cyrilzakka/clinical-trials huggingface dataset:
A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Participants With Locally Recurrent or Metastatic Breast Cancer

This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in participants with locally recurrent or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease
* Human epidermal growth factor receptor 2 (HER2)-negative and hormone receptor (HR) (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic and end organ function
* Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer

Exclusion Criteria:

* Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
* Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor for advanced or metastatic breast cancer
* History of intolerance to a taxane-containing therapy
* History of clinically significant cardiac or pulmonary dysfunction
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease
* Active autoimmune disease or active inflammatory disease
* Immunocompromised status due to current known active infection with human immunodeficiency virus (HIV) or due to the use of immunosuppressive therapies for other conditions
* Need for current chronic corticosteroid therapy
* Pregnant, lactating, or breastfeeding women
* Current severe, uncontrolled systemic disease
* Known untreated or active central nervous system (CNS) metastases
Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay

A randomized controlled clinical trial in two groups of supplementation with high protein enteral formula and a normocaloric enteral formula in two groups of 37 patients .

Patients with acute myeloid leukemia have a high risk of suffering sarcopenia, which decreases the oncology therapy clinical response, functional ability and quality of life. Chemotherapy is used in these patients, some of them inhibit angiogenesis and act in an important way in physiological processes of muscle anabolism. The vascular endothelial growth factor (VEGF) and its receptors (VEGFR) play a crucial role in both normal and malignant angiogenesis. Activation of the VEGF pathway leads to endothelial cell activation, proliferation and survival.

The objective of this study is to compare the effect of the use of a high protein, high energy enteral with omega 3 formula (Supportan DKN) against a standard enteral formula (Fresubin® Original DRINK) on body composition, days of hospital stay, quality of life, associated muscular strength with levels of VEGF in patients with acute myeloid leukemia during induction chemotherapy.

An open clinical trial was designed, in which a group of patients will receive, as part of their nutritional requirements a hyperproteic hyperenergetic enteral formula versus standard formula during the 21 days of the first cycle of antineoplastic treatment. We will measure body composition, muscle strength and serum concentrations of VEGFR in both groups to be able to compare its effect.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a confirmed diagnosis of AML
* Tolerance to oral feeding
* Induction Chemotherapy
* Patients with nutritional risk of positive malnutrition (Score +3 NRS).
* Candidates to receive enteral nutrition, as well as chemotherapy according to medical indications.
* Life expectancy greater than a week and with the possibility of starting oncological treatment. Have informed consent obtained by the patient prior to randomization

Exclusion Criteria:

* Geriatric patients (\> 60 years)
* Patients with acute gastrointestinal bleeding, ileus and shock
* History of recurrence of neoplasm
* Renal failure
* Atrophy of the gastrointestinal mucosa
* Central nervous system disease,
* impaired cardiac function.

Elimination criteria:

Lack of follow up Incomplete data. Insufficient amount of genetic material to perform the determination of the VEGF material.

Absence of the determination of the levels of VEGF prior to the start of oncological therapy.
Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia

A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US

Eligibility Criteria:
Inclusion Criteria:

* adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia
* age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia
* initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
* No CNS involvement at relapse
* No isolated extramedullary relapse
* Other inclusion criteria may apply
Caregiver Burden in Cerebral Palsy Undergoing Hip and Knee Surgery

The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are:

Q1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more positively to this situation? Participants will be asked to answer the scales given to them periodically before and after the surgery.

One of the most common causes of disability in childhood is cerebral palsy, which develops due to damage to the central nervous system. Children diagnosed with cerebral palsy face different problems in every period of their lives. The child, his/her family and the society he/she lives in should be considered as a whole. There is a mechanism that mutually affects each other.

Parenting, caring for and living with a child with cerebral palsy can have many negative effects on the lives of parents and create additional burdens for them. Parents may have to choose between their own needs, the needs of other members of the family and the needs of the child with cerebral palsy, and may spend most of their time with their disabled child. This can negatively affect the burden, stress level, physical activity level, quality of life, psychological status and self-efficacy perception.

The primary aim of this study is to evaluate the caregiver burden in Cerebral Palsy, which is the most common cause of morbidity in the pediatric age group in orthopedics, and to analyze the factors that negatively affect it. Our hypothesis is that the functional mobilization status of patients will increase, especially as a result of hip surgeries, reducing caregiver burden.

Eligibility Criteria:
Inclusion Criteria:

1. Parent Age

   a. Being in the 20-60 age group.
2. Diagnosis

   1. Having a child with clinically diagnosed cerebral palsy
   2. The movement scale of the cerebral palsy patient is between GMFS 3 and 5
3. A minimum follow-up of 12 months after surgery
4. The primary carer is the mother or father

Exclusion Criteria:

1. The patient and his/her family have been lost to follow-up
2. Having another disabled person in need of care in the family
3. Family's unwillingness to participate in the study
4. Loss of a parent
Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients

Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze.

In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation.

Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.

The research' want to monitor tissue perfusion and indicators of tissue damage and viability in critically ill patients by using DOS.

Non-invasive Optical Techniques DOS,near-infrared diffuse optical spectroscopy (NIR-DOS.

NIR-DOS provides functional physiologic tissue/organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. The application of frequency-domain photon migration analysis (FDPM) to NIRS allows independent measurements of tissue absorption and scattering properties at depths of 1 cm or more below the skin surface.

Such capabilities will improve early diagnosis, detection, optimization of therapy, assessment of adequacy of resuscitation, and alteration in management plans for all of these critical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years or older, male or female
* Trauma/Critical Care patient

Exclusion Criteria:

* Subject is not Trauma/Critical Care patient
Comparison of Stretching and MET in Lower Cross Syndrome

The aim of the study is to compare the effects of stretching exercises \& muscle energy techniques in the management of lower cross syndrome and to find the effective treatment in the lower cross syndrome management.

In 2015 the systematic review estimated that prevalence of Chronic low back pain in 24 to 39 year old individual was 4.2% and the individual between 20 to 59 was 19.6% . The genesis and perpetuation of Low back pain (LBP) has many underlying factors among which one is proposed by Janda's concept of pelvic crossed syndrome. This condition describes a pattern of tight and weak muscles around the pelvis. Marked postural deviation is seen such as increased lumber lordosis and depending on this lordosis the muscle involvement can be distinguished. The center of the gravity is slightly anterior to S1 or S2, which means pelvis position, is key to faulty or good alignment.

Various studies have been done on muscle imbalance Lower crossed syndrome (LCS) using Stretching and Muscle energy Technique (MET). Both have shown superior effects when compared to other treatment modalities/techniques. However there is paucity of literature on effectiveness of stretching and MET in management of LCS.

Eligibility Criteria:
Inclusion Criteria:

* LCS pattern in standing position
* Patients having Chronic low back pain
* Age : 20-50 years
* Both male and females
* Positive Prone Hip Extension movement pattern test

Exclusion Criteria:

* Fracture (wedge compression #)
* Inflammatory disorder
* Acute disc bulge
* Lumber instability
* Idiopathic scoliosis
* Patient with Rheumatoid arthritis (RA) and other systemic diseases
Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations

A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations


Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with cancer
2. Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
3. Age \> 18 years
4. Written informed consent

Exclusion Criteria:

1. Taste and smell alterations not caused by the cancer or anti-cancer treatment
2. Galactosaemia
3. Use of thickener to be able to swallow safely
4. Allergies to any of the product ingredients or any of the flavours
5. Current prescription for ONS, enteral nutrition or parenteral nutrition
6. Diabetes mellitus Type I or Type II
7. Open sores or severe inflammation in the mouth or throat
8. Undergoing dialysis
9. Hepatic encephalopathy
10. Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
11. Known pregnancy or lactation
12. Average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women or drug abuse in opinion of the investigator
13. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
14. Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
15. Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
Telemonitoring of Geriatric Cancer Patients Using Handheld Devices

Cancer is becoming a chronic disease, with the requirement of a lifelong intake of cancer-controlling drugs. While young(er) patients may cope with this, geriatric cancer patients may require a more customized and tailored follow up.

Most elderly patients have multiple other diseases ("comorbidities") and, due to many other factors, may per se not tolerate or simply not follow anticancer therapies. This may not only impair quality of life (QoL), but on the long rung also the therapeutic outcome (survival).

Handheld devices provide a new reporting/communication tool for patients and health care providers. TeleGraPH will assess if these devices are a suitable communication modality in a cohort of geriatric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Karnofsky Performance Status ≥ 70
* histologically confirmed malignant tumor (cancer)

Exclusion Criteria:

* concurrent severe and/or uncontrolled concomitant medical conditions
* Patients unwilling or unable to comply with using a handheld device
Study to Evaluate a Probiotic in Healthy Subjects With a History of Abdominal Discomfort and Bloating

This is a multicenter, double-blind, randomized, placebo-controlled, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group, 6-week study of a probiotic for abdominal discomfort and bloating in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and non-pregnant, non-lactating women aged 18 to 75 years of age;
* Body Mass Index (BMI) \< or = 40;
* if female, postmenopausal or using adequate contraception
* if over 50 years of age, have had a colonoscopy performed in the previous 5 years with findings that are normal for this population
* be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria during the study and be willing to refrain from taking any medications or preparations that treat lower digestive upsets
* have experienced abdominal discomfort and bloating at least twice a week, on average, over the last 3 months.

Exclusion Criteria:

* have been under a physician's care for functional bowel disorders within the past year or have taken prescription medication for functional bowel disorders within the past year;
* have alarm symptoms suggestive of an underlying disease;
* have prior GI surgery (appendectomy and hernia repair are not excluded and cholecystectomy at least 3 years ago is not excluded);
* have a significant acute or chronic coexisting illness or condition;
* have used systemic steroidal agents within the last 30 days;
* have used oral or systemic antibiotics within the last 30 days;
* have used probiotics at least 3 times a week within the last 30 days;
Development of a Community-based Network for Drug Abusers

Hidden drug abuse remains a significant concern for public health. An appropriate intervention is necessary to encourage hidden drug abusers to report their situations and seek professional help. This project aims to develop a community-based network to identify and refer hidden drug abusers in Hong Kong, and assess its effectiveness.

This study will be completed within 18 months, and be divided into 3 Phases, including (1) a video competition for anti-drug abuse, (2) development of a community-based network through training 150 peers aged 13-18 as anti-drug ambassadors (ADAs) to deliver anti-drug messages based on the AWARD model, and (3) a mass promotional campaign organized by ADAs in the community. A one-group pre-test and repeated post-test design will be adopted to evaluate the overall effectiveness of the community-based network. We will assess the knowledge, attitudes and practices regarding anti-drug abuse of the ADAs. Data collection will be conducted at baseline, post-training, 3 months and 6 months after the training workshop.

Eligibility Criteria:
Inclusion Criteria:

* Aged 13 - 18 years
* Able to speak Cantonese and read Chinese

Exclusion Criteria:

* identified cognitive, behavioral or learning problem(s)
* identified mental illness(es)
Comparison of Two Universal Composites in Posterior Teeth

The aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.

A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. Two independent examiners, who were blinded to the composites used evaluated the restorations according to the FDI (World Dental Federation) criteria. Bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. The statistical analyses were carried out with McNemar, Pearson Chi-square and Cochran Q tests (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* a need for at least two but not more than four posterior tooth-colored restorations
* the presence of teeth to be restored in occlusion
* teeth that were symptomless and vital
* a normal periodontal status
* a good likelihood of recall availability.

Exclusion Criteria:

* partly erupted teeth
* absence of adjacent and antagonist teeth
* poor periodontal status
* adverse medical history
* potential behavioral problems.
Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering exclusively from osteo arthritis (OA), Stage II-V \[Ahlbäck, 1968\] will be operated.
2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria:

1. Previous major knee surgery
2. Other significant disabling problems from the muscular-skeletal system than in the knees
3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
4. Patients with active or suspected infection.
5. Patients with malignancy - active malignancy.
6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
9. Female patients planning a pregnancy during the course of the study.
10. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
12. Patients with other severe concurrent joint involvements, which can affect their outcome.
13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
14. Patients under the protection of law (e.g. guardianship).
SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy

The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy

The study is a randomized clinical trial，and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* 18 ≤ age ≤ 70 years old
* Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted therapy , etc.
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Having given written informed consent prior to any procedure related to the study
* Expected survival time ≥3 months

Exclusion Criteria:

* History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
* Hemoglobin\<90g/L
* Inadequate hematopoietic function which is defined as below:

  * white blood cell (WBC) less than 3,500/mm\^3
  * absolute neutrophil count (ANC) less than 1,500/mm\^3
  * platelets less than 80,000/mm\^3
* Inadequate hepatic or renal function which is defined as below:

  * serum bilirubin greater than 2 times the upper limit of normal range
  * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
  * blood creatinine level greater than 1.5 times ULN,Creatinine clearance\<60ml/min
* Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
* Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
* Psychiatric disorder or symptom that makes participation of the patient difficult
* Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
* Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
* Known DPD deficiency
* Participate in other clinical trial before the start of this trial
* Patient compliance is bad or researchers believe that patients are not suitable for this treatment
* Known to have active hepatitis patients