cyrilzakka/clinical-trials huggingface dataset:
Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)

The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Small-cell lung cancer.
* Patients who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy.
* Measurable or assessable disease.
* Life expectancy \>2 months.
* Patients with a therapeutic risk level of \<5 points (see section 6: "Treatment flowchart").
* Age \>18 years;
* Performance status (WHO) \<2;
* One measurable target lesion in a non irradiated region;
* Prior radiotherapy authorized unless it targeted the only measurable lesion;
* Biological criteria: WBC \>2000/mm3, PMN \>1500/mm3, platelets \>100 000/mm3, creatinemia \<2 x ULN, bilirubinemia \<ULN, ALT and AST \<2.5 x ULN (\< 5 N if liver metastases)
* normal ECG
* written informed consent.

Exclusion Criteria:

* Non small-cell lung cancer.
* No objective response to platinum-based therapy
* Complete response lasting more than three months after the last course of first-line treatment.
* Symptomatic brain metastases.
* Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable disease manifestations.- Concurrent participation in another clinical trial.
* Therapeutic risk level of 6 points or more (see table)
* Uncontrolled clotting disorders;
* Uncontrolled severe infection;
* History of another malignancy, except for cervical carcinoma in situ or basocellular cancer that are considered cured;
* Psychological, familial, sociological or geographic circumstances preventing treatment follow-up as defined in the protocol;
* Patients deprived of their rights for administrative or legal reasons.
Evoked Retinal Response

Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect the retina (the light-sensitive part of the eye). RP causes the breakdown of photoreceptor cells (cells in the retina that detect light). Photoreceptor cells capture and process light helping us to see. As these cells breakdown and die, people experience progressive vision loss. There is no known cure for retinitis pigmentosa. The investigators have observed that short pulses of focused ultrasound can cause perception of light when directed to spots on the retinal surface. The investigators propose to conduct a study to determine if pulsed ultrasound will stimulate the perception of light in the absence of functional photoreceptors in people with RP

Patients affected by retinitis pigmentosa (RP) and related diseases suffer loss of vision due to death of photoreceptor cells. The investigators have observed that short pulses of focused ultrasound can cause perception of light (phosphenes) when directed to spots on the retinal surface. If this phenomenon is caused by direct stimulation of the retinal nerves, which seems probable, then it might be possible to use this phenomenon to produce a form of vision in such patients. The investigators propose to conduct a study of a small cohort of patients affected by RP to determine if pulsed ultrasound will evoke a perception of light in the absence of functional photoreceptors.

Eligibility Criteria:
Inclusion Criteria:

* retinitis pigmentosa
* legally blind in at least one eye

Exclusion Criteria:

* unable to lay down on an exam table
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults, 18 through 70 years of age, inclusive
* Diagnosis of Major Depressive Disorder according to DSM-IV criteria
* HAM-D17 total score \> or = 22 at Screening and Baseline

Exclusion Criteria:

* History of non-response to paroxetine
* Patients who have been previously treated with agomelatine
* History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
* Any current Axis I disorder other than major depressive disorder which is the focus of treatment
* Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
* Use of any psychoactive medication after the screening visit
* Female patients of childbearing potential who are not using effective contraception

Other protocol-defined inclusion/exclusion criteria may apply
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan

The purpose of this study is to evaluate the diagnostic performance of \[68Ga\]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in patients with neuroendocrine neoplasms (NENs) and healthy volunteers (HVs). The data from this study will provide the evidence for diagnosis of \[68Ga\]Ga-DOTA-TATE PET/CT imaging in patient with NENs in Japan.

All enrolled participants will undergo \[68Ga\]Ga-DOTA-TATE PET/CT imaging. \[68Ga\]Ga-DOTA-TATE will be administered intravenously at a dose of 2 Mega-Becquerel (MBq) / kilogram (kg) (0.054 Millicurie (mCi)/kilogram (kg)) of body weight up to a maximum total dose of 200 MBq (5.4 mCi), and PET/CT imaging will be acquired 40 to 90 minutes after the intravenous administration of \[68Ga\]Ga-DOTA-TATE.

