cyrilzakka/clinical-trials huggingface dataset:
Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
* HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive
* Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
* Tumor involvement of at least one axillary lymph node (N0 with HER2/c-neu over expression are also eligible)
* Absence of any clinical or radiological evidence of local or metastatic disease
* Premenopausal or postmenopausal women aged 18-75 years old
* Adequate bone marrow function (absolute neutrophil count \>1500/mm3, platelet count \>100.000/mm3, hemoglobin \>10gr/mm3)
* Adequate liver (bilirubin \<1.0 times upper limit of normal and SGOT/SGPT \<2.5 times upper limit of normal) and renal function (creatinine \<1.5mg/dl)
* Adequate cardiac function (LVEF\>50%). Normal electrocardiogram and absence of significant heart disease
* Written informed consent

Exclusion Criteria:

* Positive pregnancy test.
* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
* Previous history of other invasive malignancy other than non-melanomatous skin cancer.
Prevalence of Sedentary Lifestyle, Pre-hypertension, and Obesity

Hypertension has been a serious problem among people from different ages in the last few decades, so by taking this in consideration we decided to search for specific risk factors that cause hypertension in young healthy adults, and to achieve that we are looking for pre-hypertension, obesity, and sedentary lifestyle among this group by using different scale tools and questionnaires.

Hypertension has been a serious issue worldwide and there is a wide variety of content in literature regarding its risks, treatment modalities, and disease course. In this study, it was aimed to investigate the "pre-hypertension" state, which is the pre-step of hypertension, and to find its risk in young adults. While screening literature we found the incidence of pre-hypertension to be between 17% and 49% in individuals aged 18-30 years. However, study methods have generally been limited to blood pressure and anthropometric measurements. In our study, a holistic research will be carried out with different scales and questionnaires by enriching the method part.

The aim of this study is to determine the incidence of prehypertension, sedentary life and obesity in healthy young adults aged 18-25, and then to determine the relationship between these risk factors. 382 young adults will be included in this study. Blood pressure will be measured with a sphygmomanometer, subcutaneous fat tissue with a caliper, height with a height measurement device, waist and hip circumference with a tape measure, and body weight with a scale, BMI (body mass index) and double product will be recorded according to the data received by doing specific calculations. Participant's physical activity status will be evaluated with the International Physical Activity Scale and Leisure Activity Scale, dietary habits with the Dutch Eating Habits Questionnaire, sleep status with the Pittsburg Sleep Quality Questionnaire, and psychosocial status with the Perceived Stress Scale and Beck Depression Scale.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subjects

Exclusion Criteria:

* Smoker Subjects
* Alcohol drinker Subjects
* Subjects who use drugs that affect blood pressure
The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis

The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. The main questions it aims to answer are:

* Does autologous blood transfusion increase the incidence of new metastases?
* Does autologous blood transfusion affect postoperative hemoglobin levels and the number of circulating tumor cells in the blood?
* Can autologous blood transfusion reduce the rate of allogeneic transfusion during and after surgery for spinal metastases?

In this study, participants underwent standard open spinal decompression surgery, and when blood transfusion was needed, autologous blood transfusion or allogeneic blood transfusion was used. Participants will be patients with lung cancer spinal metastases. Investigators will use flow cytometry, immunohistochemistry, and tumor cell culture methods to measure the number of circulating tumor cells in the blood before and after autologous blood transfusion.

Investigators will compare participants who receive autologous blood transfusion with those who do not to observe if there are differences in:

* The incidence of new metastases
* The rate of allogeneic transfusion during and after surgery
* Postoperative hemoglobin levels
* The number of circulating tumor cells in the blood
* The cost associated with transfusion

Eligibility Criteria:
Inclusion Criteria:

* The age range is 18-75 years old;
* The pathological diagnosis was lung cancer and spinal metastatic tumor;
* Expected survival \> 3 months, can tolerate surgery;
* Unstable spine; And/or spinal cord nerve compression, nerve function; Progressive decline, palliative spinal open decompression surgery
* Patients with intraoperative/postoperative Hb\<90 g/L or other conditions requiring blood transfusion

Exclusion Criteria:

* Serious heart dysfunction or heart failure, diagnosed blood system diseases, coagulation disorders;
* Severe renal insufficiency or need hemodialysis treatment;
* Sepsis or septicemia;
* Unable to obtain consent from the patient or family.
QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study

This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method

This multicentre study aims to evaluation the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method

Eligibility Criteria:
Inclusion Criteria:

* Presenting with signs and symptoms of a respiratory infection.
* Consent or assent to be obtained
* Able to communicate (speak, read and write) in local language, and able to understand and sign the required study documents.
* Willing and able to provide Nasopharyngeal Swab (NPS) Specimen collected per manufacturer's instructions.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
Muscle Weakness and Post-traumatic Knee OA

This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.


