cyrilzakka/clinical-trials huggingface dataset:
An Early Phase 2 Clinical Study of KSP-0243

A phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study to administer KSP-0243 or a placebo once daily after breakfast for 8 weeks in 100 patients with mild to moderate active ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 74 years old (both inclusive)
* Patients who have been given the diagnosis of ulcerative colitis for at least 12 weeks
* Patients with an endoscopic view typically seen with ulcerative colitis spreading \> 15 cm from the anal verge
* Patients with mild to moderate active ulcerative colitis who meet the certain conditions
* Patients who have an inadequate response to a fixed-dose oral 5-ASA formulation (mesalazine or salazosulfapyridine) continued from at least 2 weeks prior to the start of the screening period

Exclusion Criteria:

* Patients who underwent an enterectomy or are expected to require an enterectomy during the study period (except appendectomy)
* Patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with Clostridium difficile)
* Patients with any of the following concomitant illnesses with the severity considered inappropriate as a study patient by the principal investigator or the subinvestigator or medical history thereof:
* Hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases,
Healthy and Affordable Protein Rich Foods for African Market

This study is to gather information on school feeding programs and to measure the effect on linear growth and cognitive performance when providing a high-quality milk protein source or a combination of a high-quality milk protein source and rice proteins as a nutritional supplement to school children in Ghana. Children will receive a meal with a protein powder supplement with vitamins and minerals mixed into it. Participation is expected to last for 9 months.

1200 Children aged 6-7 years attending school will be enrolled throughout twenty primary schools (60 per school). Participants will be randomized to one of four groups: Control: Vitamins/minerals-200 mg premix contain the required micronutrients as per UNICEF recommendations.

For groups 1-3 the same vitamin/mineral mix will be used along with Group 1. Vitamins/minerals + Milk Protein (8.75 g)-the milk protein is a skim milk powder with the sugar lactose.

Group 2. Vitamins/minerals + Milk/plant Protein (8.75g)-the milk protein is a skim milk protein powder and the plant protein is a rice protein concentrate and the sugar lactose.

Group 3. Vitamins/minerals + Milk Protein (4.38g)-the milk protein is a skim milk protein powder with the sugar lactose.

At baseline measurements-weight,height,mid-upper arm circumference,and body composition will be taken, fasting blood spot test will be administered to measure levels of Insulin and insulin like growth factor and other metabolic test, and computer based cognitive testing. Demographic information will be collected along with a dietary survey. Primary outcomes are cognitive performance on standardized tests and change in height-for-age z-score over the supplementation period, 9 months total. Questionnaires will be administered to collect demographic data and dietary information.

At the mid-point all measurements will be taken again and cognitive testing will be repeated.

At the end of the study all measurements will be taken again, cognitive testing repeated, blood spot samples taken again, and a short survey will be administered about the protein powders.


Eligibility Criteria:
Inclusion Criteria:

* Ghana school children between the ages of 6-9 years old

Exclusion Criteria:

* children with severe malnutrition
* chronic debilitation disease
* milk allergy
The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters

Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance, physiological expenditure index and gait parameters in diabetic individuals. Within the scope of this project, based on the above mentioned reasons, we plan to produce a personalised off loading insoles designed for diabetic foot.

Excessive localized loading on the plantar surface leads to repeated microtrauma and the development of diabetic foot ulcers. The plantar region, subjected to constant weight-bearing pressure, develops chronic wounds due to dangerous vascularity. Excessive plantar pressure is considered the primary risk factor for plantar ulcers in diabetic individuals; custom insoles are considered the gold standard in treatment for off-loading plantar pressure.

The off-loading technique, which reduces plantar pressure, is an effective ulcer prevention strategy for neuropathic feet with impaired sensation and increased plantar load and tissue stress.

A review of the literature shows that previous studies have clearly demonstrated that off-loading insoles are effective in reducing abnormal plantar pressure in a specific area and that they also have some effect on the pressure distribution in surrounding areas. However, the potential impact of this positive effect on postural balance, postural control, and individuals' physiological expenditure and energy consumption has not been sufficiently studied.

Therefore, it is considered important to investigate the relationship between changes in plantar pressure distribution, postural balance, physiological expenditure index, and walking parameters in diabetic individuals.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 40 and 65,
* Wagner Classification stages 0 or 1,
* He has type I or type II diabetes,
* No history of amputation surgery,
* Individuals using shoes suitable for insoles will be included in the study.

Exclusion Criteria:

* - Using an assistive device (long-walking device, walker, canadiene, etc.),
* He has a history of amputation,
* He has a Charcot foot deformity,
* The one with the open wound,
* Physical disability that may restrict joint movement,
* Individuals using shoes that are not suitable for insoles will not be included in the study.
Platelet Rich Plasma in Hiatal Hernia Repair

Rationale: Gastroesophageal reflux disease (GERD) is a common disease caused by a dysfunctional lower esophageal sphincter and an abnormal esophageal hiatus or hiatal hernia. Approximately 30% of large hiatal hernias will recur after surgery, in part due to weak connective tissue at the hiatus. Platelet rich plasma (PRP) is a promising autologous therapy that may address this shortcoming by substantially enhancing wound healing of the hiatus after repair.

Intervention: PRP will be applied to mesh used in hiatal hernia repair.

Objectives: The objective of this study is to determine the efficacy of PRP in hiatal hernia compared to traditional hernia repair without PRP.

Study population: 150 patients 18 years and older with large (\>5cm) paraesophageal hernias.

Study methodology and study arms: a 1:1 allocation ration will be used to randomly assign 75 patients to the experimental arm (PRP with mesh) and 75 patients to the control arm (mesh only).

Study outcomes: The primary outcome will be 1-year postoperative hernia recurrence based on video esophagram and/or upper endoscopy. The secondary outcome will be GERD-Health Related Quality of Life (GERD-HRQL) scores and dysphagia scores at 6 and 12 months.

Follow-up: Patients who undergo fundoplication and hiatal hernia repair with mesh are seen in clinic for follow-up at two weeks, six weeks, six months, one year, and annually thereafter. Video esophagram or upper endoscopy will be performed at 1 year after surgery to assess the primary outcome. The investigators secondary outcome of reduction in GERD-HRQL score will be determined by a difference in the GERD-HRQL score from the preoperative score to the postoperative scores taken at 6 months and 1 year. The investigators secondary outcome of dysphagia will be determined by EAT-10 scores taken at 6 months and 1 year.

Statistics/Analysis: Descriptive statistics will be used. Intention to treat and per protocol analyses will be performed. Frequentist and Bayesian statistical analyses will be used to determine statistically and clinically important outcomes.


Eligibility Criteria:
Inclusion Criteria:

- Documented hiatal hernia \> 5cm on preoperative video esophagram or upper endoscopy

Exclusion Criteria:

* Non-English speaking patients
* Prior antireflux surgery
* Platelet count less than 100,000
* History of platelet dysfunction
* Antiplatelet therapy up to ten days prior to surgery
* Corticosteroids use up to one month before surgery
* Diabetes
* Active malignancy or treatment for cancer within the last year
* Pregnancy or active breastfeeding
* Active smoking
Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection

This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18
* Post renal transplantation time: ≥ 6 months
* Stable kidney function ( serum creatinine \< 3.0mg/dl; variation \< 0.5mg/dl at 2 appointments in minimum distance of 6 days)
* Stable Tacrolimus Sandoz© dose \> 2 weeks before inclusion in this Non Interventional Study (NIS)
* Written and oral informed consent

Exclusion Criteria:

* Well-known poor compliance with immunosuppressives
* Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
Bioequivalence Study of CJ-30061 in Healthy Male Volunteers

To compare the pharmacokinetics and safety after a single dose administration of CJ-30061 and co-administration of Exforge® 5/160mg, Lipitor® 20mg in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 19 to 55 years at the time of signing informed consent form.
* Subject with BMI from 19kg/m\^2 to 27kg/m\^2
* Decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of Investigational products of the study

Exclusion Criteria:

* Subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease.
* Subject who fall under the criteria below in laboratory test.

  * AST/ALT, total bilirubin, GGT, Uric acid \> UNL (upper normal limit) x 1.5
  * CPK \> UNL x 2.5
  * CrCL \< 60mL/min
* Subject who fall under the criteria below in Blood Pressure test (siSBP \< 100mmHg/siSBP ≥ 150mmHg or siDBP \< 70mmHg/siDBP ≥ 100mmHg)
The Effects of Dexamethasone on the Time to Pain Resolution in Dental Periapical Abscess

An individual's quality of life can be seriously affected by the severity of dental pain. The emergency department is a common place to find those seeking relief from their dental pain- often times seeking removal of the affected tooth, dental anesthetic injections or oral pain medications. There are a number of dental infections that cause this type of debilitating pain. One such dental infection is termed periapical abscess. This infection involves the tooth pulp. These infections can arise in three ways: introduction through a defect in the enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of the pulp from mechanical irritation. As this disease process continues there are a number of complications including chronic pain and, more seriously, the spread of infection into deep spaces which can be a life threatening condition.

The Emergency Department treatment of this infection includes pain control, antibiotics and dental referral for ultimate management of the infection.

The purpose of our study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain. Steroids are a commonly used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief from throat pain. As the pain from periapical infection is thought to be largely from the pressure we speculate that the anti-inflammatory effects of steroids may decrease the inflammation thus the pressure and may ultimately lead to a decrease in time until the patient experiences some relief from their pain.


Eligibility Criteria:
Inclusion Criteria:

Patients included if they had clinical diagnosis of pulpitis/dental apical abscess and physical exam revealed pain with percussion of the affected tooth/teeth plus or minus evidence of periapical abscess (gingival erythema, swelling, draining pus). Written informed consent was obtained from each patient prior to enrollment in the study.-

Exclusion Criteria:

1. Younger than 18 years old
2. Immunosuppression : HIV patient, transplant patient, chemotherapy
3. History of diabetes
4. Recent (\<1 month) or chronic steroid use
5. Hospitalization required due to intractable vomiting/pain
6. Pregnancy, self report
Effects of Fun Physical Activity on the Interest to Daily Physical Activity and Sarcopenia of Elderly People

In this research, the elderly living in nursing homes were selected in two group control and intervention.

Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).

Have of a healthy life with minimal complications in this period. Most important issue in improving the health and quality of life of the elderly is maintain their independence in physical activity. World Health Organization (WHO) is believed that, the first indicator of the health of a society is physical activity of the society.

The studies show that sarcopenia leads to a decrease in the function and increase of disability 2/1 male and 3/1 are older women. sarcopenia leads to some perturbation such as, movement disorders, impaired balance, the incidence of inflammatory disease and dementia. In this reserch, the elderly living in nursing homes were selected in two group control and intervention.

Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises.

(including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).

Eligibility Criteria:
Inclusion Criteria:

* age more than 60 year

Exclusion Criteria:

* absence more than 3 session training
Ropivacaine Volume for Ultrasound-guided Retrograde Infraclavicular Brachial Plexus Block

The retrograde infraclavicular brachial plexus block has been proved an effective and safe approach. Realtime ultrasound guide will facilitate a successful peripheral nerve block. The purpose of this study was to determine the medium effective volume required to produce an effective retrograde infraclavicular block using an ultrasound (US)-guided technique.

Thirty adults undergoing elective upper limb surgery received an US-guided retrograde infraclavicular block. The initial concentration of 0.5% ropivacaine injected was 30 ml, which was subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient. The medium effective volume (EV50) was determined using the Dixon and Massey up-and-down method. The effective volume in 95% of patients (EV95) was calculated using probit regression.

Eligibility Criteria:
Inclusion Criteria:

* Elected upper extremity operations
* BMI 17\~30kg/m2
* ASA I/II

Exclusion Criteria:

* Infection at injection site
* Sepsis
* Coagulation Dysfunction
* Phrenic nerve palsy
* Pneumothorax
* Recurrent laryngeal nerve palsy
* Clavicle fracture combined with nerve damage
Three-Year Trial on a New Testosterone Gel

The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.

The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW).

A minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW.

Eligibility Criteria:
Inclusion Criteria:

men with

* hypergonadotropic hypogonadism
* hypogonadotropic hypogonadism
* late-onset hypogonadism

combined with an initial Testosterone serum level of \< 11 nmol/l

Exclusion Criteria:

* known or suspected carcinoma of the prostate
* clinically relevant abnormalities in clinical chemistry or haematology
* any severe medical conditions at the opinion of the investigator
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine

To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.

Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule. These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Rehabilitation Coordinators in Orthopedic Care

REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic.

REKO-O is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic

Eligibility Criteria:
Inclusion Criteria:

* Not recovered in accordance with care plan or cannot be operated and wants an extension of his sick leave

Exclusion Criteria:

* Obvious medical complications for surgery (wound infection, prosthetic dislocation, stopper or the like)
* Permanent disability pension
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity

This study will test the potential of two techniques using light properties of adipose tissue to diagnose crown-like structures and inflammation to be compared with pathologic examination of adipose tissue biopsies from ongoing clinical studies.

Adipose tissue (fat) inflammation is emerging as an important harbinger of disease development including Type 2 diabetes, heart disease and potentially cancer. The hallmark feature of adipose tissue inflammation is the crown-like structure, a dying fat cell surrounded by immune cells attempting to clear the damage. Current methods for detecting adipose tissue inflammation rely on invasive procedures such as fat biopsies. We propose developing methods that use the light reflection properties of inflamed adipose tissue as a potential non-invasive method to detect adipose tissue inflammation.

Eligibility Criteria:
Inclusion Criteria:

-Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol

Exclusion Criteria:

-History of any skin disease
Repeated Educational Intervention for the Prevention of Diabetic Foot Ulcers in High-risk Patients

Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Either diabetic neuropathy or previous foot ulcer

Exclusion Criteria:

* Arteriopathy of lower limbs, with ABI\<0.8 or needing revascularization
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses

Collection of nasal secretions from infants and toddlers for viral testing is usually done using the nasal washing technique described by Hall in 1975. This is cumbersome. Previous attempts to use swabs have been unsuccessful because the swabs didn't work well. A newly designed swab may work better and in this study we compare the new swab with the old style nasal washing.

.

Collection of nasal secretions from infants and toddlers for viral testing is typically performed using the nasal saline aspirate technique described by Hall in 1975.

Nylon flocked swabs (NFS) and universal transport medium for room temperature (UTM-RT) (Copan Medical, Murrieta, CA) storage media have been found to be an effective collection and transport method for bacteria causing sexually transmitted infections.

We adapted these swabs and storage medium to collect respiratory viruses from children less than18 months old and compared detection rates using NFS and traditional nasal aspirates. We will determine the relative roles of the UTM-RT and NFS release and therefore measured viral detection rates of common respiratory pathogens in traditional saline aspirates stored in UTM-RT.

Our primary hypothesis is that nasal secretions collection using NFS stored in UTM-RT will lead to a higher detection rate of the respiratory viruses we arestudying; namely RSV, Influenza and human metapneumovirus from than collection of unpreserved saline nasal aspirates in children less than 18 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Treating clinican ordered RSV antigen testing

Exclusion Criteria:

* Refusal of consent
* Age \> 18 months
International Pancreatic Surgery Outcomes Study - PancreasGroup.Org

"Snapshot" study worldwide over 3 months in 2021. Provide a verified record of true morbidity and mortality. Identify modifiable predicting factors of outcome. Obtain PubMed citable co-authorship,

The PancreasGroup.org team is conducting a "snapshot" clinical study investigating the outcomes of pancreatic surgery worldwide. This "collaborative" model for snapshot clinical studies is a well-established approach for assessing current practice in a short period of time.

There will be 3 months of prospective enrolment and 3 months follow up within a 12-month frame. The study will provide highly valuable data on outcomes after pancreatic surgery.

The investigators are aiming at providing a verified record of true morbidity and mortality in consecutive unselected patients. This way the investigators will help identify relevant, modifiable predicting factors for outcome after pancreatic surgery.

Eligibility Criteria:
Inclusion Criteria:

* All indications (including benign and malignant)
* Open, laparoscopic or robotic.
* Elective or emergency.
* Partial or total pancreatectomies.
* Pancreatic tumour enucleations.
* Procedures with concomitant vascular or other organ resections.
* Pancreatic duct drainage procedures (e.g. Frey, Puestow, or Beger)
* Adults 18 years of age or older.

Exclusion Criteria:

* Pancreas or islet cell transplantation.
* Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife).
* Endoscopic (e.g. endoscopic retrograde cholangiopancreatography, stent or lithotripsy) procedures.
* Endoscopic transgastric and surgical necrosectomies excluded.
* Patients less than 18 years of age excluded.