cyrilzakka/clinical-trials huggingface dataset:
Hepatitis B Patients Under Oral Nucleos(t)Ide Treatment With Intermittent Assessment of Kidney Function

Patients with chronic Hepatitis B who are under oral antiviral treatment for at least 6 months at study start will be monitored once yearly for kidney function changes within their routine outpatient visit. Therefore urine samples will be collected and some additional blood test will be done within the routine blood sampling.

This non-interventional, long-term observational cohort study will evaluate demographic, clinical, biochemical and virological parameters of outpatients with chronic Hepatitis B who are under oral antiviral treatment with an approved Nucleos(t)ide for \> 6 months at study inclusion.

During their routine outpatient visits annually an assessment of their kidney function especially for a proximal tubular dysfunction will be performed and their comedication will be explored. Patients included in the study are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* chronic Hepatitis B Virus infection
* indication for an antiviral treatment due to the recent german Hepatitis B guidelines and oral intake of an approved Nucleos(t)ide for a minimum of 6 months at inclusion
* ALT \< 2 x UNL (upper normal limit) at study inclusion
* age 18 - 89 years
* signed informed consent form

Exclusion Criteria:

* coinfection with Hepatitis D Virus (HDV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
* Comorbidities that will hinder the study performance (e.g. malignancies, relevant psychiatric disorder)
* hepatocellular carcinoma or hepatic metastases
* legally incapacitated patients
Macular Thickness Measurements Using Retinal-thickness OCT

Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)


Eligibility Criteria:
Inclusion Criteria:

1. Ability and agreement to give informed consent (IC)
2. Diagnosis of AMD or DR in SE by OCT
3. Ability to undergo OCT scans

Exclusion Criteria:

1. AMD and DR in the same SE
2. Evidence of macular disease other than AMD or DME in SE
Reliability And Validity Of Urdu Version Of Boston Carpal Tunnel Syndrome Questionnaire

Translate and culturally adapt Boston Carpal Tunnel Syndrome Questionnaire into Urdu language and find its reliability and validity in Pakistani Carpal Tunnel Syndrome patients To check its correlation with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale.

The original version of Boston Carpal Tunnel Syndrome Questionnaire will be translated into Urdu. Among idiopathic Carpal Tunnel Syndrome, 110 patients will be included in the study by convenience sampling. The selection of the patients will be done according to the criteria. Boston Carpal Tunnel Syndrome Questionnaire will be correlated with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale and these questionnaires will be provided three times to a single patient for their assessment. Firstly, they will be provided prior to treatment and secondly just after having treatment. Thirdly, they will be given after seven days of treatment. Internal consistency and reproducibility will be used to determine reliability. Boston Carpal Tunnel Syndrome Questionnaire will be correlated with Disabilities of the Arm, Shoulder and Hand questionnaire and Visual Analog Scale to assess validity. From each patient informed consent will be obtained. Statistical Package of Social Sciences software, version 24 will be used for the analysis of data.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or above 18 years.
* Absence of any cognitive impairment.
* Patients having positive Tinel and Phalen test.

Exclusion Criteria:

Presence of any of following conditions.

* Diabetes
* Polyneuropathy
* Hypothyroidsm
* Rheumatoid arthritis
Treatment of Depressed Women Who Have Been Sexually Abused

The purpose of this study is to compare Schema-Focused Therapy plus antidepressant medication and antidepressant medication alone for the treatment of major depression in women with a history of childhood sexual abuse.

Schema-Focused (SF) Therapy is an extension of cognitive therapy that was developed to address the treatment needs of patients with long-standing mental disorders. SF therapy focuses on early maladaptive schemas (EMS): broad, pervasive themes regarding oneself and one's relationship with others, developed during childhood and elaborated throughout one's lifetime, which are dysfunctional to a significant degree. SF Therapy involves the identification of the particular EMS that is most relevant for each patient and attempts to modify the relevant schemas by altering the distorted views of self and others.

Participants are assessed pretreatment, after 12 weeks, posttreatment, and 3 and 6 months posttreatment. The severity of depressive symptomatology is measured and a self-report Beck Depression Inventory is administered. At the end of the study and at the follow-up intervals, participants are given the Longitudinal Interval Follow-up Evaluation, an instrument that assesses the severity of depression and dysthymia symptoms.

Eligibility Criteria:
Inclusion criteria:

* Major depression
* History of childhood sexual abuse
Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation

This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.

