cyrilzakka/clinical-trials huggingface dataset:
Dexrazoxane and Cisplatin in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as dexrazoxane and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may help kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of dexrazoxane when given together with cisplatin in treating patients with advanced solid tumors.

OBJECTIVES:

* To establish the maximum tolerated dose of a 96-hour continuous infusion of dexrazoxane hydrochloride and a single-dose, one-hour infusion of cisplatin in patients with advanced solid tumors.
* To determine the pharmacokinetics of dexrazoxane hydrochloride and cisplatin when given concurrently.
* To describe the toxicities of infusional dexrazoxane hydrochloride and cisplatin given in combination.

OUTLINE: Patients receive dexrazoxane hydrochloride IV continuously over 96 hours beginning on day 1 and cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically during course one for pharmacokinetic studies. DNA isolated from the samples is also analyzed for oxidative DNA damage by gas chromatography/mass spectrometry.

After completion of study treatment, patients are followed periodically.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically confirmed advanced, incurable cancer that is unresponsive to prior chemotherapy regimens or for which no standard chemotherapy regimen exists
* History of brain metastases allowed if controlled by radiotherapy or surgery and patient's neurological status is stable

  * Concurrent corticosteroids allowed as long as required dose is stable or decreasing
* Not eligible for a higher priority study

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Karnofsky performance status 60-100%
* Life expectancy ≥ 12 weeks
* ANC ≥ 2,000/mm³
* Platelet count ≥ 100,000/mm³
* Serum creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 60 mL/min
* Bilirubin ≤ 1.5 mg/dL
* SGOT \< 3 times upper limit of normal
* Recovered from any recent severe infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

Exclusion criteria:

* Patients with any nonmalignant intercurrent illnesses (e.g., cardiovascular, pulmonary, neurologic) that are either poorly controlled with currently available treatment, or are of such severity that the investigators deem it unwise to enter the patient onto this study

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy or chemotherapy and recovered
* Recovered from prior major surgery

Exclusion criteria:

* Concurrent treatment for severe infection
Search for Biological Markers of Orosensory Perception of Fatty Acids in Healthy Subjects and Possible Modifications in Patients With Type 2 Diabetes and in Obese Non-diabetic Patients.

Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to determine in healthy humans whether the orosensory perception of fatty acids is followed by a modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1, secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue (leptin, ghrelin, adiponectin).

We also aim to determine whether the hormonal response induced by orosensory stimulation by lipids is modified:

* in patients with type 2 diabetes
* in obese non-diabetic patients We expect to show an increase in biological markers biological, and more particularly in certain digestive hormones such as Pancreatic polypeptide, GIP, GLP-1...after stimulation of the lingual lipid receptor, CD36. We will also determine whether or not this response is modified in patients with type 2 diabetes and in obese non-diabetic patients.

We also wish to measure the subjects' gustatory detection threshold for a fatty acid (linoleic acid), and to determine whether there is a relationship between the orosensory perception threshold for linoleic acid and the physiological status of the subjects. In order to achieve this, the thresholds for healthy subjects will be compared with thresholds for obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid in healthy subjects will be lower than that in obese or diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided written consent
* Healthy volunteers:
* Men \> 18 years
* 19 \<BMI \< 25 kg.m-2
* Fasting triglyceridemia \< 1.50 g/l
* Fasting glycemia \< 1.10 g/l
* Without regular medical treatment
* Patients with type-2 diabetes:
* Men \>18 years
* type 2 diabetes (fasting glycemia \> 7 mmol/l at the diagnosis) treated with diet or diet + oral antidiabetics (metformin, and/or insulinsecretion agents \[hypoglycemic sulphonamides, or glinides\] and/or glitazones and/or acarbose)
* Stable oral antidiabetic treatment for 3 months
* Obese non-diabetic patients:
* Men \> 18 years
* BMI 30 kg.m-2
* Fasting glycemia \< 1.10 g/l
* HbA1c \< 6.0%
* Absence of treatment with hypoglycemic agents (including benfluorex)
* Absence of medical treatment for obesity
* Absence of a history of surgery for obesity (band, by-pass) or gastric stimulator (type Tantalus)

Exclusion Criteria:

* Persons not covered by the national health insurance
* Smokers, or smoking cessation within the 3 months preceding inclusion
* Persons with eating disorders:
* Severe digestive disease (enteropathy with absorption disorders, inflammatory digestive disease)
* Pancreatic insufficiency
* History of pancreas surgery
* Type 1 diabetes
* Renal insufficiency
* Hepatic insufficiency
* Treatment with proton pump inhibitors, insulin, GLP-1 analogues, DPP-4 inhibitors
Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

The aim of the study will be to assess the effectiveness of Diacutaneous Fibrolysis technique on pain, range of motion (Patellofemoral joint mobility test and muscle length test), strength and function in patients with Patellofemoral Pain Syndrome and muscle shortening.

Muscle imbalance is one of most important factor associated with Patellofemoral Pain Syndrome. Shortening of lateral muscles of the thigh have a close relationship with patella position and tracking and patellofemoral pain. The scientific evidence for effectiveness of any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor.

Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique to release adherences and fibrosis between the different musculoskeletal structures. Diacutaneous Fibrolysis is applied by a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually.

The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied in the soft tissues more related with patellofemoral pain.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral patellofemoral pain longer than three months
* Anterior or retropatellar pain of non-traumatic origin that is provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping, jumping, or stair ascending/descending.
* The presence of pain on palpation of the patellar facets, on step down from 25 cm step, or during a double leg squat.
* Pain over the previous week equal to or greater than 3 on a 10-cm visual analogue scale.
* The presence of muscle shortening in rectus femoris or tensor fascia lata muscle length test and/or hypo-mobility or stiffness in the compartmental muscle play.

Exclusion Criteria:

* Previous knee surgery or traumatic lesions
* Concomitant injury or pathology of other knee structures
* History of patella subluxation or dislocation
* Evidence of knee joint effusion
* Pain in and/or referred from the hip or lumbar spine
* Currently undergoing physiotherapy treatment for Patellofemoral pain syndrome or use anti-inflammatories or corticosteroid medication at the same time of the study.
* Subjects unable or unwilling to give informed to written consent or fulfil questionnaires.
A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500

The purpose of this study is to:

1. Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of \[14C\]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
2. Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Biological males ≥ 18.0 and \< 55.0 years of age at time of providing Informed Consent.
* Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
* Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:

  1. is documented to be surgically sterile (i.e., successfully vasectomized); or
  2. agrees to use double-barrier contraception for at least 3 months after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 3 months post dose.
* Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen.
* Non-smoker

Key Exclusion Criteria:

* Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG or laboratory tests at Screening, Admission or predose on Day 1.
* Any history of serious allergic/hypersensitivity reactions.
* History or presence of alcohol or drug abuse within 2 years prior to Screening.
* Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void. Usual habit of \< 1 or \> 3 bowel movements per day.
* Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of the thorax and bony skeleton) within the past 12 months .
* Participation in another clinical study in which a \[14C\]-labeled drug was administered within 1 year prior to Admission.
* QTcF interval (QT interval corrected for heart rate per Fridericia's formula) \> 450 msec at Screening, Admission or predose on Day 1. Personal and family history of long QT syndrome or unexplained sudden death in a first-degree relative under 50 years of age.
* Glomerular filtration rate (GFR) \< 80 mL/min/1.73 m2
* Loss or donation of blood (approximately 500 mL or greater) within 60 days prior to study drug administration on Day 1; donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1; or donation of plasma within 30 days prior to study drug administration on Day 1.

Additional protocol defined inclusion/exclusion criteria may apply.
Gene Testing in Patients With Colon Cancer

RATIONALE: Analyzing the structure of genes found in a person's cancer cells may help doctors improve methods of treating patients with colon cancer.

PURPOSE: Clinical trial to study the genes of patients treated with chemotherapy for colon cancer.

OBJECTIVES:

* Determine the relationship between disease free survival, overall survival, and tumor replication error status for patients who have received adjuvant chemotherapy for colon cancer on CALGB protocol 8896.
* Determine the prognostic and predictive values for response to this therapy in these patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients who received chemotherapy for colon cancer as part of CALGB protocol 8896
* Underwent an initial resection for adenocarcinoma of the colon and were determined to have a high risk of tumor recurrence based upon nodal disease or local extension of tumor with obstruction or perforation due to tumor
* Surgical specimen blocks available, including tumor tissue and normal tissue
Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients. Mortality remains high for those patients with comorbidities (50% for patients with the most severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids remains controversy. Some retrospective studies in that field did not find any beneficial effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies were retrospective, non randomised studies including various underlying disease and severity of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult to interpret all the results.

The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV immunocompromised patients with a double blinded randomised clinical trials comparing adjunctive steroids to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Severe PcP : 1 / interstitial acute pneumonia with possible or typical criteria for PcP and positive specimen for Pneumocystis jirovecii (excluding PCR) ; or interstitial acute pneumonia with typical criteria for PcP and positive PCR in respiratory specimen. 2/ Arterial pression of Oxygen (PaO2) \< 60 mmHg on room air need of 3 L/min oxygen for saturation \>92% or tachypnea\>30min need of mechanical ventilation for acute respiratory failure.
* Treatment for PcP started for less than 7 days.
* Non-HIV immunosuppression : malignant hematological disease, solid tumor cured for less than 5 years, allogenic stem cell transplant, Steroids (\>0.3mg/kg equivalent prednisone for more than 3 weeks or \> 20mg/days for more than one months) or other immunosuppressive treatment for more than one months or solid organ transplantation.
* Signed inform consent by patient or relatives
* Health insurance

Exclusion Criteria:

* HIV Serology HIV 1 or 2 positive
* Need of steroid ≥1mg/kg/j equivalent prednisone for another pathology (acute Graft versus Host disease (GVH= for example)
* Contra-indication for steroids
* Pregnancy of breath-feeding
* Denied to participate
* No health insurance
* tutelage
Urinary Catheter Exchange on Admission of Septic Elderly With Permanent Catheter Before Initiation of Antibiotics

In the era of emerging antibiotics resistant microbiology, we look for better outcome in the treatment of infections in the elderly.

