cyrilzakka/clinical-trials huggingface dataset:
Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)

Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have investigated the impact of narcolepsy on patients' academic background, socio-professional integration, and quality of life.

Narcoleptic patients may experience more difficulties in their academic and professional path than non-narcoleptic people. These difficulties would be multifactorial (related to the disease itself, comorbidities, external factors ...).

As a better understanding of these determinants could help to inform patients and guide them in their choices, this study propose to establish a comprehensive inventory of educational and professional trajectories of narcoleptic patients in France in order assess the specificity of the difficulties encountered by the people concerned in their life course and to appreciate the attitude of the academic and professional circle with respect to the disease.

This category 3 study (according to the French law "Loi Jardé") is based on the case-control model and will be conducted in all National Reference and Competence Centers for Narcolepsy and Hypersomnia. It will include a population of adult and paediatric patients. It will answer questions about work and schooling in these patients.


Eligibility Criteria:
Inclusion Criteria:

The case group:

* Children (6 years \<age \<18 years) or adults with type 1 narcolepsy diagnosed on:
* a clinic in favor of narcolepsy: excessive daytime sleepiness lasting for more than 3 months.
* cataplexy and an positive multiple sleep latency test (mean sleep latency ≤ 8 min and ≥ 2 SOREM) or a hypocretin dosage in the CSF \<110pg / L.
* Patients followed in one of the centers participating in the research.

The control group:

* At least one person close to the case (cousins, close friends ...).
* For adults: same sex as the case and if possible same age (+/- 5 years).
* For minors: same sex and if possible same age (+/- 2 years).
* Person not suffering from narcolepsy.

Exclusion Criteria:

The case group:

* Patients refusing to participate.
* Patients who do not speak the French language (incompatible with the reading, the comprehension and the filling of the questionnaires).
* Patients whose diagnosis of type 1 narcolepsy is not certain and / or has type 2 narcolepsy.
* Patients with narcolepsy symptomatic of another neurological disease.

The group controls:

* Person refusing to participate.
* Person who does not speak French (incompatible with reading, understanding and filling out questionnaires).
* The brothers and sisters of the case cannot be witnesses of the study.
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from ulcerative colitis
* Naïve from Adalimumab
* Starting a treatment with adalimumab
* Capable of and willing to grant authorization for use/disclosure of data collected
* Able to read, understand, and complete patients questionnaires

Exclusion Criteria:

- None
Prehabilitation in Geriatric Patients With Colorectal Neoplasia

This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.

Patients will follow an intensive prehabilitation course before surgery:

* Colon cancer patients will do 4 weeks of prehabilitation before surgery.
* Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.

The prehabilitation course is structured around the following aspects:

* Frailty assessment and identification of optimisation fields
* Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
* Assessment by an integrative medicine specialist
* Nutritional pre-qualification
* Cardiovascular, respiratory, motor prehabilitation
* Emotional and psychological prehabilitation


Eligibility Criteria:
Inclusion Criteria:

1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
2. Male/female participants who are at least 70 years of age on the day of signing informed consent.
3. Patients with confirmed diagnosis of colorectal cancer awaiting major surgery.

Exclusion Criteria:

1. Clinical need for emergency intervention.
2. Severe cognitive impairment (MMSE\<20\*)
3. Severe dependency (ADL\<3)
4. Stage IV colorectal neoplasia
3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT

Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software


Eligibility Criteria:
Inclusion Criteria:

* good general health conditions;
* presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);

Exclusion Criteria:

* no clinical evidence of major facial asymmetry;
* use of medication that would influence or alter wound healing;
* temporomandibular joint disorder history;
* smoking
Sleep Quality Among Students in Sohag University.

The study will be done among undergraduate students in Sohag University for assessment of quality of sleep and its determinants .It will be done in practical faculties and theoretical faculties .

Sleep is very necessary to our physical and mental health. Sleep is classified into satisfactory and unsatisfactory sleep. Good sleep is sleep which is sufficient in duration and has a good quality while bad sleep is the sleep which makes individual feels unsatisfactory .

University students are exposed to poor sleep, due to high work and study loads. Poor quality sleep has negative consequences on the daily life activities , associated with memory reduction , reduced learning abilities which ultimately can lead to reduce their academic achievements, and can also trigger negative health outcomes, such as mood disturbance, fatigue, impaired concentration .

Eligibility Criteria:
Inclusion Criteria:

* students who are in the first four years in the selected faculties .

Exclusion Criteria:

* students who will refuse to participate in this study.
Coping Skills for Alcohol Use

A total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). Participants will complete 4 weekly assessments and a 1- and 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

- Eligibility criteria at recruitment include: 1)18-25 years old; 2) Currently live in the state of WA, 3) Have a valid email address and phone number, 4) Drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month

Exclusion Criteria:

* None
Laparoscopic Assisted Transvaginal Cholecystecomy

Laparoscopic cholecystectomy is currently the standard procedure for removing the gallbladder. This procedure usually requires the insertion of four trocars into the abdomen for passage of laparoscopic instruments; each trocar requires a small incision, which results in postoperative pain and scarring. There has recently been a tremendous surge in interest within the surgical community to further reduce the pain, invasiveness, and cosmesis of laparoscopic surgery. To achieve this goal, surgeons are either reducing the number of trocars placed through the abdominal wall or eliminating them completely The goal of this project is to evaluate the feasibility of performing transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization. This has the potential to decrease postoperative pain, improve cosmesis, and lead to a shorter recovery following cholecystectomy.

20 female patients will be enrolled. Patients who are scheduled to undergo elective laparoscopic cholecystectomy will be invited to participate in this study. The laparoscopic instrumentation will be sterilized using standard methods. Conventional and new laparoscopic and endoscopic equipment will be used for this project; all equipment is commercially available and is FDA-approved for laparoscopic procedures. Access will be obtained into the peritoneal cavity at the umbilicus in a standard fashion, either by use of a Veress needle technique or by insertion of a trocar using the open technique. Through a single umbilical incision, a 5mm trocar will be placed into the peritoneal cavity. A 5mm laparoscope will then be inserted into the peritoneal cavity. This will be used to monitor safe peritoneal entry of a dilating12mm transvaginal trocar. Subsequent operative visualization will be by use of a flexible endoscope which will be placed through the transvaginal port. The gallbladder will be retracted using sutures as well as endoscopic and / or laparoscopic graspers. In order to obtain the critical view of safety \[5\] the cystic duct and artery will be dissected, ligated and divided by use of conventional laparoscopic and new articulating instruments. The dissected gallbladder will be retrieved transvaginally. If for any reason suitable retraction or dissection cannot be performed using the transvaginal strategy, the case will be promptly converted to a standard laparoscopic approach by the insertion of additional transabdominal trocars.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo elective laparoscopic cholecystectomy
* Women 18-75 years of age
* English or Spanish speaking

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classification of ≥ 3
* Morbid obesity (BMI ≥35)
* Pregnant women
* Acute cholecystitis
* Any ongoing intra-abdominal infection
* Prior upper abdominal or pelvic surgery and/or adhesions
* Virgins
* Women with an active sexually transmitted disease or any vaginal infection
* History of dyspareunia
Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease

This investigation is undertaken to:

* Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
* To assess the safety and tolerability of the device in patients with PD.


Eligibility Criteria:
Inclusion Criteria:

1. Parkinson disease: Clinically diagnosed
2. Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
3. Experiencing at least two of following symptoms and/or side effect on a daily basis:

   * Rigidity
   * Tremor
   * Bradykinesia
   * Dyskinesia (treatment side effect)
4. Provision of informed consent, i.e., the subject must be able to:

   * Read and understand the Patient Information and Consent Form
   * Sign the Patient Information and Consent Form.

Exclusion Criteria:

1. Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
2. MMSE \<24
3. Other neurological diseases
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Blood glucose criteria must be met

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of significant diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.

The objectives of the study are to assess FX005, as compared to placebo control, for:

* Safety and tolerability
* Analgesic effect
* Pharmacokinetics

Analgesic effect will be assessed using the Western Ontario \& McMaster University Osteoarthritis Index (WOMAC), the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and patient and clinical observer global assessments.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥40 years of age
* Diagnosis of unilateral or bilateral osteoarthritis of the knee for at least 6 months; confirmation of osteoarthritis according to American College of Rheumatology Criteria (clinical and radiological)
* Kellgren-Lawrence grades II or III
* Mean score for the WOMAC A subscale (pain) between 2.0 and 3.5 for the index knee
* Score of 2-3 for the WOMAC A1 score (pain on walking) for the index knee
* Body mass index ≤ 40 kg/m2
* Willingness to abstain from use of restricted medications during the study
* Willingness and ability to comply with the study procedures and visit schedule

Exclusion Criteria:

* Kellgren-Lawrence Grade 0, I or IV radiographic stage of the index knee
* Clinically apparent tense effusion in index knee
* Presence of surgical hardware or other foreign body in the index knee
* Clinical signs and symptoms of active knee infection or crystal disease
* Intra-articular corticosteroid within 3 months of Screening
* Intra-articular hyaluronic acid within 6 months of Screening
* Other intra-articular therapy within 3 months of Screening
* Prior arthroscopic or open surgery of the index knee within 12 months of Screening
* Planned/anticipated surgery of the index knee during the study period
* History of malignancy or other serious, non-malignant, significant, acute or chronic medical (e.g.. uncontrolled diabetes) or active psychiatric illness
* Skin breakdown at the knee where the injection would take place
* Women who are pregnant, nursing or likely to become pregnant during the time of the study
* Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year) not using effective contraception
An Observational Study to Assess Treatment & Outcomes Data in Patients Receiving Long-Acting Injectable Risperidone

The purpose of this study is to assess treatment and outcomes data in patients receiving treatment with long-acting injectable risperidone.

This is an observational (study in which patients/participants are observed) and multicentre (at multiple sites) study. This is one-country arm of a multinational study. This study consists of 2 years of retrospective (a study in which the patients are identified and then documented backward in time and 2 years of prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) study periods during which medication utilization review will be done, determining medication usage patterns and outcomes associated with the use of risperidone long acting, in clinical practice. Usage of risperidone according to label was recommended during the study. The planned recruitment period will be 6 months. Retrospective observation will be 2 years for hospitalization history and at least 1 year for medication usage. Total duration of prospective observation for each patient with a complete follow-up will be 24 months. Data collection during the follow up period will be scheduled every 3 months ± 2 weeks. In addition, this study is proposed in Belgium to satisfy the demand from Belgian Reimbursement Authorities to collect clinical data on the impact of risperidone long acting on treatment compliance, number of hospitalizations and potential prevention of relapses. Also, this data will provide documentation on switch from oral to parenteral treatment. Data will be pooled from different physicians and/or countries. The objectives of this study are: collect clinical outcome data at the request of the Belgian Reimbursement Authorities; prospectively assess medication usage patterns to document clinical efficacy and long-term treatment outcomes of risperidone long acting, in a naturalistic setting; collect retrospective data, to compare with risperidone long acting; document reasons for initiating risperidone; collect data on switch of treatment to risperidone long acting.

Eligibility Criteria:
Inclusion Criteria:

* Patient who started long-acting injectable risperidone treatment after agreement between doctor and patient
* Ambulatory patient or not chronically full-time hospitalized patient. Full-time hospitalization at the moment of inclusion for maximal 6 months
* The treatment and treated indication according to local label
* Patient had given informed consent in agreement with local legislation

Exclusion Criteria:

* Patient participating in another medication related study, chronically full-time hospitalized patient, who according to the treating physician had no perspective of being discharged within the planned observation period
* Patient suffering from treatment resistant schizophrenia
* Pregnant or breastfeeding females or females with planned pregnancy within two years
Diabetic/Metabolic Cardiomyopathy: Prevalence and Phenotype

"Little is known about the prevalence, determinants and phenotypes of the cardiomyopathy associated with diabetes and/or metabolic syndrome. The emergence of new therapies (SGLT2 inhibitors) that may mitigate and even prevent the onset of heart failure offers new opportunities.The objective of this protocol is to evaluate the prevalence and phenotypes of cardiomyopathy confirmed by echography in people at high metabolic risk defined as living with diabetes or obesity."

Heart failure (HF) is a frequent disease with a global prevalence of 2.3% that may culminate up to 10% in the elderly. HF is associated with poor outcomes, namely multiple recurrent hospitalizations and high mortality. It is well known for several decades that diabetes is associated with a high cardiovascular mortality, with most physicians initially focusing on coronary artery disease solely. More recently, the concept of specific diabetic and/or metabolic cardiomyopathy emerged with different phenotypes. Obesity and hypertension are highly prevalent in patients with type 2 diabetes (T2D) and several studies have shown similar "diabetic cardiomyopathies" and "obese cardiomyopathies". Congestive HF was found to be two to three times more frequent in patients with T2D than in those without. Asymptomatic HF is underestimated by lack of systematic screening of these patients which prevent them from benefiting from early therapeutics. To our knowledge, no previous study has been made with systematic screening for HF in obese patients without obvious HF signs. Several tools can be used to examine the possible presence of cardiomyopathy and/or HF. The detection of cardiomyopathy at an early, preclinical stage may be of particular interest. First, studies have demonstrated that HF management is more effective at an early stage, with some drugs being associated with a reverse remodeling. Second, the class of SGLT2 inhibitors has proven to reduce the risk of hospitalization for HF in high-risk patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years-old or more)
* At high metabolic risk: diabetes of any type and/or obesity (body mass index ≥ 30 kg/m²)
* Admission in the departement of Diabetology-Obesity-Nutrition, Avicenne Hospital, Bobigny, France
* Patient informed and having signed consent
* Patient affiliated to a social security scheme or entitled

Exclusion Criteria:

* Any know cardiac disease: coronary artery disease, heart failure, cardiomyopathy, pulmonary embolism \< 6 months, pulmonary hypertension, rhythm disorders \< 6 months
* Blood pressure \> 180/110 mmHg
* Severe renal failure as defined by estimated glomerular filtration rate \< 30 ml/min
* Age ≥ 80 years
* Previous inclusion in the study
* Patient under guardianship curatorship
* Patient on AME (aide médicale d'état)
Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

Precision Cancer Medicine for Advanced Cancer Through High-throughput Sequencing

This study supports the collection of tumor specimens for CLIA-certified genomic testing and research testing in parallel. CLIA-certified tests have established measurements of accuracy and precision which allow for return of results. This study does not involve treatment, only testing, which could be used to meet eligibility criteria in other trials.

Eligibility Criteria:
Inclusion Criteria:

1. A histologically or cytologically confirmed diagnosis of cancer
2. Patients with any malignancy.
3. Patients must have tumor suitable for research tumor biopsy (as assessed by trained specialists in interventional radiology) and Patients are medically fit to undergo a tissue biopsy or surgical procedure to get tumor tissue OR If Patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation.

   OR Patients are undergoing standard of care surgeries or procedures where fresh specimens will be first used for routine pathologic assessment and only then will leftover tissue be used for research purposes.
4. Procedure-specific signed informed consent prior to initiation of any study-related procedures.
5. Women and minorities are included in this protocol.
6. Patients with multiple malignancies remain eligible.
7. Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible.

Exclusion Criteria:

1. It is the enrolling study physicians discretion to decide if a patient is not fit enough to undergo tissue biopsy.
2. Patients who are incarcerated are not eligible to participate.