Liver metastases are detected in 40-50% of patients diagnosed with colorectal cancer. Local treatments like surgical resection or radiofrequency ablation result in 5-year survival of 35%. However, relapse still occurs in 70% of patients. Stereotactic body radiotherapy (SBRT) has emerged as a valid treatment not only to provide excellent symptom palliation, but also is effective in local control of metastatic lesions and improves survival. The potential efficacy of SBRT as adjuvant radiotherapy in CRLM patients after surgical resection or radiofrequency ablation is still unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven unresectable metastatic colorectal cancer (CRC)
2. Primary resection of colorectal cancer (CRC)
3. Age≥18 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. Absence of evidence of extra-hepatic diseases
6. 1 to 3 liver metastases with an individual maximum diameter of up to 5 cm
7. Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed
8. Aspartate aminotransferase, alanine aminotransferase \& alkaline phosphates must be ≤ 2.5 times of the upper limit of normal. Total bilirubin must be within the limit of normal.
9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3.
10. Patients must provide verbal and written informed consent to participate in the study.
11. Absence of any severe pulmonary or cardiac diseases

Exclusion Criteria:

1. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
2. Patients who are pregnant
3. Patients with severe organ dysfunction
4. History of liver radiotherapy
5. Unwillingness to participate or inability to comply with the protocol for the duration of the study
6. Participation in any investigational drug study within 3 months preceding the start of study treatment
7. Patients not suitable to take part in clinical trials judged by researches
How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?

The hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar. We predict that this potentially adverse effect of dietary sugars on blood lipids will be more pronounced in people with a raised level of stored fat inside their liver, as compared to people with a low level of stored fat.

This study aims to determine the metabolic mechanism(s) by which dietary extrinsic sugars (sucrose and fructose), promote the formation of a high risk dyslipidaemia, known as an atherogenic lipoprotein phenotype (raised plasma triglyceride, low HDL and predominance of small, dense LDL), in men with raised cardio-metabolic risk and percentage of liver fat, as determined by magnetic resonance spectroscopy (MRS). The study examined the impact of diets high and low in extrinsic sugars, on the metabolism of lipids and lipoproteins in vivo, of two groups of men with a high (\>10%)and low (\<2%)percentage of liver fat, by the trace-labelling of these lipid moieties with stable isotopes, and detection by gas chromatography mass spectrometry. The study had a two-way cross-over design, with two, 12 week dietary interventions separated by a six week wash-out period. The dietary intervention with high and low sugars was achieved by a dietary exchange with supermarket foods, which were consumed within the homes of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Male gender,
* Increased cardio-metabolic risk ('RISCK' criteria Jebb et al (2010) Am J Clin Nutr 92, 748-758).
* Apo E3E3 genotype

Exclusion Criteria:

* Any abnormal result in blood screen (renal and liver function, haematology)
* Diabetes
* Smoker
* Excessive alcohol consumption (\>27units/week)
* Medication likely to affect lipid metabolism
* \>3kg weight loss in preceding 3 months
* Any medical condition (eg. GI tract, allergies) affecting lipid metabolism or ability to comply with dietary interventions
* Involvement in any other study
ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
* Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function

Key Exclusion Criteria:

* Prior therapy with a c-Met inhibitor.
* Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
* Major surgical procedure within 4 weeks prior to randomization
* Known symptomatic brain metastases.
Evaluation of Volume Status in Peritoneal Dialysis Patients

Patients with kidney failure on dialysis have a much higher risk of developing cardiovascular disease as compared to the general population. Recently, two large studies have shown that increasing the amount of dialysis does not decrease cardiovascular disease. It is known that retaining too much fluid leads to high blood pressure and thickening of the heart wall. Peritoneal dialysis is a method of home dialysis which allows dialysis patients autonomy and independence. This study will measure blood levels of a protein called N-BNP and measure the extent of body fluid by a machine called a bioimpedance analyzer. This device administers an undetectible electric current which distributes throughout total body water. The relationship between these tests and the clinical presence of volume expansion will be assessed. In addition, the extent of total body fluid and it's impact on heart attacks, heart failure and stroke will be determined.

Patients with end-stage renal disease (ESRD) have a higher risk than the general population of developing premature cardiovascular disease; the reasons for this are complex. Two recent randomized controlled trials in peritoneal dialysis patients have demonstrated that targeting patients to higher dialysis clearance values is not associated with a reduction in mortality. It is known that patients on peritoneal dialysis are more likely to be volume expanded, develop left ventricular hypertrophy, and have inadequate blood pressure relative to patients on hemodialysis. As a result there has been increased attention on the role of fluid management in reducing the risk of developing congestive heart failure and other adverse cardiovascular events in peritoneal dialysis patients.

