cyrilzakka/clinical-trials huggingface dataset:
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males between the ages of 18 and 55
2. Non-Smokers
3. Body weight range form 154-220 lbs
4. No history of clinically significant metabolic disorders.

Exclusion Criteria:

1. Any history of low CYP450 2D6 activity
2. History of alcohol abuse or recreational drugs
3. History of any clinically significant disease or condition affecting a major organ system
4. Donation or loss of blood, 60 days proceeding to screening visit.
A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.

108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
* Measurable disease according to RECIST criteria
* Age \> 18 years
* WHO performance score \< 2
* Estimated life expectancy of \> 12 weeks
* Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
* Renal function: Cr ≤ 1.25×UNL
* Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
* Documented informed consent to participate in the trial

Exclusion Criteria:

* Subjects with distant metastases
* Pregnancy or breast feeding. Women of childbearing age must use effective contraception
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Evidence of bleeding diathesis or serious infection
* pregnant or lactating woman
* Patient participation in other studies
Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA Nephropathy

IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.

Primary IgA nephropathy (IgAN) is an immunopathological diagnostic term for a type of glomerulonephritis characterised by the deposition of IgA or IgA-dominant immune complexes in the glomerular tunica albuginea. And in China IgA nephropathy accounts for about 45% of primary glomerular diseases and about 26% of renal biopsies in patients with chronic failure. Among them, about 15-40% of IgA nephropathy patients progress to renal failure after 10-20 years; IgA nephropathy has become one of the main causes of end-stage renal failure.The nonsteroidal salicorticoid receptor antagonist (MRA)- finerenone reduces the risk of composite renal outcomes, ESKD, or renal death in patients with type 2 diabetes and CKD.There are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.

Eligibility Criteria:
Inclusion Criteria:

* primary IgAN diagnosed by renal biopsy;
* receive RASI inhibitors for at least 3 months;
* serum potassium \<5 mmol/L;
* protein-to-creatinine ratio (PCR) \>0.3 mg/g

Exclusion Criteria:

* secondary IgAN;
* autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, lupus nephritis,;
* previous renal transplantation;
* chronic hepatic disease, malignant tumor, active malignancy, heart failure with ejection fraction \<40%;
* followed up less than 6 months;
The Effect of Magnesium Supplementation During General Anesthesia on the Quality of Postoperative Recovery in Children

Evaluation of prevention of emergence delirium and analgesic effect of magnesium on children

Children \< 8 years old who scheduled for elective opthalmic surgery are randomly assigned to Magnesium (Mg) group and control group. Before anesthetic induction, modified Yale Preoperative Anxiety Scale (m-YPAS) is assessed. Routine anesthetic induction is performed, and neuromuscular blocker is not used. Laryngeal mask airway is inserted and controlled ventilation is started.

In Mg group, Mg of 30 mg/kg is administered for 10 minutes and then continuously infused (10mg/kg/hr) until 5 minutes before surgery end. In control group, the similar volume of saline is infused.

Pediatric Anesthesia Emergence Delirium (PAED) scale and pain score (Modified Children's Hospital of Eastern Ontario Pain Scale, CHEOPS) will be measured immediately after and 30 minutes after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 and 7 years
* American Society of Anesthesiologist physical status 1 and 2
* Children scheduled for opthalmic surgery

Exclusion Criteria:

* Allergy history to any drugs
* Risk of malignant hyperthermia
* Neuromuscular disease
* With arrhythmia
* Any pulmonary, cardiac, hepatic and renal disease
* Obesity
Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults

Analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults.

