cyrilzakka/clinical-trials huggingface dataset:
Effect of Enhanced Feedback to Hospitals in an Emerging Clinical Information Network

A cluster randomised pragmatic trial will be conducted within an emerging clinical information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to an enhanced feedback intervention delivered over a nine-month period and compared to standard feedback. The trial to be implemented during a phase of implementing change in guideline recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake of the revised pneumonia treatment recommendations.

The international guidelines for the classification and treatment of childhood pneumonia were revised recently and in Kenya the national guidelines changed in February 2016. We designed an enhanced feedback intervention aimed at improving uptake of the revised pneumonia treatment policy within a clinical network of 12 Kenyan county referral hospitals.

Hospitals were randomized to receive either enhanced feedback (n = 6 hospitals) or standard feedback (n = 6 hospitals) delivered over a six-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations. The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure) will be reported as a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 59 months admitted to participating network hospitals with WHO pneumonia diagnosis eligible for treatment with oral amoxicillin

Exclusion Criteria:

* Children aged 2 to 59 months with WHO pneumonia diagnosis and co-morbid illnesses requiring intravenous antibiotic treatment including severe acute malnutrition, bacteraemia, meningitis, or
* children presenting with pneumonia and tuberculosis or cough lasting more than 2 weeks, or severe malaria
Efficacy and Safety Study of Risedronate, Cholecalciferol Combination Tablet in Patients With Osteoporosis

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis.

The purpose of this study is to evaluate the efficacy and the safety of Risedronate with and without cholecalciferol on vitamin D status, Bone Mineral Density (BMD) and bone markers.

Eligibility Criteria:
Inclusion Criteria:

1. Male osteoporosis patients over 19 years of age
2. Female osteoporosis patients with menopause

   * Definition of osteoporosis

     * They had a BMD T-score -2.5 or less at mean Lumbar spine(L1-L4), Femoral neck or total. Or evidence of at least one vertebral fracture
   * Definition of menopause(can be one of three condition)

     * For 12months spontaneous amenorrhea
     * For 6months spontaneous amenorrhea with serum FSH(Follicle stimulating hormone) is 40mlU/mL and over
     * 6weeks after bilateral ovariectomy whether hysterectomy or not.

Exclusion Criteria:

1. Patients with esophagus disorder (i.e:esophagostenosis)
2. Patients administered with osteoporosis therapy(except calcium, Vit.D medication)within the previous 3 Months
3. Patients with serum calcium concentrations 8.0mg under
4. Patients with severe nephropathy (CCr 30mL/min less)
5. Patients with unable to sit upright or stand for 30minutes
Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.


Eligibility Criteria:
Inclusion Criteria:

* Have confirmed diagnosis of cystic fibrosis
* Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and height
* Be able to reproducibly perform spirometry maneuvers
* Be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

* Have abnormal renal or liver function
* Have chest x-ray at screening suggesting clinically significant active pulmonary disease
* Be colonized with Burkholderia cepacia
* Have had a lung transplant
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are

* To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
* To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Among patients enrolled in the XIENCE V USA who have completed Study Phase I, some will be eligible to participate in the XIENCE V USA Long Term Follow-up (LTF) Cohort. This LTF cohort is a prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS continued safety and effectiveness in real world settings from 1 year after the index procedure up to 5 years. The XIENCE V USA LTF cohort will consist of the following from the initial 5,000 patients:

* The first 1,500 on-label patients who are treated in accordance with the XIENCE V EECSS Instruction for Use (IFU), and consecutively enrolled in the XIENCE V USA study
* The remaining patients who do not participate in the HCRI-DAPT cohort
* Data monitoring committee up to two years

Eligibility Criteria:
Inclusion Criteria:

* The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

Exclusion Criteria:

* The inability to obtain an informed consent.
* Age limit is determined by investigator.
* There are no angiographic inclusion or exclusion criteria for this study.
Thrive Intervention in Schools

This study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts.

The intervention is a 6-8 week caregiver-child intervention (THRIVE) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). THRIVE will be compared to an asynchronous on-line parenting education program, Parenting Wisely (PW). This online parenting course will be accessed at www.parentingwisely.com.

Existing school counselors will be trained in the delivery of THRIVE to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. In addition to testing the effectiveness of THRIVE compared to PW, we will also compare two implementation strategies: THRIVE-Coached and THRIVE-Low Coached (LC). We will assess ongoing coaching of THRIVE trainees to increase therapist efficacy and adherence to the intervention (THRIVE-Coached). This will be compared to implementation of THRIVE with low supports (e.g. weekly supervision) provided only for the first case following the initial training (THRIVE-LC\].

