cyrilzakka/clinical-trials huggingface dataset:
A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors

Cachexia is a common complication of various advanced malignant tumors, which seriously affects the quality of life and survival time of patients. In view of the clinical problem of non-nutritional response in patients with cachexia, the investigators plan to carry out a clinical case-control study on the intervention of creatine combined with curcumin in participants with cachexia. On the whole, the investigators limited the study subjects to upper digestive tract tumors and diagnosed participants with early cachexia. The main purpose of this study is to determine whether the combination of the two can play a positive and stable role in inhibiting the inflammation of cachexia and improving metabolic status, so that basic nutrition can play a role, in order to reduce the level of skeletal muscle consumption, maintain weight, improve quality of life, save medical costs and extend survival time.

This is a prospective open controlled study. The intervention is targeted at participants with early cachexia in upper gastrointestinal tumors.Both control group and intervention group receive basic nutritional support. On the basis of this, the intervention group will be given creatine and curcumin orally.The purpose is to investigate whether creatine combined with curcumin can improve the inflammatory and the nutritional state, correct the disorder of nutrient metabolism and improve the prognosis of participants.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of advanced tumors of the upper digestive tract with untreatable or postoperative recurrence of esophageal and gastric cancer III-IV
* Meet the diagnostic criteria of early cachexia (anorexia and metabolic changes, involuntary body mass reduction ≤5% within 6 months)
* Radiotherapy, chemotherapy or immunotherapy in our hospital
* Understand and fill in a variety of rating scales
* Informed consent, voluntary participation in this study

Exclusion Criteria:

* Neoadjuvant chemotherapy patients
* Intestinal obstruction or gastrointestinal bleeding
* Severe heart, lung and renal insufficiency
* Coagulopathy
* Clinical diagnosis with diabetes and other metabolic diseases
* The expected survival time is less than 1 month
* With cognitive dysfunction or poor coordination
* Allergy to creatine or curcumin
* With a history of drug abuse
* Doctors or researchers deem unsuitable for study participation
A Study Of PF-04449913 In Select Hematologic Malignancies

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. They may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response.
* ECOG performance status 0 to 2
* Adequate organ function

Exclusion Criteria:

* Patients with active CNS disease
* Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer
* Active GVHD other than Grade 1 skin involvement
* Known malabsorption syndrome
* Patient has an active, life threatening or clinically significant uncontrolled systemic infection
Lifestyle Changes Reducing Type 2 Diabetes Risk Among Arab Canadian Muslim Women.

Aim: The purpose was to investigate whether modifiable risk factors for type 2 diabetes can be reduced by an intensive healthy lifestyle intervention designed for Arab Muslim women.

Methods: Women were assigned randomly to either an Exercise and Nutrition Group (ENG) or a Control Group (CG). The ENG attended a women-only supervised exercise program that presented Arabic music and traditional Lebanese Dabka steps three times/week in the Mosque Gym for 12 weeks. A nutritionist was available one hour/week for nutrition education. The CG followed their typical day.

Women were assigned randomly using a computer-generated random numbers table to either an Exercise and Nutrition Group (ENG) or a Control Group (CG). The women received step-by-step instructions on how to complete a consecutive 3-day food record (including two week-days and one weekend day) and an exercise log for 7 days using a pedometer (YAMAX SW-200 Digi-Walker) to determine steps/day. The information and instruction were delivered to the women in English or Arabic. Body weight and height were measured to the nearest 0.1 kg and 0.1 cm, respectively. Women came to the lab after a 12 hour fast and a blood sample was drawn. Waist and hip measurements were taken along with resting blood pressure. Estimated fitness levels was measured by a trained kinesiologist using a Step Test (Siconolfi et al. 1985). All baseline measurements, including the 3-day food intake record and the 7-day pedometer step count log were repeated at the end of the 12-week intervention in both groups. The ENG group attended a supervised women-only exercise program that presented Arabic music and traditional dance steps (the Lebanese Dabka) three times a week in the London Muslim Mosque Gym and received nutrition education over the 12 weeks, one session per week.

