cyrilzakka/clinical-trials huggingface dataset:
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder.

Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active psychotic symptoms.

Participants are randomly assigned to receive risperidone (Risperdal), olanzapine (Zyprexa), or molindone (Moban) for 8 weeks. After 11/2005, no additional patients will be assigned to olanzapine treatment. Patients with significant improvement and without side effects continue maintenance therapy for another 44 weeks. Participants who show significant negative symptoms after 8 weeks may be started on a mood stabilizer or antidepressant. Weight gain, metabolic changes, neurocognition, functional outcome, psychotic symptoms, extrapyramidal side effects, and the ability to sustain effective therapy over time are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms
* Free of depot antipsychotic medication for at least 6 months. Oral antipsychotic medication at entry into the study is allowed, provided the participant has not had an adequate trial during the present episode of psychosis.
* If taking antidepressant or mood stabilizing medication, stable dosing for at least 30 days prior to entry.
* Good physical health

Exclusion Criteria:

* Risperidone (RIS), olanzapine (OLA)\*, or molindone (MOL) for 8 weeks or more during THIS episode, with 2 weeks at the maximal dose (6 mg/day of RIS, 20 mg/day of OLA, or 140 mg/day of MOL)
* If using antidepressant and/or mood stabilizing medications, treatment for fewer than 30 days immediately before entry
* Intolerance or nonresponse to RIS, OLA\*, or MOL during any previous treatment
* Bipolar affective disorder,post traumatic stress disorder, personality disorder, or psychosis not otherwise specified
* Currently meeting Diagnostic and Statistical Manual version IV (DSM IV) criteria for major depression episode
* DSM IV criteria for substance abuse or dependence with intention to continue illicit substance abuse
* Endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics
* Mental retardation
* Risk of suicide or homicide that is not adequately controlled in the current setting
* Pregnancy or refusal to practice contraception during the study

"\*" OLA exclusion not applicable after 11/2005
Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture

The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women aged 45-75 (at least 2 years after menopause)
2. With primary osteoporosis
3. Patients with Colles fractures with a fracture time of no more than 7 days
4. conservative treatment after fracture (closed reduction and immobilization)
5. no multiple fractures
6. Informed well and agree to participate in this clinical trial

Exclusion Criteria:

1. Combine other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and other diseases that doctors believe may affect the healing process.
2. In addition to primary osteoporosis, any disease affecting bone metabolism or treatment response, including serum PTH\>65pg/ml, 25-hydroxyvitamin D\<20ng/ml, alkaline phosphatase\>135U/L, history of bone tumor, Paget disease, history of radiotherapy
3. The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
4. Those who are allergic to PTH or any excipients
5. Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
6. Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.
The Effect of Januvia (Sitagliptin) on Oxidative Stress in Obese Type 2 Diabetic Subjects

Sitagliptin is a new oral hypoglycemic anti-diabetic drug used either alone or in combination with metformin or a thiazolidinedione for control of type 2 diabetes mellitus. Sitagliptin has been shown to have fewer side effects in the control of blood glucose values.

Obesity and diabetes are states of increased inflammation and can influence the free radicals and inflammatory markers (chemicals in the blood which increase due to inflammation in the body) and are also major risk factors for atherosclerotic disease. In this study we want to see the effect of sitagliptin on these markers. We believe that Sitagliptin may exert an anti-inflammatory effect in the human. The purpose of this study is to determine if the addition of sitagliptin to diabetic patients will provide added benefit. We believe that sitagliptin provides these added benefits by suppressing free radicals (charged substances that cause damage to the body) and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Males or females with age 20-75 years inclusive.
* Type 2 diabetes
* Males and Females BMI \> 30
* Subjects on statins, ACE inhibitors, thiazolidenediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the course of study.
* BP under control -No change required to BP medications
* HbA1c \> 7%

Exclusion Criteria:

* Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
* Pregnancy
* Hepatic disease (abnormal LFT's),Renal impairment (serum creatinine \> 1.5),
* Participation in any other concurrent clinical trial
* Any other life-threatening, non-cardiac disease,
* Uncontrolled hypertension (BP \> 160/100 mm of Hg)
* Congestive Heart Failure
* Use of an investigational agent or therapeutic regimen within 30 days of study
* Subjects on Exenatide, incretin or insulin therapy
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)

This study will utilize a retrospective cohort design. Using the Clinical Practice Research Datalink (CPRD) linked with Hospital Episode Statistics (HES) datasets, all patients with a record of VTE diagnosis between 1 April, 2008 and 31 March, 2013 will be identified and followed from the occurrence of VTE (index date) to the first of 24 months after the index date, end of the study period, leaving the database, or death.


Eligibility Criteria:
Inclusion Criteria:

VTE events will be included if:

* they are identified by at least one Read code diagnosis of acute VTE in the CPRD, or one ICD-10 code of VTE in the HES database, during the study period; and
* they occurred in patients ≥ 18 years old at time of VTE occurrence; and
* CPRD acceptability quality criteria are present

Exclusion Criteria:

VTE events will be excluded if:

* Patients have fewer than 12 months of computerized data available prior to VTE occurrence. The date of start of computerized records will be the latter of the patient's date of current registration with the practice or the practice's Up-to-Standard (UTS) date (date from which practice data is of research quality)
The Effect of Home Visit Supported Nursing Education Program on Some Parameters in Elderly People Living Alone at Home

It is aimed to develop healthy lifestyle behaviors of elderly people living alone at home, reduce their loneliness levels and increase their social support capacity.The research was planned as a quasi-experimental research. The research population consists of elderly people living alone at home who are registered to the Elderly and Home Care Unit of a Municipality of a province.

When elderly people want to live in their own homes, an important issue arises: loneliness. Loneliness is a common problem among older adults and has become increasingly common in recent years. Loneliness not only affects psychological well-being, but also negatively affects physical health, increasing the likelihood of illness and death.When people live longer, they are more likely to experience health problems such as physical weakness, cognitive decline, and chronic diseases. Weakness among older people creates a state of vulnerability that increases the risk of adverse health outcomes, leading to reduced daily activities and the need for long-term care.This study aims to develop healthy lifestyle behaviors, reduce loneliness levels and increase social support capacity of elderly people living alone at home.The research was planned as a quasi-experimental research. The research population consists of elderly people living alone at home who are registered to the Elderly and Home Care Unit of a Municipality of a province. Elderly people who are registered to a home care unit, live alone, and are over the age of 65 and agree to work will be included in the research. Individuals under the age of 65 and those with mental disabilities will be excluded from the study. The independent variable of the research is; The status of receiving a home visit supported nurse care program was determined as the dependent variable of the study: Healthy Lifestyle Behaviors Scale II score, loneliness scale score, social support scale score.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years or older
* receiving home care services
* agreeing to participate in the study
* be literate

Exclusion Criteria:

* Individuals under the age of 65
* be mentally retarded
* not volunteering
Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants

The investigators are conducting a randomised controlled trial to investigate the clinical and cost effectiveness of Ramipril which is an anti-hypertensive medication in patients with intermittent claudication. The investigators aim to recruit 78 participants in total. The investigators will randomise the 78 participants into two groups: Ramipril group with 39 participants and Placebo group with 39 participants. The investigators will measure Ramipril's effect on walking by doing a simple treadmill test and measuring the maximum walking distance the participant can walk. The investigators also want to examine Ramipril's effect on arterial function, cardiovascular prognosis, quality of life and cost effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral or bilateral intermittent leg claudication which was stable for the last 6 months.
* Patients with ABPI \< 0.9 at rest at least in one leg.
* BP ≤ 160/90 and a stable medication regimen for the last 6 months.
* Able to give informed consent
* Able to comply with study protocol

Exclusion Criteria:

* Documented bilateral renal artery stenosis
* Unlikely to be compliant with medication or follow up as determined by the recruiting institution.
* Pregnancy
* Patients with critical limb ischemia (This includes patients with ischaemic rest pain and ulceration \> 2 weeks and/or a resting ankle pressure \< 50mmHg- Grades II and III according to Rutherford et al 1997.\[56\].
* Patients who had a recent (less than 3 months) angioplasty or bypass surgery
* Patients who are unable to perform a treadmill test due to a limiting heart, respiratory or arthritic disease
* History of angioneurotic oedema
* Currently taking ACE inhibitor or Angiotensin receptor blocker
* Contraindication to ACE inhibitor
* History of ACE inhibitor intolerance
* A creatinine rise of \> 30% from baseline and/or Potassium \> 5.9 mmol/l
* Unwillingness to participate.
* Level 1 evidence for ACE inhibitor treatment, including:
* Documented heart failure, left ventricular dysfunction or ejection fraction \<35% on previous echocardiography

  * Uncontrolled hypertension, BP \> 160mmHg systolic or 100mmHg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions
  * Recent (\< 3months) myocardial infarction or stroke
  * Chronic renal impairment (serum creatinine \> 250 micromol/l)
FAVOR Opioid Recovery Coaching Evaluation

The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.

These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.

The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the ED with opioid overdose or withdrawal

Exclusion Criteria:

* Age \<18
* Known pregnant female
* Prisoners
Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.

All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy.

Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle.

All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Age ≥ 18 years
* Histologically confirmed adenocarcinoma of colon or rectum (any T, any N, any M) receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations

Exclusion Criteria:

* Prior treatment with fluoropyrimidines
* Prior or concurrent chest radiotherapy
* Any prior or concurrent treatment with cardiotoxic drug
* Any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )
oncoFISH Cervical Test for Detection of 3q26 Region Gain

The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.


Eligibility Criteria:
Inclusion Criteria:

* Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.
* Women with previous or current STD or HIV may be included
* Women with previous LSIL history may be included.

