cyrilzakka/clinical-trials huggingface dataset:
Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia

The goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever.

The main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'SAFE study'.

Participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. An additional blood sample, urine sample and stool sample will be collected.

Researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
* Age older than 16 years;
* Intensive therapy is started within three days before randomization for one of the following haematological conditions:

  * Remission induction chemotherapy for newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); OR
  * Re-induction chemotherapy for relapsed after haematological remission lasting for a minimum duration of 6 months; OR
  * Conditioning regimen to prepare for an allogeneic HCT; OR
  * Conditioning regimen to prepare for an autologous HCT.
* Expected longstanding (≥ 7 days) neutropenia (ANC \< 0.5x10\^9/L);
* Expected length of hospital stay of at least 10 days.

Exclusion Criteria:

1. Clinically or microbiologically documented infection;
2. Patient already receives broad spectrum antibiotic therapy;
3. Any critical illness for which Intensive Care Unit treatment is required;
4. SOFA score ≥ 11;
5. Longstanding neutropenia (\>21 days) prior inclusion;
6. Previous enrolment in this study;
7. Not able to provide written informed consent;
8. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol;
9. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
Investigation of Pain Coping Methods and Related Factors in Postmenopausal Women

Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. Coping strategies with pain are used to manage the pain and its impacts. The present study aimed to compare active and passive coping strategies used and pain severity in postmenopausal women according to their demographic characteristics. Also, the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.

Musculoskeletal pain (MSP) reflects of musculoskeletal conditions related to tissues such as tendons, muscles, ligaments, nerves, and other joint structures. If MSP lasts for longer than three months, it becomes chronic. The prevalence of chronic MSP (cMSP) increases with aging and its ratio changes between 35,7% and 49,8%. The previous studies demonstrated the differences in the prevalence of cMSP between men and women. According to most of the studies, older women adults are more vulnerable to experience than men due to some differences in perception of pain such as biological characteristics, their roles in daily life, beliefs or coping strategies with pain.

Oestrogen has a prominent role in the physiology of muscles, tendons, ligaments, and bones. The decline of this sex hormone during menopause transition could lead to MSP, particularly in the postmenopausal period. Indeed, an increasing rate of cMSP in postmenopausal women has been reported.

Coping strategies with pain are used to manage the pain and its impacts. Coping with pain requires the self-regulation of individuals using cognitive and behavioral reactions. Dealing with cMSP is a process that can need the making of changes in daily life and activities This study aimed to compare active and passive coping strategies being used and pain severity in postmenopausal women according to their age, marital status, educational status, and exercise habits. Also, subdomains of strategies and subdomains of pain and the relationship between pain and coping strategies in postmenopausal women with cMSP will be examined.

Eligibility Criteria:
Inclusion Criteria:

* complaints of pain in anywhere of their body.
* presenting at least 1 year of amenorrhea
* being between the ages of 50-69 years.

Exclusion Criteria:

* have rheumatological, orthopedic and neurological diseases,
* have compression fractures, malignancies,
* have a chronic disease that will lead to secondary osteoporosis,
* have a drug use that will lead to secondary osteoporosis
Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women

The purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA.

This is a randomized clinical trial conducted to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA. All women receive standard prenatal care, including nevirapine for the prevention of mother-to-child transmission of HIV.

Eligibility Criteria:
Inclusion Criteria:

- HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.
Impact Of Digital Photography & Conventional Method On The Accuracy Of Dental Shade Matching In The Esthetic Zone

The aim of this study:

Is to evaluate the accuracy of digital photography in optimizing shade matching when compared to conventional method of shade selection.

Randomized control trial, 2 groups will be included. Group 1: Color matching using Vita 3D master, using modified (USPHS) criteria Group 2: Color matching using digital photography using (Photoshop adopt) the assessment will be through a questionnaire for the patient satisfaction outcome using Visual analogue scale

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18-70 years old, able to read and sign the informed consent document.
2. Patients requiring restorations in the esthetic zone.
3. Patients don't have active periodontal or pulpal diseases
4. Patients willing to return for follow-up examination and evaluation.

Exclusion Criteria:

1. Patients in the growth stage.
2. Patients with poor oral hygiene and lack of motivation.
3. Psychiatric problems or unrealistic expectations.
Anatomical Evaluation of the APL Tendons in Thumb CMC Joint and Osteoarthritis

Certain ligaments in the human body are designed to be a static stabilizer and others to have a sensory function thus remains an unresolved issue.

The presence of mechanoreceptors (sensory corpuscles and free nerve endins) in the human knee and ankle ligaments has implies a sensory role of ligaments in providing afferent information, which in turn regulates intrinsic stiffness in the muscles surrounding the joint, contribuiting to dynamic joint stability.

The aim of this study is to use immunohistochemical methods to analyze the general innervation and possible existence of sensory corpuscles in the thumb carpometacarpal (CMC) joint. This study can help to know the contribution of the tendon insertions and ligaments in the dynamic thumb CMC joint stability.

The accessory APL tendons insertions, number of accessory tendons and insertion in trapezium can be a mechanical factor that develop osteophytes and thumb CMC joint osteoarthritis.

Antibodies against the general nerve marker protein gene product 9.5 (PGP 9.5) and the glial marker S-100 will be use to depict innervation and corpuscular structures. Innervation pattern and sensory corpuscules were investigated by other authors in the wrist. S-100 immunoreactivity is in the Schwann cells in the central regions of the corpuscle, and PGP 9.5 immunoreactivity marked the axonal structures in the corpuscles. The presence of nerve fascicles and particularly sensory corpuscles in the structures, for exemple capsule and APL insertion near the thumb carpometacarpal joint suggest that these structures in the CMC joint have a propioceptive role in the stability of the joint.

Eligibility Criteria:
Inclusion Criteria:

* Specimens: Adults from 50 to 90 years.

Exclusion Criteria:

* Specimens: younger than 50 or older than 90 years.
Video Head Impulse Test and Seasickness Susceptibility

This a case control study on seasickness susceptibility. 86 healthy maritime personal were divided to seasickness susceptible and non susceptible groups based on a seasickness questionnaire (Golding) and motion sickness score.

All subjects from both groups underwent video head impulse testing (vHIT). VHIT parameters - gain, asymmetry ect were compared between both groups.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 healthy military naval subjects
* At least six month of active sailing.

Exclusion Criteria:

* A history of hearing loss
* Ear pathology observed at otoscopic examination
* A neck injury precluding head movement.
* Abnormal otoneurological examination findings
* Subject's withdrawal of informed consent.
* Failure to complete the video head impulse test.
Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 yo;
* Patient with aer lobe keloid;
* Patient with an indication of reconstructive surgery;
* Signature of informed consent from the patient;
* Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study;
* Patient with French social insurance.

Exclusion Criteria:

* Patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality);
* Patient with know nickel allergy;
* Patient with know silicon allergy;
* Pregnant women;
* Legal incapacity or limited legal capacity;
* Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator;
* Patient without health insurance;
* The patient is in the period of exclusion of another study.
Effect of Intermittent Oro-esophageal Tube vs. Nasogastric Tube on Feeding Amount in Stroke Patients

The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Anchor for Robotic Sacrocolpopexy

1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery for this portion of the procedure.
2. SECONDARY OBJECTIVES:

   i. To assess intraoperative and ii. postoperative complication rates, iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall appearance

By applying a commonly used surgical technique of absorbable anchors to a new surgery, Sacrocolpopexy (SCP), operative time may be decreased while providing similar patient outcomes. Absorbable anchors have been validated in mesh fixation during laparoscopic surgical repair of hernias. This technique potentially takes less time than traditional suturing, thus decreasing cost and morbidity of anesthesia. The investigators hypothesis proposes that for women undergoing SCP at a large managed care organization, participants receiving anchor suture staples to attach the mesh to the vagina compared to participants receiving standard treatment will require 50% shorter surgical time for the mesh attachment portion of the surgery. The investigators secondary hypothesis is for women undergoing SCP at a large managed care organization, participants receiving anchor suture staples to attach the mesh to the vagina compared to participants receiving standard treatment will have similar rates of intra-operative and post-operative complications and surgical failure. On VAS, patients will not have different appearance of the vaginal walls. Surgeons will report higher satisfaction with the anchor technique.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 or older
* Diagnosis of POP, defined as the descent of one or more of four different anatomic structures, a)the uterus(cervix), b)the apex of the vagina (in those status post hysterectomy) c) the anterior vaginal wall, or d) the posterior vaginal wall. This is defined on exam as the POPQ points Ba, C, or Bp \>0 cm beyond the hymen, uterine(cervix) descent into at least the lower half the vagina (defined as point c\> -tvl/2) or post hysterectomy vault into the lower 2/3 of the vagina. Bothersome bulge symptoms as indicated on question 3 of the Pelvic Floor Disorder Inventory (PFDI-20) form relating to 'sensation of bulging' or something 'falling out'
* Desire surgical treatment for POP with SCP
* Available for up to 6 months of follow up
* Not pregnant or desiring future pregnancy
* Written informed consent is obtained.

