cyrilzakka/clinical-trials huggingface dataset:
Facial Function Reanimation by Electrical Pacing in Unilateral Facial Paralysis.

Purpose of the trial is to study the activations of paralyzed facial muscles in a unilateral facial nerve palsy with a multi-channel electrical stimulator. The principle of the device is to measure muscle activity of the healthy side of the face by surface electromyography (EMG) and to use this information to stimulate the corresponding muscles of the paralyzed side. The ultimate goal is to develop a prosthetic device for persons with a facial nerve palsy.

The trial consists of several different studies. The studies' aims are 1. To study activations of paralyzed facial muscles by the electrical stimulation. 2. To study different stimulation pulse waveforms, frequencies, and electrode placement and their effect on the muscle activations and the tolerability of the stimulation. 3. To study whether a symmetrical movement on the paralyzed side can be achieved with electrical stimulation when compared to the movements of the healthy side. 4. To study tolerability of stimulation-elicited eye blink when watching a film and the effect of the stimulation-induced blink on the eye symptoms, the visual acuity, and the effects of the stimulation on the lacrimal fluid. 5. To develop a method for facial pacing, i.e. measuring the muscle activations on the healthy side of the face and to use this information to stimulate and activate the healthy side of the face.

Forty subjects with a chronic facial nerve palsy are recruited to the studies. Each subject can participate in one or several studies. Another forty subjects with an acute facial nerve palsy are recruited to the study on the tolerability and effect on the eye symptoms. Additionally, altogether ninety healthy volunteers are recruited to the studies in order to gather preliminary information on the tolerability and the effects of the stimulations.


Eligibility Criteria:
Inclusion Criteria:

* a unilateral peripheral facial nerve palsy (patients)
* willingness to participate (patients, healthy volunteers)

Exclusion Criteria:

* malignant diseases (a previously treated cancer is not an exclusion criterion)
* unstable cardiovascular disease
* severe immune deficiency
* other severe neurological diseases (causing cognitive or physical impairment)
* diabetic neuropathy
Outcomes of Urological Surgery During Periods of Social COVID-19 Containemnt: is it Reasonable to Limit Access to Surgical Care for All?

The French healthcare system has been strongly mobilized since the start of the Covid-19 epidemic to take care of patients with Covid-19. This should not overlook the fact that some treatments, surgeries and examinations of non-Covid-19 patients must imperatively be maintained according to the assessment of their risk-benefit balance. In context, it appears that this is not always the case. In addition to the necessary social containment measures, there are general limitations on patient access to the operating theater, neglecting the individual interest of naive non-Covid-19 patients. Certain studies which report a higher and earlier risk of death of undetected and ultimately operated Covid-19 patients has reinforced, as a precaution, the massive deprogramming of naive patients and the restrictive access of surgical care for all. We believe that this could lead to a risk of delayed treatments and renunciation of care for naive patients who should not be considered at risk a priori in the event of surgery. The individual clinical and local health context should be first considered for appropriate surgical decision-making.

As such, the French Department of Health and Human Services (DGS) has given general guidelines regarding the maintenance of follow-up and care for non-Covid-19 patients in this context of containment and major mobilization of health care professionals to care for people with COVID. Surgeries which could not be postponed because of the patient's status or if their postponement exposed to a significant risk of loss of chance, if needed in the light of the recommendations issued by learned societies, were concerned. In this sense, the investigator have selected the naive Covid-19 patients from Nice Hospital who should benefit from elective or urgent urological surgeries, taking into account their individual risk and the territorial epidemic rate. Their rate of ICU stays following their surgery has been analysed and their surgical follow-up outcomes during the epidemic period evaluated, according to the anti-Covid-19 measures established in Nice Hospital by comparing them to an earlier period without Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* naive patient for elective or emergency urological surgery

Exclusion Criteria:

* minor less than 18 year old
Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

The clinical benefits of sunitinib and sorafenib have been demonstrated in patients with cytokine-refractory metastatic renal cell carcinoma. Sunitinib has also been shown to improve progression free survival and overall survival in a comparative study with interferon-alpha. When sunitinib is used as first-line molecular-targeted therapy, switching to sorafenib is one of the treatment options after disease progression. Reversely, when sorafenib is used as first-line molecular-targeted therapy, sunitinib is used as second-line therapy. The goal of cancer treatment is cure, and if cure is not possible, it is to prolong survival. In this study, sunitinib or sorafenib will be administered as first-line molecular-targeted therapy and treatment switched to the other test drug, sorafenib or sunitinib, when disease progression is detected to assess which treatment sequence produces longer progression free survival and offers a better safety profile (causing fewer adverse events). The purpose of this trial is to compare progression free survival of first line sunitinib versus sorafenib, and that of two treatment sequences, i.e. sunitinib followed by sorafenib versus sorafenib followed by sunitinib.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-80 years old, both inclusive
* ECOG performance status of 0, 1, or 2
* MSKCC risk of favorable or intermediate
* Histologically confirmed renal cell carcinoma
* No ischemic heart disease
* Laboratory findings meet the following criteria:

  1. Respiratory function: %VC, 80% and FEV1.0,70%
  2. Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3
  3. Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin \<1.5 x ULN
  4. Serum creatinin \<2.0mg/dl, blood urea nitrogen (BUN) \<25mg/dl
  5. Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.

