cyrilzakka/clinical-trials huggingface dataset:
The Effect of Circadian Rhythm on Physical Performance in Healthy Male Individuals

Little is known about optimizing the timing of exercise periods to maximize the health benefits of exercise. Furthermore, exercise is a potent modulator of skeletal muscle metabolism and it is clear that skeletal muscle has a robust circadian profile. Circadian rhythms can be observed in behavior, physiology, and metabolism. Various studies show that exercise changes the rhythm of the clock machines in skeletal muscle. Studies examining the relationship between exercise, especially strength training, and circadian rhythm are quite limited in the literature. Although some studies have shown that force peaks in the afternoon/evening hours, regardless of muscle group and contraction speed, there are no studies on how much this time interval varies from person to person and chronotype.

The aim of this study is to investigate to what extent strength training given at appropriate times for morning, evening and intermediate chronotypes creates changes in performance in healthy adult male individuals.

After participants are informed about the research, evaluation and exercise protocol, their signed consent will be obtained.

The Morningness-Eveningness Questionnaire will be applied until 30 participants with morning type and 30 evening type chronotypes are reached. (Estimated for 100 students) After determining 30 morning type and 30 evening type participants, isokinetic evaluations will be made and vertical jump heights will be measured (T0).

Then, 15 morning type participants will be included in the morning exercise program (08:00) and 15 morning type participants will be included in the evening exercise program (18:00).

15 evening type participants will be included in the morning exercise program (08:00) and 15 evening type participants will be included in the evening exercise program (18:00).

Thus, some of the participants from both morning and evening groups will be included in strength training for 6 weeks, at a time appropriate to their chronotypes, and some at a time incompatible with their chronotypes. Isokinetic evaluations and vertical jump height measurements will be repeated at the end of the strengthening exercise program, which will last 3 days a week for 6 weeks, a total of 18 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Being male,
* Between the ages of 18-30
* Having a chronotype that was morning person or evening person in the Morningness-Eveningness Questionnaire

Exclusion Criteria:

* Being female
* Having an intermediate chronotype in the Morningness-Eveningness Questionnaire
* Having a history of surgery or limitation in the knee area
* Having a metabolic, neurological, or orthopedic disorder.
Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI

This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506 as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in patients with metastatic CRC. It will also determine the impact of the combined administration on the concentration of drugs over time (pharmacokinetics) of BAY73-4506, oxaliplatin, 5 FU, and irinotecan.

This study will be conducted at approximately 5 - 8 study centers in Germany. Up to 60 patients will be enrolled into this study to ensute that at least 12 - 15 patients for each combination regimen can be evaluated for safety and pharmacokinetics. For this reason a minimum of 20 patients will receive mFOLFOX6 in combination with BAY73-4506 and at least 20 patients will receive FOLFIRI in combination with BAY73-4506.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological documentation of adenocarcinoma of the colon or rectum.
* At least 1 measurable lesion as per RECIST
* ECOG Performance Status of 0 - 1
* Life expectancy of at least 12 weeks.
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* More than 1 previous chemotherapy for Colorectal Cancer. Adjuvant chemotherapy for Colorectal Cancer (Stage I, II, II) is permitted, if the adjuvant therapy ended \>6 month before screening.
* Previous FOLFOX treatment for patients who will be included in the mFOLFOX6 cohort apart from FOLFOX treatment in an adjuvant setting.
* Previous FOLFIRI treatment for patients who will be included in the FOLFIRI cohort.
Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers

The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
2. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
3. BMI of 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
3. Any evidence of a concomitant disease judged as clinically relevant by the investigator
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
6. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Implementation of a Best Practice Primary Health Care Model for Low Back Pain

POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP.

INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP.

CONTROL: Current routine practice for LBP care before implementation of the BetterBack model of care.

OUTCOME: Patient reported measures (function, activity, health), therapist reported measures (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of implementation) and cost-effectiveness.

AIM: To deliver best practice recommendations for LBP and study their most effective implementation through the BetterBack model of care.

METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist outcomes as well as cost-effectiveness compared to current routine care.

Low back pain (LBP) is a major health and socioeconomic burden. LBP is usually a result of benign dysfunction and context that affects the patient's perception of pain and limits their activity and participation. At present there are no national clinical guidelines or best practice models of care in Sweden focused on the primary care of low back pain. Implementation of a model of LBP primary care based on international evidence-based guidelines is needed to improve care and patient outcomes in Sweden. This project aims to investigate the effectiveness of a best practice model of care (BetterBack) for the primary care management of LBP. A cluster randomised trial with dog leg design will be conducted in the Östergötland Health care region. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist reported outcomes as well as cost-effectiveness compared to current routine care. This by improved patient outcomes in terms of physical function, low back pain intensity, activity level, work and quality of life. Furthermore, improved care processes and knowledge support for physiotherapists can lead to a smaller proportion of patients requiring specialist care.