Extracellular fluid volume and total body water can be accurately assessed with multi-frequency bioimpedance analysis (BIA). Estimation of volume expansion by measuring the natriuretic peptide N-BNP produced by cardiac tissue in response to ventricular wall stretch can also be used.

The purpose of this study is to determine whether volume status, as measured by BIA and N-BNP levels, correlates with clinical volume assessment, cardiovascular outcomes, peritoneal membrane transport properties and markers of inflammation such as serum albumin and C-reactive protein.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients,
* 18 years of age or older,
* with end stage renal disease on peritoneal dialysis for a minimum of 3 months

Exclusion Criteria:

* Peritonitis in previous 3 months;
* history of bilateral lower limb amputation;
* inability to provide informed consent;
* presence of a pacemaker or defibrillator;
* anticipated death or transplant within 6 months of recruitment
The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?

The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of exercise tolerance evolution during a pulmonary rehabilitation program in people with all stages of severity of Chronic Obstructive Pulmonary Disease (COPD).

Currently, the reference test in assessing functional capacity in COPD patients during pulmonary rehabilitation is the six-Minute Walking Test (6MWT). However, the realization of the 6MWT requires a 30m-long corridor, according to the American Thoracic Society Guidelines. Lack of sufficient space can prevent the realization of 6MWT, especially for private practitioner pulmonologists, and also in hospitals. The six-minute stepper test (ST6) which can be performed in a normal room, should be an interesting alternative.

Eligibility Criteria:
Inclusion Criteria:

* Patient with COPD wtih all stages of severity
* Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course

Exclusion Criteria:

* Pneumonectomy, Lobectomy less than 6 months
* orthopedic problem
* Balance disorder
* Weight \> 110kg
Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery

Pregnant women with iron deficiency anemia during third trimester will be assessed for serum ferritin and peak systolic value for fetal middle cerebral artery to find out their correlation with preterm delivery.

Preterm delivery, defined as delivery before 37 weeks of completed gestation (259 days), is a major cause of neonatal morbidity and mortality. Despite extensive research, preterm birth still accounts for 5-10% of all deliveries in developed countries and rates are on the increase, including in the UK. While mortality associated with preterm delivery has declined due to use of antenatal steroids and improvements in neonatal intensive care, preterm babies still remain at risk of major complications. These include respiratory distress syndrome, necrotising enterocolitis, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and long-term cognitive and sensory impairment. Two major determinants for the mortality and morbidity of babies born preterm are gestation at delivery and birthweight. Prematurity therefore carries significant cost implications to both healthcare services and society in general. High hemoglobin along with anemia was examined in an observational study. At entry to care, which ranged between 6 and 8.4 wk gestation, women with hemoglobin levels exceeding 130g/L had a greater than twofold increase in risk of preterm delivery and infant low birth weight. Neither risk was statistically significant, however, because of the small numbers with high hemoglobin. Similarly, a concentration of the iron storage protein, ferritin, that is high for the third trimester of pregnancy is also associated with an increased risk for preterm and very preterm delivery. Over the last twenty years, interest has been shown in using ultrasound parameters or Doppler studies of fetal blood to assess fetal anaemia. Middle cerebral artery Doppler has taken over and has replaced amniocentesis as a screening test for fetal anaemia in high risk pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female from 24 weeks till 37 weeks gestation.
* Patients diagnosed as iron deficiency anemia.

Exclusion Criteria:

* Medical disorders as hypertension or diabetes.
* Kidney and liver diseases.
* Any other causes of anemia as haemoglobinopathies.
No More Sleepless Nights in Perimenopause

The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are:

* Are HRT and CBT-I effective in reducing insomnia in menopausal women?
* Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population?

Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions.

Participants will:

* Complete a screening and baseline assessment
* Receive Hormone Replacement Therapy (as prescribed), Cognitive Behavioral Therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks.
* Keep a daily diary (sleep e-diary), to assess sleep-quality.
* Wear an electroencephalogram (EEG) during 6 nights (3 at baseline \& 3 post-intervention), to assess deep sleep cycles and waking episodes.
* Receive a phone call for intervention compliance
* Complete a post-intervention assessment.


