cyrilzakka/clinical-trials huggingface dataset:
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Eligibility Criteria:
Inclusion Criteria:

* Ultrasound examination demonstrating:

  1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
  2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.
* If fetus exists, fetal size less than 12 weeks+6 days
* Closed cervical os
* Eligible to consent for research according to local regulations

Exclusion Criteria:

* Active bleeding at enrollment and/or history of bleeding within the prior week
* Allergies or other contraindications to the use of mifepristone or misoprostol
* Suspected ectopic pregnancy
* History of trophoblastic disease
* Coagulation disorder and/or currently taking anticoagulants
* Any serious medical condition
VALIANT CAPTIVIA Post-market Registry

The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009.

The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections.

The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.

1. Use of controls

   1. This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned.

      Sample size
   2. There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.
2. Number of investigation sites and study duration

   1. 15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
   2. There will be no minimum nor maximum number of enrolled subjects per investigation site.
   3. The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

Eligibility Criteria:
Inclusion criteria

* Age ≥ 18 years or minimum age as required by local regulations
* Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System
* Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form')
* Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment
* Willingness and ability to comply with the CIP

Exclusion criteria

* High probability of non-adherence to physician's follow-up requirements
* Participation in concurrent interventional trial which may confound study results
* Prior implantation of a thoracic stent graft
Surgical Pain After Inguinal Hernia Repair (SPAIHR)

The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* The subject will have elective ( the subject chooses, but does not have to undergo surgery for an emergency) open unilateral inguinal herniorraphy (hernia repair), using mesh Lichtenstein surgery procedure and under general anesthesia and fentanyl or sufentanil/propofol initiation and sevoflurane or isoflurane maintenance plus local anesthetic infiltration at the conclusion of surgery. Study surgery should be anticipated to be in the morning.
* Expected to be able to use and tolerate non-steroidal anti-inflammatory drugs (such as naproxen), tramadol, oxycodone, and acetaminophen/paracetamol for pain control after surgery.
* The subject will be available for a visit within 72 hours of the day of surgery if not admitted the night before for baseline assessments before taking any study medication, and then to receive study medication prior to the day before surgery.
* The subject is expected and agrees to remain at the hospital (or intermediate care facility) for a minimum of 3 hours following surgery.

Exclusion Criteria:

* Subjects with non elective or emergency surgery (must have the surgery no matter what), or hernia with incarceration (the trapping of abdominal contents within the hernia itself).
* Subjects with hernia repair that is not a primary repair. The planned use of nerve block or spinal/epidural/paravertebral anesthesia or surgery is not planned with general anesthesia.
* Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia.
1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study

This is observational study to assess the prognosis of patients hospitalized with COVID-19 confirmed by RT-PCR and exposed to trimethylxanthine (TMX).

Trimethylxanthine is the active molecule present in coffee. Due to the lack of etiologic treatments and considering interest about old treatments as an avenue for research, we conducted a comparative study aiming to evaluate the effect of 1,3,7-trimethylxanthine on COVID-19 infected patients. This is actually a study about methodology.

The objective of this study is therefore not to demonstrate the effect of the substance on the disease but the importance of a rigorous methodology in scientific research. This project is called "Method and Teaching of Scientific Studies".


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18,
* No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects),
* Infectious Disease Unit admission.

Exclusion Criteria:

* Secondary effects about Trimethylxanthine,
* Refuse to participate
Effects of Ba Duan Jin for Patients With Pulmonary Nodules

Many researches shows that Ba Duan Jin has clinical efficacy on cancer rehabilitation, respiratory diseases, psychological health, quality of life and so on. Studies examining the effects of Ba Duan Jin on patients with pulmonary nodules are sparse. Therefore, the aims of the present study are: 1) to examine the effects of Ba Duan Jin on physical and psychological condition, and 2) to examine the effects of Ba Duan Jin on quality of life.

In recent years, with advancement in computed tomography (CT) technology and its widespread use, pulmonary nodules are common incidental findings. Pulmonary nodules are used to appear as well-circumscribed radiographic opacity. They can be single or multiple. There are multiple causes of pulmonary nodules. Most nodules are benign, but some may also represent bronchogenic carcinoma or metastatic lesions. The prevalence of malignancy is detected nodules varies between 0.2% and 18%. Thus, the preoperative individuals would suffer from depression or anxiety caused by uncertain progression of pulmonary nodules; the postoperative individuals would suffer from both physical and mental trauma.

