cyrilzakka/clinical-trials huggingface dataset:
A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer

Background: The aim of this study is to develop a prediction model for radiation-induced trismus (maximal interincisal distance equal to or less than 35 mm) based on a multivariable analysis of dosimetric and clinical factors.

The maximum inter-incisal opening (MIO) of hean and neck cancer (HNC) patients who undergo radiotherapy (RT) ± concurrent chemotherapy with radical intent, will be prospectively measured prior to RT (baseline) and 6 months post-RT.

The potential risk factors (clinical and dosimetric) will be first screened by univariate analysis and then by multivariate analysis. At the end of this process, the features identified as relevant, will be used to fit a logistic regression model and calculate the probability of observed trismus during the 6-month follow-up after RT

Eligibility Criteria:
Inclusion Criteria:

* HNC
* treatment definitive or postoperative external beam radiotherapy, either alone or in -combination with chemotherapy or cetuximab at least 6 months follow-up

Exclusion Criteria:

* primary tumor out-side the head and neck region, intracranially, or if it originated from the nasal vestibule
* patient death during RT or within the first 6 months after the start of RT, no outcome data available
Study of Nimotuzumab Combined With IMRT in Elder Patients With Cervical Squamous Cell Carcinoma

To evaluate the efficacy and safety of Nimotuzumab combined with IMRT in elder patients with locally advanced cervical squamous cell carcinoma

This is a perspective, multi-center, open-label and single arm study.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥65 years old
2. Histologically confirmed primary cervical squamous cell carcinoma in stage IB3-IVA (FIGO 2018)
3. At least one measurable lesion according to RECIST 1.1 guideline
4. Patients are intolerant to or refuse chemotherapy.
5. No serious hematopoietic dysfunction, nor abnormal heart, lung, liver and kidney function, nor immunity deficiency. And the results of lab test meet the following criteria:

   Hemoglobin ≥90g/L Absolute count of neutrophils≥2×109/L orwhite blood cell count≥4.0×109/L； Platelet count≥100×109/L； AST≤2.5×ULN ALT≤2.5×ULN TBIL≤1.5×ULN；

   Serum creatinine≤1.5×ULN or CrCl\> 60 mL/min(according toCockcroft-Gault):

   Serum creatinine≤1.5×ULN Female CrCl=(140-Age)×Weight（kg）×0.85 / (72×Scr mg/dl)
6. ECOG score 0-2
7. Expectancy of life is at least 3 months.
8. Eligible for pelvic MRI examination.
9. The patients voluntarily received nimotuzumab combined with radiotherapy.
10. Patients can comply with the protocol and are willing to sign informed consent.

Exclusion Criteria:

1. Patients who have received treatment for cervical cancer, including surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy
2. Patients who have bilateral ureteral obstruction, who cannot be placed ureteral stents or perform pyelostomy.
3. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or with fistula risk.

.4)Patients infected with HIV. 5)Active hepatitis B (HBV DNA quantitative test results exceed the detection threshold), or HCV infection (HCV RNA quantitative test results exceed the detection threshold) 6)Patients with severe underlying disease that makes it possible to safely receive the treatment. And the severe underlying disease include but not limited to active infections requiring systemic medication, decompensated heart failure (NYHA grade III and IV), unstable angina pectoris, and acute myocardial infarction occurred within the first 3 months of enrollment.

7)Patients with a history of prior malignancy other than cured basal cell carcinoma of the skin.

8)Patients with Crohn's disease and ulcerative colitis. 9)Patients are allergic to Nimotuzumab or its compounds. 10)Patients with neurological or psychiatric abnormalities that affect cognitive ability.

11)Intracavitary brachytherapy cannot be performed that was assessed by the investigator.

12)Other factors were assessed by investigators to be unsuitable to this study.
Treatment of Humeral Fractures With Long PHILOS Plates Using a Modified Technique and Approach Avoids Radial Nerve Palsy

Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. At the University Hospital Basel, these fractures have been treated in an adapted procedure with long PHILOS plates using a modified technique and approach. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

Radial paralysis is a well-known complication of plate osteosynthesis on the humeral shaft. With regard to surgical treatment, there are major differences in terms of surgical access and implant selection. At the University Hospital Basel, these fractures have been treated in an adapted procedure for about 10 years. A long Philosplatte (Synthes company) is inserted from the proximal end via a deltoido-pectoral approach. This is a minimally invasive procedure (MIPO = minimally invasive plate osteosynthesis). The standard implant is first twisted distally by approx. 45°-90° and then lies anterior to the humerus. The distal screws can then be filled via anterior stab incisions. This adapted surgical technique is adapted to the anatomical course of the radial nerve. This ensures a safe distance from the plate/access to the nerve. The nerve does not have to be explored openly and the distal row of screws can be used minimally invasively via stab incisions. This study is to retrospectively analyze the effectiveness of the surgical technique in relation to iatrogenic radial paralysis.

Eligibility Criteria:
Inclusion Criteria:

* surgery at the University Hospital Basel between 06/2010 and 12/2020 for a proximal humeral shaft fracture

Exclusion Criteria:

* Patients with a documented rejection
Impact of the Chikungunya Outbreak in Reunion Island on the Quality of Life After 10 Years

QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK cohort by comparing scores of SF-36 health survey.

QoLCHIK is a prospective cohort telephone study on the quality of life of people from the TELECHIK cohort, measured by the SF-36 health survey. TELECHIK was a telephone survey conducted 2 years after the 2005-2006 outbreak in Reunion Island and drawn from the SEROCHIK study which aimed at assessing the seroprevalence of chinkungunya over the island between august and october 2006.

A sample of 440 people (220 per group) was calculated and to be drawn from TELECHIK cohort, 220 with a serodiagnosis of chikungunya and 220 with negative serology.

Eligibility Criteria:
Inclusion Criteria:

* People from the TELECHIK cohort

Exclusion Criteria:

* People with other diseases or disorders which could impact quality of life (predefined list)
* Minor
* Elderly over 85 yo
* People with a risk of exposure (in an endemic/epidemic area) after 2005-2006 Reunion Island outbreak
Effect of Finerenone in IgA Nephropathy

The aim of this trial is to conduct a randomized, multicenter, placebo-controlled, double-blind clinical trial to determine the safety and efficacy of Finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.

The primary endpoint event was the change in urinary albumin/creatinine ratio between the two groups at 12 months of treatment.

This is a randomized, multicenter, placebo-controlled, double-blind clinical trial aimed at clarifying the safety and efficacy of finerenone in reducing proteinuria and protecting renal function in patients with IgA nephropathy.

Study population will include participants with renal biopsy confirmed IgA nephropathy (eGFR ≥ 30 mL/min/1.73 m2) and UACR ≥500mg/g ≤3500mg/g. Participants receiving maximum tolerated dose of RAS inhibitor treatment for more than 3 months are eligible for the study.

The study will be conducted at 4 sites. 120 participants will be randomised to one of 2 arms in a 1:1 ratio:

* Finerenone 10mg/20 mg
* Placebo 10mg/20 mg For each participant, the total duration of participation will be approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Kidney biopsy confirmed IgA nephropathy within 2 years, with secondary IgA nephropathy excluded;
* Age ≥ 18 years;
* Maximum tolerated dose of RAS inhibitors for more than 3 months, with urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g; V1 laboratory test showing urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g. After maximum tolerated dose of RAS inhibitors or ARB, V2 urine albumin/creatinine ratio ≥ 500 mg/g and ≤ 3500 mg/g;
* eGFR calculated by EPI ≥ 30 ml/min/1.73 m²;
* Serum potassium level ≤ 4.8 mmol/L;
* SBP ≤ 150 mmHg, DBP ≤ 110 mmHg;
* LVEF \> 40%;
* Willing and able to provide informed consent.

Exclusion Criteria:

* There are clear indications for the use of immunosuppressive therapy, such as: nephrotic syndrome (urine protein greater than 3.5 g/d, blood albumin less than 30 g/L), pathological minimal change disease combined with IgA nephropathy; the proportion of crescents in kidney biopsy is ≥ 50%.
* Any existing life-threatening condition with a life expectancy of less than 2 years;
* Active infection, HBV infection, or active lesions (nodules, cavities, or tuberculomas);
* AKI causing renal dysfunction;
* Use of steroids/immunosuppressive drugs within the past 3 months;
* History of malignant tumors, regardless of treatment status or evidence of local recurrence or metastasis;
* Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of the investigational drug;
* History of drug or alcohol abuse within the past 12 months;
* History of drug allergies or contraindications;
* Previous noncompliance or unwillingness to follow the study protocol;
* Any condition that may affect safety or efficacy;
* History of kidney transplantation or currently receiving immunosuppressive treatment;
* Pregnant or breastfeeding women;
* Obese patients with a BMI \> 35.
Trial Comparing Electric and Harmonic Scalpel in Mastectomy

Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.

The population of this study was formed by women aged older than 18 years old, with breast carcinoma (ductal ou lobular) at any stage, form whom modified radical mastectomy is proposed. Patients were excluded if the present blood dyscrasia, collagen diseases, known uncontrolled chronic disease, infections (mammary or axillary, ulcerated tumors and pregnancy. The women were submitted to modified radical mastectomy consecutive allocated in electric scalpel group and the other group with harmonic scalpel.

Electric scalpels were calibrated at 40 watts of cutting and coagulation power and harmonic scalpel with a GEN04 generator calibrated at power levels 3 and 5, using the HP054 handpiece and HF105 curved blade.

Local postoperative complications analysed were seroma, hematoma, skin necrosis and infection.

Eligibility Criteria:
Women with breast cancer candidate to a radical mastectomy during the year of 2008.

Prospective trial with women stratified consecutive.

Inclusion Criteria:

* Breast carcinoma (ductal or lobular)
* Modified radical mastectomy was the surgery to be realized

Exclusion Criteria:

* Not inclusion criteria
* Blood dyscrasia, collagen diseases, known uncontrolled chronic diseases, infections (mammary or axillary), ulcerated tumors and pregnancy
Effectiveness of Treatment for Relational Aggression in Urban African American Girls

This study will evaluate the effectiveness of a school-based social cognitive group treatment in reducing aggression (bullying) among relationally aggressive urban African American girls.

Relational aggression, also known as "female bullying," is a type of psychological aggression in which covert tactics are used to harm other people and their relationships. These tactics include humiliation, intimidation, coercing, shaming, malicious teasing, shunning, and using other forms of emotional abuse in an attempt to harm others. Although aggressive behavior is typically common among younger children, most children become less aggressive as they mature and develop better interpersonal skills. However, consistent aggressive behavior can lead to further problems and increased violence in the aggressor. In this study, a social cognitive anger management group intervention called Friend to Friend (F2F) will be evaluated as a way to develop more productive social and emotional functioning among relationally aggressive urban African American girls.

Participants will be randomly assigned to either the F2F program or a psycho-educational attention control (PAC) group. All participants will attend 40-minute treatment sessions twice a week for a total of 10 weeks. The sessions will occur during the girls' lunch or recess period. Participants assigned to the F2F program will learn how to identify signs of physiological arousal, react to a potential conflict while generating alternatives to the solution, and apply previously discussed social cognitive strategies to different situations. Culturally specific cartoons, videotape illustrations, and role playing will be used to portray these improved strategies and behaviors. Participants assigned to the PAC group will learn different organization and homework strategies as well as how to improve their study skills in an attempt to improve their overall academic performance. Outcomes will be assessed through observation, school reports, and questionnaires for all participants at baseline, immediately after treatment, and 9 months after treatment.

Eligibility Criteria:
Inclusion Criteria for Schools :

* Urban school located in Southwest Philadelphia
* Student body is more than 80% African American
* Large school with at least three classrooms per grade
* Not currently involved with systematic anti-aggression social skills program

Inclusion Criteria for Participants:

* In the 3rd, 4th, or 5th grade
* Meets diagnostic criteria for relational aggression

Exclusion Criteria for Participants:

* Enrolled in special education and not integrated into a regular education classroom
Bach Music in Preterm Infants: No "Mozart Effect" on Resting Energy Expenditure

Exposure to Mozart music significantly lowers resting energy expenditure (REE) in healthy preterm infants. Whether this finding is related to music per-se or to music by Mozart is unknown. The objective is to study whether J.S. Bach music has a lowering effect on REE similar to that of Mozart music.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants at post menstrual age of 30-37 weeks who were appropriate for gestational age, clinically and thermally stable, gavage-fed, were eligible for recruitment.
* At the time of the study they were all tolerating full enteral feeding (150-160 cc/kg weight/day) without significant gastric residuals (\<5% of total feed), they were all growing steadily, and had no electrolyte imbalance.
* All infants who were recruited successfully passed a hearing screening test prior to discharge (otoacoustic emission and automated auditory brainstem response)

Exclusion Criteria:

* Infants with significant complications of prematurity such as intraventricular hemorrhage, periventricular leucomalacia, necrotizing enterocolitis, active apneas of prematurity, patent ductus arteriosus, active infection, electrolyte imbalance and major congenital anomalies.
Comparative Trial in Compression Therapy in Leg Lymphedema

The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with Trico bandages.

