cyrilzakka/clinical-trials huggingface dataset:
Pelvic Floor Rehabilitation for Gynecological Cancer Patients

As cancer treatment improves, the cancer survivor's quality of life and level of function have gained increasing importance. Pelvic floor function is directly affected by gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a patient's life. PFD negatively affects health-related quality of life (HRQOL). Evaluation of PFD provides information about the disease burden and treatment-related effects directly from the patient's perspective and informs clinical decision-making. The pelvic floor musculature and sacral nerves are not easily accessible, and it is difficult to test them. Several functional assessments have been used to evaluate pelvic floor dysfunction; however, reports on methodology are sparse, and consensus on their use is lacking. Research on functional outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.

Patients with cervical or colorectal cancer who underwent surgery or radiotherapy are recruited for the study.

* PFM strength is measured using a perineometer (BioCon-200,McubeTechnologyCompany,Seoul,Korea). Vaginal pressure is measured using a vaginal silicon pressure sensor (cmH2O; sensitivity0.06kPa,sensitivity 5mV, threshold1.5V).
* The motor evoked potentials (MEPs) from the pelvic floor are obtained by sacral and transcranial magnetic stimulation using a Magstim 200 stimulator (Magstim Co., Whitland, Wales, UK). Patients are instructed to lie in the left lateral decubitus position,intra-anal sponge electrode (Dantec,Skovlund, Denmark)was lubricated and gently inserted into the anal canal.
* Monophasic single pulses of magnetic stimuli were delivered to the vertex corresponding to the primary motor center in the precentral gyrus using a double-cone coil(9902-00,Magstim). A figure-eight coil(9762-00,Magstim)was used to stimulate the dorsolateral area of the sacrum corresponding to the exit of the sacral cortical facilitation
* We measured the latency, amplitude, and excitability threshold(ET) of MEPs detected in pelvic floor muscles with and without facilitation. The excitability threshold at rest(RET) is defined as the lowest intensity that produced MEP responses of 100μV For optimal facilitation, we measure the latency of the MEPs with minimal contraction (10% of MVC) with RET intensity and amplitude with a moderate contraction
* Patient-reported HRQOL Quality of life General and condition-specific aspects of HRQOL were assessed using the EORTC QLQ-C30 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Women with gynecological cancer who had radical hysterectomy and pelvic lymph node dissection

Exclusion Criteria:

* infectious diseases of the urinary tract and vagina
The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients

There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. This is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. Firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years
* Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999

Exclusion Criteria:

* Allergic to test substances
* Known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases
* Known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently
* Usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks
* Unable to cooperate with researchers or maintain ordinary dietary habit
Permissive Hypercapnia and Brain Development in Premature Infants

In the US, every year approximately 30,000 infants are born very prematurely, with birth weight less than 1000 grams. These infants usually require ventilators to help them breath normally during the first few weeks of life. Although the ventilator is lifesaving, it can also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury. Importantly, there is new research showing that high carbon dioxide may cause brain injury. In our proposed research, we will use magnetic resonance imaging methods to evaluate the brain in 40 very premature infants at term-equivalent age (Half of them had permissive hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse effect on brain development.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants with birth weight 401-1000 g

Exclusion Criteria:

* Those with complex congenital anomalies, central nervous system malformations, chromosomal abnormalities, or hydrops fetalis
Memantine and Antipsychotics Use

To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine.


Eligibility Criteria:
Inclusion criteria:

* Current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
* MRI or CT scan supporting the diagnosis of DAT without indications of any relevant other CNS disorders.
* Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.
* The patient should have German as a mother-tongue or at least speak the language fluently.

Exclusion criteria:

* Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
* Modified Hachinski Ischemia score greater than 4 at screening.
* Intake of any medication that is contra-indicated in combination with memantine.
* Treatment with depot antipsychotics.
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine or lactose.
* Known or suspected history of alcoholism or drug abuse within the past 10 years.
* Previous treatment with memantine or participation in an investigational study with memantine.
Serratus Intercostal Block Versus Epidural Analgesia in Eventration: Prospective Observational Study

Adequate pain control, rehabilitation and early postoperative recovery are currently the model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions.

We conducted an observational study with a low level of intervention. Epidural analgesia prior to general anesthesia and serratus-intercostal block prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC.

Adequate pain control, rehabilitation and early postoperative recovery are currently model to follow according to the recommended guidelines.In this project the main objective is to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior to surgical intervention in eventration or abdominal wall repair interventions.

