cyrilzakka/clinical-trials huggingface dataset:
H-34 DELTA Revision Cup

THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup.

This is an observational study designed to reflect real life clinical practice as closely as possible. Thus, clinicians are free to choose the method to implant and total hip arthroplasty in accordance with the current local Delta Revision acetabular cup Indication for Use and current clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* male or female in whom a decision has already been made to perform a total hip arthroplasty with DELTA Revision acetabular cup as per indication for use. The decision to implant DELTA revision acetabular cup must be taken prior to, and independently from the decision to enroll the patient. This decision should be made in accorsance with routine clinical practice at the study site concerned.
* Age ≥ 18 years old
* All patients mist give written informed consent approved by the study site's Institutinal Review Board (IRB)/Ethical Committee (EC)
* Patient is able to comply with the protocol

Exclusion Criteria:

* Adult patients with any DELTA Revision acetabular cup contraindication for use as reported in the current local instruction for use.
* For female patiens, current pregnancy and/or lactation or planning a pregnancy
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients

This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.

Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate in clinical trial, and sign informed consent form
* with cardiac failure symptoms, including oppression in chest, breathe hard, lower limb edema. And new york heart association class as two to four
* heart color ultrasound indicate left ventricular ejection fraction (LVEF) \< 40%
* content of serum NT-proBNP \> 450pg/ml

Exclusion Criteria:

* with severe drug allergy history or allergic constitution
* patients were severe infected
* with malignant tumor or with high tumor marker
* with severe cardiorespiratory dysfunction, hematological system disease
* with severe mental disorder, cognitive impairment
* with persistent atrial fibrillation, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy or restrictive cardiomyopathy patients
* end-stage renal insufficiency, pregnancy, or breast feeding women
* bleeding tendency, active gastrointestinal ulcer
* recent have major surgery, stroke, cancer, hepatic function insufficiency or other life-threatening condition.
* under other therapy that possibly influence MSC security or efficacy
* donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
* participant/donor: alcoholism, drug addicted, mental disease
Family Intervention for Mental Illness and Substance Abuse

This study will evaluate a family intervention program for individuals with bipolar disorder, schizophrenia, or schizoaffective disorder and co-occurring substance use disorders.

Substance use disorder (SUD) in persons with severe mental illness may worsen the course of psychiatric illness. The loss of family support for individuals with mental illness is a major contributing factor to housing instability, homelessness, and other problems. Despite progress toward integrating mental health and substance abuse services, interventions that improve the course of mental illness while helping the families of the mentally ill are not currently available. Enhancing skills for coping with mental illness may be an effective strategy for treating SUD, decreasing caregiver burden, and improving the long-term outcomes for people with mental illness.

Patients and their families are randomly assigned to either the Family Intervention for Dual Diagnosis (FIDD) program or family psychoeducation. The FIDD program lasts for up to 3 years and includes both single and multiple-family group formats. The family psychoeducation program consists of 6 weekly sessions. Routine assessments are conducted on all patients, and relatives are evaluated on a wide range of outcomes, including substance abuse, hospitalizations, psychiatric symptoms, legal problems, aggression, housing and homelessness, family burden, social support, and quality of life. To determine the effectiveness of the FIDD program, knowledge of mental illness and problem-solving skills are assessed in the families following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Have schizophrenia, schizoaffective disorder, or bipolar disorder
* Have a current substance use disorder (within the past 6 months)
* Are willing to have at least 4 hours of contact per week with family members or significant others
* Plan to remain in the community
* Have family members or significant others who consent to participate in the study and plan to remain in the community
Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerb. in Patients With CF

The goal of this research study is to better understand current treatment practices for pulmonary exacerbations (lung infections) and whether the Cystic Fibrosis National Patient Registry (CFFNPR)can be used for this type of study.

Cystic fibrosis (CF), a life-shortening genetic disease, is marked by acute episodes during which symptoms of lung infection increase and lung function decreases. These pulmonary exacerbations (PEs) are treated with varying antibiotics for varying time periods based on needs determined by individual patients, their families, and the health care providers. Cystic fibrosis pulmonary guidelines for the treatment of PE published by the Cystic Fibrosis Foundation (CFF) in 2009 provided recommendations for treatment and also identified key questions for which additional studies were needed.