Eligibility Criteria:
Health care practictioner sample

Inclusion Criteria:

* Registered physiotherapists practicing in the allocated clinics and regularly working with patients with LBP

Patient sample

Inclusion Criteria:

* Males and females 18-65 years; Fluent in Swedish; Accessing public primary care due to a current episode of a first-time or recurrent debut of benign low back pain with or without radiculopathy

Exclusion Criteria:

* Current diagnosis of malignancy, spinal fracture, infection, cauda equine syndrome, ankylosing spondylitis or systemic rheumatic disease, previous malignancy during the past 5 years; Current pregnancy or previous pregnancy up to 3 months before consideration of inclusion; Patients that fulfill criteria for multimodal/multi-professional rehabilitation for complex longstanding pain; Severe psychiatric diagnosis
Phase I Orally Administered 14C-AZD2171 in Patients With Solid Metastatic Tumors

Open, non-randomised, radiolabelled, single centre study with a total of six patients with solid metastatic tumors to determine the rates and routes of elimination of 14C-AZD2171 and its metabolites.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed metastatic tumor which is refractory to standard therapies
* life expectancy is 12 weeks or longer
* WHO performance status is 0-12

Exclusion Criteria:

* radiotherapy and chemotherapy within 4 weeks before the start of the study treatment
* patients with a history of poorly controlled hypertension
* history or evidence of any medical condition that might affect gastrointestinal function
* patients that have participated in a radiolabelled study in the last 5 years
The Time Point of Carboprost Methylate Administration and Perioperative Complications

Artificial abortion is the most widely used procedure in termination of first-trimester pregnancy. Cervical ripening before the operation guarantees operative convenience and decreases complications. An overstrained cervical dilation associates with uterine perforation, cervical laceration and cervical incompetence. To address the issue, various mechanical and pharmaceutical methods have been applied to prepare the cervix before transvaginal procedures. Prostaglandin analogues (PGs) play an important role in ripening the cervix or promoting uterine contraction in gynecology and obstetrics. As most tissues express prostaglandin receptors, vomiting, nausea, fever, diarrhea and abdominal pain can hardly be avoided with PGs administration. Longer PGs action contributes to better cervical ripening, but more uncomfortableness at the same time. These annoying symptoms may affect the participants' satisfaction and increase perioperative risks. To balance the safety and effectiveness of the surgery as well as patients' feeling, a proper timing for cervical ripening should be investigated. However, the administration timing of PGs has not reached a broad consensus, ranging from 16 hours to 2 hours before surgery. Carboprost methylate (CM), a PG-F2α analogue, has been used nationwide for cervical ripening in China. To minimize the side effects of PGs without affecting cervical ripening, the investigators intended to explore shortening the action time of CM in cervical preparation before artificial abortion. Thus, the investigators conducted this prospective cohort study and aimed to examine the efficacy of early and delayed vaginal administration of CM before surgery, and optimized both the perioperative safety and participants' convenience. The investigators hypothesize that early vaginal administration of CM would not affect the cervical ripening status, but will greatly reduce the unpleasant complications among the participants.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-59
* Signed informed consent.
* Admitted to hospital for surgical termination of unplanned pregnancy
* Gestational weeks range between 7 to 10
* Average diameter of the gestational sac was no larger than 4cm

Exclusion Criteria:

* Massive vaginal bleeding
* Severe abdominal pain at admission (numerical rating scale, NRS\>3)
* Genital tract infection
* Contraindication of PGs (including uncontrolled hypertension, asthma, glaucoma, severe heart disease or allergy to prostaglandins, etc.)
* Prior history of vaginal delivery
A Clinical Cohort Study of Pneumonia in Respiratory Intensive Care Unit

From 2003 when Severe Acute Respiratory Syndromes (SARS) appeared，many new types of respiratory viruses emerge in endlessly. Therefore, the epidemiology and the clinical character has changed quietly, especially severe pneumonia. This cohort study aim to obtain the contents of severe pneumonia patients in Respiratory Intensive Care Unit (RICU). Through the clinical data analysis, the investigators could get the information of the pneumonia caused by different reasons, such as morbidity and mortality, risk factors, clinical symptoms and radiographic changes, the respiratory support parameter and so on. The investigators hope the result could guide them do the clinical work of severe pneumonia better in the future.


