cyrilzakka/clinical-trials huggingface dataset:
Statin Lowering Testosterone and Sexual Function

Statins may decrease serum testosterone levels via decreasing cholesterol. This longitudinal study detected the effects of rosuvastatin on free testosterone levels and sexual function in men with type 2 diabetes.

Methods:

Investigator enroll 150 men with type 2 diabetes and hypercholesterolemia. Biochemical assessments include serum total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein, triglyceride, prolactin, thyroid-stimulating hormone, luteinizing hormone, follicle stimulating hormone, total testosterone and serum sex hormone binding globulin (SHBG). All parameters are measured before statin treatment, after 6 months of statin treatment and 6 months after discontinuing statin treatment. Scores of the sexual health inventory for men (SHIM) are also evaluated.

Autonomic neuropathy and hypogonadism are the cause of impotence in men with diabetes. Hypercholesterolemia is also one of the dominant co-morbidity of diabetes. Many men with diabetes are being treated with statins to low down the serum levels of cholesterol. However, cholesterol is the major substrate for testosterone biosynthesis, statin may decrease serum testosterone levels via decreasing cholesterol level. In previous studies, few longitudinal studies with few enrolled subject were done before and with conflict results. Free testosterone is also not routinely used, so compromised the accuracy. The investigators will analyze the effect of statins on free testosterone levels in a longitudinal study of men with type 2 diabetes and do animal study to realize if the statin will influence the sex organ of rat.

Methods:

Investigator will enroll 150 men with type 2 diabetes and hypercholesterolemia. Clinical and biochemical assessments include blood pressure, HbA1C, lipid profile, height, weight, and waist circumference, luteinizing hormone (LH), follicle stimulating hormone (FSH) and free testosterone , which will be measured before statin treatment, after 3 months of statin treatment and then after quitted statin treatment for 3 months, and also give questionnaire about sex function.

The investigators expect:

1. Statin may potentially lead to hypogonadism or impotence In men with type 2 diabetes.
2. The relationship between blood glucose, lipid profile, blood pressure, anthropometric measures and serum free testosterone levels may also be revealed.
3. If this hypothesis is adverse, statin treatment will not influence gonadal function and has that side effect.

Eligibility Criteria:
Inclusion Criteria:

1. Type2 diabetes mellitus for more than 2 year.
2. Male subjects
3. Not received statin therapy for more than 1 year
4. Normal sexual activity
5. No hypogonadism history.

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Duration of diabetes less than 2 years and more than 10 years
3. Renal function impairment (creatinine level \> 1.4 mg/dl)
4. Cancer or organic disease associated with hypogonadism,
5. With testosterone on antiandrogen drug therapy
Sensitivity to Change of the Lower Extremity Functional Scale in Patients With Stroke

The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke.

The purpose of this study was to investigate the reliability, construct validity, and sensitivity to change of the Lower Extremity Functional Scale (LEFS) in individuals affected by stroke. Patients were measured with the LEFS at the beginning and end of physical therapy treatment, or at 8 weeks of physical therapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable patients receiving inpatient or outpatient physical therapy care for lower extremity dysfunction due to stroke

Exclusion Criteria:

* Unable to understand English
* More than moderate assist for bed mobility and coming to sitting from the supine position
* Lower extremity amputation
* Unable to reach overhead, grasp an object, or feed self with an upper extremity
The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia

This will be a randomised control trial designed to test the effectiveness of lactoferrin in the management of treatment-induced anemia in patients with hematological malignancies.

Chemotherapy induced anemia (CIA) is a common adverse event in cancer patients reported to occur in 20-60% whilst the resulting low hemoglobin level is associated with impaired quality of life. Lactoferrin (LF) is a non-haem iron-binding protein that is part of the transferrin protein family, along with serum transferrin, ovotransferrin, melanotransferrin and the inhibitor of carbonic anhydrase, whose function is to transport iron in blood serum.

The aim of the study is to test the effectiveness of LF along with standard care in the management of treatment-induced anemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide)
* Ability to independently complete the questionnaires

Exclusion Criteria:

* Allergy to Milk
* Lactose intolerance
* Celiac disease
* Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)
GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide

Allogeneic hematopoietic cell transplantation (HCT) is an important therapeutic strategy for many malignant and benign hematologic diseases. Haploidentical HCT has been increasingly used in patients lacking a HLA-matched donor due to its prompt availability, possibly lower cost and results comparable with other donor types. Graft-versus-host disease (GVHD) is the main cause of morbidity and mortality after HSCT, and prophylactic strategies are routinely used. In the context of haploidentical HCT, posttransplant cyclophosphamide plus cyclosporine and mycophenolate mofetil (MMF) is the most common platform used in Brazil. Data comparing MMF and methotrexate (MTX) as GVHD prophylaxes have proved controversial in other donor types, yet some large studies have showed that MTX is associated with lower risk of GVHD and improved long-term outcomes. Moreover, it is known that MMF is a potent inhibitor of natural killer (NK) cells, possibly interfering with the graft-versus-leukemia effect in haploidentical HCT. Given the possible advantages and the absence of consistent evidence regarding safety, efficacy and ideal dosage of MTX as GVHD prophylaxis in this setting, we propose a phase I / II study evaluating this drug in adult patients with hematologic malignancies undergoing haploidentical HCT with posttransplant cyclophosphamide.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia and chronic myeloid leukemia in complete morphologic remission, myelodysplastic syndrome with less than 10% in bone marrow or peripheral blood, Ph-negative acute lymphoblastic leukemia in complete morphologic remission, chemosensitive Hodgkin lymphoma or non-Hodgkin lymphoma in at least partial remission
* Donor type: haploidentical related donor
* Graft source: bone marrow or peripheral blood
* Recipients of non-myeloblative or myeloablative intensity conditioning
* Left Ventricle Ejection fraction \> 40%
* Estimated creatinine clearance \> 40 mL/min
* Adjusted DLCO ≥ 40% and FEV1 ≥ 40%
* Total bilirubin \< 2x ULN e ALT/AST \< 2.5x ULN

Exclusion Criteria:

* Prior allogeneic transplant
* Ex-vivo graft manipulation (T-cell-depleted or CD34-selected grafts)
* Use of alemtuzumab or anti-thymocyte globulin
* KPS \< 70%
* Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment
* Pregnant or lactating women
* Patients seropositive for human immunodeficiency virus (HIV) or active hepatitis B or C infection by PCR
* Presence of fluid collection (ascites, pleural or pericardial effusion) that may interfere with methotrexate clearance or make methotrexate use contraindicated
* Patients with a serious medical or psychiatric illness likely to interfere with participation in this study
Fetal Cardiac Remodeling in Singleton Pregnancies Conceived by Assisted Reproductive Technology (Biopsied and Non-Biopsied ICSI) Versus Those Normally Conceived

The study aims to assess the presence of fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) as compared with those conceived spontaneously (SC).

For gynecologists, reaching a conclusion about fetal cardiac remodeling and dysfunction in singleton pregnancies conceived by assisted reproductive technology (Biopsied and Non-Biopsied ICSI) or conceived spontaneously (SC) that would influence the clinical decision and best practice. Besides enriching the clinical evidence in fetal cardiac remodeling and dysfunction.

For society, the conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for fetal cardiac remodeling and dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged \>18 years
2. Singleton pregnancy
3. Women who are willing and able to attend serial ultrasonographic examinations during the whole pregnancy
4. Women willing to sign an informed consent

Exclusion Criteria:

1. Multiple pregnancies; more than one fetus
2. Any maternal medical disease, including asthma, chronic hypertension, diabetes mellitus, heart disease, extracardiac anomalies, human immunodeficiency virus or hepatitis infection, immunological disorders, lupus, and thyroid disease
3. Diagnosis of fetal malformations; fetus with a structural or chromosomal anomaly
4. Fetus with Small-for-Gestational-Age (SGA) or intrauterine Growth Restriction (IUGR) (a fetal weight that is below the 10th percentile for gestational age) as determined through an ultrasound.
5. Smokers or drug/alcohol women
6. Inability to understand and provide written informed consent
1% vs. 2 % Lignocaine for Endobronchial Ultrasound Guided Transbronchial Needle Aspiration

Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is no literature on the efficacy of lower concentrations (1%) versus a higher (2%) during EBUS TBNA. This study would help to determine whether 1% lignocaine is as effective as 2% lignocaine for airway anaesthesia during EBUS-TBNA.

For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to 1% lignocaine or 2% lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the concentration of lignocaine used. Two different concentration of lignocaine solution will be labelled as solution 'A' or solution 'B' containing either of 1% or 2% lignocaine solution .Operator will be provided either solution A or B based on the initial randomisation.

During the procedure, 1.5ml aliquots of the provided lignocaine solution will be delivered through the bronchoscope using spray-as-you go technique. The total number of aliquots used during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided 2 VAS charts to mark the severity of cough and overall procedure satisfaction.

Post procedure, patients will record the pain experienced while undergoing the procedure on the faces pain rating scale.

Eligibility Criteria:
Inclusion Criteria:

* Indication for diagnostic or therapeutic flexible bronchoscopy
* Age \> 18 years

Exclusion Criteria:

* Refusal of consent
* Known documented hypersensitivity to lignocaine
* Procedure performed under general anaesthesia
* Pregnancy
* Hypoxemia (oxygen saturation \[by pulse oximetry\] \< 92% with Fio2 of ≥ 0.3
Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.

Eligibility Criteria:
Inclusion Criteria:

* Has an established diagnosis of migraine with or without aura
* Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the study
* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening
Abdominal Massage to Prevent Postoperative Ileus After Colorectal Surgery

Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive measures have been included in the Enhanced Recovery After Surgery Program such as early mobilisation and enteral feeding or minimal invasive approach.

Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.

Various studies have evaluated the value of physiotherapy and massage for resumption of normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical study on operated rats, abdominal massage also improved normal bowel function recovery.

Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a reduction of time of hospitalization. Even though the results on time to first flatus and anxiety seem interesting, Deep abdominal massage has never been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>18years (homme et femme de plus de 18 ans)
* Elective Patients undergoing colorectal surgery with intestinal anastomosis (Colectomy, Anterior Resection, intestinal resection or stoma closure) without protective stoma creation in an Enhanced Recovery After Surgery Program
* Able to give the consent
* Affiliated to Social Security

Exclusion Criteria:

* Mental disorders
* Cutaneous infection on the abdomen
* Pregrancy and breast feeding
* Patients unable to give their free consent (incarcerated, legal protection measures)
Study of BMS-986012 in Subjects With Small Cell Lung Caner

A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

* Histological or cytological confirmed small cell lung cancer (SCLC)
* Eastern Cooperative Oncology Group Performance Status 0-1
* at least one measurable lesion that is not amenable to resection.
* Adequate organ function

Exclusion Criteria:

* Symptomatic central nervous system (CNS) metastases
* Grade ≥ 2 peripheral neuropathy
* Uncontrolled or significant cardiac disease
* Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)

Other protocol defined inclusion/exclusion criteria could apply
Radiotherapy With Humidification in Head And Neck Cancer

This is a two arm randomised phase III trial which will evaluate prospectively the benefits of humidification in patients receiving radiotherapy / chemoradiation for head and neck cancer. The intent of humidification is to moisturise the mucosa. The rationale for the use of humidification with radiotherapy can be considered an extension of the general principle of moist wound care in wound management.

This phase III trial will address four hypotheses. The primary hypothesis is:

Humidification will modulate the natural history of mucositis resulting in a clinically significant reduction in the intensity of severe acute mucositis as a function of time for CTCAE grade \> 1 mucositis (e.g. grade 2 or higher), measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions \> 1

The additional hypotheses are:

* Humidification will palliate the acute symptoms of mucositis and xerostomia
* Humidification is cost effective through a reduction in hospital bed occupancy
* Humidification will improve the functional outcome, particularly swallowing function, of patients with head and neck cancer treated with radiotherapy

Eligibility Criteria:
Inclusion Criteria:

Patients who meet the following criteria will be eligible:

* Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx
* Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)
* Prescribed dose of radiotherapy is at least 60 Gy
* Receiving definitive or post-operative adjuvant Radiotherapy
* Receiving Radiotherapy as sole modality or Chemoradiation
* Patient \> 18 years old
* Available for follow-up for up to 2 years
* Life expectancy greater than 6 months
* Written informed consent
* Participation of patients on other clinical trial protocols permitted

Exclusion Criteria:

Patients who meet the following criteria will be excluded:

* Presence of tracheostomy or stoma
* Diagnosis of T1 / T2 glottic carcinoma
* Undergoing CPAP therapy -Treatment with Amifostine or Palifermin (keratinocyte growth factor) during radiotherapy
* History of previous radiotherapy to the head and neck region, excluding superficial radiotherapy to cutaneous squamous cell carcinoma or basal cell carcinoma
* High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator
Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker

Physical activity is an important aspect of cancer therapy but correct measurement of physical activity is difficult. In this study, the physical activity of patients undergoing cancer therapy is assessed by questionnaire and by motion tracker. The results are then compared to answer whether there are differences between the two measurements. Findings of this study will help to improve the assessment of physical activity in cancer patients.

Although physical activity has been identified as a relevant determinant of cancer therapy outcome, its valid assessment remains challenging. In principle, direct and indirect assessment instruments can be employed for assessment of physical activity. While direct instruments, e.g. accelerometers, are considered to provide a more objective measurement, indirect tools such as questionnaires are less expensive and more applicable for use in larger study populations. The validity of both forms of measurements in cancer patients is however not well studied. Therefore, this study aims to elucidate the relative validity of an accelerometer in comparison to a standardized physical questionnaire at different time points of cancer therapy. Findings of this study will allow conclusions regarding the ideal modalities for assessment of physical activity in cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* verified diagnosis of lymphoma, colorectal or pancreatic cancer
* requirement of surgical, chemo or radio therapy
* provision of informed consent

Exclusion Criteria:

* pregnancy
* inability to provide consent
* use of a rollator
rTMS in the Treatment of PTSD

The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz \[Hz\]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.


Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)
* no change in psychotropic medications within 4 weeks before the start of rTMS
* age \> 19 years and \< 70 years
* competency to give informed consent

Exclusion Criteria:

* any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil
* implantable devices, including cardiac pacemakers and defibrillators
* other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy
* psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders
* substance abuse/dependence within the past 3 months
* active suicidal risk as judged by the clinician
* borderline or antisocial personality disorder
* acute medical illness, including cancer
* any significant central nervous system disorder, such as brain mass, stroke, etc.