There is growing interest in non-pharmacological approaches that could potentially improve pulmonary nodules patients' physical condition, psychological condition and quality of life.

Ba Duan Jin, a traditional Chinese health-preserving technique, combines the traditional Chinese medicine and traditional Chinese philosophy and embrace the body, breath and spirit. There is substantial evidence that Ba Duan Jin has benefits for cancer rehabilitation, respiratory diseases, psychological health, and quality of life. The effects of Ba Duan Jin on patients with pulmonary nodules are yet to be further investigated.

The present pilot clinical study aims to apply Ba Duan Jin to patients with pulmonary nodules, and to evaluate the effects on physical (pulmonary function), psychological (depression and anxiety), and quality of life. Participants allocated to the Health Education Group take part in the 16-week health education including work, rest, diet and other basic programs according to the different conditions of participants. Participants allocated to the Ba Duan Jin Group take part in the 16-week Ba Duan Jin plus health education program. The study plans to enroll 60 participants in 2 years (30 for Ba Duan Jin plus health education program, and 30 for health education program), expecting that Ba Duan Jin has a better effect on improving physical condition, psychological condition and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed by CT scan of the lung(s).
* Subject is male or female, age 18 to 75.
* Subject has a clear mind and the ability to read, to talk and to communicate.
* Subject agrees to participate in this study and sign to the informed consent.

Exclusion Criteria:

* Subject has recurrence of cancer.
* Subject has severe somatic disease.
* Subject has history of psychosis, mania, or severe personality.
* Subject is pregnant, lactating or breast-feeding women.
* Subject is engaging in other clinical trial.
"Pain and Emotional Changes on Relationships Between Anxiety and Olfaction"

Introduction: This prospective study aimed to assess the impact of olfaction on providing positive emotional responses and reducing dental anxiety and pain.

Material: A randomized double-blinded controlled study was enrolled on female patients. The olfaction was stimulated via lavender essential oils. Patients were divided into lavender and control groups. Patients in lavender group inhaled 2 % lavender vapors. In control group, patients inhaled distal water vapors. The variables included pain, anxiety, and vital signs. Anxiety was measured through Modified Dental Anxiety Scale (MDAS) and Speilberger State-Trait Anxiety Inventory (STAI) questionnaires. Pain was evaluated through visual analog scales (VAS). Vital signs included the systolic (SBP) and diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). All variables were assessed before the intervention, 20 minutes after inhalation of vapors, and at the end of dental settings. The last evaluation was on the day after visits. P-values \< 0.05 were considered significant.

ABSTRACT:

Background: The purpose of the study was to determine to what extent olfactory aromatherapy reduces the intensity of dental pain and the level of dental anxiety. It also attempted to corelate between olfactory aromatherapy, stages of dental visits, and various dental procedures.

Methods: Female patients were enrolled in a randomized controlled study. Olfactory aromatherapy was performed using lavender oils. Patients were randomly assigned to one of two groups: the lavender group, in which patients inhaled 2% lavender vapors, and the control group, in which patients inhaled water vapors. Pain score, anxiety score, and changes in vital signs were among the predictable variables. Anxiety and pain were assessed using the Modified Dental Anxiety Scale (MDAS), Speilberger State-Trait Anxiety Inventory (STAI), and visual analog scales (VAS). The vital signs were systolic (SBP) and diastolic (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). Variables were evaluated before inhalations, 20 minutes after inhalations, at the end of settings, and on the following day.

Eligibility Criteria:
Inclusion Criteria:

* Adult females over 18 years,
* Attending morning sessions of clinics (9 am),
* Liable for administration of local anesthesia, tooth preparation either for:

  1. Filling procedures or crown preparations
  2. Endodontic treatment
  3. Teeth extraction
  4. Eubgingival scaling

Exclusion Criteria:

* Males
* Females who had:

  1. Allergies
  2. Bronchial asthma
  3. Common cold
  4. Pulmonary diseases
  5. Migraine
* Females who taking:

  1. Antidepressants
  2. Anxiolytic drugs
  3. Opioids
  4. Other medications that affect emotional responses
* Pregnant females
Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty

Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.

120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.

