cyrilzakka/clinical-trials huggingface dataset:
High Intensity Body-weight Circuit Training in Type 2 Diabetics

Exercise has been shown to be effective at improving fitness, as well as markers of glucose tolerance and control, in persons with type 2 diabetes. Recently, several investigations have demonstrated that improvements are realized by patients with high intensity interval exercise which is characterized by periods of vigorous exercise alternated by periods of moderate exercise. Typical interval training sessions require significantly less time to complete than traditional modes of exercise wherein moderate intensity activity is sustained for some time. This may be especially beneficial to those with type 2 diabetes, as lack of time is a frequently cited reason for not engaging in regular exercise. Bodyweight circuit training carries the potential to similarly improve health and metabolic function in persons with type 2 diabetes, and may do so with even a smaller accumulation of exercise because this type of exercise involves a greater percentage of the trainee's muscle mass compared with common forms of interval training (e.g., treadmill or cycle exercise). The purpose of this study is to quantify the effects of 3-4 sessions per week of bodyweight circuit training sustained for 5-10 minutes per session on health-related physical fitness and glucose tolerance/control in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes of at least 1 year
* hemoglobin A1c level between 6.0% and 10%

Exclusion Criteria:

* Currently engaging in a physical activity
* Currently taking exogenous insulin
* Undertaking a regiment or lifestyle modification intervention.
* Cardiovascular or Pulmonary diseases.
Topical Aluminium Chloride vs OnabotulinumtoxinA Intradermal Injections in Residual Limb Hyperhidrosis (Lower Limbs)

The aim of this study is to demonstrate onabotulinumtoxinA superiority to aluminium chloride for the treatment of residual limb hyperhidrosis.

After randomization patients will receive either OnabotulinumtoxinA once or topical aluminium chloride for 6 months. All patients will be evaluated during 3 study visits (week 4, week 12, week 24) and 1 phone call (week 18).

Eligibility Criteria:
Inclusion Criteria:

* Lower limb amputees suffering from residual limb hyperhidrosis with important cutaneous, functional, social and professional consequences, whatever the amputation cause
* HDSS ≥ 2 (Hyperhidrosis Disease Severity Score)
* Men and women
* 18 to 75 years old
* Written informed consent
* No exclusion criteria
* Social assurance

Exclusion Criteria:

* Botulinum toxin injection necessity for another disease
* Evolutive Central neurologic disease or myasthenia.
* Egg or albumine allergy
* Botulinum toxin or other excipients hypersensibility
* Legally protected Adults and people unable to give an informed consent. (article L-1121-8 from Public Health Code), people without freedom and people hospitalized without consent (article L-1121-6 from Public Health Code)
* Pregnant women or giving breast women (article L-1121-5 from Public Health)
* Patient refusing participating
* Previous hyperhidrosis treatment with aluminium chloride in the last 4 weeks
* Previous hyperhidrosis treatment with botulinum toxin in the last 2 years
* Other ongoing hyperhidrosis treatment
* Large residual limb eczematiform lesions: corticoids treatment (for example: Locapred® 1 application per day during 1 week then decrease).
* Aminoglycoside ongoing treatment
Acute Dose-dependent Effects of DMT in Healthy Subjects

N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min). In Ayahuasca, DMT is consumed together with harmala alkaloids that inhibit MAO to increase the oral bioavailablitity of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience and is currently being investigated. However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 and 65 years old
2. Sufficient understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during the study
6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions
7. Willing not to operate heavy machinery within 6 h of DMT administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2

Exclusion Criteria:

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medication that may interfere with the effects of the study medication
9. Tobacco smoking (\>10 cigarettes/day)
10. Consumption of alcoholic beverages (\>20 drinks/week)
Effects on Pain and Function of Orthopedic Manual Therapy in Patients With Painful Disc Displacement With Reduction

The objective of this study was to compare the short- and medium-term effects in pain and temporomandibular joint (TMJ) and function of implementing a manual therapy (MT) intervention treatment combined with a therapeutic exercise (TE) program, versus an isolated TE program and a non-intervention in patients with disc displacement with reduction (DDCR) with pain.

Study Design: The study adopted a single-blind, randomized, controlled clinical trial approach. Adults with disc displacement with reduction clinical diagnosis, pain and loss of function were eligible for inclusion.