Compared to those randomized to PW, we expect children who receive THRIVE will have significantly better behavioral and socio-emotional outcomes. Caregivers who receive THRIVE will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving.

Therapists in the THRIVE-Coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the THRIVE-LC condition. Therapists in the THRIVE-Coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the THRIVE-LC condition. Parents and children receiving THRIVE from therapists in the THRIVE-Coached condition will have better socio-emotional outcomes than those in the THRIVE-LC and PW conditions.


Eligibility Criteria:
Inclusion Criteria:

* Near the clinical threshold on the Teacher or Parent Report Form
* An active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role)

Exclusion Criteria:

* Autism
* Major neurological disorder
* Participating in active weekly individual or family therapy
Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis

This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.

This is a prospective longitudinal study that will evaluate the utility of change in liver stiffness (LSM) and spleen stiffness measurements after a test meal in patients whom the diagnosis cannot be reliably ruled in or ruled out based on two measurement of LSM by TE per standard of care. This includes patients in whom there is discordance between clinical impression and LSM and/or LSM are in the grey zone (LSM between 10 and 15 kPa). Liver biopsy/HVPG which is performed as standard of care will be used as gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* History of chronic liver disease who have had a liver stiffness measurement performed that is discordant with clinical impression (clinically the patient appears to have cirrhosis but LSM \<10) or clinically there is no evidence of cirrhosis but LSM\>15) or LSM are in the grey zone (LSM between 10 and 15 kPa)

Exclusion Criteria:

* Any signs of decompensated cirrhosis (e.g., jaundice, ascites, variceal hemorrhage, or hepatic encephalopathy)
* Hepatocellular carcinoma
* Patients with chronic Hep C who have undergone antiviral therapy
* Ongoing alcohol abuse
* Acute hepatitis
* Pregnancy
OTO-313 in Subjects With Subjective Tinnitus

The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
* Subject is able to use the electronic diary to complete their daily tinnitus ratings
* Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age-related hearing loss; resolved otitis media; ototoxic drug exposure.
* Subject is willing to comply with the protocol and attend all study visits.

Exclusion Criteria:

* Subject has pulsatile tinnitus, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
* Subject is pregnant or lactating.
* Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
A Trial to Compare Three Methods of Performing Hysterosalpingography

The purpose of this study is:

* to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate;
* to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure.

A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice").

The operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. The degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10.

A nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. Moreover, the assistant will note down the personal data and the history of the patient. The operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered.

At the end of HSG both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10.

Eligibility Criteria:
Inclusion Criteria:

* infertility

Exclusion Criteria:

* hypersensitivity to iodine or radio-opaque contrast dye
* cervicitis
* genital bleeding
* genital malignancy
Metastatic Tumor Research and Outcomes Network

The registry aims to collect patient information such as patient demographics, co-morbidities, clinical, diagnostic, and therapeutic data, as well as information on adverse events and HRQOL outcomes specific for patients with metastatic spine tumor(s).

To prospectively determine the prognostic variables (clinical, diagnostic, and therapeutic) within patients diagnosed with metastatic spine tumor(s) that are associated with:

* patient reported outcomes (HRQOL)
* morbidity data
* local tumor control
* survival

Outcome measures:

Variables which will be collected in the registry that are applicable to patients with metastatic spine tumor include:

* • Patient details
* Details of previous treatment
* Diagnosis
* Symptoms
* Treatment details for the index target
* Imaging information

The following outcome measures will be collected:

* Patient reported outcomes:

  * Euroqol EQ-5D-3L
  * Euroqol EQ-5D VAS - Quality of Life
  * Neck Pain Numeric Rating Scale (NRS)
  * Arm Pain NRS
  * Back Pain NRS
  * Leg Pain NRS
  * SOSGOQ
  * Patient assessment
* Ambulation
* Pain medication
* Nutritional Status Tool (PG-SGA©)
* Morbidity data
* Local disease recurrence data
* Overall survival data

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 or older.
* Patient diagnosed with a metastatic tumor of the spine
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/ICF
  * Willingness and ability to participate in the registry according to the Registry Plan
  * Signed and dated EC/IRB approved written informed consent (if consent is required by the EC/ IRB at the registry site)

Exclusion Criteria:

• Patient diagnosed with a primary tumor of the spine.
Development and Testing of a Generic Screening for Use in Application Process of Medical Rehabilitation Services

The primary objective of this research is the development and testing of a brief cross-indication instrument (screening) for use in the approval process of medical rehabilitation services. In addition to the empirical foundation, this generic instrument should have a high level of acceptance of both applicants and payers of rehabilitation services. Furthermore, an everyday and economic use for the routine application process for medical rehabilitation services at the German statutory pension insurance scheme should be provided. In the first study phase, a long instrument was tested with a sample of rehabilitees that received approval of medical rehabilitation services. This assessment including the measurement of rehabilitation-related somatic, psychological and social impairments was first tested for its psychometric properties and then reduced to a short instrument (screening) using quantitative methods. In the second study phase, the then-existing screening will be part of the application documents for medical rehabilitation services to assess its management properties and practicability in everyday use of the German statutory pension insurance scheme.


Eligibility Criteria:
Inclusion Criteria:

* Member of German Federal Pension Insurance
* Approval of a medical rehabilitation according to § 15 SGB VI

Exclusion Criteria:

* Returning questionnaire after beginning of medical rehabilitation
Evaluating the Relationship Between Blood Clotting Disorders, Inflammation, and Obesity in Individuals With Venous Disorders and Post-Thrombotic Syndrome

Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome (PTS) is a painful condition that can develop following a venous thrombosis in one of the deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein, other factors may be responsible for the development of this condition. This study will analyze genetic and biologic samples from participants of a previous study to examine other possible causes of venous diseases and PTS.

The long-term effects of venous thrombosis, known collectively as PTS, include persistent swelling, pain, cramps, and numbness in the leg. These symptoms result from impaired return of blood through the veins of the lower leg to the heart. PTS is believed to occur as a result of direct damage to the valves and walls of the vein. There may be specific factors that make certain individuals more prone to PTS. Individuals who are obese, have a genetic predisposition to blood clotting disorders, or have high levels of inflammation biomarkers may have an increased risk of developing venous diseases. The purpose of this study is to investigate the possible link between these factors and the occurrence of chronic venous disease and PTS. The study's findings will be useful in developing new prevention and treatment strategies.

This study will examine previously collected data from participants in the San Diego Population Study, a study that gathered information on the prevalence of chronic venous disease in a multi-ethnic group of individuals. There will be no study visits specifically for this study. Researchers will examine stored genetic and biologic samples of 370 control participants and 370 participants with chronic venous disease. Specifically, levels of inflammation biomarkers, levels of obesity-related biomarkers, and genetic predispositions for blood clotting disorders will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the San Diego Population Study
Behavioral Health Services for Women Receiving Public Assistance

The purpose of this study is to determine whether access to behavioral health services has been affected by welfare reform.

This study examines patterns of behavioral health service use among a group of female household heads who receive Temporary Assistance to Needy Families (TANF) and have serious mental illness (SMI). The findings from this study will be used to determine the feasibility of conducting a full-scale longitudinal study of the impact of welfare reform outcomes on female household heads who have SMI and are currently or formerly recipients of welfare.

Eligibility Criteria:
Inclusion Criteria:

* Female head of household on TANF at any time during first quarter of 1997 and used at least one behavioral health service during that quarter
* DSM IV diagnosis of serious mental illness
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)

This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or above at the time of the screening
* Ability and willingness to provide written informed consent and to comply with the schedule of protocol requirements
* Diagnosis of SLE
* Active lupus nephritis

Exclusion Criteria:

* Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
* Severe renal impairment
* Lack of peripheral venous access
* Pregnancy or breast feeding mothers
* History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin
* Known severe chronic pulmonary disease
* Evidence of significant uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would preclude patient participation
* Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) prior to screening
* Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
* Known active infection of any kind prior to Day 1
* History of serious recurrent or chronic infection
* History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinoma of the skin that has been excised and cured).
* History of alcohol or drug abuse prior to screening
* Major surgery prior to screening, excluding diagnostic surgery
* Previous treatment with CAMPATH-1H
* Previous treatment with a BAFF directed treatment (e.g. anti-BLyS) prior to screening
* Previous treatment with a B-cell targeted therapy other than one directed at BAFF (e.g. anti-CD20, anti-CD22)
* Treatment with any investigational agent prior to screening
* Receipt of any live vaccines prior to Day 1
* Intolerance or contraindication to oral or i.v. corticosteroids
* Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test
A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients

A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the Rome III Diagnostic Criteria
* Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

* Patients with a history of surgical resection of the stomach, small intestine or large intestine
* Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* Patients with a history or current diagnosis of colitis ischemic
* Patients with a current diagnosis of enteritis infectious
* Patients with a current diagnosis of hyperthyroidism or hypothyroidism
* Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
* Patients with a history or current diagnosis of malignant tumor
* Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them