cyrilzakka/clinical-trials huggingface dataset:
Clinical and Health Economic Evaluation With a New Baha® Abutment Combined With a Minimally Invasive Surgical Technique

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

Despite extensive soft tissue reduction, the most common complications associated with Baha implants are related to adverse skin reactions around the abutment. The reduction of the skin also adds complexity to the surgical procedure that is otherwise a routine type of skin incision. A less invasive surgical technique avoiding reducing the thickness of the skin would render a simpler and shorter procedure and would be aesthetically appealing to the patients, as permanent hair removal in the area around the abutment would not be required. Faster healing and less numbness (sensory loss/ paraesthesia) at the implant site may also be expected if the soft tissue thickness is left intact.

The Cochlea Baha BA300 Abutment together with a surgical procedure that includes soft tissue reduction was CE marked in April 2010. The test abutment, Cochlear Baha BA400, together with a surgical procedure that does not require soft tissue reduction was CE marked in June 2012.

The rationale behind this investigation was to make a 'head-to-head' comparison between the BA300 and BA400 Abutment and the associated surgical techniques in order to collect information regarding complications (inflammation/infection, numbness and pain), aesthetic outcome and utilisation of direct medical cost associated with surgery.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for the Baha system
* Signed informed consent

Exclusion Criteria:

* Patient scheduled for simultaneously bilateral implant surgery
* Uncontrolled diabetes as judged by the investigator
* Condition that could jeopardize osseointegration and/or wound healing, e.g. osteoporosis, psoriasis and use of corticosteroids
* Unable to follow the cleaning instruction
* Unable to follow investigational procedures, e.g. to complete quality of life scales
* Participation in another investigation with pharmaceuticals and/or device
* Condition that may have an impact on the outcome of the investigation as judged by the investigator
* Suitable implant position for the 4 mm implant not found during surgery due to insufficient bone quality and/or bone thickness
Efficacy of Nutrition Education in Alleviating Premenstrual Syndrome (PMS) Among Chinese College Students at Hainan University, China

This study aims to evaluate the efficacy of nutrition education-based intervention on PMS severity, perceived stress, and lifestyle-related outcomes among the students at Hainan Vocational University of Science and Technology

Premenstrual syndrome (PMS), occurring during the luteal phase of the menstrual cycle and spontaneously resolving after menstruation begins, is a prevalent psychological and somatic disorder among women of reproductive age.Lifestyle modifications can help alleviate PMS symptoms, including dietary changes (such as reducing salt and sugar intake or increasing consumption of vegetables and fruits), engaging in regular physical activity, stress management, and avoiding smoking.This study is a parallel, unblinded, randomized controlled trial assessing the efficacy of nutrition education-based intervention on PMS severity, perceived stress, and lifestyle-related outcomes in Chinese college students. Participants will be randomly assigned to two groups: the nutrition education-based intervention group (NEI) and the control group. The nutrition education-based intervention program will span 6 weeks. The participants in the "passive" control group will receive no further intervention and will each be provided with The PMS Management Booklet. Data will be collected through online surveys at baseline, post-intervention, and at 1-month and 3-month follow-up points after the completion of the intervention. Data analysis will be performed using SPSS 26.0.

Eligibility Criteria:
Inclusion Criteria:

1. Females students aged 18 to 30 years
2. PMS scores（6-36）
3. Regular menstrual cycles (defined as a menstrual cycle of 21 to 35 days)
4. Not using hormonal compounds (such as contraceptive pills), drugs (such as fluoxetine and escitalopram), or non-drug treatments affecting premenstrual syndrome, such as special diets
5. No participation in interventional studies related to premenstrual syndrome in the past 6 months

Exclusion Criteria:

1. Amenorrhea
2. Polycystic ovarian disease (PCOD)
3. Those who are unable to attend according to intervention protocol
Efficacy and Safety of L-Pantoprazole Sodium Injection to Treat Upper Gastrointestinal Ulcer Bleeding

The purpose of this study is to evaluate the safety and Efficacy of L- Pantoprazole sodium to treat upper gastrointestinal ulcer bleeding.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years, gender:both.
2. Patients whose Forrest classification were in Ⅰ b-Ⅱ c were diagnosed with non-variceal duodenal and / or gastric ulcer bleeding by endoscopy within 24 hours and patients manifested vomiting and / or black stools and other symptoms of upper gastrointestinal bleeding.
3. Patients were diagnosed with upper gastrointestinal bleeding mild to moderate;
4. Informed consent granted.
5. Patients agreed to take medicine and assess.

