cyrilzakka/clinical-trials huggingface dataset:
Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection

To determine whether administration of human recombinant erythropoietin (REPO) improved or eliminated the anemia seen in human immunodeficiency virus (HIV) infected patients after therapy with zidovudine (ZDV).

BACKGROUND:

Reports had shown that between 24 and 78 percent of patients with Acquired Immune Deficiency Syndrome treated with zidovudine for four to six months developed significant bone marrow toxicity, requiring zidovudine dosage alterations, blood transfusions, or cessation of therapy. While zidovudine efficacy had been demonstrated in patients with AIDS or ARC, it was also evaluated in patients with AIDS-related illness, as well as in asymptomatic HIV-infected individuals. The clinically significant zidovudine-induced anemia developing in a substantial number of these patient groups and requiring blood transfusions could cause a significant drain on the blood supply in the United States.

The project was part of an Institute-initiated study on the Pathobiology of Bone Marrow Suppression in AIDS or AIDS-Related Complex. The concept was approved at the May 1987 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in December 1987.

DESIGN NARRATIVE:

Double-blind, placebo-controlled. Patients received intravenous REPO (1000 IU/kg) or placebo twice per week. The five patients in Group A had no transfusion history. The five patients in Group B had a history of transfusions. Prior to the study, the authors determined that treatment would continue for twelve weeks or until the hemoglobin reached 12.5 g/dl. After the twelve week study period, patients were eligible to receive open label erythropoietin (500 IU/kg, twice a week). For numerous reasons, recruitment of patients was a major problem in this trial. The study originally estimated a total of 64 patients.

Eligibility Criteria:
No eligibility criteria
Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer.

The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（Cisplatin or Carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer.

Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years , male or female;
2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
3. ECOG PS 0\~1;
4. No prior treatment or immunocheckpoint inhibitors for ES-SCLC;
5. Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC；
6. Patients with asymptomatic brain metastases who have received previous treatment
7. Has provided tumor tissue samples
8. Estimated survival time ≥8 weeks;
9. There is at least one measurable lesion that conforms to RECIST criteria v1.1.For lesions that have received previous radiation therapy, the lesion can only be included in the measurable lesion if the disease progression is clear after radiotherapy and the lesion is not the only measurable lesion.
10. Before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol.
11. Has adequate hematologic and end organ function

Exclusion Criteria:

1. Prior systemtic treatment for ES-SCLC;
2. Prior treatment with any CD137 agnist or immunocheckpoint inhibitors.
3. Subjects with active or untreated central nervous system (CNS) tumor metastasis;
4. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
5. Cancerous meningitis;
6. Uncontrolled or symptomatic hypercalcemia;
7. Other malignant tumors within 5 years prior to the first dose of study treatment
8. Subjects with any active, known or suspected autoimmune disease;
9. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis .
10. Subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery;
11. Significant cardiovascular disease, such as New York Heart Assoc
Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

This study will determine the effectiveness of sertraline administration after a stroke in preventing the onset of post-stroke depression.

Persons who suffer from a stroke are at high risk for developing post-stroke major depression (PSMD), an illness that has a negative impact on post-stroke physical rehabilitation and is associated with increased morbidity and mortality. Unfortunately, early detection and successful treatment of post-stroke major depression improves, but does not normalize, stroke rehabilitation outcomes compared to stroke survivors who never developed post-stroke depression. Therefore, preventing the onset of PSMD and its associated disability is an attractive possibility. This study is a placebo controlled, 10-month double-blind trial of sertraline in the prevention of PSMD in stroke survivors, with a 2-month naturalistic continuation phase. The primary outcome will be the incidence of Major Depression post-stroke. Additional outcomes will include the severity of depressive symptoms post-stroke and the level of disability experienced by the two treatment groups. An exploratory analysis will also be conducted to elucidate participant characteristics that may be moderators of the participants' response to the preventive intervention, thereby refining the profile of disabled stroke survivors most likely to benefit from the preventive intervention.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00781326

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke within 3 months of study entry
* Admitted to a UPMC hospital for acute inpatient treatment or rehabilitation of stroke
* Speaks English
* Females willing to use an effective form of birth control throughout the study

Exclusion Criteria:

* Meets DSM-IV-TR criteria for a major depressive episode
* History of any bipolar disorder
* Psychotic or history of a psychotic disorder
* Meets DMS-IV TR criteria for alcohol or substance abuse or dependence criteria within 3 months of study entry
* Current treatment with antidepressant medication for any reason (e.g., anxiety disorder, neuropathic pain)
* Primary hemorrhagic stroke
* Language impairment severe enough to prevent valid neuropsychiatric assessment
* History of another CNS disease other than prior stroke or psychiatric illness (e.g., head trauma, multiple sclerosis, HIV with CNS involvement)
* Pulse \<50 or \>100 beats per minute
* Significant hyponatremia (Na \<130meq)
* Current hypothyroid state
* Medically unstable including symptoms of delirium (determined by review of the subject's medical status with the treating (clinical) physician; standard blood chemistry lab work will be obtained if not checked within the preceding 30 days)
* History of sensitivity to sertraline
* Pregnant or breastfeeding
A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe

This is a prospective, non-interventional study (NIS) measuring health-related quality of life (HRQoL), treatment satisfaction, and other patient-reported outcomes (PROs) of ADPKD patients in Europe.

This is a prospective, non-interventional study (NIS) measuring HRQoL, treatment satisfaction, and other PROs of ADPKD patients in Europe. The study aims to enrol at least 486 patients. Data will be prospectively collected at clinics, from medical notes and via PRO measures for each patient at Baseline, Month 1, Month 3 and subsequently at 3 month intervals up to and including the final assessment (18 months maximum follow-up time). No visits with the patients' treating physician will be imposed by the protocol. Any clinical visits will occur as per normal clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged ≥ 18 years.
* Patient has a diagnosis of ADPKD between CKD Stages 1-3, and is deemed by their treating physician to likely have rapidly progressing disease.
* Patient has a life expectancy greater than 18 months at time of enrolment.
* Patient is able and willing to give informed consent, if required according to local regulations.
* Patient is fluent in local language.

Exclusion Criteria:

* Patient is currently participating in, or has in the last 12 months participated in an interventional clinical trial.
* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient.
* Inability of the patient to complete PROs remotely.
Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis?

Bronchiectasis is a chronic chest condition which causes a persistent cough and frequent chest infections. One of the main forms of treatment is chest physiotherapy. Physiotherapy is thought to improve cough and help clear the airways of sticky sputum. Traditionally, physiotherapy techniques can be awkward, but recently a new device (a simple mouthpiece, called the Acapella device) has been developed to make physiotherapy practise easier. This study aims to assess how helpful regular physiotherapy using a new mouthpiece is in patients with severe bronchiectasis.

Study being carried out in the Department of Respiratory Medicine, Royal Infirmary of Edinburgh.

The study is entitled "Is regular chest physiotherapy an effective treatment in severe, non cystic fibrosis bronchiectasis?" This is a small randomised controlled pilot crossover study assessing the efficacy of regular chest physiotherapy using an Acapella mouthpiece in severe non cystic fibrosis bronchiectasis. 10 patients will be randomised to receive full instruction in use of the Acapella device (twice daily therapy) and ten patients will continue with their standard treatment regimen. The study will be conducted over seven months.

At the beginning we will randomly allocate them to receive either the current standard treatment regimen for bronchiectasis or to receive instruction in the use of the Acapella physiotherapy device for the first 3 months.

After these 3 months all will receive the current standard treatment regimen for 1 month.

Following this, those that received current standard treatment will receive Acapella physiotherapy device for 3 months and those that received Acapella physiotherapy device will stop this and receive current standard treatment for 3 months.

All participants will be reviewed on 6 occasions (start of study and then at months 1, 2, 3, 4 and 6). At each review, sputum samples will be collected, routine bloods, spirometry and exercise testing performed and health related quality of life questionnaires be completed.

At the end of the study should patients have felt benefit with the physiotherapy with the Acapella device, they should continue using it regularly on a twice-daily basis.

Eligibility Criteria:
Inclusion Criteria:

* Moderate and Severe Bronchiectasis
* No regular chest physiotherapy

Exclusion Criteria:

* Moderate or Severe COPD
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects

The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian men aged 18-55 years and ≥65 years
* Women of non-childbearing potential
* Japanese men aged 18-55 years
* Subjects were deemed healthy on the basis of medical history, physical examination, Electrocardiogram (ECG), vital signs and safety tests of blood and urine
* Subjects were able to give fully informed written consent

Exclusion Criteria:

* HDL-C level ≥2.59 mmol/L
* Abnormal Holter ECG
* Family history of long QT syndrome, hypokalaemia or Torsade de Pointes
* Vital signs or 12-lead ECG values outside the acceptable range
* Positive tests for hepatitis B and C, HIV 1 and 2
* Positive urine pregnancy test (women only)
* Severe adverse reaction or allergy to any drug
* Drug or alcohol abuse
* Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects)
* Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995
* Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
* Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
* Clinically relevant abnormal findings at the screening assessment
* Clinically relevant abnormal medical history or concurrent medical condition
* Possibility that volunteer would not cooperate
A Study of Oraxol® in Gastric Cancer Patients

The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.

Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
2. Advanced/metastatic/recurred gastric cancer(PhaseII)
3. ECOG performance status ≤ 2
4. Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL \*AST/ALT/ALP ≤ 3 X the upper limit of normal but \<5 if liver or bone metastasis is present

Exclusion Criteria:

1. Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
2. Patients who have received bone marrow transplant or are to receive bone marrow transplant.
3. Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
Bronchial Injury Caused by Bronchial Cuff

Double lumen endotracheal tubes (DLT) are wildly used to maintain independent lung ventilation during thoracic surgery. Our aim is to assess whether the DLT bronchial cuff inflated or not is associated with tube displacement and bronchial mucosal injury while changing position.

Experiment group: Before changing from supine position to lateral position, inflate air into the bronchial cuff of double lumen endotracheal tube (DLT) and adjust cuff pressure to 25-30 mmHg.

Control group: Do not inflate air into the bronchial cuff before changing position.

Main result: Degree of left bronchial mucosal injury. Secondary result: Displacement of double lumen endotracheal tube after changing position.

All patients receive general anesthesia and are intubated with left DLT in the supine position. The fiberoptic bronchoscope is used to check the position via tracheal lumen of DLT. The bronchial lumen is placed at the left bronchus and the edge of bronchial cuff is visible by fiberscope.

Before changing position, the bronchial cuff of experiment group is inflated with air and adjusted cuff pressure to 25-30 mmHg. Both groups of patient's neck are fixed by neck collar in order to prevent displacement of DLT by neck rotation. After changing into lateral position, the assistant inflates 2 ml of into the bronchial cuff of control group and adjust cuff pressure to 25-30 mmHg. The investigator, blinded to the tube assignments, uses the fiberoptic bronchoscope to check position of the tube again via tracheal lumen of DLT and record the distance of displacement.

At the end of the surgery, both lumens of DLT are sucked and bronchial cuffs are deflated. After pulling out 3 cm of the DLT, the patient is changed into supine position and the fiberoptic bronchoscope is used to check the degree of bronchial injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube.

Exclusion Criteria:

* ASA status \> III, coagulopathy, known airway damage, difficult intubation, tracheostomy, double lumen endotracheal tube is displaced during operation which interferes one lung ventilation and needs to be adjusted.
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.

PRIMARY OBJECTIVE

• Evaluate 18F-FPPRGD2 and 18F-FDG as PET/CT or PET/MRI radiotracers for imaging prediction and assessment of response to anti-angiogenesis therapy in participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC).

SECONDARY OBJECTIVE

• Progression-free survival (PFS) at up to 1 year after initial scans and treatment

OUTLINE:

Patients undergo 18F-FPPRGD2 and 18F-FDG PET/CT or PET/MRI medical imaging at baseline and at regular medical care follow-up (6 to 12 weeks).

After completion of study imaging, patients are followed up at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent
* Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis
* Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

* Pregnant or nursing
* Contraindication to MRI
* History of renal insufficiency (only for MRI contrast administration)
Short Time Low PEEP Challenge and Mini Fluid Challenge

Optimizing fluid therapy is one of the main concerns for anesthesiologists during the intraoperative period. It becomes even more important in high-risk long lasting surgeries as pancreaticoduodenectomy. Therefore evaluating fluid responsiveness prior to fluid loading is highly recommended. To the best of our knowledge there is no study comparing the abilities short time low PEEP challenge and mini fluid challenge in predicting fluid responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy

Exclusion Criteria:

* Body mass index (BMI) \> 35 kg / m2
* any ventricular dysfunction
* Crs \< 35 ml / cmH2O
* valvular heart disease
* ASA score \> 3
* cardiac arrhythmia
* history of lung disease
Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis

A randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control 10 patients treated with mucoadhesive gel containing 2% of basil extract 4 times per day (test group) for 20 min after every meal and before going to bed. The other 10 patients treated by mucoadhesive gel without drug which was used as placebo (composed from 6% w/w PVA (Mw = 31-50 kDa, 98-99% hydrolysed) and 2% w/w sodium tetraydroxy borate) 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals (negative control group)

A randomized double-blind placebo controlled trial will be carried out on 20 patients complaining from aphthus ulcer and 10 patient healthy control. Inclusion criteria will be: (i) age \> 18 years; (ii) a clear history of RAS(recurrent apthous stomatitis)occurring no less than four times a year; (iii) presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment; (iv) ulcers that took \> 5 days to resolve without treatment. Individuals will excluded if they: (i) had underlying systemic disease(s) or a history of immunologic disorder(s); (ii) were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement; (iii) are smokers; (iv) are pregnant; (v) had a history of abusing drugs or alcohol; (vi) could not provide written informed consent.

10 patients treated with mucoadhesive gel containing 2% of basil extract 4 times per day (test group) for 20 min after every meal and before going to bed. The other 10 patients treated by mucoadhesive gel without drug which was used as placebo (composed from 6% w/w PVA (Mw = 31-50 kDa, 98-99% hydrolysed) and 2% w/w sodium tetraydroxy borate) 4 times per day 10 healthy patients will be selected to participate in the study to test the salivary level of endocan in the healthy individuals (negative control group)

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* a clear history of RAS (recurrent apthous stomatitis) occurring no less than four times a year;
* presentation with one or two ulcers measuring 10 mm in diameter for 48 hours and yet to receive treatment;
* ulcers that took \> 5 days to resolve without treatment.

Exclusion Criteria:

* had underlying systemic disease(s) or a history of immunologic disorder(s);
* were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs \< 1 month before study commencement;
* are smokers;
* are pregnant;
* had a history of abusing drugs or alcohol;
* could not provide written informed consent