The investigators conducted an observational study with a low level of intervention. Epidural analgesia prior to general anesthesia and serratus-intercostal block prior to general anesthesia) following the criteria applied in each case according to the operating room anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal eventration repair, over 18 years of age, ASA I-III. Signature of the IC.

We will assess the analgesia provided by both techniques and to compare the results.

Eligibility Criteria:
Inclusion Criteria:

* abdominal eventration repair,
* over 18 years old,
* ASA I-III.
* Signature of the IC.

Exclusion Criteria:

* Allergy to Local anesthetic
Areal and Linear Comparison of Gingival Recession

Recent advances in digital technology have led to the emergence of precise methods for measuring gingival recession and tissue thickness. This study aimed to compare digital measurement methods and conventional periodontal probe measurements for the assessment of gingival recession influenced by the gingival phenotype.

This study involved 128 gingival recession sites from 28 systemically healthy patients aged 18-45 years. The participants were categorized into two groups on the basis of gingival thickness. The plaque index, gingival index, probing depth, clinical attachment level, gingival recession depth, and gingival recession width, and keratinized gingival thickness and width were measured using a manual periodontal probe and an intraoral optical surface scanner. Statistical analysis was performed with nonparametric tests because the data were not normally distributed. P\<0.05 indicated statistical significanct.


Eligibility Criteria:
Inclusion Criteria: The study included systemically healthy subjects aged 18-45 years with systemic disease or systemic disease under control.

Exclusion Criteria: The exclusion criteria were as follows:

* Patients with a history of radiotherapy,
* Patients with chemotherapy,
* Immunosuppressive use,
* Tobacco use,
* Smoking,
* Patients with labially exposed teeth and teeth with prominent root protrusions,
* Pregnancy and lactation,
* Patients with uncontrolled diabetes,
* Patients with postorthodontic extractions,
* Patients with gingival recession, .Patients with gingival enlargement caused by piercing and nail-biting habits.
CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved

Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.


Eligibility Criteria:
Inclusion Criteria:

* T1N0 SCC of glottic carcinoma with anterior commissure involve
* No nodal metastasis and distant metastasis
* All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
* Expected lifetime\>1 year
* Patients and families agreed to participate in the test and sign the informed consent
* Without cognitive impairment.

Exclusion Criteria:

* With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients
* Patients with pregnancy and lactation
* Have surgery contraindications
Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression

The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar disorder in the postpartum treatment will receive either a placebo or celecoxib add-on treatment. Patients will be monitored regularly to assess psychiatric symptoms and side effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib in bipolar postpartum depression.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton
* diagnosis of bipolar postpartum depression - depressed with peripartum onset
* have a 17-item Hamilton Rating Scale for Depression score of \>18
* have failed to respond to an adequate trial of the mood stabilizer
* are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)
* are able to communicate (written and oral) in English and capable of giving consent

Exclusion Criteria:

* current major depressive episode of more than 6 months duration
* a current comorbid psychiatric disorder
* history of alcohol or substance abuse within the 12 months before screening
* concurrent psychotherapy
* high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)
* current hepatic, renal, or cardiac disease, chronic pain, coagulation disorders, esophageal or gastro duodenal ulceration within the previous 30 days
* known immediate-type hypersensitivity to COX-2 inhibitors, sulfonamides, ibuprofen, or diclofenac
* breastfeeding mothers
Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer

The lymph nodes involvement is one of the most important prognostic factors in endometrial (EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal role in the choice of the adjuvant therapy.

Since the modern imaging techniques are not yet able to accurately detect lymph nodes metastasis, pelvic systematic lymphadenectomy has still an important role and it still represents the gold standard in EC and CC. The sentinel lymph node (SLN) biopsy, which is a standard practice in breast cancer and melanoma, is often used in some early stage gynaecological cancers such as EC and CC.

Indocyanine green (ICG) is the most used tracer for the detection of SLN in gynaecological cancer, especially in laparoendoscopic setting. ICG allows a complete visualization of the lymphatic drainage and, for this reason, it may be used even in systematic pelvic lymphadenectomy to guide the surgeon during the procedure. Several studies have demonstrated an advantage of the ICG-guided lymphadenectomy in other types of cancers, showing a higher number of lymph nodes removed with this technique when compared to standard lymphadenectomy (without ICG).

To date, there is no published study about ICG-guided systematic pelvic lymphadenectomy in EC and CC. In this scenario, the aim of this study will be to compare systematic ICG-guided pelvic lymphadenectomy and standard lymphadenectomy in EC and CC.


Eligibility Criteria:
Inclusion Criteria:

* Women affected by endometrial or cervical cancer
* Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.

Exclusion Criteria:

* Women undergoing open surgery (laparotomy) for the surgical management of endometrial or cervical cancer.
Effects of Probiotic and HIIT in Obese Women

The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women.

High-intensity interval training (HIIT) is a time-efficiency exercise mode that has been shown to reduce body fat, fasting blood insulin levels, arterial stiffness, and aerobic capacity, helping to prevent and improve chronic diseases. Probiotics, on the other hand, have been found to have similar effects, including improving insulin sensitivity and endurance exercise performance, as well as reducing body fat. However, the additive effects of HIIT combined with probiotic supplements are unclear. In addition, on average, the life expectancy of women is longer than that of men. Middle-aged women are at high-risk for obesity and metabolic-related problems that threaten their long-term health. Therefore, whether the combination of HIIT and probiotics can be utilized to enhance the wellness of middle-aged women is the objective of this study.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age between 35-55 years old
* Total body fat percentage greater than 30%

Exclusion Criteria:

* Male
* Participants who were taking probiotics supplementation or antibiotics
* Percentage of total body fat less than 30%
Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria.
* Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine.
* Patients, men and women, must age from 18 to 65 years old.
* Patients must have moderately active RA based on the criteria of the DAS-28 score from 3.2 to 5.1.
* If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
* If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.

Exclusion Criteria:

* Skin allergies or broken skin;
* Taking TwHF agents, glucocorticoids and biological agents;
* Female patients who are pregnant, breast-feeding or planed to be pregnant;
* Subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.
Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty

Chronic rhinosinusitis, a common diagnosis in children, remains a poorly understood disease. Adenoidectomy (surgery to take out the adenoid pads- infection fighting glands in the back of the throat) is performed since the adenoid pad may trap germs that enter a child's body and can get so swollen with bacteria that they become infected themselves. Functional endoscopic sinus surgery (FESS) and adenoidectomy are currently the most common surgeries performed on children with this disease. Another treatment is adenoidectomy and irrigation of the maxillary sinus without FESS. New technology has emerged using a balloon catheter to dilate (open) the sinus passage in addition to the adenoidectomy and irrigation. This study seeks to answer if children with chronic rhinosinusitis who undergo adenoidectomy with balloon dilation of the maxillary sinus passage and irrigation experience improved quality of life outcomes compared to children with chronic rhinosinusitis who undergo an adenoidectomy with maxillary sinus irrigation without dilation of the sinus passage.


Eligibility Criteria:
Inclusion Criteria:

1. Sinonasal symptoms of at least 12 weeks' duration or recurrent sinusitis \>3x/year
2. Failure to respond to 3-week course of antibiotic and 3 month course of nasal steroid preparations or antihistamines as well as saline nasal irrigation
3. Rhinosinusitis documented by CT scan following oral antibiotic course.

Computer tomographic findings considered to be consistent with sinusitis include partial or complete sinus opacification.

Allergy and immunology workup will be recommended on an individual basis -

Exclusion Criteria:

1. Patients with extensive sinonasal polyps, extensive sinonasal osteoneogenesis, sinonasal tumors
2. History of facial trauma that distorts sinus anatomy
3. Ciliary dysfunction
4. Pregnancy will be excluded.
5. Patients with cystic fibrosis, craniofacial anomalies, metabolic disorders, or immunodeficiencies
6. Patients who have had their adenoids removed and thus may be candidates for functional endoscopic sinus surgery will also be excluded.
7. Patients with a history of sinus surgery or significant anatomic abnormalities on CT scan that would require endoscopic sinus surgery or septoplasty would also be excluded.

Of note, children who will be undergoing concurrent surgeries will not be excluded.

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Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, exact information about influence on tear film thickness and corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.

Recently a new method for assessment of tear film thickness based on ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged over 18 years
2. Signed and dated written informed consent
3. History of dry eye syndrome for at least 3 months
4. Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
5. OSDI ≥ 22
6. Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
7. No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria:

1. Presence of an ocular pathology judged by the investigator as incompatible with the study.
2. Any other clinical relevant ocular abnormality except DES.
3. History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein.
4. History of known clinically relevant allergy.
5. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, haematological disease; severe psychiatric illness, etc.).
6. History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0).
7. Pregnancy, lactation.
8. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised.
9. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses).
10. Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment.
11. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
12. Subject is a ward of court.