* Duration of screening period is up to 35 days
* Imaging period will be completed within one day followed by safety follow up visit (Day 8) after imaging day (Day 1)

Eligibility Criteria:
Key Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Participants must be adults \>= 18 years of age
3. ECOG performance status 0-2
4. For patient with NENs only: Participants with confirmed NENs based on histopathology, imaging and other relevant examination, or with suspected NENs which localization cannot be confirmed by CIM
5. For HVs only: Male or female participant in good health condition as determined by no clinically significant findings from medical history, physical examination, vital signs, lab test and ECG
6. Women of childbearing potential must have a negative urine or blood pregnancy test.

Key Exclusion Criteria:

1. Inability to complete the needed investigational and conventional imaging due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation
3. Known allergy, hypersensitivity, or intolerance to \[68Ga\]Ga-DOTA-TATE and \[111In\]In-Pentetreotide
4. Therapeutic use of any somatostatin analogue except for the following washout period

   * Short-acting analogs of somatostatin can be used up to 24 hours before injection of \[68Ga\]Ga-DOTA-TATE.
   * Long-acting analogs of somatostatin can be used up to 28 days before injection of \[68Ga\]Ga-DOTA-TATE.
5. Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of \[68Ga\]Ga-DOTA-TATE
6. Use of other investigational drugs within 30 days before screening
7. Participants who are pregnant.
8. Participants who are lactating.
The Effect Of Heel Protector In Intensive Care Units

Purpose: It was aimed to evaluate the effectiveness of using heel protector products for the prevention of heel pressure sore and plantar flexion contracture in patients hospitalized in intensive care units for a long time.

Design: The study is conducted as a Randomized Controlled Study. Method: Heel protectors will be used in the intervention group among the patients in the intensive care unit who meet the inclusion criteria of the study, and the control group will be positioned with a pillow, which is the standard practice. As calculated in the G-Power program with reference to the source, a total of 42 patients were determined to be included in the intervention group and 42 patients in the control group. These patients will be followed for a total of 14 days. Heel Scalp Evaluation and Goniometric Measurements will be made according to Braden Pressure Wound Risk Assessment Scale, Ramsey Sedation Scale, NPUAP and EPUAP Staging System and recorded in the data collection form created by the researcher.

H1: The heel protector is effective in preventing heel pressure ulcer. H0: The heel protector has no effect on preventing heel pressure ulcer. H2: The heel protector is effective in preventing plantar flexion contracture. H0: The heel protector has no effect on preventing plantar flexion contracture. H3: The heel protector is effective in improving the joint range of patients with plantar flexion contracture.

H0: The heel protector has no effect on improving joint range in patients with plantar flexion contracture.


Eligibility Criteria:
Inclusion Criteria:

* High-risk patients; patients who were intubated or extubated in the ICU for at least 5 days and received sedation
* Patients with Braden Pressure Sore Risk Assessment Scale 16 and below
* Patients with a Ramsey Sedation Scale of 4 and above

Exclusion Criteria:

* BMI over 30
* Patients with vascular disease
* Patients with albumin level below 2.5 mg/dL
* Patients mobile within 5 days
* Patients hospitalized with heel pressure ulcer
* Despite being included in the study, the patient becomes mobile before 15 days
* Patients with a medical condition that contraindicates the use of heel protectors
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm

Comparison of the consumption of blood and coagulation products (packed red blood cells, fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates, coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics) before and after the introduction of a designated trauma related transfusion and coagulation algorithm.The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Two level-1 trauma centers in Switzerland (Hospital Lucerne, University Hospital Zurich) are included in the study. Predicted probability of a massive transfusion by the trauma associated acute hemorrhage score (TASH)is correlated with the actual rate.

Trauma is one of the leading causes of death worldwide. After death due to direct craniofacial injury, exsanguination is the next major cause for trauma mortality.

After initial pre-hospital treatment the patient is admitted to the hospital. If multiple injuries are present the patient is transferred to a specialized trauma center.

Besides surgical treatment, the patient needs stabilization of the vital functions by the Anesthesiologist. Due to loss of blood volume, dilution of the circulatory blood volume and pathological activation of coagulation/fibrinolysis, trauma induced coagulopathy (TIC) is initiated. This needs to be treated and avoided whenever possible.

