cyrilzakka/clinical-trials huggingface dataset:
An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.

The data source for this study will be the Clinical Practice Research Database (CPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the CPRD. Use in Bipolar Disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. Use of asenapine in the general practice setting among pediatric participants will be described.

The primary comparison cohort will be aripiprazole. Participants in the aripiprazole cohort will be matched to participants treated with asenapine based on respective time after market entry. In addition, non-matched cohorts will be used to describe utilization of aripiprazole and other comparators.

Eligibility Criteria:
Inclusion Criteria for Participants Treated with Asenapine:

* At least 1 prescription for asenapine within the study period
* Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
* A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine

Inclusion Criteria for Participants Treated with a Comparator:

* Age 18 years or greater at the time participant receives a prescription for the comparator
* At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period
* Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
* A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine

Exclusion Criteria:

* None
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer

To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~65 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
7. Signed informed consent；
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

1. Expected Overall survival \< 6 months;
2. Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Group intEgrative MINdfulness Over the Internet Using an Online Platform

This is a one-year study designed to improve upon the latest version of an education website for adult chronic pain patients called Our Whole Lives for Chronic Pain (OWL-CP). We will gain feedback from stakeholders, beta test new versions, and add the ability to conduct live Medical Group Visits through and on the virtual platform we are creating, GEMINI.

The objectives are:

1. To create a wireframe version of the Group Integrative Mindfulness over the Internet (GEMINI) website, based on feedback from previous projects, for further beta testing.
2. To engage 8 patients with chronic pain in a focus group or individual meeting (utilizing the video-conferencing tool, Zoom) to obtain feedback on the wireframe version of GEMINI through a usability test and qualitative, semi-structured interview (Cohort 1).
3. To create a prototype of the GEMINI system, using all previously collected feedback data (mentioned above), for further beta testing with both patients and providers.
4. To engage 16 patients with chronic pain in focus group(s) to collect feedback on the patient portal side of the tool, through holding a non-intervention, GEMINI telehealth session using the prototype website. No personal health information (PHI) or medical record data will be collected or recorded during this faux session (Cohort 2).
5. To engage 8 health care providers in evaluating the provider portal through asking them to conduct a GEMINI telehealth session with study staff role-playing as chronic pain patients (Cohort A).
6. To end the project with a tested, active prototype of the GEMINI chronic pain management/education/telehealth tool.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older (Patients and Healthcare Providers (HCP))
* self-reported chronic physical pain for at least 12 weeks (Patients)
* average pain intensity for the previous week \>4 on a 0 to 10 numerical rating scale (Patients)
* English fluency enough to follow instructions and answer survey questions (Patients and HCPs)
* Providers who treat patients for pain will be eligible for inclusion (HCPs)

Exclusion Criteria:

* Subjects who are not willing or unable to participate in a focus group or individual appointment over a video conferencing platform/on the University of Massachusetts (UMass) Worcester campus and watch a computer screen and give feedback (Patients

  * HCP)
* Fetuses, prisoners, and other vulnerable populations are not eligible (Patients \& HCP)
* Providers/medical students or residents directly supervised by or reporting to the Primary Investigator (HCP)
BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older

The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years and older
* No treatment with any other investigational agent within 28 days or 2 half-lives (whichever is longer) prior to enrollment

Exclusion Criteria:

* Contraindications, warnings, and precautions for bevacizumab
Inion OTPS Biodegradable Fixation System for the Ankle

The purpose of the investigation is to compare post-operative fracture and wound healing using Inion OTPS Biodegradable Fixation System implants versus Conventional metal implants.


Eligibility Criteria:
Inclusion Criteria:

* Distal fibular fracture including either instabile/dislocated Weber class B or any Weber class C fracture OR bimalloelar fracture with lateral malloelus fracture and medial malleolus fracture OR trimalleolar fracture with lateral and medial malleolus fractures and posterior malleolus fracture with less than 1/4 of the articulas surface fractured
* Fresh/acute fracture
* Aged between 18 and 60 years

Exclusion Criteria:

* Contraindication for the Inion OTPS Biodegradable Fixation System:Active or potential infection,patient's conditions, limited blood supply, insufficient quantity or quality of bone,where patient cooperation can not be quaranteed
* Multiple trauma
* Previous ankle fracture
* Pregnancy
* Bone malignancy
* Any clinically significant condition based on investigators judgement
* high-load bearing applications
A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).


