cyrilzakka/clinical-trials huggingface dataset:
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus

Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate hypertension
* Type 2 diabetes mellitus
* Presence of protein in the urine (albuminuria)

Exclusion Criteria:

* Kidney disease not caused by diabetes or hypertension
* Renal artery stenosis
* Myocardial infarction or stroke within the last 6 months
* Type 1 diabetes mellitus
* Pregnant or lactating females
* Cancer within the last 5 years
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects who participated in and completed Wyeth study 0887X 101518.
* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

* Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518.
* History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518.
* Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.
Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions

Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )

Study to evaluate the bioequivalence of orally administered metformin preparations, Extended release tablets, 750 mg in normal healthy subjects under fasting and fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Healthy male and female subjects aged 18 to 45 years.
* Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
* Have a body mass index between 18,5 and 27 kg/m2.
* Females must have a negative pregnancy test.
* Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.

Exclusion Criteria:

* History of serious allergic problems/events
* Medicinal intolerance.
* History of allergic reactions to memantine or investigator's product components
* Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
* Acute infectious diseases in less than 4 weeks before the start of the study.
* Subjects who have taken medication 4 weeks preceding before the study.
* Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
* Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
* History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
* Smokers.
* Participation in other clinical training is less than than for 3 months before the study.
* Lack of signed informed consent form.
* ECG or vital signs abnormalities (clinically significant).
* Positive testing for alcohol, drugs, pregnancy.
* Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
* Any diet, for example, vegetarian, for 2 weeks before taking the study medications.
* Women with preserved reproductive potential who have unprotected sexual intercourse with an unsterilized male partner within 30 days prior to taking the study medication.
* Heart rate below 60 or above 80 beats per minute.
* Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
* Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.
A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options

This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.

The CHANGE study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of AVANCE Nerve Graft to hollow tube conduits. The first phase (pilot phase) assesses projected differences expected between two treatment groups. The second phase of the study provides comparison data between the two treatment groups.

AVANCE Nerve Graft is current regulated in the United States as a 361 HCT/P Tissue for transplantation; not a Drug, Biologic, or Medical Device. Hollow tube conduits are currently regulated in the United States as medical devices.

Eligibility Criteria:
Inclusion Criteria:

* Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCE™ in at least 1 digital nerve;
* Undergo End to End nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the AVANCE™ group or nerve entubulation in the Hollow Nerve Conduit group;
* Be willing to comply with all aspects of the treatment and evaluation schedule over a 12 Month duration; and
* Sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures.

Exclusion Criteria:

* Nerve gaps of \< 5 mm or \> 20 mm;
* Estimated distance of regeneration of \>125 mm (distance from injury site to sensory target)
* Nerve crush or avulsion injuries;
* Incomplete nerve transections;
* Injury requiring replantation of target digit;
* Contralateral digital injuries corresponding to the target digit;
* Nerve injuries in the affected limb proximal to the crease of the wrist;
* End to side nerve repair;
* Injuries with significant vascular damage which may impair adequate perfusion of the target limb;
* Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system;
* Use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity;
* Subjects age ≤18 years or ≥70 years;
* History neuropathy, diabetic or any other known neuropathy;
* Secondary nerve repair \>12 weeks post initial injury;
* Currently enrolled in another investigational study;
* Expected use of medications during the study that are known to cause peripheral neuropathy;
* History or Reynaud's or other disorder known to compromise circulation or sensation in the upper extremity; and
* Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
A Team Model of Hypertension Care in African Americans

This Team Education and Adherence Monitoring (TEAM) trial will evaluate the cost-effectiveness of a pharmacy-based intervention in a randomized controlled trial involving 597 treated hypertensive African American patients in five Wisconsin cities. The study involves 28 community pharmacies (14 intervention, 14 control) owned by two pharmacy corporations. Intervention pharmacists and pharmacy technicians implemented a 6-month blood pressure (BP) monitoring program that involved working together as a team with patients and their physicians to achieve improved medication adherence, healthy lifestyles, drug therapy, and hypertension control.

Researchers screened and enrolled 20-25 subjects in each study pharmacy. Intervention pharmacists and technicians attended a 7-hour TEAM training program on BP monitoring, JNC 7 guidelines, and specially designed tools for assessing and improving medication adherence, lifestyle, patient scheduling and retention, and collaboration with physicians. Intervention teams received specially designed tools, automatic BP monitors, and furniture for setting up and implementing a blood pressure clinic at their pharmacy. Staff from control pharmacies received printed information only and provided "usual care". Outcomes will be determined by blinded data collectors who will re-check patients' BPs and administer follow-up surveys after 6 and 12 months. Researchers also will survey pharmacy staff and review pharmacy records to determine changes in refill adherence and prescribing.

Eligibility Criteria:
Inclusion Criteria:is African American and 18 years old or older; has active prescription for BP drug; obtains all BP drugs at the study pharmacy; is able to read and fill out short questionnaires; is able to come to pharmacy for 6 monthly pharmacy visits if needed; has screening BP between 140/90 mm Hg and 210/115 mm Hg.

