cyrilzakka/clinical-trials huggingface dataset:
Intermittent Theta Burst Stimulation After Acute Stroke

This pilot sham-controlled study aims to determine the safety and efficacy of repetitive transcranial magnetic stimulation given as a facilitatory intermittent theta burst stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute stroke patients.

The patients with first-ever, MRI-confirmed monohemispheric ischemic stroke in the middle cerebral artery territory, and NIH Stroke Scale motor arm score 1-2 with recordable active motor thresholds (aMT) of the extensor carpi radialis (ECR) between 2-4 weeks after the stroke onset, are randomized into two groups to receive either iTBS1200 or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. All have standardized medical and intensive rehabilitation treatments. The outcome measures included Action Research Arm test (ARAT), Fugl-Meyer test (FMT), aMT and motor evoked potentials (MEPs) of ECR.

Eligibility Criteria:
Inclusion Criteria:

* Patients with first-ever, subacute (between 2-4 weeks post-stroke), monohemispheric ischemic stroke within the middle cerebral artery (MCA) territory, and mild to moderate hand paresis (NIHSS motor arm score 1-2) are enrolled.

Exclusion Criteria:

* age over 75, severe hand paresis without detectable active motor threshold (aMT) of the extensor carpi radialis (ECR), seizure history (clinical or EEG abnormalities), psychosis, aphasia, apraxia, concomitant neurological diseases or severe systemic diseases (e.g. sepsis, advanced malignancy, hepatic or renal failure.
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition

The purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.

A randomized, open label, two treatment, two period, two sequence, single dose, crossover bioequivalence study of Fluoxetine Hydrochloride Delayed-Release capsules 90 mg of Dr. Reddy's laboratories limited, Generics, India and Prozac®weekly 90 mg delayed release capsules of Eli Lilly and company, USA in healthy adult human subjects under fed conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (11 Underweight and Overweight Min. \& Max. Chart).
* Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
* Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
* Informed consent given in written form according to section 11.3 of the protocol.
* Female Subjects

  * of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies,diaphragm, intrauterine device, or abstinence.
  * postmenopausal for at least I year.
  * surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

* Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
* Alcohol dependence, Alcohol abuse, i.e., regular use of more than 2 units of alcohol or 10 units per week or a history of alcoholism (one unit of alcohol equals 1/2 1 of beer 200 ml wine or 50 ml (of spirits) within last 6 months or recovered alcoholics , or drug abuse within past 1 year.
* Moderate to heavy smoking (\> 10 cigarettes/day) or consumption of tobacco products.
* History of difficulty in swallowing capsules.
* Clinically significant illness within 4 weeks before the start of the study.
* Asthma, urticaria or other allergic type reactions after taking any medication.
* Positive urine drug screening, Human Immunodeficiency Virus, Hepatitis B \& C tests.
* Any history of hypersensitivity to fluoxetine.
Effect of Manual Therapy and Inmediately Application of Plantar Orthoses

Limitation of ankle dorsiflexion is directly related to pronated foot. For its treatment, plantar orthoses and manual therapy are used. There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.

The popularity of long-distance running has increased because it can be practised in many settings, the low cost and the links to prevention of health problems. In running between 19-79% of runners may suffer a running-related overuse injury each year. Pronated feet have been identified as a risk factor for lower limb overuse injury, and several studies have found that ankle dorsiflexion limitation is related to pronated feet.

There is a lack of evidence on their combination, as to when the cast should be taken after manipulation. Our hypothesis proposes that it is more effective to cast immediately after manipulation.

The main objective is to compare the effect of manipulation with motion (MWM) performed immediately prior to casting for plantar orthoses (PO) with the effect of manipulation with motion performed one week prior to casting for plantar orthoses on ankle dorsiflexion (ankle DF) and foot pronation in runners with hyper pronator feet secondary to a limited ankle DF.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 18 and 45.

They will be randomised into two groups; group A, which will undergo MWM and have the moulds taken in phenolic foam immediately after the manipulation. The other group will be group B, which will undergo the MWM, and the moulds will be taken one week after the manipulation.

Eligibility Criteria:
Inclusion Criteria:

* Runners who run on asphalt.
* Individuals who run at least \>6 hours per week for 6 months prior to study participation.
* Participants with hyperpronated feet secondary to ankle ROM limitation.
* Runners with an ankle DF difference of \>1.5cm in both feet or an ankle DF of less than 11.5cm according to the Lunge Test.

