnosed with stage III or IV breast cancer
* Unable to speak, read, and write in English
Effectiveness of Simulation Based Training in Implementing One Hour Bundle Sepsis

This study aimed to compare simulation training with conventional training (case-based discussion only) to improve team performance in implementing one-hour sepsis bundle in the intensive care unit

This was an experimental randomized single-blind study to examine the role of simulation-based training in improving team performance in conducting sepsis management. Subjects were sixteen doctors and twenty-four nurses working in the intensive care unit. The subjects were randomly divided into two treatment groups: the discussion group and the simulation group. Each treatment group was further divided into four small groups consisting of two doctors and three nurses. Prior to the training, every subject received a pretest for cognitive evaluation and a posttest at the end of the training. The performance of both groups in implementing one-hour sepsis bundle was assessed by solving a sepsis case in high fidelity manikin.

Eligibility Criteria:
Inclusion Criteria:

* Doctors working in Dr. Cipto Mangunkusumo Public Hospital's ICU
* Nurses working in Dr. Cipto Mangunkusumo Public Hospital's ICU

Exclusion Criteria:

* Doctors and nurses who are not fit or healthy to undergo this training
Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

The purpose of this study is to find out what effects, good and/or bad, the combination of irinotecan and temozolomide has on Ewing sarcoma.

Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat pediatric patients at MSKCC. The investigators have used these two drugs for many years to treat patients with Ewing sarcoma whose cancer has relapsed.

For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have their cancer cured by the chemotherapy and surgery/radiation therapy.

This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT regimen. The investigators are trying to improve the success of standard therapy by adding these drugs. The use of irinotecan and temozolomide in this study is experimental because they have not been used before in patients with newly diagnosed Ewing sarcoma. However the investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma. It is not known if adding these two drugs will improve the outcomes of patients treated for Ewing sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to one year and less than or equal to 40 years at the time of diagnosis
* Newly diagnosed, previously untreated patients with histologically or molecularly confirmed Ewing sarcoma
* Adequate hematologic function:
* Absolute neutrophil count ≥ 1,000/K/mcl
* Platelet count ≥ 100,000/Kmcl
* Adequate renal function:
* Normal creatinine for age (See table below) OR
* Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 Age(Years) Maximum Serum Creatinine (mg/dL) ≤ 5 0.8 6 to ≤ 10 1 11 to ≤ 15 1.2 ≥ 16 1.5

Adequate hepatic function:

* Total bilirubin ≤ 1.5 x the ULN
* AST ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\]
* ALT ≤ 2.5 x the ULN \[in the absence of hepatic involvement of tumor. Patients with hepatic involvement are considered eligibile for study\]

Normal cardiac function:

* Shortening fraction ≥ 28% by echocardiogram OR
* Left ventricular ejection fraction (LVEF) ≥ 50% on technetium- 99m pertechnetate radionuclide cineangiography (MUGA) or echocardiogram
* Patients must consent to an indwelling central venous catheter.
* Sexually active patients of reproductive potential must be willing to use an effective method of contraception.

Exclusion Criteria:

* Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of eg. spinal cord compromise or threatened airway)
* Pregnant or breastfeeding females
Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable Chronic Obstructive Pulmonary Disease (COPD)

Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.

Skeletal muscle dysfunction is common and impaires exercise capacity in patients with chronic obstructive pulmonary disease (COPD)Exercise training is the main component of the treatment of COPD.

Neuromuscular electrical stimulation (NMES) is successful in COPD patients who are unable to perform exercise training. The NMES has positive effect on peripheral muscle function, exercise capacity and breathlessness in activities of daily living in COPD patients who had an abnormal body composition or who were too dyspneic to leave their home. A nonrandomized uncontrolled study has shown that application of NMES at home for improved exercise capacity in patients with better-preserved muscle mass. Evidence from a preliminary study without applying sham NMES revealed that NMES applied as complementary to ambulatory respiratory rehabilitation program increased quadriceps strength, quality of life and six minute walk distance in severe to very severe patients.

Despite documented benefits of NMES in COPD patients, the place of NMES as an adjunct to pulmonary rehabilitation in COPD patients who were able to do regular endurance and strength training on is unknown. Therefore, the purpose of this study was to compare the effects of NMES plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, dyspnea, fatigue, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic obstructive pulmonary disease
* being 35-75 years of age
* being eligible to participate in endurance trainin
* no acute exacerbation in last month, no change in drugs and no usage of antibiotics in last three weeks

Exclusion Criteria:

* medical conditions which could place patient at risk during neuromuscular electrical stimulation and exercise training (orthophedic and neuromuscular disorders, metal implants in the lower limbs, advanced heart failure, aortic stenosis, deep venous thrombosis a cardiac pacemaker, \>50 mmHg pulmonary artery pressure and/or an acute exacerbation of symtomps in the preceeding four weeks)
* being unable to understand the questionnaires and unable to cooparate.