This is a randomized parallel study (two arms) with blinded outcome assessments. The participants' recruitment will be done by a non-probabilistic sampling resulting from invitations to Basic Health Units. The sample size estimation indicated 164 participants. Participants will be allocated, by means of a randomization process, to one of two groups (82 for each group): Experimental Group (multimodal circuit exercise) or Control Group (cycle of multidisciplinary lectures on pain ). The primary outcomes are global chronic pain intensity and global functional disability scores. The secondary outcomes are functional mobility and cardiorespiratory capacity. All analyses will be processed using the RStudio software. The differences will be considered statistically significant when a 2-tailed p-value is less than 5% (p \< 0.05). The statistical analysis will follow the intention to treat. Discussion: This study will discuss the effects of multimodal circuit exercise on global chronic pain intensity and global body functional disability scores. The hypothesize is that multimodal exercises will reduce musculoskeletal chronic pain and disability in older adults to the same extent as traditional supervised and structured exercises.

Eligibility Criteria:
Inclusion Criteria:

* Subjects from both sexes;
* Aged 60 or higher;
* Had a history of chronic pain in at least one synovial joint for more than three months.

Exclusion Criteria:

* Participants with some types of co-morbidities that may interfere with the research parameters, such as a history of stroke, stenosis of the spinal canal, severe heart disease, fibromyalgia, rheumatoid arthritis;
* Participants who presented a level of pain between 7 and 10 points on the Numeric Rate Scale (NRS) in any body location;
* Participants being under psychiatric treatment with sensory deficits (visual, auditory and intellectual)
* Participants performing any supervised and structured exercise at the moment of study enrollment or six months before.
Workplace-based HIV Self-testing Among Men in Uganda (WISe-Men)

This study seeks to determine whether workplace delivery of HIV self-testing will lead to an increase in uptake of HIV testing and subsequent linkage to care or prevention services among men in Uganda.

The current coverage of HIV testing and counseling in Uganda is 60% with only 34% of these being men and only about 55% of males living with HIV know their status (MoH, 2016). The challenges with HIV testing require a new focus and new approaches to reach people with undiagnosed HIV infection.

HIV self-testing (HIVST) is one such innovative approach to making testing more accessible to several under-served populations such as men and key populations (WHO, 2013).

In this regard, this study seeks to determine whether providing HIVST in workplace settings will increase the uptake of HIV testing services among men employed in private security services in Uganda and improve linkage to treatment and prevention services.

Design: Cluster randomized trial in two Ugandan districts

Participants: Male employees of private security companies

Eligibility Criteria:
Eligibility Criteria:

* 18-60 years old
* Employed \>6 months in the private security company
* Men who have not tested for HIV before
* Men who tested HIV \>one year ago
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation

Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old;
* Spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.;
* The patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home;

Exclusion Criteria:

* Short expected survival from malignant diseases;
* Muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied;
* Suffering from other neurological diseases;
* Planned to undergo other surgeries within 3 months;
* Unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;
Cultural Adaptation, Validity, and Reliability of the Turkish Version of North Star Ambulatory Assessment

The aim of this study is to translate the "North Star Ambulatory Assessment (NSAA)" scale into Turkish and make its cultural adaptation and to demonstrate the reliability and validity of the Turkish version in patients with ambulatory DMD. For the translation into Turkish, validity and reliability of the NSAA, necessary permission was obtained from the developer of the questionnaire, Prof. Dr. Francesco Muntoni, via e-mail. In the study, first of all, the translation and cultural adaptation process will be completed, and then reliability-validity studies will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with DMD
* Ambulatory
* Being between the ages of 4-18
* Agreeing to participate in the research voluntarily

Exclusion Criteria:

* Insufficient cooperation with the physiotherapist,
* Have had any injury and/or surgery of the lower extremities in the last 6 months,
* Having neurological problems in addition to DMD. -
Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (advanced Cervical Cancer)

This study is an early exploration clinical study with one arm.

