cyrilzakka/clinical-trials huggingface dataset:
Brain Injury Biomarkers in the General Population

The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age and no more than 80 years of age
* Willing to undergo consent
* PI believes volunteer is appropriate candidate for study

Exclusion Criteria:

* Participating in another clinical study that may affect the results of either study
* Non-English speaking
* Venipuncture not feasible
* Blood donation within 1 week of screening
* PI determines volunteer is not medically suitable for study participation
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.

Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.

Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.

Eligibility Criteria:
Inclusion Criteria:

* Have selected Sonata for treatment of fibroids in the presence of heavy menstrual bleeding
* Presence of at least one submucous myoma (type 1, type 2) or transmural fibroid (type 2-5)
* Willing and able to read, understand, and sign the informed consent form and to adhere to all study follow-up requirements

Exclusion Criteria:

* Preexisting adhesions within the endometrial cavity as indicated by an ESH score ≥ I as determined by the investigator
* One or more Type 0 fibroids and/or endometrial polyps of any size
* Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in this study
INTER-PATHOLOGIST READER STUDY

This is a post study histology analysis from previously obtained pathology slides.

This is a post study histology analysis. Pathologists will use digital histology slide scans of suspicious nevus/nevi obtained from previously conducted studies to provide histopathology gradations of histological features as outlined in the Orlucent histology atlas (LBL0713 Histopathology Atlas for Grading of Dysplastic Nevi and DEF0713-1 Histopathology Definitions for LBL0713).

Eligibility Criteria:
Inclusion Criteria:

1. Histology scans must have been obtained from previous consented subjects that allows post study ad hoc analyses.
2. Histology scans must be available from the data collected from the Orlucent OMS002, SFI001 or SFI003 Studies and are of good quality.

Exclusion Criteria:

* NA
Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection

This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.

This study is designed to demonstrate the safety and efficacy of using protective device/drug to prevent renal injury during renal artery stenting (RAS) and to assess whether the preventative effects are measurable, and if there is a differential treatment effect for either device alone or in combination.

Specific goals of the study include:

* To establish device and drug safety
* To identify appropriate markers for renal injury
* To measure effectiveness of drug and device
* To enable the design of FDA efficacy trials for renal artery stenting inclusive of device and or drug

The study will address the four following hypotheses:

* AngioGuard™ distal protection device provides significant protection from atheroembolization during RAS procedures as measured by affected kidney GFR at 1 month after the procedure.
* Abciximab (ReoPro) offers protection against platelet aggregation and embolization as measured by affected kidney GFR at 1 month after the procedure.
* AngioGuard™ and Abciximab are safe, alone and in combination.
* Is there an interaction effect between AngioGuard™ and ReoPro for efficacy and safety?

Eligibility Criteria:
Inclusion Criteria:

Any one or more of the following:

Meet Angiographic criteria plus

* Systemic hypertension at baseline, or a history of hypertension
* Congestive heart failure at baseline, or a history of CHF
* Renal insufficiency at baseline, or a history of renal insufficiency
* Angina, or a history of angina

Exclusion Criteria:

* Less than 18 years old
* Contraindications to device/drug
Chronic Neck Pain and Kinesiophobia

In this study, the primary aim was to examine the relationship between kinesiophobia and clinical outcomes in individuals with chronic neck pain. The secondary aim was to compare the level of neck disability, pain, endurance, functionality, muscle and grip strength, and quality of life in individuals with chronic neck pain who had and did not have kinesiophobia; and to determine the determinants of kinesiophobia in patients with chronic neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain complaints that have been ongoing for at least 3 months
* Between the ages of 18-65
* Complaints of numbness and tingling
* Volunteer who can cooperate during communication

Exclusion Criteria:

* History of spinal trauma or surgery
* Neurological, rheumatological, systemic or musculoskeletal problems that affect movement
* Serious comorbidities (such as advanced renal failure, previous history of CVA, malignancy)
* Muscle weakness
Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer

This is an open, single-arm, phase I clinical trial to evaluate safety and efficacy and of 6b11-OCIK injection in the treatment of recurrent drug-resistant ovarian cancer

This is a phase I clinical trial of cytotoxic T cell injection induced by dendritic cells loaded with 6B11 anti-idiotype minibody (6b11-OCIK injection) for recurrent drug-resistant ovarian cancer. Main purpose of this research is to determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer. Moreover, secondary purpose is to evaluate the effect of 6B11-OCIK injection on the immune system of patients, the efficacy of autologous 6B11-OCIK injection in the treatment of patients with ovarian cancer obtain and the correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. Thirdly, exploratory purpose is to evaluate the effect of 6B11-OCIK injection on laboratory examination.

Eligibility Criteria:
Inclusion criteria:

1. 18-70 years old patients.
2. Diagnosed as Ovarian Cancer, who had relapsed after initial treatment; Relapse after drug resistance: clinical remission after early chemotherapy, but progression or relapse within 6 months after chemotherapy,or achieve no response after early chemotherapy.
3. Administered with Doxorubicin.

Exclusion criteria:

1. Symptomatic and uncontrolled Brain metastasis or pia meningeal metastasis; Patients with spinal cord compression; Symptoms related to central nervous system lesions or symptoms indicating disease progression;
2. Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks.
3. Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia;
4. Women with positive serum pregnancy test or lactation;
Nifedipine Treatment in Preterm Labor

This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.

Preterm labor is defined as the presence of uterine contractions of sufficient frequency and intensity to effect progressive effacement and dilation of the cervix prior to term gestation (between 20 and 37 weeks).

It is a major health problem of increased incidence, affecting approximately between 7-10% of pregnant women in developed countries with a high socioeconomic costs and high rates of fetal mortality, although perinatal progress.

This study may allow to establish the existence of differences in perinatal outcomes and to define the first choice drug for tocolysis.

Eligibility Criteria:
Inclusion Criteria:

The study population and the inclusion criteria is established by patients between the 24th and 33+6th weeks of pregnancy, fixed by an ecography during the first three-month period, and with a threat of preterm labor (TLP), by the American College of Obstetricians and Gynecologists (ACOG's) criteria:

* Four contractions or more with a duration of at least 30 seconds during 30 minutes
* Documented cervix changes:

  * The cervix changes in a nulliparous woman are: both cervix tact with 0 to 4 cm of dilatation and cervical effacement of at least a 50% (vaginal ultrasound alternative with cervix length two standard curvatures under the average for the gestational age)
  * The cervix changes in a multiparous woman are: 1 to 4 cm of dilatation and cervical effacement of at least a 50% (same ecographic alternative as the nulliparous).
* Patient who had signed the informed consent.

Exclusion Criteria:

Exclusion criteria of the pregnant mother and intrauterine fetal:

* Prior treatment with a different tocolytic from the ones in the protocol.
* Chorioamnionitis.
* Premature rupture of membranes.
* Vaginal Bleeding.
* Major fetal malformations.
* Intrauterine growth retardation (IGR): IGR\<percentile 5.
* Cardiopathies (aortic stenosis, congestive heart failure).
* Blood Pressure lower than 100/60 mmHg.
* High transaminase levels.
* Uterine malformations.
* Use of magnesium sulphate.
* Severe hypertensive disorder, defined as blood pressure equal to or greater than 160/100 mmHg or any figure associated with severe preeclampsia.
* Non-reassuring cardiac frequency tracing defined as category II and III of National Institute of Child Health and Human Development (NICHD).
* Asthmatic patients treated with betamimetics.
* Hypertensive patients treated with vasodilators.
* Patient in treatment or treated with another product/s in investigation during the four weeks prior to randomization.
* Hypersensitivity to any drug of the study.
Neuropsychological Profiles and Musical Engagement in Parkinson's and Alzheimer's Disease

The goal of this Multicenter observational pilot study is to Compare the specifics of musical engagement (behaviors related to music in everyday life) in subjects aged over 60 with Alzheimer s disease, Parkinson s disease and control subjects.

The main questions it aims to answer are:

1. The description of different profiles of musical engagement in early-stage AD, in PD and in healthy elderly subjects.
2. The extent of executive, mnestic and hedonic dysfunctions will impact differently on emotional engagement, autobiographical evocation and sensitivity to musical reward, and will therefore enable distinct profiles to be drawn up.

Participants will have an intervention consisting of an interview with a neuropsychologist lasting approximately 2 hours, including :

* A semi-structured interview to check the participants eligibility and gather demographic data.
* Neuropsychological tests and questionnaires will then be administered.
* A relative of the study participant will help complete questionnaires.

Music therapy appears to be highly relevant as a Non-Medication Intervention in Alzheimer s (AD) and Parkinson s disease (PD). It is said to reduce depressive symptoms following music therapy sessions in dementia . With regard to Parkinson s disease, music therapy brings benefits in terms of motor skills, communication, breathing and emotional aspects. Reviews point to the need to differentiate beneficial effects according to different pathologies.

