cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Eligibility Criteria:
Inclusion Criteria:

Healthy females

* 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active women requesting birth control
* In good general health, confirmed by medical history, physical (including gynecologic) examination and screening laboratory values

Exclusion Criteria:

* Known or suspected pregnancy;
* Lactating women
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use

Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Antibiotics resistant is serious problem in helicobacter pylori eradication. Clarithromycin is very important antibiotics in eradication. But clarithromycin resistance is increased. Major cause of clarithromycin resistance is past consumption of macrolide. Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.

Eligibility Criteria:
Inclusion Criteria:

* Peptic ulcer disease
* Gastric MALT lymphoma
* Early gastric cancer
* Familial history of gastric cancer
* Idiopathic iron deficiency
* Chronic idiopathic thrombocytopenia
* Atrophic gastritis
* Helicobacter infected dyspepsia
* Long term NSAIDs use

Exclusion Criteria:

* Pregnant
* Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
* Previous stomach surgery
* Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
* Previous Helicobacter eradication
* Allergy for Helicobacter eradication medicine
Endoscopic Lung Volume Reduction After Catheter-based CV Measurement in Patients With Heterogeneous Emphysema and Complete Interlobar Fissures

This clinical trial evaluates the impact of catheter-based measurement of interloabr collateral ventilation prior to endoscopic lung volume reduction in patients with hetereogeneous emphysema and complete interlobar fissures in high resolution computed tomography.

50 patients (25 per center) with heterogeneous lung emphysema with indication for endoscopic lung volume reduction by valve implantation will be prospectively included in the study. Heterogeneity of emphysema and fissure completeness of the relevant lobe will be proven from high resolution computed tomography (HRCT) prior to enrolment in the study. Fissure integrity will be analyzed by a core radiology. If fissure completeness is proved, patients will be enrolled in the study. All recruited patients will additionally receive a collateral ventilation measurement by using the Chartis® Pulmonary Assement System during a flexible bronchoscopy. Depending on the results of this measurement, patients are divided in two parallel arms: A: complete fissure integrity and low collateral ventilation (CV negative) B: complete fissure integrity and high collateral ventilation (CV positive) Following the CV measurement, each patient will receive valve therapy.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* ability to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements
* severe lung emphysema (FEV1\<45%, RV\>150%, TLC\>100%)
* pO2\>60 mmHg with 4l O2, pCO2 \< 60 mmHg at rest
* heterogeneous lung emphysema diagnosed with HRCT and perfusion scintigraphy
* confirmed heterogeneity by YACTA®
* disclosure of parallel channels through relevant interlobar fissures
* age \> 30 years
* stable COPD without exacerbation 8 weeks prior to screening
* dose of cortisone\< 20 mg prednisone or equivalent OCS
* non-smoker or ex-smoker who stopped smoking for at least 4 months prior to the screening visit
* current CoHb \< 2,5%

Exclusion Criteria:

* BMI \< 18 mg/kg2
* significant bronchiectasis with sputum production of 4 tablespoons/day
* 6-minute-walk distance \< 150 m
* myocardial infarction within 6 weeks prior screening visit
* decompensated heart failure
* cardiomyopathy with moderate or severe restricted LVF
* long-term medication with Clopidogrel
* status after lung resection (Lobectomy/Pneumonectomy)
* existing pregnancy
* female subjects of child-bearing potential without acceptable forms of contraception
Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the laser group will be compared to the improvement in the sham group.

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. There is a need for effective non-invasive treatment alternatives. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. Validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and follow up period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stress urinary incontinence
* sexually active
* at least one vaginal delivery

Exclusion Criteria:

* pelvic organ prolapse greater than stage I
* urgency or mixed UI
* infection
* previous gynaecologic surgery or irradiation
* refuse consent
Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy

The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal woman patient age 18-45 years
* Women with regular period
* Women with ovarian neoplasm (size: 3-10cm)
* Laparoscopic surgery required
* Body mass index 18.5-27.9kg/m2
* Subject able to comprehend and give informed consent for participation in this study
* Signed informed consent form

Exclusion Criteria:

* Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure
* The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free
* Women with Polycystic ovary syndrome
* Baseline AMH less than 0.5ng / mL
* Known to have participated in any other clinical trials or hormone therapy within 3 months
* Women during pregnancy and lactation
* Women in acute stage infection of reproductive system or other parts
* Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery
* Women with known or suspected poor compliance who cannot complete the trial
* Those who can not sign the informed consent
Using Combination of Synthetic Bone Substitutes During Extractions

The study was designed to assess the effectiveness of conservation ridge preservation (horizontal and vertical dimension) after tooth extraction with and without combination of bone substitutes based on synthetic (calcium sulfate mixed with phosphate.

Using the combination of these two bone substitute is taken in order to diminish the alveolar ridge alternations after tooth extraction. the investigator will measure the horizontal and vertical changes (primary outcome) and the adverse effects (secondary outcome)in 4 months period

Eligibility Criteria:
Inclusion Criteria:

1. Patients over age 18.
2. Patients who require extraction of teeth for Periodontal or other dental reasons (up one tooth in each quarter when there are existing adjacent teeth).

Exclusion Criteria:

1. Inability to pass informed consent procedure
2. Pregnant women
3. Breastfeeding women
4. Patient taking medications that affect bone metabolism such as bisphosphonates
5. Extractions sites contaminated
6. Smoking over 10 cigarettes a day
7. Patients with removable prostheses
Comparison of Hemodynamic Changes by Using the Videolaryngoscope and the Macintosh Laryngoscope

Tracheal intubation techniques that avoid or minimize pharyngolaryngeal stimulation might attenuate the hemodynamic stress response. Tracheal intubation using video laryngoscope needs comparatively less airway manipulation so, the investigators expect less hemodynamic response while using videolaryngoscope.

The hemodynamic stress response to tracheal intubation can precipitate adverse cardiovascular events in patients with cardiovascular disease. Which is shown to greatly increase the risk of myocardial infarction or stroke, especially in elderly patients with hypertension. Direct laryngoscopy and laryngoscopic stimulation of pharyngolaryngeal structures may be an important factor in the hemodynamic stress response associated with tracheal intubation.

Patients were randomly allocated to two groups using a permuted block randomization method: 1) patients intubated by using the videolaryngoscopy 2) patients intubated by using the Macintosh laryngoscope . SAP, MAP, and heart rate were measured and recorded in the operating room: At baseline, before intubation, immediately after intubation and 1,2,3,4 and 5 minutes after tracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status II-III,
* aged over 65 years,
* controlled hypertensive patients,
* scheduled for elective coronary artery bypass grafting.

Exclusion Criteria:

* American Society of Anesthesiologists Physical Status IV,
* ejection fraction \< 40%,
* any anatomical abnormality in head, neck or face,
* Mallampati score of IV,
* history of difficult intubation or laryngoscopy
Bloodpressure and NIRS During the Immediate Transition

Blood pressure will be measured in min. 5/10/15 after birth. Cerebral tissue oxygenation (crSO2) monitoring with NIRS in addition to routine arterial oxygen saturation (SpO2) monitoring with pulse oximetry will be performed continuously during the first 15 minutes after birth


Eligibility Criteria:
Inclusion Criteria:

Term and preterm neonates observed routinely immediately after birth at the resuscitation desk

* Decision to conduct full life support
* Written informed consent

Exclusion Criteria:

No decision to conduct full life support

* No written informed consent
* Congenital malformation
WithDRawal Impact Of Postoperative Beta-Blocker

The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.

Aim 1: The primary aim is to evaluate the impact of withdrawing BB on exercise capacity (peak oxygen consumption, VO2 max) in patients who underwent CABG. The investigators hypothesize that withdrawing BB 1 month after CABG will improve exercise capacity 2 months after CABG.

Aim 2: The secondary objectives are to evaluate the impact of withdrawing BB on a MACCE (major adverse cardiac and cerebrovascular event) and fatigue-related symptoms in patients who underwent CABG. The investigators hypothesize that withdrawing BB after CABG for 1 year will be non-inferior to continuing BB in terms of MACCE incidence.

Eligibility Criteria:
Inclusion Criteria:

* Participants who underwent coronary artery bypass graft(CABG) surgery at Yale New Haven Hospital who presented to 1-month postoperative visit
* ejection fraction \>50%, and in sinus rhythm at the time of hospital discharge or enrollment.

Exclusion Criteria:

* those who underwent combined valve + CABG surgery or aorta + CABG surgery.
Gut Microbiota Pilot Study

Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.

Microbiota is known to effect metabolism. Patients in specific conditions like hypovolemic shock, sepsis might have changes in status of microbiota. This is pilot study to get status of microbiota from normal control. Stable patient who are admitted to ICU for observation will be gathered. Samples will be collected via rectal swab at time of admission and analyzed via Next generation sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Older than 17 years old
* Every patients who are admitted to ICU

Exclusion Criteria:

* With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome
* With history of immunosuppressive agents.
* Initial systolic blood pressure \<100
* Initial pulse rate \> 100
* Need emergent operation at brain or torso
* Need vasopressor, transfusion
A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants 11 through \<15 years of age at the time of randomization.
* Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
* Available for the entire study period and can be reached by telephone.
* Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
* Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.

Exclusion Criteria:

* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
* History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
* Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
* Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).
Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer

This study is a retrospective study to compare the efficacy and safety between trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) with TAS-102 monotherapy in refractory metastatic colorectal cancer (mCRC) from November 2020 to October 2022 at the Hunan Cancer Hospital.

Our retrospective analysis was conducted to explore the efficacy and safety of patients treated with at least 1 cycle of TAS-102 with or without BEV in patients suffering refractory mCRC from November 2020 to October 2022 at the Hunan Cancer Hospital. Data from the electronic medical records were the sources. In TAS-102 monotherapy group, TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days were given to patients, while on days 1 and 15, every 28 days, patients received bevacizumab (5 mg /kg, intravenously) in TAS-102 plus BEV group. The median OS (mOS) was the primary end point.while mPFS, the ORR, the disease control rate(DCR) and the incidence of treatment-related adverse events (TRAEs) were the secondary end points.

Eligibility Criteria:
Inclusion Criteria:

* 1.Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).

  2. Have progressed from at least 2 lines of standard treatment,including fluoropyrimidines, irinotecan, oxaliplatin, with or without targeted drugs, like bevacizumab and cetuximab (only for RAS wild-type). Fruquintinib or regorafenib was permitted but not required for inclusion.

  3.Has measurable or non-measurable disease as defined by RECIST version 1.1 4.Is able to swallow oral tablets. 5.Estimated life expectancy ≥12 weeks. 6.Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 7. Has adequate organ function.

Exclusion Criteria:

* 1.Pregnancy, lactating female or possibility of becoming pregnant during the study.

  2.Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation).

  3.Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.

  4.Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection

Background: after resection of medulloblastoma in children they suffer from signs and symptoms of ataxia which impedes their activities of daily living. purpose: to investigate the effect motor imagery training on balance, severity of ataxia and gait parameters on children after resection of medulloblastoma. Methods: Fifty children surfing from cerebellar ataxia after medulloblastoma resection were selected from tumors hospital of Cairo University, their age ranged from seven to nine years old, they were randomly assigned into two matched control and study groups. The control groups received the selected physical therapy program while, the study group received motor imaginary training in addition to the selected physical therapy program. Both groups were evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by kinovea software.

Motor imagery is an effective method to enhance motor performance applied in rehabilitation programs it did not impose a physical load on patients, was confirmed through clinical evidence from meta#analysis. Motor imagery means thinking in motor task with executing it to activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by thinking.

Eligibility Criteria:
Inclusion Criteria:

* The children had signs of ataxia
* loss of balance
* able to understand and execute test instructions
* the children are in the follow up period after medulloblastoma resection

Exclusion Criteria:

* medically unstable
* visual impairment
* increased intracranial pressure
* any other neuromuscular diseases.
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs

Participation in one of the three interventions psychoeducation by professionals, psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate of patients with schizophrenia compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder (ICD-10)
* Age 18 to 67 years
* Hospitalised or treated in day care clinic

Exclusion Criteria:

* More than 12 months of hospitalisation within the last two years
* Substance-dependency (principal diagnosis)
* Mental retardation ICD-10 Chapter F70-79
* Fluency of German language not given