cyrilzakka/clinical-trials huggingface dataset:
Trial of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003142 in Participants with Rapidly Progressive ADPKD

Eligibility Criteria:
Inclusion Criteria:

* Able to understand the procedures of this trial and provide written informed consent voluntarily;
* Age between 18 to 55 years, male or female;
* ADPKD diagnostic criteria were met before randomization;
* Rapidly progressive ADPKD criteria were met.

Exclusion Criteria:

* 12 weeks prior to screening, patients had taken tolvaptan or another ADPKD improvers, or patients who were assessed by the investigator to be likely to use diuretic during the trial period;
* Praticipants who are unable to feel thirst, or have difficulty with fluid/food intake;
* Patients who have previously received decompression surgery for renal cysts; or who received major surgery within 12 weeks before signing the ICF;
* The investigator think that the praticipant is unable to comply with the requirements of the trial or cannot be evaluated by the trial.
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 45
* weight : over 55kg and 18.5 \< BMI, 25.0
* have to give their consent to participating clinical trial by oneself

Exclusion Criteria:

* has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc \> 430ms or uncontrolled arrhythmia
To Compare Efficacy and Safety of CT-P16 and European Union-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

To demonstrate that CT-P16 is similar to EU-Approved Avastin in terms of efficacy as determined by objective response rate (ORR) during the Induction Study Period


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as recurrent disease or stage IV
* has at least 1 measurable lesion by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1

Exclusion Criteria:

* has predominantly squamous cell histology non-small cell lung cancer
* had surgery for metastatic non-squamous non-small cell lung cancer (nsNSCLC)
The Usefulness of the New EHS/AHS Classification of Primary Umbilical Hernias in the Selection of Method of Their Treatment

The aim of the study is to assess the usefulness of the new classification of primary umbilical hernias in the choice of treatment of patients.

The study is conducted as a retrospective analysis of material from the hospital database

A retrospective analysis will include patients operated on in the Department of General Surgery of the Hospital of the Brothers Hospitallers in the period from January 2016 to December 2022. The incidence of recurrence will be assessed based on outpatient records and a telephone survey. Hernias will be classified according to the EHS/AHS guidelines as small, medium and large. The qualification will take into account the old and new classification of hernias.

Eligibility Criteria:
Inclusion Criteria:

* Repair surgery for primary umbilical hernia

Exclusion Criteria:

* Repair surgery for recurrent umbilical hernia
Study of Different Pain Scores in Single-Port Access (SPA) Laparoscopic Hysterectomy Versus Conventional Laparoscopic Hysterectomy

Purpose:

The attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as Single-Port Access (SPA) laparoscopic surgery. This new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. In this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-60, female
* Symptomatic (Dysmenorrhea, Palpable mass, Pelvic pain or discomfort, Urinary symptom, Increasing size, Menorrhagia) myomas or adenomyosis
* Suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (USG)
* At least a 6-month thorough follow-up record available
* Informed consent

Exclusion Criteria:

* Endometrial hyperplasia without myoma or adenomyosis
* Body Mass Index more than 30
* Huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in USG
Comparison of Hemoccult, Magstream and OC-Sensor Faecal Occult Blood Tests in Colorectal Cancer Screening

Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 74 years
* Informed consent signed

Exclusion Criteria:

* Recent digestive symptoms
* Complete colonoscopy less than 5 years ago
* Personal history of colorectal cancer or colorectal adenoma or colonic disease requiring regular colonoscopy surveillance
* Familial history of colorectal cancer in a first degree next of kin before 65 years, or two cases in first degree next of kin.
* Severe extra-intestinal disease
* Screening ill-timed (ex. depression)
Diagnosis of Tuberculosis in Swiss Children

1. The primary objective is to improve the sensitivity of novel immunodiagnostic tests for detection of TB disease in children.
2. The secondary objective is to determine biomarkers that discriminate children with TB infection and disease.

1. This will be done by measuring a variety of parameters in the blood samples and compare them with the current diagnostic gold standard for TB or for culture/NAAT non-confirmed TB cases a consensus case definition is used.

   Currently available immunodiagnostic tests (IGRA/TST) will be compared to novel immunodiagnostic tests which will include:
   * several novel, additional M. tuberculosis-specific Antigens
   * cytokines that are highly expressed
2. Since there is no diagnostic gold standard for TB infection we will rely on a clinical composite reference standard for diagnosing TB infection. Biomarkers will be determined by:

   * including M. tuberculosis-specific antigens that are specifically expressed in either TB infection or disease,
   * measuring phenotypes and cytokine production of M. tuberculosis-specific cells.
   * performing NMR Analysis with biofluids in order to identify metabolomic signatures in patients with TB disease and TB infection

Eligibility Criteria:
Inclusion Criteria:

* all children / adolescents \< 18 years of age undergoing evaluation for TB exposure, infection or disease.

Exclusion Criteria:

* children / adolescents with TB infection or disease who have already been started on anti-mycobacterial treatment, children who have been treated for TB previously.
Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial

Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.


Eligibility Criteria:
Inclusion Criteria:

* 1.Clinical diagnosis of chronic fatigue syndrome, 2.Age between 18 to 65 years old. 3.Must be able to accept moxibustion treatment 4.Never receive any treatment or has suspended treatment over 2 weeks 5.Patients with good adherence, signed informed consent by themselves

Exclusion Criteria:

* 1.Other primary disease caused by chronic fatigue 2.Pregnancy or breast-feeding women. 3.Merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.Has took durg for insomnia treatment 5.Has received acupuncture,massage for chronic fatigue syndrome treatment 6.Suffered from infectious disease
PK and PD Crossover Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant Epoetin and Eprex, in Healthy Subjects.

The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration of 100 IU/kg in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 20 and 55 years, clinically healthy;
* BMI between 18.5 and 30;
* Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
* VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
* Human serum ferritin between 36-262 mcg / L;
* Counting of reticulocytes in peripheral blood ≤ 3%;
* Serum erythropoietin \< 30 mIU / mL.

Exclusion Criteria:

* Participation in clinical trials in the 12 months preceding the survey;
* Body weight \> 100 kg;
* Presence of iron deficiency anemia;
* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
* Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
* Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
* Clinical history of autoimmune or hereditary anemia;
* Clinical history of chronic bleeding;
* Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
* Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
* Prior therapies with erythropoietin;
* Albumin below 3.5 g/dL or higher than 4.8 g/dL;
* Signs or clinical history of bone marrow aplasia;
* History and clinical or laboratory liver disease;
* History and clinical or laboratory nephropathy;
* Principal Investigator of the study criteria.
Sun Protection Factor Assay (SPF Assay 206/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Pregabalin Treatment and Prevention Post-herpetic Neuralgia

Pregabalin is effective on herpetic neuralgia, but whether can prevention post-herpetic neuralgia still need to confirm.

Pregabalin has been recommended as the first-line drug for post-herpetic neuralgia (PHN) therapy currently due to its efficacy and safety. However,there was no valuable report at present on the clinical efficacy of pregabalin for acute and subacute herpetic neuralgia (SHN), expect for a smaller study which included 29 outpatients who had acute zoster pain for a period of 7-1 4 days. And it is not clear whether early application of pregabalin can reduce the incidence of PHN.

Therefore, this study was rational designed to evaluate the efficacy and safety of pregabalin in the treatment of herpetic neuralgia，and follow-up to the 8 months, evaluation whether impacting the accidence of PHN.

It is the first time in the international that treating acute herpetic neuralgia (AHN) and SHN with pregabalin as a large sample size clinical trial. The results of this study will be great significance for guiding the clinical medication.

Eligibility Criteria:
Inclusion Criteria:

1. Pain occurs within 90 days of rash onset
2. Numerical rating scale (NRS) greater than 50 mm

Exclusion Criteria:

1. Patient with nervous system disorders which impair completing the pain diaries
2. Patient with history of illicit drug or alcohol abuse within the last 2 years
Demand-driven Management of Essential Tremor

This study evaluates the effectiveness of tremor control using various strategies for implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor. Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or thalamic electrodes.

Essential tremor is effectively treated with deep brain stimulation of the ventralis intermedius nucleus of the thalamus, presumably because high-frequency stimulation disrupts aberrant cerebellar-thalamic input. For the most part, patients with essential tremor have a kinetic tremor that is present or worsened with movement. However, DBS therapy is currently continuous, and thus, stimulation occurs when the patient will not benefit symptomatically from treatment. This exposes the patient to unnecessary stimulation, which can lead to unnecessary usage of battery, unnecessary exposure to stimulation side-effects, and can possibly contribute to tolerance to DBS therapy.

One possible solution is selective stimulation when movement is required. This study will determine signals predictive of motor activity using external sensors such as EMG, and cortical biomarkers of real and imaginary movement that are well-characterized.

The primary aim is to demonstrate successful initiation and modulation of DBS therapy using the Activa PC+S system and implanted cortical or thalamic electrodes. Putative improvements in battery usage related to stimulation on-time and definition of coupling signals between thalamus and cortex that characterize tremor state are secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Appropriate candidates for DBS with essential tremor

Exclusion Criteria:

* Not meeting inclusion criteria based on tremor amplitude, neuropsychological testing, etc.
* Prior trauma to the brain on side of putative implantation of stimulator
Prospective Double-blinded Randomised Comparison of Profix Mobile to Fixed Bearing Knee Replacements

This is a randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. Participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. The literature and joint registry of Australia shows that one of the prosthesis may be inferior to the other. Our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty

Exclusion Criteria:

* refusal to participate
* other simultaneous surgery
* post traumatic osteoarthritis
* prior open knee surgery
Physiologic Indicators for Prognosis in Abdominal Sepsis Study

Early detection and timely therapeutic intervention can improve the prognosis of patients with sepsis. However, early diagnosis of sepsis can be difficult; because determining which patients presenting with signs of infection during an initial evaluation, do currently have, or will later develop a more serious illness is not easy.

Physiological deterioration often precedes clinical deterioration as patients develop critical illness. In this study, the investigators aim to evaluate vital signs in a global cohort of patients with acute secondary peritonitis, determining which parameters are statistically significant to predict in-hospital mortality and ICU admission.

The study will be a worldwide multicenter observational study. The study will include patients admitted in the surgical department with acute peritonitis during a four-month study period (February 1, 2018 - May 31, 2018).

The study will not attempt to change or modify the clinical practice of the participating physicians: neither informed consent or formal approval by local Ethics Committee will be required because of the purely observational nature of the study.

The study will be monitored by the principal investigator, which will investigate and verify missing or unclear data submitted to a central database.

The study protocol has been approved by the board of the WSES and the study will be conducted under its supervision. The board of the WSES grants the proper ethical conduct of the study.

The data collection will be anonymous, as well as the name of the patients or hospital will be not collected in the website. Every hospital will continue following their ethical standards and local rules. The list of the submitted cases will not be recognized by investigators and linked to the submitting hospital. Individual researchers will take personal responsibility of data collection of this study.

In each center, the coordinator will collect and fill the data in an online case report system. These data included the following:

* Patient and disease characteristics
* Diagnostic profiles
* Treatment profiles
* Post-operative course

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of acute (secondary) localized or diffuse peritonitis.

Exclusion Criteria:

- Clinical diagnosis of acute pancreatitis
Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program

The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.

Patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study.

The primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center.

As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed.

In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.

Eligibility Criteria:
Preoperative Inclusion Criteria:

* Age ≥ 70 years
* Geriatric patients with hip fractures Treated either with oOsteosynthesis or oEndoprosthesis
* Ability of the patient or assigned representative to understand the content of the patient information / Informed Consent Form
* Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved written informed consent

Preoperative Exclusion Criteria:

* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
RCT Comparing Lightweight vs. Heavyweight Meshes in Incisional Hernia Repair

In this randomized, controlled, prospective multicentre clinical trial with a parallel group design a large-pore, lightweight polypropylene mesh (Ultrapro®) is compared to a small-pore, heavyweight polypropylene mesh (Premilene®), within a standardized, retromuscular mesh augmentation to identify the superiority of the lightweight mesh. Included patients are examined at five scheduled follow-up visits (5 and 21 days, 4, 12 and 24 months after surgery). The primary outcome criterion is foreign body sensation 12 month after surgery. Further secondary endpoint criteria are the occurrence of haematoma or haematoma requiring surgery at the 5-day visit, seroma, wound infection, and chronic pain within 24 months postoperatively. Quality of life was investigated by the SF-36®.


Eligibility Criteria:
Inclusion Criteria:

* fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter

Exclusion Criteria:

* hernia of other location
* recurrent hernia
* incarcerated hernia
* emergency surgery
* patients with a malignancy or chemotherapy within the last 3 months
* pregnancy
* participation in other studies
* patients with a wound infection
* missing informed consent