cyrilzakka/clinical-trials huggingface dataset:
Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition

Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH control the production of female hormones (such as estrogen and progesterone) and the development of eggs by the ovary. Progesterone and estrogen then decrease the number of GnRH pulses produced by the brain (and therefore the number of LH pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important for normal menstrual function in adult women. The purpose of this study is to learn more about how GnRH and LH pulses are controlled during puberty. The information gathered in this study will hopefully allow us to learn more about how menstrual cycles are normally established in girls during puberty.

In this study, the investigators will aim to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in girls in early and mid puberty. Ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.

Eligibility Criteria:
Inclusion Criteria:

* Girls ages 8 to 14
* Tanner 1-3 pubertal stage
* Pre-menarchal
* Normal screening labs

Exclusion Criteria:

* Abnormal screening labs
* Congenital adrenal hyperplasia
* Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
* Hemoglobin \<12 mg/dL or hematocrit \< 36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit.)
* Weight \< 31 kg
* History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
* On hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study
* Pregnant or breast feeding
* Participation in a research study within the past 30 days that involved taking a study drug.
* Participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days.
* Cigarette smoking
* History of surgery that required bedrest within the past 30 days
* Family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy)
* In order to ensure an adequate number of younger girls, no more than 4 enrolled subjects will be Tanner stage 3
Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.

Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease patients
* Primary ileocolic anastomosis
* C-Reactive Protein data available in medical file

Exclusion Criteria:

* Protective stoma
* Associated resection with or without anastomosis during intervention
A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia

Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research.

From December 2019, 12 cases of new coronavirus pneumonia broke out in Wuhan, and then the epidemic spread rapidly. Till February 1, 2020, there were 14446 confirmed cases in China, 19544 suspected cases, and 304 deaths. There were confirmed cases reported in 34 provincial administrative regions in China; 23 foreign countries reported new coronavirus pneumonia cases, 147 confirmed cases. In the face of the rapid spread of the epidemic, people's panic and anxiety have seriously affected the prevention and control of the epidemic. In the face of the occupational exposure risk and treatment brought by the sudden outbreak of the epidemic, the change of mental state of medical staff may affect the prevention and control of the epidemic. In order to help the epidemic prevention and control, the investigator plan to carry out investigation research.

Eligibility Criteria:
Inclusion Criteria:

* can use mobil phone or computer
* volunteer to take part in the investigation

Exclusion Criteria:

* can not use phone or computer
* unwilling to take part in the investigation
Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer

Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.

Primary objective:

Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.

Secondary objectives:

Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove


Eligibility Criteria:
Inclusion Criteria:

* Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
* Patients aged 18 and older
* Nail toxicity \< grade 2 (CTC-AE version 3.0)
* Informed patients with signed consent

Exclusion Criteria:

* History of treatment with taxane
* Raynaud syndrome
* Distal metastasis in superior extremity
* Nail diseases
* Distal arteriopathy
* Cold intolerance
* Peripheral neuropathy\>=2
* Pregnancy, breast feeding
* Unable to give informed consent
* Unable to have a medical follow-up for social, geographical, family or psychological reasons
Allograft and Tantalum Cone Reconstruction in TKA Revision

A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft.

Study of radiological and clinical outcomes.


Eligibility Criteria:
Inclusion criteria:

* \> 18 years old
* TKA revision using tantalum cone or allograft

Exclusion criteria:

* \<18 years old
* no reconstruction used in TKA revision
Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for patients´ screening:

* Patients of both sexes aged 18 or more.
* Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
* Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
* Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
* Patients who have granted their written informed consent.

Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:

Inclusion Criteria for patients´ follow-up

* Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).

Exclusion Criteria:

* Combined histology of non-small cell and small cell lung cancer.
New International CTEPH Database

The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival.

The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (incident patients)
* Patients must have been treated with anti-coagulation for at least 3 months before diagnosis of CTEPH
* Patients must be willing to provide informed consent
* Patients must meet the following criteria for CTEPH:

  * Mean pulmonary artery pressure (PAP) ≥ 25 mmHg at rest
  * Abnormal VQ scan, pulmonary angiogram, computed tomography (CT) pulmonary angiogram, or magnetic resonance (MR) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines

Exclusion Criteria:

* None specified
Comparison of the Effects of Dexamethasone and magnesıum Sulphate Used as Adjuvant in Infraclavicular Nerve Block.

The aim of this prospective clinical study is to compare the effectiveness of dexamethasone and magnesium sulfate added as adjuvants to bupivacaine in infraclavicular brachial plexus block used under ultrasound guidance for upper extremity surgeries.