Exclusion Criteria: history of organ transplant or kidney dialysis, symptoms of advanced congestive heart failure, memory impairment that interferes with daily functioning,terminal illness,pregnancy, alcohol or substance abuse problem,physician recommendation of exclusion for other condition that may require special care or limit participation in the study.
Study of XL647 Administered Orally Daily to Patients With Solid Tumors

The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subject has histologically confirmed malignancy that is metastatic or unresectable
* Subject has disease that is assessable by tumor marker, physical, or radiologic means
* Subject is at least 18 years old
* Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
* Subject has a life expectancy ≥ 3 months
* Subject has normal organ and marrow function
* Subject gives written informed consent
* Subject must use an accepted method of contraception during the study
* Female subjects of childbearing potential must have a negative pregnancy test

Exclusion Criteria:

* Subject has received anticancer treatment within 30 days of first dose of XL647
* Subject has received another investigational agent within 30 days of first dose of XL647
* Subject has known brain metastases
* Subject has corrected QT interval (QTc) of \> 0.45 seconds
* Subject is currently receiving anticoagulation therapy with warfarin
* Subject has uncontrolled intercurrent illness
* Subject is pregnant or breastfeeding
* Subject has known HIV
Elbow Pain in Hemodialysis Patients and Its Effect on Daily Living Activities of the Patients

The study will include the patients undergoing hemodialysis.

The study will include the patients undergoing hemodialysis. The patients with surgery at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases affect the interview will be excluded. Sociodemographic properties which include age, gender, duration of dialysis, educational level, comorbid diseases, vascular access area, hand dominancy will be asked. The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP), the Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS) will applied to all patients.

All the demographic results and vascular access area for hemodialysis will be detected. All data for normality will be tested by using Kolmogorov-Smirnov test. To compare the differences between groups, Mann Whitney U test will be used

Eligibility Criteria:
Inclusion Criteria:

* being over 18 years old having hemodialysis treatment

Exclusion Criteria:

* any surgical operation at upper extremity in last 3 months, the presence of conditions such as cancer, chronic hearing loss and neurologic diseases can affect the interview.
MiBo ThermoFlo Lid Temperature Evaluation

This study is a prospective, contralateral, single-site, single-visit unmasked evaluation of external and internal eyelid temperature after treatment with the MiBo ThermoFlo.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Between 18 and 80 (inclusive) years of age at the time of screening.
  4. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or breastfeeding.
  2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with participation in the study.
  3. Clinically significant (Grade 3 or 4 on the FDA classification scale) slit lamp findings (e.g. corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection).
  4. Grade 3-4 Percentage of Partial Meibomian Glands on the Pult 5-point grading scale.
  5. Any active Ocular Infection or Inflammation
  6. Any history of eyelid surgery or abnormality
  7. History of Metal Implants in the Eyelids
  8. Any known hypersensitivity or allergic reaction to ultrasound coupling gel.
  9. LASIK Surgery within 2 weeks of the Baseline Visit.
  10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  11. History of MiBo ThermoFlo or Lipiflow treatment Within the Last 6 months.
  12. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial

The aim of our study is to determine whether the use of a tourniquet during TKA would affect total measured blood loss , operation time, postoperative complications; hemoglobin concentration; limb swelling and postoperative pain.

Tourniquets are widely used in total knee arthroplasty (TKA) . TKA has been reported to be associated with significant blood loss which at times necessitates transfusion. Although the tourniquet is widely used by orthopedic surgeons, its role is controversial . Several studies have shown that using a tourniquet in TKA could reduce the total blood loss, while results from others indicated the opposite . Therefore the relationship between the use of a tourniquet and the total blood loss of patients undergoing TKA is still unclear. The use of a tourniquet is believed to be effective for decreasing intraoperative blood loss and creating a bloodless surgical field, which theoretically would facilitate the cementing technique and other surgical procedures. However, reactive blood flow reaches its peak within five minutes after the tourniquet has been released Complications reported as a consequence of tourniquet application are skin injury \[skin abrasions, blisters, breaks , pressure necrosis\], nerve injury, post tourniquet syndrome, Deep venous thrombosis, Postoperative pain, wound healing disorders and early infections

Eligibility Criteria:
Inclusion Criteria:

* any patient with knee osteoarthritis undergoing primary total knee arthroplasty

Exclusion Criteria:

1. patients with hemorrhagic disease
2. patient with revision total knee arthroplasty
3. patient with history of vascular thrombosis
4. patients taking anti-platelet agents due to cardiovascular disease
5. patients with hemoglobin level below 10gm/dl
Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia

The purpose of this study is to determine the safety and effects (good or bad) of Campath-1H antibody in the treatment of lymphoplasmacytic lymphoma.

