cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 20 and 28 kilogram per meter square (kg/m\^2), inclusive (BMI=weight/height\^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg
* Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
* Participant must be healthy based on physical and neurological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (including QT corrected according to Fridericia's formula \[QTcF\] less than or equal to \[\<=\] 450 milliseconds \[msec\] for males and \<= 470 msec for females) performed at screening. Abnormalities, which are not considered to be of clinical significance by the Investigator, are acceptable. The presence of left bundle branch block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD) will lead to exclusion
* Participant must have systolic blood pressure (SBP) and heart rate (HR) within normal limits at screening and at Day -1: supine SBP of at least 90 millimeters of mercury (mmHg) and maximum 150mmHg, supine diastolic blood pressure (DBP) should be above 50mmHg and below 90mmHg and the HR must be between 45 beats per minute (BPM) and 100 BPM. If the results are outside the normal reference ranges above, retesting will be allowed once during the screening phase
* Non-smoker (not smoked for 3 months prior to screening)

Exclusion Criteria:

* Cardiac arrhythmias or other cardiac disease, hematological disease, hypertension, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies at screening visit
* Participant has a history of drug or alcohol use disorder or psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 6 months before screening (for example psychotic, bipolar, major depressive, or anxiety disorder) or positive test result(s) for alcohol and/or drugs of abuse (opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission
* Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola per day
* Clinically significant acute illness within 7 days prior to study drug administration
Ocular Mysathenia Gravis Generalization

Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.


Eligibility Criteria:
Inclusion Criteria:

- Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database

Exclusion Criteria:

- OMG differential diagnoses
Safety and Efficacy of CDB-2914 in Comparison to Levonorgestrel for Emergency Contraception

The purpose of this study is to assess the safety and efficacy of CDB-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.


Eligibility Criteria:
Inclusion Criteria:

* women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
* present within 120 hours of unprotected intercourse
* regular menstrual cycles
* No current use of hormonal contraception
* Willing to not use hormonal methods of contraception until study completion
* At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
* For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
* Able to provide informed consent
* Willing to abstain from further acts of unprotected intercourse until study completion

Exclusion Criteria:

* One or more acts of unprotected intercourse more than 120 hours
* current or recent use of hormonal methods of contraception
* currently pregnant or breastfeeding
* tubal ligation or current use of IUD
* Use of hormonal emergency contraception since last menstrual period
* Current use of IUD
* Tubal ligation
* Partner with a vasectomy
* Unsure about the date of the last menstrual period
* Severe asthma insufficiently controlled by oral glucocorticoid
* Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
The Effect of Virtual Reality Treadmill-Based Gait Training on Gait and Balance Ability in Chronic Stroke Patients

Walking independence is one of the most important goals for stroke patients and a major factor influencing their return to society after the onset of stroke. Stroke patients experience walking difficulties due to hemiplegia and have an increased risk of falls due to impaired balance ability. Recent studies have shown that treadmill-based walking training incorporating virtual reality can help improve walking and balance functions in actual stroke patients. However, there are few randomized clinical trials with control groups, highlighting the need for further research to ensure the reliability of clinical effects.

Therefore, this study aims to investigate the impact of treadmill-based training incorporating virtual reality on walking and balance functions. The training equipment to be used is the C-mill VR+ device, which enables walking training and assessment, balance training and assessment, and obstacle training using a front screen and treadmill videos. The investigators intend to thoroughly examine the walking ability and balance ability of the subjects obtained through this equipment, along with various evaluation tools.


Eligibility Criteria:
* Inclusion Criteria:

  1. Adult patients aged 19 years or older.
  2. Confirmed diagnosis of stroke by a neurologist or neurosurgeon through radiological methods such as CT or MRI.
  3. Chronic hemiplegic stroke patients, six months post-stroke onset.
  4. Patients with a Functional Ambulatory Category score of 3 or higher.
  5. Patients with a Mini-Mental State Examination (MMSE) score of 10 or higher, who understand the study, are willing to participate voluntarily, and have given consent to participate.
* Exclusion Criteria:

  1. Acute/subacute stroke patients within six months of stroke symptom onset.
  2. Patients with quadriplegia.
  3. Patients with ataxia.
  4. Patients with severe joint contracture of the lower limbs that makes wearing orthotics difficult.
  5. Patients with neurological, musculoskeletal, or cardiopulmonary diseases that affect walking.
  6. Any other cases deemed inappropriate for participation by the researcher.
Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization in patients with non-small-cell lung cancer (any stage.

