cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Common Bile Duct Stones Clearance During Pregnancy

Background: Pregnancy is associated with a higher risk of common bile duct stones. Currently Endoscopic Retrograde Cholangiopancreatography (ERCP) is the treatment of choice for symptomatic choledocholithiasis. However, ERCP during pregnancy is associated with hazards of radiation exposure, as well as challenging patient positioning and anesthesia

This is a retrospective analysis of endoscopic common bile duct stone clearance in pregnant patients with symptomatic choledocholithiasis between June 2015 and June 2023.

Sedation and anesthesia was done by safe medications by senior anesthetist, and the endoscopic procedure was performed in left lateral decubitus instead of prone position. The gravid uterus was kept away from the monopolar electrocautery current pathway. Radiocontrast injection and fluoroscopy was deleted and replaced by trans-abdominal US and endoscopic bile aspiration Data including perioperative outcomes and follow up data will collected, tabulated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with symptomatic common bile duct stones.

Exclusion Criteria:

* Presence of pancreatitis or cholangitis.
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 Diabetes Mellitus
2. FBG level \> 140 mg/dL and \< 270 mg/dL
3. Fasting TG level \< 500 mg/dL
4. BMI of 22 to 40 kg/m2, inclusive
5. Other Inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Previous participation in an ONO-5129 protocol
2. Previous treatment with TZD agents or other current antidiabetics
3. History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
4. Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
5. Other exclusion criteria as specified in the study protocol
Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder

To investigate the intervention effect of high definition transcranial alternating current stimulation (HD-tACS) on suicidal ideation in patients with depressive disorder and its underlying neural mechanism by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Forty patients with depressive disorder diagnosed by DSM-5 were recruited from the Anhui Mental Health Center and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving high definition transcranial alternating current stimulation (HD-tACS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), electroencephalography (EEG), and HD-tACS treatment conducted by trained researchers at the Anhui Mental Health Center. All the participants were randomized (1:1) to receive an "active HD-tACS" or "sham HD-tACS" treatment protocol. tACS: the central electrode was placed over F3 with return electrodes placed at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 30 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as individual alpha frequency (IAF). Sham HD-tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 15 and 15 seconds.

Before and after the treatments, the patients received a battery measure of neuropsychological tests, resting EEG, and MRI scans in multimodalities. The neuropsychological assessment included HAMD, MADRS, BDI, HAMA, BSS, C-SSRS, PHQ15, RRS, TEPS, PVAQ, MoCA, Stroop Test, VFT, DST, and AVLT. Multimodal MRI includes 3D-T1, rs-fMRI, and DTI. The symptoms of the patients were followed up one and two months after the end of treatments.

Eligibility Criteria:
Inclusion Criteria:

* the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and HAMD\>17, BSS\>6, PHQ-15\>5.
* the age ranged from 18 to 65 years old, and the length of education was more than 5 years.
* the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion Criteria:

* accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
* accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
* accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective
SI Joint Fusion and Decortication Using the SImmetry System

The purpose of the SI Joint Fusion and Decortication Using the SImmetry System study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion of the SI joint and relief of SI joint pain symptoms.

This is a prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device. The study will be conducted at a single site and 25 subjects will be implanted and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
* Subject has two (2) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
* Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
* The subject has two (2) diagnostic SIJ injection at least one (1) resulting in a ≥50% decrease in pain in the joint(s) from the anesthetic portion of the injection
* The subject has VAS back pain score of ≥ 50 mm
* The subject is at least 18 years of age and skeletally mature
* The subject agrees and is able to comply with study requirements

Exclusion Criteria:

* Subjects contraindicated per the cleared labeling will be excluded from participation in the study
* The subject has pelvic soft tissue or bony tumors
* The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
* The subject has a history of a central nervous system (CNS) disorder(s)
* The subject is indicated for or awaiting other spine surgery
* The subject is pregnant or is planning on becoming pregnant in the next two years
* The subject has uncontrolled insulin dependent diabetes mellitus (Type 1 Diabetes)
* The subject has chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview
* The subject is receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
* The subject has a history of significant emotional or psychosocial disturbance (untreated or uncontrolled anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview
Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome

Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female neonate or infant, with PWS genetically confirmed.
2. Age \<92 days (plus a tolerance of up to 8 days maximum) (for preterm infants, born before 37 weeks amenorrhea, corrected age will be applied).
3. Signed informed consent obtained from the parents/holders of parental authority.
4. Parents willing and able to comply with all study procedures.

