cyrilzakka/clinical-trials huggingface dataset:
Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer

Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially severe CVD and associated morbidity. Mechanisms underlying the cardiovascular toxicities of VEGFI and cisplatin are unknown, but effects on vascular function may be important.

The INTELLECT study will phenotype the endothelial effects of VEGFI and cisplatin using a variety of methods.

There remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this study will inform its design.

The information gained from this pilot study will guide the development of interventional pharmacological studies that are directed towards the most appropriate pathophysiological processes, at the most appropriate time and in the most appropriate patient groups treated with platinum based chemotherapy for testicular cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of stage 1 low-risk germ cell testicular cancer treated with orchidectomy, or IGCCC good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer treated with orchidectomy (and or retroperitoneal surgery) plus cisplatin based chemotherapy, 12 - 18 months or 5 - 7 years previously.
* Aged between 18 and 50 years inclusive, at time of enrolment

Exclusion Criteria:

* Unable to provide written, informed consent
* Unable or unwilling to attend for investigations
* Current active involvement in a clinical trial
* Those receiving drug treatment for any vascular disease:

  o Including hypertension, hyperlipidaemia, cerebrovascular disease, ischaemic heart disease or heart failure
* Asthma
* Chronic obstructive pulmonary disease
* Diabetes mellitus
* Arial fibrillation/flutter
* Oral anticoagulation therapy
* Cigarette smoker or tobacco use
* Recreational drug use
* Ongoing inflammatory, infective or autoimmune disease
* Other malignant disease diagnosed in previous 7 years
* Previous venous or arterial thrombotic/thromboembolic event
A Clinical Study With the Medical Device PowerSpiral for Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

The objective of the SAMISEN study phase B is to assess the performance and safety of diagnostic and therapeutic procedures with the Olympus Motorized Spiral Enteroscope (PowerSpiral) in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

The main objective of this registry is to collect data on the safety and performance of the motorized PowerSpiral device during Post-market Clinical Follow-up in subjects with surgically altered gastrointestinal anatomy indicated for an Endoscopic Retrograde Cholangio-Pancreatography (ERCP). It is assumed that this motorized PowerSpiral device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes.

As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the motorized PowerSpiral device.

Eligibility Criteria:
Inclusion criteria

1. Signed informed consent
2. Patients with surgically altered upper Gastrointestinal anatomy (Roux-en-Y and Billroth II types) with a biliary indication for ERCP where access with conventional ERCP devices is of no avail and after careful risk assessment.

Exclusion criteria In addition to be eligible for study enrollment a subject must not meet any of the exclusion criteria listed below.

1. Age under 18 years
2. Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period
3. Any contraindication to standard enteroscopy or ERCP (e.g. severe coagulopathy or known coagulation disorder; bowel obstruction / stenosis, stents or other instruments implanted in the intestinal tract, suspected GI perforation, esophageal or gastric varices, eosinophilic esophagitis) as judged by the investigator after careful individual risk assessment
4. Concurrent participation in another competing clinical study
5. Pancreatic indication for ERCP in patient with surgically altered anatomy
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-80 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 4 weeks in duration

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
* Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
* Patients who are considered a suicide risk
Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

The primary objective of this study is to compare disease-free survival (DFS) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.

This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 clinical trial. The main purposes of this study are to examine the efficacy and safety of standard adjuvant chemotherapy plus moxifloxacin or placebo as care for patients with operable breast cancer. This study is designed to recruit up to 520 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Have provided written and signed informed consent;
2. Histologically confirmed invasive ductal carcinoma;
3. Planned to received (neo)/adjuvant chemotherapy;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
5. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
6. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
7. Compliance with the study protocol.

Exclusion Criteria:

1. Pregnant or breast feeding;
2. Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
3. Hypersensitivity to moxifloxacin or quinolones compounds;
4. Concomitant with other antitumor therapies or participating in other clinical trials;
5. Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease;
6. Severe uncontrolled co-infection, or severe metabolic disorders;
7. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
8. Poor compliance, unwillingness or inability to follow protocol to continue the study;
9. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
Revival Active Program for Adolescents With Depression

Active play and sports has shown to be effective intervention in managing depression. Extending the support with Mind body therapy, Revival Active Program was designed as an early intervention for adolescents.

To measure the efficacy and feasibility of the community based revival active play intervention for adolescent depression, present pilot study was undertaken.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with depression as per the DSM IV-TR criteria
* Parents willing to give written informed consent

Exclusion Criteria:

* Physical limitation for active sports
* Co-morbid mental health diagnosis
* high risk of self harm/ suicide
* history of self harm or harming someone else
Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.

