cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy

Laparoscopic operative procedures have revolutionized gynecological surgery. These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. Trigger point injection removes the pain developing point and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin. An literature showed that patch of local anesthetics showed the effect of trigger point inject. The purpose of this study is to investigate the alleviation of shoulder pain, headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying on shoulder in patients undergoing total laparoscopic hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I or II
* age 20\~70
* patients undergoing total laparoscopic hysterectomy

Exclusion Criteria:

* history of shoulder surgery
* coagulopathy
* infection or trauma of shoulder
* general inflammation
* allergy to local anesthetics
Study on the Visual Condition in Parkinson's Disease

Non motor symptoms and signs in Parkinson's disease (PD) also include a series of visual deficits; deepening these aspects could be useful for a better management of symptoms, to standardize a specific protocol for the issues related to vision and also to understand how these aspects are important for the understanding of the mechanisms underlying the PD.

In Parkinson's disease (PD) several non-motor signs and symptoms already occur in the early stages of the disease; the symptoms are diverse and these also involve visual difficulties which commonly affect the majority of patients and which gradually worsen the quality of life.

The most common malfunction produced by PD is the dysfunction of dopaminergic pathways that may be responsible for a series of visual deficits too:

* decreased visual acuity and decreased sensibility to light and color,
* strabismus and forms of sensory and eye movement dysfunctions,
* eyelid dysfunctions and dry eye syndrome

Moreover, in patients affected by PD, typical retinal features were discovered for the first time in 2004 by the use of OCT (Optical Coherence Tomography) such as:

* the reduction of the retinal nerve fiber layer (RNFL)
* a typical thinning of the macular thickness, even if with different results. In the follow-up of the PD, these retinal features, verifiable by the use of OCT, could be considered as a marker of the pathology.

For these reasons it may be useful:

* quantify in an objective manner how much the visual aspects affect the overall deterioration of the quality of life in patients with PD
* demonstrate the validity of a specific and integrated outpatient diagnostic protocol for the study of visual and ophthalmological disorders in patients with PD
* demonstrate the diagnostic role of early changes in macular thickness and of the optic disc in subjects suffering from PD using the OCT
* establish orthoptic evidence in patients with PD

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients affected by Parkinson's disease (PD) according to the diagnostic criteria of the United Kingdom Brain Bank, in the ON phase of their usual treatment
* Hoehn-Yahr Stage from 1 to 3
* Signature of the Informed Consent and of the privacy form

Exclusion Criteria:

* Patients with symptoms and signs compatible with atypical parkinsonism
* PD patients treated with antagonist drugs for central dopaminergic receptors (first and second generation antipsychotics) in the last 6 months before enrollment
* Patients suffering from other neurological diseases
* Patients with evident cognitive impairment (MMSE \<24/30)
* Patients with manifest eye movement disorders prior to the diagnosis of PD.
* Patients with daltonism
* Patients with amblyopia
* Patients suffering from high anisometropia
* Patients suffering from advanced cataracts
* Patients suffering from glaucoma
* Patients suffering from maculopathy
* Patients suffering from pathologies of the optic nerve
* Patients with severe visual field deficits
* Patients with refractive defects above 5 diopters
A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms

Phase I, multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation.

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation. The first stage of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL-306 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second stage of the study is a dose expansion phase where three cohorts of patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* Signed Informed Consent Form;
* Relapsed/refractory Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia(CMML) and others myeloid neoplasm;
* IDH1 and/or IDH2 mutated disease status as assessed by local laboratory;
* Cooperative Oncology Group (ECOG) performance status of 0-2;
* Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.

Exclusion Criteria:

* Previously treated with any prior IDH1 inhibitor, IDH2 inhibitor, or IDH1/IDH2 double-targeted therapy and had disease progression during treatment;
* with known involvement or clinical symptoms of central nervous system (CNS);
* Patients who have undergone HSCT within 60 days;
* Without adequate liver or kidney function;
* With known infection with active hepatitis B or C;
* With known infection with human immunodeficiency virus (HIV);
* History of clinically significant or active cardiac disease;
* Active clinically significant infection;
* Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors;
* Pregnancy or breast-feeding.
A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza

Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Positive Influenza rapid antigen test;
* Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours;
* At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection:

  1. Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;
  2. Respiratory system symptoms: cough, sore throat, nasal congestion.
* Time of disease symptoms ≤48h

Exclusion Criteria:

* Diagnosed as severe influenza patient ;
* Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach After subtotal resection, etc.);
* Have used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir dipivoxil, amantadine, or diamond) within 2 weeks before screening Ethylamine, etc.);
* Acute respiratory infections, otitis media, sinusitis or other infectious diseases such as bronchitis, pneumonia, tuberculosis, etc. occurred within 2 weeks before screening, and are in the acute stage;
* Patients who also suffer from bacterial or viral infections and need systemic antibacterial or antiviral therapy
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.

