cyrilzakka/clinical-trials huggingface dataset:
Effects of Fetal Movement Counting in Third Trimester of Pregnancy

The aim is to test effects of using formal kick counting chart in the third trimester of pregnancy in an unselected population. The research questions are:

Does Fetal Movement Counting (FMC):

1. Improve the identification of risk pregnancies/pathology?
2. Affect the women's well-being?
3. Stimulate maternal-fetal attachment antepartum?

Fetal activity serves as an indirect measure of central nervous system integrity and function, and regular FM can be regarded as an expression of fetal well-being.A hypoxic fetus responds automatically by redistributing blood away from the non-essential organs which lead to a reduction of non-vital activities; movements. Conversely, pregnancies in which the mother report decreased fetal movements (DFM) is associated with adverse outcomes and may indicate danger for the fetus. In cases were DFM are associated with complications of pregnancy, maternal lack of sensitivity and awareness to fetal movements may be a risk factor for her pregnancy. The most important current identifier of DFM is the women's perception of what is a decrease of FM. Fetal movement counting may be a tool for the mothers that might increase identification of risk pregnancies.

The outcome measures are (referring to the research questions above):

1. Identification of risk pregnancies/pathology?

   1. Primary outcome measures: Numbers of identified pathological conditions in pregnancies (fetal growth restriction (FGR), acute caesarean section on fetal indication/non-reactive non-stress test (NST), oligohydramnios, pathologic blood flow in arteria umbilicalis, maternal perception of absent fetal movements for more than 24 hours before admission to hospital, or perinatal death).
   2. Secondary outcome measures: Frequency of consultations because of maternal concern, use of resources in evaluation of these pregnancies (NST, ultrasound, Doppler, recurrent consultations), induced or spontaneous start of delivery, mode of birth.
2. Affect the women's well-being?

   1. Primary outcome measure: Maternal concern.
   2. Secondary outcome measure: Maternal satisfaction with use of FMC and sense of control in interpretation of signals from own body and child.
3. Stimulate maternal-fetal attachment antepartum?

   1. Primary outcome measure: Maternal-fetal attachment.
   2. Secondary outcome measure: Health promoting behavior in pregnancy (smoking habits, use of alcohol, attending standard program for antenatal care).

Eligibility Criteria:
Inclusion Criteria:

* women booking at screening ultrasound in pregnancy week 17-20
* native speaking women
* singleton pregnancies

Exclusion Criteria:

* women with pregnancies with severe anomalies or other cause to consider termination
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.

Exclusion Criteria:

* Pregnancy and lactating
* Serious underlying disease other than UC
* Former gastrointestinal resections
* Medication for UC other than mesalazine
* Known allergic reactions towards compounds in the study drug.
* Expected lack of compliance due to mental state or language problems
The Impact of Hypoxia on the Biochemical and Morphological Parameters of Blood in Rowers.

The response to hypoxia is very individual and epending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. The results of this study have shown that 18 days of the LH-TL method does not significantly increase the level of EPO and VEGF in rowers. However, reticulocytes, immature red blood cells, have shown significant differences after 18-d LH-TL between groups. Further research should be carried out to investigate an optimal hypoxic dose and time, which will raise EPO, VEGF, and morphology variables.

The Polish national rower team athletes, 13 males (ages 27,0±4,2 years), were randomly divided into two groups: 1) The hypoxic group (H) included 8 rowers participating in sports training and the LH-TL method, hypoxic rooms (FiO2=14.5%, corresponds to an altitude of 3000 meters). 2) The control group (C) presented 5 rowers participating only in sports training and living in normoxic rooms, at the same sports camp. Rowers were observed during the preparatory period. The hypoxic group lived and slept in hypoxic rooms, for at least 8-14 hours per day. During the camp, all rowers followed the same training schedule and diet.All participants' saturation and heart rate were measured daily, morning and evening, throughout the camp period. Venous blood samples were taken four times, at the beginning of the camp (Baseline), after 5 days, after 12 days, and after 18 days of the camp. Body composition parameters such as body mass index, body fat, and free fat mass were estimated using the bioelectrical impedance method of an analyzer Tanita BC 418 (Japan). Data analysis was performed using Statistica. The response to hypoxia is very individual. Depending on many aspects, such as the type of training, duration, intensity, or hypoxic stimulus, hypoxia affects the athlete in various ways. The results of this study have shown that the blood parameters did not increase significantly in the hypoxic group compared to the control group. However, reticulocytes, immature red blood cells, have shown significant differences after 18-d LH-TL between groups. Further research should be carried out to investigate an optimal hypoxic dose and time, which will raise EPO, VEGF, and morphology variables.