Transfusion of allogeneic blood and coagulation product itself leads to an increased morbidity and mortality. Infectious and immunologic reactions account for that phenomenon.

This led to a paradigm change in the therapy of TIC. In 2009 a new coagulation factor based coagulation algorithm was introduced in the Hospital Lucerne and the University Hospital in Zurich / Switzerland. With the help of point of care coagulation measurement, tailored coagulation factor based coagulation management and avoidance of allogeneic blood products was initiated.

The investigators now want to analyze the impact of the coagulation algorithm by comparing the periods before and after the introduction of the algorithm.

The consumption of blood and coagulation products (packed red blood cells, fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates, coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics) before and after the introduction of a designated trauma related transfusion and coagulation algorithm will be recorded and compared. The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Predicted probability of a massive transfusion by the TASH score (trauma associated acute hemorrhage) is correlated with the actual rate.

Eligibility Criteria:
Inclusion Criteria:

* male and female trauma patients
* admitted to the University hospital of Zurich or the Hospital of Lucerne, Switzerland
* injury severity score \>= 16
* time period 2005-2007 and 2012-2014

Exclusion Criteria:

* incomplete data
* denial of informed consent
Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

To evaluate the influence of circadian rhythm on progesterone levels during follicular phase of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.

The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle. Sample size calculations show that the study needs to recruit 10 women to show any significant differences in progesterone secreted in the morning at 8 am compared to that secreted in the evening at 8 pm. We have increased the number of participants to 12 in order to compensate for any possible drop outs. The hormones FSH, LH, Progesterone and Estradiol will be measured at days 2/3, 8, 10 and 12 of a normal and stimulated cycle so that each patient serves as her own control.

This study will provide the basis to establish the optimal blood sampling time for progesterone measurement and to more accurately determine the cut-off level for progesterone for favourable pregnancy outcomes in ART.

Eligibility Criteria:
Inclusion Criteria:

* Indication for IVF / ICSI - treatment
* Age ≥ 18 years and ≤ 35 years
* Ovarian reserve parameters in the adequate age - range, determined by Anti-Mullerian-Hormone (AMH) and Antral Follicle Count (AFC)(16)
* Able to understand the aim of the study and to provide consent
* Regular cycle (25-35 days)

Exclusion Criteria:

* Diagnosis of polycystic ovarian syndrome (PCOS) Rotterdam criteria
* Endometriosis stage 3 or 4 AFS
* Treatment with GnRH-analogues during the previous 6 months
* Intake of oral contraceptive pill (OCP) or any hormonal treatment during the last 3 months
miRNA in Fetal Overgrowth

The purpose of this study is to determine whether placental and umbilical cord blood miRNA expression is altered in women with obesity with macrosomic neonates to when compared to miRNA expression from control patients.

MicroRNA's are a class of non-coding RNA's that function as translational repressors and are thought to modulate tissue development, proliferation, differentiation and function. Differential expression of certain placental miRNA's has been associated with preeclampsia.

The fetal origins of adult disease hypothesis suggests that risk factors from intrauterine environmental exposures affect the fetus' development during sensitive periods, and increases the risk of specific diseases in adult life. Our aim is to understand factors that predispose fetuses to fetal overgrowth in utero, especially in women with obesity. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* prenatal care \& delivery at the Hospital of the University of Pennsylvania system
* Normal glucose tolerance test results (less than 120 mg/dl)

Exclusion Criteria:

* Multiple gestation
* under 18 years old, or over 45 years old
* chronic hypertension
* preeclampsia
* chronic steroid use
* diabetes
* major fetal anomaly
* connective tissue disorder requiring medication
* active HIV
* Hepatitis C
Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD).


