cyrilzakka/clinical-trials huggingface dataset:
A Prospective Feasibility Study for TAMIS

Most recently, the Transanal Minimally Invasive Surgery (TAMIS) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.Previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. TAMIS has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. This group of patients have also a high rate of conversion to open surgery. Focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. The selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. This is a prospective observational feasability study of the TAMIS-procedure.


Eligibility Criteria:
Inclusion criteria:

* rectal cancer with histological diagnosis
* tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope.
* suitable for elective resection

exclusion criteria:

* preoperative magnetic resonance imaging (MRI) showing diameter of tumor size \>6 cm
* American Society of Anesthesiologists (ASA) class IV and V
* anticipated need of intensive care unit (ICU)
* history of previous major abdominal surgery
* computer assisted tomography (CT) or MRI evidence of tumor infiltration of adjacent organs
* obese patient with body mass index \>35kg/m2
* those, who do not understand the requirements of the protocol
* pregnancy
* more than one colorectal tumor
Streamlining the Efficiency of PrEP Implementation

This is a pilot facility-based direct-to-pharmacy PrEP refill delivery to streamline care pathway in Kenyan public health HIV facilities implementing PrEP. Data on up to 500 PrEP users will be evaluated to understand delivery efficiency and in-depth interview with users and delivery key informants will be conducted to identify barriers and facilitators of implementation.

A prospective, pilot implementation evaluation of patient-centered differentiated care service. The core components of the multifaceted implementation strategy include: 1) 3-monthly refills, 2) direct-to-pharmacy refill visits, 3) HIV self-testing (HIVST) while waiting for refills, 4) Rapid risk assessment for ongoing risk, adherence, side effect, and acute HIV symptoms. Clinics will implement either: 1) current PrEP patient flow without any change or 2) a pilot differentiated pharmacy-based follow up PrEP care pathway. Clinics will implement only one delivery model thus eliminating risk for confusion in the clinic about delivery models and permitting a full-scale test of the system, since the efficiency in PrEP delivery is in part at the system level, above and beyond the individual client encounter. For this pilot project designed to primarily test delivery efficiency, feasibility and acceptability of direct-to-pharmacy care pathway at systems level using existing public health infrastructure, pilot and control clinics will be of comparable size selected to reflect the implementation nature of the design.

The specific aims are:

Aim 1: To evaluate whether a differentiated care model improves the efficiency of PrEP delivery while resulting in equivalent or better: 1) patient waiting time, 2) early PrEP continuation, and 3) adherence.

Aim 2: Conduct mixed-methods study to understand patient and provider perception, experiences , feasibility and acceptability of a differentiated PrEP delivery model.

Aim 3: Assess the efficiency, cost and cost-effectiveness of a facility-based differentiated PrEP care.

Eligibility Criteria:
Inclusion Criteria:

For HIV-negative participants:

* Of legal age (≥18 years)
* Able and willing to provide written informed consent for research component of the project (blood draw for adherence, brief surveys and in-depth qualitative interviews)
* HIV uninfected based on negative HIV tests, per Kenya national guidelines
* Currently or previously accessed PrEP at participating HIV clinic

For Key delivery informants:

* Able willing and able to provide consent in order to participate in the survey and qualitative interviews.
* Works at any of the clinics implementing PrEP delivery. Key informants may include HIV testing service nurses, counselors, clinicians, social workers, or clinic managers.

Exclusion Criteria:

* Not meeting any of the inclusion criteria listed above.
Effect of Carbonated Soft Drinks on the Body Weight

Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.

The investigators aim is to investigate the long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).

The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-50 years;
* BMI between 28-36 kg/m2;
* Weight stabile 3 months prior to the study inclusion;
* Less than 10 hours of weekly exercise

Exclusion Criteria:

* Diabetes
* Allergic to phenylalanine or milk
* Smoking
* Pregnancy or breast-feeding
Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).


Eligibility Criteria:
Inclusion Criteria:

* CNV of less than 1 year duration due to presumed ocular histoplasmosis
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age 21 years and older
* Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter
* Best corrected visual acuity of 20/25 to 20/400
* Birth control therapy for females of child-bearing age

Exclusion Criteria:

* CNV due to presumed ocular histoplasmosis for greater than 1 year
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception : surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
* A recent history of smoking (within 1 year of study enrollment)
* Prior treatment with intravitreal aflibercept injection
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Uncontrolled glaucoma in the study eye (defined as IOP greater or equal to 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Presence of significant subfoveal fibrosis or atrophy
* Intraocular surgery (including cataract surgery) in the study eye within 2 months of enrollment
* Active intraocular inflammation (grade trace or above) in the study eye
* History of allergy to fluorescein, ICG or iodine, not amendable to treatment
* Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either
* Require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or
* If allowed to progress untreated, could likely contribute to loss of at least 2 snellen equivalent lines of BCVA over the 12 month study period
* Prior/Concomitant Treatment:
* Panretinal photocoagulation treatment
* Previous intraocular steroids or PDT within 3 months
* Previous participation in any studies of investigational drugs within 30 days preceding Day 0 (excluding vitamins and minerals)
* Previous treatment with intravitreally (in either eye) or intravenously administered Avastin (bevacizumab) within 60 days
* Previous use of Macugen or Lucentis in study eye within 60 days
* Prior submacular or vitreous surgery
A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria

* Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT.
* ECOG Performance Status of ≤ 1.
* Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-PD-(L)1.
* All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained during the screening period.
* Prior toxicities must have resolved to grade ≤1.
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.

Exclusion Criteria

* Prior treatment with Docetaxel.
* Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases.
* Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea.
* EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy.
* History of cerebrovascular accident and coagulation disorders.
* Participants with interstitial lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization.
* Known toxicity on prior checkpoint inhibitor treatment.
* Participants who received more than one line of anti- PD-1/PD-L1 treatment.
* Participants who received previous CTLA-4 inhibitor treatment.
* Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Study of Hyperbaric Oxygen Therapy in Addition to Standard Growth Factor Support for Hematopoietic Progenitor/Stem Cell Mobilization

The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.

Subjects will receive HBOT daily for 10 days in conjunction with standard growth factor treatment regimens for stem cell mobilization. The role of HBOT in stem cell mobilization as well as its role on oxidative stress will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are being considered for autologous stem cell transplant as part of their routine care who have failed at least one prior attempt at stem cell mobilization with any of currently available standard regimens using growth factors.
* Patients in who the use of Mozobil® is medically justified but is not possible because of insurance or financial reasons
* Patients scheduled to begin standard growth factor treatment with Neupogen® as part of routine care.
* Patients who have had a bone marrow evaluation performed within one month prior to enrollment as part of routine clinical care or under IRB# 02815.
* Patients who have had a chest x-ray or CT Chest within 60 days prior to enrollment.
* ECOG performance status ≤ 3 performed within 60 days prior to enrollment which will be determined by history.
* Patients who are at least 18 years of age at the time of registration.
* Patient must have signed an IRB-approved informed consent and understand the investigational nature of the study.

Exclusion Criteria:

* Clinically significant hepatic dysfunction as noted by direct bilirubin or AST \>3 times the upper normal limit or clinically significant concurrent hepatitis within 60 days prior to enrollment.
* History of New York Heart Association (NYHA) Class III or Class IV heart failure
* Recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias from medical history.
* Untreated pneumothorax from medical history.
* Uncontrolled seizure disorder from medical history
* Uncontrolled insulin dependent diabetes (verified by routine labs in medical record)
* History of severe claustrophobia
* Severe COPD (FEV1 \< 50% of predicted on pulmonary function test) performed within 60 days prior to enrollment
* Untreated ear barotraumas from medical history
* Pregnancy or currently breastfeeding (females of childbearing potential must agree to use adequate contraception during the study). A urine pregnancy test will be performed prior to initiating HBOT.
* Patients currently receiving Bleomycin, Cisplatin, Disulfiram, Doxorubicin, and Sulfamylon.
* Any other condition that the PI determines may jeopardize the safety of the subject during the course of the study
A Usability Validation of the MuCopilot Mobile Application, a Digital Tool for the Unsupervised Objective Assessment of Cystic Fibrosis

The study aims to assess the usability and safety of use of MuCopilot, a smartphone application that measures objective data on lung function, global exercise capacity and patient reported outcomes of patients with Cystic Fibrosis (CF). These data are collected during unsupervised digital tests performed in the patient's home environment between consultations.

The primary objective is to validate the usability and safety of use, in order to assure that the patients use the medical device as intended without any unacceptable error of use and without unacceptable risk.

The study will include 17 CF patients and will be conducted in France. They will participate in 1 inclusion visit and 1 visit in-clinic (1h30).

Patients will be able to download the free MuCopilot mobile application. During the visit, patients will complete 3 digital tests in order to monitor CF functions (cough, dyspnea \& walking) and 1 symptom questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Aged ⩾ 18 years old
* Patients diagnosed with cystic fibrosis
* Enrolled in or benefiting of a Social Security program
* Having read the information sheet and signed the informed consent form
* Owning a personal smartphone which version is above 14 for IOS and 8 for Android included with a good internet connexion
* Able to read French and understand pictograms on a smartphone app

Exclusion Criteria:

* History of lung transplantation
* Pregnant women and women who are breastfeeding
* Any medical condition that could interfere with the proper conduct and results of the study (clinician's judgement)
* Illiterate in French
* Inability to use a smartphone or MuCopilot application
* Person under legal protection (including guardianship or curatorship)
Artificial Intelligence and Bowel Cleansing Quality

The main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device.

The patient's perception of colon cleanliness prior to undergoing a colonoscopy has been studied as a predictor of colon cleanliness quality, demonstrating to be a powerful predictor of inadequate cleanliness. A convolutional neural network developed by our group, trained with photographs of rectal effluents at different moments of colon preparation, has achieved high diagnostic accuracy. Based on all this experience, the next step would be to evaluate in a randomized clinical trial whether this neural network integrated into a computer application associated with cleaning recommendations improves the colon cleanliness quality of patients compared to a control group, being the objective of this project Therefore, the main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device. Consecutive outpatient patients meeting inclusion criteria and none of the exclusion criteria who have been requested to undergo colonoscopy will be included in the study and randomized to mobile artificial intelligence application or control group The intervention group will receive a response from the AI system in order to determine the quality of colon cleansing: adequate preparation or inadequate preparation. In addition, the system will issue specific recommendations based on the quality of cleansing. Patients assigned to the control group will undergo colonoscopy preparation according to standard recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients referred for outpatient colonoscopy
* Sign informed consent

Exclusion Criteria:

* Incomplete colonoscopy (except for poor bowel preparation)
* Contraindication for colonoscopy
* Allergies.
* Refusal to participate in the study or impairment to sign the informed consent.
* Colectomy (more than 1 segment)
* Dementia with difficulty in the intake of the preparation.
* Inability to use the smartphone application
Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.

The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* 18- 38 years old
* at least one patent tube
* unexplained infertility, anovulation, mild to moderate male factor infertility
* previous failed IUI

Exclusion Criteria:

* indicated for ICSI
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate

The aim is to determine if high-dose amoxicillin/clavulanate is more effective than standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at a primary care office.

The aim was amended in February 2016--because of the unexpected unavailability of the original high-dose formulation of amoxicillin/clavulanate--to compare the effectiveness (versus standard dose) of extended-release (the original formulation) versus immediate-release amoxicillin/clavulanate.

Eligibility Criteria:
Inclusion Criteria:

1. Adult 18 or over
2. Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
3. Clinician and participant chose to start antibiotic treatment

Exclusion Criteria:

1. Previously enrolled in the study
2. Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
3. Specific medication concerns: lactating (since safety of clavulanate unknown); taking allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash with amoxicillin); chronic kidney disease with glomerular filtration rate \< 30; significant hepatic impairment; history of antibiotic-associated colitis
4. Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
5. Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin within the past month (risk of penicillin-resistant pneumococci), very ill patient (though not ill enough to send to hospital); immunocompromise
6. Need to hospitalize the patient
Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty

Evaluate the effect of the PICO medical device, compared to the Opsite Post-Op Visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk of local complications, undergoing hip arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* aged between 55 and 85 years inclusive,
* Patients with BMI ≥ 30 + ASA 3 + Diabetes mellitus
* Patients suffering from coxarthrosis candidates for hip arthroplasty surgery or revision of hip arthroplasty

Exclusion Criteria:

* Age\> 85 years, \<55 years
* Patients who are unable to understand and want.
* Patients with severe neurological disorders or with severe disabilities.
* Oncological patients and patients with malignant tumor at the edge of the wound
* Patients who have undergone radiotherapy treatment
* Patients with bleeding disorders
* Patients on anticoagulant treatment with warfarin or NAO
* Previously confirmed osteomyelitis
* Patients with liver cirrhosis
* Patients with non-enteric fistulas
* Patients with necrotic tissue with the presence of eschar at the intervention site
* Patients with autoimmune thrombocytopenia.