Intervention: Patients in the study were randomized into three groups, 25 subjects to the manual therapy and therapeutic exercise group, 25 to the therapeutic exercise group and 25 to the no intervention group. Subjects were excluded if there was presence of surgical history, dentistry treatment and use of medication. The dependent variables were the presence of clicking, TMJ function, cervical disability, pain, and range of motion of the TMJ. Subjects in every group were assessed after four weeks of intervention and after eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Disc displacement with reduction diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders; in the last 30 days, any TMJ noise present during the exam or clicking detected with palpation during at least one of three repetitions of jaw opening, closing, protrusion, or laterotrusion movements.
* equal or greater than 30 mm on the VAS scale
* Age is greater than or equal to18 years.

Exclusion Criteria:

* Participants were excluded if they had received interventions of TMJ surgery or TMJ steroid injections in the previous month, a rheumatoid diagnosis, neurological or psychiatric diseases, or pregnancy.
PhysioTouch for Treatment of Radiation Fibrosis

A quarter of a million women will develop breast cancer (BC) in this year alone. Many of these women will have side effects as a result of their breast cancer treatment. Radiation Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. The PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of using the PhysioTouch in addition to current standard of care for treatment of BC-related RFS.


Eligibility Criteria:
Inclusion Criteria:

* History of radiation therapy for breast cancer
* Clinical or suspected RFS
* Reported functional impairments

Exclusion Criteria:

* Metastatic disease of soft tissue
* History of bilateral radiation therapy
* Previously diagnosed shoulder impairments not related to RFS
* Prior treatment with PhysioTouch
* Current or recent pregnancy
* Current breastfeeding
* Other contraindications to safe and meaningful participation at discretion of study team
Protocol for a Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries

The primary purpose of the Research Sample Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cell transplantation (HCT) or other cellular therapy.

Representatives of participating centers and investigators or research groups may request access to research samples contained in the Research Sample Repository for the purpose of conducting research including:

* investigating molecular explanations for histocompatibility or clinical outcomes through analysis of genomic, epigenetic, or other biomolecular data
* evaluating the factors that affect transplant or cellular therapy outcome
* studying the distribution of HLA tissue types in different populations
* studying the success of transplantation, cellular therapies or supportive care in the management of marrow toxic injuries
* performing de-linked (anonymous) research

Research samples will be accepted from the following four categories:

* Hematopoietic Cell or other Cellular Therapy Donors
* Cord Blood Units
* Hematopoietic Cell Transplantation or other Cellular Therapy Recipients
* Patients with Marrow Toxic Injury

Eligibility Criteria:
Eligibility to participate in the Research Sample Repository Protocol:

Hematopoietic Cell (HC) or Other Cellular Therapy Donors

* Donors are eligible to participate in the Research Sample Repository if they have donated or are scheduled to donate HCs or cellular therapy products to an allogeneic recipient either by a marrow harvest or by apheresis. This includes adults with and without decision making capacity and children.
* All donors registered on the National Marrow Donor Program (NMDP) Registry, regardless of whether they have been requested to donate a product for a patient, are eligible to participate in the Research Sample Repository.

Cord Blood Units (CBUs)

* Testable material from CBUs (Specimens) infused at treatment centers covered under the C. W. Bill Young Transplantation Program are eligible for inclusion in the Research Sample Repository. Material may be submitted by participating treatment centers, centralized laboratories and Cord Blood Banks.

Hematopoietic Cell Transplantation or Other Cellular Therapy Recipients

* All U.S. recipients of allogeneic or autologous HC transplants or cellular therapies are eligible to participate in the Research Sample Repository. This includes adults with and without decision making capacity and children.

Patients with Marrow Toxic Injury

* Any patient who is treated for a marrow toxic injury at a center participating in the NMDP's Radiation Injury Treatment Network (RITN) is eligible to participate in the Research Sample Repository. This includes adults with and without decision-making capacity and children.
* Eligible patients may have received support care only, growth factor support, hematopoietic stem cell transplant or other appropriate medical treatment for marrow toxic injury
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease

The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.

A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1.0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. On dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at baseline, on dosing Day 1 (or Day 2) and on dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on post-dosing Day 14.