Eligibility Criteria:
Inclusion Criteria:

* member of national rower's teams, and sports camp participant.

Exclusion Criteria:

* negative symptoms of hypoxia, and/or injury.
Defective Atypical Protein Kinase C (PKC) Activation in Diabetes and Metabolic Syndrome

The investigators are examining the activation of insulin signaling factors in skeletal muscles of human diabetics. The investigators are characterizing the defects in signaling, and are examining the effects of anti-diabetic agents and exercise on signaling to glucose transport biochemical machinery and whole body glucose disposal.

We have provided clear evidence that insulin activation of all three signaling components, Viz., IRS-1-dependent PI 3-Kinase, atypical protein kinase C (aPKC) and PKB/Akt is defective in diabetic muscle. These defects are best seen when insulin activation is conducted at both half-maximal and maximal stimulation. Moreover, whereas previous studies had shown that treatment with metformin (Met) alone improves aPKC activation, or that treatment with thiazolidinedione (TZD) alone produces increases in activation of IRS-1/PI3K and aPKC when evaluated at maximal insulin stimulation, we have recently found that combined treatment with Met plus TZD for 6 weeks provokes marked increases in insulin effects on all three signaling factors at both half-maximal and maximal insulin stimulation. This work is being prepared for submission for publication.

We have also evaluated the improvement in insulin signaling in diabetic muscle 4 hours after acute endurance (one-legged) exercise and found that the responsiveness of aPKC to the lipid PI3K-derived activator, PIP3, was improved. Also increased was the activation by insulin of IRS-2-dependent PI3K, ERK1/2, and downstream protein synthesis machinery, viz., p70S6 kinase and eukaryotic elongation factor eEF2. These effects of exercise would be expected to enhance glucose transport and utilization by muscle, and promote protein synthesis, i.e., an anabolic response.

Eligibility Criteria:
Inclusion Criteria:

* Stable uncomplicated type 2 diabetes
* Able to be off oral treatments for 2 months

Exclusion Criteria:

* Diabetic complications related to heart, eye, nerve problems
* Renal impairment
* Cardiovascular disease
* Hepatic disease
* Prior history of other disorders or complications caused by diseases
* Insulin therapy needed
The Effects of Various Cooking Oils on Health Related Biomarkers in Healthy Subjects

Fats and oils play important roles in maintaining human nutrition and health through providing energy, essential fatty acids, and acting as modulators of many biological processes (signal transduction, immunity and inflammation). Due to differences in the fatty acid composition and content of antioxidants of individual cooking oils, the degree of oxidative and thermolytic reactions may vary oil by oil. It is lack of human feeding study to investigate the molecular mechanisms on how and which deep-fried oil exerts its adverse effects. The investigators are also lack of biomarkers for monitoring deep-fried oil exposure. Therefore, the purpose of this study is to compare how human body responds differently to several popular uncooked and deep-fried oils with varied fatty acid compositions with respect of oxylipin profile, inflammatory markers, non-targeted metabolomics, and transcriptomics. The investigators will recruit 20 volunteers, provided them once a week the milk shakes prepared from 60g of olive oil, soybean oil, palm oil, camellia oil, tallow (butter), and deep-fried oils of the last 4, respectively; in comparison with a no-fat milk shake control. The experiments lasted for 10 weeks.。Each time; serum, plasma, whole blood and urine samples were collected at baseline, after 2 hours, and after 4 hours. The investigators anticipate to find biomarker(s) for deep-frying, and contribute to the understanding of molecular mechanisms on how deep-fried oils exert adverse effects toward health through integrative omics or so-called system biology approaches.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking, non-drinker, usual dietary intake
* BMI : 18.5\~27 kg/m2

