cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate the Effect of Ketoconazole Mediated CYP3A4 Inhibition on Pharmacokinetics of Tamsulosin in Healthy Male Volunteers

Study to investigate the effect of CYP3A4 inhibition by ketoconazole on the single oral dose pharmacokinetics of tamsulosin and to investigate the effect on safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

All participants in the study will be

* Healthy males
* Ranging from 21 to 50 years of age
* Body mass index (BMI) within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication and/or related drugs of these classes
* Non extensive metabolizer (EM) for CYP2D6
A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus

A Pilot of Metformin Postpartum

The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.

Eligibility Criteria:
Inclusion Criteria:

* Gestational Diabetes

Exclusion Criteria:

* Cannot tolerate metformin
Effects of Two Types of Concurrent Training in Functional Performance and Cognitive Function of Older Adults

The goal of this randomized controlled clinical trial is to identify and compare the impacts of traditional concurrent training and concurrent training consisting of strength training combined with dance classes on functional performance, cognitive function and quality of life in older people. The main question it aims to answer are:

• The concurrent training consisting of strength training combined with dance classes can provide similar benefits to traditional concurrent training in neuromuscular and cardiorrespiratory performance, cognitive function and quality of life in older people?

Participants will training one of the two types of concurrent training (traditional concurrent training or concurrent training consisting of strength training combined with dance classes), two times a week, over 12 weeks.

Researchers will compare traditional concurrent training, concurrent training consisting of strength training combined with dance classes and a control group without exercise to see if this modalitys of physical exercise can provide increases in neuromuscular and cardiorrespiratory performance, cognitive function and quality of life in older people.


Eligibility Criteria:
Inclusion criteria:

* Be male or female aged between 65 and 75 years old
* Do not practice regular physical exercises for at least three months
* No history of competitive sports throughout life
* Not having musculoskeletal and neurological diseases or disorders that may influence the performance of the exercises or affect the test results
* Not having health conditions in which physical exercise is contraindicated
* Achieve a score of no less than 24 on the Mini Mental State Exam
* Achieve a score of up to 9.11 on the Baecke Physical Activity Questionnaire.

Exclusion criteria:

* Miss more than 20% of training sessions
* Miss more than three workouts in a row
* Failure to attend any of the evaluations will be excluded from the study.
Delivery Pain and Postpartum Comfort

In this study was aimed that acupressure applied on the BL32 point and shower application reduced the intensity of labor pain experienced by the pregnant women in the active phase of labor and increased their postpartum comfort

Acupressure and shower are methods that can help reduce pain severity. This study thus aims to determine the effects of acupressure and shower on labour pain and postpartum comfort. This study was a randomized controlled trial (RCT). This study was the control group consisted of 40 pregnant women, while the experimental groups (acupressure and shower) consisted of 80 pregnant women in total. The experimental groups received routine labour care and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10 cm). The control group only received routine labour care. A maternal information form (MIF), the Visual Analog Scale for Pain (VASP) and the Postpartum Comfort Questionnaire (PPCQ) were used to collect data. CONSORT checklist was used to report the current study.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were being 20-40 years of age;
* Having a foetus in vertex presentation
* Having a foetus weighing 2.5-4 kg, as determined through ultrasonography
* Being primiparous
* Being between 37 and 42 gestational weeks with a single foetus
* Having planned to have a spontaneous vaginal delivery
* Not having used nonpharmacological pain control methods previously
* Having a cervical dilation less than 5 cm (Dabiri et al., 2014)
* Not having received analgesia or anaesthesia.

Exclusion Criteria:

* Were having a systemic disease during pregnancy (gestational diabetes, hypertension)
* Taking medication regularly
* Having a problem that prevented the woman from communicating
* Undergoing psychiatric treatment (pharmacotherapy or psychotherapy)
* Requiring an operative vaginal delivery (forceps, vacuum)
* Receiving pharmacological interventions for labour pain.
A Natural History Study to Assess the Clinical Outcomes of Patients With Complement Factor I Deficiency-Mediated Disease

This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.

This study will follow participants with a disease which is associated with an absence or deficiency in Complement Factor I (CFI) as confirmed in the CFI-001 screening study.

