cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

1. Explore pharmacodynamics

   * glucose
   * insulin
   * C-peptide
   * glucagon
   * intact GLP-1
   * DPP-4 activity
   * CGMS (continuous glucose monitoring system)
2. Assess Safety

   * adverse events
   * clinical laboratory test
   * physical examination

Pharmacodynamic assessment

* CGMS data is obtained from day 1 to day 3 (48 hours)
* PD is measured before (day 1) and after drug administration (day 2)

  1. AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
  2. MAGE (mean amplitude of glycemic excursion) from CGMS data

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with type 2 diabetes mellitus
* 6.5% ≤ HbA1c \< 9.0%
* Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
* Stopped treatment of other anti-diabetic agents for more than 12 weeks
* 16 kg/m2 ≤ body mass index \< 30 kg/m2

Exclusion Criteria:

* Fasting glucose ≥ 200 mg/dL
* Required insulin therapy
* Patients with neuropathy, retinopathy or renopathy
* Contraindicated for mitiglinide or sitagliptin
Importance of Integrated Pulmonary Index in Pediatric Bronchoscopy

Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements. In this study, we wanted to evaluate the value of IPI in cases of pediatric bronchoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Bronchoscopy is a procedure that is frequently applied in diagnostic or interventional conditions like hemoptysis, tracheobronchial stenosis, malignancy, recurrent lung infections, etc. It is routinely performed under general anesthesia or sedation in pediatric cases. In our clinic, we routinely perform diagnostic or interventional pediatric bronchoscopy procedures with an anesthesia team outside the operating room under monitored anesthetic care (MAC). Routine monitoring of MAC consists of electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). These monitorizations are described as minimum in many practice guidelines, and sometimes monitors such as end-tidal carbon dioxide (ETCO2), body temperature, analgesia/nociception index (ANI) can be added to them.

Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2).(1,2) When these parameters exceed physiological limits, patients require interventions consisting of various maneuvers or drug administration in order to maintain the normal functioning of the cardiorespiratory system. If we look at the scoring, a score of 8-10 is considered normal, a score of 5-7 indicates a situation that may require intervention, and a score of 1-4 indicates that the patient needs intervention.

The above-mentioned IPI is a relatively new tool, and there is limited data in the literature regarding its usability in patients undergoing interventional procedures under MAC.(3,4) In this study, we wanted to evaluate the safety of IPI in cases of pediatric bronchoscopy performed under sedation. Routine monitoring and drug applications for the procedure will be in accordance with the institutional protocols, and additional IPI monitoring will be performed. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 physical status
* Elective upper or lower gastrointestinal tract endoscopy

Exclusion Criteria:

* ASA physical status of 4 or more
* Patients with any contraindication for off-site anesthesia
Paracetamol Discontinuation in the Elderly After Long-term Consumption

To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.

Aim: To investigate if long-term treatment of paracetamol can be discontinued without worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.

Trial design: Patients are randomized to either arm 1: standard care (paracetamol continuation) or arm 2: experimental treatment (placebo).

The investigation is double-blinded.

Patients are screened and recruited from Department of respiratory medicine at Copenhagen University Hospital Bispebjerg. Patients with a daily consumption of 3 grams or more of prescribed paracetamol and who comply with the other eligibility criteria will be invited to participate in the trial and asked for written, informed consent. If given we collect data regarding the patient's medications, any medication changes during the intervention and followup, frailty (FRAIL Scale), self-reported history of falls, recent admissions, self-reported health-related quality of life (EQ-5D-5L), level of function tested by hand grib strength and sitting-rising test, and death.

Data is collected at baseline and after 2 weeks when ending treatment intervention, and a 26 week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or more
* Regular daily users of 3 to 4 grams of paracetamol for at least 6 months prior to enrollment

Exclusion Criteria:

* Malignant pain cf. their medical records
* Patients using other regular analgesics cf. indication on prescription
* Patients receiving paracetamol tablets with modified release or sustained release
* Patients in warfarin treatment
* Patients with terminal illnesses, cf. their medical records.
* Patients receiving dosages dispensed by their pharmacy
* Mini-Mental State Examination (MMSE) score less than 25
* Patients with or suspected to have COVID-19.
Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.

the objective is to produce a collection of great scientific interest for lymphoma research from CELESTIMO's clinical trial patients' samples to increase knowledge of treatment with mosunetuzumab's for patients with follicular lymphoma (FL).

study population involves patients participating to CELESTIMO study in France. 10 sites are expected in this biobanking protocol study

Biological samples will collected as part of routine care (tissue and blood already sampled in routine and/or CELESTIMO study) at screening, at C4, at C12 or at progressive disease/relapse.

Eligibility Criteria:
patients who participate to CELESTIMO study (NCT04712097)
Fecal Microbiome Transplant

Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)

The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
2. Age ≥ 3 years old.
3. Recurrent C. difficile or Moderate to Severe C. difficile.
4. Satisfactory completion of the medical interview and physical exam conducted by a study team member
5. Participants must be between 3 and 21 years of age (inclusive)
6. Signed informed consent form, and assent (if applicable)

Exclusion Criteria:

1. Patients \<3 years old
2. Patients with other co-morbid intestinal infectious processes
3. Recipients with a history of severe (anaphylactic) food allergy
4. If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
5. Patients with severe IBD.
6. Ongoing/anticipated antibiotic use for non-CDI indication
7. Adverse event attributable to a previous FMT
8. Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
9. Any other condition for which the treating physician thinks the treatment may pose a health risk
10. Predicted death within time period of follow-up
11. Patients who are on supraphysiologic doses of corticosteroids
Study With Improved Solubility Pazopanib

The pharmacokinetics of a new formulation with Pazopanib will be studied. This will be done in a patient cohort of n = 12.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic cancer;
* Able and willing to give written consent;
* WHO performance status of 0, 1 or 2;
* Able and willing to undergo blood sampling for PK analysis;
* Minimal acceptable safety laboratory values;
* Negative pregnancy test for female patients with childbearing potential;
* Able and willing to swallow oral medication.

Exclusion Criteria:

* Any treatment with investigational drugs within 30 days prior to receiving the investigational treatment;
* Any treatment with CYP3A4, BCRP or PGP interfering drugs;
* Patients who received treatment with Votrient(R) kess than 1 week ago;
* Woman who are pregnant or breast feeding;
* Patients suffering from any known condition that may influence the dissolution or absorption of Pazopanib.
Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.

OBJECTIVES:

Primary

* To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.

Secondary

* To assess the toxicities associated with MammoSite® RTS in these patients.
* To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
* To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
* To correlate the local recurrence rate with time between surgery and implant.

OUTLINE: Patients undergo placement of the MammoSite® Radiation Therapy System (RTS) device into the cavity where the tumor was removed either at the time of surgery or percutaneously under ultrasound guidance after surgery. Within 2-5 days after the device implant, patients undergo partial-breast irradiation delivered by MammoSite® RTS twice daily for 5 days.

After completion of study therapy, patients are followed up periodically for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma

  * Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
  * Pathologic staging of the axilla preferred

    * Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors
* Unicentric tumor

  * Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
* Must have undergone lumpectomy as definitive surgery

  * Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery

    * Re-excision to obtain negative margins allowed
* Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
* No multicentric carcinoma (invasive or DCIS) in more than one quadrant
* No clinically or pathologically positive regional lymph nodes
* No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing \> 25% of the primary tumor
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No collagen-vascular disease, including any of the following:

  * Dermatomyositis
  * Systemic lupus erythematosus
  * Scleroderma-mixed connective tissue disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
* Failed conventional therapy.
* Willing to make daily calls on a touch-tone telephone.

Exclusion criteria:

* History of or current chronic or severe constipation.
* Bloody diarrhea, abdominal pain with rectal bleeding.
* Thrombophlebitis.
* Abnormal thyroid stimulating hormone (TSH) value.
* Alcohol and/or substance abuse within past two years.
* Pregnant or lactating.
* History/treatment of malignancy within past five years.
The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients (body weight \< 10 kg)
* diagnosed with congenital heart diseases
* scheduled for repair operation with CPB
* in the Department of Cardiovascular Surgery, Xijing Hospital

Exclusion Criteria:

* systemic infections
* other systemic diseases
Expanded Access to Veliparib

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to veliparib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. EAP is also available for other indications where there is reasonable scientific basis for efficacy.

Expanded Access

Eligibility Criteria:
Inclusion Criteria:

* The patient has relapsed/refractory disease and exhausted all standard treatments.
* The patient has documented Breast Cancer (BRCA), BRCA associated RING domain (BARD), or Partner and Localizer of Breast Cancer (PALB) or other acceptable deoxyribonucleic acid (DNA) mutations.

Exclusion Criteria:

* The patient is eligible for a Poly Adenosine diphosphate ribose polymerase (PARP) inhibitor clinical trial.
* The patient has previously received a PARP inhibitor for the same disease.
Flipped Autograft for Treating Surgical Wound Dehiscence

This case report describes a novel technique for management of peri-implant wound dehiscence that involves using auto graft from the same surgical site to seal the dehiscence defect.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients in a healthy systemic condition.
2. Both genders
3. Patients should have single missing tooth.
4. Seibert Class I ridge defect.
5. Patients should approve to deliver a signature to a written consent after study nature explanation.

Exclusion Criteria:

* 1- Patients with any smoking habits. 2- Pregnant females, decisional impaired individuals, Prisoners and handicapped patients.

  3- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.

  4- Patients with infections either periodontally or periapically.
Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering

The incidence of postanesthetic shivering (PAS) after general anesthesia is affected by the anesthesia maintenance agents. This study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.

Inadvertent perioperative hypothermia and postanesthetic shivering (PAS) are common after anesthesia regardless of anesthesia methods. The incidence of perioperative hypothermia and PAS after general anesthesia has been reported to be 37.5 to 77.2% and 20 to 70%, respectively. Shivering begins when vasoconstriction, a major mechanism to prevent body heat loss, is insufficient. PAS is one of the most common discomforts in the recovery room after general anesthesia. Therefore, PAS is common in hypothermic patients.

Volatile or intravenous anesthetics impair the autonomic thermoregulatory vasoconstriction which usually preserves core body temperature. However, benzodiazepines, such as midazolam, do not significantly impair thermoregulation control, even when used in combination with common opioid doses. Remimazolam, a novel benzodiazepine, has been reported for the thermoregulatory vasoconstriction threshold and onset time of vasoconstriction in terms of core body temperature in patients undergoing robotic-assisted and laparoscopic radical prostatectomy. It decreased the vasoconstriction threshold less than propofol, one of the intravenous anesthetics, and the onset of vasoconstriction was faster than propofol.

Investigators hypothesized that remimazolam reduced the incidence of hypothermia compared to sevoflurane, one of the volatile anesthetics, and eventually lowered the frequency of PAS. Therefore, this study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 19 and 65 y, with ASA physical status classes I or II

Exclusion Criteria:

* Patients with history such as thyroid disease, cardiopulmonary disease, blood coagulation disorder, liver dysfunction, cranial nerve disease, alcohol or drug abuse, a known allergy to the study drug, and those who had core body temperature \> 38°C or \< 36.5°C, BMI \> 30 kg.m-2 or febrile illness were excluded. Patients who underwent surgery for less than 60 min, and those who did not consent to this study
A Clinical Study of Treating Influenza With Liugan Shuangjie Heji

This prospective randomized controlled trial studies the efficacy and safety of treating influenza with the reconciling exterior and interior therapy. A total of 300 cases of seasonal flu in Beijing is to be collected, and divided into one treatment group and two control groups. Patients in the treatment group will receive Liugan Shuangjie Heji, while patients in control groups will receive Shufeng Jiedu Capsule and Oseltamivir Phosphate Capsule respectively, for a course of 5 days. The study assesses the efficacy and safety of treating influenza with the reconciling therapy based on the following outcome measures: the time it takes from the medicine intake to 0.5℃ drop of body temperature, and the time it takes for the body temperature to return to normal.


Eligibility Criteria:
Inclusion Criteria:

1. The disease in flu season of flu, in line with the western medicine clinical diagnostic criteria for influenza;
2. All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior;
3. The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher;
4. Aged between 18 to 65 years;
5. Voluntary and signed informed consent.

Exclusion Criteria:

1. The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs;
2. Routine blood WBC is greater than the upper limit of normal;
3. Chest X-ray examination with inflammatory exudation images;
4. With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal;
5. Pregnancy, nursing mothers, and allergic constitution;
6. Participated in clinical subjects for nearly three months.
A Trial of SHR8735 in Healthy Subjects

This is a phase 1 open-label study.

This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
* Be able to comply with all the requirements and able to complete the study.
* Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
* No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
* Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion Criteria:

* Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form).
* History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-1. The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet).
* Severe, active psychiatric conditions that require ongoing treatment.
Electrical Vestibular Nerve Stimulation (VeNS): A Follow-up Assessment of Long-term Usage

A follow-up assessment study of the long-term safety of vestibular electrical stimulation as delivered by the Vestal DM Device.

A retrospective, open-label, follow-up study assessing the long-term safety and efficacy of vestibular electrical stimulation as delivered by the Vestal DM Device.

Eligibility Criteria:
Inclusion Criteria:

* Vestal DM user (more than 6 months)

Exclusion Criteria:

* Vestal DM device user (less than 6 months)
Brain Wave Entrainment Using Alpha Frequency Binaural Beats on Adolescent Swimmers

Relaxation techniques and binaural beats added to music have a positive effect on athletic performance of swimmers than music therapy and mental training alone

EEG measurement after Relaxation techniques and binaural beats added to music have been employed showed a positive effect on the athletic performance of swimmers when BB have been added to music therapy and mental training

Eligibility Criteria:
Inclusion Criteria:

- adolescent swimmer

Exclusion Criteria:

-