Exclusion Criteria:

1. Over the past two weeks have suffered from acute illness.
2. None of the subjects was taking any supplemental vitamins, antioxidants or medication at that time.
3. Taking steroids or non-steroidal anti-inflammatory drug, such as Aspirin or Panadol in the past one week.
4. Cancer or other severe diseases was diagnosed.
Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument

BACKGROUND Nursing homes are important locations for palliative care. Through comprehensive geriatric assessments (CGAs), evaluations can be made of the palliative care needs of nursing home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that evaluates diverse palliative care needs of adults in all healthcare settings. The evaluation results in Client Assessment Protocols (CAPs: indications of problems that need addressing) and Scales (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate and adjust care plans. This study aims to examine the effect of using the interRAI PC on the quality of palliative care in nursing homes. Additionally, it aims to evaluate the feasibility and validity of the interRAI PC.

METHODS This study covers phases 0, I and II of the Medical Research Council (MRC) framework for designing and evaluating complex interventions, with a longitudinal, quasi-experimental pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic literature search is conducted. In phase I, the interRAI PC instrument is adapted for use in Belgium and implemented on the BelRAI-website and a practical training is developed. In phase II, the intervention is tested in fifteen nursing homes. Participating nursing homes fill out the interRAI PC during one year for all residents receiving palliative care. Using a pretest-posttest design with quasi-random assignment to the intervention or control group, the effect of the interRAI PC on the quality of palliative care is evaluated with the Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the predictive validity of the PIM and the convergent validity of the CAP 'Mood' of the interRAI PC. Qualitative data regarding the usability and face validity of the instrument are collected.

DISCUSSION This is the first study to evaluate the validity and effect of the interRAI PC in nursing homes, following a methodology based on the MRC framework. This approach improves the study design and implementation and will contribute to a higher generalizability of results. The final result will be a psychometrically evaluated CGA for nursing home residents receiving palliative care.


Eligibility Criteria:
Inclusion Criteria:

* 65+
* residing in a nursing home
* having palliative care needs (based on the 'surprise question': 'would you be surprised if this person was to die within 6 to 12 months?') (Hubard G, 2011)

Exclusion Criteria:

* 65-
* not residing in a nursing home
* no palliative care needs
L Test in Children With Cerebral Palsy

The aim of the study was to investigation of the validity and reliability of the L test in children with cerebral palsy. Eighty children with CP with mean age of 11.60±3.85 (56 boys, 24 girls) were included in the study. ICC ((Intraclass Correlation Coefficient) was used to assess interclass, intraclass and test- retest validity of the L test. Two independent examiners made L test, for the inter-rater reliability, twice within 1 day for the test-retest reliability. The minimal clinical important difference at 95% confidence interval intra-class correlation coefficient and standard error of measurements were calculated. The correlations of L test with Timed up and Go Test (TUG) and Timed up and Down Stairs Test (TUDS) were assessed for concurrent validity.

Inclusion criteria were: cerebral palsy diagnosis, absence of other diseases that may impact gait performance, ambulatory for at least 20 meters, maximum level 2 according to Gross Motor Function Classification System. Exclusion criteria were: difficulty in following the instructions, severe lower extremity pain that affects mobility, orthopedic surgery within the last 12 months, Bothulium toxin A injection for lower extremity within the last 3 months and walking with a physical assistance from another person. Informed consents were obtained from the parents of the participants for the trial. Assessments were conducted in a special training and rehabilitation center where children with cerebral palsy received regular treatments.

Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy diagnosis, absence of other diseases that may impact gait performance, ambulatory for at least 20 meters, maximum level 2 according to Gross Motor Function Classification System

Exclusion Criteria:

* difficulty in following the instructions, severe lower extremity pain that affects mobility, orthopedic surgery within the last 12 months, Bothulium toxin A injection for lower extremity within the last 3 months and walking with a physical assistance from another person.
Clinical Study of Endostatin in Improving Radiation Pneumonia and Fibrosis

To verify the efficacy and safety of endostatin in the treatment of SRILI（symptomatic radiation-induced lung injury） and fibrosis. The results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.

