cyrilzakka/clinical-trials huggingface dataset:
Reducing Post-tonsillectomy Pain by Tonsil Pillars Suturing.

comparing post-tonsillectomy pain with and without suturing tonsil pillars to investigate whether suturing tonsil pillars reduces the pain of post-tonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 and over.
2. patients with tonsillectomy indication due to chronic Tonsillitis.

Exclusion Criteria:

1. patients with tonsillectomy indication without chronic tonsillitis ( due to other causes).
2. chronic disease, chronic neurology disease.
3. chronic psychology disease.
4. bleeding tendency.
Study About no Antimicrobial Prophylaxis in Totally Laparoscopic Distal Gastrectomy

Laparoscopic gastrectomy has fewer infectious complications compared to open surgery. Recently, the incidence of postoperative infectious complications was greatly reduced due to the development of surgical techniques and improvement of prevention and control of surgical infection. Previous multicenter, phase II study (KSWEET-01) revealed that the incidence of infectious complications of laparoscopic gastrectomy without prophylactic antibiotics was not significantly higher than previously reported data.

Therefore, this study aim to prove the safety of totally laparoscopic distal gastrectomy without prophylactic antibiotics, specially reference to the postoperative infectious complications.

The purpose of this study was to investigate the non-inferiority of incidence of infectious complications in the experimental group that did not use prophylactic antibiotics compared to the control group using prophylactic antibiotics.

The primary endpoint is the incidence of surgical site infections within 30 days after surgery and the difference limit of the non-inferiority of the experimental group is assumed to be - 0.05 (5%). Assuming that the incidence of postoperative infectious complications in the control group is 5% and the incidence of infectious complications in the experimental group is assumed to be about 8%. It is assumed that the significant level is 5% and the power is at least 80%.

According to the above method, a total of 260 patients (130 patients in each group) are needed when 117 patients are needed in each group and about 10% of drop rates and protocol violence are considered.

Eligibility Criteria:
Inclusion Criteria:

* A patient undergoing totally laparoscopic distal gastrectomy for the gastric cancer located in the low or middle part of the stomach
* A patient who underwent limited lymphadenectomy (D1 or D1+) with clinical T1-2N0M0 stage based on 8th edition of the International Union Against Cancer (UICC) tumor node metastasis (TNM) classification
* From 18 to 75 years old
* Eastern Cooperative Oncology Group (ECOG) status 0-1
* American Society of Anesthesiologists (ASA) score I-II
* A patient with appropriate bone marrow function, renal function, lung function, and liver function
* Before the surgery, decide to participate in this study and agree with the written informed consent

Exclusion Criteria:

* A patient who underwent previous abdominal surgery
* Combined other abdominal organ cancer
* A patient who received chemotherapy and radiotherapy within the last 6 months
* Combined organ resection other than cholecystectomy
* A patient undergoing emergency surgery due to perforation or bleeding
* A patient who have received antibiotic treatment for other infectious diseases within one month of operation
* Severely malnourished patient
Cyclophosphamide As Graft-versus-host Prophylaxis After Allogeneic Stem Cell Transplantation for Multiple Myeloma

The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.

The present study is a multicenter, prospective Phase II-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group.

In this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

1. Multiple myeloma newly diagnosed with deletion 17p or translocation 4;14 or multiple myeloma with 1. or 2. relapse after autologous stem cell transplantation
2. Patients age: 18 - 65 years at time of inclusion (female and male)
3. Performance status ECOG \< 2
4. Availability of haploidentical, matched or mismatched related or unrelated donor
5. Patients understand and voluntarily sign an informed consent
6. The study population includes female of childbearing potential (FOCP). FOCP have to agree to comply with the applicable contraceptive requirements of the protocol as named below for the duration of the study and 6 months after end of study or having post-menopausal status or be permanently sterilized (at least 6 weeks post-sterilization).
7. Men who are sexually active with FOCP must be instructed to use male contraception (condom) in order to avoid exposure of an existing embryo/fetus. Contraception should be continued until 6 months after end of study.

Exclusion Criteria:

1. Severe active infection or other uncontrolled severe conditioning
2. Severe renal, hepatic, pulmonary or cardiac disease, such as:

   * Total bilirubin, SGPT or SGOT \> 3 times upper the normal level
   * Left ventricular ejection fraction \< 30 %
   * Creatinine clearance \< 30 ml/min
   * DLCO \< 35 % and/or receiving supplementary continuous oxygen
3. Positive serology for HIV
4. Pregnant or lactating women (positive serum pregnancy test)
5. Women of child-bearing potential with unclear contraception
6. Age \< 18 and \> 65 years.
7. Uncontrolled invasive fungal infection at time of screening (baseline)
8. Serious psychiatric or psychological disorders
9. Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal nerve. Current treatment strategies include oral medications as first line therapy with surgical interventions reserved for those patients who are refractory to medications or unable to tolerate medication side effects. Despite these current treatment options, many patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine adjustment of the needle tip and direct observation of the medicine.

Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic nerve pain with great success. Steroids can be short or long acting in duration with varying side effects. If there exists a difference in duration of action, using the longer acting drug will provide a greater period of symptom relief for the patient and may allow the patient to undergo fewer interventional procedures.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting to the Northwestern Pain Center who are eligible and scheduled to receive a ultrasound-guided trigeminal nerve block.

Exclusion Criteria:

* Exclusion is the same for patients who are not eligible for ultrasound guided nerve blocks.
Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers

The main objective of the study is to refit existing soft lens wearers with two different daily disposable contact lens types, Lens A and Lens B, to determine their performance after one week of wear.

This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-wear design involving two different daily disposable lens types. Each lens type will be worn for approximately one week, during which participants record their subjective lens-wear experience.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears soft contact lenses, for the past 3 months minimum;
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere -1.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Habitually wears one of the study contact lenses;
3. Has any known active\* ocular disease and/or infection that contraindicates contact lens wear;
4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
8. Has undergone refractive error surgery or intraocular surgery.
Observational Study for Assessing Treatment and Outcome of Patients With Primary Brain Tumours Using cIMPACT-NOW and 2021 WHO Classification

Every new classification depends on its prognostic power and on the type of treatment given. With the rapid evolution of diagnostic methods and the advance in new treatments, there is much less reliable information available on how patients with newly defined brain tumour entities should be treated and what to expect from the current treatments.

The goal is to determine whether the new 2021 WHO classification, based on cIMPACT-NOW recommendations, results in more homogeneous patient groups than the old 2016 classification. Furthermore, it will help derive provisional guidelines on how patients with these newly defined tumour entities are best treated. These recommendations will be based on the experience of EORTC investigators with chosen treatments and their experience as reported in this data collection report.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or recurrent primary brain tumours, notably those considered rare brain tumours or rare subtypes of common brain tumours.
* Archival tumour tissue from primary tumour available at the site. Representative tissue from first surgery is preferred, but tissue from surgery for recurrence is allowed.
* Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
* Inclusion in interventional studies prior and after
RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin

The aim of this study is to compare two therapeutical strategies concerning the combination therapy (peginterferon alfa-2a and ribavirin) in naïve patients with chronic hepatitis C of genotype 1. "Reference" strategy corresponding to standards of care recommended by the French consensus conference versus "Test" strategy corresponding to adaptation strategy of ribavirin dose during the first week according to AUC (area under the curve) of ribavirin plasmatic concentration after the first intake (Day 0) of 600 mg


Eligibility Criteria:
Inclusion Criteria:

* 65 years \>Age \>= 18 years
* Chronic hepatitis C documented by PCR performed within 3 months and at liver biopsy within 18 months or with serum markers of fibrosis performed within 3 months before inclusion or FibroScan performed
* Naive patients for who the physician decided to initiate a combination treatment of chronic hepatitis C with pegylated interferon alfa-2a plus ribavirine
* Genotype VHC-1
* Compensated liver disease (Child-Pugh \<=6)
* Negative HBsAg test and HIV-RNA test
* Negative pregnancy test at baseline in women in age of procreation and efficient contraception all along the treatment period, and up to 7 months after discontinuation for women and men
* Signed consent form
* Patient with a social cover

Exclusion Criteria:

* Non HCV liver disease
* Non-1 HCV genotype
* Organ transplant whatever the organ
* Clinical or radiological evidence of liver carcinoma
* Severe psychiatric disorder
* Non compensated thyroid dysfunction
* Woman pregnant or breast-feeding
* Recent history of epilepsy (less than 6 months)
* Absolute contraindications to one of the drug of combination therapy
* Biological abnormalities at pre-treatment check-up, such as:

Neutropenia (\<1500/mm³); Haemoglobinemia (\<13 g/dL for men et \<12 g/dL for women); Thrombopenia (\<90 000/mm³);

* Kidney failure (creatinine clearance\>70 ml/min)
* Hypersensitivity to epoetin or one of its excipients
* Treatment by epoetin within 2 months prior inclusion
* Chronic cardiac failure (grade III or IV - NYHA classification)
* High blood pressure unwell-controlled (SBP \> 180 mmHg during inclusion in spite of hypertension treatment)
* Previous history or risk of venous thrombosis
* Major surgery within the previous 3 months
Nurse-led Program Efficacy on Blood Pressure Control

The diagnosis and control of hypertension depend on accurate measurements of blood pressure (BP); alternative approaches to measuring BP, such as ambulatory blood pressure monitoring or home blood-pressure self-measurement (HBPM), are gaining increasing acceptance in the diagnosis of hypertension and the monitoring of hypertensive patients.To achieve accurate BP measurements at home, measurement guidelines must be closely followed. However, previous studies have shown that patient compliance is in most cases unsatisfactory.The study aims at evaluating the efficacy of a family nurse (FN)-led home blood pressure management (HBPM) training program in improving BP control based on a comparison with routine care and management.