Standard treatment for PE involves many facets including selection of antibiotics, duration of use, and outcomes that define treatment success. Understanding current treatment practices and measures of treatment success are needed before a study can be designed to define optimal treatment strategies.

This is a multi-center, prospective, observational study designed to prospectively follow patients with CF that are initially admitted to the hospital for treatment of a pulmonary exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥12 years of age at Visit 1
* Enrolled in the CFFNPR (Patients may enroll in the Registry at Visit 1 if not previously enrolled.)
* Current hospitalization for treatment of a pulmonary exacerbation
* Planned hospital admission of at least 5 days with intravenous (IV) antibiotics at Visit 1
* Able to perform spirometry at admission and willing to perform spirometry on subsequent treatment and visit days
* Willing and able to complete symptom score daily
* Willing to return for a follow up visit at end of treatment (if necessary) and 28 days after start of IV antibiotic therapy
* Written informed consent (and assent when applicable) obtained from the participant or participant's legal representative

Exclusion Criteria:

* Previous enrollment in this study
* Treatment with IV antibiotics in the 6 weeks prior to Visit 1
* Admission to the intensive care unit for current pulmonary exacerbation
* Pneumothorax on admission
* Current hospitalization for scheduled pulmonary clean out
* Current hospitalization for sinusitis as the primary diagnosis
* Massive hemoptysis defined as \> 250 cc in a 24 hour period, or 100 cc/day over 4 consecutive days occurring within one week of Visit 1
* Current pulmonary exacerbation thought to be due to allergic bronchopulmonary aspergillosis (ABPA)
* Ongoing treatment with prednisone equivalent \>10 mg/day for greater than 2 weeks initiated prior to Visit 1
* History of solid organ transplantation Currently receiving antimicrobial therapy to treat non-tuberculous mycobacterium (e.g., M. abscessus, M. avium complex)
Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis

The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.

Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥ 18 years
* Histological or cytological evidence of lung cancer
* Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan
* Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS
* Patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed)
* ECOG Performance status of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease)
* Adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/L); ALT or AST within 2 times the upper limit of the normal range

Exclusion Criteria:

* Patients with an uncontrolled infection
* Hypocalcemia
* Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate
* Patients with known hypersensitivity to any of the components of ibandronic acid
* Patients who are pregnant or lactating
* Radiotherapy to bone within the 28 days prior inclusion or during the trial duration
* Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma

The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.


Eligibility Criteria:
* with the diagnosis of allergic asthma \>1 year duration who, in addition to the standards of the American Thoracic Society (ATS) meet the following criteria:
* with a positive prick skin test (diameter of wheal \> 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. A RAST test may be performed for patients with a borderline skin prick test result.
* with total serum IgE level 30 to 700 IU/ml.
* demonstrating 12% increase in FEV1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative B-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization.
* with FEV1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting B-2 agonist use or 12 hours after long acting B-2 agonist use) at baseline.
* who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year.

or:

* been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the GINA guidelines met all of the following criteria for a severe exacerbation:

  1. PEF or FEV1\< 60% of predicted/personal best, or patient is too breathless to provide PEF.
  2. No improvement after initial treatment and therefore requiring repeated treatment with inhaled B-2 agonist (high dose, spacer or nebulized).
  3. Requiring treatment with systemic corticosteroids
* receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting B-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/ER visit.
* who are receiving an ICS dosage \> 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting B-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study).
* whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study).
* with evidence of poor asthma symptom control at screening (based on patient history) and during the 4 weeks immediately prior to baseline.
Efficacy Study of Acupoint Sticking in Summer to Treat Asthma

The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.

Asthma is a common chronic disease with an estimated 300 million worldwide. Treating Winter Diseases in Summer of traditional Chinese medicine treatment of asthma has a long history. But there are less related clinical trials. The purpose of this study is to assess whether Acupoint Sticking in Treating Winter Diseases in Summer is effective in the treatment of chronic asthma.

After screening period, participants will undergo a physical examination, lung function, blood and induced sputum collection while being randomly assigned to one of the following 2 groups for 6 weeks during summer dog days of treatment:

Group A will receive acupoint sticking treatment of Chinese herbal medicine and magnetic stickers once every two days； Group B will receive acupoint sticking treatment of Chinese herbal medicine and sham magnetic stickers once every two days.

Questionnaires to assess asthma control and quality of life will be completed. A physical examination, blood collection, and induced sputum collection will occur at selected visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mild-to-moderate remission phase of asthma
* Patients who have given written informed consent

Exclusion Criteria:

* Participation in another clinical trial 1 month prior to study entry
* Participation received acupoint sticking of winter disease cured in summer
* Use of corticosteroids 4 weeks prior to study entry
* Patients who are allergic to therapeutic medicine
* Female patients in lactation period, pregnancy or planning to get pregnant during the trial
* Patients with severe primary diseases such as cancer, cardiovascular system, digestive system, kidney and hematopoietic system diseases
* Patients with mental illness, acrasia
Prediction of Rituximab Hypersensitivity and Desensitization Treatment

This is a single-center prospective single arm study. The purpose of this study is to assess the usefulness of skin test as a diagnostic tool to predict the hypersensitivity to rituximab in Chinese population, evaluate the rate of hypersensitivity reactions (HSRs) after the application of active desensitization therapy in the case of a positive skin test result, and investigate the mechanism of HSRs to rituximab.

Patients with B-cell lymphomas who need the administration of rituximab are recruited. They undergo skin tests with rituximab before the first infusion of this medicine. In the case of a positive skin test result, the patient will receive the desensitization procedure; if the result of skin test is negative, the challenge test will be administered. Drug challenge test consists in administering the desired full dose of rituximab according to manufacturer instructions. Challenge is considered positive when it shows an objective HSR. The patient with a positive challenge test will receive the desensitization procedure; while the patient with a negative challenge test will be given standard rituximab infusion in the subsequent chemotherapies.

Peripheral blood will be drawn from all the subjects during their initial infusion of rituximab. If the patient shows hypersensitive symptoms, the blood will be drawn one hour after the onset of reaction; while if the patient has no HSR in the whole infusion process, the blood will be drawn at the end of infusion and used as negative control. Levels of tryptase, specific immunoglobulin E to rituximab, IL-6, IL-8, and TNF-α in the serum will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Patients with B cell lymphoma confirmed through pathological biopsy
* Patients who need the treatment of rituximab and have not received rituximab before

Exclusion Criteria:

* Pregnant or lactating women
* Patients taking antihistamines in three days before the skin tests
* Long-term use of systemic corticosteroid
* Patients with skin lesions including infection, dermatitis, trauma or scar in both arms
* Patients with acute attack of asthma
* Patients with psoriasis
* Other conditions that the researchers consider inappropriate to participate in the trial
Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

A single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.

A retrospective study from January 2010 to December 2017. Eligible for analysis are: singleton pregnancies between 24 - 34 weeks' gestation who were given a single course of intramuscular betamethasone. Single course comprised of two separate doses of 12 mg given 24 hours apart. Each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; Group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). The investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis.

Eligibility Criteria:
Inclusion Criteria:

• women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution

Exclusion Criteria:

* higher order multiple pregnancies
* women who were given more than one course of betamethasone during the course of the current pregnancy
* known major congenital anomalies.
Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme

Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine. Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an increasing complexity of medical therapy. However, data on quality and management of VKA therapy with phenprocoumon in current medical care are limited. Our aim was to investigate the quality of OAC with VKA in current health care and to evaluate the potential for improvements.

The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a multicentre cohort of patients in regular medical care and a multi-local, single centre cohort of patients in a telemedicine-based coagulation service. The study program is expected to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a detailed clinical assessment of participants and anticoagulation therapy at study enrolment. Subsequently active and passive follow-up investigations are carried out to document and validate complications of the treatment. Primary short-term outcome is the distribution of time in therapeutic range; the primary long-term outcome comprises the composite of stroke, systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.


Eligibility Criteria:
Inclusion Criteria

1. Age ≥ 18 years of age at study inclusion
2. Written informed consent by patient or legal guardian, if appointed
3. Cohort A: Pretreatment with oral anticoagulation therapy with vitamin K antagonists (VKA) for at least 4 months in regular medical care including patients with self-management of oral anticoagulation therapy
4. Cohort B: Indication for oral anticoagulation therapy with VKA for at least 3 months (both drug-naive and -experienced patients) at enrolment including patients with self-management of oral anticoagulation therapy.

Exclusion Criteria

1. Contraindication to VKA treatment, e.g. pregnancy or known hypersensitivity
2. Participation in other clinical trial