cyrilzakka/clinical-trials huggingface dataset:
Agreement Between Laterality of Tsui Test and Laterality of Color Flow Doppler Signals During Labor Epidural Analgesia

Epidural analgesia for relief of labor pain is a very common, safe and reliable technique that requires placement of a catheter in the epidural space. About 5% of labor epidural catheters may need to be re-sited due to failure of analgesia. This is often caused by malposition of the epidural catheter. Many factors may influence the position of the tip of the epidural catheter and the resulting spread of local anesthetic solution within the epidural space and consequently the quality of labor pain management. The electrical stimulation of the epidural catheter, commonly known as Tsui test, can reliably confirm its positioning within the epidural space if this stimulus produces a muscular twitch under a certain current amplitude threshold. This muscular response is unilateral in 90% of the cases, not having any relationship between unilaterality and unsatisfactory catheter performance. It is unknown if this unilateral response has any correlation with the actual position of the catheter tip in terms of right or left side of the epidural space. Furthermore, the Tsui test does not give any information on the spread of anesthetic solution into the epidural space. Recent investigation shows that color flow doppler ultrasound during fluid injection through the epidural catheter may be helpful in determining the laterality of the tip of the epidural catheter; furthermore it may be able to inform about the spread the anesthetic solution, which is a limitation of the Tsui test. The investigators will perform an observational study to investigate the response patterns of Tsui test and Color flow Doppler ultrasound in the obstetric population. Women who have delivered under epidural analgesia will be approached for the study before the epidural catheter is removed. The investigators aim to characterize the laterality and current thresholds of Tsui test response and the laterality of the lumbar epidural catheter tip by color doppler ultrasound. The investigators hope to describe the findings and to correlate them with other clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have delivered vaginally under epidural anesthesia

Exclusion Criteria:

* Patients who refuse, are unable to give or have withdrawn consent
* Patients unable to communicate fluently in English.
* Patients who experience fetal or maternal complications during delivery.
Physiology, Imaging and Modeling of Essential Tremor

This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.

Deep brain stimulation (DBS) is a neuromodulatory therapy that is effective in a subset of well selected essential tremor (ET) patients. However, as many as 1/5 of patients may initially improve, but then steadily worsen following the operation. The investigators developed a technique to study a variety of alternative stimulation methods without the use of an invasive repeat surgical intervention.

The electrophysiological effects of non-conventional DBS differ from traditional DBS, however the physiological differences in the setting of human tremor remain largely unknown. This study plans to explore gaps in knowledge of neuromodulation and will collect and contribute essential information to the underlying mechanism of action of DBS. The hypothesis of this project centers around active biphasic stimulation providing a wider therapeutic window and a lower adverse event profile as compared to conventional DBS.

Eligibility Criteria:
Inclusion Criteria:

* Existing unilateral or bilateral VIN DBS for ET, non-demented (MMSE\>24), and must have a documented suboptimal tremor suppression on two successive visits (compared to the baseline post-operative improvement at 6 months following ET DBS surgery). For bilateral cases, the most affected tremor side will be studied.

Exclusion Criteria:

* No diagnosis of Essential Tremor
Patients' Comprehension and Internalization of Operative Consent Form

This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.

As above and in later sections.

Eligibility Criteria:
Inclusion Criteria:

* Planned for common elective ENT operations
* English-speaking
* Unaccompanied
* Counselled with the use of a structured surgery-specific consent form
Effect of Physiotherapy in Hospitalized COPD Patients

Chronic obstructive pulmonary disease (COPD) impacts negatively on the balance and strength of patients. Several studies have shown that acute exacerbations (AEs) decrease, pulmonary function and survival of COPD patients, and there are a lot of physiotherapy interventions to improve it during the hospital stay.

The objective of the present study is to examine the effects of a physical therapy program on balance and strength in COPD patients hospitalized due to acute exacerbation.

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. It is a progressive disease, characterized by lung function impairment with airway obstruction.

Patients with COPD suffer exacerbations; the frequency of these exacerbations increases with the severity of the disease. It has been previously shown that the level of health-related quality of life of COPD subjects deteriorates considerably with increasing severity of disease and that the deterioration is linearly related to a decrease in FEV1 % predicted normal values.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis with exacerbation.
* No contraindication of physiotherapy.
* Signed written consent.
* Medical approval for inclusion.

Exclusion Criteria:

* Contraindications for physiotherapy
* Neurological, orthopedic or heart disease
Bacterial Cellulose-monolaurin Hydrogel for Acute Radiation Dermatitis

Acute radiation dermatitis (ARD) is almost universally experienced by patients with cancer during or after radiation therapy. This condition potebtxallt leads to detrimental clinical outcomes as it adversely affects adherence to prescribed subsequent management and further worsens quality of life. Nevertheless, there remains no consensus on the appropriate intervention for ARD. This pilot two parallel-group randomized trial aims to clinically assess the potential of bacterial cellulose-monolaurin hydrogel, compared to placebo cream, to prevent high-grade ARD among Filipinos with breast cancer up to four weeks after last radiotherapy session.


Eligibility Criteria:
Inclusion Criteria:

* Female sex at birth
* Age at least 18 years at the time of invitation
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of either 0 or 1
* With histopathologic diagnosis of breast carcinoma
* Already completed prescribed mastectomy and chemotherapy (adjuvant or neoadjuvant) interventions
* Scheduled to receive hypo fractionated postmastectomy-postchemotherapy radiation therapy

Exclusion Criteria:

* Pregnant or lactating
* With concurrent or previous history of any malignancy
* With history of mediastinal or thoracic irradiation
* With current bilateral synchronous breast carcinoma
* With diagnosis of metastases from any form of breast cancer
* With any skin lesion in the planned radiation field deemed deramtologically and/or radiotherapeutically relevant
* With concomitant disease states deemed clinically significant (connective tissue diseases, infections, uncontrolled chronic disorders, renal failure, hepatic dysfunction, etc.)
* With known history of hypersensitivities and/or reactions against any component of either experimental or comparator interventions
* Inability to personally provide informed consent or to personally comply with skin care instructions
Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, multicenter, clinical trial.

Premature infants (born before 37 weeks gestational age) with patent ductus arteriosus (PDA) are the focus of the study since no trials on the additive efficacy of these two medications on the contraction of ductus arteriosus are available. Preterm infants who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen/indomethacin therapy, are eligible to this trial.

If the parents deny the consent, the patient will be treated according to the standard PDA treatment: three days' iv ibuprofen Pedea® 5mg/ml solution infusion (Oulu, Helsinki, Tartu) dosing: 10mg/kg + 5mg/kg + 5mg/kg (q24h); or three days' iv indomethacin (Turku) 0.2mg/kg + 0.1mg/kg + 0.1mg/kg (q24h). In case of any contraindications for ibuprofen/indomethacin, the treatment would be surgical ligation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (born before 37+0 gestation weeks) who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen therapy, are eligible to this trial.

Exclusion Criteria:

* severe malformation or suspected chromosomal defect
* other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Efficacy and Safety of Venus P-valve to Treat RVOT Stenosis With Pulmonary Regurgitation

A prospective, non-randomized, multi-center clinical study of the Venus P-valve for the treatment of RVOT stenosis with pulmonary regurgitation after surgery of congenital heart defect.

The aim of this protocol is to assess the efficacy, safety and performance of Venus P-valve.

Patients between 18-60 years with RVOT stenosis and moderate to severe pulmonary regurgitation (≥3+) who have undergone trans-annular patch repair of their RVOT, cardiac magnetic resonance (CMR) screening right ventricular end-diastolic volume index (RVEDVI) between 130-160mL/m2.

Post-procedure follow-ups will be scheduled at 24 hours, 30 days, 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* RVOT stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation
* Isotopic or CMR criteria of RVEDVI≥130mL/m2 and ≤160mL/m2
* Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years
* Body weight≥18 kg
* Pulmonary annular diameter between 14mm to 31mm
* RVOT length≥20mm
* The subject or his/her legal representative has provided written informed consent
* Subject will comply with protocol required follow-ups

Add any of the following conditions:

* Subject is symptomatic
* Subject presents with \>30% pulmonary regurgitation fraction as defined by cardiac MRI
* ≥3+ pulmonary regurgitation by echocardiograms
* Deteriorating RVEF%
* Progressive tricuspid valve regurgitation (at least moderate degree)
* Complicated with RVOT obstruction (RV systolic pressure\>80mmHg)
* Persistent arrhythmias

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

* Existing pulmonary artery branch stenosis or artificial pulmonary valve
* Severe chest wall deformity
* ADHF
* Active infection or endocarditis requiring antibiotic therapy
* Leukopenia (WBC\<3000mm3)
* Acute or chronic anemia (Hb\<9g/L)
* Platelet account \<100,000 cells/mm3
* In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible
* A known hypersensitivity to aspirin or heparin
* Positive urine or serum pregnancy test in female subjects
* Ileofemoral vessel characteristics that would preclude safe placement of introducer sheath
Investigation of the Effect of Custom Made Insoles on Foot Pressure Distribution and Gait Parameters in Patients With Morton's Neuroma

The aim of our study is to investigate the effect of the use of custom made insoles in the treatment of Morton's neuroma on foot pressure, temporal and spatial gait parameters.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of unilateral Morton neuroma
* Confirmation of the diagnosis of Morton's neuroma with Magnetic Resonance Imaging (MRI)
* Pain level of the patients while walking is at least 3 according to the Visual Analogue Scale (VAS).
* Volunteer to work

Exclusion Criteria:

* Symptomatic musculoskeletal disease in the lower extremity
* Peripheral nervous system disease
* Presence of rigid deformity in the foot
* Extremity or contralateral extremity surgery with Morton's neuroma
Fatigue in Rheumatoid Arthritis - Longitudinal Study

To investigate how the fatigue vary over time in persons with rheumatoid arthritis (RA) and which factors that may influence the fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Diagnose of RA, age 20-65 years,

Exclusion Criteria:

* other serious physical or mental illness
Rheumatologic Adverse Events and Cancer Immunotherapy

In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs.

The number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist.

The aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cancer needed to be treated by immunotherapy

Exclusion Criteria:

* Patient already treated by immunotherapy
Avatrombopag for HCC Patients With Thrombocytopenia Who Intend to Undergo TACE and/or HAIC

This study is conducted to evaluate the efficacy of avatrombopag for thrombocytopenia in patients with hepatocellular carcinoma (HCC) who intend to undergo transarterial chemoembolization (TACE) and/or hepatic arterial infusion chemotherapy (HAIC).

This is a single-center, prospective study to evaluate the efficacy of avatrombopag for thrombocytopenia in HCC patients who intend to undergo TACE and/or HAIC.

30 HCC patients with thrombocytopenia will be enrolled in this study. Avatrombopag (platelet count \[PLT\] \<40×10\^9/L, 60mg P.O. QD; PLT of 40-75×10\^9/L, 40mg P.O. QD) will be administered to the patients and last 5-10 days. When the PLT reaches ≥100×10\^9/L, the treatment will be discontinued.

The primary end point of this study is the proportion of patients with PLT \>75×10\^9/L or doubling from baseline. The secondary endpoints are the proportion of patients with PLT \>75×10\^9/L, the proportion of patients with PLT doubling from baseline, the increace in PLT, the proportion of patients who successfully receive TACE/HAIC, .adverse events.

Eligibility Criteria:
Inclusion Criteria:

* HCC with diagnosis confirmed pathologically or clinically
* Patients who need to receive TACE and/or HAIC, or have plans to undergo another treatment (3-6 weeks after the previous treatment)
* Child Pugh class A or B
* ECOG PS 0-2
* PLT ≤ 75×10\^9/L (10 days before interventional therapy)

Exclusion Criteria:

* Thrombocytopenia caused by hematological diseases, non chemotherapy related thrombocytopenia (excluding liver cirrhosis with hypersplenism)
* PLT \<30×10\^9/L
* History of hepatic encephalopathy, refractory ascites, or hepatorenal syndrome
* History of arterial or venous thrombosis within 6 months
* Uncontrolled severe infections
* Pregnant or breastfeeding female patients
* Immune deficiencies, such as autoimmune diseases, HIV infected individuals, etc
* Anticoagulation or antiplatelet therapy witch cannot be suspended during the treatment period: heparin, warfarin, rivaroxaban, dipyridamole, non-steroidal anti-inflammatory drugs, aspirin, verapamil, Ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, erythropoietin, etc;
* Administration of blood products within 7 days prior to the baseline visit (excluding albumin infusion)
* Allergy to avatrombopag or any of its formulations
* History (such as gastrointestinal bleeding within 3 months, high risk of thrombosis, such as portal vein main flow velocity\<10cm/s) which may affect the safety of the patients or their ability to complete the study
Treatment of Myeloma in Patients <= 65 Years Old With Response >= 50% After HSC Autotransplant by Allogenic Transplant Genoidentical or Phenoidentical After Reduced Intensity Conditioning

Donor mobilization :

Donor will be mobilized with G-CSF (Granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days.

Hematopoïetic Stem Cell Harvest:

By 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules CD34+ /kg is required. If the CD34+ \>= 2 and \<= 4x106/kg: the center must decide on the strategy Decision. In case of insufficient graft : a Bone Marrow Harvest is recommended Conditioning : Fludarabine - Busulfan - ATG

* D-5 : Fludarabine (30 mg/m²)
* D-4 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
* D-3 : Fludarabine (30 mg/m²)+ Busilvex (0,8 mg/kg every 6 h)
* D-2 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg)
* D-1 : Fludarabine (30 mg/m²) + ATG (Genzyme) (2.5 mg/Kg) GVHD Prophylaxis: CsA alone at 3 mg/ kg + Methotrexate D1, D3 and D6 only in case of minor ABO incompatibility and with an anti A/B antibodies titer\> 1/32.

