cyrilzakka/clinical-trials huggingface dataset:
Somatostatin Analog Treatment of Acromegaly Before Pituitary Surgery : Comparison With Neurosurgery Alone

The aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly.

Somatotroph pituitary adenoma is the most frequent cause of acromegaly. A transsphenoidal removal of the tumor is used as the first line treatment. Somatostatin analogs are used as to whether recovery was not obtained after surgery or pituitary surgery was contraindicated. Previous studies with somatostatin analogs have shown a drop in plasma GH and IGF-1 levels and a reduction in adenoma size in 75 and 25% of patients respectively. Retrospective studies suggest that a treatment with somatostatin analogs performed before surgery may be of interest to improve anesthesic conditions and surgical outcome. The aim of present study is to prospectively evaluate the interest of a first line treatment with a long-acting somatostatin analog (Sandostatin) before performing a pituitary surgery in acromegalic patients with either a micro or a macroadenoma to improve peri-operative conditions and hopefully surgical outcome. After informed consent, untreated acromegalic patients will be included and randomly assigned to one of the following treatment procedures : either pituitary surgery or a six month treatment with long-acting Sandostatin 30 mg monthly for 6 months before performing transsphenoïdal adenoma removal. The patients will be evaluated before any treatment, on months 3 and 6 of the treatment with Sandostatin (for the patients enrolled in this arm of the study) and on months 3 and 12 after pituitary neurosurgery. Each evaluation will include clinical data, hormone testing and radiological (MRI) investigation. The main endpoint will be the rate of recovery proved by a normalisation of GH secretion and plasma IGF-1 level. Secondary endpoints will include the evaluation of clinical, radiological, biological, anesthesic, surgical and pathological parameters. A comparison between the two arms will be performed at entry into the study, at the time of surgery and then on months 3 and 12 following the transsphenoidal removal of the somatotroph adenoma.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* 18-80 years old
* untreated acromegaly
* unsuppressed GH secretion after a glucose load and elevated IGF-1 plasma levels
* presence of a pituitary adenoma on MRI
* informed consent given.

Exclusion Criteria:

* acromegaly previously treated
* contraindication to pituitary surgery
* associated hyperprolactinemia above 200 ng/ml
* visual field defect needing rapid transsphenoidal surgery
* contraindication to a treatment with octreotide
A Research on Hidden Blood Loss in Laparoendoscopic Single-site Radical Hysterectomy With Pelvic Lymphadenectomy

The aim of this cross-sectional study is to evaluate the hidden blood loss in patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy and identity its risk factors.

The electronic medical data of 105 patients who undergo laparoendoscopic single-site radical hysterectomy in the following year to treat cervical cancer will be analyzed retrospectively in this study. The amount of hidden blood loss will be calculated according to Gross's formula. And multiple linear regression analysis will be employed to identify its risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the study with informed consent;
2. Females aged 20-80 who are confirmed with cervical cancer and are treated with laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy.

Exclusion Criteria:

1. Pregnancy, lactation, postmenopause, or planned pregnancy within two years;
2. Suspected or identified as other tumors of genital tract;
3. History of hyperparathyroidism, infectious diseases (tuberculosis, AIDS), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery);
4. Other diseases or heavy injuries that will interfere with the results;
5. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Aromatherapy for Reducing Labor Pain

Pregnant women who eligible with inclusion criteria are random to two groups. Aromatherapy group will receive the aromatherapy during labor along with standard pain control.

Non-aromatherapy group will receive standard pain control during labor


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Nulliparous
* 37 complete weeks of gestation
* Cephalic presentation
* No emergency obstetric complication
* In labor

Exclusion Criteria:

* Medical or obstetric complication preclude vaginal delivery
* Essential oil allergy
* Side effect of aromatherapy
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache

The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache


Eligibility Criteria:
Inclusion Criteria:

* patients with migraine
* patients 18 years aged or above

Exclusion Criteria:

* patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
* patients pregnant or planning on becoming pregnant during the study period
A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients

This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.

This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma;
2. Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs;
3. Women ≥18 years of age;
4. Eastern Cooperative Oncology Group performance status score ≤2;
5. Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion.
6. Complete medical records;
7. Informed consent form signed.

Exclusion Criteria:

1. Not ovarian metastatic colorectal cancer confirmed by radiology or histology;
2. Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study;
3. Other conditions that would influence patient compliance;
4. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.
Smartstep Smartphone PAD

The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone programs may increase the efficiency of such efforts. The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at Grady Memorial Hospital's vascular clinic.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable intermittent claudication
* Able to give informed consent
* Age 18-89 years

And one of the following:

* ABI \< 0.9 after 10 minutes of rest OR
* For subjects with an ABI of \>1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of \< 0.70 must be obtained for subject qualification. If ABI is \> 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.

Exclusion Criteria:

Life-threatening process including:

* Sepsis
* Critical limb ischemia (Rutherford class 4-6)
* Unstable angina
* Active malignancy with life expectancy \< 6 months
* Severe NYHA Class IV heart failure

Condition other than PAD that limits walking before claudication onset

This includes, but is not limited to:

* Severe angina or dyspnea
* Arthritis
* Muscle weakness/pain

Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation

Inability to attend study visits
WIN: a Feasibility Study of a Weight-Neutral Health Intervention

The WIN intervention aims to improve the mental, social and physical health as well as quality of life of participants with BMI≥30 without focusing on their weight, and with no aim of weight loss. The WIN 6 months intervention is based on the principles and methods of the weight neutral movement Health at Every Size (HAES). The content is developed in a co-design process that involved Danish participants who have lived or professional experiences with such approaches.

The intervention uses the method of intuitive eating to align eating behaviours with internal cues of hunger and fullness rather than rules, restrictions and external cues. The intervention also draws on components from Acceptance and Commitment Therapy (ACT) to manage body image concerns and weight stigma.

The WIN group intervention comprises bi-weekly two-hour sessions with 11-12 participants and two WIN-therapists. Session 1 is an individual session and sessions 2-12 are group sessions. The programmes include psychoeducation, group discussions and homework about topics within the weight neutral approach such as intuitive eating, weight stigma, enjoyable movement and self-compassion.

Overview of sessions 1-12:

1. Individual session with a WIN therapist to explore the participant's expectations and needs in relation to commencing intuitive eating and body acceptance.
2. Introduction to weight-neutral health
3. Your body, Your rules
4. Intuitive eating I
5. Intuitive eating II
6. Body Respect and Weight Stigmatization
7. Self-compassion and confronting your inner critical voice
8. Body awareness, Rest and Movement - Yoga and Your strong body
9. Body awareness, Rest and Movement, intimacy and sexuality
10. Follow-up on intuitive eating
11. Follow-up on challenges
12. Strategies for resilience

Optional WIN elements include two support network events, up to 24 2-hour sessions of WIN-physical activity (Rest and Movement (12 sessions) and Competent Body Training (12 sessions)), and three individual online sessions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old at screening.
* BMI ≥30 kg/m2.
* Residence in the Capital Region of Denmark.
* Able to understand and communicate in Danish.
* Informed consent.

Exclusion Criteria:

* Intends to become pregnant during the intervention or is currently pregnant.
* Has used weight loss medications or GLP-1 agonist treatment within the past 6 months or intends to use weight loss medications or begin any other intensive weight loss treatment during the WIN intervention.
* Has severe psychiatric or physical conditions that may interfere with participation or may present a safety concern.
* Cannot transport themselves to the group sessions.
* Is deemed unable to complete a two-hour group session, as assessed by the investigator at the clinical screening interview.
* Takes part in other research involving weight loss treatment that would compromise participation in this study.
The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination

The main aim of the investigator study is the success of predictivity cervical consistency index (CCI), anterior uterocervical angle (aUCA) and posterior uterocervical angle (pUCA) in second trimester terminations.

This prospective clinical study includes 136 pregnant women with a diagnosis of in utero ex fetus who were hospitalized for medical termination in the gynecology service of Health Sciences University Bursa High Specialization Training and Research Hospital Gynecology and Obstetrics Clinic as a single center. The participants were divided into 2 groups as those whose treatment was completed in the first 24 hours (who were completely aborted and removed the fetal material and its attachments ) and those who aborted within 24-48 hours when additional cycles were needed. Furthermore who applied to additional treatment methods were recorded (cervical balloon, hysterotomy ) during these periods. In all pregnant women; characteristic features, abortion times, doses of misoprostol used, anterior- posterior uterocervical angle, cervical length, cervical consistency indexes and gestational weeks were saved.

Eligibility Criteria:
Inclusion Criteria:

* women who had a termination indication in the second trimester and had abortion or abortion in our hospital
* women who have had a miscarriage or abortion with a normal vaginal route or hysterotomy

Exclusion Criteria:

* multiple pregnancies
* pregnant women with misoprostol-related allergies
* scar pregnancies or heterotopic pregnancies
* patients with a history of previous conization or cervical surgery,
* patients with placental invasion anomaly
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.


Eligibility Criteria:
Inclusion Criteria:

Both of following symptoms should be observed.

* Lower abdominal pain and/or lower abdominal tenderness.
* Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).

Exclusion Criteria:

Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.

Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
Microarray Analysis for Human Genetic Disease

This study will look at genetic changes which occur in the development of male and female breast cancer and other cancer. It will use a new technology called DNA microarray hybridization that looks at a wide array of genes to identify disease-associated patterns in the human genome (complete set of human genes). Numerous studies have linked particular genes to a given disease, but there is very little information on patterns of gene expression (production of proteins from genetic coding) in the entire human genome.

Pinpointing genetic abnormalities in disease may help classify different forms of cancer and perhaps lead to new avenues of treatment or prevention. A primary goal of this study will be to create a database of gene expression for human cancers and other disorders that will provide the basis for finding genetic abnormalities in disease.

Tumors specimens used in this study will be taken from tissues biopsied from patients with breast, colon cancer, sarcomas or melanoma as part of their routine care. Patients in the study will be among those receiving care at the: Department of Oncology, University Hospital, University of Lund, Sweden (breast cancer); Department of Medicine, University of Michigan, Ann Arbor, Michigan (breast cancer); Surgery Branch, National Cancer Institute, Bethesda, Maryland (melanoma), Johns Hopkins Univ. (colon cancer), Memorial Sloan Kettering (sarcoma).

Patients in the study will have a family history taken and will complete a questionnaire. Some patients will be asked to have a blood test. Breast cancer patients will have a mammogram if one has not been done within the last year.

The purpose of our study is to make use of a novel technology that the Cancer Genetics Branch of the NHGRI has been a leader in developing. This technology for genome-wide expression analysis, DNA microarray hybridization, is the focus of our protocol. We will access tissue banks collected by our collaborators that contain excess tissues obtained during routine clinical care. Specimens will be processed for large-scale gene expression analysis and DNA copy number determination using DNA microarrays. The development and analysis of this gene expression and gene copy number database are the primary purpose of this study. Currently available and new bioinformatics tools will be applied to the data for the characterization of disease subsets (e.g., early vs. advanced stage cancer) as well as to mine the data for specific genes which are linked to given disease states.

Eligibility Criteria:
* Clinical inclusion/exclusion criteria will be dependent upon the collaborating Institutions' requirements.
A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer

This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.

Additional surgical staging procedures are permissible but not required.

* Risk factors: patients must fit one of the following:

  * Pelvic lymph node metastases
  * Paraaortic lymph node metastases
  * Grade 3 with myometrial invasion \>50%
  * With stromal invasion of cervix
  * Known extrauterine disease (excluding second primary) confined to the pelvis.
  * High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma,
* No known gross residual disease, or distant metastases.
* Eastern Cooperative Oncology Group (ECOG) score\<=2; Age 18\~75.
* White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl.
* Acceptable hepatic and renal function: creatinine \<=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) \<=2\*normal.
* No medical contraindications to chemotherapy, or radiation therapy.
* Study-specific signed informed consent.

Exclusion Criteria:

* Prior pelvic radiation therapy.
* Positive peritoneal cytology only for stage IIIa (FIGO 1998).
* With history of other malignancies less than 5 years.
* With gross residual disease, or distant metastases.
* With endometrioid endometrial carcinoma and no risk factors:

  * with myometrial invasion \<50%
  * Grade 1\~2, with myometrial invasion \>50%
* With serious internal diseases which affect designed treatment
* With psychotic disorders
Study of Apatinib as an Inhibitor of Tumor Angiogenesis

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), so it can inhibit tumor angiogenesis. This phase I study aims to determine the drug's toxicity and to find a dose level to be used in a phase II study in solid tumor patients.

Apatinib is a tyrosin-inhibitor agent targeting at VEGFR (vasoendothelial growth factor receptor) to inhibit tumor angiogenesis. The anti-angiogenesis effect of apatinib has been viewed in preclinical tests (see protocol). This phase I clinical study is going to evaluate its toxicity and to find an appropriate dose level to be used in a phase II study in heavily treated solid tumor patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 70 years of age
* Histological or cytological confirmed solid malignant tumor
* ECOG performance status of ≤ 2
* Standard regimen failed or no standard regimen available
* Life expectancy of more than 3 months
* Duration from the last therapy is more than 6 weeks for nitroso or mitomycin; more than 4 weeks for operation or radiotherapy; more than 4 weeks for cytotoxic agents or growth inhibitors.
* Laboratory values: hemoglobin ≥ 9.0g/dl, neutrophils ≥ 1.5×10\^9/L, platelets ≥ 100×10\^9/L , ALT ≤ 2.5 x upper limit of normal (ULN), AST ≤ 2.5 x ULN, serum bilirubin ≤ 1.5 x ULN, serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, PT, APTT, TT, Fbg normal

Exclusion Criteria:

* Pregnant or lactating women
* Any factors that influence the usage of oral administration
* Evidence of CNS metastasis
* History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
* Receiving the therapy of thrombolysis or anticoagulation
* Abuse of alcohol or drugs
* Allergy to the ingredient of the agent or more than two kinds of food and drug
* Less than 4 weeks from the last clinical trial
* Disability of serious uncontrolled intercurrence infection
A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy

This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all safety information was obtained


Eligibility Criteria:
Inclusion Criteria:

1. Patients using rebinim ® during general anesthesia and fiberoptic sedation
2. Patients need to sign informed consent

Exclusion Criteria:

1. Patients who are participating in or planning to participate in any interventional clinical trial
2. The investigator considers that there are any other reasons for the patient's ineligibility for the study