cyrilzakka/clinical-trials huggingface dataset:
Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer

Bisphosphonates have been used extensively in the treatment and the prevention of skeletal complications associated with bone metastases in patients with breast cancer and prostate cancer.

The purpose of this study is to assess the effect of zoledronic acid patients with prostate cancer or breast cancer and bone metastasis.


Eligibility Criteria:
Inclusion criteria:

* Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment.
* Breast cancer with at least one cancer-related bone lesion
* Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2
* Normal liver and kidney function
* Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone.

Exclusion criteria:

* Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)
* Current/active dental problems including
* infection of the teeth or jawbone
* dental or fixture trauma
* current or previous osteonecrosis of the jaw
* exposed bone in the mouth
* slow healing after dental procedures
* recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
* Patients with clinically symptomatic brain metastases. Severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety
* Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG
* History of diseases with influence on bone metabolism such as Paget´s disease and primary hyperparathyroidism and with need of treatment for osteoporosis (defined according to DVO, T-Score ≤2.5).
* Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 1 month

Additional protocol-defined inclusion/exclusion criteria may apply
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

* Intaoperative blood loss
* Risk of Postpartum hemorraghe in the first 24 hrs
* HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Then we will compare between two groups regarding

* Intaoperative blood loss
* Risk of Postpartum hemorraghe in the first 24 hrs
* HB pre and postoperative for all patients

Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Eligibility Criteria:
Inclusion Criteria:

women attending for elective CS.

* Age between 20-35 years.
* Normal placental site
* Normal coagulation profile
* Full term pregnancies(above 37 wks)
* Medically free
* Spinal anesthesia
* Living baby
* Average liquor by U/S

Exclusion Criteria:

* • Women attending for emergency CS

  * .age below 20 or above 35
  * Abnormal placentation (Placenta previa,accrete,increta or percreta)
  * Women with coagulopathy
  * Preterm pregnancies (before 37 wks)
  * Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
  * General anathesia
  * IUFD
  * Oligo or polyhydraminos by U/S
Muscle Impact of Treating Osteoporosis

Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including:

1. Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or
2. A previous adult fragility fracture of the spine or hip or
3. Would be treated based on FRAX National Osteoporosis Foundation treatment thresholds of a 10-year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.

Exclusion Criteria:

1. Patients with a calculated creatinine clearance \< 35 ml/min or
2. Who have a contraindication for bisphosphonates or denosumab or
3. Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or
4. Subjects with severe liver disease or
5. Those who have been on oral bisphosphonates for the past 1 year and intravenous bisphosphonates for the past 2 years prior to the study or
6. Men
An Insulin Sensitivity Study in Healthy Subjects

This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.0 and \< 25.0 kg/m\^2 at screening and randomization
* No prior history of regular smoking or nicotine use
* Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
* Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
* Additional criteria may apply

Exclusion Criteria:

* Has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality
* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
* Has a lifetime history of diabetes
* Has a known risk of narrow-angle glaucoma
* Has a clinically significant illness within 30 days prior to screening or admission to the clinic
* Has a history of dependence on any substance other than caffeine
* Has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period
* Has a positive urine drug screen for drugs of abuse at screening or admission to the study site
* Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic
* Has had any vaccinations in the 4 weeks prior to screening or admission to the clinic
* Chronic use of non-steroid anti-inflammatory drugs (NSAIDs) and acetaminophen, except for low-dose Aspirin is not allowed
* Use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by Investigator
* Has prior use of any antipsychotic medication, including on and off label uses
* Additional criteria may apply
Follow-up of Children With Gastrointestinal Malformations and Postnatal Surgery

The aim of this single center study is to measure the impact of standardized neonatal pediatric surgeries due to gastrointestinal malformations on the children's motor and cognitive development and psycho-emotional competence.

To measure the neurodevelopment, the children will be tested with the Bayley Scales of Infant Development II Assessment.

Objectives:

The primary objective of this study is to compare differences in the score of Bayley Scales of Infant Development II Assessment (consisting of cognitive, verbal, nonverbal, motor development levels) between children with gastrointestinal malformations and early postnatal surgery at the age of 2 years and a control group.

The secondary objective is to measure the growth of the patients compared to healthy children in the control group, to capture post-traumatic stress situations in families, and to capture the children's psycho-emotional competence.

Study design:

The study is designed as a cross-sectional single center study. The study patients are children of 2 years of age who underwent neonatal surgery in our clinic since June 2008 due to a gastrointestinal malformation.

The control group consists of matched pairs concerning gestational age, weight and gender.

The study consists of five parts:

* Introductory interview including the medical history
* Bayley Scales of Infant Development II Assessment
* Pediatric examination with anthropometry
* Questionnaire survey of post-traumatic stress situation
* Final conversation with the parents about the results

The neurodevelopmental testing is performed by the child psychologist and the pediatric examination by the pediatrician.

Study population:

The study is purely exploratory and based on the number of patients born in our hospital with the malformations mentioned above (approximately 40).

Each patient is compared against a healthy child of the same gestational age, weight class and gender (control group).

Eligibility Criteria:
Inclusion Criteria:

Patients:

* At follow-up between 18 and 36 months of age
* At birth a gastrointestinal malformation
* Postnatal surgery
* No other serious malformations
* No serious complications of birth (e.g. asphyxia)
* \> = 33. week of gestation at birth
* Follow-up appointment when not acutely ill
* Parental Consent

Healthy individuals:

* At follow-up between 18 and 36 months of age
* Uncomplicated postnatal period
* No malformations
* No surgery until follow-up appointment
* \> = 33. week of gestation at birth
* Follow-up appointment when not acutely ill
* Parental consent

Exclusion Criteria (both groups):

* Absence of parental consent
Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

The aim of this study is to assess the safety and effectiveness of Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Ozempic as prescribed by study doctor. The study will last for about 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The decision to initiate treatment with commercially available Ozempic has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study.
* The participant with T2DM is scheduled to start treatment with Ozempic based on the clinical judgment of their treating physician as specified in the approved label in Korea.
* Informed consent is obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male/female age greater than or equal to (\>=) 19 years at the time of signing informed consent.

Exclusion Criteria:

* Participants who are or have previously been on Ozempic therapy.
* Known or suspected hypersensitivity to Ozempic, the active substance or any of the excipients.
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Female patients who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by Korea regulation or practice).
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain

The main objective of this study is:

• To evaluate the immediate hypoalgesic effect of an aerobic exercise session of different intensities in patients with chronic low back pain;

The secondary objective is:

• To explore whether pain intensity, level of physical activity, functionality, catastrophizing, kinesiophobia, anxiety and depression interfere with the immediate hypoalgesic effect of exercise.

There will be 3 groups of participants, an asymptomatic control group that will not perform any exercise and two groups of individuals with low back pain. One group will perform exercise at 90% VO2máx and the other at 60% VO2máx.

All the three groups will be assessed at baseline for pressure pain threshold, pain intensity, pain phenotype, disability, kinesiophobia, catastrophizing, anxiety and depression, physical activity, and aerobic capacity. In addition, pressure pain threshold and pain intensity will also be assessed at post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* All groups:
* age between 18 and 65 years old
* Participants with low back pain:
* non-specific LBP (defined as pain between the costal margins and the inferior gluteal folds, which is usually accompanied by painful limitation of movement and may be associated with pain referred down to the leg)

Exclusion Criteria:

* All groups:
* presence of pathology of the nervous system, cardiovascular or carcinogenic, rheumatic diseases (for example, rheumatoid arthritis), fibromyalgia, previous history of lumbar surgery, medication that affects or alters heart rate, any contraindication to exercise and pregnancy.
Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.

The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.

The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine.

This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) I or ASA II
* Spinal Anaesthesia for lower limb surgery
* Patient Consent

Exclusion Criteria:

* relative or absolute contraindications for spinal anesthesia
* history of hypersensitivity to the local anesthetics or components
* opioids for anesthetic adjuvant
* spinal lesions, peripheral neuropathies or any other neurologic disorders that leads to changes of sensitivity
* Body mass index = or \> 35
* lumbar puncture difficulty
* ventricular extrasystoles
* dementia, others loss of cognitive ability
* difficulty in the spine
* spinal cord surgery
* anaphylactic reactions or Stevens-johnson Syndrome
* polytraumatism
* alcoholism abuse and use of illicit substance
* Changes in the blood test
* Others conditions judged by investigator's opinion
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation

Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with esophageal squamous cell carcinoma;
2. 18 - 80 years old;
3. ECOG PS 0-1;
4. Thoracic esophageal cancer (20-40cm from the incisors);
5. Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024;
6. Received the McKeown procedure in our hospital's single treatment group;
7. Received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device;
8. Complete clinical materials.

Exclusion Criteria:

1. History of other malignant tumors;
2. Incomplete or missing clinical materials;
3. Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
4. Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed;
5. Patients who underwent 3-field lymph node dissection;
6. Patients with clear intraoperative recurrent laryngeal nerve section;
7. Highly suspected anastomotic fistula before the first endoscopic evaluation (abnormal secretion at the cervical anastomotic site, abnormal drainage fluid in the chest tube, and high fever that other reasons cannot explain);
8. Lost to follow-up.
Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence

This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence

Sphincteric incompetence is most commonly found in men who have had radical prostatectomy (RP). RP is the most common treatment for localized high-risk Prostate Cancer in North America.

The Contino®, a urethral insert, was conceived by a prostate cancer survivor and worn for 10+ years without incident, and a First in Human clinical trial was completed without serious adverse event. The basis for this clinical trial is a post market clinical follow-up study. No drug treatment will be administered.

Eligibility Criteria:
Inclusion Criteria:

1. Male 18 years of age or older
2. Evidence of sphincteric incompetence as assessed by the Investigator
3. ECOG 0 or 1 performance status
4. Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day

Exclusion Criteria:

1. Inability to consistently insert the Contino® into his own urethra and remove it
2. Less than 2 months post radical prostatectomy for localized prostate cancer
3. History of significant incontinence that is other than stress incontinence
4. Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions
5. Untreated urethral stricture disease
6. Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator)
7. Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator)
8. Body Mass Index (BMI) greater than 32 kg/m2 (in the opinion of the Investigator provided the subject is able to insert \& remove the device)
9. Known immune deficiency either due to disease or medications (in the opinion of the Investigator)
10. Uncontrolled diabetes (in the opinion of the Investigator)
11. An UTI (in the opinion of the Investigator)
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects

The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy male subjects
* 20 to 40 years of age
* 17.6 to 26.4 kg / m² of body mass index (BMI)

Exclusion Criteria:

* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction
* Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)
* Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)
* Subject with known sensitivity to common causes of bleeding (eg nasal)
Treatment of Primary CNS Lymphoma

The purpose of this study is to evaluate the efficacy and safety of FVD regiment (fotemustine, teniposide and dexamethasone ) for patients with primary CNS lymphoma.

Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FVD regiment(fotemustine, teniposide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.

Eligibility Criteria:
Inclusion Criteria:Age range 14-60 years old; ECOG performance status 0-2; Estimated survival time \> 3 months Histological confirmed PCNSL None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent. -

Exclusion Criteria:Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato

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Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.

Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking