cyrilzakka/clinical-trials huggingface dataset:
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.

Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of these antihemorrhoidal products has not yet been documented in pregnant women.

Proctofoam-HC® has been on the Canadian market for 25 years. It combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain.

We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy is safe for the mother and fetus.

Eligibility Criteria:
Inclusion Criteria:

* For intervention group, any pregnant woman with a primary anorectal condition during the third trimester of pregnancy
* For control group, women in third trimester of pregnancy not treated with Proctofoam, and matched on maternal age and smoking status
* for either group,no other pregnancy complications

Exclusion Criteria:

* exposure to known teratogens during pregnancy as evident either during the prenatal or postnatal interview
* insufficient English language skills to understand the questionnaires and assessment material
* Women who have received other corticosteroid medications (systemic or topical)during pregnancy
* Women with the following conditions: abscess, fistula, tuberculosis, varicella, acute Herpes Simplex or fungal infection
* age less than 18 years
* History of previous reaction to any of the product's components, such as: local irritation, hypertrichosis, hypopigmentation, etc.
* Known Intrauterine Growth Restriction (IUGR) or a chronic state that may cause IUGR (SLE, placental insufficiency).
* Multi fetal pregnancy
* Binge alcohol consumption (5 or more drinks on one occasion,in a row or within a short period of time)
The ED50 of DEX for Providing Sedation in Different Female Age Group

Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age, and current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.

90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ patient undergoing lower extremity surgery
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25.0kg/m2

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. People who were language or hearing impaired
5. Sensory block reached to T8 or higher.
6. People who had lung infection or sleep apnea syndrome.
7. Pregnancy
8. Chronic renal failure
9. Alcohol or drug abuse
10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

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Lynparza Breast Cancer Clinical Experience Investigation

To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

To characterise the development of adverse drug reactions (ADRs) of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy under actual post-marketing use.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable or recurrent BRCA mutated HER2 negative breast cancer with prior anticancer chemotherapy

Exclusion Criteria:

* The patients who are not started on Lymparza for the first time
Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)

Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia. The objective of this study is to examine the influence of insulin resistance on the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine the prevalence of insulin resistance in different populations of CHC patients.

consecutive patient sampling

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CHC according to local regulations
* Naïve Pegylated Interferon (PEG-IFN) CHC patient
* No contraindications for PEG-IFN CHC therapy
* Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
* Willingness to give written informed consent and willingness to participate in and comply with the study requirements.

Exclusion Criteria:

* PEG-IFN treatment in history
* Contraindications for PEG-IFN CHC therapy
* Females who are pregnant or breast-feeding
* Male partners of females who are pregnant
* Potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity

The objective of the present trial is to demonstrate Magnetic stimulation as an useful complementary treatment in order to improve patients' evolution without the need of extensive surgical lesion.

Patients with refractory post stroke upper right limb spasticity will operated by Median nerve or Median/ Cubital selective neurotomy depending upon more affected territories.

Some of them could be also also operated with posterioris tibialis neurotomy to treat equine's foot whenever also clinically present. Preoperative motor blocks might be possitive in all cases.

A week later, they will be treated by magnetic stimulation on selected antagonistic muscles, related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with an equipment Dipol Zeta D5 (Russian Federation), with 1.5 tesla of intensity.

Trials will be repeated twice a week in sessions of 30 minutes during 6 months with simultaneous intensive classic rehabilitation.

Patients will be monthly evaluated by the mean score of Modified Ashworth Scale, related to fingers, wrist, elbow and shoulder and also with Barthel Scale.

Eligibility Criteria:
Inclusion Criteria:

* Severe and refractory right Hemiparesia or Hemiplegia, affecting hand function.
* Failure of kinesic treatment
* 2 points or more Improvement on Modified Ashworth Scale after anestethic blockade

Exclusion Criteria:

* Severe cardiovascular disease
* Severe pulmonary disease
* Neoplasia advanced disease
* Joint anchylosis
* Irreversible retraction for muscle fibrosis
Sitagliptin in Combination With Metformin and Sulfonylurea

This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.

The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-75
* Type 2 diabetes
* At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) \>7.0%)
* Able to comply with all scheduled visits and requirements of the protocol

Exclusion Criteria:

* Any contraindications to the use of metformin or a sulfonylurea agent
* Extreme hyperglycemia or symptoms of polyuria or polydipsia
* Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
* History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
* Episodes of symptomatic hypoglycemia averaging greater than once per day
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min
* Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable
* History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
* Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
* Current pregnancy or lactation.
* Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
* Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
* Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.
Smartphone-Based Markerless Motion Capture for Orthopaedic Clinical Use

The investigators propose to create a markerless smartphone-based MCA application using AR to measure joint motion and gait patterns to address this technology gap for a simple and inexpensive MCA.

Aim 1 will establish a testable AR-based smartphone app that measures clinically relevant lower-extremity motion components. Existing AR code will be adapted to identify and quantify hip, knee, and ankle range of motion in both the coronal and sagittal planes. Output will be produced directly to the phone display and can also be downloadable. Both single-motion and sequential-motion (gait) measures will be captured.

Aim 2 will then compare the app-based MCA to traditional gold standard MCA in healthy volunteers. A dedicated human biomechanics lab with capability for MCA with reflective markers will be utilized to test both MCA methods. Patients will perform a box jump and normal walking gait, and the measurements from both the standard marker-based MCA system and the smartphone markerless MCA system will be statistically compared.

Eligibility Criteria:
Inclusion Criteria

* 18-65 years old
* No known spinal pathology
* No previous lower extremity surgery
* No significant cardiac history

Exclusion Criteria

* \<18 or \>65 years old
* Known spinal pathology
* Previous lower extremity surgery
* Significant cardiac history
Assessment of Gait After Dysport Treatment

This pilot study will aim to understand the potential benefit of the assessment of walking using video slow motion for muscle selection and the development of an image catalogue guide of the potential results of injection of abobotulinumtoxinA by comparing foot postures before and after injection. The objective is to evaluate the use of video assessment to improve muscle selection for the injection of botulinum toxin A to improve walking outcomes. Primary outcomes include: self-selected velocity (SSV), maximal velocity (MV) and symmetry of walking. Secondary outcomes include: passive range of motion (PROM), Modified Ashworth Scale (MAS) and the Tardieu Scale (TS). Fifteen persons post stroke or TBI over age 18 with equinovarus foot deformity who are able to ambulate will be included in the study. Dysport 1000 to 1500 units will be used to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), tibialis posterior and long toe flexors. The duration of subjects' participation is 4-6 weeks.

This is a prospective, single arm, non-randomized clinical study with pre-post assessment to include post-stroke and Traumatic Brain Injury (TBI) outpatients with spastic ankle / foot muscles amenable to botulinum toxin injection. Subjects must be able to walk without braces.

AbobotulinumtoxinA injection in a dose range of 500 to 1500 units one time to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors, knee flexors, tibialis posterior and long toe flexors.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged ≥ 18
* Equinovarus foot deformity appropriate for botulinum toxin treatment (naïve or non-naïve)
* Modified Ashworth Scale between 1 to 3
* Women of reproductive potential must use effective contraception for the duration of the study

Exclusion Criteria:

* Inability to walk without leg brace
* Previous surgical intervention to affected/ankle/foot
* Uncontrolled seizures
* Pregnancy or lactation
* Known allergic reactions to Dysport
* Treatment with another investigational drug or other intervention in the past 4 months
* Modified Ashworth Scale 4
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
* Lower motor neuron disorder
* \< Four months post botulinum toxin or serial casting
RGX-111 Gene Therapy in Patients With MPS I

RGX-111 is a gene therapy which is intended to deliver a functional copy of the α-L-iduronidase (IDUA) gene to the central nervous system. This is a safety and dose ranging study to determine whether RGX-111 is safe and tolerated by patients with MPS I.

Mucopolysaccharidosis type I (MPS I) is a rare recessive genetic disease caused by a deficiency of α-L-iduronidase (IDUA) leading to an accumulation of glycosaminoglycans (GAGs) in tissues of patients with MPS I. While currently available therapies, enzyme replacement therapy (ERT) and hematopoietic stem cell transplantation (HSCT), provide clinical benefit over untreated disease progression, they still possess significant limitations. ERT does not cross the blood-brain barrier and, therefore, does not treat the central nervous system (CNS) effects of the disease, and HSCT has clinically relevant morbidity and mortality and is not able to completely treat the CNS effects. RGX-111 is designed to deliver a functioning gene enabling the production of IDUA in the brain. This is a Phase I/II, first-in-human, multicenter, open-label, dose escalation study of RGX-111. Up to 11 subjects with MPS I will be treated in 2 dose cohorts and will receive a single dose of RGX-111. Safety will be the primary focus for the initial 24 weeks after treatment (primary study period) whereupon, subjects will continue to be assessed (safety and efficacy) for up to a total of 104 weeks following treatment with RGX-111.

Eligibility Criteria:
Inclusion Criteria:

1. Has documented evidence of CNS involvement due to MPS I or documented diagnosis of severe MPS I
2. Subjects who have had HSCT may be enrolled in the study if the PI, medical monitor, and sponsor agree that he/she can participate in the study.

Exclusion Criteria:

1. Has contraindications for intracisternal and intracerebroventricular injection or lumbar puncture.
2. Has contraindications for immunosuppressive therapy.
3. Has neurocognitive deficit not attributable to MPS I or diagnosis of a neuropsychiatric condition.
4. Received intrathecal (IT) laronidase at any time and experienced a significant AE considered related to IT administration
5. Has received intravenous (IV) laronidase at any time and experienced a significant AE considered related to IV administration.
6. Received any investigational product within 30 days of Day 1 or 5 half-lives before signing of the Informed Consent Form (ICF), whichever is longer.
7. Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN) or total bilirubin \>1.5 × ULN at screening unless the subject has a previously known history of Gilbert's syndrome and a fractionated bilirubin that shows conjugated bilirubin \<35% of total bilirubin.
Continuous Control of Tracheal Cuff Pressure and Microaspiration in Critically Ill Patients

We hypothesized that continuous control of tracheal cuff pressure would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.