This study was conducted on 90 patients who underwent upper extremity surgery under infraclavicular brachial plexus block.

90 patients included in the study were randomized into 3 groups of 30 people each by the sealed envelope method.

30 participants were included in Group Bupivacaine, 30 participants were included in Group Bupivacaine + Dexamethasone and 30 participants were included in Group Bupivacaine + Magnesium sulfate.

The study was started as double blind. According to the local anesthetic used, patients were group B (30 patients, 20 cc 0.5% bupivacaine + 5 cc 0.9% NaCl), group B+D (30 patients, 20 cc 0.5% bupivacaine + 4 mg dexamethasone + 4 cc 0.9% NaCl), group They were divided into three groups as B+M (30 patients, 20 cc 0.5% bupivacaine + 150 mg magnesium sulfate + 4 cc 0.9% NaCl).

Complications of the patients, such as sensory block and motor block onset times, peroperative hemodynamic parameters, need for additional analgesia, postoperative block duration, analgesia duration, opioid and NSAID consumption, nausea and vomiting, were recorded

Eligibility Criteria:
Inclusion Criteria:

* Participants providing informed written and verbal consent
* 18-65 years old
* ASA I-II
* Cases undergoing elective upper extremity surger

Exclusion Criteria:

* Cases that do not accept regional anesthesia application
* Those who are under 18 years of age and over 65 years of age
* ASA III and above
* Cases in which the operation was started with infraclavicular block and then transferred to general anesthesia.
* Those with liver and kidney dysfunction
* Those with diabetes mellitus
* Those with drug allergies
* Patients with acid-base and electrolyte disorders
* Pregnant women
* Emergency cases
* Those with neuropathic disorders
* Those with significant psychiatric and cognitive disorders or substance addiction
* Those with a history of clavicle fracture, pneumonectomy, contralateral hemidiaphragmatic paralysis, pneumothorax, phrenic or recurrent laryngeal nerve palsy.
* Cases with BMI\>30 or BMI\<18
* Patients in whom regional anesthesia was contraindicated (sepsis, local infection, coagulopathy, heart disease, hypovolemia) were not included in the study.
A Pilot Therapeutic Trial Using Hydroxyurea in Type I Spinal Muscular Atrophy Patients

The objectives of this trial are: to establish a safety profile for use of Hydroxyurea in children with Type I Spinal Muscular Atrophy; to identify reliable outcome measures for HU treatment in Type I SMA; and to detect the clinical efficacy of HU treatment in children with Type I SMA.

SMA is a neuromuscular disorder characterized by degeneration of spinal cord motor neurons and muscular atrophy. SMA is classified into three clinical subtypes according to the severity and age of onset (Types I, II and III). Type I SMA (also called severe, infantile or acute SMA, or Werdnig-Hoffman disease) is the most severe phenotype. The onset of symptoms is within the first 6 months of life, and weakness of intercostal muscles and lack of airway protection lead to respiratory insufficiency and aspiration pneumonia, often resulting in early infant death.

In our laboratory, our preliminary results indicate that HU treatment significantly increases both SMN mRNA expression and intact SMN protein levels in vitro. These data confirm previous observations that in vitro treatments of SMA lymphocytes with hydroxyurea resulted in augmentation of the SMN2 gene expression in a dose and time related manner. Based on these exciting pre-clinical data, coupled with the well-documented side-effect profile of HU in children, we are conducting a pilot clinical trial using HU in children with Type I SMA. This clinical trial study is intended to establish the safety profile in children with Type I SMA; to identify reliable outcome measures; and to detect the possible clinical efficacy of HU treatment in children with Type I SMA.

Eligibility Criteria:
Inclusion Criteria:1. Laboratory confirmation of a homozygous deletion or mutation of the SMN1 gene 2. Clinical Diagnosis of Type I SMA (never achieved independent sitting) 3. Onset of disease before the age of 6 months 4. Enrollment in study within 6 months of diagnosis Exclusion Criteria:1. Known hematological disorders, such as chronic anemia (defined as platelet count less than 100,000/mm\^3) in two contiguous measures in two weeks 2. Severe systemic disorders such as congenital heart disease, other major birth defects involving internal organs, or severe birth asphyxia 3. Participation in SMA clinical trials for other experimental drugs 4. Requiring continuous respiratory support before the initiation of HU treatment
Effectiveness of Preoperative Surgical Scrubbing Using Clorhexidine Digluconate and Parachlorometaxylenol (ECP)

Despite the wide variety of products and antiseptic agents, no agent is ideal for every situation. The investigators would like to evaluate the difference in reducing bacterial load, using 4% chlorhexidine digluconate and 3% parachlorometaxylenol after a preoperative surgical scrubbing.

The investigators conducted a controlled, prospective, randomized study to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using 4% chlorhexidine digluconate and 3% parachlorometaxylenol. Samples were taken from the hands of each volunteer after a preparatory handwash, pre-surgical scrubbing, post-surgical scrubbing and 3 hours after surgical scrubbing.

Eligibility Criteria:
Inclusion Criteria:

* No systemic diseases.
* Healthy skin on hands, without cuts or abrasions.
* Short and clean fingernails.
* No use of substances with antimicrobial action (e.g. medicated soaps or creams).

Exclusion Criteria:

* History of eczema.
* History of psoriasis.
* Allergies to any of the ingredients of the solutions or contraindication to its use.
Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.

PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer.

OBJECTIVES: I. Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with renal cell cancer currently treated with interleukin-2 (IL-2). II. Evaluate the effect of different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity.

OUTLINE: This is a dose escalation study of Biomed 101. Patients receive oral Biomed 101 three times daily, followed by interleukin-2 IV on days 1-5 and 16-20. Cohorts of 5 patients receive escalating doses of Biomed 101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities. Patients are followed for 1 month.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed renal cell cancer No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: No hepatic failure No encephalopathy Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: No renal dysfunction requiring dialysis for greater than 72 hours Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of sustained ventricular tachycardia (greater than 5 beats) No uncontrolled cardiac rhythm disturbances No recurrent chest pain with echocardiogram changes No angina No myocardial infarction No pericardial tamponade No moderate or severe coronary artery disease (New York Heart Association class 3 or 4) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant neurological dysfunction including seizure or clinical signs of other significant neurological disease No gastrointestinal bleeding requiring surgery No concurrent infection requiring antimicrobial therapy No bowel ischemia or perforation

PRIOR CONCURRENT THERAPY: At least 30 days since prior investigational drugs No other concurrent investigational drugs No intubation required for greater than 72 hours No prior enrollment in this study
Characterizing the Intraocular Scattering at Different Wavelengths

This is a single-site, unmasked, 4-visit, randomized 3x3 cross-over clinical trial to quantify intraocular light scatter in different age groups.


Eligibility Criteria:
Inclusion Criteria:

Potential subjects must satisfy all the following criteria to be enrolled in the study:

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be at least 18 years of age and not greater than 75 years of age at the time of consent.
4. Has had an eye examination within the last two years.
5. The subject's distance vertex corrected spherical equivalent refraction must be in the range of +4.00 D to -6.00 D in each eye.
6. The subject's refractive cylinder must be ≤2.50 D in each eye.
7. The subject must have distance best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or lactating.
2. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with their ocular health. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
3. Have any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
4. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids, monoamine oxide inhibitors. See Section 9.1 for further examples.
5. Use of any ocular medication that may interfere with study procedures as determined by the Investigator.
6. Have a history of irregular cornea.
7. Have a history of moderate to severe dry eye.
8. Have Participated in clinical trial within 7 days prior to study enrollment.
9. Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
10. Have any contraindications to pupil dilation.
11. Have any known hypersensitivity, allergic reaction or other contraindication to proparacaine, tropicamide, phenylephrine or sodium fluorescein.
12. Have any allergies to dental mold materials or contraindications to having a dental mold made.
13. Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities that may interfere with the study measurements.
14. Have any ocular scars in the central 6 mm of the cornea that may interfere with the study measurement.
15. Have any current ocular infection or inflammation.
16. Intraocular pressure \> 21mmHg OD or OS.
17. Ocular angle assessed by Van Herick measurement of grade 2 or less OD or OS.
Metronom Continuous Glucose Monitoring System

The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged ≥18 years
* Type 1 diabetes for at least 6 months according to the WHO definition treated with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months (for T1D only)
* Body Mass Index (BMI) \<35 kg/m²
* Flash or continuous glucose monitoring (FGM, CGM) user
* Willing and able to wear the Metronom CGM System for the duration of the study and undergo all study procedures
* HbA1c ≤86 mmol/mol

Exclusion Criteria:

* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
* Any mental condition rendering the subject incapable of giving his consent
* Subject is using any medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
* Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* Subject is actively enrolled in another clinical trial
* Known adrenal gland problem, pancreatic tumour, or insulinoma
* Known bleeding disorder
* Known hypersensitivity to adhesive or skin lesions that hinder sensor insertion
* Inability of the subject to comply with all study procedures
* Inability of the subject to understand the subject information
* Subject donated blood in the last 3 months