cyrilzakka/clinical-trials huggingface dataset:
Study of Anlotinib in Patients With Small Cell Lung Cancer (ALTER1202)

To compare the effects and safety of Anlotinib with placebo in patients with small cell lung cancer(SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of small cell lung cancer
* Advanced small cell lung cancer who had at least two chemotherapy regimens,at least one measurable lesion (by RECIST1.1)
* 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients who have been used anlotinib
* Patients who have been used targeted drugs(such as sunitinib,bevacizumab,endostar),Immune targeted drugs
* 4 weeks or less from the last cytotoxic therapy, radiation therapy or surgery
* Patients whose primary lesion with active bleeding within 4 months
* Carcinomatous meningitis
* Patients who known to the central nervous system
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Patients with any severe and/or unable to control diseases，including：

  1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
  2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥450ms(male),QTc≥470ms（female）) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
  3. Patients with active or unable to control serious infections;
  4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
  5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)\>10mmol/L)
  6. Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed;
* Patients with non-healing wounds or fractures
* Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis

The purpose of this study is to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.

This study is a Phase 2, randomized, double-blind,placebo controlled, parallel group study to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.
* Ages at ≥18 and ≤ 65 years.
* The diagnosis of atopic dermatitis will be confirmed according to the criteria of Hanifin and Rajka at the Screening Visit and Have a clinical diagnosis of atopic dermatitis for at least 6 months.
* Have an Investigator's Global Assessment (IGA) score of 2, or3 at screening and at baseline.
* Have atopic dermatitis on the head (excluding hair-bearing scalp), neck, trunk, or limbs, covering at least 2% of total BSA and up to and including 20% of total BSA at Screening and at baseline.

Exclusion Criteria:

* Subjects with other dermatologic disease besides AD whose presence or treatments could interfere the assessment of disease (eg, psoriasis).
* In the opinion of the investigator, have any clinically significant laboratory abnormality that would affect the participant's participation in the study.
* Use of topical treatments for AD within 2 weeks of baseline.
* Vaccinated or exposed to a live or attenuated vaccine within the 12 weeks of baseline, or is expected to be vaccinated these vaccines during treatment.
* A history of alcohol or substance abuse within 12 months prior to Screening that in the opinion of the investigator will preclude participation in the study.
Constrictive Pericarditis in the Adult Congenital Cardiac Population

The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis

The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.

Constrictive pericarditis is a notoriously difficult diagnosis to reach. There are no signs, symptoms or pathognomonic diagnostic tests for pericardial constriction. In the adult congenital patients, it is also difficult. In addition, with pulmonary insufficiency, constrictive pericarditis may mask the findings of progressive right sided ventricular dilation and heart failure.

The primary aim of this study is to determine the clinical and radiographic findings with constrictive pericarditis in the adult congenital population and determine the degree of right heart failure and dilation from pulmonary insufficiency in the presence of constrictive pericarditis

The secondary aim is to elucidate ways to better diagnose constrictive pericarditis and elucidate ways to diagnose right heart failure in the presence of constrictive pericarditis.

Study Design and Methodology:

Retrospective chart review - approximately 15 patients

Preoperative data:

ECHO and cath findings

Operative data:

Operative findings

Postoperative data:

ECHO and cath findings

Eligibility Criteria:
Inclusion Criteria:

* patients in the adult congenital heart disease clinic who have been diagnosed or operated on with constrictive pericarditis

Exclusion Criteria:

* those who do not meet the inclusion criteria
Development of a Judo Specific Reactive Agility Test: a Reliability and Validity Study

Primary aim of this study is to develop a new reactive agility test spesific for Judokas and evaluate it's validity and reliability. Secondary aim is the investigation of relationship between reactive agility performance score and some of the physical fitness parameter scores related to health and performance.


Eligibility Criteria:
Inclusion Criteria:

* Active judo training of minimum 300 minutes in a week.
* At least 3 years of Judo experiance
* No acute injury or illness that prevents judo training
* No use of drug or medicine that can/may affect noromusculer control

Exclusion Criteria:

* Major trauma in 6 months prior to study
* Judokas that can't complete the test properly
Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2066

The study is carried out in order to determine the relationship between AZD2066 exposure and mGluR5 receptor occupancy in the brain and to demonstrate that AZD2066 can displace \[11C\]AZ12713580 from mGluR5 binding-sites in the Central Nervous System


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* BMI (Body Mass Index) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg
* Normal MRI (Magnetic Resonance Imaging) scan at visit 2

Exclusion Criteria:

* History of previous or ongoing psychiatric disease or condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
* History of psychotic disorder among first degree relatives (parents, siblings)
* History of use of antipsychotic, antidepressant or anxiolytic (anxiety treatment) drugs, prescribed or non-prescribed use. History of antidepressants or anxiolytics for non-psychiatric conditions such as pain or post-operative insomnia is allowed
Unilateral Versus Bilateral TLIF for Degenerative Lumbar Spondylolisthesis

A prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(TLIF) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis

Traditionally many spine surgeons prefer single level TLIF surgery via bilateral facetectomy for increasing union rate. Our hypothesis - "Single level TLIF via unilateral facetectomy is sufficient for achieve successful fusion rate"

Eligibility Criteria:
Inclusion Criteria:

* lumbar degenerative spondylolisthesis
* indicated for surgery

Exclusion Criteria:

* not agreed for the study
Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates

Burnout Syndrome is a medical condition caused by long-term job-related strain and is defined by presence of either one or more of the three states i.e. emotional exhaustion, depersonalization and lack of personal accomplishment. Burnout has been shown to cause decreased work output and mental well being of employees and increase errors at workplace. Burnout is observed in various lines of work and but has been found to be especially high among academic students undertaking professional studies as well as healthcare professionals. Medical students in their clerkship years undergo high stake exams, while adapting from classroom and simulation learning to participate in clinical care of patients in hospital care setting with no prior experience, which much them vulnerable to developing burnout during medical school. Burnout can effect medical students' well-being, which may continue into their internship and residency so greater emphasis in required on creating an awareness of burnout and identifying any factors associated to its development.

Burnout syndrome can develop after a prolonged response to chronic emotional and interpersonal workplace stressors, and is defined by 3 dimensions - emotional exhaustion, depersonalization and lack of personal accomplishment. Burnout syndrome can be prevalent in up to half the medical students and those studies have suggested poor mental health among them. Various external and internal factors may contribute to burnout in medical students and little is known about the impact and mechanism of these factors in developing burnout. Burnout can develop, persist or worsen in residency years and it has been found to frequent among Diabetes specialty residents in United Kingdom as well in Emirati medical residents. Burnout can affect overall wellbeing of medical students with health consequences as well as poor work engagement/ educational outcomes.

To the best of authors knowledge no data exists on burnout in undergraduate medical students in clinical years (clerkship) in United Arab Emirates

Eligibility Criteria:
Inclusion Criteria:

1. Medical students (5th and 6th year) of college of medicine and health sciences in United Arab Emirates University
2. Currently attending the college, not on sick leave or long-term absence.
3. Agreed to participate after Informed consent

Exclusion Criteria:

Self-reported presence of active mental health illness or current treatment.
Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake

The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing melphalan autologous transplants will be included in this study
* All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
* Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
* Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.

Exclusion Criteria:

* Patients \<18 years of age
* Pregnant women
* Prisoners
* Patient unable to provide informed consent.
Liver Transplant Does it Affect the Brain

Neuronal damage caused by neuroinflammation in patients undergoing major surgery is the most determinant factor of postoperative cognitive disfunction (POCD). Neuronal damage can be detected through the measurement of biochemical markers of brain damage. The aim of this study was to evaluate neuronal damage and its association with POCD during liver transplantations. After the approval of the ethics committee and patient consents, preoperative and postoperative cognitive functions of 33 patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels. As a result, there was no statistically significant difference between preoperative and postoperative MMTs. However, there was a statistically significant decrease in postoperative GFAP and a statistically significant increase in NSE compared to preoperative values. The decrease in S100β level was statistically insignificant. In conclusion, neuroprotective approaches in the investigator's anesthesia protocol protect patients from brain damage during liver transplantation and prevent the development of POCD, which was indicated by the insignificant change in MMT scores and S100β level and the significant decrease in GFAP. Since the significant increase in NSE levels during liver transplantations was deemed to might have been associated with causes other than neuronal damage, NSE should not be evaluated as a marker of brain damage in these operations.


Eligibility Criteria:
Inclusion Criteria:

* Score of 23 or above on the Mini Mental Test (MMT) conducted in the preparation room prior to the operation,
* No gastrointestinal bleeding in the last 1 month
* No history of neuroactive drug use
* Consented for the study.

Exclusion Criteria:

* Hepatic encephalopathy,
* Neurological disorder
* Psychiatric disorder,
Theta Burst Study Ghent

50 Right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be treated with in total 20 Theta burst sessions; these will be spread over 4 days. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes. Patients will be selected using the structured Mini-International Neuropsychiatric Interview (MINI). All will be at least stage I treatment resistant. Because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. Only habitual benzodiazepine agents will be allowed.

All patients will be closely matched for gender and age with 50 never-depressed medication-free healthy volunteers. Only baseline measurements will be collected: no volunteer will undergo the treatment.

We expect that real Theta burst treatment and not sham will result in a significant and clinical meaningful response.


Eligibility Criteria:
Inclusion Criteria:

* antidepressant-free unipolar depression
* age between 18 and 65 years
* right handed
* at least stage I treatment resistant

Exclusion Criteria:

* current or past history of epilepsy, neurosurgical interventions, having a pacemaker or metal or magnetic objects in the brain, alcohol dependence and suicide attempts within 6 months before the start of the study.
A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers

This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion Criteria:

* Scheduled to receive another vaccine during study period
* History of H5 influenza infection or received H5 influenza vaccine
* Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
* History of seizures
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease

This is an open-label, prospective post marketing surveillance study to be performed in Sweden. Only data of patients idiopathic PD should be documented, in whom the treating physician plans to initiate a pharmacotherapy with PPX ER independent of this observational study. The questionnaires (Morisky Medication Adherence Measure, patient preference scale, CGI-I, PGI-I) will be used to document routine care in a standardized way and thus ensure high validity of the observational data. As the degree medication adherence of patients is routinely evaluated by their physicians, as is patient preference and possible symptom improvement after initiation of a new therapy, the patient questionnaires will be used to standardise medical routine care and to ensure validity of observational data.


Eligibility Criteria:
Inclusion criteria:

1. Patients suffering from idiopathic PD who before inclusion into the observation had been planned to be treated with PPX ER according to the SP, and where decision of treatment was made independently of the patients¿ inclusion into this observational study
2. Stable dose of PPX IR for at least 4 weeks before inclusion into the observation
3. Male or female PD patients aged at least 30
4. Ability to reliably complete self-rating scales (Morisky Medication Adherence Measure, patient preference scale) according to the physician¿s judgement
5. Written informed consent by the patient for study participation.

Exclusion criteria:

1. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems) according to the physician¿s judgement.
2. Any contraindications against PPX ER according to the Summary of Product Characteristics (SPC).
Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term

Oral disorders are currently widely described in the premature birth population, but few studies compare them to their prevalence in the full-term population.

In addition, new behaviours and eating habits are regularly emerging in our society.

The objective of this study is to compare the severity of signs of oral disorders between the group of preterm infants and the group of term infants born without organic pathologies that compromise oral development.


Eligibility Criteria:
Inclusion Criteria:

* Children whose age ≥ 24 months and ≤ 36 months
* Full-term or prematurely born (\<33 SA) at Nice University Hospital

Exclusion Criteria:

* Children with congenital pathologies (with malformations in the oro-facial sphere)
* Children with neurological and developmental pathologies unrelated to prematurity
* Children with ENT deformities
* Parental langage barrier
A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects

This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
2. Subjects with a body Mass Index (BMI) from 18.5 to less than 25.0 and a body weight of 40.0 kg or over at the screening test
3. Subjects who are judged by the principal investigators or subinvestigators as an eligible for the clinical trial participation based on the results of tests conducted in the screening, VISIT 1 and prior to the administration of the investigational drug.

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2. Subjects who have any unsuitable medical histories for participation in this clinical trial, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
3. Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.

Other protocol defined exclusion criteria could apply.