cyrilzakka/clinical-trials huggingface dataset:
Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment

The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.

Participating sites consist of academic and non-academic hospitals and fertility clinics in The Netherlands. There are two treatment arms (MOH/IUI treatment with LPS vs MOH/IUI treatment with placebo) with a non-blinded superiority design. Participants are randomly distributed across both treatment arms for the entire study-period (six months, non-crossover).

Eligibility criteria are: 1) couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. 2) Indication for MOH/IUI treatment is in accordance with current (dutch) NVOG guidelines; Diagnosis of unexplained (primary or secondary) infertility with Hunault \<30% (or \>30%, after an expectant management period of at least 6 additional months). Total mobile sperm count (VCM) \>10 million. 3) Females aged \>18 years with regular menstrual cycle.

(Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation.

Main outcome is pregnancy within 6 months of treatment, leading to Live birth. Secondary outcomes are; Clinical pregnancy rate. Miscarriage rate. Multiple pregnancy rate. Pregnancy complications. Perinatal outcomes. Side effects and compliance to therapy. Added Medication Costs. Budget impact.

The analyses will include a cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

* Couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months.
* Diagnosis of unexplained (primary or secondary) infertility
* Hunault \<30% (or \>30%, after an expectant management period of at least 6 additional months).
* Females aged \>18 years with regular menstrual cycle.
* Total mobile sperm count (VCM) \>10 million.

Exclusion cirteria:

* Cycle irregularities
* Male factor infertility
Video Game Balance Training for Patients With Diabetic Neuropathy

This study evaluated the effects of interactive video game-based exercise (IVGB) on balance in diabetic patients with peripheral neuropathy. Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.

Participants in Group A received IVGB intervention for the first 6 weeks (intervention phase), with no exercise in the subsequent 6 weeks (control phase), whereas participants in Group B received no IVGB intervention in the first 6 weeks (control phase), followed by 6 weeks of IVGB intervention (intervention phase). The IVGB intervention protocol consisted of 30-minute training sessions comprising four tasks designed to focus on lower limb strength, balance, and coordination training. Balance assessments consisted of both subjective and objective measures, including the Modified Falls Efficacy Scale (MFES), Time Up and Go (TUG) test, Berg Balance Scale (BBS), and Unipedal Stance Test (UST). For all participants, these tests were conducted at weeks 0, 6, and 12 of the experiment.

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years of age
* medical diagnoses of diabetes under regular medication control and diabetic peripheral neuropathy confirmed using an electrodiagnostic test
* independent community ambulatory individuals
* intact cognition (Mini-Mental State Examination score of \>24).

Exclusion Criteria:

* other neurological diseases such as dementia, Parkinson's disease, spinal cord injury, or stroke;
* severe visual impairment, musculoskeletal disorders, unhealed plantar ulceration, lower limb amputation, poor cardiopulmonary function, or other diseases affecting walking ability or any other disease due to which individuals were unable to walk without assistance
* any other condition associated with a high risk of falling.
* Inability to follow simple instructions
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18-64 years (both inclusive).
* Type 1 diabetes mellitus (as diagnosed clinically) \>= 12 months.
* Treated with multiple daily insulin injections or CSII \>= 12 months.
* Current total daily insulin treatment \< 1.2 (I)U/kg/day.
* Current total daily bolus insulin treatment \< 0.7 (I)U/kg/day.
* BMI 18.5-28.0 kg/m\^2 (both inclusive).
* HbA1c \<= 9.0 % by local laboratory analysis
* Fasting C-peptide \<= 0.30 nmol/L.

Exclusion Criteria:

* Known or suspected hypersensitivity to IMPs or related products.
* Type 2 diabetes mellitus.
* Previous participation in this trial. Participation is defined as randomised.
* Participation in any clinical trial within 3 months prior to this trial.
* Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
* Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods
Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.

Objectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.

Methods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.

Significance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.


Eligibility Criteria:
Inclusion Criteria:

* Children 4-18 years old with fecal incontinence for a period greater than 6 months.
* FI frequency of ≥ 3 episodes/week.
* After appropriate medical evaluation, FI cannot be explained by another medical condition.
* Normal colonic transit study, defined as passage of 80% of markers on day
* Normal RAIR on anorectal manometry

Exclusion Criteria:

* Patients currently fulfilling rome IV criteria for functional constipation.
* Patients with evidence of fecal retention.
* Patients who had had good response to treatment for overflow incontinence.
* Absent RAIR on anorectal manometry.
* Any radiologic evidence of dochylosigmoid or distended colon.
* Any known organic condition that may affect bowel transit.
Effect of APRV and LTV on Lung Ventilation and Perfusion in Patients With Moderate-to-severe ARDS

Low tidal volume ventilation (LTV) has been proposed and widely used in patients with acute respiratory distress syndrome (ARDS) to prevent ventilator-induced lung injury (VILI) and mitigate its effects. The LTV strategy is intended to protect the "baby lung" from overdistension while simultaneously allowing acutely injured tissue to continually collapse. Airway pressure release ventilation (APRV) is a highly effective strategy improving lung recruitment and oxygenation in clinical studies, but its effects on lung injury and mortality is debatable. Animal studies revealed that APRV could normalize post-injury heterogeneity and reduce the risk of VILI. Our objective was to investigate the impact of APRV and LTV on regional ventilation and perfusion distribution in ARDS patients by electrical impedance tomography (EIT).


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 and ≤80 years;
2. Moderate-to-severe ARDS patients according to the Berlin definition;
3. Endotracheal mechanical ventilation ≤48 h before enrollment;
4. Expected to require continuous invasive mechanical ventilation ≥72 h.

Exclusion Criteria:

1. Severe chronic obstructive pulmonary disease, severe asthma, pulmonary bulla, subcutaneous emphysema, mediastinal emphysema, etc;
2. Contraindications to the use of electrical impedance tomography (e.g., chest surgical wounds dressing or presence of pacemaker)；
3. Pulmonary interstitial lesions；
4. End-stage of chronic disease, with an expected survival period of \<6 months；
5. Body mass index \>35 kg/m2;
6. Refractory shock；
7. Intracranial hypertension；
8. Pregnant and parturient woman；
9. Intra-abdominal pressure persisted \> 20 mmHg and could not be relieved within 24 hours；
10. Severe thoracic deformity；
11. Severe cardiac dysfunction；
12. Atrial fibrillation and other malignant arrhythmias that seriously affect cardiac output；
13. Pulmonary embolism；
14. Extracorporeal membrane oxygenation is needed；
15. Prone positioning was performed before randomization；
16. Patients who have participated in other clinical trials within 30 days；
17. Patients who have not signed informed consent.
Relevance of the Self-assessment of Skills for Self-administration of Adrenaline by Auto-injectors in Patients at Risk of Severe Anaphylactic Reaction (PacAdré)

To investigate the correlation between self-assessment by patients and an assessment by a health professional of the skills needed for self administration of adrenaline by auto-injectors. These skills include the identification of situations requiring the administration of adrenaline and the technical abilities to achieve it.

Hypothesis:

A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on the patient's self-assessment alone.

Intramuscular Adrenaline is the standard treatment for severe to moderate anaphylaxis. Self-administration of Adrenaline by the patient using an auto-injector pen in case of anaphylaxis is a major axis of management of patients with severe food allergy, hymenoptera venom allergy or systemic mastocytosis. This self-administration skill requires prior therapeutic education of the patient. This education must be repeated over time and must include two components: the identification of anaphylactic situations requiring the self-administration of Adrenalin and the technical skills and abilities to carry out this self-injection.

Numerous studies have investigated the technical skills for using Adrenaline auto-injector pens according to the device prescribed, the importance of therapeutic education, the optimal frequency of therapeutic education sessions for self-administration and the main barriers to the use of Adrenaline.

To our knowledge, no study has investigated the correlation between patients' self-assessment of the skills required for self-administration of Adrenaline by self-injecting pen and an external assessment of these same skills by a health professional.

A self-assessment correlated with an external assessment would make it easier to adjust the frequency of therapeutic education sessions based on patient self-assessment alone.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Follow-up at the CHU Grenoble Alpes or at the CH Métropole Savoie with at least one consultation every 2 years
* With a pathology at risk of severe anaphylaxis:

  * Severe food allergy and/or,
  * Allergy to wasp venom and/or
  * Systemic mastocytosis
* With a current adrenaline prescription that is more than a year old

Exclusion Criteria:

* Patient with a pathology at risk of severe anaphylaxis not identified in the inclusion criteria (isolated drug allergy, idiopathic anaphylaxis, etc.)
* Patient with cognitive or memory disorders
* Patient not speaking French or with a limited understanding of the language
* Patient not affiliated to a social security scheme
* Refusal of the patient to participate in the research or inability of the patient to give his consent
* Patient under guardianship or subject deprived of liberty
Vitamin D Deficiency and Postoperative Hypocalcemia

Hypocalcemia is a frequent adverse event after thyroidectomy. It is usually related to hypoparathyroidism, but preoperative hypocalcemia, hypomagnesemia or vitamin D deficiency contributes to it. This study aims to determine the frequency of vitamin D deficiency or insufficiency in patients submitted to thyroidectomy, to define the risk attributed to vitamin D deficiency to postoperative hypocalcemia, to identify other factors associated to postoperative calcium disorder, and to evaluate the benefit of preoperative treatment of vitamin D deficiency to prevent postoperative hypocalcemia.

Subjects to be submitted to total thyroidectomy will be included in the study. The investigators will evaluate serum levels of total calcium, ionic calcium, phosphorus, magnesium, creatinine, albumin, alkaline phosphatase, fasting glucose, thyroid stimulating hormone (TSH), free thyroxin (FT4), intact parathyroid hormone (PTH), 25 hydroxy vitamin D (25OHD), osteocalcin, C-terminal telopeptide (CTX) and procollagen type 1 amino-terminal propeptide (P1NP). Patients will be randomized to 3 groups: (1) 30 subjects with 25OHD \< 20 ng/mL that will receive 100,000U of cholecalciferol weekly for 4 weeks before surgery, (2) 30 subjects with 25OHD \< 20 ng/mL that will not receive cholecalciferol before surgery and (3) 30 controls with 25OHD \>= 20 ng/mL that will not receive cholecalciferol before surgery. Afterwards, the investigators will evaluate immediate postoperative PTH and measure serum levels of total calcium, ionic calcium, magnesium, alkaline phosphatase, osteocalcin, CTX and P1NP in first and second postoperative days for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients that will be submitted to total thyroidectomy

Exclusion Criteria:

* \< 18 year-old
* chronic renal failure (creatinine \> 1.5 mg/dL)
* fasting glucose \> 200 mg/dl
* albumin \< 3.5 g/L
* preoperative use of calcium supplements, bisphosphonates, corticosteroids
Bed Rest or no Bed Rest?

A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the administration of medications are performed as always and there are no variations. The only highlighted procedure in this study is immediately after the embryo transfer. There are two groups: one which will rest in bed for 10 minutes after the transfer and one which will not rest after the transfer. Both procedures are common, usually depending on the habitual clinical practice of each clinic internationally. Patients from both group receive the routine post transfer instructions and treatment.


Eligibility Criteria:
Inclusion criteria:

* Infertile Patients with fertility problems due to tubaric or ovarian problems with normozoospermatic couple
* Patient and her couple with ages between ages 20 - 49 years old
* BMI \< 25 kg/m2
* IVF treatment with oocyte donation
* Elective transfer of 2 embryos of day 3 embryos or day 5/6 embryos transferred
* First cycle of embryo transfer

Exclusion criteria:

* Patients with uterine abnormalities, significant uterine fibroids, Hydrosalphinx
* History of recurrent pregnancy loss
* severe male factor were excluded from the study
Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without combination chemotherapy in treating postmenopausal women with stage I or stage II breast cancer that can be surgically removed.

OBJECTIVES: I. Compare the potential benefits of adjuvant tamoxifen with or without cyclophosphamide, methotrexate, and fluorouracil (CMF) in postmenopausal women with stage I-IIIA, unilateral, invasive breast cancer.

OUTLINE: This is a randomized study, multicenter study. Patients are stratified according to nodal status (positive vs negative or unknown) and hospital region. Patients undergo surgical resection with or without local radiotherapy, as appropriate. Radiotherapy begins within 8 weeks of surgery for patients randomized to arm I and within 4 weeks after completion of chemotherapy for patients randomized to arm II. Patients are randomized to 1 of 2 treatment arms, preferably within 2 weeks after surgery. Arm I: Beginning within 4 weeks after surgery, patients receive oral tamoxifen daily. Treatment continues for 5 years. Arm II: Beginning within 4 weeks after surgery, patients receive tamoxifen as in arm I and cyclophosphamide IV, methotrexate IV, and fluorouracil IV on day 1 (CMF). Chemotherapy continues every 3 weeks for 6 courses. Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven unilateral, invasive breast cancer Stage T0-3, N0-1, M0 No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No carcinoma in situ alone, including Paget's disease of the nipple without underlying invasion No evidence of distant disease, including ipsilateral supraclavicular node enlargement unless proven benign No history of pure carcinoma in situ in either breast Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 70 and under Sex: Female Menopausal status: Postmenopausal, defined by 1 of the following criteria: Last menstrual period more than 1 year before initial surgery Any age with prior bilateral oophorectomy (for nonmalignant reason) Age 50 and over with prior hysterectomy (for nonmalignant reason) without oophorectomy If at variance with the above definitions, hormonal assays in postmenopausal range take precedence Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other serious illness No other prior invasive malignancy except adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY: Not specified
Extended VALidation of HUman Papillomavirus Assays and Collection DEvices for HPV Testing on Self-samples

The "Extended VALHUDES" study is a Clinical Performance / Diagnostic Test Accuracy Study that aims to extend validation, achieved as part of the "Belgian VALHUDES", of HPV testing using BD Onclarity on samples collected using Copan's devices for dry self-sampling of vaginal material and for first-void urine: FLOQSwab® 5E089N and UriSponge™.

Women accessing the Colposcopy Centres for a colposcopy examination and fulfilling the selection criteria will be asked, after written informed consent, to self-collect a first-void urine (with UriSponge™ 8E031S100 device) and a vaginal sample (with FLOQSwab® 5E089N device), prior to undergoing colposcopy. Just before colposcopic examination, a clinician will also collect a cervical sample using a Cervex-Brush.

A colposcopy-targeted biopsy or histology following excisional treatment of a cervical precancer lesion will be undertaken if appropriate. The colposcopy and/or histological findings will be used as the gold standard. In case of normal satisfactory colposcopic findings without biopsy taking, colposcopy will provide the study outcome.

Virological accuracy of HPV testing using: \[a\] BD Onclarity on FLOQSwab® 5E089N vaginal self-samples, \[b\] BD Onclarity on UriSponge™ 8E031S100 urine specimens, will be compared to BD Onclarity testing on a cervical samples collected by a clinician.

Eligibility Criteria:
Inclusion Criteria:

* Women, referred to colposcopy due to abnormal Pap-test result, who agree to participate in the study by signing an informed consent form

Exclusion Criteria:

* Women younger than 25 or older than 64 years of age
* Hysterectomized women
* Women with known pregnancy
* Non-consenting women
* Women that are not able to understand and/or sign the informed consent.
Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.

Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed
* Resectable patients after imaging assessment and evaluation of general condition of the patient
* TB\>85μmol/L
* WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
* No serious disease in heart, lung and kidney
* Written informed consent

Exclusion Criteria:

* Unresectable patients.
* Patients have received biliary drainage procedure such as PTBD before admission
* Complicated with chronic hepatitis
* Myocardia infarction record within six months
* Women in pregnancy
* Serious disease in heart, lung or kidney