OBJECTIVES: I. Evaluate the efficacy of MCE (mitoxantrone/cytarabine/etoposide) followed by granulocyte colony-stimulating factor to mobilize peripheral blood stem cells (PBSC) in patients with chronic myeloid leukemia (CML). II. Evaluate the toxicity of this regimen. III. Evaluate the cytoreductive effects of this regimen in CML as determined by the ability to mobilize Philadelphia chromosome-negative PBSC. IV. Assess the time of peak CD34+ and CD34+/CD38- cell concentrations in the peripheral blood of patients treated with this regimen.

OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 DHAD Mitoxantrone, NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor (source not specified) HU Hydroxyurea, NSC-32065 MCE DHAD/ARA-C/VP-16 VP-16 Etoposide, NSC-141540 Single-Agent Cytoreduction followed by 3-Drug Combination Chemotherapy/Stem Cell Mobilization. HU; followed by MCE; G-CSF.

PROJECTED ACCRUAL: 30 patients will be entered over 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic or accelerated phase Ineligible for allograft protocols or no available HLA-matched sibling marrow donor No patients under age 55 who have consented to unrelated donor search unless: Search unsuccessful for 6 months and unlikely a donor will be found Transplant from an unrelated donor declined No history of CML blast crisis No grade III/IV myelofibrosis

PATIENT CHARACTERISTICS: Age: Over 17 to under 66 Performance status: Not specified Life expectancy: No limitations from disease other than leukemia Other: No hepatic, renal, pulmonary, or cardiac dysfunction that would preclude transplant preparative regimen No HIV antibody No active infection

PRIOR CONCURRENT THERAPY: At least 1 month since interferon
Multi-component HIV Intervention Packages for Chinese Men Who Have Sex With Men -Test, Link and Care (TLC)

1. The number of MSM who are tested for HIV in the 4 study clinics over 12 months will increase compared with historical data from the same 4 clinics over the past 12 months prior to the intervention.
2. Persons diagnosed with HIV over the duration of 12 months will have higher CD4 counts at diagnosis than persons diagnosed with HIV over the past 12 months prior to the intervention


Eligibility Criteria:
Inclusion Criteria:• Men who had sex with another man in the last 12 months based on self-reporting (sex can be defined as oral, anal, or mutual masturbation)(including transgendered women)（including transgendered women）;

* Aged 18 years or older;
* Living and/or working in the defined districts of municipal Beijing;
* Able and willing to adequately grant informed consent. For the purposes of this activity participants must consent to questionnaire surveys, receipt of phone messages, and serological testing;
* Having not previously participated in HIV testing in this study.

Besides these criteria, additional criteria for the HIV Linkage and Care pilot Research Clinical Trial are:

* Men who are being identified as HIV positive during the testing campaign in Phase I of the study;
* No plan to leave Beijing in the next 12 months.
* Willing to comply with study procedures.
* Having a cell phone and willing to receive study related SMS texts

Exclusion Criteria:

Having previously been found to be HIV positive based on self-reporting during eligibility screening;

* Serious psychological disturbance or cognitive impairment interfering with the participant's ability to comply with the study visit schedule and procedures, as judged by the local study clinician;
* Any other medical or psychiatric condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere substantially with the study objectives or interpretation.
Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert

The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not greater than 6) compared to medical treatment using a dinoprostone slow-release-vaginal-insert.


Eligibility Criteria:
Inclusion Criteria:

* medical indication for induction of labor
* 18 years of age
* signed informed consent
* cephalic presentation
* no PROM
* 37+0 - 42+0 weeks of gestation
* Bishop-Score ≤ 6
* no contra-indication for medical induction of labor
* no clinical signs of infection

Exclusion Criteria:

* fetal anomalies
* contra-indications for medical induction of labor
* placental pathologies
* St.p. surgery with opening the uterine cavity (incl. caesarean section)
* PROM
* multiple gestations
* \< 37-0 weeks of gestation
* St.p. cervical tear
Evaluation of Fertitonex Effects on Semen Parameters in Clinical Varicocele Patient.