Exclusion Criteria:

1. Patients were diagnosed with upper gastrointestinal bleeding by endoscopy caused by esophageal varices and portal hypertensive gastropathy, Mallory-Weiss syndrome, dieulafoy disease.
2. Pregnant women or breastfeeding women.
3. Patients who had undergone surgery because of ulcer complications or gastrectomy, gastrointestinal anastomosis within 30 days before the trial.
4. Patients were diagnosed with gastrinoma or gastric malignancy.
5. Patients had other associated complications, which may affect the efficacy.
6. Patients who like alcohol abuse, drug addicts or others which are not suitable for drug trials.
7. Patients who were allergic to any ingredient of any PPI and allergies.
8. Patients diagnosed with small vessel spurting who had to undergo endoscopic hemostasis or surgery or severe gastrointestinal bleeding.
9. Patients suffering from serious heart, brain, lung, liver, kidney disease or severe hypertension.
10. Patients who had coagulopathy, whose PT wasmore three seconds than normal controls, whose APTT\> 1.5 times the upper limit of normal or low-dose heparin treatment.
11. Patients whose systolic blood pressure less than 90mmHg or lower \> 30mmHg than the baseline systolic blood pressure, pulse pressure less than 20mmHg, hematocrit less than 20%.
12. Patients who participated in other clinical trials within three months before this trial.
13. Patients who need to use other drugs which may affect the trial during the trial or a week before the trial.
14. Patients who were considered unsuitable for selected candidates.
Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?

The pelvic floor muscle training (PFMT) is a conservative treatment, currently considered as first line for women with stress urinary incontinence (SUI). However, in practice, about 30 to 50% of women are unable to perform the correct contraction of the pelvic floor muscles (PFMs). When requested to perform the muscle contraction, the contraction of the gluteal muscles, hip adductors, or abdominal muscles is observed initially, rather of contraction of the levator anus muscle. Some factors make it difficult to perform the contraction of the PFM, such as its location on the pelvic floor, and its small size, followed by a lack of knowledge of the pelvic region, as well as its functions. Associated with these factors is the use of the muscles adjacent to the PFM, as previously mentioned. In order for women to benefit from a PFMT program for the treatment of SUI, the awareness phase of PFM can't be omitted, since the literature is unanimous in stating that pelvic exercises improve the recruitment capacity of the musculature, its tone and reflex coordination during the effort activities.

Research Questions: The objectives of this study is to test the hypothesis that the provision of verbal instructions about the anatomy and function of PFMs associated with the use of body techniques awareness and vaginal palpation helps in learning the correct contraction and improves the function of the PFMs.

Design: A single-centered, double-blind (investigator and outcome assessor) randomised controlled trial with two physiotherapy intervention groups.

Measurements: The primary outcome measure will be the number of fast muscle fibres, as determined by the number of effective contractions (fast and with full force contraction, 1 second each) out of ten contractions performed. The secondary outcome measure will be the PFM function (vaginal palpation and visual observation), the occurrence of associated contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM , and self-efficacy scale for practising PFM exercises.

Eligibility Criteria:
Inclusion Criteria:

* Patients with predominance of SUI symptoms and ≥ 2 g leakage measured by pad test and without capability to contract the PFM properly

Exclusion Criteria:

* Not included if they were younger than 18 years old, had chronic degenerative diseases, pelvic organ prolapse greater than stage I by POP-Q, neurologic or psychiatric diseases, ability to contract PFMs, had previous pelvic floor re-education programs and/or pelvic floor surgeries
ACTIVE-IBD Study: Physical Activity and Sleep in Paediatric Inflammatory Bowel Disease

Assessment of physical activity on children with Inflammatory Bowel Disease using questionnaires and wrist watch based activity monitors.

The participants will be recruited from paediatric IBD clinics and will undergo questionnaires to assess their activity level, disease activity and quality of life scores. The participants will then be invited to wear a wrist based accelerometer for a week. The participants will complete a physical activity diary, food diary and stool chart at the same time.

Results will be analysed to see the level of physical activity and assess if the participants are meeting the recommended level of physical activity


Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents from age of 6 to 18 years of age
* Confirmed endoscopic/histology based IBD diagnosis
* Under the care of the Southampton University Hospitals NHS Foundation Trust paediatric gastroenterology team
* Able to provide consent / assent to participate in the study
* Able to understand and/or cooperate with the study requirements
* Pregnant participants will be included as long as they can complete the physical assessmentsExclusion Criteria:
Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma

BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.


Eligibility Criteria:
Inclusion Criteria:

* All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study

Exclusion Criteria:

* Not Applicable
HIV Indicator Diseases Survey Across Europe - UK Arm

In Europe many patients infected with HIV remain undiagnosed, although this percentage varies between 15-80% across the continent. In the UK it is estimated to be 27%. Undiagnosed HIV results in increased morbidity and mortality and reduced treatment response, as appropriate health interventions are delayed. It also has adverse public health implications, with those individuals unaware of their HIV status being more likely to transmit the virus.

An important public health issue is how to diagnose more individuals with HIV earlier in the course of their infection. In the US, the Centre for Disease Control and Prevention (CDC) has introduced testing guidelines whereby all individuals are tested, unless they object, at any point of contact with the healthcare system - the "opt-out" testing guidelines.

At the "HIV in Europe" Conference held in November 2007, the consensus, which included patient and public involvement, was that such an approach would not be suitable for Europe. The Conference recommended further development of focused HIV testing in patients presenting with certain clinical conditions and diseases - the "indicator disease'' testing guidelines.

Cost effectiveness analyses suggests cost savings if a screened population has an HIV prevalence of at least 1%, although this rate may be as low as 0.1%. However, there is very little - if any - evidence regarding HIV prevalence for certain conditions and diseases in specific and easy to identify sections of society. The focus of attention is on those conditions and diseases which occur more frequently in individuals known to be infected with HIV.

The aim of this study is to assess HIV prevalence for several diseases and conditions, within a specific segment of the population not yet diagnosed with HIV, who present for care with that specific disease or condition. These conditions have been selected as they occur frequently in individuals already diagnosed with HIV infection. This is a pilot study to inform phase two, which will involve more diseases and conditions with a wider participation of centres across Europe.


Eligibility Criteria:
Inclusion criteria

* Aged 16 years and over
* Presenting for care with one of the indicator diseases or conditions:

  * A sexually transmitted disease
  * Malignant lymphoma
  * Cervical or anal dysplasia or cancer
  * Unexplained leukocytopenia or thrombocytopenia lasting at least 4 weeks, or hypergammaglobulinaemia
  * Seborrheic dermatitis or exanthema
* sub-study - consents to providing additional information

Exclusion criteria

* Known HIV positive
* sub-study - declines to consent for additional information to be collected
Comparing Brain Cortical Activity in Real and Immersive Virtual Reality Manual Dexterity Tasks

With advances in technology, virtual reality (VR) is increasingly used in various fields, including rehabilitation, motor learning, and neuroscience. Its ability to provide controlled, immersive, and interactive environments makes it a valuable tool for training and assessment. However, despite its growing adoption, limited evidence exists on how cortical activation in VR compares to real-world conditions. Moreover, brain cortical activity during motor tasks, such as manual dexterity tasks, remains underexplored.

This study aims to compare brain cortical activity in real and immersive virtual reality settings during a manual dexterity task. Secondary objectives include:

* Examining the relationship between brain cortical activity and kinematics in both conditions.
* Comparing brain cortical activity between hand-tracking and controller-based interactions.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Normal-to-corrected vision
* Ability to understand simple instructions

Exclusion Criteria:

* History of seizure
* Recent participation (within the last three months) in a study involving a manual dexterity task in immersive virtual reality
* Neurologic or orthopaedic pathology potentially affecting upper extremity movement
Mapping of Lymph Node Metastasis and Survival For pN+ Superficial Esophageal Squamous Cell Carcinoma

With the deeper tumor invasion, the higher LNM rate beside the bilateral recurrent laryngeal nerves(RLN) was.


Eligibility Criteria:
Inclusion Criteria:

* Our predefined search strategy identified pT1N+ ESCC cases without preoperative treatment, between February 2012 and April 2022.

Exclusion Criteria:

* The patients were excluded because they were (1)less than 10 lymph nodes removed; (2) lacked specific sites of LNM; or (3) incomplete follow-up information.
Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine

The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:

A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh.

Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.


Eligibility Criteria:
Inclusion Criteria:

* The parents were informed about the trial and have signed the consent form
* The subject is healthy
* The subject has an age of 28 to 49 days at hepatitis B vaccination
* The subject had a birth weight of ≥2500 g
* The subject has received a hepatitis B vaccination at birth
* The parents grant access to the subject's medical records
* The parents are likely to comply with instructions

Exclusion Criteria:

* The subject suffers from a severe chronic disease
* The subject has already been immunized with one or more doses of diphtheria, tetanus, pertussis, poliomyelitis, or Hib vaccines
* The subject has a known allergy to one of the vaccine components or to any of the constituents of the vaccines, including Act-HIB® and hepatitis B vaccines
* The subject has a history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections
* The subject has a known congenital or acquired immunodeficiency
* The subject is in treatment with or has been in treatment with a product which is likely to modify the immune response (i.e. immunoglobulin, systemic corticosteroids, blood products, other vaccines)
* The subject is participating in another clinical trial
Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women

This trial is conducted in Europe. The aim of this trial is to investigate whether a reformulated estradiol/norethisterone acetate (NETA) formulation is bioequivalent to that of Kliogest® (estradiol/norethisterone acetate (NETA) in healthy women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal defined as at least 12 months spontaneous amenorrhoea, with serum FSH (follicle stimulating hormone) levels at least 40 IU/L and estradiol maximum 25 pg/mL. If the date of spontaneous amenorrhoea can not be identified because of previous hormone replacement therapy, serum FSH at least 40 IU/L and estradiol maximum 25 pg/mL
* Non-smoking
* Body Mass Index (BMI) maximum 35.0 kg/m\^2
* Able to understand, read and speak German fluently
* Good state of health evidenced by medical history, physical examination including gynecological examination, and results from laboratory examination
* Willing to abstain from intake of caffeine containing food and beverages within 48 hours before drug administration

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Previous use of oral, transdermal, nasal spray, vaginal preparations and implants within 8 weeks prior to the planned first drug administration
* Known, suspected or history of breast cancer
* Known or suspected estrogen dependent neoplasia e.g. endometrial cancer
* Abnormal genital bleeding of unknown aetiology
* Known insulin dependent as well as non-insulin dependent diabetes mellitus
* Positive test for HIV (human immunodeficiency virus) and/or hepatitis B and C
* Systolic blood pressure (BP) above or equal to 160 mm Hg and/or diastolic BP above or equal to 100 mm Hg, currently treated or untreated
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

* Pregnancy or lactation.
* Positive titres for anti hepatitis B antibodies
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Simultaneous administration of any other vaccine(s).
* Administration of any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial
Efficacy of Pentoxifylline and Alpha Lipoic Acid in PCOS Resistant to Clomiphene Citrate

This study evaluate the addition of PTX and ALA to clomiphene citrate in the treatment of polycystic ovary.

Clomiphene, PTX and ALA each used in treatment of pco but they do so by different mechanisms.

Clomifene is in the selective estrogen receptor modulator (SERM) family of medication. It works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary.

PTX and ALA are used in treatment of pco due its anti-oxidant effect.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
2. Age between 18 and 39 years.
3. Period of infertility \>1 years.
4. Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance
5. Body mass index (18-30) kg/m2.

Exclusion Criteria:

1. History of pelvic surgery or infertility factor other than anovulation
2. Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
3. Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
4. Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
5. Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%).
6. Elevated serum prolactin, T.S.H and F.S.H.
7. Patients diagnosed with diabetes mellitus
8. Patients who are hypersensitive to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine or to any ingredient in the formulation or component of the container.
9. Patients with acute myocardial infraction, severe coronary artery disease.
10. Patients with hemorrhage or at risk of increased bleeding and Patients with peptic ulcers.