Eligibility Criteria:
Inclusion Criteria:

1. traumatic onset meniscal tear (i.e. specific mechanism of injury)
2. meniscectomy surgery performed within 12 months of index injury
3. meniscal tear confirmed at the time of surgery
4. subject anticipates living in close proximity to Gainesville for one year following surgery.

Exclusion Criteria:

1. bilateral injury
2. concomitant ligamentous injury
3. previous knee injury
4. articular cartilage defect \> Grade II on Outerbridge scale
5. patellofemoral joint pain \> 3/10 with activity
6. lower limb alignment \> 5 degrees of valgus or varus
7. contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer

To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.

The main objective of the ETAPH project is to offer breast cancer patients multidisciplinary care that will limit the impact of adverse effects related to hormone therapy treatment and improve their quality of life. The achievement of this objective is based on therapeutic education and nursing follow-up throughout the first year of treatment, which, thanks to active listening and coordination of the various players, will enable global and personalized patient care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting.
* Performance status (ECOG) ≤ 2
* Patient able to read and understand French (common use)
* Patient with access to an internet connection (for collection of adverse events and responses to questionnaires)
* Patient who has been informed and has given written consent to participate in the study

Exclusion Criteria:

* Patient with metastatic cancer
* Patient undergoing neoadjuvant hormone therapy
* Patient who started hormone therapy prior to inclusion in the study
* Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
* For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for geographical, physical or other reasons (at the discretion of the investigator).
* For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education.
* Pregnant and breastfeeding women
* Patient with a documented history of cognitive or psychiatric disorders
* Refusal to participate, protected adult patient, under guardianship or curatorship
Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC

This is a Phase II single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC).

The study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at informed consent signing.
* ECOG performance status of 0 or 1.
* Histologically confirmed stage II-IIIB NSCLC (AJCC 9th edition).
* Tumor size ≤5 cm.
* Deemed suitable for R0 resection by a thoracic surgeon for radical treatment.
* Adequate cardiopulmonary function for radical surgical resection.
* Eligible for cryoablation and platinum-based doublet chemotherapy.
* Adequate blood and organ function, as per laboratory tests within 14 days before enrollment.

Exclusion Criteria:

* Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
* LCNEC diagnosis.
* Known EGFR mutations or ALK translocations. For non-squamous NSCLC, EGFR mutation status must be confirmed locally or centrally if unknown.

For squamous NSCLC, EGFR testing is not required if status is unknown. ALK translocation testing is not required if status is unknown.

* Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must undergo sampling for clinical staging to exclude stage IIIB/C.
* History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
* Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
* Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
* Active autoimmune disease or history of recurrent autoimmune disease.
* Exceptions: Well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation.
* Severe infections requiring systemic treatment within the past 4 weeks.
* Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.
Laser Verses Conventional Circumferential Supracrestal Fiberotomy in Orthodontic Extrusion for Crown Lengthening

The aim of this study is to the evaluate the stability of the amount of healthy tooth structure exposed after laser versus conventional technique of fiberotomy during orthodontic extrusion.

Parallel groups, two arm, superiority Randomized Controlled Clinical Trial, with 1:1 allocation.

PICO:

Population: patients with endodontically treated teeth and short clinical crown that require crown lengthening in the esthetic zone Intervention: laser fiberotomy with orthodontic extrusion Control: conventional fiberotomy using blade with orthodontic extrusion

Outcomes:

Primary outcome: Stability of the mount of healthy tooth structure exposed.

Secondary outcomes:

* Stability of gingival Margin reference.
* Stability of the alveolar bone.
* Rate of tooth extrusion.
* Sulcus depth.
* Pain Time: 8 weeks after retention

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years old
* Teeth in the esthetic zone
* Restorable teeth with successful endodontic treatment
* Adjacent teeth with clinical attachment of at least two-thirds of the root length, thus permitting adequate support for orthodontic movement
* Crown root ratio after extrusion of the needed ferrule amount not less than 1:1

Exclusion Criteria:

* Patients with bad oral hygiene or Periodontally affected teeth
* Uncontrolled diabetic patients
* Pregnant females
* Medications that could affect tooth movement (bisphosphonate) radiation therapy less than 2 years
* Moderate-to-heavy daily smokers (who report consuming at least 11 cigarettes/day)
* Teeth with periapical inflammation, ankylosis or vertical root fracture
* Teeth with probability of furcation exposure after extrusion.
* The level of the root is 3 mm or more apical to the level of the bone
Naltrexone in the Treatment of Dissociative Symptoms in Patients With Borderline Personality Disorder

Our study aims at contributing to a valid appraisal of the magnitude of naltrexone efficacy as an antidissociative agent by using a double-blind randomized controlled trial.

