cyrilzakka/clinical-trials huggingface dataset:
Study of Antenatal Care Intervention Directed to Pregnant Women With Obesity

The purpose of this study is to determine whether a behavioural intervention focusing on diet and physical activity is cost-effective in decreasing weight gain during pregnancy among pregnant women with body mass index above 30, and has effect on the weight of offspring at birth and at 2.5 years of age

Obesity in relation to pregnancy is becoming an increasing public health issue and 48% of women assigned to antenatal care in Sweden have overweight (BMI≥25) or obesity (BMI≥30). Obesity is associated with adverse perinatal outcomes, the risks increase with increasing BMI and excessive gestational weight gain (GWG) further increases the risks of adverse pregnancy outcomes. Lifestyle intervention can help pregnant women with obesity to limit their GWG. This study evaluated whether a low-budget antenatal lifestyle intervention programme, with emphasis on nutrition and physical activity, influenced GWG and maternal and perinatal outcomes for pregnant women with obesity. The study also evaluated which specific components of the intervention that had effect.

Eligibility Criteria:
Inclusion Criteria:

* pregnant
* BMI\>30

Exclusion Criteria:

* first antenatal care visit after week 20 of the pregnancy
* abortion
* miscarriage
Lactobacillus Casei Strain Shirota Fermented Milk for Alleviating Hard Stools in Vietnam

The objective of this study is to provide evidence supporting the efficacy of fermented milk containing Lactobacillus casei strain Shirota in alleviating hard or lumpy stools. A randomized, controlled trial has been designed on constipated adults with a high prevalence of hard stools in Vietnam.


Eligibility Criteria:
Inclusion Criteria:

* Female or male, aged between 18 to 60 years.
* Aware of producing hard or lumpy stools (BS score of 1 or 2) frequently.
* Produce hard or lumpy stools (BS score of 1 or 2) ≥ 25% of bowel movements during 2 weeks of screening period.
* Voluntarily provide written informed consent to participate in the study.

Exclusion Criteria:

* Subjects whose constipation symptoms are caused by primary organic disease of the colon or pelvic floora or which, in the Investigator's opinion, is caused by medication (e.g. morphine, codeine).
* Subjects with metabolic disorders, neurological disorders or any significant diseases or concomitant condition (e.g. abdominal/gastrointestinal surgery) that, in the investigator's opinion, would interfere with participation in the study.
* Subjects with any known allergic reactions to any ingredients of milk.
* Pregnant or nursing (breast-feeding) women.
* Subjects who are unable to refrain from or anticipate the use of any medication (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and herbal supplements), except for paracetamol, oral contraceptives, or hormonal replacement therapy from 2-week before the initiation of screening of subject BS score to the end of the study.
* Subjects who are unable to refrain from or anticipate the use of any probiotics, prebiotics or yogurts from 2-week before the initiation of screening of subject BS score to the end of the study.
* Participation in another study with Investigational product within 2 months prior to this study.
* Drug or alcohol abuse.
Light Physics Enhanced Camera Navigation in Hysteroscopy

Office hysteroscopy is the gold standard technique in the diagnosis of the intrauterine pathologies. Some interventions may also be carried out through the hysteroscopy. No-touch hysteroscopy technique confers several advantages in terms of patient discomfort over the traditional technique. Clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route. The investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. This study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

Office hysteroscopy is basically used in the diagnosis of the intrauterine pathologies. 'No touch' vaginal hysteroscopy does not require a speculum or tenaculum; thus, confers advantages in terms of patient discomfort over the traditional technique. The source of the pain in traditional hysteroscopy is the distention of the uterine cavity with the saline and the contact of the hysteroscopy equipment with the vagina and the cervical canal. The benefit in the pain obtained with the 'no-touch' technique is derived from the limitation of the contact of the hysteroscopy equipment with the vagina and the cervical canal. Clinicians performing the hysteroscopy find their way from the vaginal introitus to the uterine cavity through direct visualization of the anatomic structures on their route.

Physics has been critical in the development of endoscopic techniques such as laparoscopy, cystoscopy, and hysteroscopy. The light source provides an illumined environment during the imagination with these techniques. During hysteroscopy, the light reflecting from the adjacent tissue appears bright, however, this reflection is weaker in farther tissue and these structures appear dark. With this in mind, the investigators hypothesize that the utilization of the information derived from the 'light physics' would facilitate camera navigation during no-touch hysteroscopy and consequently ease reaching the uterus. This study aimed to compare the standard no-touch technique with the 'light physics' enhanced camera navigation in terms of patient comfort and procedural pain.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for No-touch Office hysteroscopy procedure with a diagnostic purpose
* Must be nulliparous

Exclusion Criteria:

* Multiparous women
* Previous cesarean section
* Cervical stenosis
Healing of Bone/Soft Tissue to Different Abutment Biomaterials and the Impact on Marginal Bone Loss

In patients that require a dental implant, does zirconia compared to titanium, or cad-cam acrylic abutments, provide less inflammation, marginal bone loss or infection during the osseointegration period ?

Place dental Implants and zirconia, titanium, acrylic or cad-cam acrylic abutments, torque to 20 n/cm2 Evaluate Changes in inflammatory levels from T0 (baseline) to T7-12 weeks (measure intermediate points at T0 (baseline),,T1-8 Weeks and T2-12 weeks) Also evaluate outcomes marginal bone loss, gingival height levels and osseointegration

Eligibility Criteria:
Inclusion Criteria:

* Single unit implant rehabilitation
* Maxilla and mandible
* Must accept treatment plan
* Must sign informed consent
* dental extraction performed at least 3 month prior
* Must have at least 6 mm of residual bone
* Absence of oral lesions
* keratinized tissue must be present

Exclusion Criteria:

* If smoking and/or other drug addiction is present
* If local anesthetic allergy is present
* Patient subjected to chemical or radiotherapy
* if Hepatic disease is present
* If immunodepression is present
* If Pregnancy is present
* If Diabetes is present
* If Heart disease is present
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China

This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children. The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal carriage will be collected.


Eligibility Criteria:
Inclusion Criteria

* Healthy children aged 12-18 months

Exclusion Criteria

* Use of antibiotics up to 15 days prior to study inclusion
* Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible
* Children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion.
* Received any pneumococcal vaccine in the past.
* Children who have already provided a NP sample in the same study period.
* Any relevant hemorrhagic disorder.
* Any febrile process (fever ≥ 38°C) at time of screening.
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)

The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training implications for introducing this new imaging modality.


Eligibility Criteria:
Inclusion Criteria:

* Males and females over the age of 18 years.
* Patients with either suspected BE presenting for endoscopy or patients with documented BE presenting for follow-up endoscopy likely to require a biopsy or patients presenting for endoscopy for non-BE related conditions other than esophageal varices.
* Ability to provide written, informed consent.
* Females who are able to become pregnant, are willing to take a pregnancy test.

Exclusion Criteria:

* Patients on anticoagulation undergoing high risk procedures in accordance to American Society For Gastrointestinal Endoscopy (ASGE) guideline for the management of antithrombotic agents for endoscopic procedures (2009).
* Patients with esophageal varices that preclude biopsies.
* Presence of an esophageal mass that precludes full distention of the balloon from the Nvision balloon guide sheath.
* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision balloon guide sheath.
* Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the Nvision balloon guide sheath.
* Patients with known eosinophilic esophagitis.
* Patients that are pregnant.
* Patients with a history of hemostasis disorders.
Total Hip Replacement With Ceramic on Ceramic Bearing- Clinical Follow-up Study

The pain and severe wear of hip joints caused by osteoarthritis, rheumatoid arthritis, avascular necrosis and trauma can be subjected to total hip replacement (THR). A hip implant consists of 4 components: acetabular cup, femoral stem, articular liner and femoral head. As an ideal material for THR, ceramic possesses excellent biocompatibility and stability in the human bodies. Moreover, ceramic-on-ceramic interface is highly wear-resistant, preventing generation of wear particles. With the development of latest fourth-generation ceramic Delta, larger femoral heads can be manufactured to conform to the size of native femoral heads. The rate of some of the complications after THR, such as dislocation, can be significantly reduced. The purpose of the present study is to carry out a clinical follow up for each patient who has received the ceramic-on-ceramic THR in order to understand the clinical outcome. Furthermore, the possible complications, such as dislocation and squeaking, can be determined.


Eligibility Criteria:
Inclusion criteria:

Patients who has received ceramic-on-ceramic total hip replacement after the year of 2013.

Exclusion criteria:

1. Patients who are unable or unwilling to return for follow-up
2. Patients who have deep periprosthetic joint infection
3. Patients who are diagnosed skeletal dysplasia
4. Patients who suffer from mental disorders
Scalpel Versus Diathermy Skin Incision in Repeated CS

This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.

Our study aims to compare the use of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in

1. incision time,
2. incision blood loss,
3. hemodynamic changes,
4. postoperative pain,
5. wound healing
6. wound complications.

Eligibility Criteria:
Inclusion Criteria:

* women with a history of only one previous cesarean section
* age between 18 and 40 years
* gestational age of 38 to 41 weeks
* body mass index less than 30.

Exclusion Criteria:

* any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound.
* Women who conducted primary or emergency cesarean deliveries
* cardiac patients on pacemakers
* patients on anticoagulants
* women refusing to participate in the study
Waiting Time to Operation for Hip-fracture Patients

This study investigates the relationship between waiting time to surgery and the risk for medical complications and 1-year mortality in hip-fracture patients.


Eligibility Criteria:
Inclusion Criteria:

* Hip-fracture patient

Exclusion Criteria:

* Periprosthetic fracture
* Pathological fracture
Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)

Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.

This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.

Intrahepatic cholangiocarcinoma (ICC) is a malignant tumor of the liver arising from epithelial cells of the biliary tract, accounting for 10-15% of primary liver cancers, and the incidence of ICC has increased rapidly worldwide over the past decade. The long-term prognosis is dismal, with a 5-year overall survival (OS) as low as 25-30%. Many studies have highlighted lymph node metastasis as a strong predictor of poor prognosis in ICC patients, prompting efforts such as appropriate lymphadenectomy to accurately predict disease stage and reduce outcomes associated with LNM. Adequate lymphadenectomy in patients with suspected LNM is essential for achieving R0 resection and is a necessary component of complete cure and long-term survival. The routine use of highly invasive lymphadenectomy in all patients remains controversial, and lymphadenectomy rates for ICC range from 26.9% to 100% depending on the literature and are not universally adopted currently.

Currently, LNM is detected preoperatively by imaging, but imaging alone is not sufficient to diagnose LNM, as negative findings by imaging findings may have low sensitivity and may not rule out LNM. Other attempts have been made to develop predictive scoring systems based on Carbohydrate antigen 19-9 (CA 19-9) levels, location of the primary tumor, lymph node patterns on CT and MRI, and other clinical factors to predict LNM in ICC, but all these predictive systems rely heavily on judgment regarding lymph node size and tumor growth patterns are largely left to diagnostic imaging.

This study seeks to validate a panel of more accurate and non-invasive biomarkers (exo-miRNAs) in preoperative blood samples. Accurate preoperative detection of the presence of LNM would help provide clear criteria for ICC treatment decisions, such as the implementation of elective lymphadenectomy or the addition of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma.
* Received standard diagnostic and staging procedures as per local guidelines
* Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment

Exclusion Criteria:

* Lack of or inability to provide informed consent
* Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery
* Secondary liver cancer
Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains

Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development.

The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions.

Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with fluorosed teeth.


Eligibility Criteria:
Inclusion Criteria:

* Only the non-pitted Fluorosis opacities shall be included for this purpose; opacities in anterior teeth shall be classified according to Russell's criteria for differentiating fluoride and non- fluoride opacities
* Subjects classified /Teeth classified with dental fluorosis of 1-4 according to Thylstrup, Fejerskov classification of dental fluorosis 20
* Patients who will be willing to participate in the study and who will be accepting for recall visit.

Exclusion Criteria:

* History of allergy towards any dental material.
* Teeth classified as non-fluoride opacities
* Subjects with any systemic and local conditions not permitting the treatment
* Subjects who had undergone any treatment for dental fluorosis earlier
* Subjects with direct or indirect restorations in maxillary central or lateral incisors.
* Subjects not willing to participate in the study
* Subjects with fractured teeth maxillary central or lateral incisors.
AZD0914 Phase 1 ADME Study in Healthy Volunteers

This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.

This is an open-label, single dose study in 6 healthy male subjects aged 18 to 55 years. Each subject will be admitted to the clinical pharmacology unit on the day prior to dosing Check in (Day -1) and will remain in the clinical pharmacology unit until up to at least target Day 8 (168 hours post-dose).

All subjects will receive 3000 mg AZD0914 incorporating 18.5 MBq (500 Ci) of \[14C\] administered as a single oral dose following at least an 8 hour fast from food. Subjects can have water. For specific food and water restrictions.

This study will investigate the metabolic fate and routes of excretion of AZD0914.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture;
2. Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements;
3. Within body mass index (BMI) range 19 to 30 kg/m2, inclusive, at screening;
4. Non-smokers in past 6 months;
5. In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs as judged by the Investigator;

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study;
2. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QT interval corrected for heart rate (QTc) changes;
3. Any clinically significant abnormalities in clinical chemistry, hematology, or UA results as judged by the Investigator;
4. Abnormal vital signs, after 10 minutes supine rest, confirmed by repeat, defined as any of the following: systolic blood pressure \<90 mmHg or \>140 mmHg; diastolic blood pressure \<50 mmHg or \>90 mmHg; or heart rate \<40 or \>100 beats per minute;
5. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP;
Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease

Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, which in turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment.

There is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of inflammatory rheumatic joint disease
* indication of disease modifying treatment initiation with or without glucocorticoids OR
* stable DMARD treatment with parenteral glucocorticoid injection

Exclusion Criteria:

* known osteoporosis or osteoporosis treatment
* women during the transitory phase
* oestrogen treatment
* any fracture within the last year
* chronic glucocorticoid treatment
* glucocorticoid treatment within the last year prior to inclusion
* active cancer
* kidney failure
Role of Greyscale and Power Doppler Sonography in Therapy Monitoring in Early Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the role of musculoskeletal ultrasound and power Doppler in early therapy monitoring of rheumatoid arthritis patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults: age at disease onset \>18 years and \< 50 years
* Disease duration \< 3 month
* Fulfilling ARA criteria for classification of RA
* DMARD naive

Exclusion Criteria:

* Age at diagnosis \< 18 years
* Disease duration \> 3 month
* Previous use of DMARDS
* Previous use of biologics
Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise

The purpose of this study is to evaluate the efficacy and safety of intravenous abatacept administered to hospitalized COVID-19 participants with respiratory compromise.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).
* Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)
* Respiratory compromise as defined by requirement of oxygen supplementation to maintain oxygen saturation ≥ 93% but not requiring mechanical ventilation
* Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical condition that would serve as an exclusionary criteria
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Women who are breastfeeding
* Recent acute infection defined as:

  i) Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii) Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy
* History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)
* Prior exposure to BMS-188667 (abatacept)

Other protocol-defined inclusion/exclusion criteria apply