cyrilzakka/clinical-trials huggingface dataset:
Low Dose Tamoxifen for Mammographic Density Reduction

KARISMA2 is a randomized, double-blinded, six-armed placebo controlled study to identify a low dose of tamoxifen, with less side-effects and a density reduction non-inferior to the standard dose of 20 mg.

This is a dose determination study aiming to identify the optimal tamoxifen dose for reducing the risk of breast cancer. The change in mammographic density is a very good marker of therapy response. Investigators will test if 1 mg, 2.5 mg, 5 mg and 10 mg reduce the mammographic density to the same extent as 20 mg.

1440 healthy women 40-74 yrs were included when adhering the national Swedish mammography screening program between 2016- 2019. Women were randomized and treated daily for 6 months. Mammograms were taken at baseline and at end of treatment and side effects were measured throughout the study trough schedueled questionnaires and spontaneous AE-reporting.

Eligibility Criteria:
Inclusion Criteria:

* Attending the national mammography screening program, i.e. aged 40-74 and has performed a screening mammogram maximum 3 months prior to study inclusion
* Having a measurable mammographic density, i.e. ≥4.5 % density (volumetric) measured by Volpara
* Informed consent must be signed before any study specific assessments have been performed

Exclusion Criteria:

* Pregnancy at start, during time of study medication and up to 3 months after quitting study medication
* Breast feeding at start, during time of study medication and up to 3 months after quitting study medication
* Any previous or current diagnosis of breast cancer (including carcinoma in situ)
* Mammographic BI-RADS code 3 or above at baseline mammography, or at a diagnostic mammography during time of treatment (the first 6 months of the study)
* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in situ cancer of the cervix
* Currently using oral oestrogen and progesterone based hormone replacement therapy
* Current use of hormone contraceptive with hormones, e.g. hormonal contraceptive pills, or progesterone implants. Hormonal intrauterine devices are accepted.
* A history of thrombo-embolic disease such as embolies, deep vein thrombosis, stroke, TIA or cardiac arrest.
* Known APC (Activated protein C )- resistance, an inherited hemostatic disorder
* A history of major surgery of the breast, e.g. reduction or enlargement, which might affect density measurements
* Women who have an increased risk of venous thrombosis due to immobilization, e.g. using wheelchair
* Known uncontrolled diabetes
* Hypertension at baseline, defined as systolic pressure higher than 140 mm Hg and diastolic higher than 90 mm Hg
* Use of drugs that interfere with CYP2D6 expression such as Seroxat (paroxetine), Fontex (fluoxetin) and Zyban / Voxra (bupropion)
* Use of Waran (warfarin)
* Non-medical approved drugs against hot-flashes including phytooestrogen
* Not able to understand study information and/or informed consent
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population

The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).


Eligibility Criteria:
Inclusion Criteria:

* A healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the Screening Visit or, if abnormal, are not clinically significant in the Investigator's opinion.

Exclusion Criteria:

* A gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the UGI endoscopic score greater or less) on the baseline UGI endoscopy
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.


Eligibility Criteria:
Inclusion criteria:

1. Premenopausal women who are 18 years old and older
2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
3. Stable, monogamous heterosexual relationship for at least one year.
4. Willing to discuss sexual issues.
5. Willing to engage in sexual activity at least once a month
6. Normal pap smear
7. Must use medically acceptable method of contraception
8. Able to comply with daily use of a handheld entry device

Exclusion criteria:

1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
3. Partner with inadequately treated organic or psychosexual dysfunction
4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
5. Sexual function impaired by psychiatric disorder
6. Sexual function impaired by gynecological disorder
7. Major life stress that could impair sexual function
8. Substance abuse
Validity and Reliability of High-Activity Arthroplasty Score

Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score (HAAS) into Turkish and to conduct a validity and reliability study of the Turkish version.

