cyrilzakka/clinical-trials huggingface dataset:
Postoperative Adjuvant Chemotherapy in Early-stage Cervical Cancer That Not Meet Criteria of Adjuvant Therapeutic According to NCCN Guideline

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients who undergo radical surgery but do not meet criteria of adjuvant therapy according to NCCN guideline are enrolled to receive adjuvant chemotherapy. The primary endpoint was disease-free survival (DFS) rate at 3 year. The secondary endpoints were 5-year DFS, overall survival (OS) and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer.
2. The initial treatment was radical hysterectomy + pelvic lymphadenectomy by laparotomy or laparoscopy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
3. Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma.
4. Assessment of risk factors not meeting Sedlis criteria （NCCN guideline），but having one of following factors ：（1）Deep stromal infiltration（≥2/3 layer）；（2）histopathological differentiation grade G2 \~ G3；（3）Lymph-vascular space invasion ；（4）Adenocarcinoma or adenosquamous cell carcinoma；（5）Tumor size ≥2cm.
5. Age：18-70 years old.
6. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
7. Eastern Cooperative Oncology Group score 0-1.
8. Well-compliance and willing to keep in touch.
9. Willing to participate in this study, and sign the informed consent.

Exclusion Criteria:

1. Postoperative pathology has high-risk factors（lymph node metastasis, parametrial infiltration or positive surgical margin）or meets Sedlis criteria.
2. Participate in other clinical trials at the same time.
3. Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery.
4. Persons without disposing capacity.
5. Drug and/or alcohol abuse.
6. Unable or unwilling to sign informed consents.
7. Not eligible for the study judged by researchers.
A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic adrenal insufficiency
* Written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion Criteria:

* Participation in an interventional clinical trial
Teriparatide for Postsurgical Hypoparathyroidism

This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.

Transient hypoparathyroidism with hypocalcemia occurs in up to 20 % of patients after surgery for thyroid cancer, multinodular goiter or Graves' disease and is severe in around 3 to 18% of cases. Severe hypocalcemia significantly lengthens their hospital stay. This study will evaluate the effects of teriparatide (synthetic parathyroid hormone, brand name Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone.

This was a feasibility open-label, single-arm trial with historical matched controls with a planned enrollment of 15 patients with severe, symptomatic hypocalcemia that would be treated with teriparatide for a maximum duration of 3 weeks and compared the active subjects with 30 gender and age matched controls.

Therapy for hypocalcemia continued in accordance with current practice. The decision for discharge, as far as calcium is concerned, was to be reached when calcium level was \> 7.5 mg/dL and increased x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for IV calcium in the last 24 hours. Subjects were followed by phone and with blood tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide. They were off teriparatide for 24 hours prior to testing on days 9, 17 and 25.

If hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then discontinued. If hypocalcemia recurred again current standard therapy for hypoparathyroidism was continued off teriparatide.

Eligibility Criteria:
Inclusion criteria:

* Patients post bilateral thyroid bed surgery (cancer, Graves disease, multinodular goiter)
* Symptomatic hypocalcemia
* Total calcium \< 8 mg/dL persisting after 24 hours of therapy with calcitriol (minimum 0.25 mcg twice a day) and calcium supplementation (minimum 1.5 grams of elemental calcium per day)
* Parathyroid hormone (PTH) level below low end of normal range

Exclusion criteria (all subjects):

* Renal failure
* Any prior parathyroid pathology
* Pre-existing hypercalcemia
* Metabolic bone diseases other than osteoporosis
* Pagets disease

Exclusion criteria (active treatment subjects only):

* Ongoing therapy with Forteo for osteoporosis
* Active non-thyroidal malignancy or suspicion of residual thyroid malignancy
* History of skeletal malignancies, primary or metastatic
* Pregnancy
* Active or recent urolithiasis
* Digitalis therapy
* Patients at increased baseline risk for osteosarcoma, i.e., family history of osteosarcoma or prior radiation therapy involving the skeleton
* Pediatric populations
* Unexplained elevations of alkaline phosphatase
Evaluation of the Efficacy of Two Internet-based Self-help Interventions for Loneliness.