The aim of the study is to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

Infertility is defined as the inability of a couple to conceive after one year of unprotected, frequent and regular sexual intercourse. Almost 15% of all couples trying to conceive are affected by infertility, and in almost half of these cases male infertility is the sole or a contributing factor. The most common cause is idiopathic oligoasthenoteratozoospermia (OAT) that is defined as follows sperm concentration, the proportion of morphologically normal sperm and the proportion of motile sperm are all lower than the World Health Organization (WHO) reference values.

Despite extensive research, a successful treatment for OAT had not yet been developed. Small amounts of reactive oxygen species (ROS) are produced by spermatozoa in physiological conditions, and various scavengers act to reduce the concentration of these ROS in the seminal plasma. ROS are needed for capacitation, acrosome reaction and ultimately fertilization.

Antioxidants might help maintain the balance between ROS production and clearance and thus could improve sperm quality Additionally, observational studies had found a lower frequency of sperm aneuploidy in men with a higher dietary intake of antioxidants than in those with a lower intake. In semen, antioxidants decrease OS, potentially improving sperm motility and reducing DNA fragmentation.

We aim to evaluate the Fertitonex effects on semen parameters in clinical varicocele patients.

Eligibility Criteria:
Inclusion Criteria:

* Primary infertility.
* Abnormal semen analysis parameters.
* Clinically evident varicocele confirmed by scrotal duplex.

Exclusion Criteria:

* 2ry infertility.
* Normal semen analysis parameters.
* Clinically non-evident varicocele.
* Past history of varicocelectomy.
Ultrasound Evaluation of Gastric Emptying in Diabetic Patients

This is a prospective cohort study. The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to healthy controls 2 h after clear liquid and 6h after a light meal, and evaluate the mean gastric emptying time of clear liquid and light meal in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic and non-diabetic Patients scheduled for elective surgery aged 18 to 85years American Society of Anesthesia physical status classification I to III Body mass index \< 40 kg/ cm2.

Exclusion Criteria:

* Pregnancy (currently or within the past 3 months) Previous surgery of the upper gastrointestinal tract Achalasia
Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Children with JDM are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JDM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.


Eligibility Criteria:
Inclusion Criteria:

* Ages 7 to 18 years
* Diagnosis of juvenile idiopathic inflammatory myopathy (JIIM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria: ≥90% probability, age of onset \<18 years
* Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
* Minimum height of 132.5cm (required to fit on the cycle ergometer)

Exclusion Criteria:

* Subjects with newly diagnosed JIIM within the previous 6 months
* Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
* Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR \<90 ml/min/1.73m\^2)
* Subjects currently taking anti-hypertensive drugs or blood thinners
* Subjects who are currently pregnant or planning to become pregnant within the study period
Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, between the ages of 18 and 65
* Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
* Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
* Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
* Patient must be hospitalized during the study

Exclusion Criteria:

* Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
* Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
* Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
* Documented history of allergic reaction to study medication(s)
* Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
Impact of Critical Limb Ischemia on Long Term Cardiac Mortality in Diabetic Patients Undergoing Percutaneous Coronary Revascularization

Prospective cohort study of consecutive diabetic patients undergoing percutaneous coronary intervention (PCI) in whom development of critical limb ischemia was prospectively assessed by a dedicated diabetic foot clinic. Cardiac mortality at 4-year follow-up was the primary endpoint of the study.


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus
* need for coronary revascularization
* age \> 18 years

Exclusion Criteria:

* clinical contraindications to prolonged double antiplatelet therapy
* life expectancy \< 1 year
* lack of consent
The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.

Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.


Eligibility Criteria:
Inclusion Criteria:

1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
2. phase IIIB /IV based on IASLC 2009 TNM criteria.
3. at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
4. male or female, age≥18 or ≤75 years old
5. ECOG PS: 0 or 1
6. estimated time of survival: ≥ 3 months
7. suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
8. suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
9. suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
10. EKG normal
11. without no healing wound
12. no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment.
13. for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment.
14. no history of serious allergic to biologic agents, especially E.Coli products
15. the authorized ICF must be signed

Exclusion Criteria:

1. Woman in pregnancy and breast-feeding, or having productive ability without contraception.
2. Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
3. Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
4. Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms.
5. Having the tendency of bleeding, such as FIB\<2G/L
6. Being receiving adjuvant chemotherapy.
7. On other conditions investigator considers, the subject is not fitful to participate the trial.