cyrilzakka/clinical-trials huggingface dataset:
Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty

This is a prospective, cluster-randomized, two-arm, comparative study aimed at determining whether addition of tizanidine ( an oral muscle relaxant) to a multimodal pain regimen following primary TKA reduces opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* - Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
* ASA I - III
* Spinal anesthesia
* All patients will have a total knee arthroplasty utilizing a medial parapatellar approach with cruciate sacrificing implants and patellar resurfacing. A tourniquet will be used in all cases.
* Men and women between 18 and 80 years who are willing and able to provide informed consent

Exclusion Criteria:

* Opioid use greater than 10 mg/day morphine equivalents continuously for one month within 3 months preoperatively
* Inability to take/allergy to the protocol medications
* Contraindication to regional anesthesia
* Non-English speaking
* ASA IV or greater
* Psychiatric or cognitive disorders
* Allergy/contraindications to protocol medications.
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* Sensory/motor disorder involving the operative limb
* PCS score \>20
* Patients with severe cardiac or neurological conditions precluding the use of study medications
* Patients using anticoagulation other than aspirin for the 14-day period after discharge
Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer

The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed pancreatic ductal adenocarcinoma
* Patients and their families volunteered to test and signed informed consent.

Exclusion Criteria:

* Preoperative exclusion:

  1. Patients with metastasis (M1)
  2. Patients with tumor recurrence
  3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction
  4. Patients with poor cardiopulmonary function cannot tolerate surgery;
  5. receive neoadjuvant radiotherapy and chemotherapy before surgery;
  6. The patient or family member refuses to join the group;
  7. Pregnant patients
* Intraoperative exclusion:

  1. Intraoperative exploration of metastases in other parts besides the primary lesion
  2. Other organs malignant tumors metastasize to the pancreas
* Postoperative exclusion:

  1. pathology confirmed non-pancreatic ductal adenocarcinoma
Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 18 and 75 years old
* Without previous Helicobacter pylori treatment
* Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
* Ability and willingness to participate in the study and to sign and give informed consent
* Positive for Helicobacter pylori IgM antibody

Exclusion Criteria:

* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Decline to participate in the study
Nitazoxanide in Patients With Metastatic Colorectal Cancer

The aim of this study is to evaluate the potential efficacy and safety of nitazoxanide in patients with metastatic colorectal cancer.

Globally, colorectal cancer (CRC) is a major malignant tumor of the gastrointestinal tract which originates from epithelial cells of the colon and rectum. The efficacy of current cancer therapies is still limited by severe adverse effects on normal tissues and chemoresistance development. Therefore, recent efforts have been focused on the repurposing of existing drugs with good safety profiles for cancer treatment.

Nitazoxanide (NTZ) is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses. NTZ inhibited the proliferation of CRC cell lines at or below concentrations that normally exhibit anti-parasitic activity.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of stage IV (metastatic) CRC. Staging will be performed according to the American Joint Committee on Cancer (AJCC) 8th edition and will be documented by all investigating parameters of metastatic CRC
2. Male or female patients with age range from 18-65 years old
3. Women of childbearing age will be required to be on acceptable forms of contraception
4. No contraindication to chemotherapy (absence of myelosuppression)
5. Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
6. Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0
8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients who have known allergy to nitazoxanide or its metabolites
3. Patients with concurrent active cancer originating from a primary site other than the colon or rectum
4. Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs
Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute

This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.

No further details

Eligibility Criteria:
Inclusion Criteria:

* Age of over 40 with COPD

Exclusion Criteria:

* Children,
* New mothers; and
* Women intending to become pregnant
Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis

Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from \< 2% up to 40%.

Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.

This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Scheduled for ERCP for any reason

Exclusion Criteria:

* Absence of consent
* Language barrier
* No endoscopic advance to the papilla vateri
* Active pancreatitis at the time of the procedure
* Mental disability
Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy

An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* histologically confirmed adenocarcinoma of the prostate.
* Orchidectomy within the four previous weeks to enter the study.
* bone metastasis evidenced by bone scan.
* A hip DEXA study with a DS \< 3.
* No hormonal therapy previous to enter the study.
* ECOG performance score of 0-2.
* Signed written informed consent.

