cyrilzakka/clinical-trials huggingface dataset:
Influence of Thyroid Hormones on the Woundhealing Process

Main goal of this clinical investigation is to investigate different cytokines in wound fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate if different cytokine levels in euthyroid vs. hypothyroid patients exist and to what extent these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1. From the literature these 4 factors seem to be the most reasonable to measure and to focus on. Additionally we focus on these 4 factors for financial reasons, technically there wouldn't be a problem to measure more, which is correlated with higher costs. Besides, more than 6 factors would mean larger amounts of sample fluids needed, which would cause technical problems. These factors don't have to change in the same direction. Secondarily, we believe that differences in cytokine profiles of hypothyroidism vs. euthyroidism will correlate to differences in duration and clinical characteristics of the wound healing process.


Eligibility Criteria:
Inclusion Criteria:

* Near total or total thyroidectomy because of struma multinodsa (nodular goiter) with or without substitution of thyroid hormone after operation
* Total thyroidectomy because of papillary carcinoma of thyroid gland (T1/T2 carcinoma, N1, M0) with planned radio-ablative therapy (RAT) without or with rhTSH

Exclusion Criteria:

* Pat\< 18 years
* Immune disease of thyroid gland (Graves disease)
* Severe immunodeficiency
* Immunosuppressive medication because of solid Organ transplantation
* Hepatitis A/B/C or HIV
* All exclusion criteria for any surgical procedure
Effect of Practical Demonstration to Use Nasal Spray and Apply Intranasal Ointment on Epistaxis

To compare the result of verbally educating the parents about method of intranasal antiseptic cream application versus practically educating and demonstrating how to apply cream intra nasally.

The primary outcome variables was control of epistaxis through history and clinical examination on follow up visits

Eligibility Criteria:
Inclusion Criteria:

* The children of age less than 12 years presenting with anterior recurrent epistaxis

Exclusion Criteria:

* o Children with bleeding disorders.

  * Children with liver and renal failure/dysfunction.
  * Children using anti-coagulants.
  * Those children who have gross deviated nasal septum or nasal polys etc.
  * Cases who had history of nasal injuries secondary to trauma.
Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

Whether prophylactic antibiotics should be administered in the endoscopic secondary prevention of GVB or not is unclear. In this non-inferiority trial, we are aimed to evaluate whether prophylactic antibiotics are essential in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

Prophylactic antibiotics like third-generation cephalosporin is recommended for acute gastroesophageal variceal bleeding (GVB). Endoscopic sequential therapy is an option in the secondary prevention of acute gastroesophageal variceal bleeding (GVB). However, the value of prophylactic antibiotics in the endoscopic secondary prevention of GVB is still unclear. It's assumed that the procedure of needle puncture under endoscopy will cause iatrogenic variceal bleeding. Besides, the surface of intraluminal varices is nonsterile, and injection of sclerosing agent or tissue adhesive will put patients at a risk of bacteremia. As a result, it's rational to use antibiotics prophylactically in the endoscopic sequential therapy of GVB. While giving antibiotics in all patients might cause abuse of antibiotics. In clinical practice now, the prophylactic administration of antibiotics is quite subjective. We observe that quite a lot of cirrhotic patients had no infection after endoscopic secondary prevention for gastroesophageal variceal bleeding, even they have not been administered prophylactic antibiotics. In this non-inferiority trial, we are aimed to evaluate whether no value of prophylactic antibiotics will increase the postoperative infection or not, in the endoscopic secondary prevention of cirrhotic patients with gastroesophageal variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

Cirrhotic patients with a history of gastroesophageal variceal bleeding that are readmitted for endoscopic secondary prevention, and are willing to sign an informed consent form.

Exclusion Criteria:

1. Allergy to cephalosporin.
2. The patient is unwilling to sign the informed consent form.
3. Already have concurrent infection before the endoscopic operation.
4. Already have fever (body temperature \> 37.5 ℃) before the endoscopic operation.
5. Have granulocyte deficiency (neutrophil count below 0.5 \* 10 \^ 9/L) before the endoscopic operation.
6. Have massive pleural effusion or ascites before the endoscopic operation.
Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating

The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.

