cyrilzakka/clinical-trials huggingface dataset:
Thromboembolic Complications in Mild Covid-19 Cases

The aim of the study is to investigate the frequency of thromboembolic complications and the factors influencing them in COVID-19 cases that did not require hospitalization. For this purpose, patients registered at two different family health centers in Istanbul were retrospectively screened, and their status regarding post-COVID-19 thromboembolic events was recorded. The sociodemographic characteristics, medical history, COVID-19 treatments received, comorbidities, and current medications of all patients were examined and compared with the occurrence of complications.

Studies on COVID-19 complications in the literature have predominantly focused on patients treated in hospitals, particularly in intensive care units. Data on patients with mild to moderate symptoms who were followed up on an outpatient basis in primary care are quite limited. Therefore, our research investigated the incidence of thrombotic events within six months following infection in mild to moderate COVID-19 cases and the factors that might influence these events. Records of 961 individuals registered at two different family health centers in Istanbul were reviewed. Patients were contacted by phone, informed about the study, and data regarding their sociodemographic characteristics, medical histories, COVID-19 infection experiences, and medications used were collected. Comparative analyses (Fisher's exact test) and logistic regression tests were conducted.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Having had a confirmed COVID-19 infection verified by a PCR test
* Being monitored at a family health center without requiring hospitalization during the COVID-19 course
* Having at least 6 months elapsed since the infection
* Availability of the patient's medical records
* Absence of any language barrier or health issue that would prevent communication with the patient

Exclusion Criteria:

* Being under 18 years of age
* Having had less than 6 months since the COVID-19 infection
* Presence of any condition that prevents communication with the patient
* Incomplete or missing medical records of the patient
* History of hospitalization due to COVID-19 infection
Study of NNZ-2566 in Patients With Traumatic Brain Injury

The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).

Moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. There are currently no drugs available to reduce the brain damage or the persisting symptoms that result from TBI. The longer term goal of this study is to provide physicians with a safe and effective treatment for TBI.

Eligibility Criteria:
Inclusion Criteria:

* Non-penetrating TBI.
* Male.
* Age 18-70 years.
* Admission to hospital.
* Post resuscitation GCS 4-12.
* Have at least one reactive pupil.
* Randomization within 7 hours of injury with the ability to receive investigational product within 8 hours of injury.
* Hemodynamically stable after resuscitation (systolic blood pressure (SBP) \>100 mm Hg).
* Willing to undergo all neuropsychological and activities of daily living (ADL) testing (i.e. understand English, able to read, write, have sufficient motor dexterity and, be available for follow-up visits at 4-6 weeks and 12-14 weeks post injury).

Exclusion Criteria:

* Penetrating brain injury.
* Spinal cord injury.
* Presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the Investigator, interfere with or bias the assessment of efficacy.
* Non-traumatic brain injury.
* Known history of any medical or psychiatric disorder, or any severe concomitant disease, that in the opinion of the Investigator would interfere with or bias the assessment of efficacy. This includes the following: schizophrenia; bipolar disorder; major depressive disorder; post traumatic stress disorder (PTSD); generalized anxiety disorder; attention deficit hyperactivity disorder; neurodegenerative diseases (Alzheimer's, Parkinson's, Huntington's disease, vascular dementia, Diffuse Lewy Body Disease); stroke; brain tumor; multiple sclerosis (MS); seizure disorders; chronic pain disorder; alcoholism or substance abuse.
* Significant non-central nervous system (CNS) injuries sustained at the time of the TBI that in the opinion of the Investigator would interfere with or bias the assessment of efficacy.
* Weight \>150 kg.
* Participation in another clinical trial within the previous 4 weeks.
* Clinical state requiring greater than 6 L colloid or crystalloid fluid resuscitation prior to randomization.
* Inability to obtain informed consent from legally acceptable representative.
* Prior enrollment in this study.
* QTc Exclusions. The study will use the exclusion criteria as defined in ICH Guideline E14 to exclude patients with a risk of QT/QTc prolongation, as follows:

  * A marked baseline prolongation of corrected QT/QTc interval \>450 ms.
  * History of risk factors for torsade de pointes (e.g. heart failure, hypokalemia (serum potassium at screening (\<3.0 mmol/L)or family history of long QT syndrome).
The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty

the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.


Eligibility Criteria:
Inclusion Criteria:

* the ages of 40 and 70 years
* height 155-170 cm
* American Society of Anesthesiologists grade I or II .
* patients underwent total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* patients known to be allergic to any medicines.
* patients had a history of drug or alcohol abuse.
* patients were taking opioids or sedative medications,
* patients Inability to communicate with investigators to evaluate the postoperative pain
* patients were in need for postoperative ICU hospitalization .
* patients had a history of psychiatric conditions.
* Patients with a history of taking pregabalin or gabapentin .
A 3 Months Duration Interventional Study Comparing Hemodynamic Parameters Between Bolus and Fractionated Group.

The goal of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing Transurethral Resection of Prostate(TURP) surgery under Subarachnoid block(SAB).

Seventy-two patients aged 50 years and above belonging to American Physical status I and II are divided into two study group.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

The aim of this study is to compare the intraoperative hemodynamic status, characteristics of block of fractionated versus single bolus dose of Hyperbaric Bupivacaine in patient undergoing TURP surgery under SAB.

Seventy-two patients aged 50 years and above belonging to American Physical status I and II undergoing transurethral resection of prostate for benign enlargement of prostate under subarachnoid block are enrolled and are divided into two groups having 36 patients in each.

Group B will receive Injection 0.5 % hyperbaric bupivacaine 2.5 ml single bolus dose and group F will receive same concentration and volume of hyperbaric bupivacaine with two third dose initially (i.e. 1.6 ml) and remaining one third dose (i.e. 0.9 ml) after 60 seconds at the rate of 0.2ml/sec.

Intraoperative mean arterial pressure (MAP), heart rate, onset of sensory and motor block, duration of sensory and motor block, and total intraoperative consumption of vasopressor are observed and compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Age: 50 years and above patients undergoing TURP surgery under SAB
* American Society of Anesthesiologist's Physical Status: I and II.

Exclusion Criteria:

* Patients with history of uncontrolled hypertension.
* Patients with previous history of cerebrovascular accidents.
* Patients with history of spinal deformity.
* Patients with known allergy to local anesthetics.
* Patient with Infection at site of injection.
* Patient with history of coagulopathy.
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome

The study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.

This was a Phase II, single arm, open-label, dose titration, multi-center study which consisted of two distinct Study Periods plus an optional extension period in non-CD patients with CS. The 3 Study Periods (two distinct Study Periods plus an optional extension period) were as follows:

Study Period I \[Week 0 (Day 1) to Week-12\]: Study Period I was the dose titration period to achieve a stable therapeutic dose and to assess the efficacy and safety of osilodrostat.

The dosing regimen of osilodrostat in this study was titrated according to the following escalation sequence: osilodrostat 2 mg bid, 5 mg bid, 10 mg bid, 20 mg bid, and 30 mg bid. Dose adjustments were based on the serum cortisol values measured by the local lab at each site. Osilodrostat titration was done weekly for the initial 4-weeks, up to a maximum dose of 10 mg bid.

The mean of three 24-hour UFC (mUFC) values were measured to evaluate the efficacy in this period.

Study Period II (After Week-12 to Week-48): Study Period II was the period to assess the sustainability of efficacy and long term safety.

During Study Period II, only patients who tolerated and agreed to continue osilodrostat treatment continued on the study. The patient was administered with the stable therapeutic dose which was achieved in the Study Period I.

Optional extension period (After Week-48): Patients who continued to receive clinical benefit, as assessed by the study Investigator and who wished to enter the extension period were reconsented at Week-48. Patients who entered the extension period continued to be treated with the study drug without interruption to be assessed for efficacy and safety. Patients who continued to benefit from study treatment as assessed by the study investigator and who completed Week-72 were offered to participate in a separate long-term safety follow-up study. The optional extension period ended after all patients had completed Week-72 or had discontinued early.

Post-treatment Follow-up: All patients had 30 days safety follow-up after the last dose of study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed Cushing's syndrome \[i.e. ectopic corticotropin syndrome, adrenal adenoma, adrenal carcinoma, ACTH-Independent Macronodular Adrenal Hyperplasia (AIMAH), or Primary Pigmented Nodular Adrenal Dysplasia (PPNAD)\]
* For patients on medical treatment for hypercortisolism due to Cushing's syndrome, the washout periods had to be completed prior to baseline efficacy assessments

Exclusion Criteria:

* Patients with Cushing's disease
* History of hypersensitivity to osilodrostat or to drugs of similar chemical classes
* History of malignancy of any organ system, treated or untreated, within the past 5 years
* Patients receiving treatment for within 4 weeks or ≤5 x half-life of the agent (whichever is longer) before first dose of osilodrostat
* Patients with risk factors for QTc prolongation or Torsade de Pointes
Sirolimus in COVID-19 Phase 1

This is a double-blinded, two-arm, randomized, placebo controlled study comparing the virological efficacy of add-on sirolimus with standard care to placebo and standard care. Virological efficacy is defined as the change from baseline to day 7 in SARS-CoV-2 viral burden measured by quantitative real-time polymerase chain reaction.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female \>/=18 and \</=65 years of age at the time of consent
* Laboratory confirmed SARS-CoV-2 infection
* Investigator-estimated hospitalization duration of at least 5 days

Exclusion Criteria:

* Need for \>4 liters nasal cannula oxygen to maintain oxygen saturation \>90%
* Hypersensitivity to sirolimus
* Pregnant or breastfeeding
* Anticipated transfer to another study hospital within 72 hours
* Alanine transaminase (ALT) \>3 times the upper limit of normal
* Creatinine clearance \<30mL/min as estimated by Cockcroft-Gault
* Underlying immunosuppression due to daily \>5 mg prednisone equivalent a day, prior solid organ transplant, or other immunosuppression deemed by investigator to be potentially unsafe
* Co-administration with strong inhibitors of CYP3A4 and/or P-glycoprotein (P-gp) (such as ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin and others)
* Co-administration with strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) (such as phenytoin or rifampin)
* Anticipated surgery within 1 month
* Need for healing of a fracture or a significant soft tissue wound
Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women
2. Ages 18-65
3. Have schizophrenia or schizoaffective disorder
4. Would like to quit smoking within the next 6 months
5. Have smoked at least 10 cigarettes per day in the past year
6. Have breath CO level \> 10 ppm
7. Able to speak, read and comprehend English well enough to complete study procedures

Exclusion Criteria:

1. Pregnant, breast-feeding, or unwilling to use medically-approved contraception
2. Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
3. Medical disease that would preclude participation
4. Unstable psychiatric conditions
5. Body mass index (BMI) \< 15 or \> 38 kg/m2
6. Past-month suicidal intention, with or without a specific plan
7. Positive urine drug screen or breath alcohol level \> 0.01% at screening
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.

This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer. The anticipated treatment duration is approximately 140 days.

This is A multi-center, randomized, double-blind, parallel control，comparative clinical trial.

The primary objective is to evaluate whether the clinical efficacy of QL1209 and pertuzumab are similar in patients with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer.

The secondary objective are to evaluate whether the clinical safety and immunogenicity of QL1209 and pertuzumab are similar in patients with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years and ≤ 80 years when ICF is signed;
3. Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0); HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization; Estrogen receptor and Progesterone receptor negative.
4. Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1.
5. Baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan

Exclusion Criteria:

1. Stage IV metastatic breast cancer;
2. Inflammatory breast cancer;
3. Previous anti-cancer therapy or radiotherapy for any malignancy;
4. History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment;
5. Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy;
6. Major surgical procedure within 4 weeks prior to randomization or from which the participant has not fully recovered;
7. Serious cardiac illness or medical condition;
8. Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness;
9. Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol;
10. Pregnant or lactating
In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars

Adequate shaping and cleaning, followed by a good coronal seal, are prerequisites for a favorable outcome. The goal of root canal preparation is to create optimized canal geometry to allow effective irrigation and obturation with preservation of the original canal morphology.

The aim of current study is to evaluate the effectiveness of Fanta and Zunba rotatory instruments in cleaning of infected root canal of primary molars to those instrumented with manual K-files.


Eligibility Criteria:
Inclusion Criteria:

* Class I or II according to American Society of Anesthesiologists (ASA)
* Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
* Pathological tooth mobility
* Percussion sensitivity
* Swelling close to involved tooth accompanied with or without fistula
* The extension of radiolucency at the furcation area did not exceed half of the space between the furcation and the permanent successor
* No internal root resorption
* External root resorption (Physiologic or pathologic) limited to apical third and with at least two-third root intact

Exclusion Criteria:

* Uncooperativeness of child and/or parents or caregiver's behavior.
* Unrestorable tooth.
* Presence of calcific metamorphosis inside root canals.
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine

The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of Meninggococcal (A,C,Y and W135) Conjugate Vaccine in 2 months to 6 years-old children.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
* Healthy permanent residence 2 months to 6 years old.
* Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months.
* Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
* Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial.
* Receipt of blood or blood-derived products in the 3 months preceding vaccination
* Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
* Receipt of any live virus vaccine in the 15 days preceding vaccination.
* Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
* Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
* Thrombocytopenia.
* History of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
* Functional or anatomic asplenia.
* History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome).
* Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.
* Any condition that, in the judgment of investigator, may affect trial assessment.
Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor

The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

•CT-confirmed renal mass \> 4 to 7 cm (T1b)

Exclusion Criteria:

* Multiple renal tumors;
* Recurrence of renal tumor;
* Intolerance to iodine-containing contrast agents;
* Pregnancy;
* Patients with Bosniak 4 cysts
* Presence of other oncological diseases;
* Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system
* Absence of malignant pathology based on prior biopsy.
The Influence of Corticosteroid Treatment on Heart Function

Patients hospitalized in internal medicine departments are given corticosteroid treatment according clinical indications. Patients receive treatment at different dosage levels and in different preparations according to clinical indications. This study will investigate how corticosteroids effect the heart and specifically, longitudinal strain.


Eligibility Criteria:
Inclusion Criteria:

* Stable patients able to undergo Transthoracic Echocardiogram
* Patients beginning treatment with corticosteroids

Exclusion Criteria:

* Pregnant
* Patients recently or chronically treated with corticosteroids