We look for guidelines to manage an elderly who has a permanent urinary catheter, admitting to E.R. with Fever/Sepsis.

We assume that exchanging the permanent urinary catheter prior to the Urine Culture sample as well as for initiating antibiotic treatment will improve the outcome of the patients.It could help the day-to-day fight for the proper antibiotics treatment to avoid resistance.


Eligibility Criteria:
Inclusion Criteria:

* \>65 years
* Permanent Urinary Catheter
* FEVER or Septic State

Exclusion Criteria:

* Supra-Pubic Aspiration Catheters
* Septic Shock
* I.V. Antibiotics Initiated before admission
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence

This is a Phase II/III trial with two groups of adults successfully cured of category 1 pulmonary TB receiving either VPM1002 or placebo. Single dose of VPM1002 / placebo will be administered to calculate efficacy of the vaccine against TB recurrence.

The study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary TB patients who have successfully completed ATT and declared cured by bacteriological confirmation.

The eligible participants will be randomized in 1:1 ratio to receive single dose of either VPM1002 or placebo. After study vaccination, participants will be followed up for one year. Any suspected TB case during follow up will be further evaluated and bacteriologically confirmed. Study participants will be actively followed up for 2 months post-vaccination for any solicited local and regional reaction. SAEs will be recorded and reported throughout study participation.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥18 and ≤65 years.
2. Bacteriologically confirmed Category I pulmonary TB patients (including controlled diabetics with HbA1c level ≤7% and non-diabetics) who successfully completed ATT as per national guidelines.
3. Must have a sputum sample showing bacteriologic confirmation of cure - defined as smear negative.
4. Female participants who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.
5. Participant must intend to remain in the area during the study period.

Exclusion Criteria:

1. Reactive serology for HIV
2. History of extrapulmonary TB
3. Known or suspected impairment of immunological function
4. Pregnant and / or lactating female participants
Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.

Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
* Patients must be willing and able to give informed consent.

Exclusion Criteria:

* Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
* Premature discontinuation from study TVP 1012/133 for any reason.
* A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary hepatic, renal, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.
Home Based Resistance Training For Type 2 Diabetes

This study will investigate the biological and psychosocial benefits of a home-based resistance-training program for sedentary, obese adults living with type 2 diabetes.

Obese individuals with type 2 diabetes will be randomly assigned to either an experimental group where they will perform moderate to high intensity resistance training (50-60% 1RM weeks 1-3 and 70-85% 1RM in weeks 4-16) three times per week for 16 weeks or to a non-training control group. All resistance training will be performed at home using a multigym apparatus. A personal trainer (PT) will come to the homes of each participant in the experimental group to make sure that exercises are being performed safely with the correct technique, and at the prescribed intensity. In the first two weeks, the PT will come to all 3 sessions per week. In weeks 3-4 this will be reduced to 2 times per week, in weeks 5-8 the PT will come once per week and in the last 8 weeks once bi-weekly.

Eligibility Criteria:
Inclusion Criteria:

Type 2 Diabetes Overweight and Obese (BMI\>28) Living inside of City limits

Exclusion Criteria:

Ischemic heart disease Osteoporosis Musculoskeletal abnormalities Currently performing resistance training
Effect of Education on Breast Feeding on Primiparous Women

Exclusive breastfeeding is very important for an infant's growth and development. Self-efficacy is a modifiable psychological variable in sustained breastfeeding that is defined as a mother's confidence in her perceived ability about successful exclusive breastfeeding. Self- efficacy beliefs function as an important set of human motivation , affect , and action which operate on action, through motivation, cognitive and affective interventing process. teaching strategies ,based on Bandura,s self-efficacy theory and adult learning principles were incorporated in this research design. In regards with the importance of education in increasing breastfeeding self-efficacy and exclusive breastfeeding, the current study was conducted in order to compare of the effectiveness of two educational methods, i.e., "Hands on" and" Hands off" on breastfeeding self-efficacy in primiparous mothers.

In the present clinical trial, 136 nursing mother were randomly assigned to one of the three groups. Participants in the experimental groups received one of the structured one-on-one educational sessions (i.e., hands off or hands on) within the first two hours of giving birth. Mothers in control group received usual postpartum care. Follow-up assessments were conducted one, four, and eight weeks after the birth. Data collection was done through interview forms, examination and observation, checklist of breastfeeding status, breastfeeding self-efficacy and daily-feeding form.


Eligibility Criteria:
Inclusion Criteria:

vaginal normal delivery normal neonate lack of maternal- neonatal lactation problems contact number satisfying in participation in study

Exclusion criteria would not like to continue used tranquilizers or experienced stressful events