Eligibility Criteria:
Inclusion Criteria:

* Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed orally or by feeding tube.
* Term or post-term infants with a body weight of \>800 gms.
* Pre-term infants with a corrected age of less than 44 weeks.
* Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with feedings)
* At least 7 days post-surgery without anticipated need for surgery during study
* No significant laboratory abnormalities

Exclusion Criteria:

* Unstable, clinically significant disease or abnormality
* Congenital anomaly of the upper gastrointestinal tract
* Clinical evidence of acute sepsis
* Cystic fibrosis
* Medical condition requiring subject to not be fed by mouth/gastric tube
Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery

the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* aged 18-60 yr
* undergo open abdominal cancer surgery

Exclusion Criteria:

* general contraindications for epidural analgesia,
* recent history (8 weeks) of, chemotherapy or radiation,
* chronic opioid use
Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth

Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge.

A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed.

We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.


Eligibility Criteria:
Inclusion Criteria:

1. Estimated birth weight \<1500 g and/or gestational age \<30+6 weeks (and)
2. Inborn (and)
3. Parental consent

Exclusion Criteria:

1. Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
2. Outborn;
3. Parental refusal to participate to the study.
Virtual Reality Exposure for Public Speaking Anxiety

This study aims to examine the efficacy of exposure using virtual reality (VR) for public speaking anxiety in young adults in two treatment arms: a one-session VR exposure therapy with a 4-week online transition intervention versus a three-session VR exposure therapy with a 4-week online transition intervention. Previous studies have demonstrated that one-session therapy (OST) is comparable to prolonged exposure-based therapies in terms of effectively reducing public speaking anxiety. Moreover, VR offers many benefits compared to in-person exposure, namely the ability to produce anxiety-evoking stimuli without having to leave the therapist's room. However, OST VR exposure has not been directly compared to prolonged VR exposure and not for public speaking anxiety.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-30 and studying in higher education;
* experiencing a significant level of public speaking anxiety (60+ on PSAS);
* able to use a computer and have access to the internet for the duration of the study;
* able to understand, write and speak in Lithuanian;
* available to participate in one or three in-person intervention sessions and can devote the time to participate in a 4-week online program following the intervention sessions.

Exclusion Criteria:

* a history of seizures or a history of epilepsy;
* other significant medical conditions that would prevent them from participating in the program;
* high levels of depression (Patient Health Questionnaire-9 rating of 15 and above and mentions of suicidal ideation) or other significant psychiatric conditions that would interfere with participation in the program;
* a tendency to have extreme seasickness reactions or a history of adverse physical reactions to virtual reality experiences or difficulty with or lack of stereoscopic vision;
* current involvement in other psychological interventions such as psychological counseling or psychotherapy;
* use of psychoactive drugs, unless stable for three months;
* current participation in other programs aimed at reducing public speaking anxiety.
Maternal Emotions and Diet in Pregnancy

This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.

The purpose of this research study is to understand how a mother's emotional state in pregnancy influences her biological response to food intake. Natural variation in emotional and mental state is frequently experienced in daily life, including during pregnancy. While the investigators understand that a healthy diet is important in pregnancy for maintaining blood sugar levels and other metabolic factors within normal ranges for optimal development of the baby, less consideration is given to the health effects of a mother's mental state during pregnancy. It may even be possible that, regardless of what a woman eats or drinks, the way her body responds to food may differ according to her emotional or mental state.

This research is particularly interested in understanding how the combination of maternal emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to test whether and how an individual's emotional response to a mental challenge of varying complexity during pregnancy modifies the body's metabolic response to a standard breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Hispanic ethnicity
* English and/or Spanish speaking
* Multiparous
* 28-30 week's gestation
* Pre-pregnancy BMI 25.0-34.9 kg/m2
* Singleton, intrauterine pregnancy
* Non-smoker
* Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)

Exclusion Criteria:

* BMI \<25.0 or ≥35.0 kg/m2
* \>30 week's gestation
* multiple pregnancy
* nulliparous
* present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)
* current smoker
* current psychiatric disorders or undergoing treatment/taking psychiatric medications
* Use of systemic/frequent corticosteroids or thyroid meds
* Diabetic or presence of other metabolic or neuroendocrine disorders
Repetitive Transcranial Magnetic Stimulation for "Voices"

OBJECTIVES:

I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms.

Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends.

Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends.

This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Inclusion criteria:

* Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
* Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
* Right-handed
* At least 4 weeks on stable antipsychotic medication

Exclusion criteria:

* history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
* history of epilepsy in first degree relatives
* estimated IQ less than 80
* unable to provide informed consent
* significant unstable medical condition
* current treatment with clozapine or bupropion
* cochlear implants or other metal in the head (surgical, etc.)
* history of cardiac arrhythmia
* cardiac pacemaker
* active drug or alcohol abuse within prior 6 weeks
* pregnancy