Exclusion Criteria:

* History of any other malignancy
* Central nervous system metastases. However, patients who remain asymptomatic, have no new or enlarging lesion in the CNS within 6 months of enrollment in this study, and require no corticosteroids may be enrolled.
* History of cardiac infarction, unstable angina, congestive heart failure, or symptomatic peripheral vascular disease within 12 months of enrollment
* History of cerebrovascular disorder including transient ischemic attack (TIA)
* Pregnancy or possible pregnancy at any time during the study
* Ongoing grade 2 adverse event prior treatment
* Prior treatment with any anticancer therapy including cytokine therapy such as interferon-alpha and interleukin-2
* Prior treatment with mTOR inhibitor
* Prior treatment with sunitinib or sorafenib
* Treatment with an test drug in a clinical research within 4 weeks of enrollment in this study
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy

The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
* Bidimensionally measurable disease \>2cm x 1 cm by conventional CT Scan or \>1 cm x 1cm by spiral CT Scan.

Exclusion Criteria:

* No tumors in close proximity to major veins or arteries.
* No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
* No evidence or history brain metastases.
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis

This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
* Presumed NASH based on clinical characteristics or prior liver biopsy
* ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
* MRI-cT1 value\> 800 ms
* Written informed consent

Exclusion Criteria:

* History or clinical evidence of chronic liver diseases other than NAFLD
* History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
* History of liver transplant, or current placement on a liver transplant list
* Weight loss of \> 5% total body weight within 3 months prior to Screening

Note: Other protocol-defined inclusion/exclusion criteria could apply.
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)

While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.


Eligibility Criteria:
Inclusion Criteria:

Age: 50 years or older

Exclusion Criteria:

* BMI \> 40
* Radiographic deformity of greater than 10 degrees
Cytokines in Femtosecond Laser-assisted Cataract Surgery

The investigators performed the current study to compare: 1) the pain scores by Visual Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay (ELISA); 4) the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential femtosecond laser-assisted cataract surgery (FLACS). To our knowledge, this is the first intraindividual study investigating contralateral effect in FLACS. The findings from the current study may broaden our understanding on the mechanism of sympathetic reaction, help to improve clinical performances, and provide strong clinical guidance for cataract surgeons.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive cataract patients aged 40-80 years, regardless of gender, with bilateral similar grades of lens opacity, and scheduled for sequential FLACS were enrolled in this study.

Exclusion Criteria:

* history of ocular or systematic inflammatory diseases like uveitis, rheumatism or other autoimmune diseases;
* previous ocular surgery or trauma;
* preoperative glaucoma, zonular weakness, lens dislocation, or poor pupil dilation (measured pupil diameter \<5.0 mm) or synechiae;
* use of systemic or topical steroids, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-adrenergic antagonist, or pain relief medications within 1 month prior to surgery;
* patients with baseline eye pain, having anxiety, muscle spasm around the eye or involuntary eye movement disorders which may influence the pain score;
* eyes needing for any other type of anesthesia, failed to obtain \> 100 μl aqueous humor (AH) or encountered intra-operative complications like posterior capsule rupture
Teclistamab Expanded Access Treatment Protocol for Relapsed or Refractory Multiple Myeloma Patients

The purpose of this expanded access treatment protocol is to provide patients access to teclistamab prior to market authorization. The program is limited to patients with relapsed or refractory multiple myeloma who have exhausted all treatment options available as local standard of care and who are not eligible for a teclistamab clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Relapsed or Refractory Multiple Myeloma
* Patient exhausted all commercially approved and clinically appropriate (not patient or physician preference) treatment options, and is ineligible for a clinical trial
Effects of Self-stretching and Aerobic Exercise in Gestational Diabetes.

: Gestational diabetes is a common pregnancy-related condition characterized by impaired glucose metabolism. It poses risks to both maternal and fetal health. Physical activity interventions, such as self-stretching and aerobic exercise, have shown potential in improving glycemic control and managing associated symptoms in individuals with diabetes. Objective: To determine the effects of self-stretching, with or without aerobic exercise, on glycemic control, fatigue, and stress for women with gestational diabetes

A Randomized controlled trial was conducted at khursheed majeed Hospital Lahore and was completed in 8th month after approval of synopsis .A sample of 24 women having age 20 to 40 with gestational diabetes were selected through non probability convenience sampling technique and then randomly allocated into group A(self-stretching with aerobic exercise) and group B (self-stretching without aerobic exercise). The outcome measures were glycemic control, assessed by measuring fasting and postprandial blood glucose levels using a glucometer fatigue and stress levels, measured by Fatigue Assessment Scale (FAS) and Perceived Stress Scale (PSS), respectively. These measures will be obtained at baseline and after the 7-weeks intervention period. All participants in both groups were evaluated before and after the treatment programs.

Data was analyzed by using SPSS 25. Results: Mean value of Fasting blood glucose pre-treatment (Mean Difference=0.05) and post treatment (Mean Difference=0.14) with p value \<0.05. Mean value of 2 h postprandial blood glucose pre-treatment (Mean Difference=0.04) and post treatment (Mean Difference=0.20) with p value \<0.05.Mean value of Fatigue assessment scale pre-treatment (Mean Difference=1.56) and post treatment (Mean Difference=4.21) with p value \<0.05. Mean value of Perceived stress scale pre-treatment (Mean Difference=1.05) and post treatment (Mean Difference=4.74) with p value \<0.05 Conclusion: The study concluded that both groups Aerobic exercises + self-stretching (experimental group) and self-stretching Exercises only (control group) improve glycemic control, reduce fatigue and stress in gestational diabetes. However Aerobic exercises + self-stretching is more effective than self-stretching only

Eligibility Criteria:
Inclusion Criteria:

* Age 20 -40.
* Weight: 70kg-100kg.
* Women diagnosed with gestational diabetes.
* Second and third trimester of pregnancy

Exclusion Criteria:

* Females having history of depression
* Thyroid problems
* Preexisting diabetes • Early onset diabetes
* Multiple pregnancies
Chronic Pelvic Pain in Females and Males

Pelvic pain is under-reported in healthy adults. Many patients with pelvic pain under-estimate the problem. Chronic pelvic pain can be managed properly, if diagnosed promptly.

This is a quantitative analysis of prospective clinical data. It evaluates the management of pelvic pain in a cohort population, and analyzes the treatment outcome.

Pelvic pain is common, but under-reported in healthy adults. Pelvic pain is reported more commonly in women than in men. Many patients with pelvic pain under-estimate the severity of the problem. Chronic pelvic pain can be managed successfully, if diagnosed properly. Many combinations of multimodal analgesia and rehabilitation therapy may be safe and effective for pelvic pain.

This study is a quantitative analysis of prospective clinical data. It is an evaluation of the prevalence and management of pelvic pain in a cohort population of chronic pain patients. This is an analysis of multimodal analgesia types, rehabilitation therapy types, treatment outcome, and complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pelvic pain
* Patients with sacroiliac pain
* Patients with inguinal pain
* Patients with coccygeal pain
* Patients with piriformis pain

Exclusion Criteria:

* Patients with spinal pain
* Patients who had spine surgery
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis

A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.


Eligibility Criteria:
Inclusion Criteria:

* Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score, Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3).
* Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts.
* normal vaginal pH (higher than 4.5) at baseline.
* Women aged 18 - 45 years old.
* Women can comply with all clinical trial instructions, and can return to all follow-up visits.
* Signed Written Informed Consent to participate in this study.

Exclusion Criteria:

* Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).
* Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections
* Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study.
* Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study.
* Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
* Cervicitis, abnormal PAP smear in the last 6 month.
* Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
* Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.
* Women having menstruation bleeding at enrolment.
* Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
* Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study.
* Patient is relative of, or staff directly reporting to, the investigator.
Laryngeal Mask Airway Supreme Versus Laryngeal Tube

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in non-paralyzed anaesthetized pediatric patients

The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well studied laryngeal mask airway. Both devices have a drain tube to allow access to the gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The investigators hypothesized that design differences should lead to differences in efficacy of seal and anatomic position. In this randomized, crossover study, the investigators test the hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* age 1.5 - 9 years
* minor surgery
* extraglottic airway device

Exclusion Criteria:

* age (\<18 months, \>9 years)
* weight (\<10 kg, \>25 kg)
* a known difficult airway
* risk of aspiration
Self-Weighing Instruction Feasibility Study

Scant data have been reported on the effects of weight self-monitoring during weight control. The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?

This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months. It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions. Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 25 and 35 kg/m2

Exclusion Criteria:

* Current weight loss program participation
* Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
* Current or past eating disorder
* Current pregnancy or pregnant in past year
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.


Eligibility Criteria:
Inclusion Criteria:

* Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
* Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
* All children included in the study must never have been given a prophylactic influenza inoculation.
* Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language.

Exclusion Criteria:

* Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.
* Acute disease at the beginning of the study
* Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests.
* Known allergic reactions that might have been caused by one or more components of the vaccine.
* Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.