cyrilzakka/clinical-trials huggingface dataset:
Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males

The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H) during repeated oral administration with and without co-administration of loxoprofen and the pharmacokinetic profile of loxoprofen during repeated oral administration with and without co-administration of Esomeprazole (D961H).


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male
* Body Mass Index (BMI=weight/height2) 19-27 (kg/m2)
* Body weight 50-80 kg

Exclusion Criteria:

* Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders
* Significant clinical illness from the 2 weeks preceding the pre-entry visit to the randomisation, as judged by the investigator(s) , eg, acute inflammatory disease which requires medical intervention
* Past or present cardiac, renal, hepatic, neurological or gastrointestinal disease, as judged by the investigator(s), eg, sequelae of myocardial infarction, nephritis, hepatitis and cerebral infarction
Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity

Decreased insulin sensitivity is and independent risk factor for stroke despite glycemic control. It is known that physical exercise increases insulin sensitivity in healthy subjects. Wether stroke patients can increase insulin sensitivity via physical exercise is not known.

Chronic low-grade inflammation is associated with an increased risk of stroke. Physical exercise has shown to increase IL-6 directly after exercise in untrained subjects. When fitness is increased in each subject then the peak IL-6 concentration after exercise decreases and so does the basal level of IL-6. It is not known whether stroke patients can increase physical activity level to a degree where chronic inflammation are decreased.

This study is designed to evaluate if physical exercise after stroke will increases insulin sensitivity and reduce low-grade chronic inflammation.

Stroke patients have been randomized to intervention with physical exercise or control in the ExStroke pilot trial and followed for 2 years. Using the study population from the ExStroke pilot trail blood samples will be obtained at the last control. Insulin sensitivity can be measured from fasting glucose and insulin using the Homeostasis Model Assessment (HOMA). Interleukin-6, TNF-alfa and CRP is measured to estimate chronic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* participated in the ExStroke Pilot trail

Exclusion Criteria:

* Diabetes Mellitus
* Not able to give informed consent
Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

Infertility is defined as the inability to conceive after 12 months of unprotected intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors of the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, exercise, stress, sleep, pollution...) are risk factors for infertility. Weight gain, in both members of the couple, is associated with an increased risk of Assisted Reproduction Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle makes the risk of infertility three times less likely to happen. Idiopathic infertility may greatly benefit from lifestyle factors optimization.

To evaluate and optimize periconceptional habits (diet and lifestyle factors) of unfertile couple may have favorable impact on conception and pregnancy.

The investigators propose to undertake a controlled trial of the efficiency of an integrated global care program. This trial of an intervention on lifestyle factors will be compared with the ""cohort multiple randomised controlled trial"" methodology in order to strengthen external validity by limiting bias that may result from initial consent to randomisation, or from deception of allocated treatment.

At any visit in a participating ART center, all attending couples will be invited to participate in an observational survey in order to allow access to their data. In this whole cohort, all eligible couples will be identified as consultations go. An ""on the fly"" randomisation process (ration 2 usual / 1 experimental) will select candidate couples from all eligible ones, who will be ten offered the experimental PEPCI intervention. In case of refusal of the experimental care, they will be given the usual care.

Eligibility Criteria:
Inclusion Criteria:

* Couple attending a visit in an ART reproductive center (1st care regardless of the center regardless of the number of attempts in the center or in another center)
* Heterosexual infertile couple (absence of pregnancy after 12 months of unprotected intercourse)
* Men aged from 18 to 45 and women aged from 18 to 38
* Couple having not shown any opposition to the use of their data (observational study) and given their informed written consent to collect their biological samples
* Couple with good understanding of the French language
* Couple with computer equipment including webcam and internet access at home
* Affiliation to the French health insurance organism
* No-cons to the practice of adapted physical activity (non stabilized disease: diabetes, anemia, aplastic anemia, severe malnutrition, severe osteoporosis, heart or lung disease)
* Signing of the informed consent form

Exclusion Criteria:

* BMI upper 40 for one or both members of the couple
* Viral infection for one or both members of the couple (infection with HIV, Hepatitis B or C)
* Ongoing pregnancy
* One or both member of the couple medically treated for diabetes mellitus
* One or both member of the couple medically treated for a psychotic disorder
* Inability to comply with care program"
* Couple already enroll in the study
Efficacy of a Once Daily Calcium and Vitamin D Fortified Food Product to Improve Bone Microarchitecture

The primary objective of this randomized, double-blind, placebo controlled trial is to determine the efficacy of a once per day calcium (1000mg) and vitamin D (1000IU) fortified food product on bone turnover markers, including parathyroid hormone (PTH) and microarchitecture during Army basic military training (BCT). The investigators hypothesize that consumption of a once daily calcium and vitamin D fortified food product will stabilize PTH and contribute to improved bone microarchitecture compared to placebo. The results will determine the efficacy of daily supplementation with calcium and vitamin D on bone turnover markers as well as provide novel data regarding microarchitectural changes during BCT as assessed by high resolution peripheral computed tomography (HRpQCT) scanning.

