cyrilzakka/clinical-trials huggingface dataset:
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection

The purpose of this study was to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks for treatment of acute hepatitis C (HCV), with or without HIV-1 coinfection.

The study was conducted in two steps. In Step 1, participants received four weeks of treatment with G/P for acute HCV infection and were then followed 24 weeks post treatment. Participants with HCV recurrence (reinfection, suspected relapse or undefined post-treatment viremia) or HCV virologic failure before or at the Step 1 Week 16 entered Step 2 and were offered HCV re-treatment. The remaining participants were followed in Step 1 for a total of 28 weeks. The study primary and secondary outcome measures pertain to Step 1.

In Step 2, participants were re-treated for up to 16 weeks (G/P or alternate regimen through standard of care), and were followed for 24 weeks post treatment. This post-treatment follow-up included a visit for the determination of HCV sustained virologic response (SVR12) after re-treatment. All summaries of data captured from Step 2 are pooled across HCV re-treatment regimens, as specified in the Statistical Analysis Plan.

In Step 1, study visits were scheduled at study entry, weeks 1 and 2 (on-treatment), week 4 (treatment discontinuation), and weeks 8, 12, 16 and 28 (post-treatment follow-up). In Step 2, participants had study visits during the re-treatment period, where the number of visits depended on the re-treatment regimen, and at weeks 12 and 24 post treatment. Study visits included physical examinations, clinical assessments, blood and urine collection, questionnaires, and HCV re-infection prevention counseling.

Eligibility Criteria:
Inclusion Criteria

* Acute HCV infection (or reinfection) within 24 weeks prior to entry
* Detectable HCV RNA at the screening visit

Exclusion Criteria

* Any HCV treatment during the current acute HCV infection episode
* Known preexisting cirrhosis
* Acute HIV-1 infection
* Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV)
* Chronic use of systemically administered immunosuppressive agents
* History of solid organ transplantation
* History of conditions that could interfere with the absorption of the study drug
* Concurrent use of prohibited medications
* Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation
* Females who are pregnant or breastfeeding
* Males with pregnant female partner
Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)

The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of treatment, a 9-session group therapy and a 1-day workshop followed by an individual consultation, and both are compared to standard treatment, which is one single advisory consultation. The study includes 180 patients.

The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a three-armed randomized controlled trial of ACT treatment given as a supplement to standard treatment as either 9-session group therapy or as a 1-day workshop followed by an individual consultation, compared to standard treatment, which is one single advisory consultation.

Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study includes 180 participants.

Eligibility Criteria:
Inclusion Criteria:

1. First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
2. Moderate or severe impact on daily life
3. Symptoms lasting for at least 2 years
4. Age 20-50 years
5. Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.

Exclusion Criteria:

1. Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
2. Patients with treatment demanding psychiatric disease as dominating problem
3. A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
4. Abuse of alcohol, narcotics or drugs
5. Pregnancy at time of inclusion
Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

in our study, we will investigate the impact of adding dexmedetomidine to bupivacaine for the potency of the obturator nerve block and prevention of the postoperative pain associated with transurethral surgery in comparison of obturator nerve block with bupivacaine alone

* After history taking and examination of the labs and airway of the patient , An intravenous catheter will be secured in the dorsum of the hand of non dominant hand and patients will be monitored for heart rate, noninvasive blood pressure, and oxygen saturation.
* All patients after aseptic preparation will receive subarachnoid block in lumber 3-4 or 4-5 space in sitting position.
* About 3 ml (15mg) of heavy 0.5% bupivacaine will be injected into subarachnoid space.
* After the completion of the block, patients will be laid in the supine position and subsequently waited for 5 min for fixation of drug and assessed for sensorimotor block.
* Further procedure will be performed as per the group allocation.
* ONB will be performed by classic technique 1.5cm lateral and 1.5cm caudal to the pubic tuberacle . after contact with the pubic ramus is made , the needle is redirected laterally to a point 2-3 cm deeper than the pubic ramus.(15)
* A waiting period 20 min will be allowed for the full effect of the block and then resection will be allowed to perform
* Hemodynamics (heart rate, mean arterial blood pressure) will be recorded intraoperatively and postoperative at 0, 2 and 6 hours .
* VAS score at 0,2 and 6 hours post-operatively will be assessed.
* Time to first call for analgesic requirements (duration of analgesia) will be measured.
* Total postoperative analgesic consumption in the first 24 hours post-operative will be measured.
* Incidence of complications such as nerve injury, hematoma formation, local anesthetic toxicity, intravascular injection, bleeding and bladder perforation will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be adults (above 18 years) scheduled to undergo transurethral surgery under regional anesthesia.
* ASA1, ASA2

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical class 3,4, severe cardiac comorbidity (impaired contractility with ejection fraction less than 50%, heart block, significant arrhythmias, tight valvular lesions), allergy to any study's drugs
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily provides written informed consent prior to the initiation of any study-related activities and demonstrates understanding of the procedures and methods involved in the study, agreeing to adhere strictly to the clinical trial protocol to complete the study.
2. Male or female subjects; aged 18 to 55 years.
3. Self-reports no more than a 5 kg change in body weight during the 3 months prior to screening (including the screening visit).