* Patients will receive 3 test doses of Campath-1H (3mg, 10mg, 30mg). If the patient tolerates these three test doses, then they will receive a total of 6 weeks of Campath-1H therapy three times a week.
* After the patient receives the first 6 weeks of therapy at the 30mg therapeutic dose they will be re-assessed by blood testing. If it is determined that their disease has progressed in the period of time while the patient was on Campath-1H, the patient will be removed from the study.
* If it is determined that the patient has achieved a complete remission after 6 weeks of Campath-1H treatment a bone marrow biopsy will be performed to confirm complete remission and the patient will not receive any additional treatment but will be followed for a period of 2 years.
* If the disease has remained stable or partial response has been achieved the patient will enter the second phase of therapy in which they will receive an additional 6 weeks of Campath-1H therapy. The patient will then be reassessed as described above.
* No additional therapy (as part of this study) will be performed after a 12 week course of Campath-1H.
* While the patient is on Campath-1H blood test will be performed at 3-6 month intervals over a period extending for 2 years following the last treatment. Bone marrow biopsies and/or aspirations will be conducted as necessary.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of lymphoplasmacytic lymphoma including patients with Waldenstrom's macroglobulinemia
* Adequate organ function: ANC \> 500/ul; PLT \> 25,000/ul; serum creatinine \< 2.5; serum total bilirubin and SGOT \< 2.5 times the upper normal limit.
* Age greater than 18 years
* Life expectancy of 6 months or greater
* ECOG performance status of 0-2

Exclusion Criteria:

* Chemotherapy, steroid therapy, or radiation therapy within 21 days of study entry.
* Prior Campath-1H or monoclonal antibody therapy within 3 months of study entry.
* Pregnant women
* Serious co-morbid disease, uncontrolled bacterial, fungal, or viral infection.
A Personalized Approach to Effects of Affective Bias Modification on Symptom Change and Rumination

This study evaluates the effect of a computerized intervention for depressive symptoms called Affective Bias Modification (ABM). A third of the patients will receive active ABM, a third will receive sham ABM and a third will undergo assessment only. The study will investigate if rumination mediates the effect of the intervention and investigate if specific symptom profiles affect the effect of the intervention.

A main aim of the project is to investigate how the effects of an ABM intervention on depressive symptoms are mediated by transdiagnostic rumination and how characteristics of the symptom network moderate these effects. The Affective Bias Modification Task (ABM) will be applied in a randomized controlled, double blind clinical trial with 6 months follow-up. Personalized networks are generated from prospective assessment of depression-related processes at baseline and follow-ups. Patients (n = 150) will be recruited from out-patient clinics at Diakonhjemmet Hospital, and randomized into one of three conditions: active, sham and assessment only. Patients aged 18-65 with depression (major depressive disorder) or bipolar disorder 2, with or without comorbid anxiety and/or alcohol use disorder will be included. The main hypothesis is that subjects who are in the active ABM group will exhibit less tendency for stress related (state) rumination compared to those in the placebo group. Active vs placebo ABM will decrease depressive symptoms (6 months) and this effect will be mediated by the change in state rumination. Densely connected symptom network and high strength centrality of rumination at baseline will moderate the effect of ABM. By combining mechanisms research with a personalized symptom network approach, this study will be in the forefront of understanding how a drug-free treatment option works and for whom it works best.

Eligibility Criteria:
Inclusion Criteria:

- Current or remitted Major Depressive Disorder, with or without anxiety, with or without alcohol use disorder

Exclusion Criteria:

* Neurological disorder, mania, and/or psychosis.
Energy Expenditure, Sleep and Macronutrients

The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

The prevalence of obesity has increased worldwide to epidemic proportions. For long-term treatment success permanent lifestyle changes are necessary with regard to approach to food, physical activity patterns and behavior to emotional stress. Moreover, an association has been shown between sleep disturbance and obesity. Weight loss strategies regarding food intake regulation mainly focused on changing patterns of fat and carbohydrate consumption during the last decades. The role of protein has largely been ignored. However, protein has been observed to increase satiety and energy expenditure to a greater extent than carbohydrate and fat and can therefore reduce energy intake. However, it still has to be confirmed if this effect is permanent or transient over a longer period of time. Moreover, dietary intakes may significantly affect sleep when macronutrient intakes are manipulated. Since sleep deprivation has been recognized as a risk factor for obesity, improving sleep by a change in macronutrient intake would be promising in the treatment of obesity.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age between 18-35 years
* BMI 18-27 kg/m2
* non-smoking
* weight stable (weight change \< 3 kg during the last 6 months)
* no sleeping problems
* not using a more than moderate amount of alcohol (\> 10 consumptions/wk)
* not using medication or supplements except for oral contraceptives in women

Exclusion Criteria:

* not healthy
* do not meet the criteria for BMI and age
* smoking
* not being weight stable
* using medication or supplements except for oral contraceptives in women
* sleeping problems
* using a more than moderate alcohol consumption
* pregnant or lactating
* allergic for the used food items
Comparative Study Between Lap. Dual Approach, Lap. Trans Abdominal Pre-peritoneal and Lichtenstein Procedures

This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)

inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair

Eligibility Criteria:
Inclusion Criteria:

* Adult male patient (older than 18y).
* Not complicated.
* No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia).
* No contraindication for general anesthesia.
* Not recurrent.

Exclusion Criteria:

* any one not in fulfill inclusion criteria