The goal of this prospective, randomized, controlled trial with CE marked product is to study the effectiveness (volume reduction) of 24-hour compression therapy for lymphedema, comparing C2L and Trico bandaging. Therefore 30 patients with leg lymphedema are included.

Application of marketed compression bandages (C2L or Trico bandages) used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction.

Measurements are carried out at:

Volumetry:

Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.

Pressure:

Measurements after 0h, 2h (pre and post bandage change) and 24 h;

* supine and standing to calculate the SSI;
* supine with and without dorsal flexion.

for the pressure measurement a Kikuhime (large pads) dice is used. At each new bandaging to document the SSI and the effect of dorsiflexion in the supine position

* The subbandage pressure is measured on the medial aspect of the lower leg at the transition of the gastrocnemius muscle into the Achilles' tendon (B1) (Partsch H. et al. Dermatol Surg 2006; 32: 224-233).
* Fix the sensor (sensor and tube sheathed with Cellona Soft Padding)

Statistical analysis; Analysis of variance (ANOVA) comparing volume, supine subbandage pressure with and without dorsiflexion, and SSI for the used bandages

Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female
* More than 18 years of age
* Patients with distal lymphedema of the leg requiring multilayer lymphedema bandaging of the leg
* The patient is able to understand the study and is willing to give written informed consent to the study

Exclusion Criteria:

* Allergy against one of the used materials
* Proximal lymphedema (involvement of thigh, genitalia)
* Severe systemic diseases causing peripheral oedema
* Acute superficial or deep vein thrombosis
* Arterial occlusive disease (stadium II, III or IV) or arm/leg blood pressure index (ALPI)\<0,8
* Local infection in the therapy area
* Auto-immunological disorders or vasculitis
* Use of systemic corticosteroids
Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections.

Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow ("outflow buffering").


Eligibility Criteria:
Inclusion Criteria:

* presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months
* patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy

Exclusion Criteria:

* isolated symptomatic femoropatellar osteoarthritis
* target knee prothesis
* having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation,
* target knee osteoarthritis with clinical joint effusion at selection and at randomization
* body mass index (BMI) greater than or equal to 30,
* patient having received any corticosteroid treatment by any administration route (other than inhalers, ocular, auricular route) in the month preceding randomisation,
* patient having received intra-articular steroid injection in the target knee within the month preceding randomisation or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding randomisation
Laser Versus Physiotherapy in Management of Bruxism in Children: RCS

The goal of this randomized controlled study is to compare laser acupuncture versus modified physical therapy in controlling bruxism in children. The main questions aim to answer are:

* Laser will decrease tempro-mandibular joint pain from bruxism more than modified physical therapy?
* Laser will decrease muscles activity from bruxism more than modified physical therapy? Children took 6 sessions of either laser acupuncture or modified physical therapy Researchers compared laser acupuncture versus modified physical therapy to see if any decrease in tempro-mandibular joint pain and muscles activity from bruxism

The children participated in the study as bruxers according to the American Association of Sleep Medicine (AASM) diagnostic criteria \[ Sixteen children will be randomly allocated to two groups of 8 individuals each: Group one: laser acupuncture, Group two: electromyography biofeedback training.

Pain will be measured by Visual Analogue scale; VAS (primary outcome)and muscle activity will be measured by Electromyography (Secondary outcome) of temporalis and masseter muscles. Measurements will be taken preoperatively and after 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Six to twelve years children
2. Medically free
3. Normal occlusion
4. No or low caries experience
5. Clinical dental wear
6. Clenching or grinding reported by the parents

Exclusion Criteria:

1. Children with any physical or psychological disease.
2. Children received any previous treatment for bruxism.
3. Children with tempro-mandibular joint disorders
Twinrix Alternative Schedule Study

To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months.

1. To compare the seroconversion (\>= 1 IU/l) and seroprotection (\>= 10 IU/l) rate at month 6,7,12 and 13.
2. To compare the distribution of anti-HBs at these different moments.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* a good physical condition as confirmed by history and physical examination at entry of the study;
* for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen;
* all participants have provided written informed consent.

Exclusion Criteria:

* Employees occupationally exposed to hepatitis B virus
* Other exclusion criteria listed for the vaccine (licensed vaccine):
* Each acute disease at the inclusion in the study;
* A history of hypersensibility to one of the components of the vaccine;
* Simultaneous participation in another clinical trial