Exclusion Criteria:

* Individuals who have suffered a major injury in the previous two months.
* FPI less than 6.
* Runners wearing minimalist footwear into which PO cannot be inserted.
* Individuals already undergoing treatment with plantar supports.
* Chronic widespread pain, including fibromyalgia.
* Systemic rheumatic pathologies.
* History of recent trauma or surgery
To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy

The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
2. Current usage of subcutaneous insulin pump treatment with one of the following pumps:

   * Medtronic Paradigm®
   * Animas®
   * OmniPod®
   * ACCU-CHEK Spirit®
3. Age 18-75 years
4. HbA1c of 6.0 - 9.0% at screening visit.
5. Willingness to attend 9 clinic visits.

Exclusion Criteria:

1. Pregnancy or Lactation
2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
3. Anemia
4. Congestive heart failure.
5. Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
6. Active coronary artery disease or heart procedure within the past 4 months.
7. Active foot ulceration.
8. Severe peripheral arterial disease.
9. Stroke within the past 6 months.
10. Active alcohol abuse, substance abuse, or severe mental illness.
11. Active cancer, except basal cell or squamous cell skin cancers.
12. Major surgical operation within 30 days prior to screening.
13. Seizure disorder (epilepsy).
14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
15. Currently use of corticosteroids.
16. History of major non-compliance.
17. Use of an investigational drug within 30 days prior to screening.
18. Bleeding disorder, treatment with warfarin, or low platelet count.
19. Any insulin allergy
20. Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema.
21. History of gastroparesis.
Special Drug Use Investigation of Ciproxan Injection in Pediatrics

The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.

This company-sponsored study is an one-arm, prospective, and, cohort-observational study in pediatrics (less than 15 years old) administered Ciproxan injection. All patients in the contracted institute should be enrolled into this study. Consequently 45 cases will be is planned to be enrolled in three-year period Target population is pediatrics with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa. The treatment should be performed based on the product label in Japan. The standard observation will be performed until the last date of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female and male pediatric patients (less than 15 years old) with a diagnosis of complicated cystitis, pyelonephritis, cystic fibrosis, or anthrax infected by ciprofloxacin-active microorganisms, i.e. Bacillus anthracis, Escherichia coli, Pseudomonas aeruginosa.
* Patients for whom the decision to initiate treatment with Ciproxan injection was made as per investigator's routine treatment practice.

Exclusion Criteria:

* N/A
The Effect of Body Mass Index on Etonogestrel Hormone Levels in Women Using the Single-rod Contraceptive Implant

Two-thirds of young women in the United States are overweight or obese. This excess weight may affect how their body metabolizes drugs such as different birth control methods. There is a not a lot of research about how excess weight could affect the hormone levels of the contraceptive implant. Methods like the implant contain only progesterone, which is a hormone that does not increase a woman's risk of blood clot. These methods would be preferred for overweight and obese women because excess weight also increases a woman's risk of blood clot.

The investigators propose a study comparing blood hormone levels of women using the implant for at least twelve months and in all weight categories. The investigators hope to show that all women, regardless of weight, will have hormone levels high enough to prevent pregnancy.

Two-thirds of reproductive-age women in the United States are either overweight or obese. Body composition may affect contraceptive hormone metabolism and possibly efficacy. Phase III studies to date included few women weighing more than 70 kilograms (134 of 923, 14.5%); there were no reported pregnancies in that group. Data about pregnancy rates for women in higher body mass index (BMI) categories using the etonogestrel implant exists, but we know little about how weight affects the serum etonogestrel levels. Progestin-only methods, such as the etonogestrel implant, may be preferred over combined methods including estrogens because obesity increases thrombosis risk.

The investigators propose a prospective study to compare serum etonogestrel levels in the second and third years of implant use between women across body mass index categories.

Based on previous studies, the investigators expect a difference in etonogestrel levels based on body weight; however, the investigators hypothesize that etonogestrel levels will remain above the threshold for ovulation suppression through three years of implant use for women across BMI categories.

