cyrilzakka/clinical-trials huggingface dataset:
Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.

PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma previously treated with iodine I\^131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296, 521, 792, or 915.
* Determine the long-term toxic effects of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a long-term, follow-up study.

Patients undergo testing for human anti-mouse antibody at 1, 3 and 12 months. Patients undergo physical examinations, blood tests, and immune system assessments every 3 months for 1 year and then annually thereafter. Thyroid, pulmonary, and cardiac function are assessed at 1 year and then annually as needed. Patients also undergo CT scans and bone marrow biopsy (if clinically indicated) annually for up to 10 years.

Quality of life is assessed annually.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of B-cell non-Hodgkin's lymphoma

  * Relapsed or refractory disease
* Previously treated with myeloablative doses of iodine I\^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols:

  * FHCRC-296
  * FHCRC-521
  * FHCRC-792
  * FHCRC-915

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* Not specified
Bioequivalence Study of 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide / 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers

The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets \[manufactured by Servier (Ireland) Industries Ltd\]) in healthy adult volunteers under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects, age 18 to 50 years, inclusive, body mass index (BMI) range is within 18.5 - 30.0 kg/m2, subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs, standard ECG assessment is normal (no QTc prolongation), medical history and physical examination within medically acceptable criteria, laboratory investigations tests within laboratory reference ranges (ALP and creatinine are accepted if below the reference range after being evaluated by the physician as clinically not significant). Haematology tests within 5% of reference limits.
Extension Study: Evaluating the Safety of Oral Ziprasidone in the Treatment of Subjects With Schizophrenia

To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have successfully completed a ziprasidone clinical study
* Patients not hospitalised in an acute psychiatric service
* Written, informed consent to participation.
* Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued

Exclusion Criteria:

Psychiatric:

* Subjects at immediate risk of committing harm to self or others
* Subjects requiring concurrent treatment with non-study antipsychotic agents
* Subjects requiring treatment with antidepressants or mood stabilizers
* General:
* Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose \< 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
* Acute or chronic heart disease
* Clinically significant ECG abnormalities
* Subjects with QTc \>= 500 msec (subjects with QTc \>= 450 msec and \< 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved)
* Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
* Subjects with serum K+ or Mg++ outside the normal range
* Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
* Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit)
* Pregnant or lactating women
* Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
* Subjects unable or unlikely to follow the study protocol
* Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
* Known hypersensitivity to ziprasidone or lactose
Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial

The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.


Eligibility Criteria:
Inclusion criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

* histologically confirmed locally advanced pancreatic cancer or imaging defined pancreatic cancer combined with elevated CA-19-9
* macroscopic tumor after biopsy
* age ≥ 18 years of age
* Karnofsky Performance Score \>=60
* For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
* Female participants: No pregnancy present (pregnancy test required)
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)

Exclusion criteria:

Patients presenting with any of the following criteria will not be included in the trial:

* distant metastases
* refusal of the patients to take part in the study
* previous radiotherapy of the abdomen
* Patients who have not yet recovered from acute toxicities of prior therapies
* Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively
Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass

Though Cardiac surgery under cardiopulmonary bypass (CPB) under epidural anesthesia in conscious patients is associated with increased risk of epidural hematoma. The investigators developed a monitored anesthesia care (MAC) platform for cardiac surgery under CPB. In the current prospective study, the investigators investigated the safety and effectiveness of the MAC platform versus intubated general anesthesia (IGA) in patients receiving elective open-heart surgery.

The study included adult patients who were scheduled to undergo open-heart surgery under CPB at Shuguang Hospital between April 2012 and December 2021. MAC consisted of local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil and electroacupuncture. MAC versus IGA was chosen by the patients. The investigators will investigate the safety and effectiveness of the MAC platform versus IGA in patients receiving elective open-heart surgery.

The detailed description of clinical trial will be published by protocol later.

Eligibility Criteria:
Inclusion Criteria:

* 1) NYHA class II or less;
* 2) expected aortic block time at ≤ 120 min;
* 3) body mass index (BMI) between 18 and 30 kg/cm2.