In this study, people who suffer from loneliness will be randomized to three study conditions. The first and second group get an account to an internet-based self-help intervention. The first group also receives weekly feedback from a coach and the second group receives an automated email on a weekly basis. The third group is a waiting control group. In all three conditions additional care or treatment is allowed. The aim of the study is to investigate the efficacy of an internet-based self-help intervention to reduce feelings of loneliness compared to a waiting list and the effect of support during the intervention. Assessments are at baseline, 5-week, 10-week, 6-months and 12-months post-randomization. Participants in the waiting control group get also access to the intervention and fill out questionnaires at baseline, 5-week and 10-week post-randomization and get also access to the intervention 10 weeks after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Sumscore ≥ 18 on the UCLA Loneliness Scale
* Signed Informed Consent
* Contact information provided in case of emergency
* Internet connection and device to use it (Smartphone, Computer, Tablet)
* Fluent in german language

Exclusion Criteria:

* Acute suicidality
* A current diagnose of substance dependence, a current or previous diagnose of psychotic disorder or bipolar disorder
* A current diagnosis of severe depression (PHQ-9 \> 14)
Intravascular ULTRAsound-Guided PCI in Patients With ST-Elevation Myocardial Infarction

The main goal of the ULTRA-STEMI trial is to investigate the prognostic impact of IVUS-guided PCI in patients with STEMI and correlate IVUS measurements with clinical, procedural, imaging and follow-up outcomes of interest.

Study participants will undergo primary PCI as per standardized procedures; IVUS will be performed at baseline, post-intervention and post-optimization. Manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT). Also, angiographic and peri-procedural data will be gathered. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least12 months for the adjudication of major adverse cardiovascular events.

The ULTRA-STEMI trial is a prospective investigator-initiated single-centre single-arm observational cohort study aiming to enroll 80 consecutive patients presenting with ST-segment elevation myocardial infarction (STEMI) and undergoing IVUS-guided primary PCI. IVUS will be performed at baseline, post-intervention and post-optimization. Baseline tissue characterization includes the morphological description of culprit lesion plaque and thrombus characteristics as assessed with IVUS. In patients with large thrombus burden, manual thrombus aspiration will be performed according to clinical indications. The aspirated thrombi will be collected and scanned with micro-computed tomography (micro-CT) to correlate IVUS measurements with micro-CT thrombus quantification. Also, angiographic data will be gathered to correlate IVUS measurements with pre-and post-PCI angiographic information. Post-PCI instantaneous wave-free ratio (IFR) will also be performed to assess the severity of the residual coronary-artery stenosis, if any. All patients will be followed up for at least 12 months for the adjudication of major adverse cardiovascular events.The primary endpoint will be target vessel failure at 12 months (defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization). The secondary outcomes of interest will be: radiation exposure, contrast use and kidney function effects. Other endpoints include clinical and angiographic outcomes along with post-PCI IVUS, iFR and micro-CT findings.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute STEMI undergoing primary PCI within 12 hours of symptom onset according to the 4th universal definition of myocardial infarction.
2. Age \>18 years
3. Individuals willing to voluntarily sign the consent and data protection forms before their inclusion in the clinical study.

Exclusion Criteria:

1. Patients presenting with cardiogenic shock
2. Patients with a known contraindication for primary PCI
3. Pregnancy
4. Presentation ≥12 hours after symptom onset
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons

This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count \<100 cells/mm3.


Eligibility Criteria:
Inclusion Criteria:

* CD4+ lymphocyte count \<100cells/mm3 at the screening visit.
* Documented history of HIV infections
* Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study.
* Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test).
* 3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
* 3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.

Exclusion Criteria:

* Kidney diseases.
* Liver diseases.
* Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir).
* Vomiting syndrome.
* Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation.
* Active AIDS-indicator conditions, as defined by CDC Category C.
* Other protocol inclusion and exclusion criteria to be evaluated by the research physician.
Methadone in Pediatric and Adult Sickle Cell Patients

To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 7 years and less than or equal to 40 years
* Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
* Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
* Admitted to the inpatient unit for further treatment
* Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

* Diagnosis of acute chest syndrome
* New focal neurologic findings or clinical concern of stroke
* Aplastic crisis with hemoglobin 2 g/dl below steady-state value
* Allergy to morphine or methadone
* Any other medical condition that the attending physician deems to be a contraindication to therapy
* Liver or renal insufficiency or failure, and congestive heart failure
Music Therapy For The Treatment Of Cisplatin Induced Tinnitus In Patients With rGCC: A Pilot Study

Pilot study evaluating the feasibility of recruitment, retention, and compliance to a modified Heidelberg Model of Neuro-Music Therapy (mHNMT) in patients with Cisplatin-induced Tinnitus and relapsed Germ Cell Cancer (rGCC).

This is a prospective, interventional pilot study that plans to enroll 15 patients who are receiving salvage high dose chemo and bone marrow transplant for relapsed Germ cell Cancer (rGCC). Patients will be asked to go through a series of surveys and screening procedures to determine eligibility. Once enrolled, patients will receive music therapy while they are being treated either inpatient or outpatient for their standard of care treatments.

Primary Objective To evaluate the feasibility of recruitment, retention, and compliance to a mHNMT in patients with CIT and rGCC admitted to BMT service to undergo salvage high-dose chemotherapy with tandem bone marrow rescue.

Secondary Objectives To estimate the effects of mHNMT on severity of CIT, associated distress, anxiety, depression, fatigue, benefit findings, sleep, and audiometry measures and assess number of times homework completed.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old at the time of informed consent.
2. English speaking.
3. Ability to provide written informed consent and HIPAA authorization
4. Confirmed diagnosis of CIT via a score on the TFI of 26 or greater.
5. Personal history of rGCC.
6. Previous exposure to cisplatin.
7. Admitted to BMT service to undergo HDC-tBMR for the first time. (Because this is a feasibility study, a minimum number of MT sessions will not be required).
8. Agrees not to receive music therapy outside of study.

Exclusion Criteria:

1. Severe hearing impairment greater than 60 dB HL in the region of the center tinnitus frequency
2. Patient's tinnitus can not be pitch matched.
3. Clinical diagnosis of severe mental disorder or psychiatric or neurological disease such as psychosis, epilepsy, Parkinson's disease, dementia, alcohol or drug abuse.
Motor Adaptation to Split-Belt Treadmill in Parkinson's Disease

Freezing of Gait (FOG) is a disabling symptom common in advanced Parkinson's Disease. FOG is an independent contributor to fall risk and is only partially relieved by medication. Parkinson's patients with FOG are known to have more difficulty with gait adaptation in their day to day environment. Further, asymmetry of gait has been implicated in FOG as these episodes are often elicited during asymmetric tasks such as turning. This study will examine the effect of a single session of split-belt treadmill walking on gait adaptation, gait symmetry and FOG as well as 24 hour retention of these effects.

In this proposal, the investigators will investigate whether adapting gait to modulations imposed by a split-belt treadmill, improves walking ability and reduces FOG. The investigators will test the hypothesis that motor adaptation deficits underlie FOG and that these problems are modifiable with training. To address these suppositions, the investigators propose a multi-centric study conducted in two research labs with expertise in split-belt gait analysis and FOG: University of Leuven (KUL) and Christian-Albrechts-University Kiel (CAUK). As freezers have been shown to have more difficulty with consolidation of motor learning, the investigators aim in study I (pilot phase) to first understand which split-belt parameters are optimal for training gait flexibility and lead to consolidated gains in daily walking. For this study, the investigators will recruit 60 freezers and 60 healthy controls, pooled across centers, and manipulate different split-belt conditions in one learning and retention session.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease as per the UK Parkinson's Disease Society Brain Bank Criteria
* Classification as a Freezer with the New Freezing of Gait Questionnaire (score \> 0)
* Ability to walk at least 5 min. without any aid
* Stable anti-parkinsonian medication at least 1 month prior to participation

Exclusion Criteria:

* Neurologic diseases other than PD
* Orthopedic injuries that could influence gait and balance
* Participation in treadmill training more than once a week
* Cognitive impairment (MMSE\<24) or inability to follow test instructions
* Self-reported DBS-related postural or gait disturbances
* Cardiovascular risk factors
* Peripheral neuropathy
Effects of Visual Reconstruction on Brain Function and Structure in Children With Congenital Cataract

