cyrilzakka/clinical-trials huggingface dataset:
Study on Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia

The aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga.


Eligibility Criteria:
Inclusion Criteria:

Schizophrenia Subject

1. ICD (International Classification of Diseases) 10 diagnosis of schizophrenia
2. capacity to provide informed consent, as evaluated by the MacArthur Competence Assessment Tool for Clinical Research
3. no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning

Healthy volunteers:

1. Males and females between 18 and 45 years
2. Capacity to provide informed consent
3. absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning (MMSE above24)

Exclusion Criteria:

1. Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning
2. History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine)
3. Any Contraindication to MRI like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fMRI at NIMHANS)
4. Past history of head injury resulting in loss of consciousness or neurosurgery
5. Concomitant severe medical conditions
6. Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks
7. Pregnant or lactating -
Treatment of Advanced Head and Neck Cancer

This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and survival in patients with head and neck cancer who have failed standard therapy.

The major focus of the study will involve assessment of tumor response, patient survival, tolerance to drug, quality of life, depression, pain management and nutrition. During the study we will begin to study the kinetics of opioid growth factor (OGF) exogenous administration and the relationship between plasma OGF levels, stage of disease and length of treatment. Apart from potentially having growth inhibitory action on cancer, OGF may have some psychological and other biological effects which may prove to be beneficial in the patient's treatment. Presently there is no effective therapy or quality of life adjuvants for the 30,000 Americans who develop head and neck cancer yearly.

Eligibility Criteria:
Inclusion Criteria:

* Histologically and cytologically confirmed diagnosis of squamous cell carcinoma.
* Patients not amenable to curative treatments with further surgery and/or radiation.
* Patient has failed treatment with chemotherapy
* Lesions must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline.
* Karnofsky performance rating of at lest 50%.

Exclusion Criteria:

* Patients with severe and unstable cardiovascular disease.
* Treatment naive subjects will not be included for study.
* Patients with poorly controlled diabetes, seizure disorder, primary CNS tumors or known brain metastases will be excluded.
* Pregnant or nursing women.
* Patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible.
* Patients with a fever \> 37.8 degrees C.
* Pulse \< 60 or \> 110
* Systolic blood pressure \> 170 or less than 90 are not eligible.
* Patients with nasopharyngeal squamous cell carcinoma will be excluded
* Patients with hypercalcemia will be excluded from this study
Effects of Activity on Diabetes Risk Among Breast Cancer Survivors on Endocrine Therapy (ABIDE)

The aim of this study is to learn more about how physical activity and cardiorespiratory fitness are related to diabetes risk among breast cancer patients prescribed an endocrine therapy.

80 women between the ages of 18-80 years will be recruited for this study. The study design consists of two separate in-person visits to University of Colorado Anschutz Medical Campus or Colorado State University. The study consists of glucose testing, a body composition scan, exercise testing, and a two-week period of free living activity monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Female
* diagnosed with breast cancer
* age 18-80 years
* Completed surgery, chemo- and/or radiation therapy
* Prescribed aromatase inhibitor or SERM for at least one year from the time of screening

Exclusion Criteria:

* Age \< 18 or \> 80
* Type 1 diabetes
* Type 2 diabetes
* Prescribed anti-hyperglycemic medication, insulin, or sulfonylurea.
* Pregnant, breastfeeding or planning to become pregnant in next 2 months
* Have absolute contraindications to exercise testing which are:

  1. Unstable angina
  2. Recent myocardial infarction, cardiac surgery, or vascular surgery (\<3 months)
  3. Uncontrolled high blood pressure
  4. Heart failure
  5. Peripheral artery disease (based on report of symptomatic claudication)
  6. Hepatic or renal disease
  7. Severe arthritis or mobility impairment that would interfere with exercise testing
* Suspected cognitive impairment that would prevent understanding or comprehension of study procedures.
Retroview Colonoscope for the Evaluation of Colon Mucosa Study

Colonoscopy is the "gold standard" technique for diagnosis and treatment of colonic lesions. Moreover, high definition colonoscopes (HD) associated to digital chromoendoscopy had shown better results regarding adenoma and polyps detection when compared to standard non HD scopes. However, evidence shows that during standard colonoscopy many lesions could be missed, including polyps, cancer and other kind of lesions. This could be correlated to many factors and recently reports show evidence that lesions behind the folds could be missed because the limitation of a forward view examination. Until know, a new auxiliary imaging device called "Third Eye Retroscope" had demonstrated more lesions detection during colonoscopy using a retro view, but with some limitations as absence of HD vision, the need of additional equipment and the fact the device occupies the accessory channel, limiting therapeutic efficiency. Recently a new HD colonoscope called "RETROVIEW" (PENTAX Medical) has been developed. It permits visualization of colonic mucosa in forward view, in retroflex view and allows for performance of diagnostic and therapeutics in a single colonoscope.

Primary outcome:

To determine the safety and feasibility of the retro view during colonoscopy using RETROVIEW colonoscope. Safety was measured by the number of bleeding or perforation rates as adverse event during the procedure. Feasibility was measured by the number of cases that is possible to achieve a retroflexion in the colon Secondary outcome: withdrawal phase time and total procedure time.

Eligibility Criteria:
Inclusion Criteria:

* undergoing colonoscopy for colorectal neoplasia screening, for polyp surveillance, or for diagnostic workup including anemia, abdominal pain, constipation, abnormal imaging; and if they were able to understand and provide written consent for the procedure.

Exclusion Criteria:

* age \<18; pregnancy, included history of colon resection, known inflammatory bowel disease, polyposis syndrome, radiation therapy to abdomen or pelvis, suspicion of chronic stricture potentially precluding complete colonoscopy, presence of diverticulitis or toxic megacolon, hemophilia and concurrent enrollment in another clinical investigation.
The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure

Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase.

The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing.

This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.

The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.

Eligibility Criteria:
Inclusion Criteria:

For age between 18 and 65 years are the presence of acute anal fissure (with symptoms less than 6 weeks) following chronic diarrhea and subsequent fissure.

Exclusion Criteria:

* Recurrent fissure with skin appendage.
* Long history of constipation.
* Use of immunosuppressive drugs or corticosteroids.
* Inflammatory bowel disease such as Crohn's disease and ulcerative colitis.
* Pregnancy.
* Grade 3 and 4 hemorrhoids.
* Neurological disease.
* Obsessive-compulsive disorder.
* Previous history of anal surgery
* Skin diseases such as eczema and psoriasis.
* Sexually transmitted infections, tuberculosis.
* Mucosal prolapse.
* Anal fistula and pelvic radiotherapy.
Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis

It has been observed that there are insufficient studies on whether the conservative treatment of AIS with Chêneau spinal orthosis provides 3D correction on the scoliotic curve and its effect on the spine and lower extremity parameters. The aim of this study is to investigate the effect of Chêneau spinal orthosis application on sagittal and frontal parameters at 3 and 6 months follow-up in adolescent idiopathic scoliosis.

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine that is commonly seen in individuals aged 10-18 years, and spinal orthosis application, one of the conservative treatment methods, is widely preferred today. Lyon, Milwaukee, Gensingen, Boston and Rigo System Chêneau spinal orthoses are among the most frequently preferred today. Rigo system Chêneau (RCS) spinal orthosis aims to correct scoliosis in 3D in sagittal, transverse and coronal planes. Studies have indicated that spinal orthosis application may have limited corrective effect on sagittal and transverse planes scoliotic curvature. In order to obtain the most effective result in spinal orthosis application, it is important to fully understand the connection mechanisms between different planes and their relationship with the lower extremity. It has been observed that studies on whether conservative treatment of spinal orthosis in adolescent idiopathic scoliosis (AIS) can provide 3D correction on the scoliotic curve and its effect on spine and lower extremity parameters are insufficient. AIS individuals who will undergo Chêneau type spinal orthosis application that meets the inclusion criteria will be included in the study. Demographic information of the participants will be obtained with a patient information form and a scoliosis assessment form. Radiographs are planned to be obtained using an EOS (EOS-imaging®, Paris, France) imaging device, which is a low-dose imaging device that provides simultaneous anterior-posterior and lateral views while standing. Spine and lower extremity parameters will be evaluated from the obtained images. Plantar pressure and balance assessment is planned to be performed with a DIERS Pedoscan device connected to the DIERS Formetric system. SRS-22 (Scoliosis Research Society-22) questionnaire is planned to be used in the assessment of the quality of life of the individuals. Brace Questionnaire is planned to be used in the assessment of spinal orthosis satisfaction. All data will be evaluated by statistical analysis methods.

Eligibility Criteria:
Inclusion Criteria:

* 10-18 years old
* Cobb angle: 15-45°
* Individuals with AIS who will be using a Chêneau type spinal orthosis for the first time • Spinal orthosis recommended for at least 18 hours per day
* Risser ≤ 3

Exclusion Criteria:

* Using a foot orthosis
* Neurological problem
* Surgery history
* Lower extremity length difference greater than 1 cm
Effects of Omega-3 and Whey Protein Supplementation on Lean Mass in Older Adults

To evaluate the effect of omega-3 supplementation combined with whey protein intake on lean mass and strength gains in older adults performing resistance exercise. Participants will be randomized into the 4 groups. The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin. The omega 3 + placebo group will receive 4 g per day of fish oil and 40 g per day of maltodextrin. The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil. The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein. All will perform the same exercise protocol for 12 weeks


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (at least 1 year of menstrual interruption, self-reported);
* To be able to practice strength exercises;
* To be able to carry out supplementation;
* Do not present physical, orthopedic or cardiovascular complications that prevent the performance of physical exercises;
* No history of stroke or acute myocardial infarction;
* Not being a smoker and/or alcoholic;
* Do not perform hormone replacement therapy;
* Do not use anti-inflammatory drugs;
* To have normal kidney function;
* To submit a medical certificate of health that proves that the individual is able to perform exercises.

Exclusion Criteria:

* Do not provide the necessary information for the development of the study;
* Individuals with diseases previously diagnosed and undergoing treatment, such as type II diabetes mellitus, cancer, rheumatoid arthritis, high blood pressure, dyslipidemia, cardiovascular, and kidney and/or liver diseases.
Wells and Enteric Disease Transmission Trial (WET - Trial)

Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Child resides in Berks, Bucks, Chester, Lancaster, Lehigh, or Montgomery County in Pennsylvania
* Household is served by a private well
* Participant child is under the age of 5 (under 4 at time of enrollment), who is a full-time resident of the home and drinks untreated well water (75% or more of water consumption must be from untreated well water)
* Parent/guardian has access to a phone with texting capabilities

Exclusion Criteria:

* Child participant is immunocompromised
* Child participant has a chronic gastrointestinal condition
* Child takes daily oral steroids
* Household treats water before consumption (with the exception of water softeners)
Efficacy of Adding Lidocaine 10% to Phenol in Ultrasound Guided Superior Hypogastric Plexus Neurolysis in The Management of Pelvic Cancer Pain

The superior hypogastric plexus (SHP) is a complex nervous collection located at the lumbosacral region below the level of the aortic bifurcation at the level of the lower third of the fifth lumbar vertebral body and upper third of the first sacral vertebral body at the sacral promontory Neurolytic agents, such as alcohol and phenol have been used to ablate peripheral nerves to treat pain and spasticity . These agents were nonspecific for neuronal tissue and complications have been seen involving damage to surrounding soft tissue (skin, muscle, vascular) and pain on alcohol injection

Lidocaine has been demonstrated to be neurotoxic in high concentrations at 10% and can be used as a neurolytic agent with no effect on motor function, muscle state, or surrounding tissue rather than other neurolytic.

Every Patient will be in supine Trendelenburg position, IV access in case of adverse events and for moderate sedation if needed (for patient comfort, sever anxiety or needle phobia, or history of vagal events).

The procedure will be completed under aseptic precautions. The division of abdominal aorta into common iliac arteries will be identified by using longitudinal sonography (Lumify L12-4 Linear Array Transducer 12 to 4 MHz extended operating frequency range, 34mm footprint and aperture size, and scan depth of up to 12cm. Imaging modes include 2D, color Doppler, and M-mode), and the body of the fifth (5th) Lumbar vertebra will be identified by placing the transducer transversely. A skin wheal will be raised with subcutaneous infiltration with 2% lidocaine solution nearly 3-4 cm below the umbilicus. A 15-cm Long 22-G Chiba needle will be used with out of plane technique, and the needle will be advanced under USG-guidance to reach the anterior- most point of the fifth Lumber vertebral body avoiding the vascular structures. The needle will be withdrawn nearly 1-2 mm after hitting the vertebral body to avoid injecting the drug into the periosteum. After confirming a negative aspiration of blood, known amount of neurolytic agent according to the grouping will be injected for the neurolysis of superior hypogastric plexus. The uniform spread of the drug will be confirmed under real-time sonography. Vital Sign parameters will be recorded during and after the procedure, during which patients remained fully awake

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years old.
* Either genders.
* Cancer-related pelvic pain.
* American Society of Anesthesiologists Physical Status class I and II.
* Patients receiving opioids for pelvic cancer pain with visual analogue pain scale more than 4.
* BMI \< 30.

Exclusion Criteria:

* . patient refusal. local or systemic sepsis. Coagulopathy. unstable cardiovascular and respiratory diseases. previous neurological deficits, history of psychiatric disorders history of drug abuse distorted local anatomy. allergy to the used medications.
Intravitreal Aflibercept Injection in Vision Impairment Due to DME

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years with type 1 or 2 diabetes mellitus
* Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye
* Decrease in vision determined to be primarily the result of DME in the study eye
* BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye

Exclusion Criteria:

* Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
* More than 2 previous macular laser treatments in the study eye
* Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
* Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
* Active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
* Uncontrolled diabetes mellitus, as defined by HbA1c \> 12%
* Only 1 functional eye even if that eye is otherwise eligible for the study
Effects of Chios Mastiha Essential Oil on Cholesterol Levels of Healthy Volunteers

A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.

Background Chios Mastiha essential oil (CMO) is a natural product extracted from the resin of Mastiha, possessing antioxidant, anti-microbial, anti-ulcer,anti-neoplasmatic and cholesterol lowering capabilities in vitro, and its hypolipidemic effect was confirmed in animal studies. Yet, there are no randomized, placebo-controlled clinical studies in the literature regarding CMO's hypolipidemic effects in humans.

Design A prospective, randomized, placebo-controlled study was designed to study the hypolipidemic effect of CMO capsules on healthy volunteers with elevated cholesterol levels.

Methods 192 healthy volunteers were screened and eventually 160 of them with total cholesterol\> 200 mg/dl participated in the study. They were randomized with a 2:1 ratio of receiving CMO capsules (containing 200 mg mastiha oil per capsule) and placebo for a total of 8 weeks respectively. 113 patients received CMO and 47 were randomized in the control group, and all of them completed the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

- Increased total cholesterol \>200 mg/dl, in adult volunteers (≥18 years old) of any gender, not amenable or not willing to receive pharmaceutical therapy.

Exclusion Criteria:

* Participation in any other study during the recruitment period
* Contribution in the design or accomplishment of the study
* Known cardiovascular disease (coronary artery disease, carotid artery disease, peripheral vascular disease, stroke, diabetes mellitus, aortic aneurysm)
* Patients in high or very high risk of CVD according to SCORE2
* Subjects amenable to pharmaceutical lipid-lowering regimens according to current guideline, or any other pharmaceutical regimen with hypolipidemic effects