Exclusion Criteria:

* 1) systolic pulmonary blood pressure \> 70 mmHg;
* 2) chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, or simplified airway risk index \> 3;
* 3) Child-Pugh grade B or C liver insufficiency or renal insufficiency (24-h creatinine clearance \< 80 mL/min and blood urea nitrogen \> 7.5 mmol/L);
* 4) coagulopathy (aPTT prolongation \> 10 seconds versus normal controls, PT prolongation \> 3 seconds versus normal controls, and INR \> 3.0).
InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study

It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.

The aim of the study is to describe the real world use of InductOs in Spine fusion in France.

Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012
2. Patient as medical records documenting Study Procedure with at least: Age, sex, medical history, primary diagnostic indication, level(s) treated, procedure(s) type, interbody device's information if used
3. Patient has received the "information and non-objection letter" and reception is confirmed by registered courier
4. Patient is ≥18 years old at the date of the Study Procedure

Exclusion Criteria:

1. Patient declines participation
2. Vulnerable patients, unable to understand the non-objection letter or unable to exercise free decision to refuse to participate to the study (at investigator's discretion)
3. Patient died since study procedure\*
4. Participation in concurrent interventional trial during study participation (from Study Procedure to last study follow-up) which may confound study results
The Attractive 2 Trial - Pharmacokinetics of ATR-258 Oral Capsule vs. Oral Solution Formulations in Healthy Volunteers

This is a single-centre, open-label, randomised, 2-period cross-over, Phase 1 comparative trial to assess the ATR-258 pharmacokinetic (PK) parameters of an oral capsule formulation in comparison with an oral solution formulation, both given as single doses to healthy volunteers. The order of treatment, i.e., the treatment sequence capsule - solution or solution - capsule, will be randomised.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Body mass index ≥ 18.5 and ≤ 30.0
* Medically healthy participant
* Willing to use of double barrier contraceptive method if of childbearing potential

Exclusion Criteria:

* History or clinical manifestation of any clinically significant disease
* History of dysphagia or any other swallowing disorder
* Current smokers or users of nicotine products
* History or manifestation of drug abuse, alcohol abuse and/or excessive intake of alcohol
3D Planned Surgery of Acute Fractures Performed With 3D Guides Printed at the Point of Care

The aim of the study is to assess the accuracy of fracture reduction performed with surgical guides designed and 3D printed at the point of care in comminuted fractures of femur- and tibia-shaft.

The 3D planning of surgeries and their execution with 3D printed templates adapted to the individual patient is an established procedure for elective surgeries such as corrective osteotomies for mal-united fractures. Currently, the planning and production of 3D templates are performed mainly by external companies. The duration until delivery usually exceeds four weeks. Therefore, it is not possible to use them in acute cases (e.g. acute fractures) that need to be treated surgically within a few days.

The most frequent postoperative deformity in long bone shaft fractures is malrotation. In femoral fractures, clinically relevant rotational errors (\>15°) occur in up to 40% of cases after surgical treatment, which either results in a poor clinical outcome or requires revision surgery. In tibial diaphyseal fractures, up to 50% of rotational errors have been reported. The higher the degree of comminution the higher the chances of malrotation postoperatively. Due to the comminuted situation, no reliable bony references exist intraoperatively and the surgeon can only estimate the correct length, axis and, rotation based on the contralateral leg. This ultimately leads to a high number of revision surgeries or poor outcomes. Porcine and human cadaveric feasibility studies conducted by the study team utilizing site 3D planned and printed reduction guides showed excellent accuracy of fracture reduction.

This project aims to apply this technique to the clinical setting by conducting a clinical study. The accuracy of 3D planned surgery performed with surgical guides designed and printed at the point of care will be assessed and the complication rate will be compared to the known literature.

It was hypothesized that the mean deviation between the measured postoperative rotational alignment and planned rotation alignment in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 5°. Additionally, it was hypothesized that the rate of clinically relevant deviations between postoperative rotational alignment (e.g. 15°) and planned rotation in patients treated for comminuted fractures of femur- and tibia-shaft treated using 3D printed reposition guides will be less than 10%.

Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 99 years
* Comminuted shaft fracture of tibia or femur
* Intact contralateral tibia or femur
* Patient willing to participate and sign the informed consent
* Clear indication of surgical treatment

Exclusion criteria:

* Refusal to sign the informed consent
* Abnormal contralateral bony anatomy (previous surgeries, poliomyelitis, previous injury, implants)
* Pregnancy
* Acute tumor or previous tumor disease
* Acute infection
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects

The purpose of this study is to determine if the quality of life in children and adolescents diagnosed with chronic functional constipation improves after educational activity in focus group composed by these patients' mothers.

The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.

Eligibility Criteria:
Inclusion Criteria:

* Children (6 to 9 years-old) and adolescents
* Diagnostic of chronic functional constipation

Exclusion Criteria:

* Patients using calcium and/or heme
* Patients with organic diseases that causes constipation
Study Evaluating the Efficacy of Joint Replacement

Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.

Exclusion Criteria:

1. An inability to understand the Polish language,
2. Presence of neuromuscular disease and cognitive impairment,
3. Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,
4. Having rheumatoid arthritis,
5. Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.
Compare Serum Klotho Levels in Patients on Oral Antidiabetic Treatment

Klotho is a protein found in serum, kidney,heart,brain and in other tissues,it has many functions,it is viewed as the anti aging hormone. Aging kidneys are characterized by progressive scarring and measurable declines in renal function

Objectives To study serum klotho level among diabetic patients attending diabetes and endocrine clinic in Fayoum university on oral antidiabetic treatment

Study Design:

This study will be an observational prospective cohort study. The study duration will be 2 months.

Study Methods:

* Population of Study
* Group 1 :compare serum klotho levels in patients taking glimeperirde versus levels in patients taking metformin
* Group 2 : compare serum klotho levels in patients taking glimeperirde versus levels in patients taking linagliptin
* Group 3 : compare serum klotho levels in patients taking glimeperirde versus levels in patients taking impaglifluzin
* Inclusion Criteria :
* Group 1 :Diabetics candidate for oral treatment
* Group 2 :Diabetics candidate for oral treatment
* Group 3 :Diabetics candidate for oral treatment
* Exclusion Criteria :

Diabetics candidate for insulin treatment

There will be three arms to this study; the first arm will enroll patients on glimepiride and patients on metformin to compare serum klotho levels. The second arm will enroll patients on glimepiride and patients on linagliptin to compare serum klotho levels. The third arm will enroll patients on glimepiride and patients on impaglifluzin to compare serum klotho levels Each arm will enroll 40 patients, 20 patients on glimiperide treatment,20 patient will on the other drug,patients will be selected from Fayoum university diabetes and endocrine clinic

Data collection:

Patients will be subjected to; full clinical examination,waist hip ratio assessment,BMI assessment fasting blood glucose,2PP blood glucose,HbA1C, urea, creatinine, uric acid total calcium,albumin, phospherus, estimated GFR, ACR, total cholesterol, triglycerides, serum klotho, FGF 23 levels assessment , also fracrtional excretion of phospherus will be assessed. Control of blood glucose will be done along the period of the study. At the end of the 2 months,reassessment of the above mentioned parameters will be done.

Eligibility Criteria:
Inclusion Criteria:

* Diabetics candidate for oral treatment

Exclusion Criteria:

* Diabetics candidate for insulin treatment
Brief Physical Activity Intervention for Older People With Multimorbidity

Physical activity is an important determinant of health and well-being in older people. However, many older people do not achieve recommended physical activity levels and increasing older people's physical activity is challenging. This preliminary study will explore the effects of a brief physical activity intervention on physical activity and physical function in older people with multimorbidity. The findings will be used to inform the design of a subsequent adequately-powered randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥60 years
* 2 or more chronic conditions
* able to walk outside the home
* able to attend the study visits

Exclusion Criteria:

* living in a residential or nursing home
* housebound
* ≥3 falls in previous year
* dementia or significant cognitive impairment (unable to follow simple instructions)
* contraindication to increasing physical activity
* unable to read or speak English
* unable to provide consent
* no more than one person per household
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis

This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
* Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start

Exclusion Criteria:

* Transfusion of red blood cells during previous 8 weeks
* Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
* Significant acute or chronic bleeding during previous 8 weeks