cyrilzakka/clinical-trials huggingface dataset:
Type 2 Diabetes and Exercise Function in Single Leg Exercises

This study plans to learn more about the effects of type 2 diabetes (T2DM) on exercise blood flow and muscle oxygen uptake. This study will evaluate \& compare exercise function during single leg plantar flexion exercise in a total of 45 subjects from the Denver area (15 lean controls, 15 people with T2DM, and 15 overweight control subjects).

Differences between the exercise responses in people with T2DM and healthy people will help further identify the disease process of T2DM and direct future research of treatments and interventions.

It is well established that functional exercise capacity and peak oxygen uptake (VO2) are reduced in patients with type 2 diabetes mellitus (T2DM) compared with healthy counterparts. The mechanisms underlying the exercise deficit in T2DM remain largely unknown, but previous work has suggested that reduced exercise blood flow and impaired submaximal VO2 may be contributing factors. Both of these findings are consistent with a peripheral impairment of skeletal muscle oxygen delivery, oxygen utilization, or both. Indeed, dysfunction of skeletal muscle metabolism plays a key role in the pathophysiology of T2DM, and considerable work has described abnormalities of oxidative function in the skeletal muscle of people with T2DM. Given this, it is likely that the causes of exercise intolerance in T2DM may relate to specific defects at the level of the skeletal muscle, particularly given that skeletal muscle blood flow and oxidative capacity are impaired in diabetes. However, to our knowledge, no one has related these peripheral muscle abnormalities to the diminished exercise function in this patient group.

The overarching hypothesis for the proposed research is that both a failure to adequately increase muscle oxygen delivery following the onset of exercise and reduced oxidative function of skeletal muscle contribute to the acute oxygen deficit and diminished exercise tolerance that has been observed in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with and without type 2 diabetes
* 30-70 years of age
* Lean and overweight
* Sedentary subjects not participating in a regular exercise program (\<one bout of exercise/week)

Exclusion Criteria:

* Documented cardiovascular disease
* Uncontrolled hypertension: systolic blood pressure (SBP) \> 150, diastolic blood pressure (DBP)\> 110
* Obstructive pulmonary disease or asthma
* Peripheral neuropathy
* Subjects taking beta blockers, insulin, or Thiazolidinediones (TZD)
* Current or past smoking within the last 2 years
* Anemia
* Control HbA1c \> 6, T2DM HbA1c \> 10
* Type 1 diabetes
* Any implanted metal in subject's body
Comparison Between the Role of Transabdominal Ultrasound Versus Transvaginal Ultrasound in Evaluation of Placental Invasion in Cases of Placenta Previa Anterior Wall With Previous Uterine Scar

Objective:

To compare between the role of Transabdominal ultrasound versus Transvaginal ultrasound in evaluation of placental invasion in cases of placenta previa anterior wall with previous uterine scar applying the unified ultrasonographic descriptors suggested by the European working group on abnormally invasive placenta "EW-AIP' Also to evaluate the sensitivity and specificity of each criterion by comparing them with the final outcome of pregnancy Fifty pregnant women with persistent placenta previa (after 28 weeks' gestation) were prospectively enrolled into this study. Both transabdominal and transvaginal ultrasound were performed by two different operators who were blinded to the results of each other.

the placenta was studied as regarding the exact loacalization and the unified descriptors were applied and evaluated by TAS and TVS.

The ultrasound findings were analyzed with reference to the final diagnosis made during Cesarean delivery and histopathological examination

Definitive diagnosis of Abnormally Invasive Placenta was made at delivery when the myometrium was seen to be invaded by the placenta, and the pathological examination of the removed uterus showed the villi attached to the myometrium without intervening decidua (accreta), invading into the myometrium (increta) or reaching the serosa (percreta).

-Complete imaging using all diagnostic techniques (gray-scale, color Doppler) by both transabdominal and transvaginal by two expert operators, then an offline analysis of the acquired images \& volumes was done Ultrasound examination was performed using a 2D ultrasound system equipped with a 4-8-MHz trans-abdominal transducer and a 12 MHz transvaginal transducer The transvaginal ultrasound was performed by a highly experienced operator whereas the transabdominal ultrasound was performed by a less experienced one and both were blinded from the results of each other Placenta was examined while the bladder was partially full about 300 ml for adequate visualization and precise localization

The Examined placenta is considered to be suspicious of abnormal invasion in case of having one or more of the unified descriptors described by the European working Group on Abnormally Invasive Placenta "EW-AIP":

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the reproductive age group (18 - 45) diagnosed persistent placenta previa anterior wall after 28 weeks of gestation , with history of previous Caesarian Section and/or any other type of uterine surgeries

Exclusion Criteria:

* Placenta previa posterior wall
* unscarred uterus
Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.

Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74 and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected public health problem for people with schizophrenia; smoking cessation treatment is often overlooked as part of the psychiatric care for such individuals.

The most effective treatment for smoking cessation described to date is sustained release (SR) bupropion. Past research suggests that SR bupropion may be especially effective in individuals with depressive symptoms, including individuals with schizophrenia. The purpose of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with cognitive behavioral therapy (CBT), in individuals with schizophrenia.

This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion or placebo. All participants will receive weekly CBT. Participants will be followed for 3 months following completion of the 12-week treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
* Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
* Smokes at least 10 cigarettes per day
* Wishes to stop smoking
* Attended last three scheduled clinic visits, prior to study entry

Exclusion Criteria:

* Significant medical or neurologic illness
* History of severe head injury with loss of consciousness
* Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
* Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
* Currently undergoing an acute exacerbation of psychotic symptoms
* Current or history of bulimia or anorexia
* Current excessive water intake
* Recent history of mania
* Known allergy or hypersensitivity to bupropion
* Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco
* Currently receiving treatment with bupropion
* Pregnant or breastfeeding
Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)

There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.


Eligibility Criteria:
Inclusion Criteria:

* Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1 levels included in a rehabilitation and psychological program and stable under standard intensive treatment for at least 6 months.
* All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level \<250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and body surface according to laboratory reference value).
* Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ \> 75.
* The study was conducted in accordance with the Declaration of Helsinki and received the local institutional review board and Spanish Drug Agency (nº03-0456) approvals. All patients gave written informed consent prior to their inclusion in the study.

Exclusion Criteria:

* Disabling physical or mental status
* Previous or current malignancies, either active or inactive
* Intracranial space occupying lesion
* Any relevant endocrine disorder including diabetes mellitus
* History of another pituitary disorder
* Previous treatment with growth hormone
* Other systemic or joint inflammatory rheumatic conditions; and
* Known to be hypersensitive to somatropin or any of the excipients.
* Pregnant women, nursing mothers, or women with childbearing potential not using adequate contraceptive methods were also excluded.
The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation

To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.The global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.

Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural course of the infection remains incompletely described. The study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.

A fungal scalp culture will be acquired from all participants using a brush culture technique. Samples will be collected once a month over a two year time period.

Eligibility Criteria:
Inclusion Criteria:

* Preschool aged children will be eligible.

Exclusion Criteria:

* None
Well-being and the HM App Pilot (WHAP) Study

There is no single definition of well-being, but consensus exists that positive functioning beyond the absence of detrimental mental health symptoms is central. Building on related "eudaimonic" frameworks of psychological flourishing that identify qualities like environmental mastery, positive relations with others, and personal growth, this study targets brain-based skills that underlie the active cultivation of such qualities (e.g., regulating attention, empathic care, mental flexibility), and thus offers straightforward hypotheses about mechanisms of change.

The Healthy Minds Program (HMP) is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP practices address 4 constituents of well-being: awareness, connection, insight, and purpose. This pilot focuses on awareness, connection, and insight.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18-65

Exclusion Criteria:

* Individuals under 18 or over 65
* Significant meditation experience (as defined below):
* Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component).
* Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months.
* Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course.
Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.


Eligibility Criteria:
Inclusion Criteria:

* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver

Exclusion Criteria:

* Moderate to high risk for serious perioperative adverse events
* Active implanted devices
* Morbid obesity (Body Mass Index \> 40)
* History of poorly controlled seizures or epilepsy
* History of poorly controlled diabetes
* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
* Acquired or hereditary immunosuppression
* Use of smoking tobacco or other tobacco products
* Psychiatric or psychological disorder
* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
Efficacy and Safety of KW21052 Compared to Lyrica in the Diabetic Patients With Neuropathic Pain

Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.

Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 and 2 diabetic patients
* Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
* 40mm and more on VAS
* 4 and more on NRS
* Informed consented patients

Exclusion Criteria:

* Participating in another clinical trial
* Pregnancy or lactating
* Sensitivity to pregabalin
* Significant underlying disease or disorders
* Prohibited concomitant medications
* Significant laboratory abnormalities
Electronic Patient Reported Outcomes in Measuring Health-Related Quality of Life in Patients With Stage I-IV Prostate Cancer Undergoing Treatment

This pilot clinical trial studies how well electronic patient reported outcomes work in measuring health-related quality of life in patients with stage I-IV prostate cancer undergoing treatment. Using a smartphone application to measure and monitor symptoms before, during, and after treatment may help patients better detect, understand, and manage their health.

PRIMARY OBJECTIVES:

I. To explore the feasibility of collecting electronic patient-reported outcome data using validated health-related quality of life (HRQOL) assessment tools at baseline, during, and after treatment through a smartphone application in adult men throughout their course of treatment for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported ability to speak and read English
* Be able to communicate on a touch screen iPhone
* Willing to provide signed informed consent
* Willing and able to comply with all study activities
* Access to WiFi connection or cellular data
* An established clinical history of prostate cancer in a spectrum of severity (all stages)

Exclusion Criteria:

* A subject will not be eligible for inclusion in this study if in the investigator's opinion the patient has any concurrent medical or psychiatric condition that may preclude participation in this study or completion of self-administered questionnaires (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia, or other condition that would render them unable to complete a questionnaire)
* Cognitive or other impairment (e.g., visual) that would interfere with completing a self- administered questionnaire and with participating in a group discussion
Relationship Between Gut Microbiome and Adjuvant Chemotherapy in Patients With Early Breast Cancer

Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.

The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Breast cancer is the most common cause of cancer death in women. Adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. However, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. Moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy.

The human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. It is identified as a crucial determinant in cancer occurrence and development . Besides, Gut microbial alterations may influence the therapy efficacy and adverse drug event.

We collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srRNA sequencing.The purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed stage I-III breast cancer;
* Plan to receive adjuvant chemotherapy in our hospital;
* Sign the informed consent;
* Good compliance and willing to follow up.

Exclusion Criteria:

* Those who have started receiving adjuvant chemotherapy;
* Chemotherapy contraindications;
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload

A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.


Eligibility Criteria:
Inclusion criteria

* Patients who completed the 12-month core study (NCT00061750)
* Female patients after menarche and who were sexually active, if they used double-barrier contraception, oral contraceptive plus barrier contraceptive, or had undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation
* Written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation

Exclusion criteria

* Pregnant or breast feeding patients
* Patients with a history of non-compliance to medical regimens or those considered to be potentially unreliable
Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section

Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 32 weeks
* Emergency cesarean section

Exclusion Criteria:

* Allergy to clorhexidine
* Allergy to povidone
* Evidence of infection in the surgical site
* Loss to follow up at 15 days
* Surgeries that due to the emergency of the case do not allow the five minutes of skin cleaning.
Magnetic Resonance Imaging in Obstructive Sleep Apnea

There is a fundamental gap in the investigators ability to design effective surgical treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful outcome ranging from 5% to 65% for individual or combination procedures. To predict - and thereby to improve - outcomes, the investigators must determine what predicts surgical success. This project will compare findings from two evaluations: drug-induced sleep endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated important benefits, but it has important limitations. Upper airway MRI is the most complete evaluation performed during wakefulness, making it conducive to broad application and less expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe OSA. In addition to history, physical examination, and polysomnogram (sleep study), all subjects will undergo DISE and MRI to characterize the pattern of obstruction. The investigators will examine the association between DISE and MRI, focusing on specific DISE findings that have been associated with surgical outcomes. The investigators multidisciplinary team has substantial expertise and experience in OSA investigation, DISE, and upper airway MRI.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)
* body mass index \<40 kg/m2.

Exclusion Criteria:

* prior OSA surgery
* known neurologic, cardiac, pulmonary, renal, or hepatic disorders
* psychiatric problems except for treated depression or mild anxiety
* co-existing sleep disorder other than OSA
* other contraindication to DISE or MRI such as propofol allergy.