cyrilzakka/clinical-trials huggingface dataset:
Aminocamptothecin in Treating Patients With T-cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with advanced cutaneous T-cell lymphoma.

OBJECTIVES: I. Assess the antitumor activity of aminocamptothecin (9-AC) administered by 72-hour infusion in patients with advanced cutaneous T-cell lymphoma. II. Assess the toxic effects of 9-AC administered on this schedule.

OUTLINE: Single-Agent Chemotherapy. Aminocamptothecin, 9-AC, NSC-603071.

PROJECTED ACCRUAL: A total of 30 patients will be accrued; if no more than 1 response is seen in the first 15 patients, the study will close. Probable duration of study is 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, advanced stages IIB/III/IV cutaneous T-cell lymphoma Measurable or evaluable disease required Measurable disease includes: Skin disease evaluated by clinical assessment grid method Lesion measurable on imaging (i.e., CT measurement of lymph nodes) Pure osteolytic lesion Unidimensional lesion for which a normal measurement is available (e.g., mediastinal width on x-ray) Evaluable disease defined as malignant disease evident on physical or radiographic exam but not measurable by ruler or caliper, i.e.: Pelvic masses Confluent multinodular lung metastases Skin metastases CNS metastases eligible if stable for at least 4 weeks following completion of surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No contraindication to indwelling central venous catheter No active infection including HIV No other medical condition that would preclude protocol compliance No pregnant or nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological therapy allowed Chemotherapy: Prior systemic chemotherapy allowed Patients with more than 1 prior regimen analyzed separately At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Prior skin irradiation allowed At least 4 weeks since wide-field radiotherapy Surgery: Fully recovered from prior surgery Other: Prior topical therapy allowed Prior PUVA allowed
THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY

Laparoscopic sleeve gastrectomy is one of the most popular bariatric surgery in the world. The most important complication about this surgery that the leakage from the stapler line because of the inconvenient stapler choice..The stapler colour has to be chosen to the gastric wall thickness. It is not known well that the effect of Helicobacter pylori to gastric wall thickness Nobody pay any attention about being Helicobacter pylori positive when they are choosing stapler colour during the Laparoscopic sleeve gastrectomy so that everybody use the same type of stapler in Helicobacter pylori positive and negative patients during the Laparoscopic sleeve gastrectomy .Because of this inconvenient staplers use in the Laparoscopic sleeve gastrectomy the risk of leakage would be increase. Purpose of this research is that what is the effect of Helicobacter pylori to the gastric wall thickness and if the patients who will undergo Laparoscopic sleeve gastrectomy take the Helicobacter pylori eradication therapy before the surgery will gastric wall thickness increase or decrease. .

All patients who will undergo to Laparoscopic sleeve gastrectomy have upper gastrointestinal system endoscopy before the surgery in our clinical routine. In our research some patients who has Helicobacter pylori positive endoscopic biopsy will take Helicobacter pylori eradication therapy one month before the surgery and some patients will not take any medication about Helicobacter pylori. All of gastric specimens( Helicobacter pylori positive or negative ) will examine microscopically in the pathology laboratory. The two groups which preoperatively Helicobacter pylori positive detected in endoscopic biopsy will compare with Helicobacter pylori negative control group. Control group will include 30 patients. The other two groups will include 44 patients for each group . The number of patients of group has been determined by power analysis. Gastric specimen will be examined by 3 points ; fundus, corpus, antrum. All of microscopic measurements will be done from that points from minor curvatura. These 3 points ; fundus( 1 cm from the top of staple line) , corpus (middle of the staple line) , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from the minor curvatura. These 3 points will examine about wall thickness (mucosa- submucosa-muscularis propria -serosa ) and the status of Helicobacter pylori. The end of the study it can be determined the effect of Helicobacter pylori to the gastric wall thickness.

Eligibility Criteria:
Inclusion Criteria:

* All patients who will undergo to LSG will have upper gastrointestinal system endoscopy before the surgery and positive HP results.

Exclusion Criteria:

* Having allergy to the medications which use for the HP eradication therapy
* The patients who is incompatible for the HP eradication therapy
* The patients who decided to undergo to another bariatric surgery peroperatively
Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure

This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients may be male or female age 18 years or older.
* Women must be post-menopausal or surgically sterile.
* Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.
IM Olanzapine Versus Haloperidol or Midazolam

The purpose of this study is to determine whether intramuscular olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or midazolam when used in the management of acute agitation in the emergency department.

To address significant knowledge gaps by several means:

1. Investigate intramuscular use of sedative drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.

   The multi-centre RCT will determine the safety and efficacy of intramuscular olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in emergency department. Specifically, we aim to determine if administration of intramuscular olanzapine (a)is more effective than sedation with intramuscular haloperidol or intramuscular midazolam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and midazolam arms with respect to safety, efficacy and adverse events.
2. Investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. These may include patient demographics and regular medications and adherence.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.

Exclusion Criteria:

* Patients will be excluded if there are

  1. known hypersensitivity or contraindication to the study drugs
  2. reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
  3. known pregnancy
  4. acute alcohol withdrawal
  5. patients aged\>75 years.
Phospholipids as Nutritional Support for Reduction of Anxiety

The goal of this clinical trial is to learn about the effects of a milk-based dietary supplement in adults that report regular and frequent episodes of intermittent anxiety. The main question it aims to answer is: Can this extract be used to reduced symptoms of intermittent anxiety?

Participants will consume the milk-based dietary supplement every morning for 4 weeks and each week they will fill out 3 different questionnaires.

Clinical study evaluating the effects of a dietary milk-based supplement to help reduce symptoms of anxiety. The milk-based supplement is a fat-rich fraction of whey, rich in phospholipids.

24 subjects who report frequent and regular episodes of intermittent anxiety will participate in a questionnaire based clinical trial, wherein they will be consuming the milk-based dietary supplement each morning for 4 weeks.

Each week subjects will fill out 2 questionnaires evaluating their anxiety and 1 questionnaire evaluating their sleep. Changes in stress will be measured relative to baseline scores, collected during the first week before supplement consumption.

Eligibility Criteria:
Inclusion Criteria:

* Adult people of any gender
* Age 18-75 years (inclusive)
* BMI between 18.0 and 34.0 (inclusive)
* Experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations.
* Specific situations that occur regularly that cause anxiety, for example:
* Performing specific tasks at work or at home
* Inter-personal conflicts at work or at home
* Driving or commuting
* Fearful and worrying about one's own situation (such as paying bills)
* Worrying about ongoing problems experienced by others

Exclusion Criteria:

* Cancer during the past 12 months
* Chemotherapy during the past 12 months
* Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication
* Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product
* Food allergies or insensitivity related to lactose or other ingredients in test product
* People who are pregnant, nursing, or trying to become pregnant
Outcomes of Stem Cells for Cerebral Palsy

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in patients with cerebral palsy.

The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cells in 40 patients with cerebral palsy at Vinmec International Hospital, Hanoi, Vietnam.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy of any types caused by oxygen deprivation.

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
Culturally Tailored Nurse Coaching Study for Cancer Symptom Management

The purpose of the study is to see whether or not a telephone/ text message intervention, delivered by a registered nurse, is helpful in managing symptoms and can also prevent dehydration caused by chemotherapy treatment when given together for patients with metastatic breast, colon, lung or prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible for Chemotherapy for the first time (Previous \& Ongoing hormonal only treatment allowed OR Neoadjuvant \& Adjuvant chemotherapy regimens with 2+ drugs allowed)
2. \> 18 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
4. There are no life expectancy restrictions
5. Women of child-bearing potential are allowed in the study as long as they are eligible for the chemotherapy treatment.
6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients on immunotherapy only will be excluded
2. Previous chemotherapy
3. Under 18 years old
4. Medically Diagnosed with a Cognitive Impairment. Rationale for excluding people with cognitive impairment is that they would not be able to fully participate in the self-management care aspects of the intervention via the telephone, nor provide informed consent.
5. No access to a telephone
6. Blind or Deaf; If subject is Hearing-impaired or illiterate, then the subject may have a family member participate as a telecommunication surrogate with them in the study
Prediction of the Onset of Term and Preterm Labour

This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.

Preterm birth is not a single entity but rather multifactorial The mechanisms underlying preterm birth are multifactorial and include stretch, oxidative stress, inflammation, infection and thrombosis. 85% of women have no identifiable risk factors for preterm birth and there is a requirement to develop a biomarker which can be used early in pregnancy to identify such women at risk. Equally important is to have a detection tool which will allow us to offer an individualised approach to preterm birth prevention and the women to benefit personalised surveillance and timely preventative measures such as cervical cerclage or progesterone.

The aim of this study is to collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour. We will use maternal blood, urine and vaginal secretion to look for biomarkers in these samples which can be use in the clinical setting to determine which women will go on to give birth preterm. This will allow clinicians to correctly identify these women and initiate treatment in the right woman to prevent preterm labour and birth. Equally important it will reduce unnecessary intervention and admission in those women who are not at risk.