Transplant : HSC at D0

• 3 months after Transplantation :

Disease Evaluation :

* If CR : Supervision. Then if progression: 4 cycles of Bortezomib.
* If no CR : Bortezomib (4 cycles)

  • Evaluation after Bortezomib cycles
* If CR : Supervision. Then, if progression and no GvHD : DLI If no RC and no GVHD : DLI


Eligibility Criteria:
Inclusion Criteria:

* Major patients not under guardianship
* Myeloma with high b2 microglobulin level (\> 3 mg/l) and/or chromosome 13 deletion, and/or translocation t(4;14) stage I DS with high evolutive potential or stage II, III DS.

AND

* With response \>= 50% and \<= 90% after the first AutoHSCT (IFM 2005 01). The evaluation must be performed within 2 months after the first AutoHSCT.
* with an HLA identical related or unrelated donor ( match 10/10).
* Donor and recipient must have signed a written informed consent.
Intensive Smoking and Alcohol Cessation Intervention in Bladder Cancer Surgery Patients

Radical cystectomy provides the best cancer-specific survival for muscle-invasive urothelial cancer. However the postoperative morbidity remains at 11-68 %. Smoking and alcohol consumption above two drinks per day is associated with an increased risk of postoperative morbidity. Six-eight weeks of smoking and alcohol abstinence prior to elective surgery is recommended to reduce this risk, but for cancer patients the preoperative period is often very short. This randomised clinical trial (STOP-OP) will reach a conclusion on the effect of a new Gold Standard Programme for both smoking and alcohol cessation Intervention using the Gold Standard Programme (GSP) on the frequency and severity of postoperative complications after bladder cancer surgery.

The study is a multicentre randomised clinical trial involving 110 patients with a risky alcohol intake (exceeding 21 alcohol units (252 g ethanol) per week or/ and daily smoking scheduled for bladder cancer surgery. Patients will be randomised to the 6-weeks GSP or treatment as usual (control). The GSP combines patient education and pharmacologic strategies. The GSP includes benzodiazepine therapy for withdrawal symptoms, controlled disulfiram therapy, and Nicotine replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years scheduled for cystectomy due to bladder cancer
* Daily smoker or/and intake of

  -\>21 units (252 g) of alcohol pr week
* Informed consent

Exclusion Criteria:

* Cancelled operation
* Hypersensitivity to benzodiazepines, disulfiram or Nicotine replacement
* Pregnant or breastfeeding women
* Mentally incompetent patients
Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia

The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune system.

HIV infects and inactivates certain blood cells that are part of the body's immune system. The damage to the body's immune system can result in unusual infections and/or unusual forms of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients. AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients.

There is a clear risk for development of AIDS in hemophilic patients. AZT administration has been shown to inhibit HIV replication in vitro. Patients taking AZT have experienced fewer opportunistic infections and improvements in measures of immunity. The most common laboratory abnormalities observed with AZT are hematologic. However, the clinical and laboratory toxicity of AZT remains poorly understood in hemophiliacs. Hepatitis and liver dysfunction are more common in this population compared to other groups at risk for HIV infection. Because AZT is largely metabolized in the liver, drug pharmacokinetics needs to be evaluated in this patient population.

Both hemophiliacs and non-hemophiliacs take AZT for a period of 12 weeks. The first dose is administered intravenously. AZT is then given orally every 4 hours while awake (5 doses per day). Patients are evaluated by physical examinations and laboratory assessments. These include HIV culture of blood and leukocyte counts, lymphocyte counts, and lymphocyte subsets measured at study entry and every 4 weeks thereafter. Patients are hospitalized for pharmacokinetic studies at study entry and at Weeks 6 and 12. Each of these studies involves both intravenous and oral administration within 48 hours of one another. Blood is sampled at 0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after each administration and urine is collected every 2 hours for 12 hours.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a bleeding disorder such as hemophilia A or B, a lack of factor VIII (a blood clotting factor), or severe von Willebrand's disease.
* Will be available for follow-up for at least a year.
* Are at least 12 years old (consent of parent or guardian required if under 18).
* Are willing to use an effective method of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a life-threatening opportunistic (AIDS-related) infection or AIDS-related symptoms.
* Have taken certain drugs within 30 days prior to study entry including chemotherapy and interferon.
* Are taking acetaminophen or drugs containing acetaminophen.
* Are pregnant or breast-feeding.