cyrilzakka/clinical-trials huggingface dataset:
Effect of a Plant-based Ingredient on Generalized Hormonal Responses

The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, Age at start of the study \>20 and \<50 years;
* Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2;
* Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
* Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
* Agreeing to be informed about medically relevant personal test-results by a physician;
* Informed consent signed;
* Willing to comply to study protocol during study;
* Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
* Accessible veins on arms as determined by examination at screening.

Exclusion Criteria:

* Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
* Blood donation in the past 2 months;
* Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
* Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
* Reported intense sporting activities \> 10h/w;
* Consumption of \> 21 alcoholic drinks in a typical week;
* Not being used to eat breakfast;
* Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
* Use of medication which interferes with study measurements;
* Reported dietary habits: medically prescribed diet, slimming diet;
* Not used to eat 3 meals a day;
* Vegetarian;
* Reported weight loss/gain (\>10%) in the last six month before the study;
* Being an employee of Unilever and CRO;
* Allergy or intolerance to food products and aversion to food products provided during the study;
* Subject who cannot be contacted in case of emergency;
* Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
* Subject under guardianship;
* Subject who would receive more than 4500 euro's as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.

This multicenter, randomized, double-masked, controlled clinical trial evaluated the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia.

Infants were followed until death or discharge to home. The trial compared iNO therapy to mock gas delivery as the control, and otherwise incorporated conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy).

During the initial dosing, iNO was started at 5 ppm and could be increased to 10 ppm. If the infant did not respond, study gas was discontinued. For infants who responded to study gas, a gradual weaning was initiated. The total exposure to study gas did not exceed 336 hours (14 days). Infants were monitored for signs of toxicity.

Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked, certified examiners.

Eligibility Criteria:
Inclusion Criteria

* Any infant with a birth weight 401 - 1500 grams and \< 34 weeks gestational age with an OI (mean Paw x FiO2 x 100/PaO2) \> 10 on two consecutive blood gases at least 30 minutes apart, but no more than 12 hours apart.

or

* Infants \> 1500 grams and \< 34 weeks gestational age will be entered in the Larger Preemie Pilot Study if they have an OI greater than or equal to 15 on two consecutive blood gases at least 30 minutes apart, but no more than 12 hours apart.
* Infants requiring assisted ventilation with a diagnosis of RDS/HMD, pneumonia and/or sepsis, aspiration syndrome, idiopathic pulmonary hypertension, or suspected pulmonary hypoplasia associated with PROM and/or oligohydramnios.
* Greater than or equal to 4 hours after one dose of surfactant.
* Less than or equal to 120 hours of age.
* All infants must have an indwelling arterial line.

Exclusion Criteria

* Any infant in whom a decision has been made not to provide full treatment (e.g. chromosomal anomalies or severe birth asphyxia).
* Known structural congenital heart disease, except patent ductus arteriosus and atrial-level shunts.
* Infants with any major abnormality involving the respiratory system such as congenital diaphragmatic hernia, tracheoesophageal fistula or cystic fibrosis.
* Any bleeding diathesis considered to be clinically significant or thrombocytopenia with platelet count \< 50,000.
* Prior enrollment into a conflicting clinical trial such as the Neonatal Network Surfactant CPAP trial.Inclusion Criteria
Total Facet Arthroplasty System®(TFAS®) Clinical Trial

The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal. TFAS® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.


Eligibility Criteria:
Inclusion Criteria:

* Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5
* Skeletally mature male or female between the ages of 50 and 85 years of age inclusive
* No greater than Grade I degenerative spondylolisthesis at the index level
* Persistent leg symptoms,including pain, numbness, burning or tingling for a minimum duration of six months
* Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression
* Failed to respond to non-operative treatment modalities for a minimum duration of six months

Exclusion Criteria:

* Male or female less than 50 or greater than 85 years old Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level
* More than 3 vertebral levels of degenerative spinal stenosis requiring decompression
* More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation
* Not available for long term follow-up and interval visits
* Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine
* Two or more previous surgeries to the lumbar spine at the same level to be implanted
* Is being treated with other devices for the same disorder (e.g. pain control devices)
* Active systemic infection or infection at the operating site
* Osteoporosis
* Known sensitivity to device materials
* Has an immunosuppressive disorder
* Has a medical condition that may interfere with clinical evaluations
* Is obese defined by a patient body mass index greater than 40
* Has significant scoliosis (Cobb \>25°)
* Is pregnant or planning to become pregnant within the proposed three year investigation
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients

Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a mixed episode of bipolar I disorder.
* Have had at least one previous manic or mixed episode associated with bipolar disorder
* You must be between 18 and 60 years old.
* You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.
* If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.

