cyrilzakka/clinical-trials huggingface dataset:
Early Identification of Patients Presenting a First Psychotic Episode, Non Answering to First Line Support Strategies

Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.

Recently, radiological markers demonstrated a good capacity to discriminate first episode of psychosis patients, that will show a bad response to treatment. Furthermore, automatic learning methods were recently successfully applied to neurological data, but never for the first episode psychosis patients. These powerful methods are based on multivariate analyses allowing the prediction at an individual stage. The possibility to identify more precisely the population of non-answering patients would allow the adaptation of the support in first attention for these patients, and consequently to perform appropriate cares.

Researchers propose in this project to evaluate predictive factors of non response. It is defined by the lack of symptomatic remission at month 3, for patients presenting a first episode of psychosis. It will be performed on objective markers taken from imagery techniques. The link between evolution of these markers and clinical measures will be studied.

Eligibility Criteria:
Inclusion Criteria:

* men and women aged 18-35 years
* member or beneficiary of a social security scheme,
* for women, appropriate contraception will be mandatory, as well as a negative pregnancy test,
* patients with a diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder according to the DMS V
* having never received anti-psychotic treatment,
* followed in the hospital or outpatient,
* having given their written informed consent,
* that the physical examination revealed no significant clinical abnormalities

Exclusion Criteria:

* Female patients of childbearing period without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical);
* Patients pregnant or nursing;
* Presenting a serious somatic or neurological disease, especially Parkinson's disease, epilepsy, debilitating tardive dyskinesia, cardiovascular disease, severe liver or kidney;
* Featuring against-indication for an MRI; including: metallic foreign body eye or intracranial, pacemaker, heart valve, surgical clips, claustrophobia, large tattoo in the upper part of the body, not compatible with 3T MRI
* Having a history of alcohol or drug abuse in the past year;
* Participating in another clinical trial or being in an exclusion period of the previous protocol;
* Patients likely to exhibit aggressive behavior self according to the judgment of the investigators.
Cognitive Outcome After Two-stage Liver-Operation

Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.


Eligibility Criteria:
Study Group:

Inclusion Criteria:

* Patients undergoing a planned elective in situ split liver operation with following resection after approximately ten days with or without additional elective surgery in the same session at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin
* Patients aged greater than or equal to 18 years
* Patients of both genders
* Offered patient information and written informed consent
* No participation in another clinical trial according to the German Drug Law (AMG) during the trial and one month before inclusion

Exclusion Criteria:

* Lacking willingness to save and hand out pseudonymised data within the clinical study
* Accommodation in an institution due to an official or judicial order
* Staff of Charite University hospital Berlin, Virchow Klinikum
* Illiteracy
* Unability of German language use
* Visual and acoustical impairment
* core on the mini mental state examination (MMSE) at screening of 23 or less
* American Society of Anaesthesiologists (ASA) Classification greater than IV
* Ascertained psychiatric disease
* Intake of psychotropic drugs (including sleeping pills and Benzodiazepine)
* Symptomatic bradycardia
* Symptomatic heart rhythm disorder (arrhythmia)
* Coronary heart disease Canadian Society of Anaesthesiologists criteria (CSC) stadium IV or the presentation of a coronary heart disease that needs intervention

Control Group:

Inclusion criteria:

•Male and female ASA II/III patients, aged ≥ 18 years

Exclusion Criteria:

* Mini-Mental-State-Examination ≤ 23 Points
* Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing
* Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis

This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-week follow-up period.


Eligibility Criteria:
Inclusion criteria

* Ability to comply with the study protocol
* Chronic AD that has been present for at least 3 years before the screening visit
* Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications (medications or treatments applied directly to part of the body) or for whom topical treatments are otherwise medically inadvisable

Exclusion criteria

* Prior treatment with MSTT1041A
* Treatment with any investigational therapy (with the exception of biologics) within 8 weeks or within 5 half-lives whichever is longer, before screening
* Treatment with any cell-depleting agents within 6 months before screening, or until lymphocyte count returns to normal, whichever is longer
* Treatment with other biologics within 3 months or 5 half-lives before screening, whichever is longer
* Comorbid conditions that may interfere with evaluation of investigational medicinal product
* History or evidence of substance abuse that would pose a risk to participant safety, interfere with the conduct of the study, have an impact on the study results, or affect the participant's ability to participate in the study
* History of anaphylaxis, hypersensitivity to a biologic agent, or known hypersensitivity to any component of the MSTT1041A or placebo injection
* Planned surgical intervention during the course of the study
* Pregnant or breastfeeding, or intending to become pregnant during the study
* Participant who is a member of the investigational team or his/her immediate family
Grateful Strides Toward Physical Activity and Well-Being for Black Breast Cancer Survivors

This pilot study will assess the feasibility of a gratitude intervention to promote physical activity, and well-being and positively impact biomarkers of health among older African American breast cancer survivors. The intervention will also include a goal-setting component to promote exercise readiness and examine the cultural phenomena of the Superwoman schema among Black women.

In this pilot feasibility study, the overall aims are:

Aim 1. Assess the feasibility and acceptability of a gratitude journaling intervention using a pilot randomized controlled trial (RCT) design over eight weeks. We hypothesize that among the 28 participants 1) at least 80% of the participants will report the intervention to be acceptable, 2) biomarker collection will be completed in at least 80% of the surveys and the retention rate will be 80% in each group, and 3) physical activity, health markers, gratitude, well-being, and distress will improve over time.

Aim 2. Describe distributions of outcome variables and effect size for the gratitude journaling intervention on dispositional gratitude, spiritual well-being, psychological distress, exercise readiness, mental and health behaviors in African American/Black women (Superwoman Schema), and inflammatory biomarkers from baseline to post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Self-report as AA or Black
* English speaking
* History of BC (Stage I-IV); 3 months to 6 years post-adjuvant chemotherapy
* Participants on hormonal therapies or HER-2 therapy are acceptable

Exclusion Criteria:

* Self-reported regular meditation or gratitude practices (more than once a week for at least a month)
* Meeting the CDC's physical activity guidelines (at least 150 min of moderate-intensity aerobic physical activity or 75 min of vigorous-intensity physical activity, or an equivalent combination each week)
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.

Patients with locally advanced breast cancer and patients with metastatic breast cancer who have not previously received an anthracycline will be treated with docetaxel and epirubicin.

Patients with metastatic breast cancer who have already received anthracyclines will be treated with docetaxel and capecitabine.

All patients will be randomized to receive their treatment either on an every three week schedule, or on a weekly schedule.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of breast cancer
* Inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy
* Age \< 70 years
* ECOG performance status \< 2
* Written informed consent

Exclusion Criteria:

* Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
* Previous treatment with docetaxel
* Symptomatic brain metastases
* Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl
* Creatinine \> 1.25 x the upper normal limits
* GOT and/or GPT \> 1.25 x the upper normal limits in absence of hepatic metastases
* GOT and/or GPT \> 2.5 x the upper normal limits in presence of hepatic metastases
* Bilirubin \> 1.5 x the upper normal limit
* Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
* Inability to provide informed consent
* Inability to comply with follow-up
Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .

This prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the Gynecology Outpatient Clinics of, Benha University Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.

All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000 IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table. Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once on day of hCG injection and group B received no FSH on day of hCG injection. Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained infertility for more than 2 years
* Normal ovulation proved by midluteal serum progesterone level \>5 ng/ml,
* Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
* Normal semen analysis according to the modified World Health Organization (WHO) criteria
* Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.

Exclusion Criteria:

* Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
* Ovarian cysts,
* FSH \>10 mIU/ml.
* Previous intrauterine insemination (IUI )cycles,
* Liver or kidney diseases,
* Hypersensitivity to the used medications.
Skeletal Muscle Index and a Neuromuscular Blocking Agent

With the recent development of image analysis, it has become possible to measure the skeletal muscle index representing the subject's muscle mass from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the skeletal muscle index from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.

Deep neuromuscular blockade improves the condition of surgeon's surgical field during the surgery and reduces the acute postoperative pain. The dosage of neuromuscular blocking agent has been usually administered according to the patient's actual body weight, but even with the same body weight, the ratio of muscle to fat varies from individual to individual, and there are many differences depending on age, gender, and exercise level.

Therefore, if the dose of neuromuscular blocking agent is administered according to actual body weight, additional doses may be required due to insufficient neuromuscular blockade, or excessive doses may occur. However, it was difficult to quantify the muscle mass, with the recent development of image analysis, it has become possible to measure the skeletal muscle index representing the subject's muscle mass from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the skeletal muscle index from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.

