cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES:

* Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate, progression free survival, overall survival, and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate.
* Determine the toxicities of this treatment regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to treatment, prior to each course, and then at 2 months after study completion.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate
* Progressive disease despite hormonal therapy or orchiectomy
* No brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 to 80

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 9 g/dL

Hepatic:

* Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone metastasis)
* Bilirubin less than 2 times ULN

Renal:

* Creatinine less than 2 times ULN

Cardiovascular:

* Adequate cardiac function

Other:

* No other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* See Disease Characteristics
* Prior corticosteroids allowed if started at least 8 weeks prior to study

Radiotherapy:

* At least 8 weeks since prior extensive radiotherapy

Surgery:

* See Disease Characteristics
The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children

This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with short stature or a genetic target height below 2 standard deviations;
2. Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV).
3. Legal guardians consenting to participate in the study and signing informed consent forms.

Exclusion Criteria:

1. Known or suspected hypersensitivity reactions to the investigational product or related products;
2. Presence of severe systemic diseases;
3. Patients with malignant tumors;
4. Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
5. Patients unable to adhere to follow-up or receive treatment as scheduled;
6. Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.
Time to Delivery of Preterm Birth

Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.

When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.

There are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).

The purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.

Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.

When mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.

There are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).

The purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.

This is a prospective comparative study of fFN (control) and PhIGFBP-1 test (comparator) for women with singleton pregnancies between 22-34 weeks gestation presenting with self-reported signs, symptoms or complaints suggestive of preterm labour.

Both tests will be done on every participant - the tests will be sequenced so that every 5 participants the fFN test is undertaken first and then the next cohort of 5 will have the PhIGFBP-1 swab taken first. This is to remove any potential biases surrounding which test was undertaken first. Data collection (case report forms (CRFs)) will clearly document which test was performed 1st and 2nd.

Eligibility Criteria:
Inclusion criteria

* aged ≥ 18 years
* confirmed pregnancy
* gestational age between 22 and 34 weeks
* self-reported signs, symptoms or complaints suggestive of preterm labour;

  * abdominal pain
  * contractions
  * pelvic pressure

Exclusion criteria

* unable to provide written informed consent
* multiple pregnancy
* participating in an interventional clinical trial
* a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
* contraindicated to either fFN or PhIGFBP-1; e.g.

  * vaginal bleeding
  * cervical dilation ≥3cm dilated
  * evidence of rupture of membranes
  * had intercourse in last 24 hours
  * cervical cerclage in situ
  * placenta praevia
The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation

It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to these events. In addition, it is aimed to evaluate the relationship between these parameters by using devices measuring skin moisture, skin pH and Neonatal Skin Condition Assessment Scale in experimental and control groups.

The aim of this study is to investigate the effectiveness of surgical incision drape usage for securing endotracheal tubes in preterm neonates. The study will be conducted using a randomized controlled design, and participants will be divided into two groups: those using the surgical drape and those not using it. The population of the study will consist of preterm infants who are hospitalised in the neonatal intensive care unit of Batman Training and Research Hospital. Intubated preterm infants between 28-34 weeks will be included in the study regardless of gender difference. Research data will be collected by the following methods: Demographic information, Neonatal Skin Condition Rating Scale (NSCS), Skin Ph meter device and skin moisture meter device. Data will be collected every 24 hours during the intubation period. The results of the study are expected to provide important theoretical and practical contributions. The effects of parameters such as skin wounds that may occur due to endotracheal tube fixation in infants, unplanned extubation rates, skin pH and skin moisture at the site of intubation fixation will be compared between the surgical incision drep and the standard group. The research data will be analysed using IBM SPSS 27.0 Programme (Statistical Package for Social Sciences).

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants between 28-34 weeks of gestation hospitalized in neonatal intensive care unit,
* Intubated infants on invasive mechanical ventilators,
* Babies who were orally intubated were included in the study.

Exclusion Criteria:

* Congenital skin condition,
* With circulatory problems,
* Congenital anomalies and metabolic disorders,
* Small for gestational age (SGA) and large for gestational age (LGA),
* Unplanned extubation taking place,
* Babies intubated for less than 24 hours will be excluded from the study.
A Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-348

A clinical trial to compare the pharmacokinetics and tolerability of CKD-348

A randomized, open-label, single-dose, 3-way crossover clinical trial to compare the pharmacokinetics and tolerability of CKD-348 with co-administrated drugs in healthy adult volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19-year-old
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
6. Those who agree to contraception during the participation of clinical trial
7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
3. Those who donated whole blood and apheresis within 2 months or received transfusion within 1 month
4. Those who has a history of gastrointestinal surgery (
5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30mL) Smoke: 20 cigarettes/day
6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, shock, dihydropyridine sensitivity, angioedema, cardiac insufficiency
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
9. Women who are pregnant or who may be pregnant and breastfeed
Gastrointestinal Tolerance Assessment of T2309

Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Volunteer with no history of gastrointestinal disorders
* Volunteer agreeing not to consume a food supplement other than IP during the study period
* Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers

Exclusion Criteria:

* Any known or suspected hypersensitivity or allergy
* History of or active severe chronic disease or relevant systemic condition incompatible with the study
* Pregnancy or breast-feeding or have planned pregnancy in the next 4 months
* Childbearing potential woman neither surgically sterilized nor using an adequate contraception
* Inability of the subject to understand the study procedures or to give informed consent
* Non-compliant subject
* Participation in this study at the same time as another clinical investigation/study
* Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
* Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company
* Subject not covered by the government health care scheme of the country in which he/she is living
* Subject with previous, current or anticipated prohibited treatment
COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 years old,
* consulting their GP,
* assessed at risk for melanoma according to the SAMScore
* signed the consent.
Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer

The goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).

