cyrilzakka/clinical-trials huggingface dataset:
Observational Cross-reactivity Study for Colorectal Cancer Diagnosis

The objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is

Does the blood test have a low false positive rate in the main study population?

Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age at the time of blood sample collection.
* Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form.
* Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease.

Exclusion Criteria:

* Patients who have received previous chemotherapy or radiotherapy.
* In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor.
* Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome.
* Patients without appropriate staging or diagnosis.
* Patients with hemolyzed plasma.
THE EFFECT OF FAST WEIGHT EFFICIENCY AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY ON THE COBB ANGLE IN MORBID OBESE PATIENTS

Obesity has become an increasingly common health problem today. In this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. When we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. When morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress.

The aim of this study is to reveal the Cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; To investigate the effect of weight loss on vertebral anatomy.

90 morbidly obese patients who underwent Laparoscopic Sleeve Gastrectomy were included in the study. Cobb angle measurements were made by a radiologist included in the study from the PA chest radiographs of the operated patients in the preoperative period and in the first postoperative year, and they were recorded in a previously prepared database. In addition, in the preoperative period and postoperative first year evaluations of the patients; Patient satisfaction questionnaire in terms of low back pain, back pain, neck pain, and the value in% EWL of weight given after surgery were also recorded in the database.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18.
* Patients with a diagnosis of morbid obesity, body mass index\> 40

Exclusion Criteria:

* Patients who have undergone previous vertebral surgery due to any disease
* Patients hospitalized for more than 10 days due to postoperative complications
Treatment of NAFLD With Two Different Diets

The impact of popular diets on liver-related health is unclear. In this randomized, controlled trial, patients with NAFLD will be randomized to one of two popular diets or a placebo diet.

Subjects will include patients with MRI-verified NAFLD, with no concurrent liver diseases. Randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. The subjects will follow the diet for three months, after which a new MRI is performed. Main outcomes measure is reduction in liver fat.

Eligibility Criteria:
Inclusion Criteria:

* Known NAFLD

Exclusion Criteria:

* Other forms of liver disease
* Bolus insulin treatment
* Cirrhosis
The Relaxation and Blood Pressure in Pregnancy (REBIP) Study

Over 10% of women have high blood pressure during their pregnancy which may affect their health or that of their baby. There are currently no methods to prevent most high blood pressure in pregnancy and some treatments are not desirable for use in pregnancy. Previous research indicates that simple relaxation methods can reduce blood pressure and anxiety levels for some people, but this has not been well-studied, especially during pregnancy. This pilot study is intended to determine how guided imagery (imagining relaxing scenes) affects blood pressure and anxiety, and to assess how satisfied women are with this technique. Sixty-six pregnant women with high blood pressure will be randomly assigned to (1) listen to a guided imagery audio-compact disc or (2) quiet rest, at least twice-daily for 4 weeks. All women in both groups will receive all usual care, plus will have their blood pressure measured regularly during 1 day per week for 4 weeks. This study will determine if imagery lowers maternal blood pressure, and if further research on imagery effects on pregnancy health outcomes is feasible.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant, and less than or equal to (\<) 36 weeks, 6 days gestation
* At least two prenatal blood pressure readings \> 90 mmHg diastolic
* Has had clinical investigation of the hypertension
* Hearing acuity adequate to hear verbal and audiotaped instructions
* Planning to give birth at one of the study site health centres
* Competent to give informed consent

Exclusion Criteria:

* Likely to deliver within 10 days (including women with diastolic BP \>110 mmHg, or systolic BP \>170 mmHg; unstable diabetes, concurrent antepartum hemorrhage, preterm labour, and/or other significant medical)
* Prescribed antihypertensive medication at baseline
* Documented psychotic illness
* Unable to understand and read English
Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval

Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-90
* Symptomatic recurrent diverticular disease
* Benign adenomatous polyp, requiring surgery
* Early non-transmural sigmoidtumor
* Signed written informed consent, approved by ethical committee

Exclusion Criteria:

* Patients unsuitable for laparoscopy
* Pregnancy
* ASA \>III
* Coagulation disorders
* Anti-coagulants
Drainage After Rectal Excision for Rectal Cancer

After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)

After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis) The aim of the study is to assess the impact of pelvic drainage vs. non pelvic drainage on risk of pelvic sepsis after rectal excision for cancer with infraperitoneal anastomosis. The principal objective is to compare the rate of pelvic sepsis until 30 days between the 2 groups of patients who had a rectal excision with and without pelvic drainage. It is a randomized clinical trial of superiority, multicentric, without blinding, in 2 parallel groups with ratio (1:1): distribution of the number of patients in the groups.

Eligibility Criteria:
Inclusion Criteria:

* Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment
* Stapler or manual infraperitoneal anastomosis
* With or without stoma
* With bowel preparation
* Open or laparoscopic approach
* Stage T1-T4 Nx Mx
* Age 18 years old or older
* Information of the patient and signature of informed consent
* Affiliation to a regime of social insurance

Exclusion Criteria:

* Colonic cancer (\> 15 cm from anal verge)
* Abdominoperineal resection
* Associated resection (prostate, seminal bladder, vagina...)
* Simultaneous liver resection
* Total coloproctectomy
* Emergency
* Infected rectal tumour
* Pregnant women, suitable to be, or current suckling
* Persons deprived of freedom or under guardianship
* Persons under protection of justice
* Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.
Determining the Sustained Virologic Response of Declatasvir in Egyptian Patients With Hepatitis C Virus Genotype 4

This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HCV genotype 4
* Age ≥ 18 years
* HCV RNA≥ 104 IU/mL
* Screening ECG without clinically significant abnormalities.

Exclusion Criteria:

* Total serum bilirubin \> 3 mg/dl.
* Serum albumin \< 2.8 g/dl.
* INR ≥ 1.7
* Platelet count \< 50000/mm3.
* Hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (CT or MRI).
* Extra hepatic malignancy except after two years of disease free interval
* Pregnancy or inability to use contraception.
* Inadequately controlled diabetes mellitus (HbA1c \> 9%).
Dental Appliance for Parkinson's Disease

The investigators are evaluating the immediate effect of a dental mouthpiece on gait and balance among people with Parkinson disease as well as longer-term feasibility use and the effect of the mouthpiece on sleep and quality of life.

The investigators are conducting a pilot study with participants who have been diagnosed with Parkinson disease recruited from the community. Participants will attend one in-person visit and be custom fitted with a dental mouthpiece. Participants will be asked to wear the mouthpiece as much as possible for one month including while sleeping and during the day, except while eating.

Participants will be asked to return for a second in-person visit to repeat gait and balance (motor) measures.

Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of idiopathic, typical Parkinson Disease according to the United Kingdom Brain Bank Criteria, Hoehn \& Yahr stages 1-3;
* stable Parkinson disease medications for the two weeks prior to baseline visit;
* be able to walk at least 10 meters at baseline with or without an assistive device;
* have their own teeth and/or dentures;
* be willing to try to wear a mouthpiece for one month;
* are over the age of 30; and
* provide written or verbal informed consent.

Exclusion Criteria:

* pre-existing medical conditions that would inhibit full participation in the study's tasks;
* absence of any dentition;
* cognitive impairments indicated by Mini Mental Status Exam (MMSE) score of \<24;
* freezing of gait which moderately or severely impacts walking; or
* current use of an oral appliance (e.g., a dental mouthpiece, retainer, or braces).
Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases

RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the effects of the treatment and may help improve cancer treatment.

PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation therapy for brain metastases.

OBJECTIVES: I. Determine the feasibility of performing a test battery consisting of five neurocognitive measures and a quality of life instrument following radiotherapy in patients with brain metastases.

OUTLINE: Patients undergo radiotherapy 5 days a week for 3 weeks. Quality of life and neurocognitive function is assessed before study, at completion of radiotherapy, and at 1 month after completion of radiotherapy. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primary malignancy No primary site of hematopoietic origin (leukemia) No leptomeningeal involvement At least 1 measurable brain metastasis by CT or MRI

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Neurological function classification 0-2 No major medical illnesses or psychiatric impairments that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the brain Surgery: Not specified
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality. Early diagnosis and early treatment interventions may reduce the risk of mortality and morbidity.

The Primary goal of this observational study is to gather survey data to establish a national database of NEC in newborns in order to better understand the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.

NEC affects between 2 to 7% of premature infants. It is is an acquired disease, caused, in part by inflammation of the intestinal lining. NEC is the most common life-threatening gastrointestinal emergency of prematurity and it is associated with significant morbidity and mortality.

Studies have linked the consumption of non-breast milk, commercial infant formula (made from cow's milk) or formula-derived nutrition with increased risk of NEC compared to consumption of human breast milk.

The mechanism of the NEC lesions appears to involve factors including allergic reaction to the infant formulas containing cow's milk, immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation that is hypothesized to be exacerbated by infant formula consumption.

The primary goal of this National observational study is to gather survey data in order to establish a database of NEC in newborns to gain a better understanding of the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.

Eligibility Criteria:
Inclusion Criteria:

* Infants born after 2018
* Newborns that have been diagnosed with NEC and have consumed infant formula.
* Infants whose death resulted from NEC or complications thereof

Exclusion Criteria:

* Infants who were born prior to 2019
* Newborns who have been fed exclusively on breast milk.
* Subjects lacking medical records or who cannot provide a medical history.
Ankle Instability in Flamenco Dancers

The injuries in the dancers are usually associated with different factors such as the characteristics of the footwear, height of the heel and physical requirements, the articulation of the ankle being the most susceptible when the loads are not adequately dealt. The main objective is to evaluate in a sample of subjects if there is a difference in the stability of the ankle, as a consequence of previous sprains, between flamenco dancers and dancers and a dance-free control group.

An observational study. This study has involved a population of 26 subjects divided into two groups of 13 each is studied (40,15 ± 4,675 años); the experimental group is characterized by the practice of flamenco dance

Eligibility Criteria:
Inclusion Criteria:

Flamenco dancers

-

Exclusion Criteria:

* no
Evaluation of Triple Antibiotic Paste Pulp Therapy Compared to Vitapex in Primary Molars.

The aim of the study was to compare the clinical and radiographic success of triple antibiotic paste (TAP) which includes (metronidazole, ciprofloxacin, and minocycline) and Vitapex (calcium hydroxide/iodoform paste) for root canal treatment of pulpally involved teeth.

This study evaluated and compared the clinical and radiographic efficacy of non-instrumentation triple antibiotic paste pulp therapy (TAP) versus Vitapex pulpectomy in non-vital primary molars. Healthy 5 to 9 years old children with at least one non-vital primary molar were included in the study. molars were divided based on the subject's cooperation level and parental preference into two groups. In the first group, molars received TAP and in the second group, they received Vitapex pulpectomy followed by a stainless-steel crown. The TAP was freshly prepared and proportioned in equal parts by volume (metronidazole, minocycline, and ciprofloxacin=1:1:1) before the scheduled treatment appointment. The clinical and radiographic examination was performed by two calibrated and trained pediatric dentists at the pre-operative baseline and at the six- and 12-months follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

Primary molars with at least one of the following signs and symptoms were eligible and were included in the study:

* badly decayed with signs of irreversible pulpitis,
* necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency,

All the teeth included, had physiological root resorption of less than one third of the root.

Exclusion Criteria

* Teeth showing radiographic evidence of excessive internal or external root resorption,
* perforated pulpal floor,
* excessive bone loss in furcation area involving the underlying tooth germ,
* non- restorable teeth were excluded from the study.
Assessment of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) for Maternal Pre-oxygenation

The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* major
* female
* affiliated to a social security scheme or beneficiary of such a scheme
* having voluntarily and informedly agreed to participate in the study.
* non-smoker
* free from pulmonary, cardiac and neurological pathologies
* have a normal functional respiratory test at baseline.

Exclusion Criteria:

* refusal to participate in the study
* non-French speaking volunteer
* obesity defined by a body mass index greater than 30 kilogram/meter² (kg/m²)
* current pregnancy
* Volunteer in period of exclusion from further research
* Person under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty
The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)

Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor, based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore, NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort, including not only NMO but also clinical syndromes suggestive of a first episode (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer questions that could not have been addressed at the level of a single centre.

Objectives: The main objective is to describe the clinical, radiological and biological features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse myelitis (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their evolution. The second aim is to create a biobank dedicated to NMO (serum, whole blood for RNA and DNA extraction, cerebrospinal fluid), to promote translational research in the field. Methods: NOMADMUS is a prospective, multicentre, observational study of patients NMOSD and related disorder in France. Prevalent cases are included retrospectively and then followed prospectively. Incident cases are included from disease onset and followed prospectively. A minimal set of data has been defined and synthesized on specific paper forms derived from the European database for multiple sclerosis (EDMUS) forms. Patients are systematically tested regarding their AQP4-IgG and MOG-IgG status. All the data are centralised in a EDMUS-derived database in Lyon, the EDEN software. All cases are validated and classified by an expert committee.


Eligibility Criteria:
Inclusion Criteria:

Definite Devic's Neuromyelitis Optica NMO according to established criteria (Wingerchuk 1999, Wingerchuk 2006, International panel 2015)

* high risk syndromes for NMOSD, defined as: recurrent or simultaneous optic neuritis, idiopathic single or recurrent longitudinally extensive transverse myelitis (spinal cord lesion seen on MRI \>3 vertebral segments)
* patients tested positive for AQP4-IgG autoantibody or MOG-IgG autoantibody
* living in France since 5 years minimum

Exclusion Criteria:

* None