cyrilzakka/clinical-trials huggingface dataset:
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

* Must not have previously participated in any other r-HuEPO clinical studies.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS and related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.
* Maintenance dose of zidovudine (AZT) of at least 400 mg daily.

Substance abuse.
Pulse Spectrum Analysis in Adult Asthmatics: Correlation With Lung Function, Asthma Control Exhaled Nitric Oxide and Metabolites in Exhaled Breath Condensate

Our hypothesis is that radial arterial pulse may reflect the severity and airway function in asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with airy inflammation an lung funtion in asthmatics.

The microcirculation is directly involved in the cellular matabolism and homeostasis. Our hypothesis is that radial arterial pulse spectrum may reflect the airway condition in asthmatics. The aims of this study are to investigate the pulse spectrim of the radial artery in adult asthmatics, and evaluate its correlation with lung function, asthma control status,exhaled nitric oxide, and metabolites in the exhaed breath condensates.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of GINA guideline asthma patients

Exclusion Criteria:

* Cancer or immune impaired patients;
* pack-year smoking\> 5;
* long-term ventilator-dependent patients
* Control group: 30 age matched healthy controls
A Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children

The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.

Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism

Exclusion Criteria:

* Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.
Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism

The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, at least 18 years of age
* Subject has a clear understanding and agrees to all the conditions of the informed consent form

Exclusion Criteria:

* • Subject has undergone ocular surgery within the last 3 months

  * Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
  * Pregnant or nursing women
  * Those who have had corneal surgery including corneal laser surgery
  * Microphthalmos
  * Buphthalmos
  * Severe Dry eyes
  * Lid squeezers - blepharospasm
  * Nystagmus
  * corneal or conjunctival infection.
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).

Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 38 weeks (corrected age) to 2 years (24 months)
* Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours
* Persistent hypoxia
* Written informed consent

Exclusion Criteria:

* Mechanical Ventilation for \> 48 hours
* Oxygenation index ≥ 25, if arterial line was avialable
* Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange
* Neuromuscular disease or hypotonia
* Upper airway disease
* Baseline requirment for supplemental oxygen
* Untreated pneumothorax
* Off-label use of commercially available surfactant outside neonatal period
* History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody
* Head injury with Glasgow Coma Scale \< 8
* Brain death or impending brain death
* Do not resuscitate orders
* Cardiopulmonary resuscitation within 6 hours of meeting entry criteria
* Experimental therapy in which the intervention potentially affects respiratory outcomes
* Any transplant recipient
* Meconium aspiration syndrome
* Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection
A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

The main purpose of this study is to learn about the side effects of LY3437943 when given to Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year.
* Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at lead-in and screening
* Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m²), inclusive, and a body weight of at least 54 kilograms (Kg).
* Males and females not of childbearing potential

Exclusion Criteria:

* Have type 1 diabetes mellitus (T1DM)
* Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
* Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
* Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligram per deciliter (mg/dL).
* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 3× upper limit of normal (ULN).
Basket Trial of IDX-1197, a PARP Inhibitor, in Patients with HRR Mutated Solid Tumors (VASTUS)

This study is a Phase 1b/2a basket trial to assess safety and efficacy of IDX-1197 in patients with HRR mutation.

There are two parts to this study: Phase 1b, IDX-1197 dose-selection study to determine RP2D and Phase 2a, non-randomized parallel dose expansion study to confirm RP2D.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancers that have HRR mutation and are failed to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
* Measurable disease according to RECIST, v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
* Must have recovered from all side effects of their most recent systemic or local treatment (\&lt;CTCAE grade 3)
* Life expectancy greater than 12weeks

Exclusion Criteria:

* Prior treatment with PARP inhibitors
* Symptomatic CNS metastases
* History of or known carcinomatous meningitis
* Concurrent administration of any anti-cancer therapies other than those administered in this study
* Pregnant or lactating women
* Refractory nausea and vomiting, malabsorption, total gastrectomy, external biliary shunt or significant bowel resection that would preclude adequate absorption.
* Uncontrolled medical illness (such as infection requiring treatment with intravenous antibiotics)
* Severe or unstable angina, myocardial infarction or ischemia requiring coronary artery bypass graft or stent within the previous 6 months, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment or New York Heart Association (NYHA) Class II to IV heart disease.
* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
* Known hypersensitivity to IDX-1197 or any of the excipients of the product
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection

This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken once daily at bedtime for the management of multi-site pain associated with Long COVID.


Eligibility Criteria:
Major Inclusion Criteria:

* The patient is male or female, 18 to 65 years of age, inclusive.
* The patient has a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.
* The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.

Major Exclusion Criteria:

* The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
* The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
Barrow Ruptured Aneurysm Trial

With evolving endovascular technologies there is a growing debate centered on the relative safety and efficacy of the currently accepted alternatives for the treatment of ruptured cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.