Exclusion Criteria:

* Known adverse reaction to synthetic mesh, or complications including but not limited to erosion, fistula, or abscess.
* Cervical intraepithelial neoplasia (cervical intraepithelial neoplasia (CIN) 2, CIN3, or cancer)
* Unresolved chronic pelvic pain
* Prior abdominal or pelvic radiation
* Contraindications to the surgical procedures including known horseshoe kidney, pelvic abscess or active diverticular abscess or diverticulitis
Short Stitch Monomax®

A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) \< 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Primary elective and primary emergency laparotomy
* Written informed consent

Exclusion Criteria:

- Pregnant women
Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

The purpose of this study is to identify which patients, receiving Faslodex within the approved label, benefit most from Faslodex treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Locally advanced or metastatic hormone sensitive breast cancer with known estrogen receptor (ER) and progesterone receptor (PR) status
* Patient had a recurrence during or after adjuvant anti-oestrogen treatment or progression of the disease during anti-oestrogen treatment

Exclusion Criteria:

* Life threatening metastases
Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares

The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up.

The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* both males and females patients
* positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare.
* patients who have given their free and informed consent

Exclusion Criteria:

* complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding)
* ascertained hypersensitivity to the salicylates
* any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial
* clinically significant renal or hepatic impairment
* esophageal, gastric or duodenal ulcer within 30 days prior to randomisation
* patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
* treatment with any investigational drug within the previous 30 days
* treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets
* recent history or suspicion of alcohol abuse or drug addiction
* patients who become unable to conform to protocol
* patients with ascertained pregnancy
* previous participation in this study
Efficacy and Prognosis of Surgical Intervention in Patients With Carotid Artery Stenosis

This study is a prospective, single center cohort study. By combining pathological examination of carotid atherosclerotic plaque with preoperative imaging examination, we explore the imaging characteristics of high-risk carotid plaque, and explore the effectiveness and safety of different surgical methods (CAS and CEA) for high-risk plaque patients with carotid stenosis.

According to the inclusion and exclusion criteria, 100 patients with carotid artery stenosis who underwent surgical reconstruction surgery at our research center were prospectively collected from December 2023 to December 2024. Preoperative laboratory examinations such as blood routine, biochemistry, coagulation, and imaging examinations such as carotid artery ultrasound and TCCD, carotid artery ultrasound contrast, high-resolution MRI, head MRI plain scan, carotid artery CTA or DSA were completed, Based on the comprehensive evaluation of the patient's condition by the supervising physician, the appropriate surgical method (CEA or CAS) is selected. Follow up will be conducted 1/3/6/12 months after surgery to evaluate the incidence of endpoint events (cerebral infarction+all-cause death+postoperative restenosis), MoCA and MMSE cognitive scores, quality of life scores, and severe perioperative complications. At the same time, for patients undergoing CEA surgery, pathological examination of the postoperative carotid artery plaque will be conducted to clarify the nature of the plaque, and combined with imaging examination, the characteristics of high-risk carotid artery plaques will be studied

Eligibility Criteria:
Inclusion Criteria:

1. The patient is aged 45-85 years old;
2. Symptomatic patients with stenosis degree greater than 50%, or asymptomatic patients with stenosis degree between 70% and 99% (ultrasound, CT or contrast);
3. Can complete regular follow-up;
4. The patient is informed and agrees to participate in the study.

Exclusion Criteria:

-