Eligibility Criteria:
Inclusion Criteria:

* AO/OTA fracture classification 31A
* Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
* Low energy, isolated injury

Exclusion Criteria:

* Intracapsular hip fractures: AO/OTA fracture classification 31B-C
* Polytrauma patients
* Creatinine clearance less than 30 mL/min
* History of unprovoked VTE and/or recurrent VTE
* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
* Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
* History of CVA, MI, or VTE within the previous 30 days
* Coronary stent placement within the previous 6 months
* Disseminated intravascular coagulation
* Intracranial hemorrhage
Mutation p.Ile112Thr : Discrepancy Between Factor IX Level and Bleeding Phenotype

It appears that the mutation p.Ile112Thr in the factor IX gene confers a discrepancy between mild factor IX level and severe bleeding phenotype. Databases and litterature analysis are poor on this matter. The goal of this study is to compile bleeding phenotype in patients with this specific mutation to prove the clinico-biological discordance in order to improve patient care and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* hemophilia B with p.Ile112Thr mutation on factor IX gene

Exclusion Criteria: None
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
* No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
* Body mass index (BMI) of 18 to 35 kg/m\^2, inclusive. BMI=weight (kg)/height (m)\^2
* Males and females, 18 - 70 years of age

Key Exclusion Criteria:

* Liver transplant recipients
* Documented or suspected hepatocellular carcinoma
* Evidence of decompensated cirrhosis
* History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
* Current or known history of cancer
* Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
* Inability to tolerate oral medication
* Poor venous access
* Severe psychiatric disease
* History of chronic pulmonary disease
* History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
* History of or current electrocardiogram findings indicative of cardiovascular instability
* Preexisting ophthalmologic disorders considered clinically significant on eye
* History of uncontrolled diabetes mellitus
* Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
* Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
* Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
* Exposure to any investigational drug or placebo
Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 21 to 65 years.
2. Symptoms of at least 6 months duration.
3. Primarily axial low back pain.
4. At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
5. Patients with overall pain scores of greater than 6/10 (NRS).
6. Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.

Exclusion Criteria:

1. History of previous spine surgery.
2. MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.
3. Clinical or radiological evidence of significant:

   1. Disc herniation
   2. Spinal Stenosis
   3. Spinal Deformity
   4. Spondylolisthesis
   5. Spinal instability or pars-defect
   6. Facet Syndrome
   7. Sacroiliac Joint Dysfunction
   8. Myofascial Pain Syndrome
   9. Fibromyalgia
4. Current issues of:

   1. Litigation
   2. Disability
   3. Drug addiction or substance abuse
   4. Chronic pain medication abuse
5. Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.
Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections

IQP-AS-105, is a food supplement derived from garlic (Allium sativum). The objective of this study is to evaluate the possibilities of clinical use of IQP-AS-105 as a preventive medicine, based on its ability to enhance the immune system responses


Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* increased risk for infections - at least 4 cold episodes within 12 months
* commitment to adhere to their accustomed diet and physical activity
* women of child-bearing potential have to agree to use appropriate birth control methods
* written consent of the subject to participate is a prerequisite for study participation

Exclusion Criteria:

* acute / chronic upper airways disease
* chronic cough of any origin
* acute / chronic lower airways disease
* any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
* history of nasal reconstructive surgery
* presence of nasal ulcers or nasal polyps
* severe nasal septum deviation or other condition that could cause nasal obstruction
* congenital or acquired immunodeficiency disease (e.g. HIV infection)
* severe organ or systemic diseases
* body temperature above 37.5°C
* suspected swine flu or influenza
* vaccination against influenza or swine flu within 3 months prior to study start
* stomach/gastrointestinal diseases
* sleep disorder
* psychiatric disorders
* known sensitivity to the ingredients of the investigational product
* intake of products that may influence the study outcome within the last 14 days prior to study start and during the study
* analgesics , antibiotics or decongestant nose drops/spray, unless they are used as rescue medications
* pregnancy or nursing
* alcohol / drug abuse
* simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
* insufficient compliance
The Value of Second-trimester Uterine Artery Doppler Analysis in the Prediction of GDM in a Low- Risk Population

In the current literature, there are not enough studies related to the use of uterine artery Doppler indices in the second trimester for the prediction of GDM. Considering that it may be useful in the prediction of GDM in low-risk patient groups for GDM, it was found useful to consider uterine artery Doppler analysis within the scope of this study.In this study, the investigators aimed to assess the value of second-trimester uterine artery Doppler analysis in the prediction of GDM in a low- risk population.

This retrospective research was conducted between June 2020 and December 2021 at the Perinatology Clinic of Haseki Training and Research Hospital. Maternal age between 18 and 42 years and gestational age between 18 and 23 weeks were the inclusion criteria.Pregnant women's computerized records were used to compare the relevant data of women diagnosed with gestational diabetes and women with normal glucose tolerance . Transabdominal ultrasonography was performed for anatomical scanning, and the uterine artery Doppler was obtained using ultrasonographic devices with a 2.0-7.0 megahertz convex probe. The uterine artery waveforms were obtained using pulsed-wave Doppler with an insonation angle of 30° and a peak systolic velocity greater than 60 cm/s. Three identical waveforms were obtained consecutively on each side. In addition to recording the presence or absence of notching, the mean uterine artery pulsatility index (UAPI) was also obtained. Abnormal uterine artery Doppler was defined as a mean UAPI greater than the 95th percentile for each gestation.Increased uterine artery pulsatility index and/or diastolic notch in the uterine artery between 18-23 weeks of pregnancy can predict the risk of GDM in pregnant women.

Eligibility Criteria:
Inclusion Criteria:

• Pregnant women with or without Gestational Diabetes in low- risk population

Exclusion Criteria:

* Pregestational Diabetes
* Preeclampsia
* Intrauterine growth restriction
* Chronic Maternal Disease
Preoperative Diet Before Sleeve Gastrectomy

Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria:

* gastroesophageal reflux
* patients with uncontrolled psychiatric disorders
* active infections or malignancies
* other concomitant pathology considered as a contraindication for bariatric surgery
Evaluation of Sarcopenia in Patients With Stroke

The aim of this study is to investigate the prevalence of sarcopenia in stroke patients; to determine the relationship between sarcopenia and duration of stroke, age, gender, etiology of stroke, ambulation status, spasticity, nutrition and malnutrition

Sarcopenia was defined as a loss of skeletal muscle mass and decreased muscle strength. The purpose of this study was to investigate the prevalence of sarcopenia following stroke, to investigate the relationship between sarcopenia and duration of stroke, age, sex, etiology of stroke, ambulation status, spasticity, nutrition and malnutrition. Demographic characteristics, duration of stroke, sarcopenia presence (walking speed ≥ 0.8 m / s, SARC-F score ≥4, short physical performance battery score ≤ 8, thigh circumference \<33cm (The data for Turkey) \<31cm (European data)) were recorded. Hand grip strength (jamar) measured from the intact hand and TANITA BIA analysis were planned for all patients.

Ambulation level with Functional Ambulation Classification (FAC), nutritional status with 24-hour dietary recall (24HR) method, diagnosis of malnutrition with Glim Criteria, spasticity with Modified Ashworth Scale, motor development for stroke patient Brunnstrom staging, screening for frailty with Frail questionnaire activity of daily living were evaluated with Barthel Index.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic stroke (Stroke duration \> 3 months)
* Patients with a FAC score \> 3

Exclusion Criteria:

* Patients unable to cooperate
* Other diseases that cause gait disorders such as neuromuscular disease, cardiopulmonary problems.
Dutasteride for the Reduction of Alcohol Use in Male Drinkers

The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.


Eligibility Criteria:
Inclusion Criteria:

* Male outpatients age 18 to 65 years
* Have an average weekly ethanol consumption of \>24 standard drinks
* Be able to read English at the 8th grade or higher level and show no evidence of significant cognitive impairment
* Be willing to nominate an individual who will know the patient's whereabouts in order to facilitate follow up during the study
* Be willing to provide signed, informed consent to participate in the study (including a willingness to reduce drinking to non-hazardous levels)

Exclusion Criteria:

* Have a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation
* Have a serious psychiatric illness (e.g., schizophrenia, bipolar disorder, severe or psychotic major depression, organic mood or mental disorders, current eating disorder symptoms, or substantial suicide or violence risk) on the basis of history or psychiatric examination
* Have a current diagnosis of drug dependence (other than nicotine or alcohol dependence)
* Have a current diagnosis of alcohol dependence who on clinical examination by a physician, are deemed to be too severely alcohol dependent to permit them to participate in a placebo-controlled pilot study
* Have a history of hypersensitivity to dutasteride
* Current or past 4 month use of finasteride (Propecia), dutasteride (Avodart) or testosterone
* Are currently taking psychotropics other than a single antidepressant with stable dose for at least 4 weeks or a non-benzodiazepine sleep medication
* Are considered by the investigators to be an unsuitable candidate for receipt of an investigational drug