Exclusion Criteria:

* pregnant women,
* women with vaginal intraepithelial lesions,
* women on a chemotherapeutic agent,
* women with previous or current cancer except for non-cervical squamous cell carcinoma
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi

The overall aim of the mPATCH-TB Study is to identify potentially cost-effective, feasible and scalable interventions that could increase rates of completion of screening for tuberculosis and HIV among male partners of women attending primary health care in Blantyre, Malawi.

Eligible women who consent to participate - and who have a primary male partner with cough at home -will be randomly allocated, by day of clinic attendance, into a standard of care group or one of up to four intervention groups. They will be asked to identify their primary male partner and will be offered interventions according to their allocated group.

The primary outcome will compare the proportion of primary male partner that complete TB screening (defined as receipt of result of a sputum Xpert or smear result) within 14 days of recruitment in each intervention group compared to the enhanced standard of care group.


Eligibility Criteria:
Inclusion criteria for female participants

* Female
* Attends study health centre with an acute care episode
* 18 years of age or older on the day of clinic attendance
* Has a primary male partner living within their household
* Reports that primary male partner has symptoms of pulmonary tuberculosis (cough)
* Is resident within urban Blantyre

Inclusion criteria for male partner participants

* Male
* Aged 18 years of age or older on the day of clinic attendance
* Has cough
* Is living with the female participant (defined as sleeping in the same dwelling on most nights during the previous 14 days)

Exclusion criteria for primary male partner participants in trial (applied on the same day the female participant is recruited)

* Currently taking treatment for tuberculosis
* Has taken any treatment for tuberculosis in the 6-months prior to the female participant's clinic attendance
* Is taking isoniazid preventive therapy
* Plans to move out of Blantyre to live elsewhere in the following 2-months
Impact of Body Mass Index on Outcomes of Breast Cancer Management

Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. One of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.

The biological mechanisms underlying the association between obesity and breast cancer could involve interacting mediators of hormones, adipocytokines, and inflammatory cytokines which link to cell survival or apoptosis, migration and proliferation. Higher level of oestradiol produced in postmenopausal women through aromatization of androgens in the adipose tissues and higher level of insulin, a condition common in obese women, are linked to poorer prognosis in breast cancer. A possible interaction between leptin, insulin and obesity-related markers of inflammation have also been linked to breast cancer outcomes. Non-biological mechanisms could include chemotherapy under-dosing in obese women, suboptimal treatment, and obesity-related complications.

The impact of body mass index on treatment outcome in patients receiving endocrine therapy, there have been consistent results indicating that the efficacy of aromatase inhibitors vary with body mass index; however, the efficacy of tamoxifen is not body mass index-dependent. In the Arimidex, Tamoxifen, Alone or in Combination trial, which compared the efficacy of anastrozole against tamoxifen as an adjuvant treatment for hormone receptor-positive post-menopausal breast cancer patients, anastrozole, a non-steroidal aromatase inhibitor, was significantly less effective in post-menopausal breast cancer patients with a high body mass index, whereas an equal efficacy of tamoxifen was shown across all body mass index levels.

Observational study. Retrospective analysis of data that will be collected from breast cancer patients medical records as body mass index and their response to treatment, progression free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Medical records of female Patients with breast cancer at clinical oncology and nuclear medicine department, Assiut University Hospital between (1st Jan 2012 and 31st Dec 2016), their recorded body mass index and their follow up will be included in the study.

Exclusion Criteria:

* Patients' medical records that had no documented weight and height.
* Patients' medical records that had no documented follow up.
The Effects of Metformin on Self-selected Exercise Intensity, Physical Fitness and Exercise-induced AMPK-activation

The purpose of this study is to evaluate the potential interaction between metformin and exercise in order to optimize clinical guidelines for treatment of T2D.

Physical activity is a first line treatment for patients with type 2 diabetes (T2D ), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated. It is known that metformin and exercise both activates AMPK, which results in many different metabolic effects. Because of this similarity, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. With this study the investigators aim to look at the individual and combined effects of metformin and exercise in order to investigate whether an interaction occur. An Interaction will have tremendous clinical importance for patients with T2D given current guidelines where the vast majority of these patients are recommended both exercise and metformin treatment.

The investigators hypothesize that metformin treatment reduces self-selected exercise intensity, which may be explained via decreased mitochondrial complex 1 function, increased blood lactate levels, heart rate and RPE during exercise. Furthermore exercise-induced AMPK-activation is reduced with metformin treatment.

Eligibility Criteria:
Inclusion Criteria:

* male
* HbA1c \< 39 mmol/l
* BMI \< 25
* structured physical activity \< = 150 min/week
* apparently healthy

Exclusion Criteria:

* smoking
* daily pharmaceutical treatment
* contraindication to increased levels of physical activity
* ALAT/ASAT elevated 3 times above upper normal values
* renal insufficiency (eGFR \< 60 ml/min)
* prior history of lactic acidosis