cyrilzakka/clinical-trials huggingface dataset:
Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation

The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy

The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.

The primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).

Pharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.

The secondary endpoints are

* The detection of drug drug interactions with theriaque software, Micromedex software and DDI predictor tool.
* The clinical gradation by an independent expert comity of the clinical impact of avoided drug drug interaction. The expert comity will grade avoided clinical consequences in 3 levels (minor, moderate or major),
* The Economic evaluation of pharmacist intervention: Cost of the project to evaluate drug drug interaction and benefits after evaluation of avoided clinical consequences
* The Adherence evaluation of patients treated with oral cancer targeted therapy (Therefore, only patients under oral targeted therapy will be evaluated at Day0, Day15 ,Day 30 and Month 6 to determine adherence.)

Eligibility Criteria:
Inclusion Criteria:

* legal age patients
* Affiliated to social security or with another insurance system
* with a solid tumor
* who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)

Exclusion Criteria:

* pregnant women
* minor patient
Denosumab Adherence Preference Satisfaction Study

The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory postmenopausal women based on medical history
* \> or = 55 years of age at the start of screening
* Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral neck OR total hip that occur within the specified ranges based on the particular scanner that is used. At least 2 lumbar vertebrae must be evaluable by Dual X-ray Absorptiometry (DXA), or at least one hip must be evaluable by DXA
* Provide written informed consent before any study specific procedure is performed.

Exclusion Criteria:

* Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
* Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed
* Current hyper- or hypoparathyroidism
* Current hypo- or hyper calcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium
* Rheumatoid arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
* Any metabolic bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
* Any symptomatic vertebral fracture within 3 months prior to screening
* Previous participation in clinical trials with denosumab
* Vitamin D deficiency \[25(OH) vitamin D level \< 20 ng/mL (\<49.9 nmol/L)\]
* Contraindicated to alendronate therapy; contraindications for alendronate therapy include:

  1. Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
  2. Inability to stand or sit upright for at least 30 minutes.
  3. Hypersensitivity to alendronate (ALN) or other constituents of ALN tablets.
* Any known prior bisphosphonate use
* Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trail (s), or subject is receiving other investigational agent(s).
The Effect of Dynamic Tape ® on Plantar Fascitis

The Dynamic Tape ® (DT) is a new Tape (2009). Dynamic tape ® is a visco-elastic nylon tape material , greater than 200% elastic has manufactured in Asia. The material and adhesive arefast drying and breathable meaning that the tape, if it is correctly applied may stay on for up to 5 days, bearingin mind that if any discomfort, itching, burning, stinging orirritation is felt immediate removal is strongly advised.

Usually tapes are applied in plantar fasciitis to improve the symptoms. The fasciitis plantar is an pain that sometimes incapacitates the physical activity of the patients.

Objective: To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage in a sample of 15 amateur athletes affected by plantar fasciitis. The assessment will be performed using an analogue visual scale (EVA). Material and methods: the aim of the study is to evaluate a group of 15 amateur athletic subjects , all individuals suffering plantar fasciitis without any previous or current treatment. The age, from 18 to 65 years old. Samplings will be performed intentionally without a control group.

The control group will use a Low-dye tape and will be evaluated before and after a week

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of fasciitis
* Plantar fasciitis pain

Exclusion Criteria:

Current treatment of fasciitis pain
Lumbar Transforaminal Anterior Epidural Steroid Injections in Discogenic Low Back Pain

Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. Modic type 1 change is considered an inflammatory process. The aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.

Modic changes have been associated with low back pain in many clinical studies and are often considered a part of the disc degeneration process. However, in degenerative disc disease, whether the pain could be attributed to Modic changes or not is still a matter of debate.

There are different options in the treatment of low back pain due to degenerative disc disease (DDD) and Modic changes. Conservative treatments and surgical approaches are some of them. Other interventional procedures include intradiscal and epidural steroid injections which have relatively less risk of complications than surgery.

The only study in the literature investigating the effectiveness of epidural steroid injections in patients with low back pain associated with modic changes belongs to Butterman et al. They reported that patients with Modic changes (type 1) responded better to epidural steroid injections than those without endplate irregularities. However, they did not report the details of the procedure, such as the steroid and local anesthetic they used, the amount of them and the level of the procedure. Moreover, they used different approaches including interlaminar and transforaminal, which may be misleading while interpreting the results.

Based on these results, the aim of this study is to determine the effectiveness of lumbar transforaminal epidural steroid injections in Modic type-1 changes.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Non-radicular, axial back pain
* Lack of response to conservative treatments
* Detection of Modic type 1 changes in contrast-enhanced Lumbar MRI or intervertebral disc findings that may be associated with discogenic pain (nuclear signal intensity change in the disc \[black disc\], height loss, or high-intensity zone)

Exclusion Criteria:

* Patients younger than 18 and older than 65
* Describing pain radiating to the lower extremity (those with radicular pain)
* Nerve root compression due to disc herniation or other reasons
* Modic changes in more than one level
* Positive facet loading test
* Spinal stenosis or spondylolisthesis
* Diagnosed with spondylodiscitis
* Pregnancy
* Patients with inflammatory rheumatic diseases
* Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)
* Patients with exercise intolerance
Fit Over 45 - a Health Promotion Project for Inactive Female Hospital Staff Age 45+ From the University Hospital of Zürich

Background:

Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the public health recommendation of physical activity. A survey of female staff members over 45 years of age from the University Hospital Zurich at the end of 2003 showed that physical inactivity is also prevalent in this population.

Aim:

To assess whether inactive women working at a large hospital centre prefer Nordic Walking (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen by the majority improves physical performance, physical activity, body weight and composition, and bone mineral density.

Methods: The investigators will send out a questionnaire to all female staff members at a large hospital centre age 45 and older, ask whether they are inactive, and whether they prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference of the majority of the women, the investigators will then ask inactive female staff members age 45+ to participate in a 12-months randomized controlled trial comparing training plus nutrition education to nutrition education alone. The training will have a 3-month building-up phase followed up by an in part unsupervised training of 9 months. All participants will receive a lecture on healthy nutrition once a months for 12 months. The investigators will assess diet with a food frequency questionnaire at baseline and after 12 and 24 months.

The primary endpoint is: physical performance, measured with the 12-minute Coopertest.

The secondary endpoints are: level of physical activity, body mass index, body composition and bone mineral density at the spine and the hip.

Importance: This project will address the questions which physical activities are preferred by inactive women and whether the preferred training improves physical performance, physical activity, body mass index, body composition and bone mineral density. In addition, our study will explore whether those women who changed their diet in addition to being randomized to the training group have an enhanced benefit.


Eligibility Criteria:
Inclusion criteria:

* USZ-staff, at least 45 years old, insufficiently active according to the Swiss recommendation of health enhancing physical activity (neither 30 minutes of moderate physical activity at least five days in the week nor 20 minutes of vigorous physical activity at least two times per week) and written informed consent.

Exclusion criteria:

* Acute osteoporotic fracture (\<3 month), disability of the musculoskeletal system or cardiovascular diseases which do not allow an endurance training.
Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)

The objective of this study is to detect BOS in an early stage by using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of rejection over time will be monitored using non-rigid image registration methods.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Written informed consent obtained
* Patients who are planned to receive a lung transplant in the near future
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study
* The patient must be able to perform the lung monitoring at home

Exclusion Criteria:

* Pregnant or lactating female
* Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
The Drug-drug Interaction of SHR3824 and Metformin

The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 kg/m2.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SHR3824 or metformin or any of the excipients of the formulation of SHR3824 or metformin
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients

This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning regimen (and its variants) obtained from registry data in the Center for International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be completed.

Eligibility Criteria:
Inclusion Criteria:

Subjects with NHL to be included:

* Any subject with NHL that had relapsed or progressed following initial therapy with an anthracycline-based chemotherapy regimen and has achieved a subsequent partial remission (PR) or a complete remission (CR) following a salvage chemotherapy regimen.
* Any subject with NHL that was initially refractory to an anthracycline-based chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
* Any subject with an initial International Prognostic Index (IPI) score 4-5 who achieved a PR or any CR following an anthracycline-based chemotherapy regimen except subjects with Mantle cell, T cell and Natural Killer (NK) cell pathologies.
* Subjects with Mantle cell, T cell and NK cell lymphoma may be enrolled if they have PR or CR after initial therapy.
* Any subject that has relapsed or progressed following previous autologous HSCT.

Subjects with HL to be included:

* Any subject with HL that had relapsed or progressed following initial therapy with an multi-drug chemotherapy regimen and has achieved a subsequent PR or a CR following a salvage chemotherapy regimen.
* Any subject with HL that is initially refractory to a multi-drug chemotherapy regimen but who has achieved a PR or CR following a salvage chemotherapy regimen.
* Any subject that has relapsed or progressed following previous autologous HSCT.

Exclusion Criteria:

* Any subject with chemoresistant disease by demonstration of less than PR to most recent chemotherapy, and any subject with prior treatment history of autologous HSCT or high-dose chemotherapy with stem cell rescue for any medical reason will be excluded.

Excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.
Effect of Fresh Gas Flow Differences on Postoperative Nausea and Vomiting

The aim of this study is to investigate the effect of fresh gas flow applied during general anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing septorhinoplasty surgery. Patients who agree to participate in the study will be divided into three groups according to the fresh gas flow applied: low flow (0.5 lt/min) (Group L), medium flow (2 lt/min) (Group M) and high flow (4 lt/min) (Group H), and the postoperative nausea and vomiting data of the groups will be compared.

Preoperative demographic characteristics and Apfel score (smoking history, gender, postoperative opioid use, POB history) of the patients will be recorded. General anesthesia will be applied to all patients with standard ASA monitoring. In general anesthesia induction, 2 mg/kg propofol, 1 mcg/kg remifentanil, 0.6 mg/kg rocuronium will be used for all patients. Sevoflurane (minimum alveolar concentration of 1) will be used as a volatile agent and remifentanil (0.1 mcg-1 mcg/kg/h) will be used as an analgesic agent for anesthesia maintenance. After endotracheal intubation, fresh gas flow will be applied at 4 lt/min for 8 minutes, reduced to 0.5 lt/min in Group L, 2 lt/min in Group M, and maintained at 4 lt/min in Group H. After extubation, patients will be monitored in the recovery unit for at least 30 minutes, and at postoperative 0th minute (when first seen in the recovery room), 30th minute, 1st hour, 6th hour, 12th hour and 24th hour, the nausea score of the patients will be evaluated using the Numerical Rating Scale (NRS) with a score between 0 and 10. If vomiting is present, the number of times the patient vomited will be questioned and recorded. The patients' postoperative VAS scores, the amount of antiemetics used, the amount of opioids used intraoperatively and postoperatively will be recorded, and comparisons will be made between the groups and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agreed to participate in the study
* 18-65 years of age
* ASA I-II risk group patients

Exclusion Criteria:

* Patient does not accept the study
* Presence of psychiatric disorder and patient's inability to cooperate
* Cognitive dysfunction
* Hearing problems
* History of alcohol or drug addiction
* Presence of a serious pre-existing medical condition that limits objective assessment
* Complications developed during surgery
* Presence of any life-threatening condition after surgery
* Patient's classification is ASA III-IV
Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor

The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor

The main questions it aims to answer are:

* Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?
* How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups
* Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day
* Group 2 (control) Participant will not need to take a DHA

Threatened preterm labor is defined as regular uterine contractions occurring before 37 completed weeks of gestation, without any cervical dilation.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Between 24 wk to 34 wk of gestational age
* Pregnant women diagnosed threatened preterm labor (with no cervical change)

Exclusion Criteria:

* Fetal anomalies
* Multiple pregnancy
* Premature rupture of membrane
* Placental disorders: placenta previa, placental abruption
* Fetal growth restriction
* Pregnancy complication: gestational diabetes mellitus, Chronic hypertension
* Allergic reaction to DHA
Seal-V Safety and Performance Study

The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of \>18 years of age
* Signed Informed Consent
* Patients requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following:
* Peripheral bypass surgeries, such as arterio-arterial bypasses \[including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass\]
* Arteriovenous (AV) dialysis access shunt in the upper or lower extremity
* Patients able and willing to complete all follow-up visits

Exclusion Criteria:

* Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above
* Reoperation at the same treatment site
* Known sensitivity to device materials, such as indigo carmine dye or alginate
* Pregnant or lactating women
* Systemic infection
* Participation in another clinical trial or treatment with any investigational agent in past 30 days
* Congenital coagulation disorders (e.g., thrombocytopenia \[\<100,000 platelet count\], thromboasthenia, hemophilia, or von Willebrand disease)
* Severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
* Prior radiation therapy to the operating field

Intraoperative Exclusion Criteria:

* Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
* Intraoperative change in planned surgical procedure that results in the patient no longer meeting preoperative inclusion and/or exclusion criteria
* Local infection at the operating field
A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device

A prospective, open-label, and multi-centered feasibility registry.

This is a prospective, open-label, and multi-centered feasibility registry (single arm study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation (DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.

Eligibility Criteria:
Inclusion Criteria:

* Subject must consent to receiving the MitraClip device
* Subject must consent, be able, and commit to wearing the Actiwatch continuously for approximately 7 months
* Subject must consent to use of their data from this registry for purposes of exploratory research and publication and presentation

Exclusion Criteria:

* Subject is not a member of vulnerable population
* Subject must not have any disabilities that preclude reliable data collection from the Actiwatch, e.g., epilepsy with uncontrolled recurring episodes, serious stage degenerative/disabling disease (e.g. Parkinson's disease), inability to walk or will require walking aids, etc.