The population will include male and female participants ≥6 months of age (pediatric participants enrolled as permitted by local Institutional Review Board/Independent Ethics Committee). This includes patients with recurrent bacterial infections (eg, meningitis, sepsis, pneumonia, endocarditis, otitis) and patients with autoimmune and immune complex-mediated diseases (eg, glomerulonephritis, systemic lupus erythematosus, leukocytoclastic vasculitis, Bickerstaff encephalitis, meningoencephalitis).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 6 months or older
2. Affirmation of participant's informed consent or legally authorized representative (LAR)'s willingness to provide informed consent with signature confirmation before any study-related activities. (Study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) The participant (if a minor) must also be willing to give written informed assent (if able) if the minor is within the age groups 7 to 11 years old and 12 to 17 years old.
3. Confirmed CFI deficiency during the screening study, CFI-001, with a disease that is associated with an absence or deficiency in CFI
4. Stated willingness of the participant to comply with all study procedures (including multiple blood draws) and availability for the duration of the study
5. Stated willingness of the participant (or LAR) to allow access to his/her medical records with the purpose of assessing disease status and progression during his/her participation in the study

Exclusion Criteria:

1. Participation in an interventional clinical study within the previous 30 days prior to screening or within ≤5 half-lives of the investigational drug, whichever is longer
2. Having a major concurrent non-CFI-related disease that prevents the assessment of the natural course of the CFI deficiency disease
3. Having a medical, psychosocial, or familial issues that might prevent full participation and cooperation with the procedures and requirements of the clinical study as determined by the potential participant/guardian and physician investigator
Pain Coping Skills for Colorectal Cancer Survivors

Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.


Eligibility Criteria:
Inclusion Criteria:

* \>21 years old
* personal history of colorectal cancer
* finished active cancer treatment within the past 12 months
* reported pain as a concern as well as psychological distress on a National Comprehensive Cancer Network screener
* able to speak and read English
* able and willing to give informed consent

Exclusion Criteria:

* currently undergoing active cancer treatment
* have a major mental illness (e.g., schizophrenia)
* have a mental illness that is not being treated/controlled (e.g., bipolar disorder)
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)

Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).

Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.


Eligibility Criteria:
Inclusion criteria:

1. Written informed consent consistent with Good Clinical Practice (GCP) signed prior to entry into the study
2. Completion of 1199.31 study and still under treatment with pirfenidone at a stable dose

Exclusion criteria:

1. Any disease that may interfere with testing procedures or in judgement of investigator may interfere with trial participation or may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.31. However, patients may qualify for participation even though they meet the exclusion criteria (for 1199.31), if the investigators benefit-risk assessment remains favorable.
2. Any other investigational therapy received within 8 weeks before visit 1.
3. For female: Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for both at least 4 weeks prior to enrolment and 10 weeks after last study drug intake.

   For male: Sexually active males not committing to using condoms both during the course of the study and ten weeks after last study drug intake (except if their partner is not of childbearing potential).
4. Known or suspected active alcohol or drug abuse.
5. Patients who require full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, heparin), except low dose heparin and/or heparin flash as needed for maintenance of an indwelling intravenous device. As an example, prophylactic use of heparin, e.g. enoxaparin 2000 International unit (I.U.) subcutaneously (s.c.) per day, should be allowed.
6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel) therapy. As an example, chronic low-dose acetyl salicylic acid, below or equal to 100 mg per day, should be allowed.
7. Patient not compliant in previous trial, with trial medication or trial visits.
Glycemic Control and the Brain in Children With Type 1 Diabetes

The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 14 and not yet 18 years old
* Must have been diagnosed with T1D prior to 5 years old but after 6 months
* For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required
* Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth
* Be in puberty

Exclusion Criteria:

* History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program
* ADD/ADHD and/or on stimulant medication
* Any known genetic or medical problem that could impair brain development
* Abnormalities of the brain/nervous system, visual or hearing problem
* History of seizures not associated with fever before diabetes diagnosis
* Previous inpatient psychiatric treatment
* Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip
Effectiveness of Continuous Femoral Nerve Block Versus Single Shot Femoral Nerve Block for Pain Control

Both single shot femoral nerve block and continuous femoral nerve block with catheter have been shown to be effective for pain control after anterior cruciate ligament reconstruction (ACLR). Continuous femoral nerve block may be the more effective of the two in reducing pain scores and opioid consumption for the first 48 hours postoperatively.

The number of ambulatory procedures has steadily increased over the last decade. Postoperative pain is the most common cause of delayed discharge and unexpected admission after ambulatory surgery. Knee surgery was identified as one of the procedures associated with the most pain at 24 hours, with a 45% or higher incidence of moderate or severe pain. Poor pain control can counteract many of the benefits of ambulatory surgery and can lead to the development of chronic pain.

