cyrilzakka/clinical-trials huggingface dataset:
A Study and 12 Month Extension to Evaluate Two Investigational Drugs in Postmenopausal Women With Osteoporosis (MK-0217-907)

The purpose of this study and 12 month extension is to evaluate the effects of two investigational drugs on osteoporosis in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with osteoporosis

Exclusion Criteria:

* Any known allergy to the study drug
Is Urethral Catheter Necessary After Ureteroscopy and DJ Stent Placement?

After semirigid or flexible ureteroscopy operations where a DJ stent was placed, there is diversity in practice of placing a urethral catheter. The presence of vesico-ureteral reflux due to DJ stents has been proven to exist and can cause flank pain and UTI due to retrograde urine flow. The main purpose to place a urethral catheter is to keep a low-pressure bladder in order to prevent reflux alongside the DJ stent. However, this practice doesn't have an evidence-based support on the literature and some surgeons also advice patients to void frequently in the early postoperative period to avoid these aforementioned complications. The purpose of this study is to compare the 2 different approaches after ureteroscopy and DJ stent placement by evaluating the patient-reported outcomes along with laboratory tests.

Ureteral stents and foley catheters are the most commonly used disposables in urological practice. Ureteral double J (DJ) stents are frequently used to relieve ureteral obstruction and almost as a routine part of the ureteroscopic procedures by many surgeons.

DJ stent placement has the potential side effects such as flank pain and urinary tract infection (UTI) due to retrograde urine flow. As the bladder pressure increases during voiding, urine reflux occurs both beside and through the DJ stent. In order to overcome these problems, stents with antireflux mechanisms are produced, however these new stents comes with higher costs compared to conventional stents.

Foley catheters are the hands and feet of all urologists and insertion of a foley catheter can easily keep the bladder pressures as low as required. The practice of insertion of a foley catheter into the urinary bladder after ureteroscopy for kidney or renal stones and DJ stent placement doesn't have an evidence-based background and it routinely depends on the choice of the surgeon.

The aim of this study is to evaluate whether routine insertion of a bladder catheter following ureteroscopy and DJ stent placement can reduce stent-related problems due to reflux and urinary tract infections.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* Patients with indications for semirigid or flexible ureteroscopy and DJ stent placement for unilateral ureteral and/or kidney stones according to European Association of Urology Urolithiasis Guidelines

Exclusion Criteria:

* none
Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery

This is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. Possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.

Intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L\&D unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to keep newborn warm using appropriate measures. Evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of IVH or CP.

Eligibility Criteria:
Inclusion Criteria:

18 years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent

Exclusion Criteria:

multiple gestation/ known intrauterine fetal death unable to sign consent
Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects

To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI 187004 and metformin given alone.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. Subjects must be able to understand and comply with study requirements
3. Age of 18 to 50 years
4. Body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers

This study will address whether teaching the Body Scan exercise to cancer patients with hematological malignancies and their caregivers during an inpatient hospitalization improves reported physical and psychological symptoms after a two-week period. Giving patients and caregivers the opportunity to learn mindfulness and the tools to practice on their own is expected to lead to a decrease in stress and anxiety, and help empower patients and caregivers to better cope with stress in the future.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary \& self-selected patients and caregivers
* Located on the leukemia/lymphoma/bone marrow transplant floor at Barnes Jewish Hospital

Exclusion Criteria:

-Patients requiring a language translator or interpreter will be excluded from the study
Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery

Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 yrs
* BMI \<35 kg/m2
* acute, first-time, ACL rupture with or without meniscus injury
* scheduled to undergo reconstruction with a BPTB autograft

Exclusion Criteria:

* history of prior knee/lower extremity surgery or non-surgical intervention (eg, intra-articular injection) on either leg
* abnormal laxity of any lower extremity ligament other than the injured ACL
* signs or symptoms of arthritis, autoimmune or inflammatory disease or diabetes
* grade IIIb or greater articular cartilage lesions (ICRS criteria)
* women who are/plan on becoming pregnant
Escitalopram in Patients With Generalized Anxiety Disorder

The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.

The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).

Eligibility Criteria:
Inclusion Criteria:

* The patient suffers from GAD, diagnosed according to ICD-10 (International Classification of Diseases)
* The patient meets criteria as set out in the national SPC for escitalopram
* The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs

Exclusion Criteria:

* The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
* The patient has contraindications to escitalopram
* The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
* The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
* The patient is pregnant or breast-feeding
* The patient, if a woman of childbearing potential, is not using adequate contraception
Transport Distraction Osteogenesis for Ramus-Condyle Unit

this study was done to evaluate the use of transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to correct the resultant deformity

10 patients with post ankylosis deficient ramus /condyle unit who underwent release procedure in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt.

all patients were assessed clinically and by imaging using OPG, lateral and PA cephalometry, and cone beam CT to assess the deficient ramus/condyle unit (RCU) then patients were operated using transport distraction osteogenesis to lengthen the RCU. Then follow up of all patients both clinically and radiographically was adopted.