Eligibility Criteria:
Inclusion Criteria:

* Those who voluntarily agreed and signed the written consent form before participating in the study
* American Society of Anesthesiologists physical class (ASA class) 1-3
* Patients scheduled for elective colon surgery under general anesthesia
* Patients undergoing abdominal computed tomography for routine preoperative preparation

Exclusion Criteria:

* Pregnant women
* Decreased renal function (GFR\<60mL/min/1.73m2).
* Patients taking drugs that affect deep neuromuscular blockade
* Patients with a history of neuromuscular and muscle disorders
Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer

The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma
2. Patients were diagnosed during 2006-2013
3. HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.

Exclusion Criteria:

* Patients with second primary cancer within 5 years
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
* Subjects who achieved clinical response in Study A3921094 or A3921095
* Women of childbearing potential must test negative for pregnancy prior to study enrollment
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
* Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
Peer Enhanced Prolonged Exposure

The investigators plan to develop and test an intervention using peer specialists (Veterans who have managed PTSD and completed PE) to provide support services for Veterans using prolonged exposure therapy.

The investigators will use qualitative data from Veterans and PE providers to revise the investigators' manualized intervention for peer support services, then complete a feasibility trial to assess the feasibility and acceptability of Peer Enhanced Prolonged Exposure

Eligibility Criteria:
Inclusion Criteria:

* Veteran participants will be individuals appropriate for PE, i.e., :

  * Veterans who are currently seeking PE
  * meet DSM-5 criteria for PTSD or subthreshold PTSD
  * are competent to consent to research

Exclusion Criteria:

* Veteran participants do not have levels of other types of psychopathology that would prevent successful participation in the intervention
Digoxin Induced Dissolution of CTC Clusters

This single arm therapeutic exploratory study of digoxin in patients with advanced or metastatic breast cancer investigates whether cardiac glycosides are able to disrupt CTC clusters in breast cancer patients.

Circulating tumor cells (CTCs) are considered to be precursors of metastasis in various cancer types and are found in the blood of cancer patients as single CTCs and CTC clusters, with the latter featuring a higher ability to seed metastasis.

CTC cluster share several properties that commonly feature stem cell biology which drive metastases formation. Preclinical data shows that CTC clusters can be disaggregated into single cells by the treatment with cardiac glycosides such as digoxin. This single arm therapeutic exploratory study of digoxin in patients with advanced or metastatic breast cancer investigates whether cardiac glycosides are able to disrupt CTC clusters in breast cancer patients.

Patients with advanced or metastatic breast cancer in whom CTC clusters could be identified will receive an individualized daily maintenance dose of digoxin adapted to their kidney function. Blood samples for analyses of digoxin serum level and mean CTC cluster size will be drawn at specified time points.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection, radiation therapy or systemic therapy with curative intent
* Adequate organ and marrow function

Exclusion Criteria:

* Patients on treatment with digoxin or digitoxin
* Patients with atrial fibrillation or atrial flutter
* Ventricular Fibrillation or ventricular tachycardia,
* Atrioventricular heart block 2nd or 3rd degree, sick sinus syndrome or sinus bradycardia,
* Wolff-Parkinson-White Syndrome
* Hypokalemia, hypercalcemia, hypomagnesemia, hypoxia,
* Hypertrophic cardiomyopathy, aortic aneurysm
* Simultaneous intravenous application of calcium salts
* Known hypersensitivity to Digoxin, other cardiac glycosides or included compounds
* Known drug interactions of ongoing cancer therapy with digoxin
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Lack of safe contraception
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease)
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Correlation of Family History, Age at Onset & Severity of Stuttering

The aim of this study is to Detect the influence of the family history of stuttering (distance of relative) on the onset and severity of stuttering in children in these families. Also to explore developmental differences among young stutterers.


Eligibility Criteria:
Inclusion Criteria:

* 1-Age: from 7 to 15 years old. 2-Gender: both sexes will be included in the study. 3-The participants are diagnosed as stutterers by an expert phoniatrician. 4-Children will be accepted only if full information is provided concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, and the age of onset of stuttering manifestations. 5-Mentality: IQ is 80 or more

Exclusion Criteria:

* 1-Age below 7 years or above 15 years. 2-Failure to provide full information concerning the presence or absence of family history of stuttering, from both paternal and maternal sides of the family, or age of onset of stuttering manifestations.. 3- IQ less than 80
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions

The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.