Eligibility Criteria:
Inclusion Criteria:

* admit in RICU because of pneumonia of any causes
* anticipated length of hospital stay more than 72h

Exclusion Criteria:

* admit in RICU because of other causes except pneumonia
* do not agree to join this study
* admit in RICU for the second time
* anticipated length of hospital stay less than 72h
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.

Degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact. Treatment begins with conservative options (physical combined with antalgic therapy) but often requires surgical treatment.

Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery: microsurgical decompression (MiD) or decompression and instrumented fusion (MiD + F). Clinical and mechanical outcomes of two different treatments (MiD vs. MiD+F) will be compared.

An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques.

The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs, to gain the best clinical evidence, and possibly reducing the overall costs of management of this disease.

Eligibility Criteria:
Inclusion Criteria:

* degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facet joints, ligamentous hypertrophy, disc protrusion
* midsagittal spinal canal diameter of 12 mm or less
* no radiological signs of instability, i.e. pathological motion on preoperative dynamic lumbar X-ray
* ongoing symptoms for a minimum of 12 weeks with no improvement to conservative treatment
* eligibility for decompression alone (MiD) or decompression and fusion (MiD+F)

Exclusion Criteria:

* congenital, traumatic, infectious and neoplastic lumbar stenosis,
* spondylolisthesis (on static X-ray), lumbar scoliosis (Cobb\>10°),
* previous lumbar surgery, other types of operations (endoscopic decompression, anterior interbody fusions, interspinous devices etc.).
* patients with spine deformity requiring long fusion (i.e. \>=3 levels)
Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients.

OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

The present RCT is an open-label faisability study. OctaplasLG® or a placebo (0.9% NaCl) will be allocated to patients with a septic shock-induced coagulopathy defined by decreased platelets (\<150,000/mm3 or \>30% decrease within 24 hours) and an INR\>1.40, and started within the 6 hours following coagulopathy diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with:

  * a septic shock defined by Sepsis-3 criteria (Singer, JAMA 2016)
  * and a coagulopathy assessed by decreased platelets (\<150,000/mm3 or \>30% decrease within 24 hours) and an INR\>1.40 (Vincent, Crit Care Med 2013) without other etiology
* Randomization within a timeframe of 6 hours after coagulopathy diagnosis
* Age strictly over 18 years old
* Subject affiliated to a social health insurance
* Free and informed consent dated and signed.

Exclusion Criteria:

* Contraindication to OctaplasLG®
* Contraindication to preventive anticoagulation by heparin
* Any disorder with a requirement for full anticoagulation on the day of randomization
* PT prolongation or thrombocytopenia that is not due to sepsis
* History of congenital bleeding disorder predisposing to hemorrhage
* Medical condition associated with a hypercoagulable state
* Patient moribund on the day of randomization
* Do not resuscitate limitation at inclusion in the study
* Law protection: guardianship or curatorship
* Pregnancy/breastfeeding
Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU.We propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

Eligibility Criteria:
Inclusion Criteria:

* Normal CBC (Hemoglobin must be at least 11mg/dl)
* Normal renal and liver function tests
* Normal vital signs including normal blood pressure

Exclusion Criteria:

* Pregnancy
* On oral contraceptives
* On insulin lowering drugs
* On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
* On medications that will influence androgen metabolism or clearance
* On medications that will inhibit the cytochrome P450 enzyme system (Cimetidine, ketoconazole, etc)
Targeted Inpatient Navigation to Improve Care for Minority Children and Families

The overall goal of this research is to evaluate a new program designed to address basic human needs, create a safe and supportive environment for families, and help families build skills and confidence for navigating the health care system.

Specifically, we aim to pilot test the feasibility and acceptability of the Targeted Inpatient Navigation (TNav) program for families of low income, minority hospitalized children.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver ≥18 years of age, with a hospitalized child \<18 years old
* Preferred language of English, Spanish and Somali
* child with Medicaid insurance or no insurance
* child with self-reported (or parent-reported) minority race/ethnicity
* within 3 days of admission/ transfer to the medical unit on a general medicine service of a resident team

Exclusion Criteria:

* Admission for suspected child abuse
* Involvement of Child Protective Services at time of admission
* Admission for primary mental health condition, including intentional ingestion and eating disorder
* Family already enrolled in longer-term navigation services