cyrilzakka/clinical-trials huggingface dataset:
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults

The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.

After being informed about the study and potential risks, participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to convalescent plasma versus placebo. Transfusion of convalescent plasma or placebo will be administered by clinical or research personnel while the patient is hospitalized on Study Day 1. On Study Days 1-7, participants will be monitored for adverse reactions to the transfusion. Research personnel will also assess patients at Day 14 and Day 28; these assessments will be completed by phone if the participant has been discharged from the hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Currently hospitalized or in an emergency department with anticipated hospitalization
3. Symptoms of acute respiratory infection, defined as one or more of the following:

   1. Cough
   2. Chills, or a fever (greater than 37.5° C or 99.5° F)
   3. Shortness of breath, operationalized as a patient having any of the following:

   i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2 greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2 greater than or equal to 92% for a patient on chronic oxygen therapy
4. Laboratory-confirmed SARS-CoV-2 infection within the past 14 days

Exclusion Criteria:

1. Prisoner
2. Unable to randomize within 14 days after onset of acute respiratory infection symptoms
3. Patient, legal representative, or physician not committed to full support (Exception: a patient who will receive all supportive care except for attempts at resuscitation from cardiac arrest will not be excluded.)
4. Inability to be contacted on Day 29-36 for clinical outcome assessment
5. Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma, monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
6. Contraindications to transfusion or history of prior reactions to transfused blood products
7. Plan for hospital discharge within 24 hours of enrollment
8. Previous enrollment in this trial
9. Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
10. Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent plasma, or another passive immunity therapy
11. Prior receipt of SARS-CoV-2 vaccine
Role of Myostatin, Activin A and Follistatin Cachexia of ENT Cancers

The main objective of our study was to determine the modifications of blood myostatin and activin A concentrations associated with head and neck cancers. Secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.

Myostatin and activin A, two members of the superfamily TGF-β, have been shown to play a role on skeletal muscle mass regulation. In Humans, high plasma concentrations of activin A were observed in cancer patients, especially in cachectic subpopulations, suggesting their involvement in the development of cachexia.

55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. The patients underwent a complete nutritional assessment and multiple samples : blood before and 7 days after surgery, skeletal muscle biopsies, tumor biopsies. Plasma concentrations of myostatin, activin and follistatin were measured before and after tumor removal surgery. Concentrations of myostatin, activin and follistatin were also measured in an incubation medium of a tumor biopsy. Activin A and follistatin plasma concentrations were significantly increased in the cancer group (320 vs. 203 pg/ml ; p \<0.001) (3593 vs 2148 pg/ml ; p \<0.001), while myostatin plasma concentration was significantly decreased in this group (1542 vs. 2100 pg/ml ; p = 0.010). Surprisingly, data of the 7th postoperative day showed an increase in plasma activin A concentration (379 vs 320 pg /ml ; p \<0.001) while concentrations of myostatin and follistatin were not modified. A high postoperative systemic inflammation is one hypothesis to explain these later results. Myostatin, activin A and follistatin proteins were systematically detected in the medium of tumor a 48 hour-incubation period, providing a strong proof of the tumor production of these factors by squamous cell carcinoma. The activin A/myostatin/follistatin is modified in the context of head and neck cancer. Activin A particularly seems to play a role in the occurrence of cachexia while follistatin could have a protective role for skeletal muscle mass. This system could aimed in therapeutic ways to reduce cachexia in a context of cancer in order to improve the quality of life and survival of patients.

Eligibility Criteria:
Inclusion Criteria:

For case group :

* head and neck cancer
* squamous cell carinoma only
* head and neck surgery chosen as treatment of cancer
* age 18-75

For control group :

* Neck surgery for non oncologic disease
* age 18-75

Exclusion Criteria:

* heart failure, respiratory failure (requiring a long-term oxygen therapy), chronic renal failure (MDRD clearance \< 60 ml/min), moderate or severe chronic obstructive pulmonary disease and insulin-dependent diabeta for the two groups
* cachexia for control group
Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy

A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal applications of single dose of VML-0501 (100 mg Danazol), in comparison to five days of Danazol treatment administered as an oral capsule (Danatrol) at a daily dose of 600 mg, in two groups of twelve each consisting of women with suspected or confirmed endometriosis and scheduled for laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Provide written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of her normal medical care.
* Be a female who has or is suspected to have endometriosis
* Greater than or equal to 18 years of age and less than 42years.
* Scheduled to undergo laparoscopy.
* According to the local practice the women should sign a specific clause on avoiding pregnancy based on the use of two effective methods for birth control (condom and spermicidal) following 30 days after the last dose/application.
* Be non-pregnant undergoing laparoscopy for confirmed or suspected endometriosis within first 10 days of her cycle.
* Have a body mass index (BMI) \< 32 kg/m2

Exclusion Criteria:

If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial.