Studies show that TKA practice has increased in the young population in recent years. Patient-reported Outcome Measures (PROMs) used in total knee arthroplasty focus more on quality of life and pain. For this reason, individuals who can perform activities of daily living normally can get full points. There is a need for PROMs used in the assessment of higher functional skills. This study aimed to translate The High-Activity Arthroplasty Score into Turkish and to conduct a validity and reliability study of the Turkish version. The adaptation of the questionnaire to Turkish in the study will be made according to the COSMIN and Reliability and Agreement Studies Reporting Guide. The construct validity, concurrent validity, reliability, and floor and ceiling effects of the questionnaire will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* To have undergone primary total knee arthroplasty for osteoarthritis at least 6 months ago,
* To be between the ages of 18-65.

Exclusion Criteria:

* Having orthopedic, neurological, cardiovascular, or cognitive problems that may affect physical performance,
* Presence of previous lower extremity surgery
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.


Eligibility Criteria:
Inclusion Criteria:

* Documented histologically confirmed breast cancer with ERand/ or PgR-positive and HER2-negative status
* Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
* Archival tumour sample available at the time of informed consent and provided to the central laboratory around the time of randomisation. Patients must provide a formalin-fixed paraffin embedded (FFPE) tissue biopsy sample preferably taken at the time of presentation with recurrent or metastatic disease (provision of a biopsy sample taken from the bone is not acceptable).
* Patients must satisfy the following criteria for prior therapy:

  * Disease progression during treatment or within 12 months of completion of endocrine adjuvant therapy or
  * Disease progression while on or within 1 month after the end of prior endocrine therapy for advanced/metastatic breast cancer (Note: the endocrine therapy does not have to be the treatment immediately prior to trial entry).
* Patients must have

  * At least one measurable non-visceral lesion according to RECIST version 1.1 in either lymph nodes, soft tissue, skin and/or
  * At least one measurable non-visceral lesion according to RECIST version 1.1 as lytic or mixed (lytic + blastic) in bone and/or
  * At least one non-measurable (lytic, mixed lytic + blastic, or blastic) bone lesion according to RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
* Fasting glucose \<8.9 mmol/L (\<160 mg/dL) and HbA1c \<8.0%
* Adequate organ function

Exclusion Criteria:

* Previous treatment with agents targeting the IGF pathway, AKT, or mTOR pathways
* Prior treatment with exemestane (except adjuvant exemestane stopped \>12 months prior to start of study treatment as long as the patient did not recur during or within 12 months after the end of adjuvant exemestane)
* Evidence of visceral metastasis/es (i.e. liver, lung, peritoneal, pleural metastases, malignant pleural effusions, malignant peritoneal effusions) at screening. NOTE: Patients with a past history of visceral metastases are eligible if visceral metastases have completely resolved at least 3 months
* History or evidence of metastatic disease to the brain
* Leptomeningeal carcinomatosis
* More than 1 prior line of chemotherapy for HR+ HER2- metastatic breast cancer
* Radiotherapy within 4 weeks prior to the start of study treatment
* Use of concomitant systemic sex hormone therapy
* History or presence of cardiovascular abnormalities
* Known pre-existing interstitial lung disease
* Further exclusion criteria apply
End Button Tenodesis in Failed Developmental Dysplasia of the Hip Surgery

Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \& dislocation


Eligibility Criteria:
Inclusion Criteria:

- Patient with Developmental dysplasia of the hip (DDH) with :

* Age: up to 9 years old.
* Recurrent DDH .
* Failed open reduction through medial approach in the management of DDH.
* Traumatic hip dislocation .

Exclusion Criteria:

* • Paralytic hip dislocation .

  * Post septic hip dislocation.
  * Refusal to participate in this study.
Mobile Tele-rehabilitation Solution for Obese Patients.