If you agree to take part in this study, you will have the short breast MRI scan (the scan for research purposes) with contrast on a different day than your scheduled routine MRI screening scan with contrast. You will have your routine scan the first day and the research scan at least 1 day after. The research scan will take about 10 minutes to complete.

After your short breast MRI scan is completed, you will complete a questionnaire about your comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.

This is an investigational study. The short breast MRI is considered investigational.

Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older female patients
2. BMRI indication: high risk screening per ACS guidelines
3. No contraindications to undergo MRI
4. Creatinine \</=1.3 and GFR\> 40
5. No requirement for sedation.

Exclusion Criteria:

1. \<18 years
2. Male
3. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
4. Contraindication to Gd contrast agents
5. Previous documented history of moderate to severe hypersensitivity to Gd contrast agents
6. Contraindications to MRI
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)

The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.

The trial includes two parts and here is part II. This part is a multi-center, prospective, registration study which focuses on the treatment of below-knee arterial lesion. Totally 130 patients will be entered into this part. They should suffer ischemic symptom with Rutherford 3-6 for the occlusion of the below-knee arteries(anterior tibial、posterior tibial or peroneal artery). According to the lesion length, the patients will accept transluminal angioplasty or below-knee arterial bypass. They will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.

Eligibility Criteria:
Inclusion Criteria:

* The patients volunteer to join the trial and sign the formal consent.
* The patients are ≥55 year-old and ≤75 year-old.
* The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6.
* Obvious stenosis or occlusion in below-knee popliteal artery
* No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
* No surgical contraindications;no infection in operation region.
* Be diagnosed with DM for at least 1 year.

Exclusion Criteria:

* Refuse random treatment.
* Previous operations on the target artery.
* Acute lower extremity arterial thrombosis.
* Serious major organ failure.
* Allergic to the contrast agent or has contrast nephropathy.
* No clinical compliance or unfit to join the trial
Minimal Invasive Rehabilitation of Tooth Loss in the Posterior Segment (MIZE-S)

Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns and conventional bridges (fixed dental prostheses \[FDPs\]) are well established treatment alternatives. Implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. In such cases therapy with an FDP requires extensive removal of tooth structure to provide enough space for the restoration and to ensure mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand for minimal invasiveness and have been used clinically successfully. Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed while speaking or smiling or account for a colour change of the abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical performance of different all-ceramic RBFDP designs has not yet been evaluated under randomized controlled conditions. The aim of this pilot study is to calculate the sample size that allows us to accept the hypothesis that the two designs tested are similar regarding their clinical performance with adequate statistical power.


Eligibility Criteria:
Inclusion Criteria:

* missing second premolar, or first molar, or second molar
* regular patient of the department of prosthodontics of the university hospital of heidelberg
* willingness to return for recall examinations on a regular basis
* written informed consent
* abutment teeth are vital or sufficiently endodontically treated
* abutment teeth are periodontally stable
* abutment teeth have only little or no defects of the hardsubstances

Exclusion Criteria:

* Pregnancy or breastfeeding
* medically compromised condition not allowing for standard dental treatment
* Patient is not able to give written informed consent
* alcohol or drug abuse
* positive bruxism and parafunctions questionaire
* Bite-Strip \> 2
* Attrition Score \> 3
* deep bite (Angle class II/2)
* abutment tooth height \< 4mm
* missing canine or first premolar
* gap size \> 18 mm
* untreated symptomatic periodontal or endodontic lesions
* abutment tooth mobility \> grade I
* known allergies to materials used in this study
* poor dental hygiene
* planned change of residency
Fish Oil Supplementation in Gastrointestinal Cancer

Double-blind, randomized clinical trial to assess the effects of 1,55 g/day of n-3 fatty acids from fish oil concomitant chemotherapy in gastrointestinal cancer.

This study will be divided into three stages defined as: baseline (T0), middle moment (T1) and final moment (T2). At baseline, will be performer the patients identification, clinical data collection, assessment of anthropometric data and body composition, blood sample collection and questionnaires application for individuals allocated into two groups (Fish Oil Group and Placebo Group). The Fish Oil Group (GOP) will receive fish oil capsules and the placebo group (GP) will receive capsules containing olive oil, both also will receive consumption guidelines.

The list of randomization was generated by a computer program and was divided by cancer localization and gender. The researchers involved with the recruitment had access only to randomization list containing codes. The codes were distributed sequentially.

The baseline is the day of first chemotherapy. In the middle moment, five weeks after the start of study, new blood collection, questionnaires and measurement of anthropometric data will be performed. At the final moment, nine weeks after baseline, last blood collection, questionnaires and measurement of anthropometric data and body composition of fish oil and placebo groups will be performed, and will feature the end of the capsules consumption.

After 6 months and 1 year after the initiation of chemotherapy and supplementation with fish oil or placebo, survival data will be collected.

Throughout the monitoring period, the researcher and collaborators will maintain contact with the individuals included. The contact will be made in CEPON, where they receive chemotherapy, and by telephone.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with age between 18 to 70 y.
* Histopathological diagnosis of gastric cancer, or colorectal or anal canal or intestinal cancer
* Ability to start chemotherapy in institution (CEPON)
* Performance status \<= 2

Exclusion Criteria:

* Prior chemotherapy
* Inability to oral intake
* diagnosis of infectious or inflammatory disease or diabetes
* Allergy to fish and / or derivatives,
* Pregnant,
* Treatment with statins or anti-inflammatories drugs
* Intake of fish oil and/or another supplement containing omega-3 or other polyunsaturated fatty acid in the six months prior their inclusion in the study
* Continued use of supplements containing antioxidants
* Patients in palliative care
* without cognitive ability to perform the study protocol
* Enrolled in studies with new drugs
* Hospitalized patients at recruitment