Stress fractures may affect up to 2-5% of male and 8-21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel. A recent report indicates that supplemental calcium (2000mg) and vitamin D (800-1000IU) stabilizes PTH, increases tibia volumetric bone mineral density in male and female recruits undergoing Army BCT, and reduces stress fracture incidence by up to 20% in female Nacy recruits. Bone macroarchitecture has been measured in response to basic training however, the resolution of standard peripheral quantitative computed tomography (pQCT) is insufficient for assessment of microarchitectural changes, which may underlie the pathophysiology of stress fracture. With the use of HRpQCT this study will allow the investigators to evaluate microarchitectural changes within the bone tissue and assess the efficacy of a moderate daily dose of calcium and vitamin D to support bone health during BCT.

Eligibility Criteria:
Inclusion Criteria:

* Female or male US Army recruits beginning Army basic combat training at Fort Jackson, South Carolina

Exclusion Criteria:

* Pregnant or breastfeeding
* History of kidney stones or kidney disease
* History of amenorrhea
* History or endocrine disorders
* History of bone modifying disorders
* Currently taking, or have taken glucocorticoid drugs in the 2 years prior to study participation
* Currently diagnosed as anemic by healthcare professional
* Those allergic to any component of the snack bar
Effects of Chewing Gum Against Postoperative Ileus

The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy

Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.

This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Eligibility Criteria:
Inclusion Criteria:

1. Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.

Exclusion Criteria:

* 2. Ongoing treatment for mental disease 3. Diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function 4. Ongoing abuse of alcohol or other drugs 5. Previously known allergies to the content of chewing gum 6. Additional surgery after primary surgery.
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility Criteria:
Inclusion Criteria:

1. Age at study entry is at least 18 years.
2. Patient must sign and date the informed consent form prior to the index-procedure. If the patient is not able to give informed consent, a legally authorized representative must give informed consent on his/her behalf.
3. Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
4. Patient has a BMI ≥ 40 kg/m2.

Exclusion Criteria:

1. Patient is pregnant.
2. History of bariatric surgery.
3. Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
Effect of Plyometric Exercise on Stability in Professional Indoor Soccer Players: A Pilot Study

A program is proposed for two groups of professional indoor soccer players where the effect of plyometric exercises on body stability will be evaluated on a stabilometric platform.

A program is proposed for two groups of professional indoor soccer players where the effect of plyometric exercises on body stability will be evaluated on a stabilometric platform.

Four evaluations will be carried out. An initial measurement before the beginning of the first intervention phase (Visit 1), after the intervention (Visit 2; day 30), after a 15-day washout period (Visit 3; day 45) and after the second intervention phase (Visit 4; day 75).

Eligibility Criteria:
Inclusion Criteria:

* Professional soccer player in the first division of the National Soccer League (LNFS).
* Age between 18 and 35 years old.
* BMI between 18 and 32 Kg/m2.

Exclusion Criteria:

* Serious or terminal illness.
* Participants with pain associated with chronic conditions.
* Participants with body mass index above 32 kg/m2.
* Inability to understand the informed consent.
Acupuncture for Breast Engorgement During Lactation

Breast engorgement which may manifest swell, throb, and cause mild to extreme pain is the common difficulty for breast feeding woman. It occurs in the mammary glands due to expansion and pressure exerted by the synthesis and storage of breast milk and it usually happens when the breasts switch from colostrums to mature milk. However, engorgement can also happen if lactating women miss several nursing and not enough milk is expressed from the breasts. It can be exacerbated by insufficient breastfeeding and/or blocked milk ducts. Engorgement may lead to mastitis and untreated engorgement puts pressure on the milk ducts, often causing a plugged duct.

According the meridian theory, the investigators propose the acupuncture treatment for patients of breast engorgement.

The investigators will include 60 patients and measure the acupuncture effect. The inclusion criteria are women with breast engorgement and 20 years old or older. Exclusion standards are patients with: 1. diabetes mellitus 2. Psychological disease or mental illness 3. Fever \> 38 degrees Celsius 4. Mastitis 5.analgetics or anti - inflammatory agents used 6. ultrasound therapy applied


Eligibility Criteria:
Inclusion Criteria:

* women with breast engorgement and 20 years old or older

Exclusion Criteria:

* patients with:

  1. diabetes mellitus
  2. psychological disease or mental illness
  3. Fever \> 38 degrees Celsius
  4. Mastitis
  5. analgesics or anti - inflammatory agents used
  6. ultrasound therapy applied
The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin

The purpose of the study is to demonstrate, that there is no difference in metabolic control in patients with type 2 diabetes mellitus and therapy with human insulin with or without injection-meal-interval.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Aged 40 - 80 years
* Therapy with human insulin

Exclusion Criteria:

* Pregnancy
* Nutrition disorders
* Psychological disease
* Body Mass Index (BMI) less than 25 kg/m\^2
* HbA1c greater than 9%
HER2 Expression of CTC to Predict Response in HER2-positive Advanced Breast Cancer Patients Treated With ADC

To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-positive advanced breast cancer patients treated with ADC


Eligibility Criteria:
Inclusion Criteria:

* Has pathologically documented breast cancer that:

  1. Is unresectable or metastatic
  2. has confirmed HER2-positive expression defined as IHC 2+/ISH+ or IHC 3+
  3. was previously treated with trastuzumab and taxane in the advanced setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
* Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
* Receives anti-HER2 ADC treatment
* Life expectancy \> 3 months
* Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection
* ECOG ≤2

Exclusion Criteria:

* Has uncontrolled or significant cardiovascular disease
* Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses and whose origin remains unknown.

This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the visual field and progress to blindness. Along with weight reduction, acetazolamide, which reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line treatment. Its efficacy is inconsistent in resolving papillary edema and there are many side effects.

In the event of ineffectiveness or dependence on acetazolamide associated with hygiene and dietetic rules, a second line of therapy is then considered: neurosurgical (internal shunt of the LCS) or endovascular (venous stenting) treatment.

These invasive techniques have each proven their effectiveness in the rapid and permanent resorption of OP, allowing improvement or preservation of visual function. In terms of induced morbidity, the superiority of one technique over the other, if it exists, has not been established.

Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus venous sinus stenting in HTICi with moderate to severe visual impairment after failure of medical treatment defined by the absence of resorption of the OP after several months

Intervention 1 Name : internal ventricular shunt (neurosurgery)

Other name \[facultatif\] :

Description :

The internal ventricular shunt consists of the introduction of a catheter from a lateral ventricle into the atrium or peritoneum. It is associated with a valve whose opening pressure is adjustable. The goal is that cerebrospinal fluid can be absorbed extra-cranial.

Intervention 2 Name : endovacascular stenting (interventional neuroradiology)

Other name \[facultatif\] :

Description :

The placement of a vascular endoprosthesis (stent) is an interventional neuroradiology procedure aimed, by venous approach (percutaneous puncture), to restore the diameter of a venous sinus. It requires 6 months of antiplatelet aggregation. The aim is to allow better venous drainage from the brain to increase the absorption of cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* HTICi proven greater than 25cm of water
* Presence of papillary edema (grade\> 0 on the Frisen scale)
* Stenosis of at least one transverse sinus on MRI
* Failure of medical treatment and surgical / interventional indication defined by the medical team taking care of the patient
* Consent to participate in the study

Exclusion Criteria:

* Fulminant HTICi
* Contraindication to antiplatelet aggregation
* Contraindication to one or the other of the interventions under study
* Pregnant or breastfeeding woman
Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple ascending doses of PF-05231023.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects and female subjects of non-childbearing potential between the ages of 30 and 70 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines. Subjects who have other conditions but are well controlled by either diet or medications may be included as well (for example, a subject with high cholesterol level on appropriate treatment is eligible).
* Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Diagnosis of Type 1 diabetes mellitus.
* Evidence of diabetic complications with significant end organ damage
Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma

* Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV.
* Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.


Eligibility Criteria:
Inclusion Criteria

1. Extranodal NK/T-cell lymphomas
2. Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.
3. Age more than or equals to 21 years.
4. Stages IB or bulky disease, II - IV
5. ECOG performance 0-2
6. Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min; AST and ALT less than or equals to 3x ULN. Total bilirubin \< 1.5x ULN except \< 3x ULN in patients with Gilbert's (as defined as \> 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma.
7. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).
2. History of peripheral neuropathy
3. HIV positive
4. Presence of CNS disease
5. Hypersensitivity to bortezomib, boron, or mannitol
6. Contraindication to any cytotoxic drug contained in the chemotherapy regimen.
7. Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion.
8. Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.
9. Invasive or active malignancy in past 2 years.
10. Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.