cyrilzakka/clinical-trials huggingface dataset:
Different Methods of Termination of Second Trimester Abortion

The Patient are divided into 3 groups group 1 included 50 cases using misoprostol only. group 2 included also 50 cases in which using misoprostol with letrozole. Group3 included also 50 cases in which using misoprostol with Foleys catheter for termination of second trimesteric abortion between 14 and 24 weeks

Pregnant women were randomized into three equal groups: Group allocation was blindly randomized concealed by placement in numbered opaque sealed envelopes. These envelopes were kept in the labor ward and drawn in consecutive order:

Group 'A" (misoprostol only group): Pharmacological method for termination of second trimester missed abortion was done by given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses.

Group 'B'(misoprostol with letrozole group): The anti-estrogen action of letrozole has been show to be useful in pretreatment for termination of pregnancy ,in combination with misoprostol,women in the letrozole group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses.

Group 'C' (misoprotol with Foley's catheter group): Mechanical method for termination of second trimester missed abortion was done using the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* gestational age between 14 and 24 weeks
* Fetal death was confirmed by ultrasonic scan
* Unfavorable cervix using Bishop score for cervical assessment with score less than 5
* Parity less than 5
* No uterine contractions

Exclusion Criteria:

* Previous uterine scar eg scar for cessarian section
* Rupture of membranes
* Chorioamnionitis
* Placenta previa or low lying placenta.
* Women with medical disease like DM, coagulopathy or genital infections.
* Hypersensitivity or contraindications for receiving misoprostol, including:Maternal asthma.Sickle cell disease.Known hypersensitivity to prostaglandins.History of glaucoma
Treatment of Recurrent Bladder Cancer With Dendritic Cells

Treatment of recurrent bladder cancer with dendritic cells


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of pTa bladder cancer;
* Patient who require repetitive transurethral resection;
* Expression of muc-1/wt-1 by the tumor;
* EGOC 0-3;

Exclusion Criteria:

* any medical condition which can be associated with the high risk for the patient;
* pregnancy/lactation;
* chronic infections, including hepatitis B/C, tuberculosis, HIV
Group-integrated Cognitive Behavioural Therapy (Gi-CBT) to Aid Communities' Reintegration of Former Terrorists in Nigeria: A Randomised Control Trial

The project aims to make significant contributions that change the conversation in communities and policy circles through promoting knowledge of nonviolent peace strategies using the Group integrated Cognitive Behavioural Therapy (Gi-CBT) to help heal trauma, improve peace, and encourage positive rehabilitation and reintegration of former Boko Haram terrorists' members and their families.

The main question it aims to answer are:

• What is the feasibility in terms of recruitment, retention, adherence to the intervention and communities/victims' satisfaction with Gi-CBT to promote healing and improve the successful reintegration of of former Boko Haram terrorists' members and their families.into society?

Participants will be randomly allocated into two groups. The first group, the intervention group, will receive the Group integrated Cognitive Behavioural Therapy (Gi-CBT). The second group will receive government intervention involving media messages from the National Orientation Agency devoid of GiCBT.

Researchers will compare Gi-CBT group with the media orientation group to see if there are differences between a change in attitude towards ex-offenders' reintegration at base line, end of intervention and three months follow up.

Eligibility Criteria:
Inclusion Criteria:

1. community members who had previous experience of trauma as a result of Boko Haram atrocities, score 5 and above for the culturally-adapted Trauma Screening Questionnaire (Brewinn et al., 2002)
2. are aged 18+ years and above
3. are residents of the designated areas including Bornu (Maiduguri), and its environs.

Exclusion Criteria:

* those not meeting the study inclusion criteria will be excluded.
Quantitative Diagnosis of Liver Fibrosis on Multiparametric MRI

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. The purpose of this pilot study is to evaluate non-invasive multiparametric magnetic resonance imaging (MRI) techniques in the detection and grading of liver fibrosis, so that patients can be treated in time. These techniques combined could reach high diagnostic performance for detection of liver fibrosis, and could decrease the number of liver biopsies.

Early diagnosis and treatment of liver fibrosis can repress or delay the development of cirrhosis and hepatocellular carcinoma. While liver biopsy is still considered the gold standard for diagnosing and assessing the presence and degree of liver fibrosis and inflammation, it has disadvantages including the potential for sampling error and risk of complications. New imaging modalities such as diffusion weighted imaging (DWI), intravoxel incoherent motion (IVIM), diffusion kurtosis imaging (DKI), T1ρ relaxation time (T1ρ), T1 mapping of pre-contrast and hepatocyte phase using hepatocyte specific agent and susceptibility weighted imaging (SWI) allow non-invasive evaluation of liver parenchymal characteristics and may be able to detect and quantify parenchymal fibrosis alleviating the need for biopsy. Patients with chronic liver disease or normal liver parenchyma who are scheduled to undergo either liver resection or liver biopsy are included. Referred patients undergo multiparametric MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI before surgery or biopsy. The pathologic changes are evaluated using multiparametric MRI, and compared between normal/early fibrosis and advanced fibrosis. To explore if combine these techniques could reach higher diagnostic performance for detection and grading of liver fibrosis. This project will provide a reliable and noninvasive method for the monitoring stage of liver fibrosis and therapeutic evaluation.

Eligibility Criteria:
Inclusion Criteria:

* chronic liver disease (viral hepatitis, alcoholic hepatitis, or other...)
* AND willingly able to complete all research procedures and follow the entire research process
* AND scheduled for liver resection or biopsy
* AND signed informed consent

Exclusion Criteria:

* Any contraindication for contrast-enhanced MRI
* Pregnant or nursing women
* Any organ transplant history, and existing functional grafts (except corneal or fur grafts)
* Recent right upper quadrant patients with traumatic healed
* A serious history of illness or other evidence of a serious illness or suffering from any other disease
* Patients who have been enrolled in other interventional clinical trials
Study on the Efficacy Mechanism of Natural Psychotherapy for Neurosis

explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

1. To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.
2. Investigate the pathological mechanism of neurotic patients from the aspects of EEG/fMRI and biology.
3. To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* were between 16 and 55 years old;
* were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
* had an illness duration of at least 12 months;
* were able to participate in the entire trial and face-to-face on-site assessment

Exclusion Criteria:

* pregnant or breastfeeding;
* suffered from organic brain diseases or severe physical illness;
* had a history of substance or alcohol abuse
* were at high risk of suicide
Serum Ceramides Level in Systemic Lupus Erythematosus (SLE) Patients as a Novel Marker for Renal Impairment

1. Estimation of serum ceramides level in SLE patients as anovel marker for renal impairment
2. Correlation serum ceramides level with histological classification of LN,C3,C4,ANA,ANTI DS DNA ,CRP ,ESR , eGFR , creatinine /protein ratio
3. Follow up estimation of ceramides level in LN patients after 3 cycles of treatment

Systemic lupus erythrematosus (SLE) is an autoimmune disease with increasing prevalence and incidence , The clinical manifestation is multifaceted and targets the musculoskeletal system, the skin and different organs like lung and kidney From 30-80% of SLE patients develop lupus nephritis (LN) which often leads to chronic kidney disease (CKD) and end-stage renal disease (ESRD) and is associated with an overall poor prognosis and high mortality Diagnosis of LN is made by kidney biopsy, which still remains the gold standard Histological evaluation distinguish between different stages of LN upon morphological changes within the kidney . However, noninvasive methods to diagnose and guide LN therapy are currently not established in the clinic. On the other hand, an early diagnosis is important for the therapeutic success and thereby lowers the risk of ESRD In this context, classical clinical markers for renal dysfunction are insufficient for an early assessment of the need for renal biopsies and subsequently to decide about the optimal therapy. Even though traditional biomarkers like antids DNA antibodies and complement deficiency are widely accepted as diagnostic instruments to assess disease activity, their specificity is rather low, and they appear to be more suitable to confirm diagnosis of SLE and LN in an already likely clinical setting Ceramides are a family of waxy lipid molecules ,composed of sphingosine and fatty acide ,found in high concentration with in the cell membrane of eukaryocyte cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer Ceramides and other sphingolipids found in cell membrane were purely supporting structural elements,also participate in variety of cellular signaling, regulating differentiation, proliferation, Programmed cell death(PCD) Sphingolipids are a heterogenous group of lipids with more than 400 single compounds formed by structural and chemical modifications of a sphingosine backbone Recent studies reveal that blood sphingolipids not only have important signaling properties but also serve as biomarkers in various renal disease Patyna etal in 2019 concluded that ceramides in blood could act as potent biomarker for renal impairment in patient

Eligibility Criteria:
Inclusion Criteria:

* Forty five patients will SLE with and without renal impairment diagnosed as SLE according to SLICC classification criteria for SLE

Exclusion Criteria:

* Malignant tumor ,infectious diseases, Alzheimer disease ,type 2 diabetes mellitus vitamin D intaker, obesty , cardiovascular disease (HTN,HF ,ischemic heart disease)
Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home

Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations.

Many studies have shown the positive effect of changes in health (physical activity, nutrition, socialization) on functional abilities of aged subjects. Intervention at subject's home is an easy and inexpensive way to delay the onset of dependence in the elderly population. Health coaching is defined as "a regular series of phone calls between the patient and the health care professional to support and encourage the patient and promote healthy behaviors such as treatment control, healthy eating and physical activity ".

The aim of the study will be evaluate impact of a telephone coaching program on evolution of autonomy in subjects aged 75 years or more living at home

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 75 years or more
* subjects living at home
* subjects able to use phone
* subjects agree to participate to the study

Exclusion Criteria:

* subjects do not speak French
Clinical- and Immunological Activity, Safety and Tolerability of Different Doses / Formulations of AFFITOPE AD02 in Early Alzheimer's Disease

This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.

AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent capability
* Early AD, based on episodic memory deficit and hippocampal atrophy
* Age from 50 to 80, inclusive
* MMSE of 20+
* Brain magnetic resonance imaging scan consistent with the diagnosis of AD
* Stable doses of medications (cholinesterase inhibitors and memantine allowed)
* Caregiver able to attend all visits with patient

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric illness
* Significant systemic illness
* Autoimmune disease
* Prior treatment with experimental immunotherapeutics for AD including IVIG
* Women of childbearing potential without birth control
* Contraindication for MRI scan
A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania

The purpose of this study is to learn more about the challenges with breast cancer diagnosis in Tanzania and the support available to improve this process.


Eligibility Criteria:
Participant Inclusion Criteria:

* Breast cancer survivor, patient advocate or key healthcare personnel

  * Key healthcare personnel are defined as hospital and laboratory leaders, pathologists, laboratory scientists and technicians, oncologists, nurses, and surgeons, with:
  * \>12 months of employment at the affiliated institution
  * Administrative or clinical involvement in the delivery of breast cancer care services.
* Age 18 years and above
* Permanent residents or citizens of Tanzania
* Participant and/or LAR willing and able to consent
* Fluent in Swahili and/or English by self-report

Participant Exclusion Criteria:

* Key stakeholder not residing at their particular institutions during data collection will be excluded.

Eligibility criteria for Chart Reviews

Inclusion Criteria for chart review:

* Age 18 years and above
* Permanent residents or citizens of Tanzania
* Received breast cancer diagnosis

Exclusion Criteria for chart review: none
Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.

The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status class II and III,
* Full term pregnancy.

Exclusion Criteria:

* Patient refusal to epidural analgesia,
* Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
* Cardiac diseases
* Severe pre-eclampsia,
* Breech presentations
* Antepartum hemorrhage
* Cephalopelvic disproportion
* Body mass index ≥40 kg/m2.
Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.

The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.


Eligibility Criteria:
Inclusion Criteria:

* totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders

Exclusion Criteria:

* evidence of systemic or psychic pathology that contraindicates implant treatment.
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation

The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes.

Background: Previous research has shown positive effects of music therapy for people with schizophrenia and other mental disorders. In clinical practice, music therapy is often offered to psychiatric patients with low therapy motivation, but little research exists about this population. The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes. An additional aim of the study is to examine the mechanisms of change through music therapy.

Method: 144 adults with a non-organic mental disorder (ICD-10: F1 to F6) who have low therapy motivation and a willingness to work with music will be randomly assigned to an experimental or a control condition. All participants will receive standard care, and the experimental group will in addition be offered biweekly sessions of music therapy over a period of three months. Outcomes will be measured by a blind assessor before and 1, 3, and 9 months after randomisation.

Discussion: The findings to be expected from this study will fill an important gap in the knowledge of treatment effects for a patient group that does not easily benefit from treatment. The study's close link to clinical practice, as well as its size and comprehensiveness, will make its results well generalisable to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Non-organic mental disorder
* Low therapy motivation
* Willingness to work with music

Exclusion Criteria:

* Severe mental retardation
* Life-threatening somatic illness
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to study-specific screening procedures
* Life expectancy of ≥ 60 days
* Eastern Cooperative Group (ECOG) performance status ≤ 2
* Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
* Negative serum pregnancy test (within 7 days of first dose)
* Negative urine pregnancy test immediately prior to first dose

Exclusion Criteria:

* Known HIV
* Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
* Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
* Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
* Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
* Patient unable to swallow capsules
* Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat

Other Protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin

The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18, CHADS2 score\>=1
* Patients cannot be treated long-term with Warfarin
* Eligible for clopidogrel and aspirin
* Provide written informed consent and agree to comply with required follow-ups

Exclusion Criteria:

* Need to take Warfarin
* Presence of rheumatic, degenerative or congenital valvular heart diseases
* Early stage or paroxysmal AF
* Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%)
* Heart failure NYHA grade IV
* Recent 30 days stroke or TIA
* Presence of active sepsis or endocarditis
* Cardiac tumors or other malignancy with estimated life expectancy \<2 years
* Abnormal blood test; renal disfunction
* LAA removed or heart implant patients
* Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
* Patients have history of mechanical prosthesis operation
* Patients who are pregnant, or desire to be pregnant during the during the study
* Participation in other trials
* A known allergy to nitinol
* Patients will not be able to complete the trial

Esophageal ultrasonic exclusion criteria:

* LAA Ostium \<=12mm or \>=30mm
* LVEF \<30%
* Presence of thrombus in the heart
* High risk PFO
* Mitral valve stenosis (valve area \<2 cm2