Regional techniques have been shown to be effective after ACL reconstruction, allowing faster patient recovery with fewer side-effects than intravenous administration of opioids. Different regional techniques have been applied and studied after ACLR. Femoral nerve block for ACLR either as a single bolus or as a continuous infusion markedly decreases intravenous analgesic requirements and postoperative pain. To the Investigator's knowledge, no study has compared these two techniques after ACLR with patellar tendon graft or allograft.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists score between 1-3
2. Scheduled to undergo Anterior Cruciate Ligament reconstruction with patellar tendon graft or allograft under general anesthesia

Exclusion Criteria:

1. Localized infection of the groin or generalized sepsis.
2. Hypersensitivity or known allergy to local anesthetics.
3. Preexisting nerve damage in surgical limb.
4. History of chronic pain with either (a) daily opioid requirement exceeding the equivalent of 50 mg morphine or (b) daily prescription of tricyclic antidepressants, gabapentin, pregabalin, or tramadol for pain.
5. Patients who elect to have knee surgery under spinal anesthesia or who cannot undergo general anesthetic.
6. Patients who decline to have a femoral nerve block with catheter.
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.

Intraoperative epidural administration of steroids following discectomy for herniated lumbar disc has been the topic of multiple studies in the literature. The results have been mixed, with the majority of the studies finding some benefit, but outcomes have varied drastically amongst the many studies. The aim of this study is to develop a grading scale for intraoperative assessment of nerve root inflammation to determine if this subjective assessment is an adequate indicator for response to epidural steroids following discectomy. Patients will be allocated randomly preoperatively to the intervention group versus control group. Pictures of the spinal cord and associated nerve root will be captured intraoperatively. These pictures will be scrutinized postoperatively and an inflammation grade will be assigned. The investigators will then identify if nerve roots with a higher-grade of inflammation respond differently to epidural steroid administration when compared to lesser-grades of inflammation. This will be measured with the a variety of outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation
* Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
* Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present
* Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation

Exclusion Criteria:

* Concomitant spinal stenosis, segmental instability, or spondylolisthesis
* Previous surgery at the affected level or recurrent herniation
* Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression
* Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
* Diagnosis of or symptoms concerning for cauda equina syndrome
Follow-Up for Study Participants Treated With an Allogeneic CAR T-Cell Product

An observational, long-term follow up (LTFU) study of participants who received an allogeneic CAR T product in a prior clinical study. Participants will be followed for 15 years after their last infusion of an allogenic CAR T cell product.


Eligibility Criteria:
Inclusion Criteria:

* Received an allogenic CAR T-cell product infusion to treat an oncologic condition in a previous Allogene or Servier sponsored clinical study

Exclusion Criteria:

* Less than 12 months of follow up after the last allogeneic CAR T-cell product, unless approved by the Allogene Medical Monitor
Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of At Risk and Stunted Children

This is a non-randomized open label 6 months intervention study that aims to assess the effectiveness of consuming milk daily for 6 months will improve the linear growth rate of children aged 12-36 months.


Eligibility Criteria:
Inclusion Criteria:

1. Malaysian child
2. Boys and girls between the age of 12 and 36 months
3. Length-for-age z score (LAZ) \<-1.5 SD and \> -3 SD according to the WHO Growth standard
4. Weight-for-age z score WAZ \<1.0 SD and \> -3 SD
5. Parents and/or legal guardian who can speak and read Malay or English language
6. Written informed consent from parents and/or legal guardian
7. Child who are apparently healthy with no obvious on-going infection and no history of chronic illness.
8. Child with no physical and/or mental illness
9. Parents and/or legal guardian who owns a mobile phone or smart phone
10. Mothers who have ever received breastfeeding counselling from a qualified breastfeeding counsellor.

Exclusion Criteria:

1. Child with zinc protoporphyrin (ZnPP) value of \>65 (at either -T3 or T0)
2. Clinical symptoms of iron deficiency as examined by Doctor even with zinc protoporphyrin (ZnPP) value between 40-64
3. Child with severe acute malnutrition, other chronic diseases or any congenital disorder or deformity
4. Child with an ongoing episode of diarrhoea or a history of persistent diarrhoea in the past month
5. Child with history of cow's milk allergy/intolerance to milk
6. Child who is already taking multivitamins, including iron, before enrolled to the study
7. Child who is taking breastmilk as part of the diet
Prognosis Stratification for pT4bN0M0 Colorectal Cancer Following Multivisceral Resection

The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.

Patients with pT4b stage colorectal cancer (CRC) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (MVR), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. In this study, investigators attempted to evaluate the prognostic factors of pT4bN0M0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients.

This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.The prognostic factors of pT4bN0M0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pT4bN0M0 patients.

Eligibility Criteria:
Inclusion Criteria:

1. The patient was pathologically diagnosed as colorectal adenocarcinoma.
2. Patients with pT4bN0M0 colorectal cancer.
3. Patients with R0 resection.

Exclusion Criteria:

1. Patients with distant metastasis.
2. Patients with R1 or R2 resection.
3. Patients with lymph node metastasis
4. Recurrent colorectal cancer.