To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks, every 10 weeks.

To perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A specific protocol will be written for this part.

This is a single-arm, non-randomized Phase II trial of DLPC-9NC administered by aerosol 5 consecutive days per week for 8 weeks every 10 weeks.

Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks.

Patients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course.

Eligibility Criteria:
Inclusion Criteria:

* All patients, 18 years of age or older, with resectable lung cancer (any stage) or stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma, who have failed standard chemotherapy or radiotherapy for their disease or who refuse standard therapy are eligible.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have a Zubrod performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \>1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
* Patients must not have a known symptomatic respiratory disease other than cancer, and must have a pulmonary function test equal to \>50% FEV1, \>50% FEV1/FVC, \>50% TLC, and \>50% DLCO of predicted values.

Exclusion Criteria:

* Patients with symptomatic brain metastases are excluded from this study.
* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
* Any criteria that is borderline and may lead to ineligibility will be reviewed by the PI, who may override the eligibility criteria, after receiving sponsor agreement, if entry into the study is deemed to potentially benefit the patient.
Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation

The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

1. Previously essentially healthy
2. Newly acquired spinal cord injury, T12 level or higher
3. Receiving in-patient care on the rehabilitation ward.
4. Expected admission duration \>= 4 weeks
5. 16 years old or older

Exclusion Criteria:

1. Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction
2. Severe head injury with impairment of cognitive function
3. Allergy to cranberry
4. Renal failure
5. Warfarin (Coumarin) treatment with unstable INR
6. Current symptomatic urinary tract infection
Comparison of Three Methods for NG Tube Placement

Background and Aim: Tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. This method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. The purpose of this study was to compare the three methods of the NG tube placement in intubated patients in the emergency department of university-affiliated hospitals of Isfahan from2016 to 2018.

Materials and Methods: This study was a randomized and prospective clinical trial. The statistical population of this study was all patients who had been referred to the emergency department of Al-Zahra and Ayatollah Kashani hospitals in Isfahan between2016and2018. The sample size was 25 in each group, and in total 75 subjects. The first group was NG tube insertion by the conventional method, the second group was using brake cable and the third group was embeddedby highwayman's hitch or draw hitch, using a silk thread. For all patients, demographic characteristics and possible complications were recorded. Finally, the data were analyzed using SPSS20 software at two statistical levels of descriptive and inferential.


Eligibility Criteria:
Inclusion Criteria:

* all intubated patients, referred to the emergency department

Exclusion Criteria:

* the presence of symptoms of skull base fracture,
* bleeding disorders and coagulopathies,
* maxillofacial trauma, which led to deformity and impairment of NG tube,
* upper respiratory tract diseases and anomalies,
* nasal congestion and nostril stenosis,
* esophageal disorder (esophageal stenosis and esophageal varicose vein),
* and a history of head and neck radiotherapy.
* Patients who had been intubated in other centers and being referred to these two centers were also excluded.
Personalized Lifestyle Intervention and Weight Control

This trial aims to investigate whether tailored lifestyle consultation through SNP testing leads to more effective weight loss among overweight or obese individuals compared to general lifestyle guidance for weight control.


Eligibility Criteria:
Inclusion Criteria:

* overweight or obese individuals

Exclusion Criteria:

* a past history of bariatric surgery or eating disorders
* currently pregnant or planning a pregnancy within 2 years
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion

Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.

There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
* Low or moderate cardiac risk according to American College of Sports Medicine
* Post-Concussion Symptom Scale (PCSS) score greater than 9

Exclusion Criteria:

* History of neurological surgery
* Seizure disorder
* Use of medication or medical device that would alter heart rate, blood pressure or autonomic function
* Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity
* Unable or unwilling to provide informed consent
Normative Values Laser Nociceptive Evoked Potentials Depending on the Age

Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly.

Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly. Normal values that are available have been obtained in young subjects. However, various studies have shown that the integration of nociceptive messages depended on age. The aim of this study was to establish normal values of nociceptive evoked potentials for each age group of 18 to 75 years.

Eligibility Criteria:
Inclusion Criteria:

* major

Exclusion Criteria:

* Neurological history
* Neuralgia history (\> 3 months)
* Pathology can cause neuropathy (unbalanced thyroid dysfunction, diabetes, kidney failure, chronic hepatitis, HIV ...)
* Dermatological disorder known type of Lucite or photosensitivity
* Medical treatment analgesic, psychotropic or anti-epileptic underway
* Toxic acquired in the last 72 hours (alcohol, cannabis, other toxic ...)
* Pregnant women
* Incapacitate to stand still
* Participation in another biomedical research in the field of pain in the three months prior to inclusion.
An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids

This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II (Very strong class) TCs
* Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; Water per Oil emulsion) as per investigator's routine treatment practice
* Patients who are aged over 20
* Patients who are able to understand and sign a written informed consent

Exclusion Criteria:

-Patients participating in an investigational program with interventions outside of routine clinical practice

* Patients with any contraindication to TCs
* Patients who are regarded as ineligible by the investigator
* Patients who are pregnant or breastfeeding
* For Period 2 (Spring-Summer), patients enrolled in the Period 1
A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury

To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.

The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with TBI and their caregivers. The treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. The goals are to evaluate the impact of the treatment program on improving health outcomes for people with TBI. The investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.

Eligibility Criteria:
Inclusion criteria:

* age 19 years or older
* sustained a TBI
* at least 6-months or greater out from injury
* willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use)
* able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor)
* not currently enrolled in a health and wellness program or research study involving a health/wellness program or intervention
* indicates a potential health goal to lose weight and does not independently prepare their own meals, cook, grocery shop, but has a caregiver defined by providing some type of ongoing support (emotional or instrumental) who is willing to participate as a study partner during the intervention condition
* has access to a telephone
* has regular access to the internet from a computer or laptop
* not pregnant (due to the effect on engaging in certain health promoting behaviors such as weight loss)
* does not have a significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)

Exclusion criteria:

* non-English speaking
* difficulty hearing
* significant problems with communication
A Study Investigating Treatment Factor X in People With Factor X Deficiency

The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg.

The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent given, or for subjects aged 12-17 years, have given written assent and whose parent/guardian has given written informed consent
* At least 12 years of age at dtae of written informed consent
* Have hereditary severe or moderate FX deficiency
* Currently treated with Fresh Frozen Plasma FFP, Prothrombin Complex Concentrate PCC or factor IX/X concentrate
* Must have a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment of FFP, PCC or factor IX/X concentrate. Newly diagnosed subjects who present at the hospital with a bleed may be included
* Must have had at least 7 days, and ideally 10-14 days, since an infusion of either FFP, PCC or factor IX/X concentrate at Baseline Visit
* Females of child bearing potential must have a negative result on a HCG based pregnancy test. If they are or become sexually active, they must practise contraception by using a method of proven reliability for the duration of the study

Exclusion Criteria:

* Have a history of inhibitor development to FX or a positive result at the Screening Visit
* Bleeding at the appointment for the PK assessment
* Subjects who have thrombocytopenia
* Have clinically significant liver disease
* Known to have other coagulopathy or thrombophilia
* Have known or suspected hypersensitivity to the investigational medicinal product or its excipients
* Have abused chemicals or drugs within the past 12 months
* Have a history of unreliability or non-cooperation
* Participating or have taken part in another trial within the last 30 days, with the exception of BPL FX surgery study - Protocol Ten03. In such cases, subjects should have completed their End of Study Visit either before or on the day of Screening Visit for this study
* Female subjects who are pregnant or lactating
* Subjects planning greater than 4 weeks absence from the locality of the Investigational site, between the screening visit and the repeat PK assessment