cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)

The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal for ≥5 years (defined as no menses for at least 5 years or at least 5 years post bilateral oophorectomy).
* Prior or current treatment with oral bisphosphonate therapy (i.e., alendronate, risedronate, ibandronate) for postmenopausal osteoporosis for ≥3 years.
* BMD T-score at any hip site (femoral neck, trochanter, or total hip) ≤-2.5 and \>-3.5 as assessed by dual-energy X-ray absorptiometry (DXA) without a history of a prior fragility fracture. For participants with a history of a prior fragility fracture (except hip fracture), BMD T-score can be ≤-1.5 and \>-3.5 at any hip site.
* Serum 25-hydroxyvitamin D level of ≥20 and ≤60 ng/mL within 90 days of the time of randomization.

Exclusion Criteria:

* Evidence of a metabolic bone disorder other than osteopenia or osteoporosis
* History or current evidence of hip fracture.
* History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Active parathyroid disease. Participant with a documented history of parathyroid disease can be considered for inclusion if she has normal parathyroid hormone (PTH) at screening.
* History of thyroid disease not adequately controlled by medication.
* Current treatment with anti-seizure medication, with indices of calcium metabolism not within normal limits.
* Prior treatment with strontium-containing products; intravenous bisphosphonates; cathepsin K inhibitors; RANK ligand inhibitors; fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks.
* Use of following medications within the 6 months prior to the screening visit: activated vitamin D; estrogen, with or without progestin, at a dose high enough to have systemic effects; raloxifene or other selective estrogen receptor modulator (SERM), tibolone or any aromatase inhibitor; sub-cutaneous calcitonin (Note: use of intranasal calcitonin is allowed at any time); anabolic steroid; PTH (1-34 or 1-84); growth hormone; systemic glucocorticoids (≥5 mg/day of prednisone or equivalent) for more than 2 weeks; cyclosporine for more than 2 weeks.
* Concurrent use of cancer chemotherapy or heparin; protease inhibitors for human immunodeficiency virus (HIV) treatment; and vitamin A (excluding beta carotene) \>10,000 IU daily, unless willing to discontinue this dose during the study.
* Current treatment with cytochrome P450 3A4 (CYP3A4) inducers or treatment with CYP3A4 inducer within 4 weeks of screening.
Predictive Factors on the Results of Epidural Adhesiolysis in Patient With Chronic Spinal Pain

The primary aim of this exploratory study was to determine the demographic, clinical, and technical factors associated with treatment outcome, to create a better select treatment candidates.


Eligibility Criteria:
Inclusion Criteria:

* patients in whom percutaneous epidural lysis of adhesions was performed

Exclusion Criteria:

* nonadhesiolytic procedure
* lack of follow-up
* incomplete outcome data
A Modified Behavioral Activation Treatment for Geriatric Depressive Symptoms in Left-behind Elderly in Rural China

Background: It is essential to understand how to prevent and treat the epidemic of depression. Several studies have reported the prevalence of depressive symptoms in the urban population in China, but there is a lack of information regarding intervention for depression in rural left behind old elderly people.

Objective: To evaluate the effectiveness of a Modified Behavioral Activation Treatment (MBAT) Intervention on reducing depressive symptoms in rural left behind elderly people.

Methods: 80 rural left behind elderly people who had a Geriatric Depression Scale(GDS) score between 11 and 25 will be recruited and randomly assigned to the intervention (n=40) and control group(n=40). The intervention group will be received both MBAT and treatment-as-usual for 8 weeks while the control group received treatment-as-usual. Both groups will be assessed with the GDS, Beck Anxiety Inventory (BAI), and Oxford Happiness Questionnaire (OHQ) at baseline, immediately post-intervention, and at 3 months post-intervention.

Significance: This is the first time BA psychotherapy will be used in China.The current study will develop an intention model based on the traditional BA and CBT. The recurrence and seriousness of depression symptoms may be reduced by the intervention program. We hope that MBAT in clients will provide a direction for the management of mental health in rural left-behind elders..


Eligibility Criteria:
Inclusion Criteria:

* Over 65 years of age;
* Only one participant from each family;
* Left-behind for longer than 6 months;
* GDS score between 11 and 25.

Exclusion Criteria:

* Psychiatric and medical comorbidities that are potentially life threatening or expected to severely limit client participation or adherence;
* Those who are currently seeing a cognitive behavioral therapist, psychotherapist or counselor;
* People unable to understand and fill out the questionnaires.
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer

The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.

Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven diagnosis of invasive breast adenocarcinoma.
2. Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
3. No macroscopic evidence of distant metastases at diagnosis.

Exclusion Criteria:

1. Prior radiation to the thoracic region.
2. Pregnancy.
3. Patients with synchronous or prior malignancy.
4. Positive surgical margins.
Culturally-Tailored HIV Risk Reduction for African-American MSM

The purpose of this study to conduct a small randomized control trial to compare the relative effectiveness of a single-session of HIV testing and counseling risk reduction intervention (HCT-only) to an enhanced intervention that includes the standard HCT intervention plus a theory-based and culturally-tailored group-level intervention designed to reduce or eliminate HIV and STI risk behaviors (HCT-plus) among African-American men who have sex with men (AA-MSM).

The HCT-plus intervention will consist of the HCT-only intervention, as well as 8 small group intervention sessions focused on HIV risk reduction. Small groups will consist of 10 men who will meet once-a-week for 8 consecutive weeks. Each meeting will last approximately 2 hours. In each small group session, staff will work with men to reassess their HIV risk behavior, re-prioritize their goals as appropriate, and provide motivational support for their risk reduction accomplishments. Participants will be asked to discuss ways they have successfully avoided HIV risk behavior since the previous session, as well as to discuss situations in which they found it difficult to avoid risk. Staff will reinforce successful risk avoidance, and problem-solve with men to overcome barriers to risk reduction.

Eligibility Criteria:
Inclusion Criteria:

* reside in Milwaukee county;
* are at least 18 years of age;
* self-identify as male;
* self-identify as Black or African-American;
* can provide informed consent;
* report unprotected anal sex with a man in the past 3 months;
* report at least two sexual partners with whom they have had unprotected anal or vaginal sex in the past 3 months;
* are willing to be tested for HIV using rapid oral fluid procedures or willing to provide evidence of HIV seropositivity

Exclusion Criteria:

* Under 18 years of age,
* involvement in a HIV prevention study currently or in the past 6 months,
* Participation in the pilot phase
Effectiveness of Managing Suspected Metastasis and Progress Using Plasma D-dimer Testing in Gastric Cancer Patients

For prognosis evaluation, investigators enroll gastric cancer patients who underwent radical gastrectomy and collect the laboratory examination and clinicopathological characteristics. Then independent risk factors for overall survival will be analysed. For predicting efficacy evaluation, investigators also collect information of patients first diagnosed with metastases. Diagnostic efficacy is analysed by receiver operator characteristic curve method.

To investigate the novel predictive value of coagulation factors for postoperative outcomes after radical gastrectomy in patients with gastric cancer, investigators enroll patients with a pathologically confirmed diagnosis of gastric cancer who underwent radical gastrectomy between January 2021 and february 2017. Patients follow up data were obtained by regular follow-up. The most recent preoperative laboratory tests and clinicopathological characteristics were evaluated. Patients are devided into two groups according to our target indicator. The 5-year overall survival rate is analysed by Kaplan-Meier method. The independent risk factors for overall survival are analysed by Cox proportional hazard regression method. Investigators hypothesized that the target factor is closely related to disease progression. Whether it can be used as a tumor marker to predict metastasis is to be studied. Investigators collect laboratory examination including tumor markers of patients first diagnosed with metastases. Diagnostic efficacy is analysed and compared by receiver operator characteristic curve method.

Eligibility Criteria:
Inclusion Criteria:

* all patients were newly diagnosed with gastric cancer;
* all patients were pathologically diagnosed;
* all patients had pre-treatment coagulation test;
* stage I-IV disease;
* age≥18 years

Exclusion Criteria:

* accompanying or secondary to other tumors;
* had history of venous thrombosis or received any anti-coagulation treatment;
* acute infection or intravascular disseminated coagulation;
* pregnancy or lactation;
* history of neoadjuvant chemotherapy;
* Lost to follow-up
PCP Use of a Gene Expression Test (Corus CAD or ASGES) in Coronary Artery Disease Diagnosis

This is a prospective, multi-center study examining the clinical impact of the Corus CAD (Age/Sex/Gene Expression score - ASGES) assay in approximately 250 evaluable subjects with no history of obstructive coronary artery disease who now present with chest pain or anginal-equivalent symptoms to a primary care physician (PCP) for evaluation.

In symptomatic patients with or without prior cardiac testing, the PCP will initially decide the subject's pretest probability for coronary artery disease (CAD) based on the subject's risk factors and quality of chest pain (typical or atypical), or anginal equivalent (e.g., jaw, arm pain, or unexplained shortness of breath) and consider the results of prior testing, if applicable. The initial questionnaire will capture the PCP's initial clinical impression and decision ('preliminary decision') on how to further evaluate and manage the patient. A Corus CAD (Age/Sex/Gene Expression score - ASGES) assay will be performed at the PCP's office. After the PCP has received the Corus CAD (ASGES) result (approximately 2-3 days later), the PCP will decide on the appropriate evaluation and management of the patient ('final decision') using the Corus CAD (ASGES) result in conjunction with his/her clinical impression and/or other clinical data available. The primary aim of this study is to evaluate whether the Corus CAD (ASGES) test results is associated with a change in the PCPs' diagnostic evaluation and management of patients as compared to their initial testing and treatment decisions.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (ASGES), symptomatic subjects with unstable angina, or suspicion for myocardial infarction will be excluded from the study.

A follow-up phone call and a detailed questionnaire will be performed at 30 + 15 days, from the time of blood draw, to assess the triage decision, such as referral to any subspecialists (cardiologist, gastroenterologist, and pulmonologist), cardiac diagnostic tests performed, cardiac procedures performed, and results of these cardiac tests and procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Stable chest pain, typical or atypical angina or anginal equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form.

Exclusion Criteria:

1. History of myocardial infarction
2. Current Myocardial infarction (MI) or acute coronary syndrome.
3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms.
4. Any previous coronary revascularization.
5. Any individuals with :

   * Diabetes
   * Suspected unstable angina
   * Systemic infections
   * Systemic inflammatory conditions
6. Any individuals currently taking:

   * Steroids
   * Immunosuppressive agents
   * Chemotherapeutic agents
7. Any Major Surgery within 2 months
Does the Volume of the Embryo Culture Medium During Embryo Transfer Affects the IVF Outcomes?

The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)

The volume of culture medium used for embryo transfer is a variable that has been speculated to affect the IVF outcome. It is known that ultra high volume (\>100 μl) of medium during embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy. Similarly, some authors advocate that ultra low volume of transferring medium (\<10 μl) may negatively affect pregnancy and implantation rates.

However small differences in the volume of the culture medium may favor the outcome of the embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≤ 45y.o.
2. BMI≤36 kg/m2,
3. Baseline FSH concentration \<15 IU/l,
4. Ovarian stimulation with the same GnRH antagonist protocol
5. Normal uterine cavity with endometrium thickness \>7mm and trilaminar morphology at the Time of transfer and semen
6. Parameters of \>1 million /ml motile spermatozoa with \>4% physiological morphology -

Exclusion Criteria:

1. PGD cycles
2. Frozen -thaw cycles
3. Natural cycles or patients following different ovarian stimulation protocol were excluded from the study

   -
Ruxolitinib as GVHD Prophylaxis in AA Patients

Our study aimed to determine the prophylactic value of ruxolitinib for aGVHD in HSCT recipients of AA.Ruxolitinib was initiated at the beginning of conditioning regimen at 5 twice daily until 3 months post-transplantation. The cumulative incidence of aGVHD within 6 months after HSCT will be the primary observation item.


Eligibility Criteria:
Inclusion Criteria:

* (1) diagnosed as aplasitic anemia, including V/SAA,CAA and HAAA. (2) Age elder than or equal to 14 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member

Exclusion Criteria:

* (1) received a previous allogeneic HSCT; (2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 xthe upper limit of normal (ULN) or serum total bilirubin \> 2.5 x ULN.

  (4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.

  (5) has both moderate hepatic insufficiency AND moderate renal insufficiency; (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments; (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).

  (8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; (9) unable or unwilling to sign the consent form; (10) patients with other special conditions assessed as unqualified by the investigator
Empagliflozin-based Quadruple Therapy vs Basal Insulin-based Therapy

This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

This study aimed to evaluate the long-term effectiveness and safety of the empagliflozin as add-on thearpy compared to basal insulin-based antidiabetic agents (OADs) combination therapy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Inadequately controlled with triple OADs (metformin, glimepiride, dipeptidyl peptidase-4 inhibitor) showing HbA1c 7.5-12.0%

Exclusion Criteria:

* Type 1 diabetes
* Gestional diabetes
* Diabetes due to secondary causes
* Receiving anticancer treatment
* Receiving glucocorticoids or immune-suppressants
* Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study
* Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study
Workshops for Toddlers With Speech and Language Developmental Delay

The purpose of this study is to identify the therapeutic effects of family workshops on speech and language developmentally delayed children and their family

The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for 6 weeks.

Effects:

1. Investigate the therapeutic effects of the workshop for the toddlers with developmental delay
2. Investigate the therapeutic effects of the workshop for the parents of toddlers with developmental delay

Eligibility Criteria:
Inclusion Criteria:

* 18 to 36 months old children with speech and language developmental delay with or without delay in gross motor, fine motor, cognition, and emotional or social function

the availability of toddlers and their parents to attend one 2-hour session of the workshop per week for 6 weeks

Exclusion Criteria:

* Less than 18 months old or older than 36 months old
Exercise and Pain Sensitivity

There is ample evidence that exercise therapy is beneficial with respect to pain in patients with osteoarthritis of the knee. However, the pain relieving mechanisms are unknown. To enhance the efficacy of exercise therapy a deeper understanding of the involved mechanisms is needed.

Different exercise types may affect the pain sensitivity differently. It is hypothesized that non-specific exercises (i.e. exercises that does not involve the knee) reduces the processing of pain in the central nervous system (central sensitivity) to knee joint pain in healthy subjects. It is also hypothesized that exercises that involve the knee (i.e. specific knee exercises) reduce the sensitivity of pain receptors in the knee (peripheral sensitivity) in healthy subjects.

Healthy volunteers are recruited and randomised to one of four interventions: 1: Muscle strengthening exercises involving the thigh muscles; 2: Muscle strengthening exercises involving the shoulder muscles; 3: Cardio-vascular fitness exercises; or 4: Control (no exercises). The active interventions include exercises three times per week for 12 weeks. Pain sensitivity and a range of explanatory variables is measured before the interventions, after 4 weeks and after 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years
* Untrained (i.e. less than 2 hours of organised exercise per week in the last 6 months - physical activity related to transportation (e.g. bicycling) is not included)
* Generally healthy according a medical exam at screening, history
* Willing and able to participate in all measurements
* Willing and able to attend all training sessions
* Willing to keep the habitual activity and amount of training constant (ie screening activity and training volume).
* 20 ≤ body mass index (BMI) ≤ 28 kg/m2
* Speak, read and write Danish

Exclusion Criteria:

* Pregnant or breastfeeding
* Current or previous symptoms of autoimmune disease (eg, inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
* Planned surgery during the study period
* Current or former musculoskeletal injuries or illnesses, including but not confined to:
* Ligament Injuries
* Meniscus Injuries
* Osteoarthritis
* Patellofemoral Pain Syndrome
* Backache
* Neck pain
* tendinopathy
* Current or past diagnosis, signs or symptoms of significant cardiovascular disease, including but not limited to:
* Ischemic heart disease
* Arteriosclerosis
* Medical conditions that contraindicate exercise, including but not limited to:
* Chronic or congenital heart disease
* Asthma
* Chronic Obstructive Pulmonary Disease
* Past or current diagnosis, signs or symptoms of significant neurological disease, in-incl. but not limited to:
* Blood clot in brain
* Stroke
* Clinically significant head trauma within the last year
* Peripheral neuropathy
* Epilepsy or seizures
* Impaired balance
* Alcohol or drug abuse within the past 5 years
* Past or current diagnosis, signs or symptoms of major psychiatric disorder
* Regional pain syndromes like fibromyalgia
* Regional pain caused by lumbar nerve root or cervical radiculopathy with or at risk for developing it