cyrilzakka/clinical-trials huggingface dataset:
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects

The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of off-treatment recovery.

This is a randomized, double-blind, placebo-controlled, single-site study in healthy overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and topiramate \[PHEN/TPM\] extended-release capsule) will be administered daily as follows:

* Days 1-3: PHEN/TPM 3.75 mg /23 mg
* Days 4-6: PHEN/TPM 7.5 mg /46 mg
* Days 7-9: PHEN/TPM 11.25 mg /69 mg
* Days 10-28: PHEN/TPM 15 mg /92 mg

A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be administered intravenously on three separate occasions.

The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom will have overnight stays on 3 separate occasions.

Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4 weeks post treatment follow up).

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female 18 - 65 years of age, medically healthy with no clinically significant screening abnormalities
* BMI of ≥27 to ≤45 kg/m2
* No use of any medication (prescription, over the counter (OTC) or herbal preparations) with the exception of contraception for the entirety of the study

Key Exclusion Criteria:

* Allergy or hypersensitivity to radio contrast media, iodine or shellfish
* Plans to significantly alter their diet through fasting, very low caloric intake, elimination of certain foods (gluten, milk, meat, etc.) or similar
* Plans to undertake a significant change to physical exercise levels (i.e., initiate training for a marathon) during the study period
* Consumption of a high protein diet or protein/body building meal supplementation and/or replacement. The use of any product containing creatine is strictly prohibited
* History of glaucoma or increased intraocular pressure
* History of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression, current depression of moderate or greater severity, presence or history of suicidal behavior or ideation with some intent to act on it
* Cholelithiasis (gallstones) within the past 6 months
* History of nephrolithiasis (kidney stones)
* Evidence of any clinically significant renal, pulmonary, hepatic, psychiatric or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations or confound the interpretation of study results as determined by the investigator
* Current use of any tobacco products including cigarettes, cigars, pipes, and chewing tobacco, or nicotine replacement products (e.g., patch, gum, lozenge, etc.), or chronic use within the previous three months prior to screening
Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx

The purpose of this study is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.

The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of fallopian tubes with hydrosalpinx, will be done using a 4 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected.

All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

Hysterosalpingography will be done for all patients 0ne and 3 months postinjection to confirm tubal occlusion prior to IVF.

Eligibility Criteria:
Inclusion Criteria:

Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared for IVF.

Exclusion Criteria:

1. Acute Pelvic inflammatory disease.
2. Intra uterine pathology
Prognostic Value of Circulating Tumor DNA Dosing in Patients in Neoadjuvant Breast Neoplasia

This is a cohort, single-center, prospective study that seeks to analyze the circulating tumor DNA (ctDNA) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.

Breast cancer is a major public health problem, being the most common cancer in women worldwide. Breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. However, accurate assessment and prediction of the response is a major challenge. Circulating tumor DNA (ctDNA) has shown promise in the detection of breast cancer and clinical and cancer outcomes.

This study aims to evaluate a possible correlations between ctDNA levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer.

In order to start ctDNA surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.

Eligibility Criteria:
Inclusion Criteria:

* Information to the patient and signed informed consent;
* Locally advanced breast cancer that is a candidate for neoadjuvant therapy;
* Histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of HER-2.

Exclusion Criteria:

* Metastatic breast cancer (Stage IV);
* Additional invasive malignant disease;
* Known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements;
* Presents any organic condition that makes it impossible to carry out chemotherapy treatment;
* Pregnant or lactating women
* Received previous treatment for breast cancer.
Gait Retraining to Reduce Knee Osteoarthritis Pain

The purpose of this study is to determine how well people can be trained to produce new and different movements through the use of haptic feedback. One particular application is retraining individuals to walk differently in order to reduce knee joint loads to prevent or treat knee osteoarthritis as an alternative to surgical treatments.

During the movement retraining session, you be given different combinations of haptic, visual, and auditory feedback in order to inform you on desired movement changes. This will take place at the Human Performance Laboratory at Stanford University. Motion analysis will be done while you perform movement activities (such as locomotion).

Prior to performing these movement tasks the investigators will attach reflective markers to your body using tape, pre-wrap and/or ace bandages. The investigators will record motion of your body's movements using infrared cameras which capture anatomical data from the reflective markers on your body.

The investigators will provide you with feedback to inform you of desired movement modifications. Haptic feedback devices such as vibration motors and skin stretch devices will be attached to your body via velcro straps and will be used to give "touch" feedback. There will be a computer monitor in front of you during testing to provide visual feedback. Sounds will be played using speakers near the testing area to provide auditory feedback.

The time needed for set up and performance of the above set of tests is approximately 90 minutes. You will be performing walking and other movements for only a small part of that time. The rest of the time will be spent preparing you for the experiment. After the investigators examine your movement data, if some of the data appear inaccurate or the investigators are unable to process the data, the investigators may ask you to repeat the movement analysis at a later time.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of medial compartment pain during the previous 6 weeks
* Radiographic evidence (AP X-ray) of medial compartment knee osteoarthritis (KL score of 3 or less)
* Ability to walk unaided for 25 minutes without rest
* Age \> 18

Exclusion Criteria:

* BMI \> 30
* Previous injury or surgery on foot, ankle, knee, hip, or back inhibiting ability to adopt different walking gait
* Use of shoe insert or hinged knee brace
* Corticosteroid injection within the previous 6 weeks
* Age \> 80
The Effect of Preemptive Levator Ani Injections on Pain After Pelvic Reconstructive Surgery

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive bilateral trans-vaginal pelvic floor muscle injections with bupivacaine or no injection (standard of care) as a part of their surgical pain control

Patients undergoing vaginal pelvic reconstructive surgery for pelvic organ prolapse (POP) under general anesthesia will be randomized to receive:

1. Bilateral trans- vaginal pelvic floor levator ani muscle injections (trigger point injections) with bupivacaine:

   - 0.5% bupivacaine will be injected at several sites for a total of 5ml on each side of the pelvic floor, with each injection site no more than 1 ml (Bupivacaine was chosen by the study team because of it has a longer half life then other common local anesthetics. We plan to use the same anesthetic and dosage to standardize the protocol between patients. Other local anesthetics will not be used in addition to the bupivacaine administered for research purposes. We will limit the amount of intravenous lidocaine to less than 5mg/ kg).
2. Control- No additional treatment (standard of care).

The patient will be blinded to their randomization (single blind). The post-operative pain regimen will be standardized when possible. Patients will receive a regimen of IV and oral narcotics and Ketorolac per our routine post-operative protocol. On discharge from the hospital, patients will be given prescriptions for a standard amount of oral narcotic, 20 tablets of oxycodone (150 morphine equivalents), and 30 tablets of 600mg ibuprofen.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Able to read English and give informed consent
* Undergoing VAGINAL pelvic reconstructive surgery for POP

Exclusion Criteria:

* Hypersensitivity or allergy to amide anesthetics
* Documented chronic pain condition

  o (back pain, pelvic pain, fibromyalgia, etc.)
* Bleeding disorder
* Connective tissue disorder
* Neuromuscular disorder
* Cardiac conduction abnormality or channelopathy
* Hepatic Impairment
* Renal Impairment
* History of, or current, narcotic or alcohol dependence
* History of pelvic radiation or gynecologic malignancy
Ergonomic Considerations on Musculoskeletal Disorders and Posture in Software Developers.

The human and computer interface is becoming increasingly intuitive, but for the inexperienced user still poses formidable problems. Musculoskeletal symptoms of VDU users are believed to have a multifactorial aetiology. Software developers don't have knowledge of ergonomic principles. Faulty postures had an effect on posture.

Data will be collected from software developer companies in Lahore at questionnaire include demographic data and data collection tools. The software developer will be guided about basic ergonomic principles and data will be collected at the start of the study and in 2 stages with a 2-week interval. A quasi-experiment study will be used. The sample size will be323 (margin of error 5%, confidence level 95%, population size 2000, and dist. 50%) by Rao software. A convenient sampling technique will be used. Data will be analyzed using SPSS 21 by comparing mean and correlating variables

Eligibility Criteria:
Inclusion Criteria:

* Software engineers who have experience of more than 2 years, in the same company.
* Software engineers with the age less than 40 years and both gender.

Exclusion Criteria:

* Software engineers who had a past history of spine surgery or diseases in the Spine like disc prolapse, discitis, arthritis etc.
* Orthopedically physically challenged
* Pregnant women.
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence

The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment.

The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to provide informed consent
* Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
* Available to present for weekly treatments
* Available for follow-up at 3, 6, and 12 months

Exclusion Criteria:

1. Severe cardiopulmonary disease
2. Lesion of the Tibial Nerve
3. Use of a cardiac pacemaker or implantable defibrillator
4. History of inflammatory bowel disease
5. Active anal fissure, fistula, or abscess
6. Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy
7. Has a sphincter injury that needs sphincteroplasty
8. Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter
9. Severe distal venous insufficiency
10. Uncontrolled diabetes with peripheral nerve involvement
11. Immunosuppression
12. Pregnant or planning on becoming pregnant during treatment
13. Patients prone to bleeding
Market Research - Acceptability Study for New MCT Fat Products

This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy requiring a ketogenic or a specialist diet as part of their treatment.
* Subjects new to taking or who are already taking an MCT product and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between each new product trialled.
* Those patients who have been taking MCT in their diet should do so for a minimum of 4 weeks before commencement of the study.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from patient or parental caregiver.

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study
* Patients already on and MCT product who have been taking it in their diet for less than 4 weeks
* Patients less than 3 years of age
* Patients over 20 years.
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)

Eligibility Criteria:
Inclusion Criteria:

* Preoperative Inclusion Criteria

  1. Subject has provided informed consent
  2. Subject is ≥18 years of age (at the time of consent)
  3. Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal mesh placement

Exclusion Criteria:

* Preoperative Exclusion Criteria

  1. BMI \> 45 kg/m2
  2. Subject is undergoing emergency surgery
  3. Subject is pregnant or planning to become pregnant during study participation period
  4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
  5. Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
  6. The subject has participated in another investigational drug or device research study within 30 days of enrollment
  7. Subject has a parastomal hernia
* Intra-operative Exclusion Criteria

  1. Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
  2. Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
  3. Surgeon is unable to completely remove existing mesh from prior surgery
  4. Surgeon overlays 2 meshes
  5. Subject receives any mesh other than Parietene™ DS composite mesh
Effect of Vitamin D3 on Cardiovascular Risk Factors

The aim of this study is to investigate whether a supplementation of Vitamin D3 can be used to reduce atherosclerotic risk factors.

It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 can lower blood pressure in mildly hypertensive subjects who are naive to antihypertensive medication, whether Vitamin D reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.

major outcomes:

- decrease of systolic blood pressure in the treatment group in comparison with the placebo group

Eligibility Criteria:
Inclusion Criteria:

* human volunteers with mild hypertension

Exclusion Criteria:

* use of antihypertensive medication
* use of vitamin d or calcium supplements
* known renal, inflammatory or malignant diseases
* hypercalcemia or hypercalciuria
* participation in other clinical studies
* use of tanning booths during the study
Enhancing Exposure Therapy for Post-traumatic Stress Disorder

This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.

This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
2. Between the age of 18 and 65.
3. Medication status stable for at least 6 weeks

Exclusion Criteria:

1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
3. Current diagnosis of alcohol or substance dependence within the 3 previous months.
4. Unwilling or unable to discontinue current trauma-focused psychotherapy.
5. Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
6. Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.
Screening of Congenital Anomalies of Kidney

To evaluate the role of ultrasound in prenatal diagnosis of congenital anomalies of kidney and urinary system in third trimester of pregnancy.

Primay outcomes:

To determine incidence of congenital anomalies in kidney and urinary system in Third Timerter by ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* • Singleton pregnancy.

  * Healthy women Aged between 20 to 40 years old.
  * Third trimester

Exclusion Criteria:

* • Multiples pregnancies.

  * Maternal D.M or HTN
  * Patients\&#39; refusal to participate.
The Effect of Ribose on B-Type Natriuretic Peptide (BNP) Levels in Congestive Heart Failure Patients

The purpose of this research study is to test the effectiveness of CORvalen, a medical food, to increase cellular energy sufficiently to change or modify BNP levels in congestive heart failure patients.

B-type natriuretic peptide (BNP), is a blood test commonly used to track the progress of congestive heart failure. CORvalen, a medical food, contains D-Ribose (ribose), a natural substance that has been shown to improve the amount of energy compounds at the cellular level. Congestive heart failure has been associated with a reduced level of high-energy compounds. One researcher has called them an "energy starvation" in congestive heart failure. This study will try to assess if increasing the amount of these energy compounds is sufficient to improve BNP levels. Approximately 120 symptomatic congestive heart failure patients will participate in this 3 month study.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic adults, M/F, between 18 and 80 years of age
* BNP levels equal to or greater than 300 pg/ml.
* Primary or secondary diagnosis of congestive heart failure at the time of admission (any NYHA Class)
* Diagnosis of congestive heart failure for at least 3 months
* Able to perform 6 minute hall walk
* No therapeutic pharmaceutical class changes for at least 1 month
* Provide informed consent
* A 30-day washout period must be achieved for any patient involved in a previous clinical study.

Exclusion

* Insulin dependent diabetes (Type I)
* History of obstructive valvular disease
* History of pulmonary hypertension within the last 3 months
* History of hypertrophic or alcoholic cardiomyopathy
* History of restrictive cardiomyopathy
* History of reversible cardiomyopathy
* History of non-compliance
* Pregnancy
* Current enrollment in any other clinical study