Eligibility Criteria:
Inclusion Criteria:

* Male and female, 18 - 70 Years of age
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)
* Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control
* Patients with a history of meeting DSM-IV-TR criteria for:

  * any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode;
  * any depressive episode with psychotic or catatonic features;
  * panic disorder with or without agoraphobia;
  * obsessive-compulsive disorder;
  * Schizophrenia, schizoaffective, or other psychotic disorder;
  * bulimia or anorexia nervosa;
  * presence of borderline personality disorder or antisocial personality disorder;
  * mental retardation, dementia, amnesia, or other cognitive disorders
* Patients who are considered a suicide risk
ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

Endometriosis is a chronic disease characterized by the presence of functional endometrial glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial tissue responds to estradiol and other hormones similarly to the normal endometrium. Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of women in the reproductive age may be affected. In addition to pain which may be severe, subfertility is one of the typical problems associated with endometriosis and may be present in up to 40% of those affected. There is lack of a clear correlation between severity of pain and degree of compromised fertility. Different modes of treatment exist. Hormonal treatments are based on the suppression of estrogenic action on endometriosis as well as the endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of time, however, curative treatment frequently involves hysterectomy with bilateral oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of novel pharmacological agents would be of crucial importance. Presently, endometriosis can be reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is presently impossible to predict, new markers for the "malignancy" of each case are desperately needed.

The aim of the investigators research is to identify expression of endometriosis specific RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium of patients with careful clinical and surgical classification of endometriosis as well as healthy control women should initially enable to identify novel targets for new therapies and biomarkers. Particularly the different pain symptoms will be recorded annually and evaluated comprehensively. Furthermore, combined with an adequate 10-year follow up (based on a questionnaire, including fertility, received treatments and different pain symptoms; NRS), the study should enable for example to identify markers for endometriosis associated infertility as well as cases where the disease progresses very rapidly or reoccurs. Different forms of effective treatment may thereafter be designed following the identification of such factors.


Eligibility Criteria:
Inclusion Criteria:

* study group: surgically and pathologically verified endometriosis
* control group: existence of endometriosis ruled out in laparoscopy

Exclusion Criteria:

* no other significant disease or medication for other diseases
* suspicion of malignancy
* pregnancy
* acute infection
* insufficient understanding of Finnish language
* previous hysterectomy and/or bilateral salpingo-oophorectomy
Respiratory Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease

The aim of this clinical trial is to establish the non-inferiority of home-based respiratory rehabilitation compared to respiratory rehabilitation in center in terms of exercise tolerance as evaluated by the 6 minutes Stepper test..

This trial will also 1°) evaluate the Medico-economic aspects of the home-based Respiratory rehabilitation versus respiratory Rehabilitation in center; 2°) analyse the patient preferences between home-based respiratory rehabilitation and respiratory rehabilitation in center and 3°) Compare home-based respiratory rehabilitation vs respiratory rehabilitation in center in terms of dyspnea, quality of life, anxiety and depression.

The purpose of this study is to perform a comparative analysis of the clinical and medico-economic effectiveness of center-based RR versus home-based RR in the departments of Nord and Pas de Calais in France. All COPD patients eligible for RR and willing to participate in the study will be followed.

Patient preferences will be evaluated at inclusion. After presentation of both RR modalities, patients expressing a strong preference for one or other of the terms will be taken care of according to their wishes. Indifferent patients between the two RR modalities will be randomized.

This design is justified in the light of three cases:

* It is impossible to evaluate blind intervention,
* The effectiveness of RR depends on patient preferences,
* Patients' adherence to the protocol is facilitated.

Eligibility Criteria:
Inclusion Criteria:According to HAS recommendations, SPLF, ERS / ATS (3) (18) (19) can be included any patient, over 18 years old, with stage II - III - IV COPD presenting disabling dyspnoea in activities of daily living, and / or in the course of acute exacerbation of COPD (EABPCO), with no other respiratory pathology diagnosed.

Exclusion Criteria:

According to the recommendations, HAS, SPLF, ERS / ATS will not be included any patient having :

* co-morbidities including unstabilized cardiovascular disease,
* significant cognitive disorders: patients with a history of pathologies neurodegenerative with loss of mental faculties (example: Alzheimer)
* psychiatric disorders: patients with impaired judgment and perception
* neurological or orthopedic disorders that do not allow the realization of physical activities

Also, will not be included, the patient (s):

* waiting for lung transplantation,
* pregnant or nursing,
* in an emergency situation
* unable to receive enlightened information,
* unable to participate in the entire study,
* not covered by the social security scheme,
* refusing to sign the consent,