The planned trial enrolled 250 subjects per arm. Subjects are followed postoperatively and outcome endpoints will be assessed at Discharge, 6 Months, 1 Year, 3 Years, and 6 Years. One hundred (100) subjects will participate in neuropsychological testing at 1 Year; after the 100th subject an interim data analysis will be performed and the viability of future neuropsychological testing will be determined. Subjects will receive preoperative, intraoperative or postoperative, 3 Year follow up, and 6 Year follow up angiograms. In this fashion immediate clinical outcome, including peri-procedural morbidity and mortality, will be assessed as will long term outcome, both clinical and angiographic.

Eligibility Criteria:
Inclusion Criteria:

* Acute subarachnoid hemorrhage (SAH)
* Confirmed by CT scan or lumbar puncture
* Age 18-80 years
* Ability to give informed consent (subject or legally authorized representative)
* No anatomic inclusions

Exclusion Criteria:

* Traumatic subarachnoid hemorrhage
* Presents to hospital \>14 days post-bleed
* SAH caused by other primary disease
* No anatomic exclusions
Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize the your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought that IL-2 may help control chronic GVHD by stopping the donor's immune system from 'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in combination with steroids to treat cGVHD.

You will give yourself or be given IL-2 daily through an injection under your skin. You should rotate the injection site, if possible. You will do this once every day for 12 weeks. You will then have 4 weeks off of IL-2. During the first 6 weeks of IL-2, you will continue to take steroids without changing the dose your doctor has set for you while you are on IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you take.

While you are on study, a member of the study team will examine you to evaluate your cGVHD. These assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs and gastrointestinal system.

You will have clinic visits for evaluation of toxicity and clinical benefit approximately every 4 weeks. You will also have immunologic assays approximately every 8 weeks. Immunologic assays will measure the effect of IL-2 on immune cells.

You will be on the study for about 16 weeks. You may continue on study treatment for longer if you experience a clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
* Steroid refractory cGVHD with systemic therapy onset within the prior 6 months
* No more than 2 prior lines of cGVHD therapy
* Estimated life expectancy \> 3 months
* Adequate organ function

Exclusion Criteria:

* Ongoing prednisone requirement \> 1 mg/kg/day (or equivalent)
* Concurrent use of calcineurin-inhibitors plus sirolimus
* History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura
* Active malignant relapse
* Active uncontrolled infection
* Uncontrolled cardiac angina or symptomatic congestive heart failure
* Organ transplant (allograft) recipient
* HIV-positive on combination antiretroviral therapy
* Active hepatitis B or C
* Pregnant or breast-feeding
Vallomix Socket Preservation Study

This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction, the jawbone surrounding the removed tooth can shrink, affecting future implant placement. By placing a bone graft material in the extraction socket, we aim to maintain adequate jawbone space for future implants. This study compares how well the mixture of vallos®f (human source bone) and Bio-Oss (animal source bone) \[test\], and vallos® only \[control\] grafting materials work.

Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study. Participants will be randomly assigned to either the mixture of vallos®f and Bio-Oss (test) group or the vallos® only (control) group.

Throughout the approximately 2-year study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material placement, and dental implant placement. After the crown is placed on the implant, participants will attend follow-up visits.

Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. At least 18 years old
3. In need of one posterior tooth (premolar or molar), excluding third molar molars, planned for extraction and replacement with a dental implant
4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
5. At least one retained natural tooth adjacent to the study site

Exclusion criteria

1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
2. Previous interventions performed involving soft and/or bone grafting in the study site
3. Active treated caries
4. Uncontrolled periodontal disease present
5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
8. Self-reported use of smokeless tobacco or e-cigarette
9. Self-reported history of current alcohol or drug abuse
10. Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c \> 8.0 within last six-month
11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
A Multiple-center Study on the Effect of Different Ways of Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With More Than 50% Solid Components

A multiple-center study on the effect of different ways of lymph node dissection on the prognosis of less than 3cm ground glass nodules with more than solid components


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 75 years;
2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
3. The maximum diameter of the GGO is smaller than 3cm;
4. The maximum diameter of the solid component in the GGO is more than 50%;
5. The patient is able to undergo the lobectomy
6. The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

-

Patients meeting any of the following criteria are not eligible for this trial:

1. Patients with a history of using immunosuppressive or hormonal drugs;
2. Patients receiving radiotherapy or chemotherapy;
3. Patients who fail to comply with our follow-up strategy;
4. Other situations that are not in conformity with the standards and requirements of this trial.
Clinical Study to Assess Body Fluid Homeostasis After Administration of ACT-132577 in Healthy Subjects

This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests
* Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening

Exclusion Criteria:

- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia

This single-blind two-arm randomized control trial (RCT) aims to evaluate the pain perception during and following administration of dental local anaesthesia using two different systems; i.e. computer-controlled (CCLA) and conventional.

The administration of local anaesthesia (LA) is associated with pain, fear and anxiety. Computer-controlled LA (CCLA) aims to control the administration speed and reduce pain, fear and anxiety. This randomised control trial (RCT) aims to compare the pain perception after CCLA and conventional LA, and it uses dental students as both test and operator group versus an experienced dentist as an additional operator of the LA.

Eligibility Criteria:
Inclusion Criteria:

* Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.