The subject:

* Is pregnant (if positive-Urine pregnancy test at screening) or lactating;
* Has evidence of drug or alcohol abuse.
* Have used hormonal replacement therapy or Danazol therapy within the past 8 weeks before study entry
* Has any of the following: Epileptic Seizure, Migraine Headache, Angina, Chronic Heart Failure, Obstruction of a Blood Vessel by a Blood Clot, Liver Problems, Kidney Disease, Pregnancy, Combined High Blood Cholesterol and Triglyceride Level, Porphyria
* Undiagnosed abnormal genital bleeding
* Androgen dependant tumour
* Is Allergic to anabolic androgenic steroid.
* Smoker.
Anesthetic Efficacy of Gow-Gates Versus Conventional Inferior Alveolar Nerve Block Techniques

The purpose of this study is to determine whether Gow Gates block injection is more effective than conventional alveolar nerve block in anesthetising mandibular molars with acute pulpitis.

Pain management and adequate anesthesia are of critical importance for the endodontist. Traditionally, mandibular teeth are anesthetized via inferior alveolar nerve block (IAN). However, this technique provides a marginal success rate of 19-56% in patients with irreversible pulpitis.Gow Gates technique introduced in 1973 for anesthetizing of mandibular molars with more accuracy, success and safety.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular molars with acute irreversible pulpitis

Exclusion Criteria:

* Unhealthy patients
* Patients who had taken pain killer less than 4 hours before appointment
Use of an Investigational Digital Therapeutic in Patients With Type 2 Diabetes

BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). The BT-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. The effectiveness of BT-001 will be measured by its ability to help patients reduce Hemoglobin A1c, or HbA1c (a marker in the blood that measures blood sugar) in patients with type 2 diabetes.

The study will utilize an open-label, pragmatic design to confirm and characterize the safety and efficacy of BT-001 used in addition to standard of care (SOC) in patients with type 2 diabetes. The screening period will consist of review of Electronic Health Record (EHR) for participants that meet inclusion criteria and telephonic outreach.

Once confirmed consented, patients will then be given access to BT-001 for 90 days with an opportunity to continue using the product for an additional 275 days.

Participants will continue their standard of care with their provider in addition to using BT-001.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type2 Diabetes
* Possess a smart phone (iPhone or Android only) capable of running the smart phone application (App) used in the study;
* HbA1c level ≥7% and \<11%, as determined by the HbA1c measured within the previous 12 months;
* Willing to use a glucometer for self-monitoring blood glucose while using the study App;
* Capable of giving informed consent in English, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Unable to understand, consent to, or comply with the study protocol for any reason, including the inability to read or comprehend English. The behavioral intervention mechanisms, including educational materials and digital tools, are only available in English at this time;
* Currently taking prandial (mealtime) insulin;
* Currently experiencing heart failure of New York Heart Association Class IV;
* Currently experiencing stage 4 or 5 chronic kidney disease;
* Currently on kidney dialysis (hemo or peritoneal);
* Currently on the list for an organ transplant or previously received a transplant of any organ;
* Currently receiving treatment for cancer;
* For women only: pregnant or lactating or having the intention of becoming pregnant during the time frame of the study;
* Presumed or confirmed COVID-19 diagnosis within 90 days prior to study enrollment
End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation

In cases where there is no ventilation-perfusion problem, the end-tidal carbon dioxide (ETCO2) value is closely associated with partial arterial carbon dioxide pressure (PaCO2); therefore, the PaCO2 value can be estimated using ETCO2 measurements in patients without significant cardiopulmonary disorders. The aim of the investigator's study is to evaluate the reliability of pulmonary ventilation monitoring with ETCO2 value and to investigate at what tidal volume values ETCO2 monitoring provides reliable information.

The patients were grouped as follows: Group 1, if the tidal volume is 4 ml/kg; Group 2, if TV=6 ml/kg; Group 3, if TV=8 ml/kg; and Group 4, if TV=10 ml/kg. It was determined how many breaths per minute (minute ventilation) would be given with tidal volume x respiratory rate=6 L. The patients were ventilated with the same ventilation parameters for 30 minutes and then arterial blood gas analysis was performed. Arterial blood gas was collected at t1 for group 1, t2 for group 2, t3 for group 3, and t4 for group 4. The ETCO2 value, Peak pressure (Ppeak), Plateau pressure (Pplato), mean airway pressure (Pmean) values were recorded at the time of arterial blood gas collection. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peak heart rate (PHR) values were evaluated. The patients with a mean arterial pressure of less than 65 mmHg were excluded from the study. Partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), oxygen saturation (SO2) values were recorded from the arterial blood gas analysis. P (a-ET) CO2 gradient value was calculated.

The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaO2 values and hence the P (a-ET) CO2 gradient changed.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) classification 1, 2 risk group

Head and neck surgery under general anesthesia lasting more than 120 minutes and who progressed normotensive.

Exclusion Criteria:

Cardiac disease

Pulmonary disease

Obese patients
A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects

An open-label, single-ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 combined with STSA-1005 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, aged ≥ 18 but ≤ 45, male and female;
* Weight: Male≥50.0kg, Female ≥ 45kg; Body mass index: 19.0-26.0 kg/m2, inclusive;
* Subjects (including their partners) must take effective contraceptive measures and have no birth plan or sperm or egg donation plan during the trial period and within 6 months after the end of the last administration;
* The subjects were aware of the risks of the trial, voluntarily participated in the study and signed the informed consent form (ICF).

Exclusion Criteria:

* Have a history of serious disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular diseases) or have undergone any major surgery within 2 months prior to screening;
* The investigators determined that abnormalities in pre-enrollment physical examinations, laboratory tests, and trial-related tests were clinically significant;
* A definite history of food or drug allergies;
* Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
* History of tuberculosis; or combined with T-SPOT.TB results, low-dose chest CT comprehensive evaluation of tuberculosis infection;
* Hemoglobin was lower than the lower limit of normal value during the screening period;
* Smoking more than 5 or equivalent cigarettes per day in the 3 months before screening;
* Regular drinkers in the 6 months prior to screening, i.e. those who have consumed more than 2 units of alcohol per day (1 unit =360ml beer or 45ml spirits with an alcohol concentration of 40% or 150ml wine) in the 6 months prior to screening or have a positive alcohol test result;
* Subjects with a history of substance abuse within 1 year before screening or have a positive drug test result;
* Blood loss or blood donation \> 400ml three months before screening, or blood transfusion history within 4 weeks before inclusion;
* Participate in clinical trials of new drugs or vaccines as a subject within 3 months prior to screening；
* Vaccination was given within 1 month before screening or planned between the study period and 2 months after the end of the study;
* Use of medications that may affect immune function in the 6 months prior to screening or any monoclonal antibody or biologic treatment in the 3 months prior to screening and use of prescription drugs/over-the-counter drugs or herbal medicines in the 14 days prior to screening；
* Drink more than 5 cups of coffee, tea or cola (150ml or more per cup) daily within 3 months before screening;
* Pregnant or lactating women;
* A history of blood and needle sickness；
* Other circumstances in which the investigator considers it inappropriate to participate in the study.
Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

The purpose of this trial is to test the combination of Gleevec® (also known as imatinib mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer. Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a chemotherapy which is injected into the vein. It is approved for breast and lung cancer but has been shown to shrink many different types of tumors. Taxotere has been shown to shrink stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is being performed to see if the combination of Gleevec and Taxotere is an effective treatment for incurable stomach cancer with minimal side effects.

Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®, patients will then begin receiving doses of Taxotere intravenously once a week for two weeks in a row followed by one week without Taxotere.

Eligibility Criteria:
Inclusion Criteria:

* This study is for patients with histologically confirmed unresectable gastric adenocarcinoma and who have not received any chemotherapy other than 5-FU for adjuvant therapy either alone or in conjunction with radiation.

Exclusion Criteria:

* Patients may not have received any chemotherapy agents other than 5-FU.
* Patients may not have received 5-FU for for therapy for metastatic gastric cancer.
* Patients must be more than 5 years free of another primary malignancy except: if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
* Patients must not have Grade III/IV cardiac problems, or any severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patient must not have had previously received radiotherapy to \>/= 25% of the bone marrow, or have had major surgery within 2 weeks prior to study entry
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer

The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.

This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. This study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 OM in subjects with stage 2B or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1. This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-FU dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.

Eligibility Criteria:
Inclusion Criteria:

* History of newly diagnosed histologically confirmed resected colon cancer (American Joint Committee on Cancer \[AJCC\] Stage 2B or 3) and a candidate for adjuvant 5-FU and Leucovorin
* Eastern Cooperative Oncology Group performance status ≤ 1
* Functional hematopoietic and hepato-renal systems

Exclusion Criteria:

* Previous therapy (e.g. chemotherapy, radiotherapy or biological therapy) for colon cancer, other than surgical tumor resection
* Presence or history of any other primary malignancy
* Presence of active or chronic oral mucositis or xerostomia
* Previous treatment with other keratinocyte growth factors
Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).

In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
* Previously untreated for Myelodysplastic Syndrome (MDS)
* Age ≥18 years of age.
* Eligible for therapy with azacitidine.
* Life expectancy of at least 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Adequate baseline laboratory parameters.

Exclusion Criteria:

* Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
* History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
* Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
* Candidates for allogeneic stem cell transplant at the time of screening.