cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis

Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (SEMS). The purpose of the prospective randomized study is to compare the safety and feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary stricture caused by chronic pancreatitis.

All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.

At the initial ERCP, an endoscopic sphincterotomy will be performed and one 10 Fr plastic stent will be inserted for the initial treatment of cholestasis in all patients.Pancreatic stent will be inserted if indicated. One to three months after the initial ERCP the patients will be randomized into two groups: those who receive cSEMS and those who receive multiple plastic stents into the bile duct. For the randomization, sealed envelopes will be used. As for cSEMSs, removable cSEMSs with diameter of 10 mm will be placed. A dilation with a 8-10mm balloon will be performed before and after the stent placement to secure the stent expansion. As for plastic stents, minimum three simultaneous 10 Fr stents will be inserted after 8-10 mm balloon dilation.

After three months a further ERCP will be performed. The number of plastic stents will be increased maximally to six 10 Fr stents after dilation if possible. In the group with cSEMS, the position of the stent will be controlled.

Once the cSEMS or plastic stents have been in place for minimum six months, the stents will be removed at the last ERCP.

Follow-up

Clinical response (adequate biliary drainage) is the primary endpoint of the study. Therefore, blood liver function tests (bilirubin, alkaline phosphatase) as well as the minimum diameter of the common bile duct in the area of the stricture, the maximum diameter of the common bile duct above the stricture and the length of the stricture are measured at ERCPs at the time of the initial plastic stent insertion (i.e. the first ERCP) and at removal of cSEMS or multiple plastic stents (the last ERCP). In addition, blood liver function tests are measured and abdominal ultrasonography performed in the follow-up six months and two years after the stent removal.

Morbidity and mortality are additional endpoints of the study. Therefore, complications (deaths, stent occlusions, dislodgements or migrations, cholangitis, hemobilia, stone formation above the stent), management of complications, admission times, surgical interventions and any additional care needed are monitored and recorded during the follow-up time. Patients are asked to contact the physician at any time if symptoms such as fever, abdominal pain or jaundice occur.

Eligibility Criteria:
Inclusion Criteria:

* Benign biliary stricture caused by chronic pancreatitis

Exclusion Criteria:

* Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)

Liver resection and liver transplantation are the acceptable treatment of Hepatocellular Carcinoma (HCC). But the long-term survival is unsatisfactory as a result of high rate of intra and extra hepatic recurrences. Microvascular invasion (MVI) is the most significant risk factor affecting recurrence-free survival in patients following liver resection and liver transplantation. Tumor hypoxia (lack of adequate blood supply) is the single most important factor that predict MVI and post surgical prognosis.

Blood Oxygen Level Dependent (BOLD) MRI is a non-invasive diagnostic method of assessing tumor hypoxia by detecting signal changes secondary to changes in blood flow and oxygenation. BOLD MRI assessment of tumor hypoxia in HCC has never been correlated with pathological confirmation of MVI, the gold standard to assess MVI in HCC. In this study, the investigators propose to assess the ability of BOLD MRI to provide a discriminating quantitative threshold of intratumoral oxygenation predictive of MVI.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known Hepatocellular Carcinoma;
* Scheduled to undergo liver resection or liver transplantation.

Exclusion Criteria:

* Estimated GFR (eGFR \< 30 mL/min;
* MRI contrast allergy;
* General contraindications to MRI such as pacemaker, etc.;
* Prior tumor treatment such as transarterial chemoembolization or the tumor or radiofrequency ablation or chemoradiation;
* Pregnancy;
* Age less than 18 years.
Effects of Cultura Yoghurt in Relation to Transit Time and Digestive Discomfort in Healthy Women and Men

The aim of this study is to determine the effect of cultura yoghurt on transit time and digestive discomfort during 2 weeks of treatment in comparison to placebo in healthy women and men.

Transit time is the time it takes for a substance to pass through the gut. The major part of the transit is spent in the large bowel is therefore mainly a colonic event. It has been observed that slow transit time is associated with high prevalence of large bowel disorders. The objectives of this study is to:

* determine the effect on mean transit time after 2 weeks intake of a investigational products using radio-opaque sulphate impregnated polyethylene pellets as markers.
* determine effect of investigational products on total symptom score according to Bristol Stool Form (BSF)
* determine effect of investigational products in gastrointestinal symptoms
* determine safety of intake of the investigational products

Eligibility Criteria:
Inclusion Criteria:

* Female and Males
* Healthy
* BMI 19-29 at visit 1
* Age 18 and 60 years at visit 1
* Defecation 3-4 times per week or every second to third day (Bristol Stool Form) during the run-in
* Transit time 35 and 72 hours calculated from the abdominal X-ray at visit 3
* Signed written informed consent

Exclusion Criteria:

* Use of probiotics food or supplements during the study
* Past history of digestive disease
* Previous complicated GI surgery
* Oral use of antimicrobial medication or antimicrobial prophylaxis 4 weeks prior to screening visit
* Use of laxatives (medication or dietary supplements) during the study.
* Pregnant or lactating or wish to become pregnant during the period of the study
* Lack of suitability for participation in the trial, for any reason, as judged by the personnel at KPL Good Food Practice AB
Observational Controlled Clinical Trials, on Adult Patients With T-lymphoblastic Lymphoma Treated With Intensive Chemo/Radiotherapy or Intensive Chemotherapy Followed by Transplant. Evaluation of Clinical, Anatomy -Pathological Parameters

The purpose of the study is to create a prospective database of T-Lymphoblastic Lymphoma (T-LBL) cases in order to conduct an appropriate statistical study as well as to monitor diagnosis and minimal residual disease (MRD), to detect specific genetic profile useful to give advices on therapies, to assess if PET has a prognostic validity on T-Lymphoblastic Lymphoma (T-LBL).

Observational prospective Clinical Trial designed to:

* record all patients treated with a latest generation ALL-like therapy (e.g.: Holzer, LSA2-L2 modified, GIMEMA LAL094), an enhanced therapy (hyper-CVAD or Stanford), autologous or allogeneic transplant or reduced intensity conditioning allotransplant after induction/consolidation and also expected cases treated with high dose sequential therapy or intensified minimal residual disease (MRD) oriented therapy;
* enter classic T-LBL patients (bone marrow infiltrate \<25%) treated as long as previous section;
* monitor therapy response/phenotype ratio by the study of phenotype;
* monitor therapy response/residual disease/patients outcome ratio by the study of T-cell receptor gene rearrangement;
* evaluate any gene-profile difference between T-LBL pre-thymic phenotype and T-LBL thymic phenotype so as to correlate it to outcome;
* monitor the stage of the disease at diagnosis, during the therapy and during the follow-up by means of TAC, so to value if PET (in association with TAC) is an additional and/or outcome predicting element compared to TAC.

Eligibility Criteria:
Inclusion Criteria:

* no previous therapy, except for treatments to face up to clinical presentation of emergency;
* medical history initially characterized by nodal mass/masses;
* histological and immunophenotypic diagnosis that documents the diagnosis of T-LBL; in cases of bone marrow involvement and difficulties in obtaining nodal material, diagnosis could be based on bone marrow;
* availability of biological material for the study of TCR and gene-profile;
* age ≥ 15 years;
* all stages;
* infiltrated bone marrow \<25%;
* normal liver, renal and cardiac functions, except for alterations directly related to lymphoma;
* estimates of treatment according to one of the last generation schedules;
* written informed consent.

Exclusion Criteria:

* patients with previous HCV, HBsAg+ or suffering from HIV;
* patients with organic pathology not related to lymphoma.
Recurrence of Liver Malignancy After Ischemia/Reperfusion Injury

Severe ischemic changes of the liver remnant after hepatectomy could expedite tumor recurrence on the residual liver. Our study aimed at assessing the effect of warm ischemic/reperfusion (I/R) injuries on surgery-to-local recurrence interval and patient overall survival, during major hepatectomies under inflow and outflow vascular control.

One hundred and eighteen patients were subjected to liver resection under total inflow and outflow vascular clamping and were assigned as study group. These individuals were retrospectively matched to 112 counterparts, who underwent liver surgery applying inflow and outflow vascular clamping only of the segment harboring the tumor, sparing the liver remnant from any I/R injury (control group). The two cohorts were compared regarding recurrence-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* American Society of Anesthesiologists (ASA) distribution I to III
* Patients scheduled for major liver resection (≥3 segments)

Exclusion Criteria:

* patients with extrahepatic disease
* patients with metastatic liver tumors
Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

The goal of this study is to verify the effect of vitamin D3 combined with extensor muscle strengthening exercise in lateral epicondylitis of elbow Are there significant differences in the improvement of functional scores between the study and control groups? Are there significant differences in the improvement of sonographic findings and blood D3 levels between the study and control groups? Participant will underwent D3 injection or saline injection and extensor muscle strengthening exercise with counter force brace. All the participant will undergo functional scoring, sonographic examination and blood D3 level testings until 6 months after initial visit.


Eligibility Criteria:
Inclusion Criteria:

* lateral epicondylitis(LE) of elbow symptoms that persisted of increased for more than 3 months in which LE was defined as pain on the lateral side of the elbow and pain at the lateral epicondyle upon direct palpation and during resisted dorsiflexion of the wrist

Exclusion Criteria:

* younger than 20 years
* history of ipsilateral elbow surgery
* common extensor tendon tears more than 30% in depth
* inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, etc)
* osteoarthritis with a limitation of range of motion (flexion contracture \>30 degree and further flexion \< 100 degree)
* neurological deficits in the ipsilateral upper limb,and follow-ups less than 24 weeks
A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule

The main objective of this trial is to investigate the relative bioavailability of 100 mg nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg nintedanib.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Effects of Fiber on Satiety

The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.


Eligibility Criteria:
Inclusion Criteria:

* normal-weight adults

Exclusion Criteria:

* eating disorders,
* on medications that affect food intake,
* pregnant or lactating,
* non-breakfast eaters
Optimization of Acute Treatment in First Episode Schizophrenia

The study is a multicenter, double-blind, randomized, parallel-group study with first episode schizophrenic patients. During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol. Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages (min. 2 mg/d; max. 8 mg/d).

Considering that first episode schizophrenic patients compared to multiple episode patients respond to lower dosages of neuroleptics, the study aims to reach neuroleptic response under the lowest possible dosage of the study medication (haloperidol or risperidone). Therefore the initial dosage of the study medication is 2 mg/d. Depending on the patients' symptomatology, the daily dosage of the study medication can be increased by 2 mg in weekly intervals up to a maximum dosage of 8 mg/d. Patients with the diagnosis of schizophrenia (F20, according to ICD-10-criteria) are consecutively enrolled in the study. The patients are assessed at weekly intervals during the acute inpatient treatment phase of 8 weeks. Apart from the weekly psychopathological characterisation additionally neuropsychobiological data are assessed at the time of admission and at the end of the study. Major questions of the study are, whether patients, who have been treated with risperidone compared with those, who have been treated with haloperidol show a better treatment outcome regarding negative symptoms and exhibit fewer extra-pyramidal motor side effects. Furthermore it is hypothesised, that the treatment with Risperidone has better effects on cognitive disorders/dysfunctions and depressive symptoms and that the patients, who receive Risperidone are more compliant and have a higher quality of life.

Eligibility Criteria:
Inclusion Criteria:

* ICD-10 criteria for first episode schizophrenia
* age between 18 and 55
* informed consent

Exclusion Criteria:

* legal reasons
* insufficient knowledge of the german language
* substance abuse or addiction
* pregnancy
* serious physical illness
* organic brain disease
* contraindication to neuroleptic treatment
Does Pulmonary Daoyin of China Give Additional Benefit Over Usual Therapy in Management of Stable Chronic Obstructive Pulmonary Disease?

The purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community.

This is a multicenter, randomized, none-blind, controlled study to evaluate the effect of pulmonary daoyin therapy in moderate to very severe COPD subjects. Following a 14 day run-in period, approximately 464 subjects will be randomly assigned to none-blind treatment for 3 months. The primary measure of efficacy is the Exercise Capacity (6MWD) and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life (CAT,SF-36), frequency of exacerbations. Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (randomization, and after 1,2,3 months of treatment).

Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of moderate to very severe COPD.
* Age between 40 and 80 years.
* Without participation in other interventional trials in the previous one month.
* With the informed consent signed.

Exclusion Criteria:

* Patients with poor mobility that can not do the exercise, i.e. wheelchair bound.
* Pregnant or breast-feeding women.
* Resting pulmonary artery pressure \> 45mmHg.
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* Patients with severe comorbidities, including acute myocardial infarction and unstable angina pectoris.
* Patients with post exercise syncope and osteoarthrosis that affect movement.
* Complicated with severe heart failure (class II to IV NYHA heart function).
* Complicated with bronchial asthma, bronchiectasis or active tuberculosis;
* Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
* Complicated with pneumothorax, pleural effusion or pulmonary embolism.
* Complicated with neuromuscular disorder which affects the respiration.
* Complicated with tumors .
* Complicated with serious hepatic and renal diseases.
* Long periods of bed rest .
* Participating in other trials or allergic to the used medicine.
Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure.

A multicenter, non-randomized prospective longitudinal study to evaluate the feasibility of Tricog's Remote platform for Guideline Directed Medical Therapy (GDMT) titration and remote patient monitoring among patients with Heart Failure.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Recent hospitalization (within 4 weeks of enrollment) for HF with IV diuretic use
3. Echocardiographic data with EF measurements available in the last 6 months and after HF diagnosis
4. Established outpatient care at the participating sites
5. Eligible to receive at least 2 of the 4 GDMT classes (ACEi/ARB/ARNi, Beta-blockers, MRA, and SGLT2i) for HFrEF and HFmrEF and at least one of the three (ARB/ARNI, MRA, SGLT2i) for HFpEF
6. Not on Target GDMT for all the eligible GDMT classes
7. \>12 months of expected survival
8. Comfortable with spoken and written English communication
9. Access to Apple Watch-compatible iPhone

Exclusion Criteria:

1. Under consideration for or recipient of advanced heart failure therapies (LVAD, Transplant)
2. Current or anticipated use of home intravenous inotrope therapy.
3. Unwilling or unable to perform all study related procedures (wear watch, take measurements and maintain daily logs)
4. Post-discharge placement in nursing, rehabilitation, or long-term care facility
5. Planned (within next 6 months) surgery
6. Inability to provide written consent
Breathing Exercises Effects on Forward Head Posture

The main objective of this study is to find the effects of breathing exercises on cardiorespiratory parameters in subjects with forward head posture. This will be a Randomized Clinical Trial study with two different breathing exercises which include Diaphragmatic Breathing Exercise (DBE) for Treatment group A individuals and Thoracic Extension Exercise (TEE) for Treatment Group B individuals will be performed along with ergometric advices. Each exercise session will be done three times per week for total over a period of 12 weeks. Outcomes will be measured at baseline, 6th and 12th week with photogrammetry method for craniovertebral angle (CVA) and spirometer for pulmonary function test values (PFTs).

The Forward Head Posture (FHP)is the poor posture alignment of the body in which the craniovertebral angle is \<50 degrees. This FHP causes the deep cervical flexors to become weak and excessive use of the sternocleidomastoid and anterior scalene muscle leads towards compromised respiratory functions. The diaphragm mobility is also reduced which effect the lung volume and capacities.

FHP is due to weak deep neck flexor muscles which are compensated by the over-activity of sternocleidomastoid and scalene muscle. This in turn leads to many musculoskeletal changes like muscular imbalance, changes in stress-strain curve due to over activity of cervical spine. FHP can badly effect thoracic expansion and alveolar ventilation which can reduce vital capacity, reduce lung volumes and lung capacities thus leading towards respiratory function weakening.

Prolonged FHP not only affect the muscles but also involve ligaments of the cervical and upper thoracic spine which cause the respiratory disorders and the end result of these changes shows that 83% of individuals with this forward head posture had altered breathing pattern. This shows that there is strong relation between cervical posture and respiratory parameters.

The respiratory function is usually affected by any change in muscle activity which is caused by pain in neck flexors or extensors and their reduced activity which causes changes in vicious circle of the neck. For improvements in such forward head posture and its related problems many therapeutic and rehabilitative techniques have been used such as Kinesio tapping, myofascial release, and Mckenzie exercises.All of these showed positive impact in improving the forward head posture and reducing impairments. Some of the previous exercises mentioned showed the positive combined effects of breathing exercises and therapeutic exercises

Eligibility Criteria:
Inclusion Criteria:

* Both Males and Females are included
* Age group: Middle age adult from 30 to 45 years are included
* Individuals with forward head posture and Craniovertebral Angle \<50o

Exclusion Criteria:

* Previous history of neck or back surgery or neurological signs
* Psoriatic arthritis or rheumatoid arthritis
* Currently using muscle relaxation medication
* Cervical fracture, trauma or tumor
* Unstable cardiac condition
* Undergone any thoracic or abdominal surgery