Eligibility Criteria:
Inclusion Criteria:

* Post ankylosis deformity: Bilateral or unilateral deficient ramus-condyle unit (RCU) after TMJ release

Exclusion Criteria:

* Mentally affected patients.
* Medically compromised patients.
* Post menopausal osteoporosis.
Development of Modified Combined Apgar Scoring System for Evaluation of Infants in the Delivery Room

Apgar scoring system has been widely used for the evaluation of the infant's postnatal condition. As conventional Apgar scoring system is affected by gestational age and resuscitative efforts, there is a need for development of new scoring systems for the assessment in the delivery room. Herein, Modified Combined Apgar scoring system which includes two new parameters (cord blood pH and targeted oxygen saturation level) has been developed and the utility of this modified system was compared with Conventional and Combined Apgar scoring systems for prediction of hospitalization.

This is a prospective cohort study. Conventional, Combined and Modified Combined Apgar scores at minutes 1 and 5 are all recorded. For Modified scoring system, blood sample is obtained from the umbilical artery and pulse oximetry is used for measurement of oxygen saturation. Prediction of NICU hospitalization is used as a surrogate parameter to compare the scores.

Eligibility Criteria:
Inclusion Criteria:

Term neonates Preterm neonates Parental approval

Exclusion Criteria :

Major congenital/chromosomal abnormalities Lack of informed consent Stillbirth Outborn infants
Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects

  1. Male and Female (not of childbearing potential in Part 1 and 2a) subjects between 18 and 45 years old
  2. Free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results.
  3. BMI of 18-32 kg/m2.
* CHB Subjects:

  1. Male or female between 18 and 65 years old.
  2. Chronic HBV infection documented as a positive HBsAg, HBV DNA, or HBeAg test at least 6 months prior to the Screening Visit, or a historical liver biopsy consistent with chronic HBV infection
  3. For cohort F, G, H:

     1. HBV DNA ≥2,000 IU/mL at Screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment).
     2. ALT ≤ 5x ULN
  4. For Cohort I:

     1. HBV DNA \<LLOQ at Screening
     2. Subjects must have been receiving either TAF, TDF, or ETV consistently for ≥6 months prior to Day 1 and are willing to continue with the same NA treatment through the final study visit.
     3. ALT ≤ 2.5 x ULN
  5. HbsAg ≥250 IU/mL at screening

Exclusion Criteria:

* CHB Subjects

  1. Advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or FibroScan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease.
  2. Co-infection with HIV or other non-B hepatitis viruses.
  3. Any clinically significant or unstable medical condition or illness that could confound study findings.
  4. Subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding.
  5. Previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier \[CpAM or CAM\]) within 6 months of the Day 1 visit, or prior treatment with an HBV-targeted siRNA or antisense oligonucleotide compound at any time.
A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhPTH(1-84) is a potential treatment option. The group of participants in the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11 years. This study is designed to extend this experience and gain knowledge about how safe and effective rhPTH(1-84) is in participants with hypoparathyroidism over a long-term duration.


Eligibility Criteria:
Inclusion Criteria

* Participants that are currently or previously enrolled in the core study (AAAE0544 \[NCT01199614\]) and have maintained uninterrupted therapy with recombinant human parathyroid hormone (rhPTH(1-84)) (transient interruptions of up to 1 month continuously off treatment may be allowed).
* Signed and dated informed consent form (ICF).
* Adult men and women 18 to 85 years of age.
* History of hypoparathyroidism for at least 12 months prior to rhPTH(1-84) treatment, defined by the requirement for supplemental calcium and/or active vitamin D to maintain serum calcium along with an undetectable or insufficient Parathyroid hormone (PTH) concentration.
* Able to perform daily subcutaneous (SC) self-injections of study medication (or have designee perform injection).
* Willingness and ability to understand and comply with the protocol. Women must agree to pregnancy testing and acceptable methods of contraception, as detailed in the protocol.

Exclusion Criteria

* The participant is treated or has been treated with any investigational drug, aside from rhPTH(1-84), within 30 days of consent.
* As assessed by the investigator, the participant has any safety or medical issues that contraindicate participation in the study.
* The participant and/or the participant's parent(s) or legally-authorized representative(s) are unable to understand the nature, scope, and possible consequences of the study.
* The participant is unable to comply with the protocol, example, uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for evaluations, or is otherwise unlikely to complete the study, as determined by the investigator or the medical monitor.
* The participant is pregnant or lactating.
* Participants who are at increased baseline risk for osteosarcoma such as participant with Paget's disease of bone or unexplained new elevations of alkaline phosphatase, participants with hereditary disorders predisposing to osteosarcoma or participants with a prior history of external beam or implant radiation therapy involving the skeleton.
Effects of Spencer's Technique on Shoulder Function

The purpose of this study is to see the impact of a modified Spencer's technique on tissue stiffness, mobility, and blood flow of the shoulder joint. Spencer's technique is a well-known osteopathic manipulative treatment (OMT) that is common for treating adhesive capsulitis and is believed to help blood flow. There are studies that look at the clinical effects of the technique and/or compare it to other techniques; however, measuring the extent to which Spencer's technique, or this modified technique, improves tissue stiffness and blood flow has never been written in the literature. This study will serve as a proof of concept that this technique improves tissue stiffness, blood flow, and mobility of the shoulder join as well as the nearby areas. Using ultrasound, the investigators will measure tissue stiffness and blood flow and will analyze the mobility of the shoulder joint using a Vicon motion capture system.