This is a retrospective, prospective, post-market, observational, single-center, single surgeon study evaluating the use of the SeaSpine Shoreline device. Patients will be identified by the Investigator as needing, or already received the device during a cervical fusion surgery and meeting all the inclusion and none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Appropriate patient, as determined by the Investigator, scheduled for an elective cervical spine fusion to treat adjacent level cervical disc herniation or degeneration resulting in cervical radiculopathy or myelopathy
2. At least 18 years of age
3. Failure of nonoperative care
4. Previous anterior cervical plating
5. Psychosocially, mentally and physically able to comply with this protocol including adhering to follow-up schedule and study requirements

Exclusion Criteria:

1. Pregnancy or anticipated to become pregnant during the course of the study
2. No previous cervical spine surgery
3. Non-instrumented cervical fusion
4. Cervical fusion with separate plate fixation
5. Unwilling or unable to sign consent
6. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
7. Currently a prisoner
Intraoperative Flow Cytometry In Colorectal Cancer

This study was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.

Tissue samples from normal and cancerous colon epithelium are collected intraoperatively following standard colectomy and analyzed blindly by flow cytometry, which reports, in less than 10 min, on the origin of the sample based in the estimation of DNA and tumor index.

Eligibility Criteria:
Inclusion Criteria:

biopsy proven colorectal cancer signed informed consent for participation

Exclusion Criteria:
A Phase I Study of ZN-d5 in Chinese Subjects With Non-Hodgkin Lymphoma

A phase I dose-escalation, open-label, multicenter study to assess the safety, tolerability, clinical activity, and pharmacokinetics (PK) of ZN-d5 in Chinese subjects with non-Hodgkin lymphoma (NHL).

For the Phase I dose escalation study of ZN-d5, it is planned that after the starting dose, subsequent dose assignments will be made by means of a model-assisted design, until the MTD or RP2D is determined in the Chinese population.

Eligibility Criteria:
Inclusion Criteria:

1. NHL, relapsed from or refractory to at least 2 prior lines of systemic therapy (excluding radiotherapy and surgery); subjects must have failed or not be candidates for available standard therapy expected to provide clinical benefit.
2. Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use contraception while on study.
3. Eastern Cooperative Oncology Group performance status ≤ 1.
4. Adequate blood and other organ function, defined by the following criteria:

   1. Neutrophil count (ANC) ≥ 1.0 × 109/L.
   2. Platelet count ≥ 75 × 109/L at least 3 days after platelet transfusion (≥ 50 × 109/L permitted if the bone marrow is \> 50% lymphoma cells).
   3. Hemoglobin ≥ 8.0 g/dL.
   4. Coagulation parameters ≤ 1.5 × upper limit of normal (ULN).
   5. Liver enzymes ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN.
   6. Creatinine clearance ≥ 60 mL/min.

Exclusion Criteria:

1. Received any of the following prior to start of ZN-d5 treatment:

   1. Systemic administration of antineoplastic agents (including investigational agents) within the shorter of 28 days or 5 half-lives.
   2. Major surgery within 28 days.
   3. Radiotherapy within 14 days.
   4. Autologous or allogeneic stem cell transplantation within 60 days, or receiving immunosuppression for active graft-versus-host disease.
   5. Use of strong CYP3A4 inhibitors, P-gp inhibitors or QT prolonging agents within 5 half-lives, or potent or moderate CYP3A4 inducers within 14 days.
2. Ongoing and clinically significant non-hematologic toxicity related to prior antineoplastic therapy.
3. Presence of major cardiovascular system diseases (including QTcF \> 480 msec).
4. Positive serology for human immunodeficiency virus, hepatitis B, or hepatitis C unless no detectable hepatitis B or C viral load.
5. Unable to take oral drugs or presence of severe gastrointestinal abnormalities.
6. Active and uncontrolled clinically significant infection.
7. Other active systemic malignancy or other severe, unstable, or poorly controlled acute or chronic medical conditions.
8. Prior treatment with venetoclax or other BCL-2 inhibitors.
9. Primary or secondary CNS lymphoma.
10. Presence of post-transplant lymphoproliferative disease, Burkitt's lymphoma, Burkitt-like lymphoma, T lymphoblastic lymphoma and T lymphoblastic acute leukemia.
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer

The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.