The study consists of two stages, namely the dose escalation stage and the dose extension stage:


Eligibility Criteria:
Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

* 1.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
* 2. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 3.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 5.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures

The objective of this Compassionate Use Program (CUP) is to provide continued access to Lacosamide (LCM) for monotherapy use for patients who were receiving LCM in SP0993 and SP0994 at the time of study unblinding and close of SP0994, and who benefited from the treatment per investigator assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed the Termination Visit of SP0994 and has been treated with Lacosamide (LCM) monotherapy
* Patient is expected to benefit from participation in the Compassionate Use Program (CUP) with LCM monotherapy, in the opinion of the treating physician
* Patient is willing and able to comply with all program requirements
* Patient is informed of the details of this CUP, is given ample time and opportunity to ask questions and consider his/her participation in this CUP, and the patient or the legally authorized representative (LAR) has provided verbal consent to participate, and, if applicable to local regulations, has given written informed consent

Exclusion Criteria:

* Patient is receiving any investigational drugs or using any experimental devices in addition to LCM
* For countries where LCM is reimbursed: Patient requires another anti-epileptic drug (AED) for the treatment of seizures For countries where LCM is not reimbursed (or conditionally reimbursed: Belgium, Australia e.g.): Patient requires another AED for the treatment of seizures and qualifies for commercial LCM (and LCM is being reimbursed)
* Patient experienced emergence of a seizure type other than partial-onset or generalized tonic-clonic seizures, or occurrence of status epilepticus
* Patient developed second- or third-degree atrioventricular (AV) block or another clinically relevant change in medical condition (or electrocardiogram (ECG) or laboratory parameter)
* Patient having liver function test (LFT) results of transaminases (aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\]) ≥3×ULN to \<5×upper limit of normal (ULN)
* Patient has actual suicidal ideation or behavior
* Patient is experiencing an ongoing serious adverse event (SAE) and there is no expected benefit for him/her to continue on LCM treatment
* Female patient who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception (according to ICH guidance defined as those that result in a failure rate of less than 1 % per year when used consistently and correctly), unless sexually abstinent, for the duration of the study
* Patient was treated with carbamazepine controlled release (CBZ-CR) in SP0994
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet

A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.


Eligibility Criteria:
Inclusion Criteria:

* healthy assessed by the principal investigator or sub-investigators
* non-smoking or stop smoking at least 90 days before the study
* body weight: over 50.0kg and less than 80.0kg
* body mass index (BMI): over 17.6 and less than 26.4

Exclusion Criteria:

* participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
* donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
* received any drugs within 7 days before the study or going to receive any drugs
* deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
* deviance from normal range in lab-tests
* history of drug allergy
* history or current diagnosis of stomach, small intestine or large intestine diseases
* history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* history or current diagnosis of colitis ischemic
* history or current diagnosis of hepatic diseases
* history or current diagnosis of cardiovascular diseases
* history or current diagnosis of respiratory diseases
* history or current diagnosis of malignant tumor
* received ramosetron tablet
Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)

People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability.

The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period.

If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.


Eligibility Criteria:
Inclusion Criteria:

* Registered at a general practice situated in the Danish Capital Region or the Region of Zealand;
* Registered at general practice with International Classification of Primary Care version 2 (ICPC-2) diagnostic code p72 (psychotic disorders);
* Registered at general practice with ICPC-2 diagnostic code p73 (bipolar mood disorders);
* Prescription of Lithium (Anatomical Therapeutic Chemical (ATC): N05AN);
* Registered at general practice with ICPC-2 diagnostic code p76 AND (Prescription of Lamotrigine (N03A09) OR Carbamazepine (N03AF01) OR Valproic Acid (N03AG01));
* Registered at general practice with ICPC-2 diagnostic code p76 (unipolar depressive disorders) AND (Prescription of tricyclic antidepressants (N06AA) AND/OR venlafaxine (N06AX16) AND/OR duloxetine (N06AX21) AND/OR Monoamine Oxidase A Inhibitor (MAOi) (N06AG) AND/OR non-selective MAOi (N06AF)).

Exclusion Criteria:

* Subjected to any type of legal measure as stipulated in the Danish Mental Health Law;
* Registered with a dementia diagnosis ICPC-2 p70 (dementia);
* Receiving end-of-life care;
* Non-Danish speakers;
* Assumed by the patient's general practitioner to have an overall functional level that is too low for meaningful participation in trial.