cyrilzakka/clinical-trials huggingface dataset:
The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined.

This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed.

This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.


Eligibility Criteria:
Inclusion Criteria:

* Early stage endometrial cancer scheduled for SLN procedure
* Early stage cervical cancer scheduled for SLN procedure
* Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis
* Presence of lymph nodes metastasis (macrometastasis or low volume disease \[micrometastasis and isolated tumor cells\])

Exclusion Criteria:

* Previous (\<5 years) or concomitant malignancy other than non-melanoma skin cancer
* Advanced/metastatic endometrial cancer
* Locally advanced/metastatic cervical cancer
Analysis the Vocs in Upper GI Bleeding Patients

This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria.

Upper gastrointestinal bleeding is one of the most common gastrointestinal emergencies and has a high mortality rate. Its clinical manifestations are hematemesis and melena, gastroscopy is the gold standard for diagnosing upper gastrointestinal bleeding, but due to its expensive equipment, long training cycle of personnel, gastroscopy itself is an invasive operation, poor patient tolerance, high risk of examination, often lead to the diagnosis of upper gastrointestinal bleeding is not timely, missing the best treatment time. Volatile organic compound analysis in exhalation is based on the patient's metabolic component analysis technology, a new means of disease diagnosis, due to its advantages of convenient collection, non-invasive, rapid detection, etc., it has been applied in the diagnosis of various diseases such as drunken screening and Helicobacter pylori infection, but has not been studied in the diagnosis of upper gastrointestinal bleeding. This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria. This study will improve the timeliness of upper GI bleeding detection, which is of great significance for effectively reducing the mortality rate of upper GI bleeding.

Eligibility Criteria:
Inclusion Criteria: upper GI bleeding patients -

Exclusion Criteria: Severe cardiopulmonary disease

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Comparison of Early and Late Therapy for Adults With Operatively Treated Distal Radius Fractures

The purpose of the study is to compare two common ways of rehabilitating after surgery for distal radius fractures treated operatively with a volar plate.

Over the last three decades, operative treatment of distal radius fractures has become increasingly common compared to non-operative treatment. Over the last 15 years there has been a trend towards more invasive, internal plate fixation of fractures of the distal radius. One argument in favor of internal fixation for these fractures is that, similar to other periarticular fractures, it would be beneficial to allow early movement of the wrist articulation. There is not, however, any data to support this statement. In fact, data regarding external fixation that either immobilizes the wrist or allows wrist motion suggest that early wrist mobilization is not as important as the overall alignment of the bone in terms of final wrist motion. This question is important in patient care and in decision-making regarding these fractures. Additionally, many companies use this claim as a marketing point in spite of the lack of evidence. We consider that good quality data is needed to determine the answer to this issue and to help to resolve the related problems described above.

Eligibility Criteria:
Inclusion Criteria:

* Gender: Male or female
* Age: Older than 18
* Isolated distal radial fracture
* Fracture treated with volar plates, stable fixation
* Initial treatment within 4 weeks of trauma

Exclusion Criteria:

* Complex fractures that require additional or different material than volar plates
* Unstable fractures in which early mobilization is contraindicated
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects

In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides \< 200 mg /dL while maintaining virologic suppression.


Eligibility Criteria:
Inclusion Criteria:

* fasting triglycerides \>= 200 mg/dL but \<1,200 mg/dL
* fasting LDL \<= 160 mg/dL
* participation in a lipid-lowering diet and exercise program for at least 28 days
* treatment with stable HAART consisting of first or second RTV-boosted PI regimen plus optimized background ART for at least 3 months
* plasma HIV-1 RNA \<50 copies/mL
* CD4+ cell count \>50 cells/mm3
* male subjection testosterone replacement therapy with total testosterone level \<= 1 x upper limit of normal
* female study volunteer must use a form of contraception
* ability and willing ness to give written informed consent

Exclusion Criteria:

* any Grade 4 laboratory abnormality
* currently taking amprenavir or fosamprenavir
* required a second RTV-boosted PI for reasons of virologic failure
* atherosclerotic disease risk
* congestive heart failure (NYHA Class III or IV)
* uncontrolled hypertension
* history of pancreatitis
* active bleeding disorder
* recent history of significant renal, pulmonary, biliary, hepatic or gastrointestinal disease
* current diabetes mellitus requiring pharmacological treatment
* use of systemic cancer chemotherapy; active cancer
* pregnancy or breast-feeding
* requirement for any lipid-lowering agent after baseline
* use of hormonal anabolic therapies, systemic steroids, immune modulators
* use of anticoagulants, investigational antiretroviral drugs
* allergy to study drugs
* active CDC clinical category C event
Brain Metastasis Development Mechanism in BCBM Patients

This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Brain metastasis curative surgery patient

Exclusion Criteria:

* Gamma Knife surgery patient
Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers

Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG (electrocardiogram) in comparison to placebo


Eligibility Criteria:
Inclusion Criteria:

All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or clinically relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day for males and \> 20 g/day for females)
* Drug abuse
* Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the reference range if indicative of underlying disease or poor health
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes
* Previous tendon disease related to quinolone treatment
* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias
* Pulse rate at screening of \> 80 bpm or \< 45 bpm
* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR (Pulse rate) interval \> 220 ms, QRS interval \> 115 ms, QTcB \> 450 ms, or QT (uncorrected) \> 470 ms

For Female Subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients

Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms.

Psychoeducation can improve therapeutic alliance and medication compliance.

In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation.

The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Patient with a diagnosed and reported schizophrenic disorder announced :

  * Schizophrenia
  * Schizoaffective disorder
* Or a diagnosed and reported Delusional Disorder
* Express written consent by the participant after receiving information about the study
* Be able to communicate verbally
* Participant affiliated to a social security scheme

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Patient who does not speak French
* Participation in a psycho-education group in the last 2 years
* Patient under legal protection or guardianship
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Surgeon trained in and performing the HIPEC procedure

Exclusion Criteria:

* Not performing the HIPEC procedure
Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

The purpose of this study is to compare the number of responders to vaccination with the influenza virus vaccine at different time points after last dose of rituximab in patients with lymphoma. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with non-Hodgkin's lymphoma, treated with rituximab (with a range of 6-12 cycles) and who are in remission.
2. Completion of rituximab therapy in the last twelve months before start of the study.
3. Age ≥ 18 years.
4. Signing of informed consent.

Exclusion Criteria:

1. Completion of rituximab therapy 7-8 months before start of the study.
2. Fever at time of vaccination.
3. Previous/known allergic reaction to any of the components of the vaccines given.
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

1. At least one hypersensitive tooth in everyday life after PAV 1 in-office visit
2. At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit
3. At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry
4. Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root
5. For subjects entering the study at stage PAR-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery
6. Age ≥ 18 years and ≤ 75 years
7. Willing and able to attend the on-study visits
8. Willing and able to understand and to follow the study procedures and instructions
9. Good oral hygiene throughout the study
10. Written informed consent before participation in the study
11. Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)

Exclusion Criteria:

1. Hypersensitivity only due to sweets
2. Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate
3. Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months
4. Chronic systemic anti-inflammatory and analgesic medications
5. Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.)
6. Teeth or supporting structures with any other painful pathology or defect
7. Subject with poor health conditions
8. Concurrent participation in another clinical trial
9. Pregnant or lactating women
Effect of Spinal or Sevoflurane Anesthesia on Neutrophil Activation During Knee Surgery With Pneumatic Tourniquet

Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated with tourniquet use for total knee arthroplasty. This activation was compared in a group of patient scheduled for spinal anesthesia and for sevoflurane anesthesia

Aim of study : Assessement of neutrophil activation during ischemia reperfusion associated with tourniquet use for total knee arthroplasty. This activation was compared in a group of patient scheduled for spinal anesthesia and for sevoflurane anesthesia This activation was assessed by plasma myeloperoxidase and elastase measurements in four consecutive blood samples during and after surgery (before surgical incision and 1, 3, 24 hours following tourniquet release.

Eligibility Criteria:
Inclusion Criteria:

* Total knee arthroplasty under spinal or sevoflurane anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists class 3 and 4
* vascular disease of the lower limbs
* cardiac or respiratory disease
* immune disorder
Group Therapy for Depressed Dementia Caregivers

Depression in family caregivers of relatives with Alzheimer's Disorder and related dementias is a serious public health problem. This is a randomized, controlled, single-blind pilot clinical trial of depressed caregivers, to determine the efficacy and mechanisms of group therapy for depressed dementia caregivers.

The trial was designed to measure clinical outcomes including depressive symptoms and other secondary outcomes of caregivers of persons living with dementia. It also included magnetic resonance imagery scanning at baseline (prior to study group) and post group to identify candidate mechanisms of effects.

Notes related to outcome measurement. On 05.10.2017 (prior to participant enrollment), all secondary outcomes were approved by the UCSF IRB #16-20163. It was noted in the IRB that the primary outcome timepoint was to be obtained 4 weeks after the first group session. Due to magnetic resonance imaging scanning scheduling constraints, which occurred at the same time as the 4 weeks visit, the outcome could not be exactly four weeks post the first group session but was collected approximately at this time.

On 05.10.2017 (prior to participant enrollment), three-month post group secondary outcomes were also approved.

Eligibility Criteria:
Inclusion Criteria:

Endorse clinically relevant baseline depressive symptoms Primary caregiver for a relative with dementia

Exclusion Criteria:

Age \< 45 Meditation / guided imagery practice more than twice per week Ideas of harming relative with dementia Current violence towards relative with dementia Adult Protective Services report on file Primary psychiatric disorder other than unipolar major depression Cognitive impairment on the part of the caregiver (Mini Mental State Examination score less than 24) Unstable medical illness Planned surgery Active drug or alcohol abuse Inability to understand written and oral English.
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)

This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female premenopausal subjects
* Age: 18 to 35 years (inclusive)
* Body mass index (BMI) : ≥18 and ≤30 kg/m²
* Non-smoker for 3 months (former smokers who quit smoking \>3 months before the first study drug administration may be included)

Exclusion Criteria:

* Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
* presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis

The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria

  * GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status.
  * EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline.
* Candidates for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control during the study
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* History of drug-induced psoriasis
* Concurrent or recent use of any biologic agent
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
* Have previously received ixekizumab
* Serious disorder or illness other than psoriasis
* Serious infection within the last 12 weeks
* Breastfeeding or nursing (lactating) women
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.


Eligibility Criteria:
Inclusion Criteria:

* Japanese
* Outpatient with hypercholesterolemia
* Female participant who is of reproductive potential has to agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
* Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion Criteria:

* Uncontrolled hypertension (treated or untreated)
* Uncontrolled type 1 or type 2 diabetes mellitus
* Homozygous Familial Hypercholesterolemia or has undergone low-density lipoprotein (LDL) apheresis
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption
* History of cancer within the past 5 years (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer)
* Human Immunodeficiency Virus (HIV) positive
* History of drug/alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
* Consumes more than 25 g of alcohol per day
* Currently following an excessive weight reduction diet
* Currently engages in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
* Hypersensitivity or intolerance to Ezetimibe or Rosuvastatin
* Myopathy or rhabdomyolysis with Ezetimibe or any statin
* Pregnant or lactating
* Taking any other investigational drugs and/or has taken any investigational drugs within 30 days
Adductor Strength in Athletes Suffering a Groin Injury

assess the difference in adductor peak strength evaluated with different instruments. Hand held dynamometer vs force frame

This study aims to compare the difference in adductor strength output performed by athletes suffering a groin injury between two different assessment methods. Previous studies have observed that add strength differs depending on the evaluation method. Isometric strength can be measured with hand held dynamometer or with force plates (forceframe). Wether one method is better in order to differenciate adductor strength between healthy and injured limb is not known to date.

Eligibility Criteria:
Inclusion Criteria:

* Suffer a groin injury during the assessment period
* Accept participating in the study

Exclusion Criteria:

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