cyrilzakka/clinical-trials huggingface dataset:
Effects and Consequences for Mother and Child From Treatment for Depression

This study targets women with moderate depression during pregnancy. We aim to investigate the direct effect of the newborn child and the long term consequences on the cognitive developement on children who´s mother has been treated with CBT alone or in combination with antidepressants.

The primary objective is to study the direct neonatal effects and the long-term consequences on cognitive development in children prenatal exposed to maternal sertraline treatment compared to exposure to maternal depression treated with only ICBT.

Eligibility Criteria:
Inclusion Criteria:

1. Female \> 18 years old
2. Pregnant, gestational week 9-21.
3. Verified moderate depression according to SCID-I with or without concomitant anxiety disorder.
4. Signed informed consent
5. Able to understand the Swedish language orally and in written and able to use the internet for the ICBT, including having succeded in filling out online questionnaires
6. Are willing to participate to all study visits
7. Plans to give birth at the Department of Obstetrics at Karolinska University Hospital, Huddinge or at additional study site such as Norrland University Hospital (NUS), Umeå

Exclusion Criteria:

* 1. Known drug or alcohol abuse 2. Serious psychiatric disorder such as psychosis, bipolar disorder, severe personality disorder, ADHD/ADD, autism or mental retardation) and severe melancholic or psychotic depression.

  3. Known idiosyncrasy to Zoloft or allergy to one of the Zoloft excipients 4. Ongoing medication with SSRI, SNRI, TCA, mood-stabilizers, antiepileptic drugs ,psychotropic drugs, tramadol, propafenon, tolbutamid, flekainid, psychostimulants and atomoxetine, insulin or steroids 5. Any severe somatic disease that necessitate regular treatment with systemic steroids, severe heart and lung disease, kidney disease, liver disease, diabetes mellitus, or epilepsy with drug treatment.

  6. Women who either during screening or treatment on self-assessment forms (MADRS-S: 4 or more points on question about suicidal ideation (question 9)) report symptoms of severe suicidal thoughts or suicide plans will be contacted for structured suicide risk assessment by telephone (by experienced staff from the unit for internet psychiatry according to clinical routine). If judged necessary patients will be booked for psychiatric assessment by study nurse. If acute assessment or care is judged necessary, referral to psychiatric emergency departments will be made according to the same routine as in regular care.

Also women, who contact the study personal and report symptoms of suicidal thoughts or suicide plans will receive psychiatric assessment as specified above. Women who according to psychiatric assessment have a high suicidal risk will be excluded from the study. These women will be actively transferred into necessary psychiatric treatment as usual.

7. Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or study obstetrician
I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia

The purpose of this study is to assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. I-scan is a novel image-enhanced endoscopy system based on the post processing of reflected light without optical filters. Targeted biopsy protocol based on i-scan with magnification will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from i-scan with magnification targeted biopsies and a standard biopsy protocol and assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Eligibility Criteria:
Inclusion Criteria:

* patients with dyspeptic symptoms and aged 40 years or older
* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
* or patients with family history of gastric cancer

Exclusion Criteria:

* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
* inability to provide informed consent
Pre- Versus Postoperative Accelerated Partial Breast Irradiation

Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 51 years
* clinical stage tumor-1-2 (≤ 3 cm)
* cN0
* Grade I or grade II (biopsy)
* Histologically proven invasive ductal adenocarcinoma
* Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision to be determined by the participating centre)
* World Health Organization performance status ≤ 2
* Life expectancy ≥ 5 years
* Written informed consent

Exclusion Criteria:

* Distant metastases
* Lobular invasive carcinomas
* Pure Ductal Carcinoma in situ (DCIS) without invasive tumor
* Grade III in biopsy
* Triple negative tumors
* HER2neu positive tumors
* Lymphvascular invasion in biopsy
* TNM pathologic stage N1-3
* pN+ (micro- or macrometastases)
* Multicentric / multifocal disease on mammogram or MRI
* Diffuse calcifications on mammogram (Birads 3, 4 or 5)
* Prior treatment for the protocol tumor (no surgery, no neoadjuvant chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy)
* Previous contralateral breast cancer
* Other neoplasms in the last 5 years with the exception of:
* Basal cell carcinoma of the skin
* Adequately treated carcinoma in situ of the cervix
* Planned oncoplastic resection with tissue displacement
* No social security affiliation/health insurance
* Participation in another clinical trial that interferes with the locoregional treatment of this protocol
* It is expected that dosimetric constraints cannot be met, ie, lung/heart constraints or if the ratio PTV/ipsilateral breast \>30%
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo \[does not contain study drug\]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.