The investigators will measure the serum levels of etonogestrel in normal weight (BMI \< 25kg/m2), overweight (BMI ≥ 25kg/m2 and \< 30kg/m2), and obese women (BMI ≥ 30kg/m2) using the single-rod contraceptive implant for at least twelve months. Their primary objective is to compare the three groups and to evaluate whether etonogestrel levels fall below the critical level for contraceptive efficacy (90 pg/mL) (Díaz 1991) in any group.

Eligibility Criteria:
Inclusion Criteria:

* Woman using contraceptive implant for more than 12 months
* English or Spanish-speaking

Exclusion Criteria:

* None
Early Detection of Burnout - Healthcare Workers

Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout

Early detection of burnout was designed to provide a better understanding of warning sign of burnout in order to detect earlier workers at risk.

In the present protocol, parameters are measured on several occasions (0, 1 week, at 6 month, at 12 months and then at each occupational visit within 5 years).

Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p\<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups.

Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p\<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used.

Comparisions of categorical variables will be performed using Chi-squared or Fischer test. Marascuillo's procedure will be performed for multiple comparisons. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers at Clermont-Ferrand Hospital
* Aged: from 18 years to retirement

Exclusion Criteria:

* Participant refusal to participate
* No healthcare workers at Clermont-Ferrand Hospital
Safety and Efficacy of AeroFact in Preterm Infants With Respiratory Distress Syndrome

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with AeroFact and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 12 months corrected age.


Eligibility Criteria:
Inclusion Criteria:

1. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
2. Gestational age at birth of 26 through 31 weeks (260/7 through 316/7 weeks PMA)
3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
4. Birth weight ≤ 2000 grams
5. Post-natal age 1 to 24 hours at randomization
6. On nCPAP or NIV with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
7. FiO2 ≥ 0.23 at randomization
8. nCPAP or mPaw ≥ 6 cm H2O at randomization
9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

Exclusion Criteria:

1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization
2. Prior instillation of surfactant
3. Premature rupture of membranes (PROM) occurring \> 14 days before birth
4. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
5. Pneumothorax
6. Other etiologies of respiratory distress
7. Enrollment in another interventional study with similar efficacy endpoints
8. Apgar score at 5 min of 0-3
9. Prior cardiopulmonary resuscitation (CPR) or epinephrine
10. Base Deficit \> 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
11. Partial pressure of carbon dioxide (PaCO2) \> 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
12. Triplet or higher order multiple birth
Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. Investigators will compare an active and a sham treatment given twice weekly for 4-weeks. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.

This project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison treatment. The treatment is hoped to significantly aid in the battle against the opioid epidemic that is ravaging much of the country and the world. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near infra-red mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that we determine (through a proprietary test) to have a more positive emotional valence. Based on preliminary data, we anticipate that the treatment will be very effective in reducing drug cravings, anxiety, and depression as well as in reducing relapses. Aim I will offer twice-weekly treatments to two groups, active and sham, for 4-weeks and will look specifically for differences in opioid cravings, anxiety, depression, and opioid use. The investigators will evaluate participants weekly for safety and efficacy for 3-weeks post-treatment. In Aim II a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.

Eligibility Criteria:
Inclusion Criteria:

* all patients must between the ages of 18 and 70
* meet criterion for a history of Opioid Use Disorder (OUD) on a Diagnostic Interview.
* have opioid cravings
* Enrollment will be made without regard to gender or ethnicity.
* Patients who are receiving treatment for OUD or other psychiatric disorders, either psychological or pharmacological treatments, may continue their treatment during the time of the study but will be asked to try not to alter their treatment from the onset of the experiment until its conclusion. The statistical analysis will include covariates for doses of buprenorphine and methadone and use of non-prescribed opioids

Exclusion Criteria:

* past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
* history of violent behavior
* history of a past suicide gesture or attempt, a history of current suicidal ideation, \*history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), \*pregnancy
* current acute or chronic medical condition requiring a medication that has psychological side-effects.
* impaired decision-making capacity in the judgment of the investigators.
Berberine and Altered Fasting Glucose

The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Fasting blood glucose range:100-125 mg/dl

Exclusion Criteria:

* Diabetes mellitus
A Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)

To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients giving informed consent
* Patients with a large acute myocardial infarction randomised within 6 hours of symptom onset
* Patients scheduled to undergo primary PCI
* Patients reaching the cath lab not before 60 min and not later than 3 hours after randomisation

(Otherwise the patients fulfill the usual selection criteria for thrombolytic treatment and PCI)

Exclusion Criteria: None