cyrilzakka/clinical-trials huggingface dataset:
Transvaginal Cholecystectomy Versus Laparoscopic Cholecystectomy in Patients With Biliary Colic

A safe and effective transvaginal approach accessing the abdominal cavity through the vagina rather than the abdominal wall is today considered a routine approach for many gynecologic surgeries.

First described by Dr. Ott in Germany in 1901, it is used routinely for transvaginal surgery, for example, transvaginal hysterectomies. This transvaginal technique has been shown to compare favorably to a laparoscopic abdominal approach because of less postoperative pain, the total elimination of abdominal wall hernias and wound infections, earlier recovery and better cosmesis.

Although routinely used in gynecological surgery, the advantages of the vaginal approach have not been utilized for general surgery applications such as cholecystectomies. Open or laparoscopic cholecystectomy accessing the abdominal cavity through abdominal wall incisions is currently still considered the standard of care in general surgery for patients with symptomatic gallbladder disease.

The investigators intend to access the abdominal cavity through the posterior vaginal fornix instead of the transabdominal approach that is now performed routinely. So far, this method of accessing the abdominal cavity through the transvaginal approach for the purpose of performing intraabdominal general surgery.

The investigators' transvaginal approach has the strong potential to further decrease invasiveness and take minimally invasive surgery to the next level in order to benefit the patient even more by minimizing postoperative pain, eliminating the risk of abdominal hernias and wound infections, improving cosmetic appearance and enabling the patient to return to routine activity and work earlier. First preliminary studies show these advantages but further research needs to be done to confirm these early positive results.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Age between 18 and 65 years old.
* Biliary dyskinesia with documented Gallbladder EF \< 30% or diagnosis of biliary colic with documented gallstones or polyps by imaging.
* Body Mass Index (BMI) \< 45 kg/m2.

Exclusion Criteria:

* Any female patient, who is pregnant, suspected pregnant, or lactating.
* Any patient with acute or acalculous cholecystitis.
* Any patient with an American Society of Anesthesiologists Score \> 3.
* Any patient who is undergoing Peritoneal Dialysis (PD).
* Patients who are taking immunosuppressive medications or are immunocompromised.
* Patients on blood thinners or aspirin or abnormal blood coagulation tests.
* Patients who have a history of prior open abdominal surgery or prior transvaginal surgery.
* Patients with a history of ectopic pregnancy, pelvic inflammatory disease (PID) or severe endometriosis.
* Non English speaking patients.
Evaluation of the Training Program for Community Pharmacists for Dispensing Emicizumab (HEMLIBRA®) in France

Haemophilia A (HA) is a rare constitutional haemorrhagic disease whose drug management is based on the use of chronic lifelong replacement therapy. The occurrence of an inhibitor is a dreaded complication that impacts conventional management, consisting in using factor VIII (FVIII)-based replacement therapy, most often for prophylaxis. Although effective, these treatments can only be administered intravenously, leading to accessibility constraints and significant mental burden for patients and their relatives.

Before June 15, 2021 in France, the emicizumab (HEMLIBRA®) was available only in hospital pharmacies for the prevention or reduction of bleedings. The introduction of the dual dispensing circuit in hospital or community pharmacies, left to patient's choice, is effective from this date. These changes have important organizational consequences for patients and health professionals alongside the pathway of care. Therefore, the effectiveness of this new organization requires to be evaluated with a national French study, called PASO DOBLE DEMI. The aims of this study are twofold :

I. To evaluate the direct impact of the training programs provided to the new placeholders of the dispensing circuit ; the community pharmacists, II. To evaluate satisfaction of patients or their relatives regarding the emicizumab treatment whether they chose dispensing in the community pharmacy, or kept the dispensing at the hospital pharmacy.

The methodology was based on the 4-level of the Kirkpatrick's evaluation model; 1) the immediate reaction of community pharmacists following the trainings (Reaction), 2) their knowledge acquisition (Learning), 3) their professional practice (Behavior) and 4 ) the patients' satisfaction related to their treatment whether dispensing in hospital or in community pharmacies (Results).

The PASO DOBLE DEMI I was based on the first three levels of the evaluation model.


Eligibility Criteria:
Inclusion Criteria:

* Pharmacists practicing in a pharmacy in metropolitan France
* Working in a pharmacy chosen by the patient with haemophilia type A
* And who have agreed to dispense Emicizumab (Hemlibra®)

Exclusion Criteria:

* Other pharmacy staff (including pharmacy technician, biologist, pharmacy students)
* Retired pharmacists at the date of the study
* Pharmacists who no longer practice in a community pharmacy dispensing Emicizumab (HEMLIBRA®)
* Pharmacists who expressed opposition to participating in the study
Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.

Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive for more than 6 months
* HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
* HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
* HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* nucleoside/nucleotide naive paitents

Exclusion Criteria:

* Diagnosed HCC with AFP and ultrasound, CT or MRI
* Creatine \>130μmol/L or Ccr \< 70mL/min
* Hemoglobin \<100g/L
* Neutrophils \<1.5E+9/L
* PLT\<80E+9/L
* Coinfected with HAV,HEV,HCV,HDV or HIV
* ANA \> 1:100
* Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
* Drug abuse or alcohal addiction
* Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
* Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
* Underwent liver transplantation or liver transplantation in schedule
* Allergic to nucleoside or nucleotide analogues
* Preganency or in breastfeeding
Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-responders

Approximately 40% of resynchronization therapy recipients do not appear to clearly benefit. These patients are termed 'non-responders'. This study will assess whether a heart ultrasound (echo) technique called 'torsion imaging' can be used to increase the likelihood of benefit from resynchronization therapy.

Background: Despite advances in pharmacotherapy, patients with heart failure (HF) are at high risk for death and hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular contraction that impairs left ventricular (LV) function and results in HF progression. Cardiac resynchronization therapy (CRT) is designed to synchronize ventricular mechanical activity, improving cardiac output and reducing HF symptoms. As shown in our pilot data, at least 40% of patients do not respond to CRT despite pre-screening for the presence of longitudinal (long axis) mechanical (velocity) dyssynchrony and targeting LV lead placement to the latest site of latest velocity. Methods to improve the rates of response to CRT are required. Torsion imaging guided optimization of CRT timing is a promising approach and will be tested in this study.

Primary hypothesis: Optimization of inter-ventricular (VV) timing, guided by torsion imaging, will increase functional capacity and reduce LV end systolic volume \[ESV\] in CRT in patients who have not responded after ≥ 6 months. CRT response will be defined by a ≥ 1 functional class improvement and either a ≥ 10% reduction in LV ESV or a ≥ 5% increase in EF at follow-up versus baseline.

Secondary aims: To compare the following in torsion-guided vs usual care patients: a) echo parameters (intra-LV and VV dyssynchrony and torsion, and mitral regurgitation), b) N-terminal BNP levels, and c) generic / disease-specific quality of life.

Methods: Randomized study of patients who have not responded to CRT after ≥ 6 months.

Eligibility Criteria:
Inclusion Criteria:

* non-response to CRT as indicated,
* stable doses of ACE I / ARB and beta-blocker for ≥ 2 months, \&
* controlled heart rate if in atrial fibrillation.

Exclusion Criteria:

* inadequate images to assess torsion
* no significant augmentation in torsion with optimization
* unable or unwilling to provide informed consent,
* medical condition other than HF likely to cause death within 6 months,
* cardiac transplant planned,
* myocardial infarction or revascularization since CRT implant.
Gender Disparity and Hormones in Cystic Fibrosis

The objective of this study is to investigate the impact of hormones on lung disease in Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and healthier lives than they did 20 years ago. However, females have been shown to have a survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The hypothesis is that estrogen and/or progesterone negatively impact lung health in CF. Therefore, understanding the impact of sex hormones (including the use of birth control pills) on the disease process is increasingly important. The purpose of this study is to determine if lung function, respiratory symptoms, or various markers of lung health change during different phases of the natural ovulatory cycle in order to understand if estrogen or progesterone hormones are impacting the disease relative to fluctuations in men with stable testosterone levels. The research objectives of this project are to:

* Determine if lung function, respiratory symptoms, or various markers of lung health change during different hormonal phases of the ovulatory cycle in women.
* Determine if men change lung function, respiratory symptoms, or various markers of lung health over time.
* Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and improve lung health.


Eligibility Criteria:
Inclusion Criteria:

* Male and female cystic fibrosis patients
* Must be greater than or equal to 18 years of age.
* All subjects must understand and sign the informed consent.
* Subjects must have the ability to read and write in English.
* Female subjects starting this study must be willing to use a double barrier method of birth control (such as condom or diaphragm) used with a spermicide (a substance that kills sperm), while participating in the study.

Exclusion Criteria for Main Study:

* Women who are pregnant, breast feeding, or who have had an oophorectomy.
* Women who have received a hormone contraceptive injection (such as Depo Provera) within the last 3 months.

Exclusion Criteria for Substudy:

* Men
* Women who have a history of breast cancer, abnormal vaginal bleeding, liver disease, coronary artery disease, cerebrovascular disease, uncontrolled hypertension, diabetes mellitus with vascular disease, or have had a stroke, heart attack, or blood clot within the past year, due to a possible reaction to Loestrin.
* Women who currently smoke cigarettes, due to the increased risk of serious cardiovascular events with Loestrin use.
Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than once drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Determine the response rate (PSA and/or objective response) and duration of response to weekly paclitaxel plus estramustine in patients with metastatic hormone refractory prostate cancer. II. Determine the effect on quality of life of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour weekly for 4 weeks. Patients receive oral estramustine the day before, the day of, and the day after paclitaxel administration each week. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. A quality of life questionnaire is completed before treatment and 2 months after treatment initiation.

PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic (D1 or D2) hormone refractory adenocarcinoma of the prostate with one of the following: -Bidimensionally measurable disease -Bone only metastases with rising PSA levels -PSA only disease defined as rising PSA levels with prior confirmation of D1 or D2 disease PSA must be greater than 8 if bone only or PSA only disease Hormone failure defined as progression after treatment with orchiectomy, LHRH agonist, DES alone, or any hormonal treatment in combination with antiandrogen therapy

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other active malignancies within the past 5 years except nonmelanomatous skin cancer or other in situ cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy No prior estramustine alone or in combination with other chemotherapy No prior taxanes No more than 1 prior chemotherapy regimen Endocrine therapy: Concurrent primary hormonal therapy allowed (LHRH agonist or orchiectomy) At least 4 weeks since prior antiandrogen therapy with at least 2 rises in PSA levels Radiotherapy: At least 4 weeks since prior radiotherapy At least 8 weeks since prior strontium-89 therapy Surgery: See Disease Characteristics
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder

The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 350 mg and 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD). The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from generalized anxiety disorder (GAD) as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module
* Total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) equal or above 20.

Exclusion Criteria:

* Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months of study entry.
* Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher at screening or baseline visits.
* Patients having a moderate to high current risk for suicide.
* Patients with other current anxiety disorder assessed with the MINI: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder.
* Patients with a lifetime history according to the MINI of: bipolar disorders, psychotic disorders, antisocial personality disorder.
* Patients with severe or unstable concomitant medical conditions according to the Investigator's judgment.
* Females who are pregnant or lactating.
* Female patients of childbearing potential must use an effective method of birth control during the entire study period.
* Patients with positive test for any illicit drug included in the urine drug screen.
* Participation in a clinical trial of an experimental therapy within 3 months prior to screening
Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome

This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain-Barré Syndrome.
* Onset of GBS-related weakness ≤10 days prior to start of infusion.
* GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion.

Exclusion Criteria:

* Clinically significant findings on the screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS that may interfere with the conduct of the study, the interpretation of the data, or increase the participant's risk.
* Body weight \<30 kilograms (kg) or \>150 kg at screening.
* Unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening.
* Previous or intended treatment with either plasma exchange or intravenous immunoglobulin for GBS.
* Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
* History of prior episode of GBS.
* GBS-related weakness that improved since symptom onset, including an improvement between screening and Day 1 (baseline).
Correlation Between Facial Measurements and Tooth Size and Pulp Volume

The aim of this study was to investigate the correlation between the measurements of the specific points of the face (lower face height, midface height, the distance between zygomatic, pupillary distance,interalar distance, epicanthus distance, the distance between commissar) and the dimensions of the maxillary sixth molar tooth (mesiodistal distance, buccal palatal distance, root length, pulp volume).

Radiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. Facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, interalar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. Mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. The data obtained will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Upper dental arches which have maxillary first molars
* At least one tooth which has no deep caries, filling or crown restoration must be
* No resorption or pathology in the root of the tooth which disrupt integrity must be
* Healthy subjects

Exclusion Criteria:

* Deep caries, filling or crown restoration
* Resorption or pathology in the root of the tooth
Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Patients With Advanced Hematologic Malignancies

Chemotherapy resistance is a major cause of death in patients with advanced hematologic malignancies. The proposed novel mechanism of action, non-cross resistance with chemotherapeutic agents currently used in the clinic, and lack of CPI-613-related myelosuppression preclinically and clinically to date make CPI-613 a suitable candidate for phase I clinical trial in these patients. The current trial is one of several clinical trials of CPI-613. Other clinical trials that are conducted in patients with solid tumors have already been initiated.

The primary objective of this study is to determine the safety and MTD of CPI-613 when administered 2x weekly for 3 consecutive weeks.

The secondary objective is to determine the PKs of CPI-613 following IV administration and to observe the anti-tumor effects of CPI-613, if any occur.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically documented relapsed and/or refractory hematologic malignancy
* Karnofsky Performance Status (KPS) of \>70%.
* Must be ≥18 years of age.
* Expected survival \>1 month.
* Women of child-bearing potential must use accepted contraceptive methods
* No radiotherapy, treatment with cytotoxic agents (except CPI-613), treatment with biologic agents or any anti-cancer therapy within the 3 weeks prior to treatment with CPI-613.

Exclusion Criteria:

* Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
* Patients with active central nervous system (CNS) or epidural tumor.
* Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease).
* Pregnant women, or women of child-bearing potential not using reliable means of contraception.
* Lactating females because the potential of excretion of CPI-613 into breast milk.
* Life expectancy less than 1 month.
* Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients.