cyrilzakka/clinical-trials huggingface dataset:
Study of Paclitaxel in Patients With Ovarian Cancer

RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less.

PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
* Patients relapsing \> 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis.
* CA 125 \>2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non- measurable disease.
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance score 0-2
* Life expectancy \>12 weeks
* Patient has blood counts at baseline of:

  * Absolute neutrophil count (ANC) \>1,5 x 109 / L.
  * Platelet count \>100 x 109 / L
  * Haemoglobin (Hb) ≥9g/dl (can be post transfusion)
* Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \< 2 x UNL
* Total bilirubin ≤1.5 x UNL.
* Adequate renal function defined as serum creatinine \< 2.0 mg/dl or 177μmol/l.
* Alkaline phosphatase (ALP) \< 2.5 x UNL
* Signed informed consent obtained

Exclusion Criteria:

* Patient has peripheral neuropathy of grade ≥ 2 per NCI-CTCAE version 3.0
* Surgical procedure due to progressive disease within 4 weeks of any of the CA-125 measurements
* Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1, Cycle 1).
* Bowel obstruction at screening
* Tumours of other origin or histology
* Patient of child-bearing potential, not practising adequate contraception, or pregnant or lactating women
* Patient has a history of severe allergy or severe hypersensitivity to study drugs
* Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs, e.g. heart, lung or kidney disease, suspicion of brain metastasis or mental disorder to make the patient unable to participate in the study
* Participation in an investigational drug study within 4 weeks prior to study treatment (Day 1, Cycle 1)
CXCR4 Modified Anti-BCMA CAR T Cells for Multiple Myeloma

Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 75 years old.
2. The expected survival ≥ 12 week
3. ECOG ≤ 2
4. Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
5. The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
6. Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
7. Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
8. Voluntary informed consent is given, agree to follow the trial treatment and visit plan

Exclusion Criteria:

1. Patients with other uncontrollable cancer
2. Active hepatitis B, hepatitis C, or HIV infection
3. Other uncontrolled active disease
4. Patients with coronary heart disease, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral hemorrhage or any other severe diseases
5. Patients with uncontrollable hypertension(≥ grade II)
6. Patients with history of uncontrollable mental illness
7. Long-term use of immunosuppressants after organ transplantation (inhaled corticosteroids are excluded)
8. Unstable pulmonary embolism or any arteriovenous embolism 30 days before enrollment;
9. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
10. Patients with uncontrollable infectious disease or need systematic treatment within the 14 days of enrollment;
11. Patients had other conditions that were not appropriate for the study determined by the researchers.
Lipoprotein Apheresis in Refractory Angina Study

The goal of this study is to determine the impact of apheresis on clinical parameters and symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct a prospective, randomised controlled crossover study of 20 patients with refractory angina and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients will then crossover to the opposite study arm with the protocol repeated. The hypothesis is that the above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and Refractory Angina. Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.

Angina which is refractory to conventional medical therapy and revascularisation is challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no effect on Lp(a) levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with refractory angina for more than three months.
* Two or more episodes of angina per week.
* Previous history of myocardial infarction, coronary artery bypass graft (CABG) surgery,percutaneous coronary intervention (PCI) or any combination of the above.
* Prescribed optimal medical therapy.
* Hypercholesterolaemia with an elevated Lp(a) \> 50mg/dL and an LDL-cholesterol less than 4.0mmol/L despite optimal lipid lowering drug therapy.

Exclusion Criteria:

* Patients with poor calibre veins for cannulation.
* Patients with any other chronic systemic illness such as liver or renal failure, neoplastic disease, overt cardiac failure, unstable coronary artery disease, coronary revascularisation or a myocardial infarction within the previous eight weeks.
* Pregnancy, untreated diabetes mellitus, untreated arterial hypertension, and those with general contraindications to undergoing Cardiovascular magnetic resonance imaging or contraindications to adenosine.
Prevention of Falls in Older Adults by Specific and Progressive Balance Training

Three months of balance training with follow-up 6 and 12 months thereafter.


Eligibility Criteria:
Inclusion Criteria:

* over 60 years with either osteoporosis or Parkinsons disease

Exclusion Criteria:

* under 60 years
Shorter Duration Radiotherapy to Treat Prostate Cancer After Removal of the Prostate

Radiation therapy is one of the standard treatments for men with prostate cancer who have detectable levels of prostate specific antigen (PSA, a prostate cancer specific marker) after surgery. When radiation therapy is given to patients who have an increase in PSA after surgery, it is called "salvage radiation therapy". Currently the standard radiation therapy course length for this type of cancer is around 7 ½ -8 weeks. Sometimes, radiation therapy after prostate removal causes unpleasant side effects. A shorter course of radiation therapy, known as a "hypofractionated" course, gives fewer but higher doses of radiation than standard radiation.

The purpose of this study is to test the safety of a shorter course of radiation therapy at progressively lower dose levels and shorter lengths of treatment (hypofractionated) with patients who have had their prostate removed. The study will assess whether the hypofractionated course works better without causing additional side effects to the remaining cancer cells in the prostate bed.

Primary Objectives:

To determine the shortest dose-fractionation schedule (Dose Schedule) with acceptable grade ¡Ã 3 GU/GI toxicity rate for salvage HypoFx RT to maintain a constant, high BED for prostate cancer response while reducing the BED for late GU and GI toxicity

To assess health-related quality of life (HRQOL) of the recommended Dose Schedule of salvage HypoFx RT by demonstrating no significant change in 1-year disease specific QoL, as compared to baseline

Secondary Objectives:

To evaluate and characterize the acute and late genitourinary (GU) and gastrointestinal (GI) adverse effects associated with postoperative, hypofractionated radiation therapy.

To evaluate biochemical failure rate, defined separately as nadir plus 2 ng/mL and as three consecutive rises in PSA, at 2 years after hypofractionated, post-prostatectomy radiation therapy.

To evaluate health utilities at 1 year after HypoFx salvage RT, as measured by the EQ-5D instrument.

To evaluate changes in sexual domain of EPIC quality of life instrument at 1 year after HypoFx salvage RT.

To evaluate the treatment burden for patients undergoing salvage HypoFx RT, in order to examine whether HypoFx RT results in less burdensome treatment for patients, as measured by patient-reported direct and indirect (i.e., transportation) health care costs and lost productivity due to treatment, as evaluated by the Work Productivity and Activity Impairment Questionnaire¢-General Health (WPAI-GH).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of prostate adenocarcinoma and
* have had a prostatectomy
* have detectable PSA
* 18 years of age or older

Exclusion Criteria:

* are receiving chemotherapy or other agents intended for cancer treatment
* history of rectal surgery or lower gastrointestinal bleed
* history of bleeding diathesis or abnormal sensitivity to ionizing radiation
* had prior pelvic irradiation or are scheduled to receive pelvic nodal irradiation
A Study of Targretin Capsules in Patients With AIDS-Related Kaposi's Sarcoma

The purpose of this study is to see if it is safe and effective to give Targretin capsules to patients with AIDS-related Kaposi's sarcoma (KS).

This is a multicenter, open-label study to evaluate the safety and efficacy of Targretin capsules in patients with AIDS-related KS. NOTE: The daily dose may be reduced as necessary for toxicity management.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Serum HIV antibody positive by ELISA.
* KS documented by biopsy (repeat biopsy is not required for entry if KS has been previously confirmed histologically and the histopathology report has been reviewed).
* A minimum of 6 mucocutaneous KS lesions, including at least 3 raised lesions, each of which has been present for at least 30 days or has a longest dimension of at least 10mm, and has not received prior local or topical therapy within 60 days of study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Concurrent, serious, uncontrolled infection including, but not limited to:
* Mycobacterium avium intracellulare or other mycobacterium infection; Pneumocystis carinii pneumonia; CMV retinitis or colitis; Toxoplasma brain abscess; Cryptococcal meningitis.
* Serious intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program.
* Known allergy or sensitivity to retinoid class drugs.

Concurrent Medication:

Excluded:

* Local or topical therapy such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy to any KS indicator lesion.
* Systemic anticancer chemotherapy, systemic anticancer hormonal therapy, and/or systemic anticancer immunotherapy.
* Systemic use of retinoid class drugs, beta-carotene compounds, or Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) for any indication.
* Human chorionic gonadotropin.

Concurrent Treatment:

Excluded:

Radiotherapy, cryotherapy, photodynamic therapy, and/or laser therapy for any KS indicator lesion.

Prior Medication:

Excluded:

* Systemic treatment of KS within 30 days of study entry.
* Systemic treatment with either Vitamin A in doses greater than 15,000 IU (5,000 mcg) per day (equivalent to approximately 3 times the RDA) or other retinoid class drugs for any indication within 30 days of study entry.
* Previous local or topical therapy of any KS indicator lesion such as, but not limited to, Vitamin A, tretinoin (all-trans-retinoic acid), other retinoid class drugs, or intralesional (injection) therapy within 60 days of study entry.

Prior Treatment:

Excluded:

* Radiotherapy, cryotherapy, photodynamic therapy and/or laser therapy within 60 days of study entry.
LIfestyle INterventionS for PaIn ReliEf (INSPIRE)

This pilot study will be a placebo controlled randomised intervention study in which participants with knee pain will be grouped into the diet intervention, exercise intervention, diet and exercise intervention or placebo arm. The study involves intake of dietary supplements and performing routine exercises which are commonly used and are not pharmacological agents. The end-points of the study are non-clinical outcomes. N= 120. 2x2 intervention with 30 individuals per block: placebo, diet only, exercise only, diet + exercise


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participant eligibility includes those aged \>18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Have psychosocial or gastrointestinal (e.g. malabsorptive conditions such as IBS/IBD, coeliac)
* Are taking the following medications: immunosuppressants, anticoagulants, amiodarone and/or perhexiline
* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program
* Pregnant or breast feeding
* History or current psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Those undergoing revision, having severe hip OA, inflammatory arthropathies
* Diagnosed non-OA cause of knee pain (e.g. rheumatoid arthritis)
* Neuropathy or diabetes mellitus
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection

The purpose of this study on volunteers is whether THC and short-living metabolites are suited to detect recent Cannabis smoking within urine doping control.

About half of all positive doping cases in Switzerland have been related to Cannabis consumption (mainly recreational smoking). So far, the target analyte in urine is 11-nor-9-carboxy-THC (THC-COOH), the main metabolite of delta-9-tetrahydrocannabinol (THC), which is excreted up to several days after single use. However, the wide detection window of THC-COOH does not allow a conclusion concerning the impact on the physical performance. Therefore, the evaluation of other target analytes with shorter elimination half-lives is needed and the aim (primary endpoints) of the present study. This pharmacokinetic, open, 1-session trial on 12 healthy, male, infrequently Cannabis smoking volunteers is focussed on the GC/MS profiling of THC and metabolites in urine and plasma after standardized smoking of a single 7% THC Cannabis cigarette of the Dutch Ministry of Health, Welfare \& Sport, Office of Medicinal Cannabis. Pharmacodynamic measurements (secondary endpoints) include the side-effects monitoring by using Visual Analog Scales and checking vital functions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects; light (max. 1/month), infrequent Cannabis smokers, medium (max. 15/month) tobacco smokers experienced in the inhalation technique; age 20-30 years; body weight 75+/-15 kg; evaluation based on normal medical history, physical examination, laboratory tests (safety lab), normal lung functions (spirometry).
* Informed consent after information (written) by the study physician and principal investigator on nature, significance and scope of the trial.
* Informed consent by the volunteer regarding transmitting trial-related data to the sponsor and to the competent control authorities.

Exclusion Criteria:

* Hypersensitivity to cannabinoids. - Regular (more than once per month, weekly or daily) Cannabis use. - The use of alcohol, any medication or drugs, especially Cannabis, within the last 2 days prior to and during the 1-day session is not allowed. Cannabis use is also not allowed during the following 11 days of urine collection, i.e. up to the end of the study.
* Positive Cannabis urine test before the session.
* Driving any vehicle, and operating with machines during and within 48 h after the session.
* Psychotic or vulnerable subjects.
The Efficacy of Fenugreek Supplementation on Men's Health

1. The problem: There is limited research on the use of herbal supplements in general, and fenugreek specifically, to improve male health, particularly to increase testosterone levels. As well, no located studies have examined the effects of fenugreek supplementation on healthy men's health-related quality of life, anxiety levels, and body composition.
2. Relevant research examined the effects of fenugreek supplementation with healthy men aged between 43 and 70 years of age. The researchers found that both total serum testosterone and free testosterone increased compared to placebo after 12 weeks of active treatment. The researchers concluded that fenugreek supplementation was a safe and effective treatment for reducing symptoms of possible androgen deficiency, improves sexual function and increases serum testosterone in healthy middle-aged to older men. Another study found that fenugreek supplementation improved aging male symptoms and testosterone levels remained in a normal range in healthy men aged 25 to 45 years.
3. The importance of this study: The importance of this study is to help determine if fenugreek supplementation affects testosterone levels, body composition, health-related quality of life, anxiety, and aging symptoms in healthy men aged 21 - 45 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men between the ages of 21- 45 that were recreationally active.

Exclusion Criteria:

* Above 30% body composition, not in the age range, history of asthma, diabetes, hypoglycemia, or took any hormonal supplements such as testosterone or anabolic steroids.
Topiramate for the Treatment of Methamphetamine Dependence - 1

The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.


Eligibility Criteria:
Inclusion Criteria:

* Treatment seeking individuals as the time of the study
* Must be able to proved written informed consent
* Must have a body mass index greater than 18 kg/m(2)
* Must meet DSM-IV criteria for methamphetamine dependence
* Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
* If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

* Please contact the site for more information
Brain Imaging of Cognition Inn Schizophrenia and Depression

Schizophrenia and depression are among the most disabling disorders in all of medicine. Cognitive deficits play a key role in patients' disability, affecting their capacity to contribute actively to society by sustaining employment or academic activity. Moreover, cognitive difficulties tend to persist even after the stabilization of other clinical symptoms. Verbal memory and emotion regulation are two important cognitive domains that are impaired in schizophrenia and depression and are associated with patients' functional outcomes. In this study, we are using brain imaging to investigate the brain mechanisms underlying these cognitive deficits in these populations.

This study uses Functional Magnetic Resonance Imaging (fMRI) to help us better understand the cognitive problems that people who have schizophrenia, schizoaffective disorder, or depression experience. Cognitive problems can encompass a variety of different domains such as with attention, thinking, memory, emotion, and emotional regulation.

The study will involve three visits at The Royal's Institute of Mental Health Research. Each visit will last about 2.5 hours long.

Visits 1 and 2: We ask participants to fill out several questionnaires on a computer. We also ask participants to answer some questions about their current and past mental health. Participants will also perform some tasks involving general thinking skills.

Visit 3: This is the scan visit where we use fMRI, which is a technique that allows us to take a 3D picture of the brain using magnetic fields. It also allows us to estimate how active different regions of the brain are. During the fMRI, participants will lay down in a narrow tube in the fMRI scanner and hold still. Throughout the experiment, participant will perform three short tasks in the scanner, where they will see words and pictures and press a button to answer some questions.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* current Intelligence Quotient (IQ) \> 70 as measured by the Wechsler Abbreviated Scale of Intelligence (WASI)
* the ability to read and speak fluent English
* a diagnosis of schizophrenia, schizoaffective or major depression disorder
* stable medication for more than one month

Exclusion Criteria:

* significant neurological or other medical disorders that may produce cognitive impairment
* a recent history of substance abuse or dependence (within the past 3 months)
* any magnetic resonance imaging (MRI) contraindications (e.g. metallic head implant, history of seizure, pacemaker)
* decisional incapacity requiring a guardian
* taking medications that are rated as Anticholinergic Burden (ACB) Score 3 (severe) or taking benzodiazepines on a daily basis
Italian Lung Cancer Observational Study

LUCENT is an observational study focused on malignant pulmonary and tracheo-bronchial disease. It involves a large proportion of reference Italian thoracic surgery centers. The relevance of the study is related to the epidemiology of lung cancer in the world - also known as "Big Killer" - and the high mortality rates both in males and females.

The aim of his prospective study is to collect a large bulk of postoperative patients' outcome data and to produce up-to-date descriptive statistics of patients undergoing surgery for lung cancer. These results will be pivotal to compare the clinical results of all the relevant specialities involved in the care of lung cancer such as medical oncologists and radiation oncologists.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lung cancer
* informed consent

Exclusion Criteria:

* alcohol or drug abuse
* age \< 18
* inability to express consent