cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.
2. Weight ≥ 40 kg.
3. FEV1 ≥ 40% predicted and \< 100% predicted in the last 12 months.
4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.

Exclusion Criteria:

1. Severe or unstable CF at screening or Visit 1.
2. Any of the following values for laboratory tests at screening:

   1. A positive pregnancy test.
   2. Hemoglobin \< 10 g/dL in males and \< 9 g/dL in females.
   3. Neutrophils \< 1.0 x 10\^9 /L.
   4. Platelets \< 75 x 10\^9/L.
   5. Creatinine clearance \< 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
   6. Serum transaminases \> 2.5 x upper limit of normal.
3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars

The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.

To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.

P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.

I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).

C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.

Eligibility Criteria:
Inclusion Criteria:

1. Medically free children.
2. Age range from 4-7 years.
3. Presence of lower second primary molars with deep carious occlusal lesion.
4. No history of spontaneous pain (reversible pulpitis).
5. Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
6. Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.

Exclusion Criteria:

1. Uncooperative children.
2. Any unmet previous criterion.
Rapid, Minimally-invasive Voluntary Adult Male Circumcision

This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.

Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.

According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."

This quasi-experimental compares the open surgical technique to an alternative minimally-invasive technique using the disposable Unicirc device with tissue adhesive. The controls come from a separate randomized controlled trial (Unicirc 001) that was conducted just prior to the Unicirc 002 case series of 50 subjects. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.

Eligibility Criteria:
Inclusion Criteria:

Healthy men at least 18 years of age requesting circumcision

No anatomical penile abnormalities or infections

Able to provide informed consent to participate

Willing to participate in follow-up visits -

Exclusion Criteria:

Current illness

Penile abnormality or infection which contraindicates or would complicate circumcision

History of bleeding disorder

Past reaction to local anesthetic

-
Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke

This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight).

Improve walking ability in people after stroke is a key objective for rehabilitation. Once the rehabilitation period is finished, a reduction of functional and motor abilities is often observed in subjects when they returned home.

This study will examine if loading daily the non paretic leg with additional weights will improve walking abilities. This study will enroll 100 people who had a stroke \> three months and \< five years and who still experienced difficulties for walking.

Each patient will receive 3 months of intervention targeting their non affected leg. Half of the subjects will have to wear braces with additional weights at the non affected ankle during the day ( \> 6 hours), while the other half will wear a similar brace but without weight.

A six minutes walking test will be given before and after the intervention, as well six and twelve months later to measure the effect of these interventions. The investigators hypothesize that people receiving the additional weights to the non paretic leg will show greater improvements in their walk abilities.

Eligibility Criteria:
Inclusion Criteria:

* Hemiparesis following ischemic or hemorrhagic infarct of a single hemisphere
* First episode of stroke experienced \> 3 months and \< 5 years prior to study enrolment
* Functional Ambulation Categories (FAC) score \> 3 \< 8
* Be able to walk few meters without physical assistance
* Able to understand and follow instructions

Exclusion Criteria:

* Following inpatient physical rehabilitation
* Experienced more than 2 falls during 3 months prior inclusion
* Signs of bilateral impairments
* Daily use of a wheelchair to move
* Contra-indications for daily walk
* Currently participating in any clinical trial with a experimental walking intervention
* Severe arthrosis
* Dementia
Thyroid Disorders in Malaysia: A Nationwide Multicentre Study

This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. The study will also look at genetic susceptibility for autoimmune thyroid disorders in the Malaysian population

General hypotheses:

The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population There are different susceptibility gene for autoimmune thyroid disorder in different ethnicity in our population

This will be a cross-sectional population based study involving Malaysian adults (aged 18 year old and above). Cluster sampling will be used to select respondents that will be representative of the Malaysian population. Selected respondent will be interviewed, anthropometric measurement taken, blood and urine sample taken.

Blood will be analyzed for thyroid function (thyroxine, triiodothyronine and thyroid stimulating hormone), autoantibodies (anti-thyroperoxidase and anti-thyroglobulin). Urine will be analyzed for urinary iodine.

Those diagnosed with autoimmune thyroid disorders with strong family history of thyroid disorders (multiplex multi-generation family involvement) will have their blood sent for whole exome sequencing and linkage analysis done to identify possible susceptible gene for autoimmune thyroid disorders

Respondents detected to have hypo- or hyper- and subclinical hypo- or hyperthyroidism will be referred to their nearest health centre for further evaluation and treatment appropriate for their condition.

Eligibility Criteria:
Inclusion Criteria:

* Aged equal or more than 18 years old at the time of sampling
* Malaysian citizen

Exclusion Criteria:

* Respondents who did not give consent
Effect of Disinfective Solution as an Adjunct to Maintenance Therapy of Inflamed Periodontal Pockets

This study will determine whether the supplemental use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation.

The purpose of this study is to determine whether the adjunctive use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to scaling and root planing alone. The chemical pocket disinfection therapy consists of delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to the test site. Pro-inflammatory interleukin-1 beta and anti-inflammatory interleukin-1 receptor antagonist will be measured from the gingival crevicular fluid sampled from sites of interest.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing

Exclusion Criteria:

* Uncontrolled diabetics
* Regular users of nonsteroidal antiinflammatory drugs
* Individuals on anti-coagulants
* Individuals that have used antibiotics in the previous 3 months or require prophylactic antibiotic coverage
* Pregnant individuals
To Determine the Feasibility of a Fidaxomicin Study in Neonates and to Assess C. Difficile (Clostridium Difficile) Involvement in the Pathogenesis

The objective of this multi-center, prospective observational study is to determine the feasibility of a potential interventional study with fidaxomicin. The incidence and clinical aspects of Clostridium difficile infection (CDI) in neonates will be determined, and it will be assessed whether a subgroup can be identified where treatment with fidaxomicin therapy might improve outcome.


Eligibility Criteria:
Inclusion Criteria:

* Subject is suffering from diarrhea or other signs or symptoms consistent with CDAD (as described in section 5.2.3)
* Presence of either toxin A or B (or both) of C. difficile in the stool within 24 hours prior to enrollment using the C. difficile Quik Chek Complete® diagnostic test, provided by the sponsor

Exclusion Criteria:

Subject will be excluded from participation if any of the following apply:

* Preterm neonates
* Negative C. difficile toxin test
Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke

The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.

Many people with stroke experience a deterioration in balance and a functional decline due to hemiplegic muscle strength. This tend to restrict the persons activity in daily life and also leads to a low falls self efficacy.

High intensity exercise have shown to be effective for improving strength and balance for older people in general living in residential care facilities. It is interesting to see if this high intensity exercise also is applicable in the older stroke population.

Comparison: An intervention group receives three training sessions per week and one theory session per week during 5 weeks, compared to a control group that receives one theory session per week during 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* stroke diagnosis 3-6 months prior to inclusion
* ability to walk 10 meter with or without assistive device
* ability to understand simple instructions

Exclusion Criteria:

* TIA
* independent in walking outdoors
* serious visual impairment
* serious hearing impairment
* long distance to intervention station
Addressing Barriers to Physical Activity in Inner-City Schoolchildren With Asthma

This proposal will address the existent gaps in the literature by identifying barriers and facilitators to participation in physical activity in inner-city minority elementary schoolchildren with asthma, more that half of whom are also overweight; developing and refining a school-based intervention in partnership with the community to improve physical activity; and conducting a pilot randomized controlled trial of the intervention to determine feasibility and obtain preliminary data for a future large-scale trial.

Four schools have been recruited for pilot wait-listed cluster randomized clinical trial to determine feasibility for a large-scaled trial. Community-based participatory research approach was utilized to develop an intervention that will be delivered to two schools. Two control schools will receive intervention during year 2 of the study.

Eligibility Criteria:
Inclusion Criteria:

* children with active asthma attending 2nd-4th grades in Bronx

Exclusion Criteria:

* other medical conditions preventing participation in physical activity
Gatekeeper European 005

Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
* Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent

Exclusion Criteria:

* Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
* Developed other medical illness that may cause the subject to be non-compliant
* Extensive Barrett's Esophagus (\>2 cm)
* Unable or unwilling to cooperate with the study procedures
Fast Track Laparoscopic Surgery: A Better Option for Treating Colorectal Cancer Than Conventional Laparoscopic Surgery

To compare the outcomes of fast track laparoscopic surgery and conventional laparoscopic surgery.

Method: This study is a blinded randomized trial. 70 patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation. Outcome measures, length of hospital stay, postoperative surgical stress response (C reactive protein) and postoperative complications will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤75 years
* Good nutrition
* no systemic infection
* Elective laparoscopic surgery

Exclusion Criteria:

* Age \>75 years
* Malnutrition or an organ system infection
* Associated with obstruction, bleeding, emergency surgery or surgical intervention
* Tumor with extensive metastasis
* Before operation patient was fasting, underwent gastrointestinal decompression and received nutritional support
* Previous history of abdominal surgery
* Patient had previously undergone gastrostomy
Postoperative Pain Control & Relief in Neonates

Pain control for newborns has made significant improvements over the last 30 years. The use of narcotics remains the standard of care for neonates undergoing minor and major surgeries. Narcotics, however, are associated with adverse effects such as respiratory depression, prolonged intubation and withdrawal symptoms. Acetaminophen (Tylenol©) has been proposed as an adjunct to reduce narcotic use but current evidence from well designed studies in newborns and premature infants is limited. This study will randomly assign neonates undergoing a surgery to either morphine plus acetaminophen or morphine alone for pain control. The subjects will be followed for 72 hours after the operation and evaluate the benefits of acetaminophen for pain control.


Eligibility Criteria:
Inclusion Criteria:

* All neonates ≥ 28 weeks of gestation and \<44 weeks of gestation undergoing general surgery procedures (below) and managed postoperatively in the Neonatal Intensive Care Unit (NICU).

Minor procedures Inguinal hernia repair Laparoscopic or open gastrostomy tube placement Peritoneal drain placement for spontaneous intestinal perforation Gastroschisis bedside patch closure

Major procedures Laparoscopic or open Nissen fundoplication, duodenal atresia repair, Hirschsprung pull through, Ladd's procedure or excision of abdominal cyst Thoracoscopy or thoracotomy procedure Enterostomy or colostomy creation Exploratory laparotomy Revision or closure of enterostomy or colostomy Any Gastroschisis or omphalocele repair in operating room Repair or staged repair of congenital anorectal malformations Resection of sacrococcygeal teratoma

Exclusion Criteria:

* Any infant admitted with preoperative diagnosis of neonatal abstinence syndrome (NAS) or known intrauterine opiate exposure
* Any diagnosis of hepatitis exclusive of TPN-related biliary cholestasis
* Renal disease with creatinine \>2.0 mg/dl at enrollment
* Intraventricular hemorrhage grade 3 or greater, or cerebellar hemorrhage
* Any patient with myotonic dystrophy or other congenital disease limiting validity of pain scoring
* Opiate exposure within 14 days of operative procedure
* Non-English-speaking parents/guardians
Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol

compare the effectiveness and safety of the progestin primed ovarian stimulation (PPOS) protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy

Infertility treatments have evolved significantly over the past few decades, with various protocols being developed to optimize ovarian stimulation in assisted reproductive technology (ART). Among these protocols, the progestin-primed ovarian stimulation (PPOS) and the antagonist protocols have gained prominence, especially in hyper-responders who are scheduled for a freeze-all policy. Hyper-responders are patients who produce an excessive number of eggs in response to ovarian stimulation, which increases the risk of ovarian hyperstimulation syndrome (OHSS), a potentially severe complication .

The PPOS protocol involves the administration of progestins to suppress the premature luteinizing hormone (LH) surge during ovarian stimulation, thereby providing a controlled environment for follicle development. This method has been found to be effective in reducing the risk of OHSS and improving clinical outcomes . On the other hand, the antagonist protocol employs gonadotropin-releasing hormone (GnRH) antagonists to prevent the LH surge, offering a more immediate suppression compared to progestins .

A freeze-all policy, where all viable embryos are frozen for future use rather than being transferred immediately, is often recommended for hyper-responders to further minimize the risk of OHSS . This approach allows for the transfer of embryos in a more physiologically normal uterine environment, potentially improving implantation rates and pregnancy outcomes .

This study aims to compare the effectiveness and safety of the PPOS protocol versus the antagonist protocol in hyper-responder patients scheduled for a freeze-all policy. By examining outcomes such as the number of retrieved oocytes, incidence of OHSS, and pregnancy rates, this research seeks to provide insights into the optimal ovarian stimulation strategy for this specific patient population.

Eligibility Criteria:
Inclusion Criteria:

• All hyper responder patients according to Olivera equation for overian response peridiction index

Exclusion Criteria:

* All normal and poor responder patients according to Olivera equation for overian response peridiction index.
* Sever male factor infertility
A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin

The purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study to investigate the effect of steady-state TMC278 on the single dose pharmacokinetics of digoxin. The study consists of 3 phases, including screening phase, treatment phase, and follow-up phase. After the screening phase, participants will be randomized to one of 2 treatment sequences consisting of Treatments A and B, ie, Sequence AB (11 participants), and Sequence BA (11 participants). Treatment phase includes, Treatment A: digoxin 0.5 mg (single oral dose), and Treatment B: TMC278 25 mg once daily with digoxin 0.5 mg (single oral dose). The 2 consecutive sequences will be separated by a washout period (period when receiving no treatment) of at least 14 days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiograms, cardiac telemetry, vital signs, physical examination, alcohol breath test, and specific toxicities will be monitored throughout the study.The study duration for treatment phase will be at least 26 days.

Eligibility Criteria:
Inclusion Criteria:

* Women must be postmenopausal for at least 2 years, or be surgically sterile
* Men must agree to use a highly effective method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study medication

Exclusion Criteria:

* A positive HIV-1 or HIV-2 test at screening
* Hepatitis A, B or C infection at screening
* History of clinically relevant heart rhythm disturbances
* History of idiopathic hypertrophic subaortic stenosis, atrioventricular block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death