Patients were randomized into two groups starting with either 3 weeks of 50 mg/d naltrexone or with 3 weeks of placebo. In either case the active treatment phases (weeks 1-6) were followed by one week of placebo. The major purpose of weeks 1-2 and 4-5, respectively, was to achieve a steady state during the active treatment. The primary comparisons of psychopathology under naltrexone and placebo refer to the weeks following the intended achievement of a steady state (weeks 3 and 6, respectively).

6 weeks of treatment were split into two phases: (A) 3 weeks of pharmacologically active treatment with naltrexone and (B) 3 weeks of pharmacologically inactive treatment with placebo (cross-over design). The sequence of the two treatment phases was randomized and concealed from both the patients and the health care professionals. In both cases, the last week ("Week 7") was without pharmacological intervention.

The primary outcome was based on the DSS, a reliable and valid self-rating instrument to assess dissociative experiences and inner tension during the last 24 hours (Stiglmayr et al. 2001) Mean scores for intensity (ranging from 0="no" to 9="very strong") and for duration (average time during which a particular symptom was present during the last 24 hours (in %)) were calculated for (a) dissociation (calculated from 21 Likert type items) and of (b) aversive inner tension (one item).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD according to DSM-IV
* DES score ≥ 18
* Female gender
* Age between 18 and 50 years

Exclusion Criteria:

* Lifetime diagnosis of schizophrenia, psychotic or delusional disorder
* Current major depressive episode
* Lifetime diagnosis opioid dependence
* Current diagnosis opioid abuse
* Liver insufficiency or hepatitis
* Other major medical or neurological medical condition
* Pregnancy or lactation
* Psychotropic medication within two weeks before and during the trial (fluoxetine 4 weeks, lithium 8 weeks)
* Concomitant treatment with opioid analgetics
* Hypersensitivity to naltrexone
Safety and Efficacy Study of High Dose Melphalan to Treat Multiple Myeloma

The purpose of the study is to evaluate the safety and effectiveness of melphalan for injection for autologous stem cell transplant in multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* Patients with greater or equal to 18 years, with a upper age limit of 65 years are eligible.
* Multiple myeloma patients, symptoms conform to diagnosis of multiple myeloma of IMWG2003/WHO2008 criteria.
* Patients with responsive disease after induction therapy not more than 6 courses of treatment
* A complete response
* A very good partial response
* A partial response
* At least 4 weeks long from last cytotoxic treatment(exclude Bortezomib, thalidomide, dexamethasone);
* Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 Patient has an absolute neutrophil count of ≥1.5×109/L and platelet count≥80×109/L;
* Calculated creatinine clearance \>50ml/min by Cockcroft-Gault formula or collect urine within 24 hours.
* Patient with a total bilirubin ≤1.5 times of normal upper limit, AST,ALT≤2.5times of normal upper limit;
* Cardio-pulmonary function is adequate to conduct autologous stem cell transplant.
* Ratio of body weight and ideal body weight \<175%;
* All patients should have a life expectancy of more than 12 weeks
* Signed informed consent form voluntarily

Exclusion Criteria:

* CD34 positive hematopoietic stem cell collected \<2.0×106/kg
* Patients have a psychiatric history
* Female subject is pregnant or breast-feeding
* Patients are hypersensitive to this trial product or other alkylating agents
* Participate of other clinical trials within the past 4 weeks Active CNS lesions
* Concomitant of active infection or positive of HIV antibody
* Concomitant of other un-healed malignancy
* Left ventricular ejection fraction≤50%
* Patients with serious thrombosis
* Any severe concomitant disease that will expose study subjects to unacceptable risks.
* Patients not suitable to enroll by investigators considerations.
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
* Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
* Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.

Exclusion Criteria:

* Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
* Subjects with poorly controlled diabetes mellitus, defined as HbA1C \>9%.
* Subjects on combination ACE inhibitor/ARB therapy.
A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes

A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to use the system
* Generally healthy
* Enjoys the smell of peach or orangeade.

Exclusion Criteria:

* Silicone allergy
* IBS, bariatric surgery,
* pregnancy
* participation in another clinical study.