Eligibility Criteria:
Inclusion Criteria: - Subjects with non-myeloid malignancy - Anemia (Hgb less than 11.0 g/dL) due to cancer chemotherapy - Receiving chemotherapy and expected to receive at least 8 additional weeks of chemotherapy - Adequate renal function - Adequate liver function Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Unstable cardiac disease - Active bleeding - Active systemic or chronic infection - Severe active chronic inflammatory disease - Other hematologic disorder associated with anemia - Uncontrolled hypertension - Known iron or nutritional deficiency - Known positive test for human immunodeficiency virus (HIV) infection - History of pure red cell aplasia - History of positive antibody response to any erythropoietic agent - Erythropoietin therapy within 4 weeks before screening - RBC transfusions within 2 weeks prior to screening
School Health Center Healthy Adolescent Relationship Program

This community-partnered participatory study will work within high school health centers (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this study is to examine the effectiveness of the School Health Center Healthy Adolescent Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic environment, and the schools in which the SHCs are located. Evaluation of the intervention will involve random assignment of eight comparable SHCs in the Greater Bay Area of California that provide comprehensive health services, to either intervention or control sites. Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm reduction and ARA-related resources as well as intentions to intervene with peers. For youth reporting recent ARA victimization, the investigators will assess for increases in ARA disclosure, resource utilization, as well as reduction in ARA victimization.


Eligibility Criteria:
Inclusion Criteria:

* age 14-19
* receiving services at one of the eight SHARP Intervention school health centers
* able to read English or Spanish

Exclusion Criteria:

* clients not of the specified age range
* clients who are intoxicated or otherwise not able to provide their own consent
Eingeschränkte vs Ausgedehnte Lymphadenektomie LEA

This trial evaluates the therapeutic benefit of extended versus limited lymphadenectomy at the time of radical cystectomy in patients with bladder cancer.

The extent of pelvic lymphadenectomy in the surgical treatment of muscle-invasive, clinically locally bladder cancer is not yet standardized. There are no data from randomized, prospective studies on the prognostic role of regional lymphadenectomy.

Results of retrospective studies suggest, that the prognosis of patients with muscle-invasive bladder cancer can be improved by extending the limits of pelvic lymphadenectomy. Furthermore it could be demonstrated in a prospective study that the pattern of metastasis of bladder cancer has a high variability. About two-thirds of lymph node metastases are found outside the normally cleared areas of lymphadenectomy. In this study patients will be randomized into arms with limited versus extended lymphadenectomy.

The limited lymphadenectomy includes the removal of the obturatoric, external and internal iliac lymph nodes, the extended one includes the removal of all lymph nodes between pelvic floor and the inferior mesenteric artery. The primary objective of the study is to detemine the influence of limited versus extended lyphadenectomy at the time of radical cystectomy on recurrence-free survival. Secondary study objectives include the influence on cancer-specific survival, overall survival, complication rates, histopathologic N-stage, the localization of recurrence and influence of adjuvant chemotherapy . Adjuvant chemotherapy is optional and is recommended in patients with locally advanced disease (pT3/4) or regional lymph node metastasis (pN+).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, invasive urothelial bladder cancer, locally completely resectable (T1G3 - T4a, Nx)
* Age \>= 18 years
* Written consent of the patient
* Patient compliance and geographic proximity to allow adequate follow-up

Exclusion Criteria:

* Histologically or by imaging diagnostics proven organ metastases
* Radiographic evidence of enlarged lymph nodes (\> 1 cm) above the aortic bifurcation in conjunction with pelvic lymph node metastases
* Radiographic or other evidence of T4b-tumor (infiltration of the pelvic wall or other organ systems)
* Prior neoadjuvant chemotherapy of bladder cancer
* Prior previous pelvic lymphadenectomy
* Prior radiotherapy to the pelvis
* internal medical or anesthetic risk factors that require a short operation time
* Palliative cystectomy (f.e. bulky-disease, infiltration of adjacent structures)
* Evidence of another tumor restricting life expectancy of the patient
Implementing an Intervention to Reduce Heat Stress and Chemical Exposures

The investigators are studying the dangers that farmworkers face while working in the fields and at home. The investigators goals are:

1. Measure how much heat and chemicals farmworkers in Imperial County are exposed to.

   The investigators will ask the participants to wear a special belt under their clothes during work to measure heat. The investigators will also put two small temperature monitors in the participant's home for a day. The investigators will collect a urine sample to check hydration, and also measure the participants height, weight, blood pressure, and some blood markers for diseases using a simple finger-prick test.

   To measure chemicals, the investigators will give the participants a wristband to wear for a week and hang another in the participants home. The investigators will also collect dust from each participant's home with a vacuum. Then, the investigators will analyze everything at San Diego State University.

   After collecting samples, a trained community health worker will ask the participants a few questions about their work, lifestyle, health symptoms, and any hazards they face. The investigators will meet the participants twice at their homes to distribute the tools which will later be collected. Once the tools are collected, the investigators will have the chance to follow up with the participants if they have any questions.
2. Provide help to lower heat and chemical exposure with the help of community health workers.
3. Measure heat and chemicals again using the same methods to see if the project made a difference.
4. Talk to participants about what they liked and how the investigators can make future projects better.


