cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Pramipexole for Treatment-Resistant Depression

This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.

Depression is a serious medical illness, for which various types of treatment have been developed. Both medications and therapies have proven effective in treating depression. However, some people with depression do not benefit from these treatments. New medications are needed for treating depression in those who have not responded to commonly used antidepressants. Pramipexole (Mirapex) is most often used for the treatment of Parkinson's disease, but has been reported to have antidepressant effects as well. This study will evaluate the effectiveness of pramipexole in treating depression in individuals that have not responded to other medications.

Participants in this double blind study will be randomly assigned to receive either pramipexole or placebo, in addition to their current medications, for 8 weeks. Treatment response will be assessed at the end of this phase by measuring symptoms of depression. At this time, those individuals who have responded to treatment will have the option to continue in a 6-month follow-up study. Participants will be seen monthly throughout the 6 months to assess treatment response. Participants who do not exhibit a response to treatment will be tapered off the medication. All participants will receive 3 months of follow-up care, regardless of their response to the medication.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for major depressive disorder
* Meets criteria for current major depressive episode
* Score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) at the baseline visit
* Currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
* Agrees to use an effective form of contraception throughout the study

Exclusion Criteria:

* Pregnant
* At risk for suicide or homicide
* Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
* History of a substance use disorder within 6 months of study enrollment
* History of or current psychotic features
* Currently being treated with typical or atypical antipsychotic medications
* Currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
* Clinical or laboratory evidence of untreated hypothyroidism
* History of a 2-week or longer course of pramipexole
* Intolerance of pramipexole at any dose
* Any investigational psychotropic drug use within the last three months
* Level 3 or greater antidepressant resistance as assessed by the ATHF
* Three or more episodes of self-harm in the year prior to study enrollment
* Documented history of poor treatment adherence or frequently missed appointments
* Parkinson's disease
Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures

The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.

The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.

Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.

Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.

The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.

Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.

Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.

This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.

Biomechanical studies that compare these two lag screw modes show that axial and lateral stiffness of the femur-nail construction is greater in static mode than in dynamic modes and the torsional stiffness is greater in dynamic mode than in static modes.

There are no studies comparing the clinical results of these two variants.

Eligibility Criteria:
Inclusion Criteria:

* Low Energy Mechanism
* Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)

Exclusion Criteria:

* A fracture due to malignancy
* Previous contralateral fracture
* Inability to walk before the fracture
* An inability to comply with rehabilitation
* Follow-up of less than 6 months
Ultrasonography in Predicting Difficult Intubation in Obese Emergency Surgical Patients

Validity of ultrasonography in predicting difficult laryngoscopy and confirming endotracheal intubation in obese emergency surgical patients

The aim of the study is to determine whether preoperative ultrasound assessment of of the upper airway can predict difficult laryngscopy in emergency surgical obese patients , by analysis correlations between ultrasound measurements of anterior cervical soft in the upper airway, and the Cormack-Lehane grade. And evaluate its role in confirming the endotracheal placement The secondary objective was to determine whether clinical screening tests are independent predictors of difficult airway.

Eligibility Criteria:
Inclusion Criteria:

* Adult obese patients (BMI\>35) of both sex aged from 18 to 60 years undergoing urgent surgeries under general anasthesia with tracheal intubation.

Exclusion Criteria:

* . Patients with removable upper dentures, upper airway pathology, cervical spine fractures, full stomach, maxillofacial trauma or unstable patients and pregnant women will be excluded from the study
Impact of a Smartphone Intervention on Tanzanian Women's Childbirth Location

This study investigates whether training Community Health Workers (CHW) to use a smartphone-based prenatal counseling application as a "job aid" instead of the existing paper based standard is associated with increased women's use of maternal health services in Singida region, Tanzania.

In low-income countries, frontline community health workers (CHWs) have potential to improve women's access to maternal health services through prenatal counseling and referral. However, CHW performance can often be enhanced with sufficient training, incentives, supportive supervision and job aids. Smartphone-based applications designed to assist CHWs with referrals, health education and client counseling may improve the quality of care delivered during household visits. There is a need for rigorous scientific studies on the impact of such interventions.

This study investigates whether CHWs' use of a smartphone-based application increases women's use of maternal health services in Singida region, Tanzania. It is hypothesized that smartphone-assisted counselling by CHWs can increase use of health facility-based delivery services compared to a control group of CHWs using standard paper-based protocols. This study is conducted within the context of larger project - SUSTAIN-MNCH Project (Supporting Systems to Improve Nutrition, Maternal, Newborn and Child Health), implemented by World Vision through multiple partners.

Eligibility Criteria:
Inclusion Criteria:

* client of one of the CHWs enrolled in the mHealth study
* visited at least once by a CHW following intervention (baseline training for CHWs) and during their most recent pregnancy
* most recent delivery was a live birth and the child is still living

Exclusion Criteria:

* None
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease

The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.


Eligibility Criteria:
Inclusion Criteria:

* This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.

Exclusion Criteria:

* Subject has no new medical contraindications to continued participation in the study.
Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

This study has a randomized, evaluator-blinded, vehicle- controlled study to assess the pharmacodynamics of omiganan and omiganan with imiquimod in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis.
* Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
* Fitzpatrick skin type I-III (Caucasian)
* Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
* Able and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

* Any disease associated with immune system impairment, including auto-immune diseases, HIV and transplantation patients
* Family history of psoriasis
* History of pathological scar formation (keloid, hypertrophic scar)
* Have any current and / or recurrent pathologically, clinical significant skin condition.
* Previous use of imiquimod/ resiquimod/ gardiquimod
* Known hypersensitivity to the (non)investigational drug, drugs of the same class, or any of their excipients.
* Hypersensitivity for dermatological marker at screening
* Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrollment or planned to use during the course of the study.
* Use of topical medication (prescription or over-the-counter \[OTC\]) within 30 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area
* Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
* Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
* Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
The Drug Induced Renal Injury Consortium

Some medications are known to cause kidney damage because the person is allergic to the medication while others cause direct damage to the kidney because they are toxic at certain concentrations. Risk factors for developing kidney damage have been identified for some medications but not for all. Patients who are exposed to these important medications and develop problems with their kidneys may have some genetic risk. The purpose of this study is to determine the genetic risk factors for drug induced kidney injury. A better understanding of the role of genetics for the development of kidney injury from medications will allow us to better select medications, improve effectiveness of treatment and minimize harm.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 2 years and older
* Exposure to a candidate drug for at least 24 hours (see above)
* Patients who have developed DIRI as defined by the primary criteria
* Written informed consent or assent and consent obtained
* If patient lacks capacity to consent then surrogate consent will be obtained

Exclusion Criteria:

* Patients with a history of or have a kidney transplant
* Patients with a history of or have a bone marrow transplant
* Patients with Chronic Kidney Disease stage 5 (eGFR \< 15 mL/min/1.73m2)
* Patients on 3 or more causal drugs
* Patients with no history or time course on drug exposure
* Patient who, in the opinion of the Investigator, is not suitable to participate in the study.
* Unable to obtain written informed consent or assent
* Unable to obtain surrogate consent for patients who lack capacity
Meal Timing, Genetics and Weight Loss

Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. This project aims to study in a Mediterranean population the potential influence of genetics and food timing on obesity, metabolic syndrome and weight loss.

Meal times differ from culture to culture. These differences may influence energy regulation and, consequently, body weight. Current studies support the notion that not only "what" but also "when" the investigators eat may have a significant role in obesity treatment. Recently, it has been shown that eating the main meal of the day, lunch in Spain, late in the day is predictive of difficulty in weight loss and decreased insulin sensitivity. Furthermore, it has been shown that eating late at night when plasma melatonin concentrations are elevated, impairs glucose tolerance, particularly in MTNR1B risk allele carriers.

The main objective is to identify the mechanisms underlying the association between the timing of food intake, obesity and metabolic syndrome (MetS) in order to design effective weight loss therapies. The long-term goal is to determine the potential impact of more European, i.e., earlier meal timing on obesity, MetS and weight loss.

The challenge for the society is to develop evidence-based dietary interventions incorporating meal timing and genotype to combat the epidemic of obesity and MetS.

These goals will be achieved through three specific approaches:

* Epidemiological (observational study) (Aim 1): To assess in an obese population (n=5000) who will follow a weight loss program if clock-related (CLOCK, PER2, CRY, etc.) and melatonin-related variants (MTNR1B) interact with the timing of food intake to determine weight loss effectiveness and MetS features.
* Interventional (randomized controlled trials) (Aim 2): To determine the internal mechanisms of energy balance and circadian system implicated in the differential effects of food timing (lunch) on weight loss, MetS alterations and the intestinal microbiota (n=25), and to study the potential interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance in obese women (n=100).

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: \>25 kg/m2
* Age: \>18 years of age
* Caucasian

Exclusion Criteria:

* Receiving treatment with thermogenic, lipogenic, or contraceptive drugs
* Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis
* bulimia diagnosis, prone to binge eating
* undergoing treatment with anxiolytic or antidepressant drugs
The Relationships Between Physical Activity Level, Quality of Life and Cognitive Level in Breast Cancer Patients

The aim of this study is to determine the relationships between physical activity level, quality of life and cognitive level in patients with breast cancer and to compare the results with a population of similar age group.

This study is a cross-sectional, analytical type study and will be conducted with chemotherapy patients diagnosed with breast cancer and treated in Aydın Adnan Menderes University Faculty of Medicine Research and Practice Hospital, Department of Oncology. Patients diagnosed with breast cancer and undergoing chemotherapy will be provided by the researcher to fill out the questionnaires.

Healthy peers will also form the control group. First of all, mini mental test will be applied to all participants and those who get at least 24 points from the test will be included in the study. International Survey of Physical Activity (IPAQ),EORTC QLQC30 Quality of Life Scale,Montreal Cognitive Assessment Scale (MOCA) will be administered to all participants face to face by the researcher.

The hypotheses the investigators will test for this purpors; H0; There is no relationship between physical activity level, quality of life and cognitive level in patients with breast cancer.

H1a: Physical activity level of patients with breast cancer affects their quality of life.

H1b: Physical activity level affects cognitive level in patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Being treated at Aydın Adnan Menderes University Faculty of Medicine Research and Application Hospital
* Being diagnosed with cancer at least 3 months before the study and receiving chemotherapy treatment
* Mini mental test result of at least 24
* To be conscious,
* Be over the age of 18,
* Being diagnosed with mass-style cancer,
* Patients with walking function

In the Healthy Control group:

* Over 18 years
* Never been diagnosed and treated for cancer before
* Volunteers who do not have a disease that will impair cognitive functions

Exclusion Criteria:

* Patients with brain metastases
* Patients with cognitive and psychiatric problems
* Patients with a diagnosis of hematological type cancer
* Patients receiving palliative care will not be included in the study. For the healthy control group
* With systemic disease
* Have a chronic illness
* Having problems that interfere with physical activity
Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults

The objective of the clinical trial is to evaluate the mediating influence of force control on the pegboard times of adults (50-89 years) who are stratified into groups of faster and slower pegboard times. The hypothesis is that practice of either a pegboard test or a force-control task will reduce pegboard times, but the decrease will be greater and less similar after the two practice interventions for the slower group of participants. The outcomes are expected to demonstrate that force control is a modifiable mediator of pegboard times for this cohort, but the effect will be stronger for the group with faster pegboard times.

The study will involve a randomized, cross-over design with a one-week washout between arms. The two arms (3 weeks each) will comprise practice of the grooved pegboard test and practice of steady contractions while lifting and lowering light loads with a hand muscle. Randomization into practice order will be accomplished with a block approach (block size = 4) for each of the two groups. The outcome assessors will be blinded to practice order. The outcomes will comprise three tests of manual dexterity and the measurement of force control during submaximal contractions. The outcomes will be obtained before and after the six sessions in each practice arm.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, and speak English
* Able to arrange transportation to the Boulder campus

Exclusion Criteria:

* Cognitive impairment
* Major psychiatric condition
* Unstable depressive disorder
* Progressive neurological, muscular, cardiovascular, or skeletal disorder
* Chronic pain condition
* Currently taking medication known to influence neuromuscular function
* Recent hospitalization
* Unable to attend 12 practice sessions in 6 weeks
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-65 inclusive at the time of Informed Consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI \<35 kg/m2

Exclusion Criteria:

* Clinically-significant abnormalities in medical history including acute coronary syndrome, major surgery within 3 months of Screening, planned surgery that would occur during the study or physical examination or other screening results such as ECGs at Screening
* Clinically significant hematologic, chemistry, and urine abnormalities
* Treatment with another Study Drug, biological agent, or device within 4 weeks of Screening
* History of bleeding diathesis or coagulopathy
* Smoking \>10 cigarettes per day
* Considered unsuitable for inclusion by the Principal Investigator
* Current use of concomitant medications (including herbal or OTC medications) unless approved by Sponsor Medical Monitor
* Known history or positive test for HIV, hepatitis C or chronic hepatitis B
* Blood donation within 30 days of screening
An Investigation to Evaluate a New Donor Site Dressing in Surgical Burn Patients

The investigator will identify the test donor site and test location will be considered on the upper anterior thighs as being the most suitable if available. Circumferential donors will be considered acceptable as well.

Treatment will be initiated in the operation room following debridement and split thickness grafting of wounds. Donors will be harvested at 0.010 - 0.012 in. thickness. Treatment and dressing of test donor site will include hemostasis post harvesting with epinephrine-soaked lap sponges. Once adequate hemostasis is achieved, a Mepilex Transfer Ag dressing will be applied directly to study site. Secondary dressing will include covering with ace wrap.

Healing should be asses after 10-14 days.

A prospective, open, non-controlled clinical investigation to evaluate the adequacy of donor site healing when using a new donor site dressing, Mepilex Transfer Ag approximately 20 subjects from 2 centres in the US, presenting with the need for surgical intervention and grafting for burn injury will be enrolled. Eligible subjects will have a selected donor site designated as a "study site".

Eligibility Criteria:
Inclusion Criteria:

1. Surgical donor sites for deep partial-thickness or full-thickness burns
2. Burn of thermal origin
3. Both genders with an age ≥ 7 years at enrolment
4. Signed informed consent
5. Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.

Exclusion Criteria:

1. Any known or suspected systemic infection
2. Any known sensitivity to silver or other components/products used in this study.
3. Any active, uncontrolled, progressive or untreated malignancy. A subject who has had a malignant disease in the past, was treated with the expectation of a cure and is currently disease-free, may be considered for study entry.
4. Use of penicillamine, corticosteroid or immunosuppressive medication within 2 months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation.
5. Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
6. Requires immersion hydrotherapy at any time during study participation (note, showering hydrotherapy is allowed).
7. Subject unwilling to comply with 28 day follow-up.
8. Participation in another investigational study while participating in this study.
9. Bleeding disorders