Exclusion Criteria:

* You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.
* You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.
* Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).
* You are allergic to any of the medications involved in this study.
Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin

This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma
* Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT
* Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome
* After macroscopic incomplete resection or marginal resection (tumor-free margins \< 1 cm)
* Prior chemotherapy, including anthracyclines with/without ifosfamide (with or without RHT) or patients who cannot be given these medicines
* At least one tumor manifestation which is eligible for hyperthermia
* Performance status (ECOG) 0,1 or 2
* More than 3 weeks from last treatment
* Neutrophil count ≥ 1,5 G/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 G/l
* Albumin ≥ 25 g/l, total bilirubin ≤ 1 x ULN, ALT/AST ≤ 2.5 x ULN, AP ≤ 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance ≥ 30 ml/min, CPK ≤ 2.5 x ULN
* Patients with the ability to follow study instructions and likely to attend and complete all required visits
* Written informed consent of the subject

Exclusion Criteria:

* Uncontrolled infection (e.g. active viral hepatitis)
* Unstable cardiac status
* Peripheral neuropathy \> grade 2
* Known or persistent abuse of medications, drugs or alcohol
* Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)
* Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure
* Pregnancy or breast-feeding
* Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration
* Uncontrolled CNS-metastases
* Medical or technical impossibility for hyperthermia to heat the major target lesion
Remote Effects of Lower Limb Stretching

Recent research suggests that the skeletal muscles and the fibrous connective tissue form a body-wide network of myofascial chains. A systematic analysis of dissection studies suggests that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As fascia can modify its stiffness, strain transmission along these meridians is supposable (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to the proper functioning of the movement system. However, despite solid evidence from in vitro studies, scarce data is available concerning the in vivo behavior of the meridians. The present study is conducted to resolve this research deficit and to elucidate whether stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20) participate in the randomized controlled trial. One group performs three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively. A control group remains inactive for the same time. Participants of the third group perform 6x30 s bouts of static stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM) in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement analysis system.


Eligibility Criteria:
Inclusion Criteria:

* healthy participants after subscribing informed consent

Exclusion Criteria:

* severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases, not completely healed traumata, drug intake in the past 48 hours, pregnancy and presence of muscle soreness.
Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau

This pilot study will test the effect of a cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition.

Cash transfer (CT) programs in low-income countries that allow recipients to receive cash designated for specific household expenditures such as food and family health and education typically show significant program benefits. In particular, several programs have shown positive impacts on use of health care resources, nutrition status and self-reported health, along with significant improvements in the motor and cognitive development of young children.

Guinea-Bissau is currently the 11th poorest country and is thus an appropriate target for a cash transfer program. This project will pilot test the effect of a 2 year cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition. Family-wide assessment will be conducted to examine the impact in all family members. Baseline and 3 follow up assessments will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Families (defined as groups of individuals who routinely eat together) in 3 regions of Guinea-Bissau.
* Identified by developing scale based upon household characteristics and assets per capita. As well as access to services such as water, electricity and sanitation.
* Families having the lowest score identified as lowest income were recruited.

Exclusion Criteria:

* Families with high scores on asset scale.
* Families uninterested in participating.
Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)

Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

Screening phase:

* Age \> 18 years
* Patients with CD34+ AML or MDS post-allogeneic HSCT
* Written patient consent after consultation

Treatment phase

* AML/MDS: donor chimerism \< 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts \< 5% in bone marrow)
* Leukocytes \> 3 Gpt/l and platelets \> 75 Gpt/l (transfusion-independent)

Exclusion Criteria:

* Known intolerance to 5-azacitidine or mannitol
* Uncontrollable infectious disease
* Patients with active hepatitis B or C or HIV infection
* Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour
* Renal function impairment (creatinine \> twice the normal value, creatinine clearance \< 50 ml/min)
* Pregnancy or lactation
* Women of childbearing age, except for those who meet the following criteria:
* postmenopausal (12 months natural amenorrhoea)
* postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
* regular and correct use of a contraceptive method with an error rate \< 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of \< 1% are safer than copper coils)
* sexual abstinence
* Partner vasectomy
* Men who do not use one of the following for contraception:
* sexual abstinence
* post vasectomy
* condoms
* Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation
* Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial
* Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.
The Effects of Pork vs. Chicken/Fish in a DASH Diet on Blood Pressure Regulation in Middle Aged and Older Adults

The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.

High blood pressure is a major risk factor for heart disease and stroke and affects 50 million people in the United States. Making healthy food choices, such as those in the DASH (Dietary Approaches to Stop Hypertension) Diet, has been shown to improve blood pressure control in people with high blood pressure. The purpose of this study is to determine if the source of dietary protein (pork or chicken/fish) as a part of the DASH diet affects blood pressure control in adults with high blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* age 40-75
* BMI 25-40 kg/m2
* systolic blood pressure 120-160 mm Hg
* diastolic blood pressure \<100 mm Hg
* non-diabetic, no acute illness
* not following vigorous exercise program
* urinary continence

Exclusion Criteria:

* age \<40 or \>75
* BMI \<25 or \>40 kg/m2
* systolic blood pressure \<120 or \>160 mm Hg
* diastolic blood pressure \>100 mm Hg
* diabetic, acute illness
* following vigorous exercise program
* urinary incontinence
* current smoker
Expressive Writing on Stress and Work-Related Outcomes Among Student Nurse Interns

The goal of this interventional study is to assess the effects of an intervention on stress and work-related outcomes among Chinese student nurse interns. The main questions it aims to answer are:

* Does expressive writing reduce clinical practice stress and improve coping strategies in student nurse interns?
* Does expressive writing increase work engagement and perceived professional benefit among student nurse interns?

Participants in the intervention group and control group will perform expressive writing and neutral writing, respectively, based on different given instructions. In both groups, writing will last for 15 minutes each time, twice a week, for ten weeks.

Researchers will compare the outcomes of the two groups to see if there are differences between clinical practice stress, coping strategies, work engagement, and perceived professional benefit.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate student nurse interns in their first clinical internship (had no prior clinical practice experience)
* Have access to and proficiency in utilizing social media
* Be able to read and write via the internet
* Be willing to fill in questionnaires and write according to the assigned writing prompts
* Never participated in expressive writing or stress management intervention programs

Exclusion Criteria:

* Intern at a self-contacted hospital
* Severe current psychological conditions
* Undergoing any form of psychotherapy
* With a habit of keeping diaries

Withdrawal criteria:

* Termination of internship for whatever reason
* Not submit writing materials twice
Short Term Genetic Effects of Chemotherapy on Male Germ Cells

This study will determine the short-term effects of chemotherapy on sperm DNA.The study involves the collection of semen sample through ejaculation prior to initiation of chemotherapy and up to three time points after initiation of chemotherapy.

While medical advances in the area of cancer treatment have successfully improved the overall detection and treatment of many cancers affecting men and women alike, these very treatment modalities can adversely affect their reproductive capacity.

Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients at high risk for infertility. For men, the best recommendation for patients undergoing such therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may not always occur. Some patients have been noted to present to discuss fertility preservation options after completing their first cycle of chemotherapy. In this situation, they will most likely still have sperm which was produced prior to chemotherapy that can be collected even if the stem cells producing the sperm have been damaged or destroyed. However, there are no national guidelines addressing this particular situation. Typically, physicians may advise men to avoid conception anywhere from three months to two years after the final dose of chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ cells remain.

It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in the short window of time between exposure and potential sterility. If a safe time frame could be determined to collect sperm after a single dose of chemotherapy, then these men could be given a second chance to retain their fertility potential.

Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to undergo treatment with chemotherapeutic agents for a medical indication
* Be able to produce semen samples prior to chemotherapy and one week after first round of chemotherapy

Exclusion Criteria:

* Men who have previously been treated with chemotherapeutic agents.
* Men with significant oligospermia or azospermia.
Uveal Melanoma - Comparative Study

The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of uveal melanoma

Exclusion Criteria:

* Inadequate or missing information on the clinical course in patient charts
* Imaging not feasible due to any reason.