Exclusion Criteria:

* 1. Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities.

  2. Neonate or infant with prolongation of the QT interval. 3. Neonate or infant without medical insurance. 4. Neonate or infant with hypersensitivity to oxytocin or excipients of the product.

  5. Neonate or infant with concomitant treatment prolonging QT interval 6. Neonate or infant with family history of genetic pathology causing QT interval prolongation.

  7. Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor).

  8. Neonate or infant participating simultaneously in another interventional study.

  9. Neonates or infants whose parents' situations may jeopardize the interpretation of the results.

  10. Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl

Adipearl is an injectable filler intended to be injected subcutaneously in the face.


Eligibility Criteria:
Inclusion Criteria:

* Subject having given freely and expressly informed consent;
* Subject deemed by the Investigator to be medically fit for injection of the product;
* Female or male subjects aged 22 to 65 years (inclusive);

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject participating to another research study.
* Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
Predicting Biomarker of Gastric Cancer Chemotherapy Response

* discovery and validation of biomarker predicting gastric cancer chemotherapy response

  * Analysis for expression level of mRNA using Next generation sequencing in gastric cancer tissue by chemotherapy response
  * Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response
  * Validation of mRNA and miRNA using qRT-PCR in multiple independent cohort
* Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response

* discovery and validation of biomarker predicting gastric cancer chemotherapy response

  * Analysis for expression level of mRNA in fresh frozen gastric cancer tissue by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group Palliative chemotherapy (inoperable patients)

    * institutional primary Chemotherapy regimen (XP or Xelox)

      1. response group
      2. progression group

         Post-OP adjuvant chemotherapy
    * institutional primary Chemotherapy regimen

      1. complete response group
      2. non-responder group

      <!-- -->

      1. and 2) groups: age, sex, regimen matched
  * Analysis for expression level of miRNA using Next generation sequencing in gastric cancer tissue and blood by chemotherapy response (A) method of mRNA expression measurement: RNA sequencing (B) study group

    * the same patients in mRNA sequencing
  * Validation of mRNA and miRNA in multiple independent cohort method of measurement of RNA expression: qRT-PCR
* Biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer

Eligibility Criteria:
Inclusion Criteria:

* new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy
* patients who agreed this study and voluntarily assigned the informed consents.

Exclusion Criteria:

* patients who refused the study.
* patients who have other cancers
* heavy alcoholics
Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria

The purpose of this study is to evaluate the efficacy of the combination of Methenamine + Methylthioninium chloride compared to phenazopyridine (comparator product) in the symptomatic relief of dysuria.

* Single blind, randomized, prospective study.
* Length of experience: 03 days to 07 days.
* 03 visits (days 1, 4 and 7).
* Evaluation of the efficacy and safety of the medication.
* Shall be assessed for adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree to participate by agreeing to the terms proposed in the Clinical trial;
* Patients aged over 18 years of any ethnicity;
* Presence of dysuria with marking greater than or equal to 5 measured points on the categorical scale pre-treatment for pain symptom;

Exclusion Criteria:

* Patients who are febrile (axillary T º: ≥ 38 ° C), with back pain or lumbar;
* Patients with complicated clinical presentation of urinary tract infection;
* Patients with a history of allergy or intolerance to any known or suspected one of the ingredients of the product under investigation;
* Patients who are pregnant or during lactation, or childbearing potential and are not making use of effective contraception;
* Patients presenting with renal disease or severe liver disease, according to medical history and / or laboratory;
* Patients presenting with severe systemic disease according to the known medical history;
* Patients who received antibiotic treatment, anthelmintic within 7 days prior to study entry;
* Patients unable to understand the guidelines specified in this protocol or can not attend all study visits or unable to complete the log;
* Pregnancy or risk of pregnancy and lactating patients;
* Any finding of clinical observation (history and physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study

The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.


Eligibility Criteria:
Inclusion Criteria:

* To be a Turkish citizen,
* To be \>18 years of age,
* Lesion must be successfully crossed with a guidewire without complication,
* INVADER™ PTCA is used in the primary lesion treated during the procedure,
* Patient has signed and dated the informed consent.

Exclusion Criteria:

* Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter.
* Device use not consistent with Instructions for Use (IFU).
* Patients concurrently participating in another medical device or pharmaceutical clinical trial.
Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block

The aim of this study is to investigate the effects of the right ventricular septal pacing on left ventricular function compared with right ventricular apical pacing.


Eligibility Criteria:
Inclusion Criteria:

* the patients who need pacemaker implantation for atrio-ventricular block

Exclusion Criteria:

* Pregnancy, left ventricular dysfunction at the time of implantation
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) \< 30 mL/min) for a period of 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Complete the core study and consent for extension

Exclusion Criteria:

* Patient unable to comply with core study requirements
Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Cigarette smoking remains the most common source of preventable morbidity and mortality in the United States, with in excess of $167 billion in economic costs per year. Contingency management (CM), in which tangible incentives are provided contingent on a target behavior like abstinence, is highly efficacious in improving substance abuse treatment outcomes and is receiving increased attention for smoking cessation. Expired carbon monoxide (CO) is the most common objective smoking status test used in smoking research and treatment. Unfortunately, multiple CO tests/day are typically required to detect all smoking and reinforce sustained abstinence. The resulting logistical and resource limitations greatly limit the application of this potentially powerful quit smoking toolset. This study addresses these limitations by examining the effectiveness of using interactive voice response technology (IVR) to implement CM. Smokers who want to quit (N = 90 randomized) will receive 2 quit preparation sessions based on public health guidelines for smoking cessation and set a target quit date. Participants will be randomly assigned to 1 of 2 treatment conditions: (a) IVR-S consisting of objective smoking status monitoring using IVR, telephone counseling and transdermal nicotine and (b) IVR-CM, consisting of the same monitoring, telephone counseling and transdermal nicotine plus IVR-based CM for smoking abstinence. It is hypothesized that abstinence rates will be higher in the IVR-CM condition compared to the IVR-S, supporting a combined IVR CM approach, and thereby greatly increasing the applicability of these powerful smoking cessation tools.


Eligibility Criteria:
Inclusion Criteria:

* regular cigarette smoker
* age ≥ 18
* mailing address \& valid photo I.D.
* want transdermal nicotine

Exclusion Criteria:

* not English speaking
* in recovery for pathological gambling
* contraindication for transdermal nicotine
* female who is pregnant, nursing a child, or not using effective contraception
Dexmedetomidine on Microcirculation in Septic Shock

Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. However, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

Septic shock is characterized by significant decline in vascular response and relative hypovolemia. Fluids and exogenous catecholamines are mainstay. However, even after initial resuscitation, microcirculatory dysfunctions still exist, and represent a direct physiologic link to organ failure and death. Therefore, therapeutic strategies aiming at improving microcirculation are performed.

Dexmedetomidine was found might be beneficial to sepsis. Dexmedetomidine were found to improve microcirculation in sepsis animal studies and non-sepsis patients. However, the effect of dexmedetomidine on microcirculation in septic shock patients is unknown.

Based on the hypothesis that dexmedetomidine might improve microcirculation in initial resuscitated septic shock patients, the study was to investigate the effects of dexmedetomidine on microcirculation in early septic shock patients despite initial resuscitation. Meanwhile, to observe the possible mechanism of the effect, the correlation between dexmedetomidine dose and microcirculatory parameters as well as catecholamine level were performed.

Eligibility Criteria:
Adult patients who met the following inclusion criteria were enrolled in the study: 1) With septic shock defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference for less than 24 hours.

2) After initial fluid resuscitation but still requiring norepinephrine to maintain arterial pressure or hyperlactacidemia.

3) Need ongoing analgesia and sedation. 4) Using advanced invasive hemodynamic monitoring techniques.

Exclusion criteria were as follows:

1. age less than 18 years.
2. pregnancy.
3. heart rate less than 55 beats per minute.
4. acute hepatic failure
5. brain injury.
A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

Robotic assisted surgery for benign prostatic hyperplasia (BPH)

A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
3. Subject is able and willing to comply with all the assessments of the study,
4. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
5. ≥ 45 years of Age,
6. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
7. The subject is indicated for undergoing HoLEP procedure

Exclusion Criteria:

1. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
2. History of prostate cancer or current/suspected bladder cancer,
3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
4. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
5. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
6. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
7. Previous pelvic irradiation or radical pelvic surgery,
8. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
9. Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted),
10. Any severe illness that would prevent complete study participation or confound study results.
11. Bleeding tendency disorders,
12. Future fertility concerns,
13. Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
14. Concomitant participation in another interventional study