cyrilzakka/clinical-trials huggingface dataset:
Medial Retinacular Plication Versus Medial Patellofemoral Ligament Reconstruction for Recurrent Patellar Instability

The purpose of this study is to determine whether medial patellofemoral ligament reconstruction results in superior functional outcomes compared to medial retinacular plication surgery in cases of recurrent patellar instability.

Patients with recurrent lateral patellar instability will be assigned to undergo one of two surgical approaches aimed to prevent recurrent patellar instability and result in improvement in function. One surgical approach will be medial retinacular plication with multiple stitches while the other surgical approach will include medial patellofemoral ligament reconstruction using a hamstring tendon graft. Prior to surgery, and then during follow-up after surgery as well as at the completion of minimum two years follow-up after surgery, patients will be asked to complete subjective functional questionaires that will rate their knee function, and to undergo detailed physical examination and objective functional tests that will quantify the success of surgery. The outcomes of the surgical treatment options will be compared to determine whether medial patellofemoral ligament reconstruction results in superior function and patient subjective satisfaction compared to medial retinacular plication only.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent lateral patellar instability has been described by the patient

Imaging criteria include:

* TT-TG distance (on CT or MRI) is between 10-20 mm
* Insall-Salvati Index is between 0.9 - 1.2
* Trochlea angle is lower than 145 degrees

Exclusion Criteria:

* Only a single event of lateral patellar instability occured

Imaging criteria include:

* TT-TG distance (on CT or MRI) is below 10 mm or above 20 mm
* Insall-Salvati Index is below 0.9 or above 1.2
* Trochlea angle is above 145 degrees
* Other concomitant intra-articular patholgies, injuries, and surgeries, besides the patella instability, with were recorded at the lower limbs and did not uneventfuly healed, and as a result cause dysfunction of the lower limbs
* Significant ligamentous injuries of the knees, including cruciate and collateral injuries, as well as meniscal injuries that interfere with function
B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis

This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.


Eligibility Criteria:
Inclusion Criteria:

Patients are diagnosed with IBS. IBS was diagnosed based on the Rome IV criteria. Subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included.

Exclusion Criteria:

Subjects who are taking any probiotics, PPIs, antibiotics or any drugs affecting uric acid levels for at least one month before the study.

Subjects who decline to participate into the study.
Otago Exercise Program Combined With Action Observation Training in Stroke Patients

Stroke is one of the main causes of adult disability worldwide and global health problem. Due to ongoing neurological sequelae post stroke patients have a two-fold higher risk of falling than other people with same age or gender. As the stroke patients, balance is impaired and can lead to complications such as fall. Promising interventions that could be beneficial to improve the aspects of gait and balance include Otago exercises and Action observation training. The objective of this study is to determine the effects of Otago exercise combined with Action observation (AO) training on the balance, gait and functional activities in post stroke patients.

A double-blinded randomized control trial will be conducted at Rehabilitation centers, outpatient clinics, and Hospitals for ten months. The sample size will consist of 60 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. Participants will be randomly assigned into two groups: 30 to action observation (AO) training plus Otago exercise group (n= 30) and 30 to Otago exercise group (n= 30). The AO plus Otago and Otago groups will be performed 35 to 40 minutes of strength training and balance exercises from the Otago Exercise Program 3 times a week for 12 weeks. Data will be collected through various assessment tools including Berg Balance Scale (for balance), Dynamic gait index (for gait) and Functional Independence Measure (for functional activities). The effects of the interventions will be measured at pre-treatment and post-intervention. Paired t-test will be adopted to find the statistical difference within the groups and independent t-test will be applied to find the statistical difference between the groups. Data analysis will be performed by using SPSS 26 software.


Eligibility Criteria:
Inclusion Criteria:

Participants fulfilling given criteria will be included in this study

* Both male and female participants will be included
* The age limit for the participants will be 40-65 years
* Sub-acute and chronic ischemic stroke up to 2 years.
* Participants with BBS score between 35-40.
* Participants having Montreal Cognitive Assessment (MoCA) score greater than 24 (out of 30).
* Participants can walk with or without assistance.

Exclusion Criteria:

Participants having given criteria will be excluded from this study

* Participants with other neurological diseases.
* Participants who will not be able to understand the informed consent form.
* Participants already involved in an exercise program for fall prevention.
* Participants have no visual field defect, no abnormality in the vestibular organs, no orthopedic disease, and an unrestricted range of motion.
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2

The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes


Eligibility Criteria:
Inclusion Criteria:

* Adult, Immunocompetent men and women in good health of any ethnic group
* History of recurrent episodes of genital herpes for at least 12 months
* Seropositive for Herpes Simplex Virus HSV Type 2
* Body Mass Index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

* Present episode of genital herpes
* Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial
* Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial
* Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)
A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer

This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in combination.


Eligibility Criteria:
Inclusion Criteria:

* Patient is currently enrolled in the ELONA clinical study (ONA-XR-103) and receiving onapristone or elacestrant, either alone or in combination.
* Patient is currently benefiting from the treatment in the ELONA clinical study, as determined by the investigator.
* Patient currently has no evidence of progressive disease, as determined by the investigator.

Exclusion Criteria:

* Pregnant or nursing (lactating) women.
* Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.
Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

The purpose of this investigation is to determine the effects of Rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Negative serum pregnancy test (for women of child bearing age)
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
* IgG \& IgM levels within normal limits
* Adequate renal function as indicated by serum creatinine measurements.
* No previous biological use (investigational or approved) except for the three approved anti-TNF alpha therapies
* Patients who have been treated with anti-TNF alpha therapies must be off of infliximab and adalimumab for two months before study entry and off of etanercept for one month before study entry
* No use of phosphodiesterase type 5 inhibitors (PDE5) (i.e. Sildenafil, Tadalafil, and Vardenafil) 1 week prior to the study and during the course of the study.
* SBP ≤ 140/90 for two months prior to study enrollment

Exclusion Criteria:

* Prior history of MI, CVA, CABG, PTCA, or peripheral vascular disease
* Any serious concomitant medical condition that could interfere with the study.
* Patients with insulin dependent diabetes
* Failure to provide written consent.
* Individuals with HIV infections
* SBP \> 140/90 at two months prior to study enrollment
EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA

Purpose: The present research was conducted to study the effect of treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia.

Subjects and Methods: Forty children with acute lymphoblastic leukemia included in the current research ranged of age from 8 to 12 years. The children participated in this study were assigned randomly into two equal number groups (A and B). Group (A) includes 20 children who received balance exercises, while group (B) includes 20 children who received the same balance exercises of group (A) and treadmill training. The treatment program was applied three sessions per week (60 min for every session) for 8 weeks. Balance Master System and Biodex Balance System were used to evaluate balance of all children in the three groups before and after the treatment program.

The current research is a randomized control trial to differentiate between the treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia. Chemotherapy induced peripheral neuropathy is related to the intensity of treatment and dosage of chemotherapy which could affect the severity of its symptoms, it could result in serious problems like sensory changes and numbness , in case the sensory nerves were affected , muscle weakness and in-coordination in case the affected were the motor nerves. In addition to the psychological problems the patient experience as a result of CIPN, the patient also experience physical problems like injuries, fear of fall results from lack of sensory perception and muscle power. Treadmill training, motor training may favor proprioceptive feedback, leading to adjustments for adequate postural balance and functional performance. Treadmill exercises stimulate the kinetic, kinematic, and temporal features of walking. These exercises improve the strength of the muscles of the lower extremities, enhance motor learning, improve functional abilities, and activate the locomotor control system

Eligibility Criteria:
Inclusion Criteria:

* able to recognize commands given to them,
* understand our verbal command and encouragement,
* and stand and walk independently without repeated falling

Exclusion Criteria:

* Children with impairment of sensation or
* other neurological or psychological problems,
* tightness and/or fixed deformity of lower limbs,
* any neurological, musculoskeletal, or mobility disorders,
* cardiac anomalies,
* vision or hearing loss
Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a clinical diagnosis of moderate to severe interdigital tinea pedis, as defined by a Physician's Global Assessment (PGA) score of 2 or 3 on both feet, and moderate to severe tinea cruris, as defined by a PGA score of 2 or 3
* Participants with a mycological diagnosis of tinea pedis and tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount
* Participants must be in good general health and free of any disease that might interfere with study evaluations
* Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study

Exclusion Criteria:

* Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial
* Participants who are immunocompromised
* Participants who have a recent history of or currently known drug or alcohol abuse
* Participants with a history of intolerance or hypersensitivity to imidazole compounds, proton pump inhibitors, or the inactive components of luliconazole cream 1% or omeprazole
* Participants with a life-threatening condition within the last 6 months
* Participants with uncontrolled diabetes mellitus
* Participants who are unable to communicate or cooperate with the Investigator
* Participants using medications for treatment of tinea pedis and/or tinea cruris (see Investigator for length of time prior to study start)
* Participants receiving concomitant drugs that are known to inhibit and/or induce CYP2C19 and/or CYP3A4, or that interact with omeprazole
* Because of the potential for drug interaction with luliconazole, administration with medications that are known to be substrates of CYP3A4, CYP2B6, CYP2C8, and CYP2C19 should be carefully monitored
Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)

Comparing different method of surgical technique D2 lymph node dissection vs D3 for right colon cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Agreement of the patient to participate in trial
2. Colon cancer (only adenocarcinoma )
3. The tumor located between the cecum and the right 1/3 of transverse colon
4. Tumors T3,Т4а,b N0-2 (II-III stages)
5. Tolerance of chemotherapy
6. ECOG 0-2

Exclusion Criteria:

1. Patients with distant metastases
2. Tumors T1-2 (I stage)
3. Complications of tumor (perforation and full bowel obstruction)
4. Previous radiotherapy or chemotherapy
5. Synchronous or metachronous tumors
6. Women during Pregnancy or breast feeding period
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Sulfonylurea in Type 2 Diabetic Patients

This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and sulfonylurea in patients with diabetes mellitus.

This study is to evaluate the efficacy and safety of ASP1941 in combination with sulfonylurea in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with sulfonylurea alone. The effects of ASP1941 are compared with those of placebo. Double blind period continues for 24 weeks followed by open period in each patient.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients receiving with sulfonylurea mono-therapy for at least 4 weeks
* HbA1c value between 7.0 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
Nerve Conduction Block Using Transcutaneous Electrical Currents

The purpose of this study is to determine whether the transcutaneous application of unmodulated high frequency alternating currents could produce a quickly conduction block of peripheral nerve.

In the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 KHz can cause a peripheral nerve block. However electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents).

It has show that the diameter of the nerve it is related with the frequency to produce the conduction block. For this reason the investigators decided to applied 20KHz to observe the effects on maximal manual force and to compare versus sham stimulation.

Only one study has applied 5KHz on experimental pain and they have demonstrated changes in somatosensory thresholds.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351

The purpose of this study is to evaluate efficacy and safety of CKD-351.

Multi center, Randomized, Double-blind, Active controlled, Parallel design, Phase 3 trial to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients.

Eligibility Criteria:
Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects with IOP(Intraocular Pressure) ≥35 mmHg at Visit 1 and Visit 2 (AM 09:00) at more than one eye
2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 2
3. Subjects who were diagnosed as below with monocular or both eye

   * Acute or Chronic Closed-Angle Glaucoma
   * Secondary Glaucoma
   * Pseudoexfoliation Glaucoma
   * Neovascular Glaucoma
   * Aphakia
   * Phacocyst capsular torn intraocular lens
4. Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation ≥ -25dB)
5. Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
6. Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
7. Subjects who have medical history following

   * Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery
   * Subjects who received topical or systemic steroids within the last 1 months
8. Subjects who wore need to wear contact lenses during the study
9. Women who are nursing, pregnant or planning pregnancy during the study
10. Subjects with bronchial asthma or history
11. Subjects with severe renal impairment (creatinine clearance \<30 ml / min at screening) or hyperchloremic acidosis
12. Subjects who have received any other investigational product within 1 month prior to randomization
13. Impossible subjects who participate in clinical trial by investigator's decision
Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer

RATIONALE: Implant radiation therapy delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying the side effects and how well implant radiation therapy using radioactive iodine works in treating patients with localized prostate cancer.

OBJECTIVES:

* To determine the efficacy of permanent brachytherapy with iodine I 125 seeds in patients with localized prostate cancer.
* To determine the safety of this therapy in these patients.

OUTLINE: This is a multicenter study.

Patients undergo permanent brachytherapy seed implantation comprised of iodine I 125 into the prostate. Some patients may receive combination treatment (e.g., external beam radiation therapy (EBRT) or hormone therapy in addition to brachytherapy).

Quality of life and the International Prostate Symptom Score (IPSS) is assessed and compared.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinically and histologically confirmed localized prostate cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior or concurrent surgery
* No prior or concurrent radiotherapy
* Prior chemotherapy, hormonal therapy, and biologic therapy allowed