Eligibility Criteria:
Inclusion Criteria:

* Currently living in Imperial County, California, USA
* Currently work in agriculture
* Plan on living in Imperial Valley for the next 6 months

Exclusion Criteria:

* Not currently living in Imperial County, California, USA
* Not currently working in agriculture
* Not planning to live in Imperial Valley for the next 6 months
Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model

This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.

Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated.

In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor.

Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.

Eligibility Criteria:
Inclusion Criteria:

* Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes
* Age \> 18 years
* Swedish-speaking (understanding study information)

Exclusion Criteria:

* Multiple gestation
* Blood borne infections
KLEx Versus FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism

FemtoLASIK is a type of laser eye surgery used to correct vision problems such as nearsightedness, farsightedness, and astigmatism. It involves two main steps: creating a flap and reshaping the cornea. Refractive lenticule extraction, (KLEx) is another laser eye surgery method to correct vision issues, which involves creating and extracting a lenticule without the need of a flap. The investigators will evaluate and compare the efficacy and safety of these two procedures.

Keratorefractive lenticule extraction (KLEx) is a refractive surgery technique that does not require the creation of a flap to correct the defects. The potential advantages of this technique are related to the absence of a flap, which could make it the gold standard of refractive surgery. On the other hand, femtosecond-assisted laser in-situ keratomileusis (FS-LASIK) is the most widely practiced refractive surgery worldwide, as it offers excellent visual outcomes but does require the creation of a flap to correct the defects. The objective of this study is to evaluate the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or compound myopic astigmatism. This is a prospective randomized study. A total of 80 participants will be randomized into two groups, the KLEx group and FS-LASIK group. Following randomization, participants will be followed on the first day after the surgery, 1 week, 1, 3, 6, and 12 months. The primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative spherical equivalent within ± 0.5 diopters of the intended target. Secondary outcome parameters include quality vision measurements, refraction, visual acuity, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older
* Corneal tomography without alterations
* Myopia between -0.50 and -12.00 D
* Astigmatism between -0.50 and -6.00 D

Exclusion Criteria:

* Previous eye surgeries
* Pregnancy
* Progressive or unstable myopia and/or compound myopic astigmatism
* Ocular surface disease
Effect of Neck vs. Combined Neck-Lumbar Mobilization on Pain and Motion in Cervical Disc Herniation

Background To assess the effectiveness of Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) applied to cervical-only mobilization versus both lumbar and cervical regions on pain intensity and range of motion (ROM) in individuals with cervical disc herniation, Methods: Thirty three participants were enrolled in the study. The patients were randomly assigned to two groups. Group A received cervical-only KEOMT while Group B received combined lumbar and cervical KEOMT, Interventions were administered three times a week for four weeks. Pain was measured using the Visual Analog Scale (VAS), ROM was assessed for flexion and lateral flexion, and Neck Pain and Disability Index (NPDI) and Short-Form 36 Health Survey (SF-36) were used for evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervical disc herniation at least 8 weeks but not more than 5 years prior.
* Cervical disc herniation verified by magnetic resonance imaging (MRI) at 1 or 2 segmental levels, consistent with clinical findings.
* Neck Disability Index (NDI) score greater than 5.
* No use of analgesic medication other than the prescribed treatment before or during the study period.

Exclusion Criteria:

* History of myelopathy, whiplash-associated disorder, generalized myalgia, malignant tumor, or inflammatory disease.
* Painful back problems or neurological symptoms within the past year.
* Psychiatric disorders or drug abuse.
* Contraindications to physical therapy or inability to return to work or perform physical therapy due to other diseases or disabilities.
* Inability to communicate effectively.
* Participation in any additional interventions outside the prescribed treatment during the study period.
Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)

TAPS is a sequential trial which aims to investigate whether the administration of a blood transfusion pre-operatively to patients with sickle cell disease (HB SS or Hb SB0 thal)having low or medium risk elective surgery increases or decreases the overall rate of peri-operative complications. The proportion of patients with peri-operative complications in two randomised groups of transfused and untransfused patients will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Sickle cell disease, either Hb SS or Hb SB0 thal, confirmed by Hb electrophoresis, Deoxyribonucleic Acid (DNA) analysis or High Performance Liquid Chromatography (HPLC)
* At least 24 hourse and no more than 14 days before surgery and a date for surgery has been given
* Surgery to be low or medium risk
* Surgery to be with general or regional anaesthesia
* Written informed consent from patient/parent/guardian is given
* More than six months since previous TAPS trial surgery.

Exclusion Criteria:

* Having a procedure involving intravascular contrast radiography or an imaging procedure
* On a regular blood transfusion regime
* Had a blood transfusion within the last three months
* The planned procedure involves local anaesthetic only
* Haemoglobin level at randomisation less than 6.5g/dL
* Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation)
* Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome
* Oxygen saturation at randomisation less than 90%
* Patient is on renal dialysis
* Already entered twice into the TAPS trial
* The physician is unwilling to randomise the patient (such patients will be entered into a trial log).