cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS)

The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms.

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the eligibility of the patients to enter a desensitization protocol.

During the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. The end-point of the study is a statistically significant decrease, or elimination of PMS symptoms, compared to a solvent group.


Eligibility Criteria:
Inclusion Criteria:

1. Person is over the age of 20 but not older than age 45.
2. Person is willing to participate as evidenced by signing the written informed consent form.
3. Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)
4. Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity.
5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency
6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities
7. At least one of the PMS symptoms interfere with relationships with others

   * Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow.
   * Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.
   * For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.
   * Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.
   * Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.
   * Reliable non hormonal contraception.

Exclusion Criteria:

1. Pregnant or lactating woman
2. Oral contraceptives during last three months, including hormonal IUD (trade name mirena).
3. Serious health problems.
4. Unexplained menstrual disorders.
5. Treated by hormones (estrogen and progesterone).
A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)

This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

* To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
* To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.


Eligibility Criteria:
Inclusion Criteria:

1. Subject with sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures
2. Healthy male of female subjects aged 20 - 45 years
3. Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)

Exclusion Criteria:

1. Subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
2. Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration
3. Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study
4. Subject with presence or history of severe adverse reaction to study drug
5. Subject who cannot prevent pregnancy during the study period.
6. Female subject who are pregnant.
7. Subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
8. Subject who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization.
9. Subject judged not eligible for study participation by investigator.
Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020

Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG proposes to conduct a new epidemiological study on primary PLC in order to evaluate and analyze the changes that have occurred over the last decade.

Primary endpoint:

Estimate 1-year- and 5-year-mortality rates in patients with PLC.

Secondary endpoints:

* Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020
* Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies
* Estimate prognostic factors
* Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and KBP-2000-CPHG studies
* Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG studies


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Primary Lung Cancer histologically (or cytologically or presence of a mutation on liquid biopsy with compatible imaging) proven between January 1st and December 31st, 2020\*
* Follow-up by a lung specialist at a General Hospital
* Oral informed consent \* date of collected sample

Exclusion Criteria:

* Age \< 18 years
* Secondary lung cancer
* Recurrence of same histological type PLC- left to the investigator discretion according to the clinic and the imagery
* Previous enrolment in the study
* Freedom deprived patient following a legal or administrative decision
* Patient unable to give his(her) consent
The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant

To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults

The participant with long bone defect or bone tumor of the extremity is referred to the Radiology Department to have a full CT-scan of both limbs to facilitate the later reconstruction. With the contralateral limb CT-scan data, the implant is designed with appropriate geometry and structures through online meetings with the scientists of CSIRO, Australia. Through this discussion, the supporting guides for the precise osteotomy will also be designed and would be 3D-printed later by 3 Dimensional Tech Vision Limited Company (Vietnam) with Poly Lactic Acid material. The 3D-printed metal parts will be manufactured using Titanium - 6 Aluminum - 4 Vanadium ELI (Extra Low Interstitial) material with Electron Beam Melting technology in CSIRO (Australia). Subsequently, the 3D-printed part will undergo mechanical tests using the Instron 5500R system (Australia) to validate its required mechanical properties. If this metal part cannot fulfill the mechanical requirements, the problematic geometry will be revised and re-designed. Another prototype will be 3D-printed with the same protocol and be tested until it qualified for the mechanical requirement. When the 3D-printed model passes the mechanical test, another 3D-printed metal part with a similar design will be manufactured before transferring to 3-Dimensional Tech Vision Limited Company (Vietnam) for post-processing, surface finishing, sterilising, packaging, labeling. Eventually, the implant will be sent to Cho Ray hospital. The amount of intraoperative blood loss and operative time will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants with health insurance regardless of sex having bone defect greater than 5cm due to trauma or tumour resection agree to participate the research

Exclusion Criteria:

* Participants with contraindication to surgery
* Participants do not agree to undergo surgery
* Participants with local infection or soft tissue defect
Open Label Study of Zonisamide in the Treatment of Epilepsy in Patients With Mental Retardation

The purpose of this study is to assess the efficacy and tolerability in "real-world" clinical practice, of adjunctive zonisamide treatment in adult patients with developmental disabilities and epilepsy.

