cyrilzakka/clinical-trials huggingface dataset:
A Group Intervention for Promoting Health-related Habits (LEV-G)

Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.

Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. This study will therefore be open for participants recruited from several types of healthcare services in Sweden.

Study 1: The feasibility trial investigates the following questions:

Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session.

Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.

Do the intervention lead to adverse events? To what extent were individual goals met?

Eligibility Criteria:
Inclusion Criteria:

* both adults with and without disabilities recruited from different healthcare contexts.

Exclusion Criteria:

* Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.

  * Insufficient command of the Swedish language/ unable to understand the content.
  * Severe psychiatric comorbidity that makes participation difficult (e.g. severe depression, severe suicidality, severe anxiety, ongoing psychosis, manic episode), other circumstances that could make participation hard (e.g. homelessness).
Breakfast Omission and Energy Balance in Girls

There is a distinct lack of experimental evidence on whether breakfast consumption and omission affect energy balance-related variables. This research is of particular relevance to adolescent girls due to concerns of low rates of breakfast consumption and physical activity in this population. This study aims to compare the effect of seven consecutive days of breakfast omission with standardised breakfast consumption on free-living physical activity energy expenditure, energy intake and perceived appetite and energy levels in adolescent girls.

Observational reports showing infrequent breakfast consumption to be associated with increased adiposity and cardiometabolic disease risk in children and adolescents have fuelled concerns over the low prevalence of habitual breakfast consumption among adolescents. Yet, only experimental study designs can determine the causal effects of breakfast consumption on health-related variables and such research has typically targeted adults. Adolescent girls may respond differently to manipulations in breakfast consumption than adults because they have distinct hormonal, metabolic and behavioural profiles. Further, a link between breakfast and physical activity in adolescent girls has particular public health relevance because the adolescent decline in both breakfast consumption frequency and physical activity is more pronounced in girls than in boys. Thus, the primary aim of the current study is to use a randomised, cross-over design to compare the effect of seven consecutive days of breakfast omission with standardised breakfast consumption on free-living PAEE in adolescent girls. The secondary aims are to examine the effects on energy intake, perceived appetite and energy levels.

Using a randomized crossover design, girls aged 11-14 years will complete two, 7-day conditions. A standardized breakfast will consumed every day before 09:00 in the daily breakfast consumption condition. No energy-providing nutrients will consumed (i.e., only water) before 10:30 in the breakfast omission condition. Combined heart rate-accelerometry will be used to estimate physical activity energy expenditure and digital photography complemented with written food diaries will be used to assess energy intake during each condition; these data will be separated into three time segments: wake to 10:30, 10:30 to 15:30 and 15:30 to bed. Visual analogue scales will be used to assess perceptions of hunger, fullness, tiredness and energy levels on waking and at 09:00 and 10:30. Statistical analyses will be completed using condition by time of day linear mixed models.

Eligibility Criteria:
Inclusion Criteria:

* Parental informed consent
* Child assent

Exclusion Criteria:

* Health related issues identified from a health screen questionnaire that could be adversely affected by participation or could affect the study outcomes (e.g., allergies to the breakfast meals, fitted with a pacemaker)
* Unable to walk or wear a combined heart rate-accelerometer on the chest.
Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure

Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.

Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.

Study Objective:

Primary Objectives:

1. To evaluate the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.

Study Design:

A prospective randomized controlled trial

Study sampling:

A convenience sampling method will be used; all patients seeking medical advice for CAF at Suez Canal University hospitals, the Faculty of Medicine during the study period and fulfill the inclusion criteria will be recruited. One of the researchers who will make random allocation cards using an Excel formula algorithm will perform simple randomisation.

Methodology:

This study will include at least 99 patients with CAFs of both genders who will visit the general surgery clinic in the faculty of medicine at Suez Canal University hospital and fulfil the inclusion and exclusion starting from September 2024. Patients of both genders with CAF for the first time, above 18 years old and ASA I/II will be included in the study. While patients with sepsis, previous pelvic radiation, recurrent CAF, with malignancy, on immunosuppressive drugs, with pregnancy or lactation will be excluded. Patients will be randomly allocated into 3 groups at a ratio of 1:1:1 starting with the Sucralfate group. Formal written consent will be obtained from the study participants prior to being involved in the study. All included patients will be followed up to 40 days.

Eligibility Criteria:
Inclusion Criteria:

* above 18 years old.
* CAFs for the first time
* ASA I, II

Exclusion Criteria:

* Sepsis
* Previous pelvic radiation.
* recurrent chronic anal fissure
* Pregnancy or lactation.
* Immunosuppressive state
* Malignancy
* Refusal to participate
Study Of Intraductal Carboplatin In Women With Ductal Carcinoma In Situ (DCIS)

The primary objective of this study is to compare the safety of 100 mg carboplatin administered intraductally once on Day 1 or twice on Days 1 and 15 in women with ductal carcinoma in situ (DCIS) undergoing surgical management 2 to 4 weeks following the Day 15 intraductal infusion. Secondary objectives are to characterize the biologic and clinical effects with respect to: pharmacokinetics, extent of disease on MRI and mammogram, histopathological assessment of DCIS, and biomarker measurement of Ki-67, TUNEL and G-actin.

This is a randomized, 3-arm, saline-controlled study involving women undergoing surgical management of DCIS. Forty-five (45) women who have been diagnosed with DCIS by core biopsy will receive intraductal administration of either carboplatin or normal saline (NS) into the DCIS-involved breast duct. Thirty (30) patients (i.e., 15 patients per arm) will receive two intraductal infusions of either 100 mg of carboplatin or NS on Days 1 and 15. Fifteen (15) patients will receive an intraductal infusion of 100 mg carboplatin on Day 1 and an intraductal infusion of NS on Day 15. Patients will undergo surgical resection 2 to 4 weeks following the Day 15 intraductal infusion (i.e. 4 to 6 weeks from diagnosis).

The effect of carboplatin on DCIS in the pre-treatment core biopsy specimen and the resection specimen will be assessed. Venous blood samples will be collected for carboplatin PK analysis pre-dose and at 30 minutes, 1, 2, 4, and 8 hours following intraductal infusions on Days 1 and 15.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Scheduled to undergo surgical resection in 2 weeks or longer
* Pathological diagnosis of DCIS requiring surgical resection
* DCIS diagnosed with core biopsy
* Mammogram within 6 weeks of diagnosis
* Adequate organ function as defined by the following criteria:

Absolute neutrophil count (ANC) ≥ 1500/μl, Platelets ≥ 140,000/μl,Hemoglobin ≥ 12.0 g/dl, Creatinine \< 2.0 mg/dl

- Able to sign informed consent

Exclusion Criteria:

* Current diagnosis of invasive or inflammatory breast carcinoma
* DCIS with microinvasion on histology on core needle biopsy
* Palpable mass
* Mass on mammography
* Concurrent anti-cancer therapy
* Prior exposure to carboplatin (related to current or past diagnosis)
* Prior radiation to the breast or chest wall
* Prior areolar or breast surgery which interrupts communication of the ductal systems with the nipple
* Presence of breast implants
* Presence of ulcerating or fungal skin lesions or infection of the breasts
* Pregnant or lactating
* Impaired cardiac function or history of cardiac problems
* Poor nutritional state (as determined by clinician)
* Presence of serious infection
* Scheduled for intraoperative radiation of breast or chest wall
* Allergies to lidocaine or marcaine
* Allergies to imaging dyes
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
* Patient has no clinically significant findings on a physical examination and clinical laboratory tests
* Patient meets protocol criteria for diagnosis of IBS-C
* Patient demonstrates continued IBS-C through Pretreatment Period
* Patient maintains a minimum level of compliance with daily diary

Exclusion Criteria:

* Patient has history of loose or watery stools
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?

Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.

Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation. The assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.

Eligibility Criteria:
Inclusion Criteria:

* acceptance for living kidney donation

Exclusion Criteria:

* withdrawal of consent
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 in Healthy Subjects

It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent.
2. Aged 18-55 years (inclusive), male or female.
3. BMI within 18.0-28.0 kg/m2 (inclusive).
4. Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
5. Have agreed to take effective contraception measures.

Exclusion Criteria:

1. Have any prior clinically serious disease of any system.
2. Known or suspected allergy to the study drug or any of its ingredients.
3. Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
4. History of recurrent or chronic infection within 6 months prior to the first administration.
5. Unable to comply with dietary management during the study period.
6. Pregnant or lactating women.
Benefit of Augmented Reality Mirror Therapy in Addition to Conventional Management in Complex Regional Pain Syndrome of the Upper Extremity

Complex Regional Pain Syndrome (CRPS) is a "polymorphic joint and periarticular pain syndrome associated with various changes in sensitivity, vasomotor, sudomotor, muscular and trophic changes". The diagnostic criteria of the disease follow the Budapest criteria, namely (i) vasomotor disorders (temperature asymmetry, color changes), (ii) sudomotor/oedema (sweating changes, edema), (iii) sensory (hyperesthesia, allodynia, hyperalgesia) and (iv) motor/trophic (reduced joint mobility, weakness, tremor, dystonia, trophic disorders of skin, nails, hair).

Of the many treatments, augmented reality mirror therapy (ARMT), is novel in substituting a virtual environment for part of the real environment. This type of device has never been studied from a clinical point of view in the treatment of upper limb CRPS, whereas fMRI and clinical dissertation studies have suggested an improvement in neuroplasticity.

The aim of this study is to establish the clinical effects of ARMT on CRPS, and to evaluate its benefit within a conventional rehabilitation treatment (physiotherapy and occupational therapy).


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient with CRPS of the upper limb according to the Budapest criteria.
* Patient newly treated at the Centre d'Evaluation et de Traitement de la Douleur of the CHU of Nîmes.
* Patient with a diagnosis of CRPS for more than 3 months

Exclusion Criteria:

* The subject is participating in a therapeutic study, or is in a period of exclusion determined by a previous study
* The subject unable to express consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient is pregnant, parturient or breastfeeding
* Patient with medically significant visual impairment that is incompatible with the practice of ARMT
* Patient with CRPS secondary to a stroke
* Patient with cognitive disorders (Montreal Cognitive Assessment scale less than 26)
* Patient with Unilateral Spatial Negligence according to the Bell's test
* Patient with arthrodesis of one of the joints of the upper limbs.
* Patient with an unhealed fracture of one of the upper limbs
Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)

The main objective is to identify specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified by questioning, geographical distribution of cases) from the RNV3P data.

The secondary objectives are as follows:

* Description of cases of ANCA vasculitis seen in French occupational pathology consultation centres:

  * reasons for consultation,
  * occupational and environmental etiologies described
  * occupational situations responsible
  * aptitude notices
  * recognition as an occupational disease
* Identification of specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified on questioning, geographical distribution of cases).
* For occupational and non-occupational cases of ANCA vasculitis: identification of difficulties encountered by patients at work and proposed work adaptations.
* Estimation of the number of applications for recognition of disabled worker status made within this patient group.
* Identification of clinical severity and autoimmune profiles of ANCA vasculitis of occupational and/or environmental origin.


Eligibility Criteria:
Inclusion Criteria:

* Patient with ANCA vasculitis defined according to the International Classification of Diseases (ICD-10), i.e. M 308, M 31, N 057 and L 95, or mentioned as the reason for consultation in the text mining summary.
* Seen in consultation in the occupational disease consultation centres belonging to the RNV3P
* No opposition

Exclusion Criteria:

* Refusal to participate
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.


Eligibility Criteria:
Inclusion Criteria:

* Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
* History of disabling migraine for at least 1 year
* Migraine onset before the age of 50 years
* History of 3 to 8 migraine attacks per month (\<15 headache days per month) during the past 3 months
* MIDAS score ≥11
* Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
* Women of child-bearing potential must be using or willing to use a highly effective form of contraception
* Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed

Exclusion Criteria:

* Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
* History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures
* History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
* History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
* History of orthostatic hypotension with syncope
* Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
* Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
* History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
* Use of more than 3 doses per month of either opioids or barbiturates
* Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
* Pregnant or breast-feeding women
* History of drug or alcohol abuse/dependence within 1 year prior to screening
* Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
* Currently enrolled in any other clinical study involving an investigational product
* Relatives of, or staff directly reporting to, the Investigator
* Participants who are employees of the sponsor