Children have considerable plasticity of the visual system during the formation and maturation of various visual functions at different ages. Congenital cataracts are the leading cause of treatable blindness in children. With the continuous improvement of surgical approaches and surgical techniques, the success rate of congenital cataract surgery has been significantly improved clinically, and the visual function of children has been significantly improved after surgery. However, to date, there has been no experimental study of specific changes in the brain before and after surgery in children with congenital cataracts to explore its relationship with visual reconstruction. We aim to investigate the effects of congenital cataract surgery on the brain function and structure of children through preoperative and postoperative analysis and comparison of brain imaging such as BOLD-fMRI and DTI, and provide new ideas for the clinical treatment and prognostic assessment of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Children with congenital cataracts

Exclusion Criteria:

* Other oculo-cerebral and systemic diseases that may affect the outcome
Intraosseous Anesthesia Versus Mandibular Nerve Block in Children

The aim of the current study is to compare a new computerized intra-osseous injection system to the conventional inferior alveolar nerve block in children

Patients will be randomly allocated to one of the experimental groups.: Conventional (Inferior alveolar nerve block) and Computerized intraosseous anesthesia administration using the Quick Sleeper 5TM system (Dental Hi TecTM, Cholet, France). Both techniques will be performed by a single trained operator.

Articaine 4% with 1/200000 Adrenaline will be used for both techniques.

Eligibility Criteria:
Inclusion criteria

1. Children aging between 6-9 years with no history of previous local dental anesthesia experience.
2. American society of anesthesiologists score equal to or less than II
3. Lower 2nd primary molars requiring pulpotomy

Exclusion criteria:

1. American society of anesthesiologists Score more than II
2. Uncompliant, Uncooperative children
3. Children turning non-compliant during procedure
4. Patients taking analgesics and anti-inflammatory
5. Un-restorable teeth, teeth near exfoliation, teeth with gingival abscess/fistula, pathological mobility, pain on percussion, radiographic evidence of internal or external pathological root resorption, periapical/furcation radio-lucencies, widened periodontal membrane space.
Effect of Esketamine on 95% Induction Dose of Remimazolam

As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.

Children aged 3-12 who underwent gastroscopy were randomly divided into two groups: L group with Esketamine 0.25mg/kg and the initial dose of Remimazolam was 0.3mg/kg ,M group with Esketamine 0.5mg/kg and the initial dose of Remimazolam was 0.2mg/kg.Judging whether the sedation level of the children can meet the requirements of gastroscopy placement after injecting Remimazolam.The next dose was adjusted to 0.05mg/kg according to biased coin design,to further explore the induced dose of ED95 of Remimazolam under the background of different doses of Esketamine.

Eligibility Criteria:
Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II#;
2. aged 3#12 years#;
3. children with weight for age within the normal range#;
4. were scheduled to have a gastroscopy;

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam and esketamine;
3. recently respiratory infection, mental disorder;
4. other reasons that researchers hold it is not appropriate to participate in this trial.
Perceptions of the Annual Review of Competence Progression (ARCP) in Surgical Training in the UK and Ireland

A Prospective Cross Sectional Questionnaire Study was conducted to evaluate surgical trainees' experiences of the ARCP process in order to identify areas for improvement.

Background: Surgical trainees in the UK and Ireland undergo rigorous formative and summative assessments throughout each placement and appraisal at an Annual Review of Competence Progression (ARCP). The ARCP evaluates performance during each training year and determines progression to the next year of training. It is critical that the ARCP is a robust and fair process. The Association of Surgeons in Training (ASiT) sought to evaluate surgical trainees' experiences of the ARCP process in order to identify areas for improvement.

Methods: A Prospective Cross-Sectional Questionnaire Study was conducted An electronic survey was developed and distributed electronically to the trainee membership of ASiT in the UK and Republic of Ireland. A 57 point survey examined the specifics of one ARCP cycle as well as attitudes to the process in general. Quantitative analysis was performed, along with thematic analysis on the free-text comments.

Eligibility Criteria:
Inclusion Criteria:

* Must be a trainee member of ASiT
* All grades, Deaneries, including less than full-time/academic trainees are eligible for inclusion

Exclusion Criteria:

• Student members are excluded