cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty

To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty.

To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.

Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.

Eligibility Criteria:
Inclusion Criteria:

* Aged more than 18 years old
* American society of anesthesiologists physical status classification 1-3
* Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block

Exclusion Criteria:

* Allergy to bupivacaine
* Body weight less than 50 kilograms
* Hepatic disease
* Coagulopathy
* Creatinine clearance less than 60 ml/min
* Uncontrolled cerebrovascular disease
* Hematocrit less than 35%
Comperative Trial Between an Accommodative Iol and Monofocal Iol

a comparison of two intraocular lenses in regard of accommodative power.

A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 65
* Required cataract operation in one or both eyes
* BCVA potetial at least 20/30
* Clear intraoccular media
* Willing to participate in study as evidenced by signing a written Informed Consent

Exclusion Criteria:Main

* Prior surgery at the selected eye
* No light perception or poor potential for improvement
* Phacodonesis and damaged zonules
* Pupil size at least 6 mm.
* History of uveitis
* Macular disease decreasing vision below 20/30
* Amblyopia
* Axial length shorter than 21 mm and longer than 25 mm
Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast

Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients.

This is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.

Following an initial study carried out by the team (cf citation), physiotherapy appeared to be the most useful therapy for coping with spasticity, particularly when practised at least 3 times a week. The hypothesis is that this feeling experienced by patients is accurate, and that more frequent physiotherapy (3 additional sessions/week) significantly improves patients' walking speed, with a functional objective.

The main aim of the WALK-UP study is to evaluate the efficacy of a 6-week intensive physical rehabilitation program on walking speed in patients with SPG4 / SPAST-HSP. This is the most frequent genotype in Hereditary Spastic Paraparesis. All patients included in the study will receive at least one physiotherapy session per week in a liberal practice.

Eligibility Criteria:
Inclusion Criteria:

* Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene,
* Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses),
* At least 1 physiotherapy session per week already in place.
* Understanding of the protocol
* Possibility of connecting to the Internet from home to access video material provided as part of the protocol.

Exclusion Criteria:

* Botulinum toxin injection within 2 months of protocol inclusion
* Discontinuation of private physiotherapy,
* Refusal to participate in the protocol,
* Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial
* Pregnant women
* Not affiliated to a social security scheme or beneficiary of such a scheme
* Patient under guardianship or trusteeship
Hand Grip Strength as a Marker of Frailty in Surgical Patients

This study aims to assess if grip strength can be used as a single, objective surrogate of frailty assessment in the surgical population.

Frailty is associated with worse outcomes. Current screening surveys are cumbersome, most containing multiple components. For frail patients particularly, it can be difficult to ascertain all the information requested. There is a need for a simple, one step, objective screening measure of frailty. There is some evidence in the medicine patients that grip strength may be related to frailty, but no such information is available for surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* General surgery patient admitted to the Section of General Surgery, Trauma, and Surgical Critical Care
* Age \>60

Exclusion Criteria:

* Pregnancy
* Untreated or metastatic malignancy
* Prisoners
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?

An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore whether Saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in Denmark. We wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.


Eligibility Criteria:
Inclusion Criteria:

1. Informed oral and written consent
2. Diagnosed with a mental illness according to the criteria of ICD10
3. Hospitalised at a forensic psychiatric department during the full inclusion period
4. Age 18 years to 65 years (both included)
5. BMI ≥27 kg/m2 with one or more weight-related comorbidities (sleep apnea, hypertension (BT ≥ 140/90 mmHg with no antihypertensive treatment. BT ≥ 130/80 mmHg with antihypertensive treatment), dyslipidaemia (LDL cholesterol ≥ 3 mmol/L), pre-diabetes (HbA1c 39-47 mmol/mol) or type 2 diabetes (HbA1c ≥ 48 mmol/mol)) or BMI ≥30 kg/m2

Exclusion Criteria:

1. Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in "Informationsbekendtgørelsen § 10").
2. Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant
3. Women who are not willing to use an adequate contraceptive considered as highly effective (IUD or hormonal contraception during the full length of the study
4. Impaired hepatic function (plasma liver transaminases \>2 times the upper normal limit)
5. Impaired renal function (serum creatinine \>150 μmol/l and/or macroalbuminuria)
6. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase \>2 times the upper normal limit)
7. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
8. Hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg
9. Any condition that the investigator feels would interfere with trial participation
10. Use of weight-lowering pharmacotherapy within the preceding 3 months
11. Type 1 diabetes
12. Patients treated with insulin
13. Patients treated with other GLP-1 receptor agonist medicines
14. Known allergy to liraglutide or any of the ingredients in Saxenda®
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.

Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for screening:

* Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2
* A least one metastatic site and/or inoperable loco-regional relapse
* Measurable disease (RECIST v1.1)
* Age from 18 to 75 years
* Performance status of 0-2
* Efficient contraceptive in non-menopause women

Inclusion criteria for treatment :

* At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC
* Performance status of 0-2
* Adequate cardiac function
* Adequate hematological and biochemical blood tests

Exclusion Criteria:

* Life expectancy of less than 3 months
* Previous history of any other stage III or IV invasive cancer
* Male breast cancer
* Uncontrolled brain metastases
* Significant cumulated exposure to anthracyclines
* Current or previous significant history of cardio-vascular/pulmonary disease
* Previous use of trastuzumab
Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults

The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.

Exclusion Criteria:

* Previous vaccination with any licensed or experimental pneumococcal vaccine
* Residence in a nursing home, long-term care facility, or similar facility
* Known hypersensitivity to vaccination
* Immune deficiency or suppression
Effects Of Whole Body Vibration On Lower Extremity With Diplegic Spastic Cerebral Palsy

This study will help to determine the beneficial effects of high frequency vibration on children with diplegic cerebral palsy in improving balance ,spasticity, strength of lower limb and quality of life and a comparison between the effect of simple conventional treatment and conventional management with the usage of vibrational therapy in cp patients.

A study "Effect of whole body vibration training on mobility in children with cerebral palsy "states Whole body vibrational therapy induce an improvement in independent ambulation and mobility of lower limb by strengthening of muscles along with the refinement of walking pattern ,gait speed and stride length in children with cerebral palsy. On the basis of our study a better treatment protocol can be designed for future in diplegic spastic cerebral palsy children.

Eligibility Criteria:
Inclusion Criteria:

* Gross motor function classification level II-III
* Modified Ashworth Scale of 1-2

Exclusion Criteria:

* Auditory/ visually impaired
* Other neurological conditions e.g. spina bifida etc.
* Lower limb contractures
* Children with history of lower limb surgery in last 6 months
Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid

A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Skin type from I to VI (Fitzpatrick classification scale)
* Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients

Exclusion Criteria:

* Malignant tumor pathology
* Infectious or viral skin disease
* Immunosuppressive pathology and/or immunosuppressive treatment,
* Long-term corticosteroid treatment
* Pregnant woman
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome

The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.

Exclusion Criteria:

* Antibiotics received within the last 3 months;
* recent diarrhea
* known allergy to vancomycin
* history of C. difficile infection
* elevation of white blood cell count or fever within one week of enrollment.
Nab-paclitaxel Plus S-1(AS) Versus Nab-paclitaxel Plus Gemcitabine(AG) in Patients With Advanced Pancreatic Cancer

This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed-consent form.
2. Age no less than 18 years.
3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
6. At least 4 weeks since completion of the last operation except for diagnostic biopsy.
7. At least 4 weeks since completion of radiotherapy to lesions.
8. Not suitable for local treatment.
9. Adequate liver/bone marrow function.
10. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
11. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
2. Pregnant or breast-feeding female, or not willing to take contraception measures during study.
3. Serious infection requiring antibiotics intervention during recruitment.
4. Allergic to study drug.
5. More than grade 1 neuropathy.
6. Uncontrolled brain metastasis or mental illness.
7. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
8. Other malignancy within 5 years.
9. Can't be followed up or obey protocol.
10. Ineligible by the discretion of the investigator.
Assessing Tobacco Product Choice When the Cost of Menthol Cigarettes Increases

In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use.

We will enroll 60 smokers who will complete four lab sessions and two field assessments. Participants meeting initial eligibility criteria over the phone will complete an in-person screening visit. Breath carbon monoxide and alcohol tests will be collected. Participants will answer questionnaires on the computer and via interview about their tobacco use and medical history. Eligible participants will remain in the lab to complete additional baseline questionnaires and will be given the opportunity to sample alternative tobacco products, such as LCCs, smokeless tobacco, electronic cigarettes, and nicotine replacement.

During the next two lab sessions, participants will complete a behavioral economics assessment, the Experimental Tobacco Marketplace task, designed to simulate purchasing tobacco products online. Participants will be given 'coupons' to obtain tobacco products from the online experimental marketplace. After these lab sessions, participants will be provided with the tobacco products they selected from the online experimental marketplace to use during 3-day field assessments to validate the task. Participants will be told to only use tobacco products provided by the lab during the field assessments. At both lab sessions, participants will complete questionnaires about their tobacco use, mood, and reactions to the alternative tobacco products. At the final lab session, a qualitative interview will be conducted to learn more about the participants' experiences selecting and using tobacco products.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 and older
2. Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
3. Self-report smoking a menthol cigarette brand
4. Must report use of an alternative tobacco product(s) at least once in the past month
5. Breath CO levels \> 8 ppm (if \< 8 ppm, then NicAlert Strip = 6)
6. Speak, comprehend, and read English well enough to complete study procedures

Exclusion Criteria:

1. Breath alcohol level \> 0.01 ng/ml
2. Intention to quit smoking in the next 30 days
3. Self-reported serious medical or psychiatric conditions during the past 12 months including:

   1. heart attack
   2. stroke
   3. angina
   4. blood clots in the arms or legs for which the individual is undergoing active medical treatment
   5. cancer requiring active chemotherapy or radiation therapy
   6. chronic obstructive pulmonary disease
   7. schizophrenia
4. Pregnant or breastfeeding
5. CO reading \> 80 ppm
6. Enrollment stratum (white or African-American/black) is full
Feasibility Study of Personalized Ultra-fractionated Stereotactic Ablative Radiotherapy (PULSAR) for Cancers of the Central Lung

The objective of this study is to enhance the safety profile of SAbR in ultra-central tumors of the lung (primary or metastatic) without compromising its effectiveness.

This will be achieved by demonstrating the feasibility of applying adaptive radiation therapy given in PULSAR fractionation and using a 1.5T MR-guided linac system with real-time motion monitoring (Unity, Elekta). The hypothesis is that safety can be improved through: (1) better visualization of tumors, leading to less uncertainty when delineating GTVs; (2) reduced margins for setup, motion, or other sources of uncertainty; and (3) improved normal tissue healing between radiation fractions. To achieve this, we propose a personalized ultrafractionated stereotactic adaptive radiotherapy (PULSAR) delivery schedule, administering 5 fractions total, given as one fraction every 3 weeks (Fig. 3) and using MRI-guided adaptive treatment planning.

This study is single arm in nature and in the feasibility phase

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age.
2. Histologically proven diagnosis of cancer. At a minimum, the lung tumor in consideration for treatment must be clinically judged as related to the biopsied site.
3. Stage: Tumor (ITV) 1.5 - 5 cm in maximum diameter.
4. Tumor entirely within the 2 cm "central zone" or within 1 cm of the mediastinum, esophagus or proximal bronchial tree by investigator assessment.
5. Zubrod/ECOG Performance Status 0-2 within 30 days prior to registration.
6. Ability to tolerate MRI.
7. All men, as well as women of child-bearing potential\* must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of consent, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Note: A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

1. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
2. Plans for the patient to receive other local therapy in lung (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression.
3. Females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry.
4. Prior administration of anti-VEGF (vascular endothelial growth factor) therapy within 1 year.