To date, no study has investigated the evolution of sensitivity to musical reward in AD. Furthermore, no study has discriminated the evolution of musical engagement in several neurodegenerative pathologies.

Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria:

* 60 years and older
* French-speaking and volunteering for the study
* Living at home with a relative

Alzheimer's disease inclusion criteria:

* Biological diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria (McKhann et al., 1984)
* MMSE greater than or equal to 20

Inclusion criteria Parkinson's disease :

* Diagnosis of Idiopathic Parkinson's disease
* MMSE greater than or equal to 20

Exclusion Criteria:

* No known neurological pathologies (epilepsy and other non-degenerative CNS diseases) or psychiatric disorders (chronic psychosis and psychotic episodes)
* Autistic disorders
* History of stroke or head trauma
* Unstable medical condition (cancer)
* Subject unable to read and/or write
* Hearing impairment without hearing aids
* Refusal of consent after information
* Persons unable to give consent, research carried out in emergency situations, etc.)
* Non-affiliation with a social security scheme
* Person deprived of liberty (by judicial or administrative decision, or forced hospitalization)
* Person under legal protection (guardianship, curatorship, legal protection)
* Person participating in another research project with an exclusion period still in progress
Bioequivalence Study of Xian Risperdal Tablets Compared With Gurabo Risperdal Tablets Under Fasting and Fed Conditions in Chinese Healthy Participants

The primary purpose of this study is to assess the bioequivalence of Xian Risperdal compared with Gurabo Risperdal in Chinese healthy participants under fasting and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study and adhere to the prohibitions and restrictions specified in this protocol
* If a woman, must have a negative serum pregnancy test at screening and on Day -1 of each treatment period
* If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 2 months after receiving the last dose of study drug
* Body mass index (BMI), weight (kilogram \[kg\])/height\^2 (meter \[m\]\^2) between 19.0 and 28.0 kg/m\^2, inclusive; body weight not less than 50 kg
* After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive; diastolic blood pressure between 60 and 90 mmHg, inclusive; heart rate between 50 and 100 beats per minute (bpm), inclusive

Exclusion Criteria:

* Presence of orthostatic hypertension at screening, defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg compared to supine position when the participant assumes a standing position
* Positive test for drug screening, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines, hallucinogens or barbiturates on Day -1 of each treatment period
* Drug abusers or use of soft drugs (example \[eg\], cannabis) within 3 months prior to the study or hard drugs (eg cocaine, benzene cyclohexylidene, etc.) within 1 year prior to the study
* Received an experimental drug or used an experimental medical device within 3 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled
* Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C antibodies or syphilis serum test
Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
Recovery of Impairments Early After Stroke

Upper limb recovery after stroke is highly predictable early after stroke. Nijland et al. showed that based on two simple clinical bedside tests - 'Shoulder Abduction' and 'Finger Extension' (the so called 'SAFE model' \[Stinear et al., 2012\]) - measured within the first 72 hours after stroke, \~87% of the patients could be correctly classified as either regaining or not regaining some dexterity (recoverers or nonrecoverers, respectively) (Nijland et al., 2010). This kind of information regarding the patients' functional prognosis allows proper discharge planning, setting realistic rehabilitation goals, and adequate patient information. However, the length of hospital stay after stroke has been decreasing. Therefore, knowledge is needed regarding the ability to make an accurate first prediction within the first 24 hours after stroke onset while using simple clinical bedside assessments. This would facilitate an earlier triage and with that, an accelerated and smooth transition of patients within the stroke care continuum. In addition, a first prediction within 24 hours poststroke has the potential to decrease health care expenses, as length of hospital stay after an acute stroke is \~30% of the total costs (i.e., direct and indirect costs) associated with stroke (Roger et al., 2012; Fattore et al., 2012).

The primary objective of aRISE is to determine the ability of the behavioral biometric impairments 'Shoulder Abduction' and 'Finger Extension' measured \<24 hours poststroke to predict outcome of upper limb capacity 3 months after stroke. The secondary aim is to investigate the the added value of other simple clinical bedside tests for predicting outcome of upper limb capacity 3 months poststroke.

aRISE is a prospective longitudinal observational cohort study of 40 first-ever ischemic stroke patients, who will be assessed \<24 hours, 7 days and 3 months after stroke onset.


Eligibility Criteria:
Inclusion Criteria:

* First-ever unilateral ischemic stroke in the middle cerebral artery territory \<48 hours, confirmed by MRI-DWI and/or CT
* Age 18 years or older
* Able to follow one-staged commands
* NIHSS arm score ≥1
* Informed consent after participants' information

Exclusion Criteria:

* Modified Rankin Scale score \>2 before stroke
* Neurological or other diseases affecting the upper limb(s) before stroke
* Intravenous line in the upper limb(s) which limits assessment
* Contra-indications on ethical grounds
* Expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse
The Interaction Between Metformin and Microbiota - the MEMO Study.

Metformin has been used in Sweden since 1957, and it is recommended as first line therapy for type 2-diabetes (T2D) in national and international guidelines. However, adverse effects involving diarrhea, constipation, bloating, and abdominal pain are common which leads to discontinuation of medication or not being able to reach therapeutic doses. Here the investigators will perform a prospective study to investigate whether i) participants with T2D who experience adverse events following metformin treatment have an altered microbiota at baseline compared to participants without adverse events and ii) if the microbiota is altered in participants during onset of adverse events. The investigators hypothesis is that adverse effects associated with metformin are caused by an altered gut microbiota, either at base line or following metformin treatment. The study design is a nested case-cohort study. The investigators will recruit 600 patients and expect 200 individuals to have side effects and 400 without during a 24-month study period. Fecal samples will be collected at baseline, 2 months, and 4 months or when gastrointestinal symptoms occur. All fecal samples will be sequenced by 16s rRNA (ribosomal ribonucleic acid) sequencing to obtain a baseline microbiota profile; a subpopulation consisting of homogenous groups of participants will be in depth-analyzed using shotgun sequencing. If the hypothesis is confirmed this project may lead to bacterial therapies that will allow more patients tolerate metformin.


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes (diagnosis set within the last 12 months)
* planned metformin treatment
* Age: 40 - 80 years
* Have provided written informed consent.

Exclusion criteria:

* already started treatment with Metformin
* intestinal disease incl. irritable bowel syndrome
* treatment with antibiotics in the last 3 months
* Inflammatory disorder t.ex. rheumatoid arthritis
* anemia, haemoglobinopathy
* alcohol or drug abuse
* cancer disease under treatment
Oral Contraceptives in Reproductive Age Women

Contraception is an important issue in public health; especially when maternal risks and morbidities are considered. There is a need for consciousness about the contraceptive choices. The reproductive age women in Turkey may be stubborn or may choose to believe heath information. The oral contraceptive drugs are not used because of wrong beliefs. This survey study aims to investigate the consciousness and knowledge about the oral contraceptives in 3 different areas in Turkey.

In this study; surveys will be given to reproductive age women admitting to the obstetrics and gynecology departments in 3 different cities of Turkey. Survey questions start with the education and socioeconomical status of the participants. Mainly the questions include the knowledge, ever use about oral contraceptives.

Eligibility Criteria:
Inclusion Criteria: The women admitting to the clinics -

Exclusion Criteria:

-
Effects of Allergen Inhalation on Adenosine Receptor Expression in Sputum and Peripheral Blood

The purpose of this study is to determine whether asthmatics have different adenosine receptor expression profiles than healthy controls. We hypothesize that asthmatics will have increased adenosine receptor expression versus control subjects.

We also want to study the effects of allergen inhalation on adenosine receptor expression in asthmatics. We believe that adenosine receptor expression will be upregulated after allergen inhalation.

Both hypotheses are being tested in sputum and peripheral blood.


Eligibility Criteria:
Asthmatic Subjects - Inclusion Criteria:

* Clinical diagnosis of asthma
* Steroid naive or subjects not using their inhaled steroids for the last 4 weeks, short-acting beta-agonist for rescue medication
* FEV1 \> 70% of predicted
* Positive skin prick test for house dust mite, cat or grass pollen
* PC20 methacholine or histamine \< 8 mg/ml

Asthmatic Subjects - Exclusion Criteria:

* Use of systemic steroids in the previous 6 weeks
* Asthma exacerbations in the previous 6 weeks
* Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago

Healthy Subjects - Inclusion Criteria:

* No airway complaints
* FEV1 \> 90% of predicted
* Negative skin prick test
* PC20 methacholine or histamine \> 8 mg/ml

Healthy Subjects - Exclusion Criteria:

* Use of steroids in the previous 6 weeks
* Current or ex-smokers with ≥ 10 pack-years (≥ 2 pipe pack-years), ex smokers who stopped less than 1 year ago