Published data indicate that rehabilitation in obese patients can result in a loss of body fat and weight that is correlated to improved physical and psychological condition and reduced morbidity and mortality.

the Ivestigators hypothezise that the use of a mobile telerehabilitation solution will encourage the patient to adopt behavioral modifications allowing a reduction of fat mass

Obesity is one of the most important public health care problems worldwide and is associated with increased morbidity and mortality and high healthcare costs. Not all obese patients have the same metabolic risk. It is pejorated in case of increase in the fat mass (FM) and especially when it predominates at the visceral abdominal level.

Clinical trials have established the efficacy of lifestyle and behavioral interventions in obesity.

The recent development of telerehabilitation is a promising approach that has only been the subject of pilot studies Therefore, the investigators aim to test the effects of 3 months of telerehabilitation solution on fat mass evaluated by impedance analysis.

The telerehabilitation program Telemouv includes physical activity sessions with low intensity endurance training targeted at the level of maximal oxidation, nutritional monitoring, therapeutic education tools and motivational support

Patients with BMI \> 30 kg/m² will be randomized for the intervention.

The investigators also will analyse the effects of the solution on different anthropometric, metabolic,cardiovascular and psychological parameters, and on rest and exercise metabolism. Moreover, we will assess behavioural changes in physical activity and nutrition

At the end of the study, patients in the control group will be able to benefit from the telemouv solution in an ancillary study with a follow-up of three months.

For a alpha threshold of 5% and a study power of 90%, the study should include 22 patients in each group. Taking in account a possible 10% of dropout the study will need to include 25 patients by randomized arm to demonstrate an effect.

Eligibility Criteria:
Inclusion criteria:

* Body Mass Index \> 30 kg/m²
* Age 20-65 years

Exclusion criteria:

* Unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
* No internet access at home
Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

The investigators propose to perform a clinical randomized trial to evaluate the effect of single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete chromosome complement of the blastocyst in comparison to standard ART methods in which one or more embryo are replaced. Patients will be randomized into two groups:

* Control group: patients will have up to two embryos replaced on day 5 based on morphological and developmental characteristics, and the other embryos reaching blastocyst stage will be vitrified. If patients in the control group do not have a pregnancy to term from that fresh cycle, they will be offered free PGD either for the frozen embryos of that cycle or for the next cycle (up to the center and patient). Data from that PGD is not part of the study.
* Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.

Patients will be randomized after fertilization, and will be dropped from the study if they produce 3 or less blastocysts on day 5. The Primary efficacy endpoint of comparing the study group with the control will be (I) implantation rates and (II) multiple pregnancies (twin or higher order) comparing the first transfer.

The study may be extended to evaluate secondary efficacy endpoints which will be miscarriage rate and take home baby rates comparing the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age 33 to 42 years old (included)

Exclusion Criteria:

* MESA and TESE patients
* At least one partner carrier of a chromosomal or genetic disease
* Abnormal ovarian reserve, defined as FSH of \>10 IU/L on day 2-4 of the cycle and AMH \< 1ng /ml (If only one of the two parameters altered then patients is acceptable).
* Egg donor cycle (sperm donor is acceptable)

Exclusion criteria during stimulation:

* Less than eight antral follicles on day 2-4 of cycle

Exclusion criteria on day 5 post retrieval:

* Patients will be excluded if they produce less than 3 grade A,B or C blastocysts by day 5.
A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy

BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that are not fully elucidated. It is the same for symptomatology and urodynamic obstruction without clear identification of the part which is due to static phenomena (volume increase) and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and the difficulty of therapeutic indications between monitoring, medical treatment, and surgical operation. Experimental studies of BONT-A intra prostatic injection on animal and human models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the number of adrenergic α1 receptors.

Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.

PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A injection in the treatment of symptomatic BPH.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 50 to 85;
* Obstructive or irritative urinary symptomatology linked to a BPH;
* Score IPSS moderate to severe (8-19: moderate; 20-35: severe) or IPSS ≤ 7 in patient medically treated for symptomatic BPH;
* Increase in prostate volume on the rectal touch or ultrasound;
* Free consent, informed and written, dated and signed by the patient and the investigator (at the latest the day inclusion and before any examination requires the study);
* Subject affiliate or beneficiary of a social protection

Exclusion Criteria:

* stenosis of the urethra confirmed by endoscopic or radiological examination;
* prostate cancer suspicion;
* medical past history of surgery, radiotherapy or pelvic trauma (, breach of the urethra, pubic symphysis disjunction);
* surgical resection of the prostate (adenomecty);
* clinical or paraclinical signs of vesical sphincterial disynergia; chronic urinary retention \> 500 ml;
* BPH complications making surgery necessary: effects on the upper urinary tract: dilatation or renal obstructive insufficiency, bladder stones or diverticula.
* patient previously treated by botulic toxin (whatever injection site);
* Persons unable to understand the course of the study.
Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)

The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)

* during induction of general anesthesia,
* during a leg raising test in the Intensive Care Unit


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* ASA II, III or IV
* weight between 40 and 180 kg; BMI \< 35
* normal Allen's test and/or hand Doppler examination.

Exclusion Criteria:

* cardiac arrhythmias,
* history of vascular surgery or vascular implant in the upper limb
* Raynaud disease
Validation of a Novel Cortical Biomarker Signature for Pain

The study aims to undertake analytical validation of an brain biomarker in healthy participants experiencing a model of sustained temporomandibular pain. The biomarker could detect participants at greater risk of developing more severe pain.

Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The investigative team has uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). The biomarker signature combines resting state sensorimotor peak alpha frequency (PAF) measured using electroencephalograph (EEG) and corticomotor excitability (CME) measured using transcranial magnetic stimulation (TMS). This PAF/CME biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). In the current study, the investigators aim to undertake analytical validation of this biomarker in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain (masseter intramuscular injection of nerve growth factor). The investigators will record PAF/CME at multiple time points before and during the development of pain and use online diaries and in-laboratory assessments of pain, sleep, stress, and other psychosocial variables. Specifically, the investigators will test if the biomarker signature predicts an individual's pain sensitivity (high- or low-pain sensitive).

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* unable or refusal to provide written consent
* presence of any acute pain disorder
* history or presence of any chronic pain disorder
* history or presence of any other medical or psychiatric compliant
* use of opioids or illicit drugs in the past 3 months
* pregnant or lactating women
* excessive alcohol use
* contraindicated for TMS (metal implants, epilepsy)
Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

Intravenous thrombolysis is considered as the first choice for ischemic stroke. In the recent years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel occlusion. However, only a minority of patients can get intravenous thrombolysis or endovascular therapy due to the restricted time window and strict indications. Dual antiplatelet has been demonstrated to be effective in the patients with high risk of TIA or minor ischemic stroke (NIHSS\<4). But there is still stroke progression although dual antiplatelet. The ischemic stroke patients with NIHSS \> 3 has been recommended to give aspirin in most guidelines. Of those patients, mild to moderate stroke patients (3\<NIHSS\<10) will result in the poor outcomes if the progression occurs. In addition, large artery atherosclerosis (LAA) stroke is prone to progress. So, we argue that the mild to moderate stroke with LAA should be give more intensive antiplatelet. In the present study, argatroban combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to investigate the safety and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old;
2. Clear diagnosis of ischemic stroke patients with head CT or MRI examination;
3. The time of onset is less than 72 hours;
4. NIHSS score is less than 12 points;
5. the large artery atherosclerosis etiology
6. Signed informed consent.

Exclusion Criteria:

1. Hemorrhagic stroke or mixed stroke;
2. Patients with planned thrombolytic therapy;
3. Serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.;
4. The history of stroke and had serious sequelae (mRS\> 1);
5. Allergic to aspirin/clopidogrel and argatroban;
6. ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction;
7. Previous history of cerebral hemorrhage;
8. It is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function;
9. within 3 months of gastrointestinal bleeding or major surgery;
10. any unqualified patients judged by researchers.