cyrilzakka/clinical-trials huggingface dataset:
Prenatal Endoscopic Repair of Fetal Spina Bifida

The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch

Compared with an open approach involving laparotomy and hysterotomy, an endoscopic approach for the prenatal surgery of myelomeningocele offers at least two potential advantages: i) it may reduce the maternal and obstetric morbidity related to the hysterotomy; ii) it may be performed earlier in gestation than open surgery, therefore potentially further reducing exposition of the spinal chord to the intraamniotic environment and thus improving the overall prognosis of the malformation. This study aims to evaluate the feasibility and potential benefits of a minimally invasive endoscopic procedure for the prenatal treatment of myelomeningocele in a single-center trial.

Technically the procedure will be performed through 2 intra-amniotic ports, under fetoscopic visualization and intra-amniotic carbon dioxide insufflation. The defect will be dissected and the cord replaced in the canal. Closure will be performed by suturing paravertebral muscles using a barbed running suture. A Duragen patch will be sutured when primary closure is deemed impossible.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years old, with an assumption by health insurance, understanding and speaking French
* A term \< or = 26 +0 weeks gestational age
* Single-Pregnancy
* Myelomeningocele with higher-level defect between S1 and T1
* Arnold Chiari anomaly
* No associated anomaly or chromosic anomaly

Exclusion Criteria:

* severe foetal kyphoscoliosis associated
* Increased risk of preterm birth: cervical length \<15 mm, history of at least 2 late miscarriages, existing premature rupture of membrane
* placenta previa, accreta or placental abruption
* Maternal obesity with BMI\> 35
* Uterine anomalies : large interstitial uterine fibroid, uterine malformation
* maternal infection with a foetal transmission risk: HIV, HBV, HCV
* Maternal contradiction in surgery or anesthesia
* poor social status and/or social isolation
* impossible post-surgery follow-up
* want to have a medical pregnancy termination
Methylome Study in Sporadic Limb Malformations

Some limb malformations are known to be sporadic (non hereditary). For these malformations, no molecular cause was identified, even after whole genome sequencing. Methylation of CpG islands is an epigenetic process which is usually not transmitted to the descents. We hypothesize that sporadic limb malformations may be due to a methylation anomaly. This study will include patients with Amelia or Femur Fibula Ulna Syndrome. With patients consent, we will study the methylome on DNA samples already available in our laboratory. Each patient sample will be paired to a control of same tissue, age and sex. By bioinformatics comparison, we will identify differentially methylated candidate regions.


Eligibility Criteria:
Inclusion Criteria:

* Specific consent for this study
* DNA available in the laboratory
* For amelia : agenesia of 2 or 4 limbs
* For Femur-Fibula-Ulna Syndrome : hypoplasia or agenesia of the femur uni or bilateral with hypoplasia or agenesia or bowing of the fibula and/or of the ulna

Exclusion Criteria:

* No consent
* No available DNA or poor quality of the DNA sample
* Patient under tutorship
* Pregnancy or nursing mother
* Patient non covered by the French social security
Paracetamol CSF Pharmacokinetics Study

Despite its use for decades all over the world, the exact mechanism of action of paracetamol is not fully understood and essentially involves a combination of hypotheses. It is known to have an effect via the central nervous system, and of the many mechanisms proposed, one hypothesis is that it may have indirectly activate CB1 (cannabinoid) receptors, through its novel metabolite AM404.

This study aims to elucidate cerebrospinal levels of paracetamol and to measure the concentration of its metabolites, including AM404 in CSF. This may, in turn, give us useful information on the mechanism of action of paracetamol.

Patients undergoing spinal blockade for urological surgery were administered 1g paracetamol intravenously at varying intervals prior to spinal anaesthesia, at which time 5mls of cerebrospinal fluid and 10mls of blood were sampled, and analysed for concentrations of paracetamol, paracetamol glucuronide, paracetamol sulphate, and AM404, a known endocannabinoid reuptake inhibitor, and metabolite of paracetamol.

Paracetamol readily penetrates into the cerebrospinal fluid in animal studies and in children. This could account for the rapid central analgesic and antipyretic action of intravenous paracetamol however this remains to be studied in adults. AM404 has never before been identified in humans, and its presence in CSF following paracetamol supports the hypothesis of a central mechanism of action of paracetamol via AM404.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects aged 18 to 80 years
* Subjects undergoing surgery who require a spinal anaesthetic and paracetamol as part of their routine anaesthetic plan
* Subjects with an American Society of Anesthesiology score of I-III

Exclusion Criteria:

* Subjects with any contraindication to spinal anaesthesia
* Subjects with known clotting abnormalities
* Pregnant or lactating women
* Subjects with known hypersensitivity to paracetamol
* Patients with severe hepatocellular insufficiency
* Patients already taking regular doses of paracetamol
* Any subjects deemed medically unsuitable by the investigator
12-Week Study of Plecanatide for CIC (The CIC3 Study)

The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.

There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-80, inclusive
* Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
* Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5 years), with no clinically significant findings
* Willing to maintain a stable diet during the study

Exclusion Criteria:

* Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment assessment
* Active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable
* History of cathartic colon, laxative, enema abuse, or ischemic colitis
* Fecal impaction within 3 months of screening
* Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
* Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis
* Major surgery, stroke or MI within 60 days of screening
* Participated in a previous plecanatide clinical trial
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
4. Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria:

1. Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent)
2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization
3. Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
4. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
5. Known brain metastases or cranial epidural disease unless adequately treated
HIV Testing in Non-traditional Settings Study

Surveillance data suggests that approximately one third of the 82 000 HIV infected adults in the UK remain undiagnosed - that is, they are living with the infection but do not know this. The majority of HIV testing in the UK to date has taken place in sexual health clinics and in antenatal care. Published National guidelines advocate routine HIV testing of 16-65 year olds in more general healthcare settings in parts of the country with relatively high rates of HIV (more than 2 per thousand individuals diagnosed locally). The HINTS Study investigates the utility, feasibility and acceptability, to patients and staff, of offering routine HIV testing in four general medical settings, all set in areas of high HIV prevalence. The settings comprise: Primary Care, Outpatients, an Acute Care Unit and an Emergency Department.


Eligibility Criteria:
Inclusion Criteria (patient study only):

* aged 16 - 65 and accessing relevant healthcare setting for care
* able to consent to HIV test
* able to provide adequate contact details
* to complete written questionnaire: adequate written English
* to participate in focus group discussion (pre-study group)/participate in semi-structured telephone interview (intra-study group): ability to provide fully informed consent

Exclusion Criteria:

* known HIV positive
* unable to provide adequate contact details
* unable to provide consent (to HIV test and/or participation in questionnaire/focus group/semi-structured interview studies)
CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer with Leptomeningeal Disease

Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC.

Systemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.

The aim of this pilot trial is to evaluate the concordance/discordance of molecular profiling of CSF and plasma ctDNA after the development of leptomeningeal disease in EGFR mutant NSCLC. Patients with EGFR mutant NSCLC who develop leptomeningeal disease on a first, second or third generation tyrosine kinase inhibitor are potentially eligible for this clinical trial.

This is a prospective pilot study designed to accrue 10 patients. Baseline MRI brain and spine must be completed prior to enrolment to insure that a lumbar puncture can be completed safely. All eligible subjects will be consented for ddPCR and Canexia Follow It plasma and CSF based molecular testing. Patients will have baseline information collected and will complete baseline quality of life (QoL) questionnaires. QoL questionnaires will be obtained every 12 weeks +/- 2 weeks and survival will be measured through chart review. There will be no treatment intervention; however we will collect information on treatment received after enrolment in trial. Volume of leptomeningeal disease will be scored by number of gadolinium enhancing sites in 8 predetermined locations.

Eligibility Criteria:
Inclusion Criteria:

* Subject age is greater than or equal to 18 years at the time of signature of informed consent.
* Histologically or cytologically confirmed metastatic EGFR mutant NSCLC.
* Leptomeningeal disease based on brain MRI or CSF cytology.
* ECOG 0-3.
* Life expectancy of at least 8 weeks.
* Adequate hematologic and end organ function for testing.
* Ability to give informed consent for the study procedures defined in this protocol.

Exclusion Criteria:

* Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.
* Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
* MRI spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.
Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Muslim men and women with type 2 diabetes
* Participants who intend to fast during the month of Ramadan
* Participants who have been on a stable dose of sulfonylurea for at least three months

Exclusion Criteria:

* Participants with type 1 diabetes mellitus
* Pregnant or breast feeding women
* Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
* Participants on insulin
* Participants on any class of oral diabetic therapy other than sulfonylurea or metformin
Food Environment, Food Insecurity, and Health Behaviors in NH Hispanics

This telephone-based survey included adults of Hispanic/Latino background residing in New Hampshire (NH). Information on food security and access, food environment, and health status and behaviors was collected through validated questionnaires. This project addresses the need for assessment of barriers to nutrition and health during COVID-19 in this population.

This telephone-based survey included a convenience sample of Hispanic/Latino adults (\>18 years) with cultural origin in a Spanish-speaking country and residing in NH. A subgroup of the study population was assessed at baseline and 6-months following baseline. Validated questionnaires assessing the following outcomes were included:

* Demographics
* Food Access
* Food Security
* Physical Activity
* Dietary Intake
* Eating Behaviors
* Weighing Behaviors
* Psychology
* Sleep Behaviors
* Acculturation
* Gastrointestinal Symptoms
* COVID-19 Vaccine Behaviors

Objective food access will be assessed through mapping and calculation of proximity of subjects' residential addresses to various food sources.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic or Latino cultural background
* Current New Hampshire Resident

Exclusion Criteria:

* Previous participation (cannot complete the survey more than once unless re-contacted for follow-up)
INSTRUCT for Repair of Knee Cartilage Defects

The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.

This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.

All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy.

Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a symptomatic articular cartilage defect in the knee

Exclusion Criteria:

* Surgery on the study knee joint within 6 months
* Patients with significant malalignment (more than 5°)
* Patients with ligamentous instability of the knee
* Majority of the meniscus absent
* Severe osteoarthritis
* Intake of medications or treatments having an effect on bone or cartilage formation
Mindful Breathing Awareness Through Pursed-Lip Breathing Training

To establish the feasibility of a tool that monitors and motivates people with COPD to complete training in mindful pursed-lip breathing to enhance pulmonary rehabilitation at home.

For this pilot study patients who meet the conventional criteria for pulmonary rehabilitation at their clinical appointments will be recruited and scheduled to return for the study. After completing the informed consent, patients will be taught how to don and doff the pulse oximeter, the source of the heart rate and oxygen signals. Patients will participate in a demonstration on how to perform the intervention. Recruitment will continue until five patients have completed the pilot in a clinic setting. If necessary, the prototype will be modified and testing resumed. Once the prototype system has met the criteria for success in the clinic, five of patients will be asked to use the prototype at the clinic and to take it home for a week and perform the intervention at least five times.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥40 years old
* have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing
* have clinically significant breathlessness (breathless when walking on the level or walking a mild hill)
* be a current or previous smoker with at least 10 pack-years of cigarette smoking
* be hospitalized for an exacerbation of COPD.

Exclusion Criteria:

* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).
Menopur Mixed Protocol

The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.


Eligibility Criteria:
Main Inclusion Criteria:

* Infertile pre-menopausal female subjects
* Documented history of infertility (eg., unable to conceive for at least 1 year, or 6 months for women ≥36 years of age, or women with bilateral tubal occlusion or absence, or subjects who require donor sperm).
* Subject's male partner with semen analysis that was at least adequate for intracytoplasmic sperm injection (ICSI) within 6 months prior to the subjects beginning down-regulation with gonadotropin-releasing hormone (GnRH)-agonist. Partners with severe male factor requiring invasive or surgical sperm retrieval or donor sperm could have been used.
* Anti-mullerian hormone (AMH) \> 1 ng/mL and \< 3 ng/mL at screening.
* Eligible for in-vitro fertilisation (IVF) or ICSI treatment.

Main Exclusion Criteria:

* Oocyte donor or embryo recipient; gestational or surrogate carrier
* Previous IVF or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response was defined as development of ≤ 2 mature follicles or history of 2 previous failed cycle cancellations prior to oocyte retrieval due to poor response.
* Inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous ART attempts.
* Subject's male partners with obvious leukospermia (\>2 million white blood cells \[WBC\]/mL) or signs of infection in semen sample within 2 months of the start of subject's pituitary down-regulation. If either of these conditions existed, the male was to be treated with antibiotics and retested prior to subject's pituitary down-regulation.
* Undergoing blastomere biopsy and other experimental ART procedures.
* Body mass index (BMI) of ≤18 and ≥32 kg/m\^2