Exclusion Criteria:

* Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
* Any kind of hormonal therapy for prostate cancer previous to enter the study.
* Serum calcium corrected for albumin level \< 8.0 mg/dl.
* WBC \< 3.0x10\^3, ANC \< 1500/mm3, Hemoglobin \< 8.0 g/dl, platelets \< 75 x 10\^3/l.
* Abnormal hepatic function evidenced by ALT and AST value \>2.5 UNL
* Subjects with any other malignant disease that can affect the bone.
* Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
* Known hypersensibility to zoledronic acid or other bisphosphonates.
* Subjects that in the investigator's opinion can not cooperate with the protocol.

Other protocol inclusion/exclusion criteria may apply.
The Association of MicroRNA21-155 Levels With Acute Side Effects In Patients With Stage III NSCLC With Definitive CRT

The present investigation constitutes a prospective cohort study. The objectives encompass the assessment of miRNA expression levels in total exosomes derived from peripheral circulation tissues of stage III definite KRT NSCLC patients both at the beginning and conclusion of their treatment. Furthermore, an exploration is conducted into the potential correlation existing between alterations in miRNA levels and the incidence of acute treatment-related side effects.

Categorical variables were illustrated using both percentage distributions and numerical counts, while continuous variables were characterized using the mean accompanied by the standard deviation, and the median accompanied by the minimum and maximum values. The assessment of the normality of continuous variables encompassed a combination of visual methods such as histograms and probability plots, along with analytical tests like the Kolmogorov-Smirnov and Shapiro-Wilk tests.

In instances where data exhibited a normal distribution, Student's t-test was utilized for comparing two groups. For non-normally distributed data, the Mann-Whitney U test was applied. The comparison of categorical variables between independent groups involved Chi-square and Fisher's exact tests. Changes within dependent groups were evaluated using the Wilcoxon test. When performing pairwise comparisons among three or more groups, p-values were calculated while employing Bonferroni correction.

For the statistical analysis of the research data, the Statistical Package for Social Sciences (SPSS) version 25.0 for Windows (SPSS Inc. Chicago, USA) was utilized. The significance level was set at p\<0.05. Additionally, it is important to note that p-values falling within the range of 0.1 to 0.05 were considered indicative of a statistical trend in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* To be between 0-2 according to Eastern Cooperative Oncology Group (ECOG) performance status (PS).
* Patient with pathological diagnosis of NSCLC.
* Stage 3 Patient
* Patient with a definitive chemoradiotherapy (CRT) treatment plan.

Exclusion Criteria:

* Patient with second primary malignancy.
* History of previous radiotherapy to the thoracic region
* Patient with advanced cardiovascular disease.
* Patient with neurological or physical deficit.
* Patient with autoimmune disease
Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients

The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.
Polarization Sensitive Optical Coherence Tomography

The purpose of the study is to use the polarization sensitive optical coherence tomography (PS-OCT) developed by Singapore Eye Research Institute, to evaluate the potential OCT scleral biomarkers capable of predicting risk of myopia progression.


Eligibility Criteria:
Inclusion Criteria:

(Adult Cohort)

* Aged 21 and above
* Ability to provide informed consent
* 42 normal controls: No diabetes and free from clinically relevant eye disease that interferes with the aim of the study i.e. glaucoma, diabetic retinopathy, age-related macular degeneration, uveitis, or vascular occlusive diseases
* 76 subjects with pathological myopia (up to -12 dioptres) or staphyloma

(Children Cohort)

* Aged 10 to 18
* 23 subjects with low to moderate myopia (-0.75 to -6 dioptres)
* 23 subjects with high myopia (more than -6 dioptres)
* Ability of legal representative and subject to provide informed consent

Exclusion Criteria:

(Adult Cohort)

* Unable to give consent
* Subjects with visual acuity worse than 6/12
* Diagnosis of clinically relevant eye disease that interferes with the aim of the study (e.g. diabetic retinopathy, hereditary macular disease, glaucoma, uveitis, or vascular occlusive diseases) or conditions that may potentially result in poor quality imaging scans (severe cataract, corneal haze/opacity)
Comparing the Efficacy of Metronidazole and Minocycline Gels for the Treatment of Diabetic Periodontitis Patients

This clinical study randomized 380 diabetic chronic periodontitis patients into 4 groups: scaling and root planning alone (group I), scaling and root planning plus metronidazole gel (group II), scaling and root planning plus minocycline gel (group III), and scaling and root planning plus both metronidazole and minocycline gels (group IV). Periodontal measurements including probing depth, gingival color and texture, bleeding on probing, clinical attachment level, and recession were recorded at baseline, 7 days, and 15 days.

It was a clinical trial with four arms. The research was carried out at the Pharmacology Department, IIMC Riphah University, Rawalpindi. The sample size was calculated to be 380 using the prevalence of disease, z-score, and 5% margin of error. Written informed consent was obtained from the participants. The patients being treated for chronic periodontitis were randomly divided into four groups (I, II, III, and IV). Patients in Group I were subjected to Scaling and root planning alone. Group II patients were given metronidazole gel following Scaling and root planning. Minocycline gel was locally applied subsequent to scaling and root planning in Group III patients. The combination of metronidazole gel and minocycline gel was administered after Scaling and root planning in Group IV patients. Scaling and root planning of all the patients was done. Periodontal probing depth, the color of the gingiva, texture of the gingiva, bleeding on probing, clinical attachment level, and recession were recorded for each patient at baseline visit, after 7 days, and after 15 days to determine and compare the efficacy of local administration of drugs.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed diabetic patients on either hypoglycemics or insulin therapy suffering from periodontitis

Exclusion Criteria:

Pregnant or nursing mothers Patients with gestational diabetes Alcoholics Patients under any anti-inflammatory or antibiotic drugs (daily for ˃7 consecutive days) within the last two months of elimination before entering the study.

Known allergy to minocycline, or metronidazole. Periodontal surgeries in the past Smoking
Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs

Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.


Eligibility Criteria:
Inclusion Criteria:

* males and females \>=18 and =\<75 years
* For CD subjects: hsCRP \> 5 mg/L and Harvey-Bradshaw Index \> 8 OR when HBI cannot be determined (ie if stoma is present) or hsCRP \< 5mg/L then: active lesions on colonoscopy or flexible sigmoidoscopy or active Crohn's disease on CT or MR enterography
* For UC subjects: diagnosis of UC \> 3 months; must have endoscopy to confirm active disease during screening; total mayo score of 6 to 12 points and moderate to severe disease on endoscopy

Exclusion Criteria:

* Pregnancy or breastfeeding
* TB or active enteric infections
* Entero vesicular fistulae
* Prior use of natalizumab or vedolizumab
* Right or left heart failure including symptomatic diastolic dysfunction or unexplained elevation of troponin I (\>0.05 ng/mL)
First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And/or Metastatic Solid Tumours

The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.

In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria.

Study scheme is based on Modified Bayesian Optimal Interval (BOIN) design.

The BOIN design works by partitioning the probability of toxicity into a set of intervals. This design makes dose-selection decisions determined by the interval in which the probability of toxicity for the current dose is believed to reside. BOIN seeks a dose with probability of toxicity close to some pre-specified target level.

Total number of patients will be 30 (plus 10 replacements if Dose Limiting Toxicity (DLT) is not evaluable).

Study treatment will be up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of understanding and complying with protocol requirements.
2. Male or female patient aged ≥18 years at Screening.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant/ineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).
5. Written informed consent given by the patient before the initiation of any study procedures.

Exclusion Criteria:

1. Unable to take oral medications.
2. Clinically active central nervous system metastases and/or carcinomatous meningitis.
3. Major surgery within 30 days before the first IMP dose.
4. Pregnant or breastfeeding women.
5. Known allergy to excipients of the IMP.
6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.
7. Participation in another clinical study within 4 weeks before the first IMP dose.