cyrilzakka/clinical-trials huggingface dataset:
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection

Examine the ability of thymopentin (Timunox) to:

Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded.

Concurrent Medication:

Excluded within 90 days of study entry:

* Zidovudine (AZT).

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Patients must not have:

* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia (\< 75000 platelets/mm3).

Patient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot.

* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.
* Patients with HIV "wasting syndrome" are included.

Intravenous drug abuse.
The Effects of Types of Fruits and Vegetables on Vascular Function

The CIRCUS study is a randomised controlled, cross-over trial to evaluate the effects of increased intakes of citrus fruits and cruciferous vegetables on vascular function in 36 untreated, prehypertensive participants.

The study comprises three 14-day dietary intervention periods, preceded by one week run-in period and separated by one week wash-out periods, 9 weeks in total. The diet will be fully controlled and provided by the researchers. Participants will receive in random order three interventions:

* 1 portion of fruits plus 1 portion of vegetables, of commonly consumed types per day. Intakes are at 25th percentile of UK consumption and will exclude citrus fruits, cruciferous and allium vegetables.
* 4 portions of fruits plus 4 portions of vegetables, of commonly consumed types per day excluding citrus fruits, cruciferous and allium vegetables.
* 4 portions of citrus fruits plus 4 portions of cruciferous vegetables per day.

Eligibility Criteria:
Inclusion Criteria:

* 40 - 65 years
* Average systolic blood pressure of 125-140 mmHg at 2 measurements separated by \>30 minutes
* No use of antihypertensive medication
* No reported current or previous diabetes mellitus, (secondary) hypertension, or metabolic, cardiovascular, renal, liver, thyroid, gastrointestinal diseases
* Body Mass Index between 20 - 35 kg/m2
* Non-smoker
* Average fruit and vegetable consumption of \<4 portions per day (UK average, 40-65 years), or willing to reduce habitual daily fruit and vegetable intake.

Exclusion Criteria:

* Any medication likely to interfere with energy metabolism, appetite regulation and hormonal balance.
* Excessive alcohol intake of \> 21 units per week (females) or \>28 units per week (male) and not willing to limit alcohol intake to maximum of 1 unit/day
* Physical activity of \>=10 hours/week of moderate to vigorous physical activity
* Weight loss or gain of \>=3 kg in the preceding 3 months
* Use of dietary supplements or unwilling to stop supplement use \>= 2 weeks before enrolment and during intervention
* Pregnancy or lactation
* Intervention specific factors, including:

  * Unable or unwilling to consume provided diets during the intervention
  * Unsufficient storage space for provided diets
  * Food sensitivities or vegetarian/vegan diet by choice
  * Participation in another intervention study at the same time
  * Living \> 15 miles from the Imperial/NIHR Clinical Research Facility at Hammersmith Hospital
  * No signed informed consent
SR-WBV Training for Frail Elderly in the Skilling up Stage

This randomized controlled study aims to examine long term effects in the skilling up phase over 4 weeks on physical functional performance and strength of mechanical SR-WBV and dance therapy intervention in a frail elderly population.

This study is based on the guideline of falls management exercise programs (FaME; from Skelton and Dinan).

The goals:

Skilling up: improvement in neuromuscular control, postural control and strengthening of large muscle groups of the lower extremity.

Training Gain: improvement of functional abilities. Maintaining the Gains: muscle growth, improvement of bone density and multi-sensory exercises.

First, a pilot study was conducted with untrained elderly ("Effects of stochastic resonance therapy on postural control in the elderly population" (KEK Bern: No.228/09, Clinical Trial Registry: NCT01045746). Following, a second pilot study was conducted with frail elderly (Application of Whole-body Vibration With Stochastic Resonance in Frail Elderly: The Effects on Postural Control Clinical Trial Registry:NCT01543243).

It was found that the selected chosen form of recruitment (presentation and advertisement) and the measurements methods are suitable for untrained elderly. But for frail elderly the chosen form of recruitment and the measurement methods are not sufficient.

For this study, measurement parameters for functional performance and strength will be used.

Goals of the study in the skilling up phase:

1. Feasibility
2. Study the effect on physical functional performance
3. Study the effects on muscle strength.

The participants will be recruited in Canton Bern - Swizerland and will be randomly allocated to an intervention group or sham group.

Eligibility Criteria:
Inclusion Criteria:

* RAI (Resident Assessment Instrument) \>0
* live in canton Bern
* in terms of training load be resistant.

Exclusion Criteria:

* acut joint disease, acut thrombosis, acute fractures, acute infections, acute tissue damage, or acute -- surgical scars
* seniors with prosthesis.
* alcoholic
* acute joint disease, activated osteoarthritis, rheumatoid arthritis, acute lower limb
* acute inflammation or infection tumors
* fresh surgical wounds
* severe migraine
* epilepsy
* acute severe pain
Heart Failure and Risk of Re-Admissions Determined by Abnormal REVEAL Parameters

The purpose of the Heart Failure and Risk of re-Admissions Determined by Abnormal REVEAL Parameters (HF RADAR) study is to evaluate the ability of cardiac rhythm (Cardiac Compass) data to predict future cardiac events in heart failure (HF) patients recently discharged after a hospitalization for heart failure who have or plan to have a implanted loop recorder (ILR), specifically, the Reveal XT device. The study will enroll 40 HF patients (with LV function ≥ 40%) admitted to an acute care facility (observation status or hospital stay) for heart failure who either have a Reveal XT device in place or plan to have the ILR device inserted for clinical indication within 14 days of discharge from the hospitalization. HF patients will be followed for 6 months. Device date will be captured during normal clinic visits and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

1. Men and non-pregnant/non lactating women ≥ 18 years.
2. Admission to hospital or observation unit for worsening heart failure.
3. Has a Reveal XT device or has plans for a device implant for a clinical indication within 14 days of discharge.
4. Ejection fraction ≥40% by echocardiogram within 6 months of enrollment
5. Able to participate in the study for at least 6 months.
6. Not currently enrolled in another study.
7. Able to provide informed consent and complete scheduled study visits.

Exclusion Criteria:

1. Has a clinical indication for a therapeutic cardiac device (pacemaker or defibrillator)
2. History of permanent atrial fibrillation or atrial flutter.
3. History of uncontrolled hypertension (high blood pressure)
4. Has a previously implanted cardiac device (pacemaker or defibrillator) in place.
5. Stage IV or V chronic renal dysfunction (estimated GFR \<25 ml/min per 1.73 m2)
6. End-stage (Stage D) HF, including chronic ionotropic drugs infusions or left ventricular assist device
7. Waiting on the transplant list as an UNOS status 1A or 1B patient
Pharmacokinetics of Carbapenem Antibiotics in Obese Patients.

Tissue kinetics of ertapenem and meropenem in fatty tissue, intraperitoneal fluid and plasma.

The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs
* BMI more or even 40
* written informed consent

Exclusion Criteria:

* BMI \< 40
* pregnancy or lactation in women
* emergency surgery
* history of serious allergy or intolerance to β-lactam antibiotics
* systemic antimicrobial therapy with ceftazidime (internal standard of high-performance liquid chromatography / mass spectrometry) within a 7 days period prior to study entry
* ongoing intraabdominal infections
* terminal illness
* severe diseases of the liver, e.g. cirrhosis of the liver with ALT or AST \> 6 x upper limit of normal (ULN) and bilirubin \> 3 x ULN
* severe renal insufficiency with a creatinine clearance ≤30 mL/min.
* neutrophil count \< 1000 cells/mm3
* platelets \< 75000 cells/mm3
* coagulation studies (INR) \> 1.5 x ULN
* ongoing chemotherapy and/or radiotherapy
* ongoing therapy with valproin acid (in case of ertapenem administration).
Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone

Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise the drawbacks of the golden standard of haemorrhoidal treatment, conventional haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus prevent the haemorrhoidal zone from being part of the continence system. Apart from inappropriate application of this surgical alternative for higher grade haemorrhoids, high recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation technique itself. This is a prospective randomised controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with symptomatic grade III haemorrhoids.

All consecutive patients with symptomatic grade III haemorrhoids are randomly allocated to one of the two study arms: (A) DG-HAL with mucopexy or (B) mucopexy alone. Endpoints are pain, faecal incontinence, bleeding, residual prolapse and vascularisation of the anorectal vascular plexus. Vascularisation of the anorectal vascular plexus is assessed by transperineal contrast enhanced ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* grade III haemorrhoids
* ≥18 years of age

Exclusion Criteria:

* malignant gastrointestinal disease
* inflammatory bowel disease
* any type of proctological intervention (i.e., fistula surgery)
* recurrent haemorrhoidal disease
* anorectal trauma in the history
A Single Ascending Dose Study of CD101 IV in Healthy Subjects

A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.

Eligibility Criteria:
Inclusion Criteria:

* Males surgically sterilized or using contraception,
* No significant findings on physical, ECG, clinical laboratory tests,
* BMI between 18.5 - 32.0,
* Must provide informed consent

Exclusion Criteria:

* Females of child bearing potential,
* Signs and or symptoms of an acute or chronic illness,
* Use of prescription medications within 28 days,
* Use of OTC, supplements, and herbals within 14 days,
* Current smoker
* Previous participation in a clinical study within 28 days
Safety and Efficacy of Hunterase

The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients \< 6 years old.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has a diagnosis of Hunter syndrome based upon biochemical criteria:

   * as measured in plasma, leukocytes, or fibroblasts,

     * a deficiency in iduronate-2-sulfatase (I2S) enzyme activity of ≤ 10 % of the lower limit of the normal range
   * That corresponds to one or more of the following:

     * a normal enzyme activity level of one other sulfatase
     * Confirmed as MPS2 by genetic test results
     * shows clinical symptoms/ visible signs of MPS2
2. \< 6 years old and male
3. Patients who are able to comply with the study requirements
4. The patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study

Exclusion Criteria:

1. The patient has had a tracheostomy
2. The patient has known severe hypersensitivity or shock to any of the components of idursulfase
3. The patient has received treatment with another investigational therapy within 30 days prior to enrollment
4. History of a stem cell transplant
5. The patient has known severe hypersensitivity or shock to any of the components of test drug(excipient etc)
The Pathophysiology of Tourette Syndrome: a Multimodal Study

The purpose of this study is to characterize the functional and anatomical connectivity changes in Tourette syndrome and its relation with iron deficiency.

Tourette syndrome (TS) is a childhood-onset chronic neuropsychiatric disorder with an increasing prevalence (range 0.05-3%).The investigators previous study showed that lower serum ferritin and iron levels in children with Tourette syndrome than in healthy children. The exact mechanism explaining how iron deficiency contributes to the pathophysiology of TS is unclear.One question is whether or not peripheral iron deficiency in children with Tourette syndrome can inflence the brain extrapyramid structure and resting state brain function？Another question is how well peripheral iron indices correlate with central iron content？ The third question is for TS children with peripheral iron deficiency, oral iron supplement (5mg/Kg/d) at least 8 weeks, the peripheral iron indicies return to normal levels, how the brain iron contents and the relative structure and brain function change?, To test the above-metioned hypothesis, functional magnetic resonance imaging (fMRI) , diffusion tensor imaging (DTI) and susceptibility weighted imaging (SWI) are applied to investigate the volume change of extrapyramid structure such as caudate nucleus and putamen, resting-state brain function and brain iron content before and after oral iron supplementation in TS children with peripheral iron deficiency, TS children with peripheral normal iron levels and normal healthy controls. The investigators hope to confirm that iron deficiency may play a causal role in the dopamine metabolism and it helps to further explore the pathophysiology of Tourette syndrome and also would contribute to significant advance in the therapeutic option for TS children with peripheral iron deficiency.

Eligibility Criteria:
Inclusion Criteria:

* 6-12 years old
* Characterized by vocal tic and muscle twitch
* No positive signs was found through neurological examination, no significant psychomotor retardation,

Exclusion Criteria:

* Hepatolenticular degeneration
* Rheumatic chorea
* Myoclonic epilepsy
* History of mental disease or brain trauma
Effect of Remimazolam and Propofol on Hemodynamic Stability in Prone Position

Most of the major spinal surgeries are performed in the supine position, which causes a decrease in stroke volume and cardiac index, which leads to the occurrence of hypotension during surgery. Postoperative hypotension causes an imbalance in the supply and demand of oxygen, leading to postoperative myocardial infarction or acute renal damage, and may increase mortality one year after surgery. Propofol, which is most commonly used for total intravenous anesthesia, can further increase the incidence of hypotension during surgery. Therefore, there is a continuing demand for an anesthetic agent that is more hemodynamically stable. Remimazolam, an ultra-short acting benzodiazepine that has a similar structure to midazolam, but whose activity is terminated by esterase hydrolysis, is expected to have less hemodynamic effects than propofol. Therefore, the purpose of this study is to investigate the effect of general anesthesia using remimazolam and general anesthesia using propofol on hemodynamic safety during surgery in patients undergoing major spinal surgery in the supine position.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status: 1-3
* age: 19-80 years
* patients who are scheduled to undergo a major spine surgery in the prone position

Exclusion Criteria:

* patients who refuse to participate
* body mass index: \<15kg/m2 or \>35kg/m2
* patients with uncontrolled hypertension, hyperthyroidism, severe cardiac disease
* patients who are contraindicated to the use of remimazolam including severe hepatic disease, acute glaucoma, shock, acute alcohol intoxication
* allergic to propofol and midazolam
* patients who are judged unsuitable to participate in the study for other reasons by medical staffs
Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder (Pilot Study)

The purpose of this study is to assess the effects of active intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG) measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users


Eligibility Criteria:
Inclusion Criteria:

* CUD diagnosis

Exclusion Criteria:

* moderate or severe criteria for substances other than cocaine, cannabis, or nicotine
* unstable psychiatric disorder
* medical conditions contraindicated to TMS (e.g., medical implants, history of seizure or seizure disorder, medications lowering the seizure threshold, neurological conditions, moderate-to-severe heart disease)
* pregnancy
* hairstyles incompatible with the EEG net
* head injury with loss of consciousness
Mobile Diabetes Management

The Mobile Diabetes Intervention Study trial is evaluating a diabetes coaching system, using mobile phones and patient/ physician internet portals to allow patient-specific treatment and communication by their primary care physician. We hypothesize that timely information provided to patients and their physicians can result in reduction of A1c over 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic \[patient\]
* A1c equal to or greater than 7.5 \[patient\]
* 18-64 years of age at time of recruitment \[patient\]
* Access to the internet (does not need to be at their home, elsewhere is fine e.g. work) \[patient\]
* E-mail account \[patient\]
* Must speak English \[patient\]

Exclusion Criteria:

* No insulin pump \[patient\]
* No current alcohol or drug abuse- must be sober 1 year \[patient\]
* Not currently pregnant \[patient\]
* No terminal diagnosis \[patient\]
* No dementia or Alzheimer's \[patient\]
* No active chemotherapy \[patient\]
* No significant hearing impairment \[patient\]
* Poorly corrected vision that would impede use of phone \[patient\]
* No mute or aphasia \[patient\]
* No diagnosis of schizophrenia, bipolar disorder, or major psychosis \[patient\]
* No Medicaid or Medicare
* No uninsured
Monocanalicular Versus Bicanalicular Intubation in the Treatment of Congenital Nasolacrimal Duct Obstruction

The aim of the study was to compare the success rate of monocanalicular intubation versus bicanalicular silicone intubation in congenital nasolacrimal duct obstruction in children aged between 10 and 36 months.

In a prospective, nonrandomized comparative study, the monocanalicular intubations (MCI; n=35 eyes) through the inferior canaliculus or bicanalicular intubations (BCI; n=35 eyes) were performed under general anaeshesia in children between 10 and 36 months of age suffering from congenital nasolacrimal duct obstruction (CNLDO). The tubes were removed 3-4 months after the tube placement. Thereafter, the children were followed up for 6 months after the removal of tubes. The therapeutic success was defined as the fluorescein dye disappearance test grade 0-1 corresponding with a complete resolution of previous symptoms. The partial success was defined as improvement with some residual symptoms.

The complete and partial improvement was achieved in 31/35(88.57%) in group I with BCI and in 34/35 (97.14%) in group II with MCI, respectively, and it was not significantly higher (p=0,584).

Complications occurred in both groups. Dislodgement of the tube and premature removal was observed in four cases in group I (BCI), the loss of the tube was observed twice in group II with MCI.. Canalicular slitting was observed in 5 eyes in the group with BCI. Granuloma pyogenicum observed in 2 cases with MCI revealed in a few weeks after the tube removal. Corneal erosion in the inferior medial quadrant was observed in 1 eye with MCI and revealed in a few days after the local treatment without tube removal.

Conclusions: Both MCI and the BCI are effective methods how to treat CNLDO. The advantage of the MCI shows the lower incidence of the canalicular slit and easy placement.

Eligibility Criteria:
Inclusion Criteria:

* congenital nasolacrimal duct obstruction (CNLDO)
* resistance to a conservative therapy and/or probing

Exclusion Criteria:

- children younger than 10 months of age