Eligibility Criteria:
Inclusion Criteria:

• male and female subjects 18-50 years old

Exclusion Criteria:

* prior shoulder surgery or injury to the reported dominant throwing arm
* shoulder pain in the reported dominant throwing arm within the last 6 months
* diagnosis cervical radiculopathy or pinched nerve in the neck
* connective tissue or muscle disorders
* known pregnancy
* tobacco use
* known diabetes or prediabetes
* allergy to ultrasound gel (propylene glycol)
Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

Cyclo-oxygenase (COX) is a family of enzymes regulating the conversion of arachidonic acid to prostaglandins. COX-II is an inducible enzyme, which may be upregulated when there are stimuli such as inflammation or hypergastrinaemia. Despite radical surgery, patients with stomach cancer of advanced stages often have a poor prognosis. Reported survival in those with diseases of stage IIIa or above is less than 40%. Methods to improve patients outcome have been explored for decades with little success. In the light of current understanding on the relation between COX-II and stomach cancer, selective COX-II inhibitor may be used as a novel adjuvant therapy after gastrectomy to prevent recurrence of gastric carcinoma. The advantages of COX-II inhibitors are being relatively non-toxic with minimal side effect.

Eligibility Criteria:
Inclusion Criteria:

* Resectable advanced stomach cancer (Tumour stage ≥ T2N1 according to the 5th edition of UICC staging system) without peritoneal or distant metastases.
* Normal renal function

Exclusion Criteria:

* Solid organ metastases
* Poor performance status
* Already on long-term aspirin or NSAID
* Renal or hepatic dysfunction
* Bleeding disorder
* Hypersensitive to COX-II inhibitors/aspirin/NSAID
* No history of myocardial infarct or stoke
Magnesium and Riboflavin Treatment for Post-Concussion Headache

This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.


Eligibility Criteria:
Inclusion Criteria:

* Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion;
* Less than 3 days have elapsed since their injury;
* Able to swallow capsules

Exclusion Criteria:

* Concussion complicated by cranial bleed, skull fracture, additional severe injury;
* Kidney disfunction or failure;
* Significant gastro-intestinal dysfunction;
* Varsity Athlete;
* Two or more previous concussions;
* Women who are pregnant or breast feeding;
* Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine
Effect of a Low-carb Dietary Intervention in Obese Patients: a Pilot Trial

Effects of a 6 months low-carb dietary intervention on glycemic control, body composition and gut-brain interaction in obese and lean patients with and without glucose intolerance or diabetes


Eligibility Criteria:
Inclusion Criteria:

Group A: HEALTHY LEAN CONTROLS

* Healthy normal weight subjects with a body-mass index of 19.0-24.9kg/m2, HbA1C \<5.7% and fasting glucose \<5.6 mmol/l
* Normal eating habits
* Stable body weight for at least three months
* Informed Consent as documented by signature

Group B: PRE-DIABETIC or DIABETIC OBESE

* Pre-diabetic/Diabetic obese with a HbA1C \>5.7% and/or fasting glucose \>5.6 mmol/l) and body-mass index \> 30kg/m2, otherwise healthy
* Normal eating habits
* Stable body weight for at least three months
* Informed Consent as documented by signature

Exclusion Criteria:

Group A: HEALTHY LEAN CONTROLS

* Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
* Pre-existing diet (vegetarian, vegan, gluten-free etc.)
* Psychiatric illness
* Alcohol abuse, (smoking allowed)
* Regular intake of medications, (oral contraceptives allowed)
* Intake of antibiotics within the last 3 months before inclusion
* Regular intake of pro- or prebiotics
* Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
* Clinically relevant acute or chronic inflammatory disease
* Pregnancy
* Participation in another study with investigational drug within the 30 days preceding and during the present study.

Group B: PRE-DIABETIC or DIABETIC OBESE

* Pre-existing low carb diet (less than 45% of daily energy intake by carbohydrates)
* Pre-existing diet (vegetarian, vegan, gluten-free etc.)
* Psychiatric illness
* Alcohol abuse, (smoking allowed)
* Regular intake of medications (except: oral contraceptives, metformin, SGLT-2, statins, and antihypertensive, which are allowed)
* Intake of antibiotics within the last 3 months before inclusion
* Regular intake of pro- or prebiotics
* Chronic diseases of the gastrointestinal tract, history of gastrointestinal surgery with major changes to the gastrointestinal tract (e.g. bariatric surgery)
* Clinically relevant acute or chronic inflammatory disease
* Pregnancy
* Participation in another study with investigational drug within the 30 days preceding and during the present study.