Radiotherapy is an important treatment of lung cancer, symptomatic radiation-induced lung injury (SRILR) is the most common complications. In view of the important role of endostatin in inhibiting angiogenesis and pro-inflammatory factors, Combined with randomized controlled clinical study and small sample clinical exploration, the investigators concluded that endostatin is a new clinical technique for the treatment of radiation pneumonia（RP） and radiation fibrosis（RF）, which can reduce the recurrence rate of RP. In order to verify the efficacy and safety of endostatin in the treatment of SRILI and fibrosis, the investigators intend to use a prospective, randomized, multicenter clinical trial to classify unresectable phase III-IV Non-small cell lung cancer（NSCLC） patients with SRILI above grade 2 into the control group (standard SRILI treatment) and observation group (Endostar® plus standard treatment) on a 1:1 randomized basis. The results of this study are expected to be a new clinical strategy for the treatment of radiation pneumonia and fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients defined as NSCLC who could not be operated on, phase III-IV;
2. EOCG PS: 0-3;
3. The clinical diagnosis is RILI, with grade 2-3;
4. No major organ dysfunction, such as heart failure and chronic obstructive pneumonia;
5. No Endostar use contraindication;
6. Volunteer to participate, good compliance, can cooperate with the test observation, and sign a written informed consent.

Exclusion Criteria:

1. Patient compliance is poor and violates the test regulations;
2. Major organ dysfunction like liver and kidney occurs, such as myocardial infarction, angina pectoris, liver transaminase increased significantly;
3. Hemorrhage or thrombus occurs, anticoagulant medication is required;
4. Serious adverse drug reactions occur during treatment;
5. The patient asked to be withdrawn from the trial;
6. Other antiangiogenic drugs were used.
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). The extended observation period included participants of the core study who responded to treatment.


Eligibility Criteria:
Inclusion Criteria:

* 30 years or older
* Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN)
* Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
* 90 days washout calcitonin
* 180 day washout bisphosphonate

Exclusion Criteria:

* Allergic reaction to bisphosphonates
* History of upper gastrointestinal disorders
* History of iritis, uveitis
* Calculated creatinine clearance \< 30 ml/min at baseline
* Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria applied.
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have advanced or metastatic NSCLC or cutaneous melanoma
* Presence of KRAS or BRAF mutation (NSCLC) or NRAS mutation (cutaneous melanoma) in tumor tissue
* All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2

Exclusion Criteria:

-Dose expansion - KRAS or NRAS mutant patients groups: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. (Patients with KRAS mutant NSCLC with prior G12C inhibitor treatments are also excluded in the LXH254+trametinib expansion part). BRAF mutant patients group: Prior treatment with any EGFR, ALK, ROS1, KRAS, RAF (both BRAFV600 selective and pan-RAF), MEK1/2 and/or ERK1/2 inhibitors (for patients with BRAF V600 mutant NSCLC, prior treatments with BRAF and MEK1/2 inhibitors are allowed).

Patients who have received more than 3 lines of anti-cancer therapy are excluded.

* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
* Patients with Gilbert's syndrome or other heritable diseases of bile processing.

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients

The purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing.

A prospective randomized study to include 40 consecutive patients admitted to the general intensive care unit. The control group will receive nutritional support composed of a standard formula. The study group will receive nutritional support enriched with fish oil and anti-oxidants. The following variables will be assessed in all patients: demographics, severity of illness, assessment of bed sores. Blood tests will also be taken for the following: CD 8, CD 14, CD 18, CD 11a, CD49c, CD 49d. In addition, blood samples will be collected for TNF, IL-1b, IL-6, IL-8, and levels of C-reactive protein. Metabolic parameters such as resting energy expenditure, BMI, albumin, prealbumin, levels of zinc, relationship between omega 3 and omega 6. Theses test will be performed at time of ICU admission, days 7, 14 and 28 after admission.

The outcome: improved repair of pressure sores, together with improvement in objective parameters of immunity and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients in intensive care unit
* Grade 2 pressure sores

Exclusion Criteria:

* Immunosuppression with steroids or other agents
* Active bleeding
* Head trauma