Eligibility Criteria:
Inclusion Criteria:

* patients must be aged 60 yrs or more uncomplicated primary or secondary osteoarthritis of the hip undergoing unilateral cemented total hip arthroplasty using a metal on polyethylene bearing couple.

Exclusion Criteria:

* metabolic bone disorders, systemic disorders such as rheumatoid arthritis and patients who have taken pharmacological doses of oral steroids, hormone replacement therapy, tamoxifen, calcium or vitamin D supplements within the last year. Patients with a prior history of bisphosphonates and women of child bearing age.
Platelet Rich Fibrin VS Hyaloronic Acid in Management of Pain After Harvesting a Free Gingival Graft

Comparative study to assess the efficacy of topical application of 0.2% hyaluronic acid vs platelet rich fibrin in decreasing a postoperative pain following free gingival graft procedure .

.

- Patients of both groups will be subjected to:

1. Case history including personal data, medical, surgical history and family history.
2. Clinical Examination.

After local infiltration of anesthesia, an adequate size of supraperiosteal recipient bed was prepared to receive the palatal graft of 15 mm mesio-distal width with 8 mm apico-coronal extension.. The free gingival graft extended from the mesial line angle upper 5 and distal line angle of upper 6 .

The coronal horizontal incision, will be 15 mm long, at least 2 mm apical from the gingival margin. A second horizontal incision will be drawn 8 mm apico coronal . Care will be taken to obtain a graft thickness of 1.5 mm. Thickness will be measured at the central point of the graft during the surgery by using an endodontic file then the grafts will be positioned, and firmly adapted to the bed, and stabilized with simple periosteal sutures.

Preparation of platelet rich fibrin:( intervention group) The classic PRF protocol was introduced by Choukroun \& coworkers. PRF requires around 10 ml of blood to be collected from the forearm of patient without anticoagulant in a glass coated plastic tubes. After collection, the blood will be quickly subjected to centrifugation at 2700-3000 rpm for 12 minutes. After the completion of cycle, the blood become separated into three distinct layers; platelet poor plasma at the top, PRF in the middle and a red blood corpuscular base in the bottom. Pliers will be inserted into the tube to gently grab the fibrin clot with attached RBC's. The clot thus obtained will be compressed to form plugs to be placed in the palatal donor site and stabilized by criss cross resorbable suture then covered by periodontal pack

control group Control group: As the intervention group but the palatal wound will receive a .2% hyaluronic acid gel then covered by periodontal dressing

..

Eligibility Criteria:
Inclusion Criteria for participants:

* Patients with mucogingival defects scheduled for free gingival graft
* Age at least 18 years.
* Not having any systemic disease that could compromise wound healing
* No previous periodontal surgery on the experimental sites.

Exclusion Criteria for participants:

* Systemic diseases that may be a contraindication for any surgeries.
* Loss of maxillary premolars and molars.
* Pregnancy or lactation
* Smoking
Phase 1 Study of DW-0919 & DW-0920 in Healthy Male Volunteers Under Fasting Condition

The purpose of this study is to evaluate safety and pharmacokinetics of DW-0919 and DW-0920 in healthy male volunteers under fasting condition.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 20 to 55 years at screening.
* No significant congenital/chronic disease.
* No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History of Hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids.
* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico

Pancreatic cancer is a highly lethal disease. The cause of pancreatic cancer is multifactorial. However, around 10% of cases are associated with hereditary predisposition. Germline mutations in BRCA1 and BRCA2, CDKN2A, STK11, DNA mismatch repair (MMR) genes (MLH1, MSH2, MSH6, or PMS2), PALB2, FANCC, FANCG, and ATM have been associated with an increased risk for pancreatic cancer. The prevalence of these germline mutations varies across populations. For instance, the prevalence of BRCA1/2 germline mutations in high-risk populations can be up to 20%. On the other hand, in unselected patient population, the prevalence of BRCA1/2 germline mutations is 5-7%. In Mexican population, data on the prevalence of BRCA1/2 germline mutations in patients with pancreatic cancer are lacking. Identification of BRCA germline mutations in patients with pancreatic cancer has implications for treatment. Also, it allows genetic testing and counselling for family members. This study will determine the prevalence of germline mutations associated with hereditary pancreatic cancer using a comprehensive gene panel in an unselected cohort of patients with pancreatic adenocarcinoma in Mexico.

This is an observational study to estimate the prevalence of germline mutations in patients with pancreatic cancer. Eighty four genes will be analyzed, all of which have been associated with hereditary cancer. The genes are included on Invitae Multi-Cancer Panel ®, performing full-gene sequencing and deletion/duplication analysis using next-generation sequencing technology. The 84 genes include: AIP, ALK, APC, ATM, AXIN2, BAP1, BARD1, BLM, BMPR1A, BRCA1, BRCA2, BRIP1, CASR, CDC73, CDH1, CDK4, CDKN1B, CDKN1C, CDKN2A, CEBPA, CHEK2, CTNNA1, DICER1, DIS3L2, EGFR, EPCAM, FH, FLCN, GATA2, GPC3, GREM1, HOXB13, HRAS, KIT, MAX, MEN1, MET, MITF, MLH1, MSH2, MSH3, MSH6, MUTYH, NBN, NF1, NF2, NTHL1, PALB2, PDGFRA, PHOX2B, PMS2, POLD1, POLE, POT1, PRKAR1A, PTCH1, PTEN, RAD50, RAD51C, RAD51D, RB1, RECQL4, RET, RUNX1, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, SMARCA4, SMARCB1, SMARCE1, STK11, SUFU, TERC, TERT, TMEM127, TP53, TSC1, TSC2, VHL, WRN, WT1.

Eligibility Criteria:
Inclusion Criteria:

* Female and male participants ≥ 18 years of age.
* Diagnosed within the previous 6 months with histologically confirmed pancreatic adenocarcinoma stage I to IV.
* Participant provides written informed consent for the study.
* Participant must agree to sample collection and genetic testing using the Invitae Multi-Cancer Panel ®.

Exclusion Criteria:

* Diagnosed with pancreatic adenocarcinoma more than 6 months before presenting to the clinical site.
* Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors.
LMA Cuff Pressure and LMA-induced Complications

The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and allowing them to recoil will put the pressure of the LMA cuff within the safety range. It will also determine if remaining within this safety range has an effect on complications after surgery..


Eligibility Criteria:
Inclusion Criteria:

* Registered Mayo Clinic in Florida patients scheduled to undergo a surgery
* Planned use of LMA during surgery
* between the ages of 18-99
* short duration (\<2 hours elective surgery)

Exclusion Criteria:

* recent history of upper respiratory tract infection
* intra-cavitary or laparoscopic procedure
* risk of pulmonary aspiration
* known difficult airway
* history of gastric reflux
* BMI \> 40
* lateral or prone positions
* oral or nasal surgery
Efficacy of Dexmedetomidine for Cough Suppression in Patients Undergoing Thyroid Surgery

Maintenance of a remifentanil infusion during anesthetic emergence has been reported to decrease the incidence of coughing and thereby help to ensure a smooth emergence. It may, however, cause respiratory depression and possibly delay emergence. The purpose of this study was to investigate the effect of different dose of dexmedetomidine infusion on cough suppression during emergence from general anesthesia in patients undergoing thyroid surgery.

American Society of Anesthesiologists physical status I-II adults undergoing elective thyroidectomy under general anesthesia are recruited and randomly allocated to receive dexmedetomidine iv infusion of 0.2μg·kg-1·h-1 (Group D1, n = 100), 0.5μg·kg-1·h-1 (Group D2, n = 100), 0.7μg·kg-1·h-1 (Group D3, n = 100) or saline (Group C, n = 100). Primary outcome is the incidence of coughing during emergence. Second outcomes include severity of coughing, which is assessed using a four-point scale; Ramsay score, Bruggrmann comfort scale score, VAS pain score are recorded. The respiratory rate (RR), heart rate (HR), and mean arterial pressure are also recorded.


Eligibility Criteria:
Inclusion Criteria:

1. 30Kg/m2 ≥ BMI \> 18Kg/m2;
2. undergoing general anesthesia;
3. ASA physical status I and II
4. undergoing elective thyroid surgery.

Exclusion Criteria:

1. hyperthyroidism;
2. preoperative bradycardia;
3. liver function impairment;
4. renal function impairment;
5. heart function failure;
6. history of asthma or COPD;
7. history of diabetes;
8. cognition function impairment;
9. pregnant or lactating women