cyrilzakka/clinical-trials huggingface dataset:
Triple-arm pH Comparison

The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.

In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos.

Eligibility Criteria:
Inclusion Criteria:

1. Women age of ≥ 18 to ≤ 40
2. BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC).
3. Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination)
4. PCOS
5. Women who have ≥ 1 year of primary or secondary infertility
6. Tubal factor (unilateral, bilateral obstruction or salpingectomy)
7. Normal semen parameters
8. Male factor: oligoasthenozoospermia or obstructive azoospermia
9. Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt
10. Women who will undergo only fresh embryo transfer
11. Women who have normal endometrial thickness (\> 7 mm) and echo-pattern at the time of hCG trigger
12. Women who have normal transvaginal ultrasound during the follicular phase (defined as no intra cavity pathology; e.g. submucousal myomas, polyps or septa)

Exclusion Criteria:

1. Women who had unilateral oophorectomy
2. Women who had uterine pathology or abnormality
3. Women or their husbands who had abnormal karyotyping
4. Women with history of recurrent abortions or repeated implantation failures
5. Women who had uncontrolled diabetes
6. Women with diagnosed or undiagnosed liver or renal disease
7. Women who had a history of severe ovarian hyperstimulation
8. Women who had history of malignancy or borderline pathology
9. Women who will not meet the inclusion criteria
10. Women who will refuse to participate in the study
11. Women with endometriosis
12. Patient undergoing PGS or PGD
13. Severe male factor and non-obstructive azoospermia.
A Case-control Study on the Differentiation Between Cough Variant Asthma and Chronic Cough

this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model.

the investigators retrospectively collected information from patients with chronic cough who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019. Data of external test were also from the First Affiliated Hospital of Zhejiang Chinese Medical University, and time period was from January 2023 to April 2023.Pulmonary function test and methacholine challenge test was performed by professional technicians. Characters between patients with cough variant asthma and chronic cough were compared to establish a diagnostic model.

Eligibility Criteria:
Inclusion Criteria:

* (1) age from 18 years old to 65 years old; (2) clinical diagnosis of CVA and CC .

Exclusion Criteria:

* Exclusion criteria for CVA were: a history of COPD, bronchiectasis, bronchitis, cystic fibrosisor pneumonia, interstitial lung disease, pulmonary tuberculosis, lung cancer; cough caused by drugs or treatments; patients with upper airway cough syndromes (UACS) and gastroesophageal reflux-related cough (GERC) or other apparent causes of cough; patients who used corticosteroid (ICS) in the previous four weeks; Exclusion criteria for CC were: a history of variable airway limitation.
Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover.

By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.

To date, there are no studies in scientific literature aimed at identifying the hormonal mechanisms that could contribute to increased bone turnover in patients undergoing bariatric surgery. All randomized controlled trials conducted to date have focused on nutritional factor deficiency (vitamin D3, calcium and protein), mechanical unloading and reduction of adiposity at the bone marrow level.

By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 60 years.
* BMI (Body Mass Index: expressed as weight ratio in kg/height in m2) ≥ 35 kg/m2 with comorbidities or BMI ≥ 40 Kg/m2 without comorbidities.
* Absence of diagnosis of primary obesity.
* Absence of medical-psychiatric contraindications.
* Previous diet therapy and/or pharmacological history verified.
* Signing of the informed consent for the study.
* Patients who are clinical candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).

Exclusion Criteria:

* Presence of chronic diseases of the digestive system, such as chronic intestinal diseases, malabsorption syndrome, diverticulosis of the colon.
* Current pregnancy and/or breastfeeding via self-declaration.
* Subjects suffering from endocrine pathologies (e.g. Cushing's disease, uncontrolled thyroid disease).
* Presence of known renal insufficiency or creatinine levels above 1.8 mg/dl and eGFR \< 60 ml/min.
* Presence of chronic liver disease or ALT and AST levels above two standard deviations from normal levels.
* Presence of malignant pathology.
* Alcohol or drug abuse.
* Previous bariatric surgery.
* Severe psychological-psychiatric disorders.
* Difficulty adhering to the protocol due to language barriers or other reasons.
Hypofractionated Radiotherapy in Breast Cancer

As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.

