cyrilzakka/clinical-trials huggingface dataset:
Characterization and Kinetic of Chemotherapy-induced Cardiovascular Toxicity in Breast Cancer

The combination of epirubicin-cyclophosphamide (EC) and paclitaxel (Tax) is one of the main chemotherapy treatments used in breast cancer patients. These treatments, which can be combined with anti-HER2 therapy using trastuzumab, are frequently associated with side effects including cardiac toxicity. However, this cardiac toxicity has only been demonstrated several months after treatment and using global indices such as ejection fraction.

The assessment of myocardial dysfunction using regional deformations and the kinetic of this dysfunction during chemotherapy treatment has never been performed. In order to counteract these myocardial dysfunctions, it is essential to better describe the kinetic of the cardiac toxicity by initiating measurements since the beginning of the treatment, in order to be able to propose adapted countermeasures (e.g. exercise training) in parallel with the chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Epirubicin-cyclophosphamide + paclitaxel group:

* Female ≥ 18 years
* Stage I to III breast cancer
* Patient being planned for (neo)adjuvant therapy combining EC and Taxol on a weekly basis
* Enrolled in a social security plan
* Able to speak, read and understand French

Trastuzumab group:

* Female ≥ 18 years of age
* Stage I to III breast cancer
* Patient treated with trastuzumab
* Enrolled in a social security plan
* Able to speak, read and understand French

Exclusion Criteria:

For both groups: Epirubicin-cyclophosphamid + paclitaxel group and trastuzumab group

* Implantation of a pacemaker
* Contraindications to exercise
* Protected adult
* Psychiatric, musculoskeletal or neurological problems
* Pregnant or breastfeeding woman
* Uncontrolled high blood pressure
* Body Mass Index \> 35 kg/m²
The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration

Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration

Cartilage degeneration in the medial tibiofemoral joint is common after anterior cruciate ligament reconstruction (ACLR), which may develop into knee osteoarthritis (disability rate 21.3%). Alterations in joint biomechanical properties play an important role in cartilage degeneration after ACLR. However, the mechanism remains unclear.

Our research studied the joint kinematics and kinetics properties after ACLR and found significant changes in biomechanics in the ACLR knees. Therefore, this study will combine longitude biochemical changes in the cartilage to explore how the alterations in biomechanics would influence biochemical changes in the joint cartilage.

This study will explore the joint biomechanical properties during functional activities by motion analysis, the effects of biomechanical properties on cartilage stress distribution by finite element analysis, the long-term biochemical changes in the joint cartilage by functional MRI. This study will establish prediction models for cartilage biomechanical changes in the mid-term based on joint biomechanical properties in the early stage after ACLR, and cartilage biomechanical changes in the long-term based on joint biomechanical properties in the mid-term after ACLR. The study aims to clarify the mechanism of cartilage degeneration after ACLR and search biomechanical risk factors, in order to provide methods for clinical prevention of cartilage degeneration after ACLR.

Eligibility Criteria:
Inclusion Criteria:

Unilateral ACL rupture of the knee

Exclusion Criteria:

concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks
Physical Activity Intervention to Promote Walking Among Female University Students

This study is a parallel group randomized controlled trial among female university students designed to test the effect of a physical activity intervention on daily walking. Both groups will receive messages 2-3 times per week via WhatsApp. Intervention group will receive orientation and wear a pedometer for the study period. The follow-up duration is 3 months.

Background: Sedentary lifestyle is a major risk factor for chronic diseases. The majority of Saudi females do not meet a recommended level of physical activity.

Study Objective: To test the effect of a physical activity intervention on daily walking.

Study Design: Parallel group randomized controlled design among female university students.

Methods: Students will be randomly assigned to either the intervention or the control arm. WhatsApp groups (2 per arm) will be formed within each study arm for communications. The intervention participants will receive a brief (15-minute) orientation on diet, exercise, and benefits of keeping a healthy weight; each will be instructed to wear a pedometer every day for 12-weeks with a daily step goal of 8,000. They will receive 2-3 health-promotional (walking and diet) messages per week via WhatsApp; group interaction is optional. The control group participants will receive 2-3 non-health related messages per week. Average daily steps will be assessed in all participants at baseline and 3-month follow-up using a 7-day pedometer measurement.

Eligibility Criteria:
Inclusion Criteria:

* female
* student enrolled at Qassim University during 2016-2017 academic year
* owns smartphone with internet access
* willing to complete all study requirements

Exclusion Criteria:

* Physical disability that precludes physical activity
* Morbidly obese (Body Mass Index \>45 kg/m2)
* Physician recommendation not to exercise
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.


Eligibility Criteria:
Inclusion Criteria:

* Adult C5 inhibitor naive PNH patients (age\>=18), which is confirmed by flow cytometry evaluation.
* Must be vaccinated againast N meningitidis.

Exclusion Criteria

* Meningitidis infection or unresolved meningococcal disease
* History of bone marrow transplantation
* Other significant systemic diseases that might have impact on efficacy and safety assessment
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Treatment with oral anti-diabetic drugs for at least 3 months
* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
* Body Mass Index (BMI) less than or equal to 45.0 kg/m2.

Exclusion Criteria:

* Treatment with insulin within the last three months
* Treatment with any drug that could interfere with the glucose level
* Any serious medical condition
* Females who are pregnant, have the intention of becoming pregnant or are breastfeeding
Antimicrobials Stewardship by Pharmacist

To study the outcome of antibiotics stewardship

Retrospective cohort study by medical review and evaluation of broad-spectrum antibiotics to determine how appropriately it was bing used.

Eligibility Criteria:
inclusion criteria:

* Inpatient with infectious disease and under broad-spectrum antibiotics

exclusion criteria:

* Poor prognosis was diagnosed or received conservative therapy only.
Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure

The purpose of this study is to assess the efficiency of permanent biventricular pacing using three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in cardiac capacity and patients' functional status in subjects with congestive heart failure and a physiologic (sinus) rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more,
* Congestive heart failure (HF) in NYHA class III-IV within last 90 days despite optimal medical treatment,
* Left ventricular ejection fraction (EF) \<=35% measured with echocardiography,
* Sinus rhythm \>90% of the time in 24-h Holter monitoring 1-3 days prior to randomization,
* Inter- or intraventricular mechanical dyssynchrony ≥40ms measured with pulse Doppler and tissue Doppler echocardiography,
* Optimal pharmacotherapy during the last 90 days,
* Signed informed, written consent.

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Unstable HF requiring hospitalization with intravenous inotropic drugs within last 90 days,
* Myocardial infarction, percutaneous/surgical revascularization or any cardiosurgical procedure within 90 days prior to randomization,
* Stroke within last 90 days,
* History of chronic or persistent atrial fibrillation, flutter, tachycardia,
* Acute myocarditis,
* Implanted previously pacemaker, ICD or CRT-device,
* Participation in a concurrent trial that could confuse the results of this study,
* Mechanical right heart valve,
* Prior heart transplant,
* Valvular disease that is indication for valve surgery,
* Coronary heart disease if percutaneous or surgical revascularization is indicated and possible,
* Any state, apart from HF, that limits the estimated survival time to \<1 year,
* Unwillingness or inability to understand the nature of the study, to participate or to give written informed consent.
Long-term Follow-up of Participants Dosed with an Investigational Gene Editing Therapy for Cardiovascular Disease

LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy.


Eligibility Criteria:
Inclusion Criteria

1. A participant has completed or discontinued from a Verve sponsored clinical study in which they received at least one dose of study drug.
2. A participant has provided informed consent for LTF-001.

Exclusion Criteria: N/A
Effect of the Uterotonic Carbetocin on Acute Post Cesarean-Section Pain

Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a double-blind, prospective design patients will be either attributed to the oxytocin or the carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the cesarean delivery scar. This will be performed with a von Frey hair, resulting in a unpleasant feeling in the area of hyperalgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45, uneventful pregnancy, on term (\>37 0/7 weeks of gestation), scheduled elective CS including repeat CS

Exclusion Criteria:

* lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations
Statistical Analysis of Pediatric Task Force Data Base

To define pediatric sex-specific blood pressure percentiles that were a function of both age and height. Also, to define the precise age at which blood pressure distributions for different racial groups diverged.

BACKGROUND:

Hypertension is a well-recognized risk factor for cardiovascular disease in adults. Furthermore, many studies have shown that there is tracking among longitudinal pediatric blood pressure determinations. An important unresolved goal in pediatric hypertension research is to define at what level of pediatric blood pressure is a child at increased risk for adult hypertension. When the grant was awarded in February 1991, there had been two NHLBI Task Forces in Blood Pressure Control in Children which had published reports in 1977 and 1987. One of the goals of each task force was to define appropriate percentiles for blood pressure in children. In the Second Task Force Report, results from nine large epidemiologic studies were combined into a data base with more than 70,000 readings from which blood pressure percentiles were derived as a function of age and sex. However, many research workers stated that height is more strongly related to blood pressure than age and have urged that Normative data for pediatric blood pressure be demarcated by height rather than age.

DESIGN NARRATIVE:

Blood pressure percentiles were constructed that were a function of age, sex, race, and height, thus providing a more comprehensive profile of pediatric blood pressure distributions than any previously published work.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Suction on Post-Operative Chest Tubes

The level of suction on post-operative chest tubes after video-assisted thoracoscopic surgery (VATS) lobectomy for lung cancer has previously shown to affect duration of drainage. These results, however, are based on traditional drainage systems with water seal and need to be confirmed using digital drainage systems.

Hypothesis: Suction of -2 cmH2O is equal to or superior compared with standard suction of -10 cmH2O when looking at chest tube duration and complications.


Eligibility Criteria:
Inclusion Criteria:

* Speaks and understands Danish.
* Referred for planned VATS lobectomy for confirmed or suspected primary lung cancer.

Exclusion Criteria:

* Cannot cooperate or unable to give consent.
* Chronic drain carrier.
* Planned open procedure.
* Planned resection of additional wedge, additional lobe or thoracic wall.
Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis

This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Men or women at least 19 years of age
* Subjects with coronary In-stent restenosis planned revascularization
* In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Complex lesion anatomy that disables rotational atherectomy
* Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
* Life expectancy \< 1 years for any non-cardiac or cardiac causes
* Unwillingness or inability to comply with the procedures described in this protocol.
SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA

Space maintainers are used to preserve the space after premature loss of teeth but they could effect some factors that play a role in caries formation. The research aimed to assess the impacts of removable and fixed space maintainers on the salivary pH, flow rate, and Streptococcus mutans, Lactobacillus carriage.

Although the usage of space maintainers can reduce the severity of problems that arise from the early loss of teeth, there are concerns regarding the impact of fixed and removable appliances on factors that can lead to dental caries. All space maintainer appliances are plaque retentive since bands and brackets increase the retention of plaque and food on tooth surfaces, reduce the clearance of plaque by saliva and make conventional oral hygiene for plaque removal more difficult, therefore, they may cause caries development.Space maintainers can favor caries formation by changing the oral microflora. patients aged between 4-10 years, each of whom had an indication for a fixed (n=19) or removable space maintainer (n=19), were enrolled in this research. The salivary pH, saliva flow rate, Streptococcus mutans and Lactobacillus counts in saliva were measured just prior to the application of space maintainers (baseline-T0) and in the course of the follow-up; at the 1st (T1), 3rd (T2), and 6th (T3) months. The Wilcoxon, Mann-Whithney U test and Friedman tests were used for statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* The present research was conducted on 38 patients aged between 4-10 years, each of whom had an indication for a fixed or removable space maintainer.

Exclusion Criteria:

* Patients with a medical history that could influence microorganism carriage, including systemic disease, immunosuppression and the usage of antibiotics in the preceding 15 days, were excluded from the research
Generation of Prediction Equations for BIA of the Elderly

The objective of the study is to develop prediction equations for calculating Fat-Free Mass FFM, Total Body Water TBW, Extracellular Water ECW, Visceral Adipose Tissue VAT, total Skeletal Muscle Mass SMM and segmental SMM in a group of elderly. The prediction equations are based on linear regression analysis between the gold standard reference methods Air Displacement Plethysmography ADP, Dual-energy X-ray Absorptiometry DXA, Magnet Resonance Imaging MRI, Deuterium dilution method (D2O) and Sodium Bromide dilution method (NaBr) on the one hand and bioelectrical impedance measurements on the other hand.

Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.


Eligibility Criteria:
Inclusion Criteria:

* male and female subjects older than 60 years,
* stable medication (no changes during the past 6 months),
* subjects need to be able to sign the informed consent and privacy policy

Exclusion Criteria:

* acute disease
* intake of diuretics
* wearing of support stockings
* edema diagnosed by inspection and palpation of lower limbs
* paralysis e.g. after a stroke
* neurodegenerative diseases e.g. ALS
* tumors in treatment
* amputation
* electronic implants e.g. pacemaker
* under the skin applied injection systems (e.g. insulin pumps or pain pumps)
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the investigation site
* current alcohol abuse
* active prostheses
* electronic life-support systems, e.g. artificial heart, artificial lung
* portable electronic medical devices, e.g. ECG devices or infusion pumps
* metallic implants
* cochlea implants und heart valves prothesis (e.g. Starr-Edwards-Prothesis)
* vessel clips in the brain or medulla applied before 1995
* defeatable pumps
* catheter
* iron or metallic parts in the body (e.g. shard of metal)
* dental braces
* magnetic tooth implants
* not removeable piercings
* extensive tattoos
Postoperative Chemoradiation v.s Radiotherapy for Lymph Node Negative Cervical Cancer Patients

This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.

Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with high risk factors cervical cancer. However, the treatment modality in patients with low-risk (lymph node negative) is still disputable. It is not yet known whether cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating these patients.

Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in lymph node negative patients with early-stage cervical cancer following radical hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Undertaken radical hysterectomy with diagnosis of invasive cervical cancer (non-small cell type)
* Negative lymph node
* At least two risk factors (interstitial infiltration of greater than 1/3, vascular or lymphatic involvement, cervix neoplasms larger than 4 cm, nerve involvement)
* Eastern Cooperative Oncology Group 0-2
* Expected life span over 6 months.
* No distant metastasis
* Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl)
* Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
* Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value)
* Written informed consent

Exclusion Criteria:

* Previous history of chemotherapy or radiation
* Hypersensitive reaction to platinum/paclitaxel agent
* History of other cancer
* Concurrent systemic illness not appropriate for chemotherapy
* Active infection requiring antibiotics
* Pregnancy
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers

The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant.

Subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new subjects were enrolled and no vaccine was administered in this long-term follow-up study. There was a single visit at Year 4 at which blood samples for immunogenicity assays were taken.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Subjects who took part in and completed study 287615 (NCT00508833).
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling.
* Administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period.
* Pregnant or lactating female.
* Documented HIV-positive subject.