The quality of HBPM was found to be higher in patients who received some form of training in BP measurement from healthcare professionals than in patients who did not receive training. Although self-estimation of BP may be prone to error, this risk can be minimized through adequate patient education and training that includes simple but nonetheless important recommendations. However, unclear is whether specific training offered by nurses, who frequently have a close relationship with their hypertensive patients, could result higher patient adherence to HBPM recommendations. Therefore, we assume that a specifically tailored training program conducted by a family nurse (FN), when provided in addition to usual care, could improve patient adherence to HBPM recommendations.

Study design: single-blind, multicenter, randomized controlled trial.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of hypertension.
* Patients who visited one of two family practice offices located in Chieti or Pescara.
* Speaking and reading Italian.
* Having an active phone number and an email address.
* Providing a signed informed consent.

Exclusion Criteria:

* Mental illness.
* Cognitive impairments.
* Pregnancy.
* Institutionalization (nursing home).
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).

The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, "Blood Detected" or "No Blood Detected".

All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., "Blood Detected" or "No Blood Detected".

The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 -80 years
* Ability to give written informed consent
* Clinical suspicion of bleeding

Exclusion Criteria:

1. Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure \<100 mmHg,heart rate \> 100 / min)
2. Known current stenosis of the GI tract
3. Subject is using a pacemaker or other implantable electrical device
4. Dysphagia or difficulties in swallowing pills the size of the capsule
5. History of achalasia or known esophageal dysmotility
6. History of gastroparesis
7. History of severe constipation (1 bowel movement per week or less)
8. Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
9. Presence of psychological issues preventing participation
10. Stomach bezoar
11. History of Crohn disease
12. History of diverticulitis
13. History of bowel obstruction
14. Suspected gastrointestinal tumor disease
15. Planned MRI investigation (MRI needed before the capsule is excreted)
Active Drug Comparative, Multi-center, phase3 Clinical Study to Evaluate the Efficacy and Safety of PG201 in Osteoarthritis Patients

The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients.

This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308.

non-inferiority margin: 8mm

Patients in the PG201 group were prescribed two PG201 tablets per day(BID) and one celecoxib placebo capsule each in the morning and evening per day for 8 weeks.

Patients in the celecoxib group were prescribed celecoxib 200 mg (one 200 mg capsule and one celecoxib placebo capsule) and one PG201 placebo tablet each in the morning and evening per day for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥40 and ≤ 80years of age.
2. Patients who meet the American College of Rheumatology clinical plus radiographic classification criteria for idiopathic osteoarthritis of the knee, which are defined as follow:

   a patient who had knee pain and radiographically diagnosed osteophytes and met at least one of the followings.
   * Age\> 50 years.
   * Morning stiffness for less than 30 minutes.
   * Crepitus during movement of the weight-bearing knee.
3. Patients with symptomatic primary osteoarthritis of the knee at least in the last 3 months prior to screening.
4. Patients who received Nonsteroidal antiinflammatory drugs (NSAIDs)/Cyclooxygenase-2 inhibitor for the treatment of arthritis of the knee for at least 5 days a week during 4 weeks prior to screening.
5. Patients who had a score of 100mm pain VAS ≤80 mm at screening.
6. Patients who had a score of 100mm pain VAS ≥50 mm at baseline.
7. Patients should be able and willing to provide the written informed consent.

Exclusion Criteria:

1. Patients with a history of surgery or arthroscopy of the study joint within the previous 6 months.
2. Patients with trauma of study joint within the previous 12 months.
3. Patients with symptomatic hip osteoarthritis, other condition that would interfere with study assessments.
4. Patients with any other type of arthritis, active malignancies or any active GI, cardiovascular, renal, hepatic, neurologic, or psychiatric disease.
5. Patients with a known hypersensitivity or intolerance to Nonsteroidal antiinflammatory drugs (NSAIDs), aspirin or Cyclooxygenase-2 inhibitor.
6. Patients with uncontrollable hypertension.
7. Patients with any of creatinine, bilirubin, Alanine aminotransferase or Aspartate aminotransferase \> 1.5 times the Upper Lange of normal at screening.
8. Patients with a history of drug or alcohol abuse.
Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.


Eligibility Criteria:
Inclusion Criteria:

* Participant who previously consumed study formula through one year of age in MJN Project 6027
* 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
* Signed informed consent obtained for child's participation in the study

Exclusion Criteria:

* No exclusion criteria