The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT.

The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.

Investigators seek to assess the rate of cutaneous toxicity, the rates of lymphedema determined by arm measurements and Grade 3 brachial plexopathy in patients receiving regional nodal irradiation, as well as local control, quality of life, and fatigue levels.

Eligibility Criteria:
Inclusion Criteria:

Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy:

* Prior Chemotherapy for Breast Cancer
* Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body)
* Non-Caucasian Race
* Less than or equal to 50 years of age
* Requiring regional nodal irradiation without evidence of N3 disease

Exclusion Criteria:

* Males will be excluded
* Women who are pregnant or nursing a child may not take part in this study
Psychological and Lifestyle Factors on Health Outcomes

Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design.

A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.


Eligibility Criteria:
Inclusion Criteria:

Men and women aged 16-33 years enrolled in phase one British Army training

Exclusion Criteria:

-
SEGUDIAB Study: Evaluation of Safety in the Diabetic Patients

The safety in the diabetic patient refer so much to the accuracy of the treatment and to the handling of the diabetic in security topics. Therefore, is not only an economic question, but a more global concept that means to receive an accurate sanitary attention in line with the available evidences nowadays.

OBJECTIVE: To analyse if a brief intervention educative on the primary care professionals is followed of an improvement in the safety of the diabetic patients.

METHODS: Cluster Clinical trial, completely in primary care, on 10 basic health areas (BHA) with a random distribution of the educative intervention to realize on the sanitary professionals (5 intervention/5 control). The intervention is an educative system on adults, brief (6 hours) but with periodic reminders. To improve his skills and attitudes for the diabetics. The group control follows his usual clinical practice on the diabetics.

The participation was voluntary. The centres have been matched, being comparable in population and other characteristics, except the specific intervention; ranging between the 6-8% the prevalence observed of type 2 diabetes (T2D) in all the cases. Finally, we selected only between 45 until 75 years old as operative age group of the 45 until the 75 years like operative aim.

Inclusion criteria: T2D or T1D with age comprised between 45 and 75 years; recorded in the informatic software for primary care.

Exclusion criteria: serious or terminal illness or patients controlled exclusively by specialists.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes
* Aged between 45 and 75 years

Exclusion Criteria:

* No data in informatic system
* Severe illness
* Controlled only by specialists
Assessing Parenteral Antibiotics Versus Single-time Intra-operative Intra-dermal Antibiotic Administration for Prevention of SSI

The purpose of the study is to study the incidence of surgical site infection when patients are given local versus parenteral antibiotics

Patients undergoing above 18 years of age, giving consent and undergoing open or laparoscopic elective, CDC class I \& II surgeries will be recruited. Cases will be randomised into two cohorts viz: parenteral antibiotic (Group A) vs single-time intra-operative intra-dermal antibiotic administration group (Group B). In operation theatre, after induction of anaesthesia, Group A will receive parenteral ceftriaxone (15-20mg/kg) whereas Group B will receive single-time intra-operative intra-dermal ceftriaxone (15-20mg/kg diluted in 10 ml normal saline). Post-operatively, incision site will be covered with occlusive dressing. First check-dressing will be done after 48 hours as per the existing institutional practices. After that surgical site will be inspected daily for wound infection. Patients with healthy wound will be discharged at the discretion of the treating surgeon and will be asked to follow up in General Surgery OPD weekly for one month. Cases who developed an SSI will have samples collected from the afflicted area for bacterial culture and antibiotic susceptibility testing. On development of SSI, the treating clinical team will commence antibiotic therapy as per their protocols.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 years
* Patients undergoing open and laparoscopic elective, CDC class I \& II surgeries

Exclusion Criteria:

* Patients exhibiting hypersensitivity reaction to ceftriaxone
* Patients who are immunocompromised (retroviral disease and corticosteroid use)
* Patients not consenting to be a part of this study
* Pregnancy
* Febrile illness or leucocytosis at the time of surgery
* Planned for staged/multiple interventions during the hospital stay (endoscopies, image-guided biopsies etc)
* Patients with a possible septic focus distant from the surgical site such as diabetic foot ulcers.
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with PD with severity of the Modified Hoehn \& Yahr staging at Stage I to III.
* Age: 20 years or older (at the time of giving informed consent)
* Gender: male and female
* Both inpatient and outpatient status
* Informed consent: Patients who are able to give informed written consent in person (i.e. patients who are capable of giving informed written consent on one's own)
* Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening.

Exclusion Criteria:

* Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The seriousness refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).
* Patients with symptomatic postural hypotension. (e.g. dizziness and syncope).
* Patients who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs).
* Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week -4 to Week 0.

  * Anticholinergic agents: trihexyphenidyl hydrochloride (e.g. Artane®), piroheptine hydrochloride (Trimol®), mazaticol hydrochloride (Pentona®), metixene hydrochloride (Cholinfall®), biperiden hydrochloride (Akineton®), profenamine (Parkin®)
  * amantadine hydrochloride (e.g. Symmetrel®)
  * droxidopa (Dops®)
  * citicoline (e.g. Nicholin®)
  * selegiline hydrochloride (FP®)
  * zonisamide
  * estrogen: estriol (e.g.Estriel®)
  * CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine)
* Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood)
* Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug.
* Patients with current history or complication of carcinoma or malignant tumour.
* Patients who have history of drug allergy to ropinirole hydrochloride (HCl).
* Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation).
* Patients who have been treated with any other investigational drug within 12weeks prior to the treatment phase.
* Others whom the investigator (sub investigator) considers ineligible for the study.
Anti-mold Azole in the Prophylaxis for Invasive Fusariosis

Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis

Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and \>30 days elapses from one to other admission (episode).

Screening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs.

In a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started.

Patients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* admission for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia

Exclusion Criteria:

* prior documentation of invasive fusariosis or allergy to azoles
Single-plane Versus Real-time Biplane Approaches for Ultrasound-Guided Hip Joint Injection: A Prospective Randomized Controlled Clinical Study

The goal of this clinical trial is to compare the safety and accuracy of single-plane and real-time biplane ultrasound imaging in guiding hip joint injections and explore the application effects of imaging technology in hip joint injections.

Real-time biplane imaging, an emerging ultrasound technology, uses a three-dimensional (3D) matrix transducer to display simultaneously he longitudinal and transverse intersecting planes on a single screen without requiring rotation of the transducer. The modality displays the puncture path in real-time and exhibits the spatial relationship between the needle tip and the target site, as well as surrounding structures during guided puncture. This technology significantly improves the puncture success rate and reduces complication rates in procedures such as the placement of intrahepatic bile duct drains and central venous catheters. However, this technology has not yet been implemented for hip joint injections. Therefore, we compared the safety and accuracy of single-plane and real-time biplane ultrasound imaging in guiding hip joint injections and explored the application effects of imaging technology in hip joint injections.

Eligibility Criteria:
Inclusion Criteria:

1.15 to 80 years of age; 2.hip joint pain and/or limited hip joint mobility; 3.physical examination and imaging studies indicating hip joint pathology; 4.pain duration exceeding 6 months with no significant improvement after conservative treatment; 5.patients scheduled for hip arthroscopy.

Exclusion Criteria:

1. a history of hip joint surgery;
2. the presence of lumbar disease, ankylosing spondylitis, or sacroiliac-joint pathology;
3. femoral head necrosis;
4. drug allergies;
5. inability to cooperate, or other contraindications to puncture.
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.

The main objectives of the study are:

1. To unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.
3. These subgroups have different responses to anti-microbial therapy with potential anti-inflammatory potency (macrolides).


Eligibility Criteria:
Inclusion Criteria:

* severe asthmatics (GINA step 4 or step 5 (without anti-IgE))

Exclusion Criteria:

* viral/fungal/bacterial infection +fever (\<1 month)
* asthma exacerbation (\<3 months)
* other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)