Eligibility Criteria:
Inclusion Criteria:

* Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
* Pittsburgh Sleep Quality Index (PSQI) score \> 5
* Insomnia Severity Index (ISI) score \> 7
* Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
* Willingness to use HRT for menopausal symptom reliefs

Exclusion Criteria:

* Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
* Untreated hormonal disorder
* Obesity (BMI ≥ 30)
* Current psychotherapy
* Current psychopharmacological therapy including regular sleep medication
* History of unsuccessful CBT-I
* Psychiatric illness
* Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)
* Shift work
* Long-haul flights across different time zones in the past 3 months
* Pregnancy and lactation
* Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/)
* Inability to follow procedures or insufficient knowledge of project language
* Inability to give consent
Low-osmolar Water Soluble Contrast Agent in Management of Adhesive Small Bowel Obstruction

Adhesive small bowel obstruction (ASBO) is a condition that is commonly found in patients with history of abdominal surgery. The management for such condition can be controversial. In terms of conservative treatment, recent studies have shown conflicting outcomes on whether water soluble contrast would provide benefit in reducing number of patients needed for surgery. In addition, there are a limited number of literature that investigates the role of low-osmolar contrast in reducing operative need in patients diagnosed with ASBO.

The objective of this study is to compare the operative rate of patient diagnosed with ASBO between patients who were treated with low osmolar water soluble contrast (Iohexol) and patients who were treated traditionally.

This study is a randomized, controlled and double-blinded study, where participants who were diagnosed with ASBO will be randomly allocated into two groups:

(i) A contrast group (CG): Patients will be treated conservatively and received Omnipaque (Iohexol) via nasogastric tube

(ii) A traditional group (TG): Patients will be treated conservatively and received sterile water via nasogastric tube

After obtaining informed consent, the patient will be administered with either 100 mL of 350 mg Omnipaque or 100 mL of sterile water via nasogastric tube. The nasogastric tube will be clamped for 1 hour and patient will be positioned with 30 degree head elevation. In the contrast group (CG), surgery is indicated when contrast failed to reach the colon. Failure of conservative treatment is considered when there are no clinical improvements after 48 hours and the patient will then be proceeded for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are presented with clinical manifestation of small bowel obstruction due to adhesion and require radiological investigations
* Patients who has history of abdominal surgery over 30 days

Exclusion Criteria:

* Patients with clinical signs and symptoms of bowel strangulation, ischemia, perforation or peritonitis
* Patients with clinical signs and symptoms of bowel obstruction from non-adhesive causes, including malignancy, herniation, inflammatory bowel disease, Crohn's disease, and others.
* Patients who has history of allergy to water soluble contrast agent
Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition

The goal in this study is to evaluate the effectiveness of a cognitive remediation program that was designed specifically to address the concerns related to cognitive difficulties that are often reported among women in the menopausal transition. This cognitive remediation program has been created to provide our clients with an opportunity to learn more about the relation between menopause and cognitive function, to learn new strategies to enhance thinking skills (e.g., memory, attention) and to hear about lifestyle changes that are known to have a beneficial effect on mental functioning.


Eligibility Criteria:
Inclusion Criteria:

* Currently in menopausal transition
* Subjective cognitive complaints
* Presence of vasomotor menopausal symptoms (i.e., hot flashes)

Exclusion Criteria:

* Individuals with acute and severe depression
* Suicidal ideation
* Severe PTSD
* Psychosis
* Severe alcohol/substance use issues
Assessment Effectiveness of the Leap Motion Capture® System on the Functionality of the Upper Limb in Acquired Brain Injury

The affectedness of the motor control of the upper limb, particulary, the hand and/or fingers, appears in many neurological diseases, what is going to impact on the functionality of the subject. The use of new technologies in the rehabilitation environment, has the target to reduce the impact on the disabling conditions. So that, the goal of this investigation is to evaluate the system use effectiveness of the Leap Motion Controller® in the treatment on the upper limb on patients with neurological disease.


Eligibility Criteria:
Inclusion Criteria:

* people aged between 30 and 70 years old;
* with a confirmed diagnosis of brain damage (\>6 months);
* UL motor impairment with a Fugl-Meyer score≥16;
* a modified Ashworth scale score≤2 in the deltoid, triceps brachii, biceps brachii and in the wrist and finger flexor and extensor muscles of the upper limb

Exclusion Criteria:

* the inability to understand instructions and actively cooperate in the tasks indicated based on a score ≥ 24 in the Mini-mental Test;
* refusal to participate in the study;
* visual impairment not correctable by glasses.