Randomized controlled open label study, performed in a 10-bed ICU. All patients intubated with a PVC-cuffed tracheal tube and receiving enteral nutrition who require at least 48 h of mechanical ventilation are eligible. Patients receive continuous control of cuff pressure using a pneumatic device (intervention group) or manual control using a manometer (control group). Target cuff pressure is 25 cmH2O.

In all patients, pepsin is measured in tracheal aspirate during a 48-h period after inclusion, as proxy for gastric content aspiration. In addition tracheobronchial colonization and ventilator associated pneumonia rates will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* age \> or = 18 years
* tracheal intubation using a polyvinylchloride tube
* predictible duration of mechanical ventilation \> 48 h
* enteral nutrition

Exclusion Criteria:

* refuse to participate to the study
* no informed consent
* contra-indication for semirecumbment position
Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures

The study is a prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM procedures followed by conventional ablation including PVI versus a standard PVI procedure for the treatment of persistent atrial fibrillation (AF).


Eligibility Criteria:
Key Inclusion Criteria:

* At least two (2) documented episodes of persistent atrial fibrillation during prior 3 months
* Refractory, intolerant, or contraindicated to Class I or III anti-arrhythmic medications
* Left atrial diameter \< 6.0 cm

Key Exclusion Criteria:

* Previous AF Ablation
* Presence of structural heart disease
* New York Heart Association (NYHA) Class IV.
* Ejection fraction \< 35%.
* History of myocardial infarction (MI) within the past three months.
Comparison of Prophylactic Antiviral Efficacy in Patients Undergoing Chemotherapy: Entecavir Versus Lamivudine

Patients with chronic hepatitis B who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare. Lamivudine (LAM) prophylaxis has been recommended in such circumstance according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis including virologic breakthrough and withdrawal hepatitis occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Given relatively frequent drug resistance of LAM, studies on the proper prophylactic antiviral regimen is warranted. The present multicenter, prospective, randomized study aims to compare the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.

Chronic hepatitis B virus (HBV) carriers who are undergoing anticancer chemotherapy are at risk of HBV reactivation and hepatitis flare, and lamivudine (LAM) prophylaxis is recommended according to the practice guidelines despite of limited evidence. However, failure of LAM prophylaxis defined as virologic breakthrough during LAM therapy and withdrawal hepatitis after discontinuation of LAM therapy occurs occasionally, which may lead to liver-related morbidity and mortality as well as premature interruption or a delay of chemotherapy. Considering that LAM therapy showed relatively higher rates of drug resistance and of withdrawal hepatitis, studies on the better choice of prophylactic antiviral regimen is warranted.

The purpose of our study is to conduct a multicenter, prospective, randomized study comparing the effect of entecavir (ETV) versus LAM for the prevention of HBV reactivation in HBsAg-positive patients with hematologic and oncologic malignancy undergoing cytotoxic chemotherapy.

A total one hundred eighty HBV carriers with malignancy undergoing chemotherapy will be randomly assigned to each prophylactic therapy arm of ETV and LAM group. The primary endpoint of the study is the HBV reactivation rate during antiviral therapy and 6 months after discontinuation of prophylactic antiviral therapy.

If the prophylactic efficacy of ETV is superior to that of LAM, ETV will be the preferred prophylactic therapy for HBsAg-positive cancer patients undergoing chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* positive for HBsAg for at least 6 months
* inactive or active carrier of HBV with ALT level \<2xULN, chronic hepatitis and compensated cirrhosis (Child-Pugh class A)
* malignant tumors: non-Hodgkin's lymphoma undergoing systemic chemotherapy; solid tumors undergoing chemotherapy (including adjuvant/neoadjuvant chemotherapy or concurrent chemoradiation therapy)

Exclusion Criteria:

* positive for anti-HCV or anti-HIV antibodies
* decompensated cirrhosis or hepatocellular carcinoma
* expected survival of less than 1 year
Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

The purpose of this registry is to evaluate clinical outcome and safety data in subjects with drug resistant epilepsy treated with the VNS Therapy System. The study will collect outcomes for subjects treated with VNS Therapy in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of drug resistant epilepsy treated with VNS Therapy. Eligible subjects include those not previously treated with VNS Therapy as well as subjects receiving replacement generators.
* Able and willing to comply with the frequency of study visits.
* Subject, or legal guardian, understands study procedures and voluntarily signs an informed consent in accordance with institutional policies. In the event that the subject is under the age of 18, the subject may also be required (per EC/IRB) to sign an assent affirming their agreement to participate.

Exclusion Criteria:

• There are no exclusion criteria in this study. Investigators should refer to the local instructions for use for VNS Therapy.