Eligibility Criteria:
Group 1 inclusion criteria

* Pregnant woman
* 36 weeks gestational age

Group 1 exclusion criteria

* Risk factors for preterm birth (previous preterm birth or second trimester loss, cervical suture, previous cervical treatment, previous full dilatation caesarean, transabdominal suture).
* Planned Caesarean Section
* Any high-risk pregnancy conditions such as PET (pre-eclamptic toxaemia), OC (Obstetric cholestasis), FGR (fetal growth restriction)
* Unable to read written English
* Unable to provide informed consent
* Poor attendance with antenatal care
* Uncertain gestational age

Exclusion criteria for subset within group 1 using heart rate monitor

* Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)
* Skin condition where there is sensitivity to wearing a skin monitor
* Known heart condition or use of a pacemaker
* Taking any medications that may affect heart rate

Group 2 inclusion criteria

* Pregnant woman
* Presenting at or after 24 weeks gestational age and before 36 weeks / Symptoms of threatened preterm labour (abdominal pain) with fetal fibronectin level ≥ 50 ng/mL and without rupture of membranes
* In-utero transfer with suspected threatened preterm labour with evidence of cervical shortening and dilatation with or without a fetal fibronectin
* Rupture of membranes with or without contractions

Group 2 exclusion criteria

* Any high-risk pregnancy conditions such as PET (pre-eclampsia), OC (Obstetric cholestasis), FGR (fetal growth restriction)
* Unable to read written English
* Unable to provide informed consent
* Poor compliance with antenatal care
* Uncertain gestational age
Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)

The purpose of this post-marketing surveillance is to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients treated with fluticasone propionate and salmeterol xinafoate.


Eligibility Criteria:
Inclusion Criteria:

* Must use fluticasone and salmeterol for the first time

Exclusion Criteria:

* Patients with hypersensitivity to salmeterol and fluticasone
* Patients with infection which salmeterol and fluticasone is not effective
* Patients with deep mycosis
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase.

After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.

Eligibility Criteria:
Inclusion Criteria

* Signed Informed Consent Form, prior to screening evaluations
* In good physical and mental health
* Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation
* Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory
* Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
* Willing to donate the retrieved oocytes
* Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit

Exclusion Criteria

* Abnormal karyotype
* Any known clinically significant systemic disease (e.g., insulin dependent diabetes)
* Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
* Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV
* Diagnosed as "poor responder"
* History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy)
* Pregnancy or lactation
* Use of any investigational drug during 3 months prior to start of the current COH cycle
* Previous participation in the study
* Hypersensitivity to any trial product
Food Effects of Single Oral Dose of 600mg TR-701

This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.

Subjects will receive the following treatments in a crossover design:

Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast.

Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.

Descriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 20 to 29.9 kg/m2
* Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control

Exclusion Criteria:

* history or clinical manifestations of any clinically significant medical disorder
* history of hypersensitivity or allergies to any drug compound
* history of stomach or intestinal surgery or resection
* history of alcoholism or drug addiction within 1 year
* pregnancy, lactation, or breastfeeding
* use of any tobacco-containing or nicotine-containing products within 6 months
* use of any other medications
* use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine
The Peripheral Intravenous Catheterisation

Pain management during medical care is considered to be a basic human right and also affects patient satisfaction. In addition, effective management of acute pain contributes to improved patient outcomes. Patient satisfaction is a subjective state that indicates whether the healthcare provided has met the patient's needs and expectations. Many nurse theorists, including Florence Nightingale, have expressed the importance of providing comfort and relief for patients. In fact, comfort has been a crucial aspect of patient care since Nightingale's days, and has been considered an indispensable constituent of integrated nursing care. Studies to improve comfort may contribute to improving individuals' health outcomes, enforcing health-improvement behaviors, and improving healthcare quality as well as satisfaction and contentment of the individual and the nurse in the process of administering healthcare. In the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of PIC has been evaluated in adults, studies on nonpharmacological methods are limited. However, most of the studies were performed in healthy adults. Easy, inexpensive, and fast methods with unlikely side effects are needed to control pain and distress due to the PIC insertion in adults. Therefore, this study was performed to evaluate the effectiveness of distraction methods.


Eligibility Criteria:
Inclusion Criteria:

* Patients who ranked 4 (less urgent) and 5 (non-urgent) based on Canadian Emergency Department Triage
* Patients who had no visual, audial, or lingual disabilities, and no mental disorder.

Exclusion Criteria:

* Patients who planned to have PIC insertion and were suitable for having a peripheral intravenous catheter insertion at their antecubital location using 20 Gauge (pink) cannula were eligible.
* Patients who refused to participate in the study,
* Patients who were not eligible for a 20 G peripheral intravenous catheter insertion,
* Patients who could not be inserted a peripheral intravenous catheter at the first time