Exclusion Criteria:

1. A history of current significant disease in the neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, genitourinary, endocrine, hematologic, or immune systems, as determined by the investigator, which would render the subject unsuitable for participation in this trial.
2. A history of significant gastrointestinal disease or related symptoms, conditions affecting gastric emptying, or prior gastrointestinal surgery.
3. Subjects who have had a major surgery or severe trauma within 6 months prior to screening, or who are planned for surgical procedures during the trial period.
4. Participation in any drug or medical device clinical trial within 3 months prior to screening.
5. Any abnormal physical examination, vital signs, laboratory tests, chest X-ray and abdominal ultrasound findings deemed clinically significant by the investigator, rendering the subject unsuitable for participation.
6. Clinically significant abnormalities on 12-lead ECG as determined by the investigator.
7. Known or suspected history of drug abuse or substance dependence, or positive urine drug screen during the screening period.
Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities

Although antibody-drug conjugate(ADC) has proved effective in treating many cancers, few patients receiving ADC may experience rare but life-threatening sepsis-related toxicities such as sepsis and septic shock. Today, data about sepsis/septic shock are scarce.

The objective was to investigate reports of sepsis/septic shock adverse events related to ADC, including Gemtuzumab Ozogamicin, Trastuzumab Emtansine, Inotuzumab Ozogamicin, Enfortumab vedotin, Trastuzumab deruxtecan, Sacituzumab govitecan, Brentuximab Vedotin, Moxetumomab pasudotox, Polatuzumab Vedotin, Belantamab Mafodotin, loncastuximab tesirine and Tisotumab vedotin using international pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS).

Here, investigators use international pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS) of individual safety case reports, to identify cases of sepsis-related toxicities related to ADC.

Eligibility Criteria:
Inclusion Criteria:

Case reported in the FDA Adverse Event Reporting System (FAERS) or other international pharmacovigilance database of individual safety case reports to 12/31/2022 Adverse event reported were included the report with MedDRA terms: Sepsis(SMQ), agranulocytosis(SMQ), Opportunistic infections (SMQ).

Patients treated with ADC included: Gemtuzumab Ozogamicin, Trastuzumab Emtansine, Inotuzumab Ozogamicin, Enfortumab vedotin, Trastuzumab deruxtecan, Sacituzumab govitecan, Brentuximab Vedotin, Moxetumomab pasudotox, Polatuzumab Vedotin, Belantamab Mafodotin, loncastuximab tesirine and Tisotumab vedotin. Other cancer patients received common drug therapies such as chemotherapy, targeted therapy or immunotherapy would also be included as a comparator.

Exclusion Criteria:

Chronology not compatible between ADC and adverse event (sepsis-related toxicities)
The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis

This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a multicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department of Cochin, Saint-Antoine, Henri-Mondor hospitals (APHP) and Maison-Blanche Hospital (Reims).

The aim of this project is to improve our understanding of the role of IL-23 in the pathophysiology of axial SpA and peripheral SpA.

This objective is detailed in three specific aims:

1. Define the effects of IL-23 on gene expression and cytokine production in innate and adaptive T lymphocytes from patients with SpA, and correlate them with the patient's genotype;
2. Phenotypically characterize immune cell populations in peripheral blood and in synovial fluid from peripheral SpA patients and identify at the single cell level the cells expressing the IL-23 receptor and/or producing IL-17.

The study population to be included are patients affected by SpA, attended to in the Rheumatology Departments of Cochin Hospital, Saint-Antoine Hospital Henri-Mondor hospitals in Paris (APHP) and Maison-Blanche Hospital in Reims. Participants will be divided into two groups: Group 1 comprises patients diagnosed with axial SpA, Group 2 SpA patients with peripheral SpA or psoriatic arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age : Adults (\>18 years)
* Satisfying ASAS diagnostic criteria for SpA
* Patient has active disease, defined by the presence of active synovitis, tendinitis, or dactylitis or significant inflammatory pain of the spine, judged by the examining clinician to be due to SpA.
* Informed consent signed
* Beneficiary of health insurance, except for the AME

Only for patients of Group 1 • Patient is naïve to biological therapies

Only for patients of Group 2

* Patient is affected by peripheral SpA (ASAS criteria) or psoriatic arthritis, with inflammation of peripheral joints
* Patient requires aspiration, as part of standard care

Non inclusion criteria:

* Patient is minor
* Patient is pregnant or breastfeeding
* Patient is immunocompromised
* Patient has received biological therapy with 2 or more biologics
* Patient is receiving corticosteroid treatment \> 10 mg per day
* Patient is under legal protection, curators, guardianship
* Patient refuses consent
* Previous history of alcoholism, drug addiction, psychological problems, severe concomitant conditions that could invalidate the patient's consent or limit the patient's compliance to the treatment protocol.
* Beneficiary of the AME

Only for group 1

• Patient has received biological therapy
Postoperative Bladder Filling After Outpatient Laparoscopic Hysterectomy and Time to Discharge

The investigators hypothesize that backfilling the bladder postoperatively will reduce time to spontaneous void and subsequent discharge from the post-anesthesia care unit.

This is a prospective, single-blinded, randomized clinical trials in which patients undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to have the bladder backfilled at the completion of the surgery prior to Foley catheter removal. If the patient is assigned to group A, 200 mL of room temperature, sterile normal saline will be instilled retrograde into the bladder at the completion of the surgery prior to Foley catheter removal and the Foley subsequently removed intraoperatively. If the patient is assigned to group B, the Foley catheter will be removed intraoperatively at completion of the procedure. The standard protocol is to use a 16F Foley catheter for gynecologic laparoscopy cases, and patients in both groups will receive the same size catheter. After surgery, time to discharge and time to void will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 80
* Undergoing planned laparoscopic hysterectomy as a day surgery procedure

Exclusion Criteria:

* Women younger than 18 or older than 80 years of age
* Undergoing a non-laparoscopic unplanned surgical procedure
Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects

The aim of the study is to understand the structural and functional modifications of the host, the microorganisms, and their interactions (host/microorganism relationship) before and after the RV3278A - ET0943 product application


Eligibility Criteria:
Inclusion Criteria:

1. Related to the population:

   - Subject aged between 12 to 25 years included
2. Related to diseases:

   * Subject having acne lesions on the face, with GEA (Global Acne Evaluation) score on the face is assessed as 2 (mild) or as 3 (moderate), on a scale ranged from 0 (clear- no lesion) to 5 (very severe)
   * Subject having at least 20 open-comedones of about 1 mm in diameter on the face and possibly extractable
   * Subject having a predominance of non-inflammatory acne lesions

Exclusion Criteria:

1. Related to diseases:

   * Subject having comedones only on the nose wings
   * Subject with any other dermatological disease than acne or skin characteristics (like scar, tatoo) on the face liable to interfere with the study according to the investigator's assessment
   * Subject with an acute or chronic disease, or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
   * Severe form of acne (Acne conglobata, Acne fulminans or nodulokystic acne) or acneiform induced rashes according to the investigator's assessment
   * Clinical signs of a hormonal dysfunction or of a hyperandrogenism
   * Solar erythema on the face due to excessive UV exposur
2. Related to the treatments/products:

   * Any previous/concomitant treatment or product considered by the Investigator liable to interfere with the study data or incompatible with the study requirements or hazardous for the subject
Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

This observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for Pazopanib use outside of the clinical trial setting. The aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients treated with marketed anti-VEGF agents \[Pazopanib (VOTRIENT), Bevacizumab (AVASTIN), Sorafenib (NEXAVAR), and Sunitinib (SUTENT)\].

Two databases will be utilized for this study: a large healthcare claims database in the U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and Torsades des Pointes.


Eligibility Criteria:
Inclusion Criteria:

The anti-VEGF cohorts will include patients with the following characteristics:

* Adult patients (age ≥18 years)
* Prescribed or administered an anti-VEGF agent: Pazopanib, Bevacizumab, Sorafenib or Sunitinib on or after approval date of Pazopanib
* Diagnosed with renal cell cancer

Exclusion Criteria:

* Patients with multiple primary cancer diagnoses
Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries

To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.

Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting.

Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.

Eligibility Criteria:
Inclusion Criteria:

• ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.

Exclusion Criteria:

* Central or peripheral neurological pathologies.
* History of drug abuse, chronic pain, or psychiatric disorders.
* Pregnant women
* Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.
The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section

The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. In this study, we aim to decrease the amount of postpartum hemorrhage by clamping the uterine artery after the delivery of the baby during Cesarean delivery.

Obstetrical hemorrhage, is the most common cause of maternal mortality and morbidity that could be prevented. It can appear at early and late stage of delivery and after delivery. It Is defined as loss of more than 500 mL of blood in vaginal deliveries, whereas more than 1L of blood during C-section. The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. The incidence of postpartum anemia in Europe is 50% while in developing countries like Turkey it rises up to 50-80%. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. To preserve the hemoglobin concentrations and hemostasis and to optimize the patient's results, evidence-based methods should be performed. Given these circumstances, interventions using pharmacological, mechanical and surgical methods are necessary to minimize the blood loss. Uteroronics are the first line treatment options followed by fundal massage, controlled traction of cord and delivery of placenta, bimanual compression, intrauterine hydrostatic balloon. After these interventions, surgical interventions such as compression sutures, bilateral uterine artery ligation, hysterectomy and pelvic tamponade could be performed. In this study, we aim to decrease the amount of preoperative part of postpartum hemorrhage by clamping the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta during Cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Women gave birth \>37 GW
* singleton pregnancy
* with normal fetal development
* Not emergency C-section

Exclusion Criteria:

* C/sections with indications of plasenta prevue or placenta acrreta spectrum
* with amniotic fluid abnormalities
* multiple pregnancies
* threatened preterm labor
* who have preeclampsia or other type of obstetrical complications
* maternal obesity (BMI\>30kg/m2)
* maternal cardiovascular disease, hypertension, coagulation defects, women who use anticoagulants
* patients who underwent Cesarean section during active labor