Eligibility Criteria:
Inclusion Criteria:

* family history of type 2 diabetes (at least one parent),
* overweight or obese,
* been in Canada more than 10 years,
* mild hypertension,
* impaired glucose tolerance, or previous gestational diabetes (including giving birth to babies 4.0 kg or more),
* a sedentary lifestyle

Exclusion Criteria:

* uncontrolled hypertension,
* unstable angina,
* pulmonary and metabolic disease,
* severe arthritis or rheumatologic problems,
* already engaged in regular exercise training,
* pregnancy,
* menopause,
* already enrolled in a clinical research trial
A Study of JNJ-64530440 in Healthy Japanese Male Participants

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64530440 (JNJ-0440) in healthy Japanese adult male participants after single oral dose administration with ascending dose design.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI; weight \[kg\]/height\^2 \[m\]\^2) between 18.0 and 30.0 kilogram per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kilogram (kg), at time of screening
* Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site. If the results of the biochemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if these are grade 1 abnormal values and the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Blood pressure (after the participants has been supine for 5 minutes) between 90 and 140 millimeter of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the study drug

Exclusion Criteria:

* Any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
* History of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
* Known allergy to heparin or history of heparin induced thrombocytopenia
* History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening or at admission to the study site
Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.

Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required.

This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18-90 with a clinical suspicion of prostate cancer
* No contraindication to MRI

Exclusion Criteria

* Men unable to have a MRI scan, or in whom artefact would reduce quality of MRI
* Men unable to given informed consent
* Previous treatment (prostatectomy, radiotherapy, brachytherapy) of prostate cancer
* Ongoing hormonal treatment for prostate cancer
Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

This study will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. The study will also look at the effects of tibial plateau fractures on the quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be scanned in order for the non-injured leg to serve as the control. In this way muscle volume can be estimated from the muscle thickness at specific locations in the thigh. The muscle strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring isokinetic knee-extension torque, and functional assessment questionnaires will be completed at each study visit.


Eligibility Criteria:
Inclusion Criteria:

* All racial and ethnic groups
* Diagnosis of tibial plateau fracture
* Patients who opt for surgical treatment or non-operative treatment of their fracture
* Patients who consent to undergoing 3 MRI scans
* Patients who are willing to follow-up for a minimum of 52 weeks

Exclusion Criteria:

* Patients younger than 18 years old or older than 65
* Patients who may be pregnant or may become pregnant in the 52 weeks following injury
* Patients who have electric, magnetic, or mechanical devices currently implanted
* Patients who have abnormal ECG results
* Diagnosis of any additional lower extremity fractures other than tibial plateau
* Patients who fit the definition of a vulnerable population
Risk Taking and Decision-making in Cluster Headache Patients

Since there is conflicting and insufficient data regarding CH personality and addictive behaviour, the investigators will investigate risk- and reward seeking behaviour in people with cluster headache. If an increased tendency towards this behaviour is shown, it will add to the clinical knowledge of cluster headache and possible lead to insights in a common biological susceptibility.

Cluster headache is a severe primary headache disorder. In clinical anecdotes, people with cluster headache frequently report use of tobacco and illicit drugs. Furthermore, addictive behaviours and tattoos are considered to be more common in people with cluster headache than in the general population. The causality of these associations remains unclear. A common biological susceptibility has been proposed, predisposing people to both addictive behaviour and cluster headache. On the other hand, a role of illicit drug exposure in cluster headache pathophysiology has been suggested. The increased use of tobacco and illicit drugs could also reflect attempts to treat cluster headache attacks. In this explorative study the investigators will assess both subjective and objective measures reflecting addictive behaviour and risk- and reward seeking in cluster headache. This will add to the clinical knowledge of cluster headache and possible lead to insights in a common biological susceptibility.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-64 years
* Normal or corrected vision with acuity up to 20/60
* Presence of episodic (n=35) or chronic (n=35) cluster headache or migraine with or without arua (n=35), diagnosed according to the International Classification of Headache Disorders criteria, 3rd edition (ICHD-3, 3.1.1)

Exclusion Criteria:

* Diagnosis of uncorrected visual problems (myopia/presbiopia, peripheral vision problems or legal blindness)
* Current diagnosis of generalized anxiety disorder, depression or other psychiatric illness
* Other acute, unstable medical conditions or serious chronic diagnoses
Effect of Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt

The purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.

Compared with usual care, interventional group will (1) improve treatment attendance, (2) have less repeated suicide attempts in adults after a suicide attempts, and (3)have better patients' satisfaction with care.

Eligibility Criteria:
Inclusion Criteria:

Participants recruit adults who:

1. Discharge from an emergency department of a teaching hospital after attempt suicide
2. Aged above 18 years old
3. Agree to provide written inform consent.

Exclusion Criteria:

1. Patients were too ill to be interviewed
2. Patients have immediate and severe suicide risk.
The Effect of Dopamine on Diabetic Retinopathy

The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device.

Investigators also seek to assess if a medication called Sinemet™ CR can improve the electrical functions of the eye in participants with diabetes mellitus. This study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be randomized to a low or high dose Sinemet CR group.

The purpose of this study is to evaluate the use of electroretinogram (ERG) using a novel handheld system, RETeval, and evaluate contrast sensitivity testing in detecting pre-clinical retinopathy on a tablet device.

Investigators also seek to assess if a medication called Sinemet™ CR can improve the electrical functions of the eye in participants with diabetes mellitus. This study will include a total of 45 participants; 30 with diabetes mellitus and 15 age-matched non-diabetic controls. Participants with diabetes mellitus and electroretinogram (ERG) delays will be randomized to a low or high dose Sinemet™ CT group.

Age-matched controls will not receive Sinemet Ct drug treatment.

The study involves four visits over the course of 4 weeks, each visit consisting of 2-3 hours. Visual testing will be performed at 1 day and 2 weeks following treatment. The drug treatment will be halted and testing repeated again after a 2 week wash-out period.

Eligibility Criteria:
Inclusion Criteria

Participants with Diabetes Mellitus:

* Diagnosis of diabetes mellitus type-2
* HbA1c between 8 and 12%

Age-Matched Controls:

* Non-diabetic

Exclusion Criteria

Participants with Diabetes Mellitus:

* Currently taking dopamine-enhancing drugs (L-DOPA, bromocriptine)
* Currently taking nonselective monoamine oxidase (MAO) inhibitors
* Diagnosis of psychosis, Parkinson's disease, restless leg syndrome, major depression, confounding ocular disease (eg. visually significant cataract, glaucoma, macular degeneration, or retinitis pigmentosa)
* Pregnancy

Age-Matched Controls:

* Diabetes diagnosis
* Currently taking dopamine-enhancing drugs (L-DOPA, bromocriptine)
* Currently taking nonselective monoamine oxidase (MAO) inhibitors
* Diagnosis of psychosis, Parkinson's disease, restless leg syndrome, major depression, confounding ocular disease (eg. visually significant cataract, glaucoma, macular degeneration, or retinitis pigmentosa)
* Pregnancy
Seroma Prevention After Body Contouring Procedures

With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.


Eligibility Criteria:
Inclusion Criteria:

* All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study

Exclusion Criteria:

* Minors or patients with a designated health care proxy, revision surgeries, morbid obesity
The Hypertension in the Very Elderly Trial (HYVET)

The purpose of this study is to assess the benefits and risks of treating very elderly (those aged 80 or older) individuals with hypertension.

The benefit to risk ratio of treating hypertensives aged 80 or older has not been established. It has been suggested that at this age for each stroke prevented there is one non-stroke death. HYVET is designed to help clarify this.

HYVET is a randomised, double-blind, placebo-controlled trial in hypertensive subjects aged 80 or older. Active treatment consists of indapamide 1.5mg SR with the addition of perindopril 2mg - 4mg to reach a target blood pressure (BP) of \<150/80 mmHg. Entry criteria include a systolic blood pressure of 160-199 mmHg. Patients with isolated systolic hypertension (ISH) have been recruited since August 2003.

Eligibility Criteria:
Inclusion Criteria:

* Aged 80 or older
* Sitting systolic BP 160-199 mmHg AND sitting diastolic BP \< 110 mmHg

Exclusion Criteria:

* Known accelerated hypertension (retinal haemorrhages or exudates or papilloedema).
* Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor. Subjects allowed if treated with digoxin only.
* Renal failure (serum creatinine of more than 150 µmol/l).
* Previous documented cerebral or subarachnoid haemorrhage in the last 6 months. (Ischaemic cerebral and cardiac events do not exclude, although the patient must be neurologically and cardiologically stable.)
* Condition expected to severely limit survival, e.g. terminal illness.
* Known secondary hypertension (e.g. renal artery stenosis, chronic renal insufficiency, and endocrine cause).
* Gout.
* Clinical diagnosis of dementia.
* Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).
* Unable to stand up or walk
* Participation in a drug trial within the past month preceding selection.
* Alcohol or drug abuse.
* Less than 2 months placebo run-in.
* Contraindications to use of trial drugs
The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders

To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder

Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.

Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .

For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection.

Eligibility Criteria:
Inclusion Criteria:

* 1-Infertile women who have one of the criteria of poor ovarian response as follows ;
* Antral follicle count less than 7
* Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25

Exclusion Criteria:

1. Any endocrine or metabolic disorder such as polycystic ovary syndrome,
2. Hyperprolactinemia, diabetes and thyroid dysfunction.
3. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
4. any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia.
An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
* Treating physician's decision to initiate first-line Avastin treatment

Exclusion Criteria:

* Participation in a clinical trial evaluating anti-cancer therapies