Eligibility Criteria:
Inclusion Criteria:

Hospitalized for the management of acute decompensated heart failure (ADHF) or diagnosed with ADHF within 48 hours after being hospitalized for another reason; Diagnosis of ADHF is defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity.

Exclusion Criteria:

At high risk for hypotension (low blood pressure); Acute coronary syndrome as primary diagnosis; History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic cardiomyopathy, or pericardial tamponade; Previous enrollment in a nesiritide study; Persistent, uncontrolled hypertension (SBP \[systolic blood pressure\] \>180 mmHg).
Differentiated Thyroid Cancer Patients Treated With Different Doses of Radioactive Iodine.

1. Determine the frequency of utilizing single and multiple doses of radioactive iodine (RAI) in treatment of differentiated thyroid cancer.
2. Asses the impact of various doses of radioactive iodine on the management of differentiated thyroid cancer.
3. Investigate the influence of thyroid cancer on the quality of life of affected patients.

Differentiated thyroid cancer represents more than 90% of cancer thyroid \[1\]. Total thyroidectomy is considered the mainstay of curative therapy, with radioactive iodine (RAI) in order to ablate or treat remnant thyroid tissue in the surgical bed and/or elsewhere \[2\]. The two main objectives for treatment of differentiated cancer thyroid are reducing the probability of cancer recurrence and facilitating serological surveillance via thyroglobulin (TG). The 2015 American Thyroid Association (ATA) guidelines as well as European Consensus Conference described three main risk stratification for thyroid cancer including: low, intermediate and high risk \[3\] \[4\]. According to the 2015 ATA guidelines, low- dose (1110 MBq) 131I ablation is recommended for low-to- intermediate-risk patients, while high-dose (3700 MBq or more) 131I ablation may be required for high-risk patients to remove microscopic residual disease(4). The optimal RAI activity needed to achieve the best objective RAI response and to minimize RAI specific adverse effects is not known since there are many factors that should be considered while determining the dose including age of the patient and many pathological factors \[5, 6\]. Therefore, dose adjustment might be needed for patients with same risk classification. Just following the guidelines might not be optimal for treatment of individual differentiated thyroid cancer \[5\]. Accordingly, in our centre the administrated activities are varied among our clinicians. In this study, we aim to retrospective analyse patients with differentiated thyroid cancer received variable (single and multiple) doses of RAI in each risk group and to assess their clinical outcome. As thyroid cancer has a very good prognosis, there a debate that quality of life may be affected in patients with high risk compared to low and intermediate risks. Additionally, we intend to evaluate the impact of thyroid cancer on quality of life by questionnaire filled by patients with different risk groups.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with differentiated cancer thyroid either papillary or follicular underwent total thyroidectomy with or without lymph node dissection.

  * Available data of patients' records.

Exclusion Criteria:

* • Missed follow up data.
Determining Clinical Study Experiences of Chronic Lymphocytic Leukemia Patients

This research study aims to address the limited understanding of the challenges faced by specific demographic groups of chronic lymphocytic leukemia patients in their participation in clinical trials.

This trial will scrutinize the experiences of patients diagnosed with chronic lymphocytic leukemia as they take part in a separate medical intervention clinical trial. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chronic lymphocytic leukemia patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with chronic lymphocytic leukemia
* Patient is a minimum of 18 years or older
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients who are currently receiving any other investigational drug
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. The investigators conduct this prospective randomized controlled trial to evaluate the relative efficacy and safety of intravenous (IV) phenobarbital (PB) and valproate (VPA) in patients with GCSE.

After the failure of first-line diazepam treatment, patients with GCSE are randomized to receive either IV PB (standard doses, low rate) or VPA (standard). Successful treatment is considered when clinical and electroencephalographic seizure activity ceases. Adverse events following treatment and the neurological outcomes at discharge and 3 months later are also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive GCSE patients (after the failure of first-line diazepam treatment) who were admitted in the emergency room or neurocritical care unit in Xuanwu Hospital of Capital Medical University.

Exclusion Criteria:

* Unstable vital signs, such as a systolic blood pressure of \<90 mm Hg, a pulse of \<60 beats per min, or an arterial blood oxygen saturation of \<90%,
* Liver dysfunction (alanine transaminase or total bilirubin of more than twice the normal upper limit),
* Neurologic emergency requiring immediate surgical intervention,
* Pregnancy or breast feeding,
* Hypersensitivity to study drugs.
Breast Cancer Risk After Diagnostic Gene Sequencing

Study of the psychological impact of breast cancer risk communication in Cancer Genetics based on the personalized estimation of the BOADICEA V5/PLUS model ("Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-version 5 or PLUS").

The new BC gene testing and risk estimation using BOADICEA V5/PLUS model imply an increased complexity of communication during the cancer genetic consultation. It will be proposed to women referred to genetic counselling in the participating Cancer Genetic Clinics .

New qualitative (moderate risks, secondary results) and quantitative results (variation in the degree of cancer risk identified for the counselee and family members) and thus a personalized breast cancer risk may be obtained. How this complexity affects counselees' psychological reactions is not known.

It is primarily aimed at comparing psychosocial needs and distress in healthy women (unaffected with BC) at high risk of breast or ovarian cancer undergoing genetic testing based on an enriched gene panel (index case gene panel plus PRS) at Curie Institute in France and at the University Hospital in Cologne, Germany.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy woman, relative of a family member first tested (index case) who received a positive genetic test result (presence of a BRCA1 or BRCA2 deleterious variant or a moderate-penetrance BC gene deleterious variant) ;

   a. at Cologne University Hospital (Germany), these healthy women may also be relatives of women (index case) who received a negative non-informative test result;
2. Who accept BRIDGES gene panel testing and the breast cancer risk PRS;
3. Aged 18 years or over with no upper limit;
4. Able to give informed written consent in accordance with national/local regulations and procedures;
5. Able to understand the questionnaire language of the participating genetic clinic.

Exclusion Criteria:

1. Woman affected with BC, with recurrent BC, with metastatic BC, with an ovarian cancer (OC) or cancer of any other site;
2. Aged under 18 years old;
3. Unable to give informed written consent;
4. Unable to understand the questionnaire language of the participating clinic;
5. Unable to answer the questionnaire due to physical or cognitive disturbance
Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

Randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure.

Randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure. Follow-up period 1 month.

This protocol aims through a multidisciplinary vision, to carry out during hospitalization a comprehensive geriatric evaluation that allows to know the medical and socio-environmental needs of the patient to plan the required care at home and achieve an effective transition.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65 years or older
2. Decompensated heart failure
3. FRAIL scale equal to 3 or more points
4. Permanent residence in the Metropolitan Area of Buenos Aires

Exclusion Criteria:

1. Refusal to participate in the study
2. Terminal oncology or cardiological disease
3. Reversible or treatable etiology heart failure (e.g. Takotsubo, acute cardiomyocarditis)
4. Patients followed by geriatrics prior to admission
5. Simultaneous participation in another research protocol
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory
* Current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (Day 1) and at least 8 weeks following resolution of the last episode of acute back pain.
* Willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at Day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation \[TENS\], or physiotherapy.
* Pain must be localized from the neck (C-3 or lower) to the inferior gluteal folds and spasm assessed during the Screening physical examination.
* Body mass index range between 18 and 35 kg/m², inclusive.

Exclusion Criteria:

* Presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not.
* Presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. Evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities.
* Presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken.
* History of any neck, back, or pelvic surgery.
* History within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain.
* Subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at Screening.
Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects

The purpose of this study is to determine whether fostamatinib influences the plasma concentration of warfarin and changes its blood thinning effect, and to investigate how safe and tolerable it is when administered with warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures (including genotyping screening sample for CYP2C9 and VKORC1).
* Males or females (of non-childbearing potential) aged 18 to 55 years (inclusive)
* Subjects must be negative for occult blood (stool card) prior to administration.
* Body weight of at least 50 kg and body mass index (BMI) between 18 and 35 kg/m2 inclusive

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, or influence the results of the study.
* Healthy subject predicted to be most sensitive to warfarin based on CYP2C9 and VKORC1 genotypes.
* A protein C and/or protein S deficiency.
* Absolute neutrophil count of less than 2500/mm3 or 2.5 x 109/L
* Previous treatment with warfarin for a clinical indication (ie, participation in a previous warfarin interaction study is acceptable).