The main questions it aims to answer are:

* 5-year disease-free survival
* 5-year overall survival
* 5-year locoregional recurrence
* Adverse events after radiation therapy
* Quality of life

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

* Disease status evaluation including physical and radiological examination
* Quality of life assessment with questionnaires (BREAST-Q)
* Adverse event assessment according to CTCAE version 5.0


Eligibility Criteria:
Inclusion Criteria:

* Female with age 19 or older
* Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy
* Underwent neoadjuvant chemotherapy
* Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy
* Eastern Cooperative Oncology Group performance status 0-2
* Informed consent

Exclusion Criteria:

* Previous history of radiation therapy to the chest
* Distant metastasis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.


Eligibility Criteria:
Inclusion Criteria:

* Male or female infected with human immunodeficiency virus (HIV) and Cluster of Differentiation 4+ (CD4+) cell count ≥50 cells/µL and plasma HIV ribonucleic acid (RNA) \<50,000 copies/mL
* Receiving combination anti-retroviral therapy (ART) for at least 6 weeks before enrollment with no intention of changing therapy for 3 months after randomization
* Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of study vaccine.

Exclusion Criteria:

* History of opportunistic infections within 12 months before the first study vaccination
* History of non-infectious acquired immune deficiency syndrome-related illness such as Kaposi's sarcoma, wasting syndrome, or HIV-associated nephropathy
* History of invasive pneumococcal disease
* Known hypersensitivity to any vaccine component
* Known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Coagulation disorder contraindicating intramuscular vaccination
* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Female participant: positive urine or serum pregnancy test
* Prior administration of any pneumococcal vaccine
* Received systemic corticosteroids for ≥14 consecutive days and have not completed within 30 days of enrollment
* Received immunosuppressive therapy
* Received a blood transfusion or blood products within 6 months of enrollment
* Participated in another clinical study of an investigational product within 2 months of enrollment
* Current user of recreational or illicit drugs or recent history of drug or alcohol abuse or dependence.
A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients

This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have suffered an acute ischemic stroke and can be evaluated and treatment initiated within 6 hours after the onset of symptoms (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
* Patients who have a three dimensionally measurable lesion compatible with an acute ischemic stroke measured using MRI.
* Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
* Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
* Patients who are at least 18 years of age.
* Other criteria as specified in the study protocol

Exclusion Criteria:

* Patients who have received alteplase (t-PA) for the current stroke episode. It is assumed that all patients who are eligible will receive treatment with t-PA.
* Patients who have disability and functional limitations prior to the current stroke episode (e.g. deficit resulting from a prior stroke).
* Patients who have brain hemorrhage.
* Patients who have stroke of the brainstem or cerebellum.
* Patients who cannot be evaluated using MRI due to the presence of a pacemaker, claustrophobia, need for sedation, etc.
* Patients who have renal (kidney) disease or insufficiency.
* Patients who have active epilepsy or convulsions during the current stroke episode.
* Patients who are IV drug users or are inebriated.
* Patients who have a history of drug-related anaphylaxis.
* Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
* Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
* Patients who have a known vitamin hypersensitivity.
* Other exclusion criteria as specified by the study protocol.
Endoscopic Overlay Tympanoplasty for TM Perforation

Minimally invasive surgery is becoming more common in many surgical fields. The wide view of endoscope allows for minimally invasive transcanal approach instead of large postauricular opening. The investigators conduct this study to compared post operative pain score (by Visual Analogue Scales) between conventional microscope lateral placing tympanoplasty and endoscopic lateral placing tympanoplasty.

A main part of tympanoplasty is repair of perforated tympanic membrane. There are two popular way to approach tympanic membrane, transcanal or postauricular approach. There are two grafting techniques are applied in tympanoplasty which includes the lateral technique (overlay) and medial technique (underlay).

The lateral technique is widely used in our institute which involves placement of a graft lateral to the tympanic annulus and the fibrous layer of the tympanic remnant. The most our preferred approach in previous experience is the postauricular approach for tympanoplasty because the transcanal approach is not enough for adequate exposure. Moreover, the visualization straight through transcanal provide by the microscope is difficult by a limited view of the perforation edge due to narrowing and curved external ear canal. Postauricular approach cause many layers of tissue are violated along with a significant postoperative pain.

The author proposed this study with the aim of determining the alleviation of postoperative pain by new technique and the efficacy of endoscope for tympanoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15-70 years
* The patients who had perforation of tympanic membrane
* The perforations are all dry at the time of surgery and have been dry for at least 3 months.
* No contraindication for local or general anesthesia.
* No recent upper respiratory tract infection at least 2 weeks before surgery.
* No unstable underlying condition.
* Have at least 2 months of follow up.
* Agree to participate in the study
* Aaccept to be randomized to receive treatment
* Willing to sign an informed consent

Exclusion Criteria:

* Medial placing or inlay surgical technique
* Chronic otitis media
* Contraindication of vasoconstriction agent (adrenaline)
* Allergy to analgesic agent (Xylocaine or Lidocaine)
* Concomitant with mastoiditis.
* Previous intracranial or extra-cranial complication of chronic otitis media.
* Pregnancy
Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.

This a open, prospective, multicenter, single-arm, phase III study for clinical assessment of anti-Rh immunoglobulin (KamRho-D®) in Rh and Coombs negative women with risk sensitization. The anti-Rh immunoglobulin is an immunobiological containing high concentration of specific antibodies against factor D and "neutralizes" D antigen present in the Rh-positive fetal red blood cells (Rh +), which passed into the bloodstream of Rh-negative pregnant women (Rh).

This a phase III study in which women participants with RH and Coombs negative will receive only one dose of 1500 IU anti-Rh immunoglobulin intramuscularly up to 72 hours post exposition (child-birth) and will be following until six months to verification of negative Coombs maintenance. Safety evaluation data will include report of all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product).

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate, sign and date ICF;
* 18 years old or older;
* Mothers who are Rh-negative, negative indirect Coombs analyzed by gel agglutination method, whose just deliveries Rh positive baby.

Exclusion Criteria:

* Be participating simultaneously or have participated in another clinical trial within the last 12 months;
* Mothers who are allergic to any components of the formula;
* Mothers who have a history of IgA deficiency or IgA antibody present;
* Mothers who have a history of autoimmune hemolytic anemia with hemolysis or with pre-existing risk of hemolysis;
* Mothers who have indirect Coombs test positive at the beginning of the treatment;
* Rh-negative mothers whose delivered Rh-negative babies;
* Abnormalities of the coagulation system;
* Patients who made use of vaccines made with live pathogens in the last 03 months or will make during the study;
* Patients with clinical diagnosis of prenatal liver and / or severe nephropathy;
* Principal Investigator of the study criteria.
Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis) can serve as an additional treatment option besides standard therapy with compression stockings, common pain medication and physical treatments. This randomized, double-blinded trial compares efficacy and safety with placebo.

Enzymes are absorbed in the small intestine and taken up into the bloodstream, at least to some extent. There, they act in an anti-inflammatory manner, as was first described for the serine protease trypsin. Similarly, the cysteine protease bromelain, extracted from the stems of pineapples, is an effective phytotherapeutical drug with anti-inflammatory properties.Proteases have also been indicated to show a certain improvement of the fluidity of the blood. An additional component of the oral enzyme combination can be rutoside, or rutin, a flavonoid known to have cytoprotective and anti-inflammatory properties.

Eligibility Criteria:
Inclusion Criteria:

* male ог female patients with thrombophlebitis in the upper extremities (with ог without varicosis);
* age \~ 18 years;
* acute thrombophlebitis in the lower leg
* moderate to severe pain as monitored on a visual analog scale (VAS, value ≥ 3 cm)
* pain under pressure
* presence of at least three of the following symptoms: skin redness, hyperthermia, phlebitic cords, feeling of heaviness and tenseness.

Exclusion Criteria:

* known deep phlebothrombosis
* flourishing ulcus cruris
* arterial occlusive disease
* peripheral neuropathy
* malignant disease
* concomitant concomitant treatment ог а therapy which ended less than 7 days before baseline with corticosteroids, diuretics, anticoagulative agents, platelet aggregation inhibitors and systemic/topical use of anti-inflammatory agents, other preparations for veins and analgesics;
* known intolerance against the active ог the inactive ingredients of the study medication (especially lactose);
* pregnancy
* lactation,
* known alcohol or drug abuse
* participation in another clinical study
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Genotype 1, chronic hepatitis C
* Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant