cyrilzakka/clinical-trials huggingface dataset:
Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly

In most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). A large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. The number of hospital beds is declining persistently, calling for shorter lengths of stay (LOS). Increasingly complex treatments now take place outside hospital. Presently, many Danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. The aim of the present PhD-study is to investigate the effects of different models of transitional care among the frailest elderly patients.

Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention: Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The primary outcome is readmission within 30 days after discharge. Secondary outcomes are: mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct discharge from the Emergency Department, time at home before readmission, duration of readmission and physical functional status 30 days after discharge.

Methods The first study is conducted as a randomized controlled trial (RCT) using two different degrees of intervention. The second study is a cohort study of an unexposed control group. The third study is sub-group analyses of the RCT data according to frailty status and type of dwelling.

A focus group comprised of included patients and relatives will be set to identify additional patient related outcome measures (PROMs) and to participate in an advisory group throughout the remaining project.

Eligibility Criteria:
Inclusion Criteria

* Aged 75 years or older
* Living within the municipality of Aarhus (except for the control group, see below)
* MPI-score = 2 (moderate frailty) or MPI score = 3 (severe frailty)

Exclusion Criteria

* Included in any other kind of follow-up schemes
* Declared terminally ill or undergoing palliative care at admission
* Admitted from one specific temporary nursing home with geriatric medical assistance
* Discharge or transfer to another department, including hospice
* MPI-score = 1 (low frailty)
* Discharged to one specific temporary nursing home with geriatric medical assistance
* The patient does not want a visit after discharge
A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

Patients with a morphologically proven diagnosis AML and both the two following criteria:

* Age \> 50 years and £ 70 years.
* Not previously treated for their disease.

Randomization will be centralized by phone :

Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a morphologically proven diagnosis AML and both the two following criteria: Age \> 50 years and £ 70 years. Not previously treated for their disease.
* ECOG performance status 0 to 3
* Negative serology HIV, HBV and HBC (except post vaccination)
* Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N
* Cardiac function determined by radionucleide or echography within normal limits.
* Negative serum pregnancy test within one week before treatment for women of child bearing potential.
* Signed informed consent.

Exclusion Criteria:

* M3-AML
* AML following previously know myeloproliferative syndrome.
* Known central nervous system involvement.
* Uncontrolled infection
* Other active malignancy
The Effect of Physical Exercise in Reducing Pain in Women Undergoing Mammography

Mammography is a systematic way in the main programs of screening for breast cancer in women over 40 or 50 years old, according to screening programs, but most research has shown a frequency of discomfort and pain during the examination mammography. This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination.

This research aims to evaluate the relationship of pre-mammography guided physical activity and pain after the examination, evaluating the impact of the intervention in a group of patients undergoing upper limb exercise (SLE), compared to another group women not subject exposure (MNE), and another group with lower limb exercise (LLE). This study is a randomized controlled trial, whose intervention will be a sequence of exercises body warming and muscle stretching, performed systematic manner and supervised by a physical educator. It is expected to find in this study a possible impact of physical exercise in reducing pain after mammography examination. The results will be checked by study association between the level of physical activity, body mass index, breast density and reducing the pain effect between groups for comparison of means and variances of values of the visual analogue scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Women: 20 to 69 years old

Exclusion Criteria:

* Cardiovascular disease
* Mental diseases
* Pulmonary diseases
* Steroids use
Partially Replicate Bioequivalence Study of Quetiapine 25 mg in Healthy Volunteers Under Fasting Condition

The current study is conducted to evaluate and compare the relative bioavailability for Quetiapine in two different products containing 25 mg Quetiapine after a single oral dose administration under fasting conditions.

A randomized, single-dose, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Quetiapine plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for study.
* Age 18 - 55 years,
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant.

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug, or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
The Role of Ultrasound in COVID-19

The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if echocardiography - both conventional and advanced - can be used to predict which patients will develop acute respiratory distress syndrome (ARDS) or other short-term acute complications, especially focusing on cardiovascular outcomes. In addition, using a novel technique of lung ultrasound (LUS), The investigators aim to analyze specific LUS-findings, and associate them with short-term prognosis and development of ARDS and long-term cardiovascular morbidity and mortality. In all patients included, The investigators aim to examine long-term complications at timepoints: 2, 5 and 10 years of follow-up and examine if echocardiography - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection


Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 \> 18 years of age.

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"
Adherence With Iron Sprinkles Among High-Risk Infants

Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.

Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants
* Age 5-7 months
* Presenting for 6 months well-child care
* Caregiver speaks English or Spanish

Exclusion Criteria:

* Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
* Inability to speak English or Spanish
* Use of vitamin or iron supplements in the previous three months
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?

Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating neuropathic pain will be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain, at peak and through methadone blood levels. The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population, but also direction for the medical management of pain complicated by opioid-induced hyperalgesia.


Eligibility Criteria:
Inclusion Criteria:

Potential participants must:

1. Be between the ages of 21 and 55 years of age.
2. DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
3. Be compliant in methadone treatment
4. On a stable dose of methadone at least 6 weeks.
5. Have provided random urine samples absent of any non-prescribed drugs of abuse x 2 months
6. Be in good physical health or in the case of a medical condition needing ongoing treatment, be in the care of a physician who is willing to take responsibility for such treatment. The same conditions apply in cases of patients with a psychiatric disorder needing ongoing treatment.
7. Be agreeable to and capable of signing an informed consent.

Exclusion Criteria:

Potential participants must not:

1. Have known sensitivity to gabapentin.
2. Be substance dependent on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
3. Have any acute medical condition that would make participation medically hazardous, (e.g., acute hepatitis, unstable cardiovascular disease, liver or renal disease) or have liver enzyme values (AST or ALT) greater than 5 times normal range.
4. Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
5. Have a neurological or psychiatric illness (i.e., schizophrenia, Raynaud's disease, urticaria, stroke) that would affect pain responses.
6. Be currently taking opioid analgesic medication for a painful condition on a regular basis.
7. Be a nursing or pregnant female. Female of childbearing potential must agree to use a medically acceptable method of birth control, (e.g. oral contraceptives, barrier (diaphragm or condom) with or without spermicide, levonorgestrel implant, intra-uterine progesterone contraceptives system, medroxyprogesterone acetate contraceptive injection) or to complete abstinence. Females who become pregnant during the course of the study will be dropped from the study.
8. Have a current or past history of high blood pressure, heart disease, stroke or currently have a pacemaker.
Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients

The goal of this observational study is to investigate the proportion of Mycobacterium tuberculosis (MTB) infection in school contacts of active tuberculosis (ATB) patients. The main questions it aims to answer are:

* the proportion of MTB infection among school contacts of ATB patients
* risk factors related to tuberculosis (TB) infection
* health economic evaluation of screening strategy


Eligibility Criteria:
Inclusion Criteria:

* 13 years old or above;
* Students in junior middle school, high school and university;
* Close contact of school active tuberculosis case (e.g. in the same classroom, in the same dormitory);
* Himself/herself (together with his/her guardian for age under 18 years old) willing to participate in trial and sign informed consent.

Exclusion Criteria:

* Current clinical or sputum culture confirmed active tuberculosis
* Have completed a full course of treatment for ATB or LTBI
Observational Study on the Patients With Rectal Cancer

The aim of this observational study is to retrospectively collect current survival data for 3995 primary rectal cancer patients who were extracted from 5097 rectal cancer patients admitted in Cancer Hospital, Chinese Academy of Medical Sciences from January 2000 to December 2010. Moreover, based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients with rectal cancer treated with pre- or postoperative chemoradiotherapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Aged older than 18 years
* American Joint Committee on Cancer (six edition) stage I through IV disease
* Received either transabdominal resection, transanal excision, preoperative radiotherapy or chemoradiotherapy
* Had the histologic subtypes adenocarcinoma (not otherwise specified, mucinous or mucin-producing, mixed cell or with mixed subtypes, tubular, and papillary)

Exclusion Criteria:

* Had the histologic subtypes squamous cell carcinoma, carcinoid, neuroendocrine tumor, small cell carcinoma, leiomyosarcoma, sarcoma, gastrointestinal stromal sarcoma, melanoma, carcinosarcoma, rhabdoid tumors, or malignant peripheral nerve sheet tumors
* Only receive palliative surgery such as colostomy, sigmoidostomy
* Received palliative radiotherapy or chemoradiotherapy for metastatic disease
* With unresectable distant metastasis in liver, lung, bone, central nervous system , or peritoneal transplantation
* Had no detailed medical records
Ilioinguinal/Iliohypogastric Block for Inguinal Hernia Repair

Inguinal hernia have traditionally been done under general anesthesia. While safe, general anesthesia is associated with potential postoperative nausea/vomiting and drowsiness. Additionally, the recent COVID19 pandemic has heightened the precaution to avoid aerosol generating procedures (AGP) if possible. General anesthesia requires airway manipulation, thus necessitate performing an AGP. Recently, we began using peripheral nerve block and sedation as primary anesthetic technique for inguinal hernia repairs. While surgeon administered local anesthetic, also known as local infiltration, has been done for inguinal hernia repair, using specific nerve blocks and sedation has not been compared with general anesthesia. We believe the advantage of this novel technique can improve postoperative recovery. This retrospective study will compare the total hospital length of stay of those receiving nerve blocks and sedation as primary anesthetic techniques versus those with general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* American Society of Anesthesiologists (ASA) Physical Status I to III
* Body Mass Index (BMI) less than 45
* Single hernia repair, elective, ambulatory surgery

Exclusion Criteria:

* Opioid dependence (30 mg oral morphine equivalents daily or more)
* History of malignant hyperthermia
* Pregnancy
A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement

The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 70 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects undergoing revision hip replacement.

iii) Women who are pregnant.

iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

vi) Subjects who are currently involved in any injury litigation claims.

Additional Exclusion Criteria for Subjects Having Blood Analysis:

1. Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
2. Subjects with an occupational exposure to cobalt or chromium.
3. Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
4. Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
5. Subjects who are undergoing a simultaneous bilateral total hip replacement.
Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)

The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).


Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors
* Age \> 18 years
* signed informed consent

Exclusion Criteria:

* Patient can not understand meaning and purpose of the study