While a number of randomized double-blind controlled trials have demonstrated the value of zonisamide in the treatment of seizures, such studies lend limited insight into the efficacy and tolerance of zonisamide in real-world clinical practice. Furthermore, randomized trials tend to inquire about negative effects, such as adverse reactions, while positive effects such as improvement in mood, or sense of well-being are not similarly categorized. In addition, there is little information about experience with zonisamide specifically in adult patients with mental retardation (MR) / developmental disabilities (DD). Anecdotal experience suggests that zonisamide is exceptionally well-tolerated, and is associated with an improved general sense of well-being and quality of life in non-DD patients. In patients with MR/DD, observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing antiepileptic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, at least 18 years of age
* Diagnosis of mental retardation
* Uncontrolled seizures or intolerable side effects from current AEDs
* Legal guardian is able to consent

Exclusion Criteria:

* Sulfa allergy
* Prior exposure to zonisamide
A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures

In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. The implant combines an angular stable device with screw in screw technology for rotational stability. Therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called FNS is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.

All patients included are treated as per standard or care and followed up from the time point of enrollment until at least three months after surgery as described below. Data of a visit after 6 months and 12 months are collected if bone union according to the RUSH score is not complete after 3 or 6 months respectively or if the patient has persistent or increasing pain on the operated site.

Preoperative:

* Patient details
* Fracture Classification and comminution based on CT
* Pre-fracture HHS and EQ5D
* X-rays

Intraoperative:

* Surgery details
* Defined intraoperative complications
* Intraoperative fluoroscopy: hip ap (with leg 15° internally rotated) and lateral after reduction and after implant placement

Postoperative:

* X-ray prior to any mechanical load: hip ap (with leg 15° internally rotated) and lateral

  6 weeks and 3 months FU:
* Defined postoperative complications
* HSS and EQ5D
* X-rays

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of a medial femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
* Ability to understand the content of the patient information/Informed Consent Form
* Willingness and ability to participate in the registry according to the Registry Plan (RP)
* Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

* Pathological fracture
* Additional acute fracture
* Any not medically managed severe systemic disease
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or women planning to conceive within the registry period
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

1. Trial design: Prospective observational study
2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib

   * C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
5. Duration of Trial Recruitment: 2 years


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* 19\~80 year old male or female
* Histologically proven advanced or metastatic NSCLC
* Failed to 1st line chemotherapy
* Tumor tissue for genetic analysis
* Evaluable target lesion by RECIST v1.1
* ECOG performance from 0 to 3
* Expected survival more than 12 weeks

Exclusion Criteria:

* Previous treatment of EGFR-tyrosine kinase inhibitors
* Severe hypersensitivity to erlotinib
* Residual toxicities (above grade 2) after previous chemotherapy
* Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer

The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.

* Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels.
* On the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. Once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete.
* While on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks.
* This study also involves a Quality of Life Questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment.
* Patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer clinical stage I, II or III disease. Patients must be deemed of sufficient risk for tumor or recurrence
* Patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery
* 18 years of age or older
* ECOG performance status 0 or 1
* ANC \> 1,500/uL
* Hemoglobin \> 9 g/dL
* Platelets \> 100,000/ul
* Total bilirubin less than or equal to ULN
* AST/ALT \< 1.5 x ULN
* Creatinine within normal institutional limits
* PT/PTT \< institutional upper limit of normal
* LVEF \> 50%

Exclusion Criteria:

* Previous cytotoxic chemotherapy or therapeutic radiation therapy
* Pregnant or lactating women
* Receiving any other investigational agents
* Stage IV breast cancer
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin
* Previous exposure to G-CSF or pegfilgrastim or to recombinant erythropoetin-related growth factors.
* On antibiotics within 72 hours of registration
* Patients with immune deficiency who are at increased risk of lethal infections when treated with marrow-suppressive therapy, or HIV-positive patients receiving anti-retroviral therapy
* Sickle cell disease
* Known positive antibody response to any erythropoietic agent
* Known hematologic diseases
* Known history of hyperviscosity syndrome
* Patients on lithium
* RBC transfusion within past 4 weeks
An Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T)

This observational study aimed to evaluate the safety and efficacy of postoperative management in patients with thyroid cancer who received subtotal or total thyroidectomy.

1. Characteristic analysis of improvement in quality of life and symptoms after surgery in cancer patients
2. Multifaceted symptom evaluation of cancer patients visiting medical institutions
3. Evaluation of effectiveness and safety of treatment for postoperative symptoms in thyroid cancer patients
4. Analysis of the effectiveness and prognosis of cancer-related treatment for each patient with cancer
5. Analysis of prognostic factors for disease-free survival and overall survival of cancer patients

Among adult men and women aged 19 years or older who have been diagnosed with thyroid cancer, who have undergone partial or total thyroidectomy and visited the hospital for postoperative management, the characteristics of the visiting patient, quality of life, characteristics of cancer-related symptoms, and treatment effectiveness, We intend to conduct a prospective observational study to evaluate safety and its relationship with prognosis. In addition, we aim to form the basis for follow-up research through the establishment of an Oriental medicine cancer cohort and database.

Eligibility Criteria:
Inclusion Criteria:

* 19 years of age or older
* Those who have been confirmed to have a malignant tumor of the thyroid gland by biopsy or imaging
* Subjects who have undergone partial thyroidectomy or total resection within 1 month
* Those who have agreed to the implementation of Chinese medicine treatment
* The Eastern Cooperative Oncology Group(ECOG) performance status 0-3
* Those who understand the content of the study and agree to participate in the study

Exclusion Criteria:

* ○ When it is judged that other diseases other than cancer (dementia, cerebrovascular disease, severe organ failure, etc.) may have a significant effect on the decline of physical function

  * When it is judged that the life expectancy is less than 3 months and sufficient follow-up cannot be carried out
  * When emergency or major surgery or surgical intervention is required that takes precedence over postoperative treatment
  * Pregnant and lactating women
  * Other researchers who are judged to be unsuitable for research
Immediate Skin-To-Skin Care For Preterm Infants After Birth.

The standard procedure in our centre for preterm neonates is to enable skin-to-skin (SSC) contact within 24 hours after birth. As early SSC immediately after birth might provide numerous positive effects for mothers and their preterm neonates, the objective of this study is to evaluate the feasibility, the safety and the effect of skin-to-skin contact immediately after birth in preterm neonates born with gestational age between 26+0 and 32+0 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 26+0 and 32+0 weeks
* Written parental informed consent

Exclusion Criteria:

* No intention of full life support
* Severe congenital malformation
Non-contact Sleep Apnea Identification in Neurological Rehabilitation

To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients.

The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic.

The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI \>= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Informed Consent as documented by signature
* In-patients of RehaClinic Bad Zurzach

Exclusion Criteria:

* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Effect on Ocular Surface Symptoms of Online Education

retrospective, observational study.

Aim: The aim of this study was to investigate the effects on ocular surface symptoms of students taking online education, which was a part of the distance learning model during the COVID-19 pandemic, to be able to prevent the formation of irreversible damage with early diagnosis and treatment. With recommendations that can be simply applied, it was aimed to protect ocular health.

Material and Method: The study included 315 students who were undertaking online education and presented at the Ophthalmology Department of a tertiary level university hospital. A record was made of sociodemographic data, Schirmer test results, tear break-up time (TBUT) measurements, and Ocular Surface Disease Index (OSDI) scores. The data were analyzed statistically using SPSS vn. 22.0 software, and a value of p\<0.05 was accepted as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

Online education \>6 years \<30 years student

Exclusion Criteria:

not student not taking online education \<6 years \>30 years