cyrilzakka/clinical-trials huggingface dataset:
PASOS: Improving the Health of Immigrant Workers

This is a cluster randomized trial (CRT) to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Randomization is at the farm ranch level. Individuals at intervention ranches will receive a multi-week curriculum at the work-site on diabetes, diet and physical activity and optional supplemental sessions in the evening and weekends. The investigators will adopt the intent-to-treat principle for the primary analysis. Individuals on control ranches will receive no health educational instruction. The primary outcome is BMI. The investigators hypothesize that intervention ranches will achieve significant improvement in obesity and diabetes risk factors as compared to control ranches.


Eligibility Criteria:
Inclusion Criteria:

* Work at Reiter Brothers Inc. (RBI), a partner, or affiliate company
* Able to speak and understand Spanish
* Willing to attend weekly sessions for length of intervention
* Plan to stay in the area for the next three months

Exclusion Criteria:

* Workers without Spanish language comprehension
* Pregnant women and those planning a pregnancy within six months
* Women who are breastfeeding, unless discontinuing breastfeeding within one month
* Individuals who, without health care provider approval, are: unable to undertake moderate physical exercise, taking medicine for high blood pressure or heart conditions, have bone or joint problems, lose consciousness or fall due to dizziness, or have developed chest pain within the last month
* Individuals taking medications that affect weight
* Individuals with therapeutic diets
* Diabetic status determined by health care professional after HbA1c testing result is \>6.5%
* If spouse / cohabitant is already in the study
Social Goals and Individual Incentives to Promote Walking in Older Adults

The goal of this randomized and controlled trial is to test whether a financial incentive of a donation to achieve a social goal is more effective to motivate and sustain a daily walking habit than the same dollar value given to an older adult. The investigators will achieve this using a novel computer platform utilizing a digital pedometer-internet interface.


Eligibility Criteria:
Inclusion Criteria:

* Adult 65 years of age and older
* Can read and speak English
* Access to a personal computer with high-speed internet connection and functional Universal Serial Bus (USB) port for the study duration
* Able to walk 1/4 mile (i.e., 2 to 3 blocks) without stopping
* No pedometer use in last 30 days

Exclusion Criteria:

Major medical conditions including:

* serious heart and lung diseases
* diabetes requiring insulin therapy
* severe arthritis
* neurologic disorders
* dementia
* heavy alcohol use
* recent knee or spinal surgery
Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease

We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. For these purposes, a blinded sham controlled randomized controlled trial will be performed.

Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using remote controls, smartphone or tablet. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be tested.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed PD
2. Hoehn \& Yahr I to IV
3. Age 50-80 years old
4. written and signed informed consent
5. dexterous difficulties-

Exclusion Criteria:

1. Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA \< 21)
2. Inability to understand the scope of the study and to follow study procedures according to the protocol e.g. complete questionnaires (i.e. due to cognitive problems)
3. Exclusion criteria for TMS and Sham application, such as current pregnancy, personal history of epilepsy or epileptic fits, and any psychiatric, neurologic, or medical history.
4. Participation in another interventional trial.
Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%

This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-desirable condition that leads to higher mortality rates and longer hospitalization times. One group will receive the 0.12% chlorhexidine mouthwash and the other group will receive the 2% chlorhexidine mouthwash.


Eligibility Criteria:
Inclusion Criteria:

* Patients with minimum required age of consent that were admitted to the intensive care unit and who received at least 48 hours of mechanical ventilation.

Exclusion Criteria:

* Patients who wish to withdraw consent and leave the study.
Physical Exercise and Depressive Symptoms in Moderately or Severely Depressed Adults

This study is a comparative trial comparing the time course of depressive symptoms between moderately and severely depressed participants over a 10-week long exercise program

Sixty depressed French adults (34 with symptoms of moderate intensity and 26 with symptoms of severe intensity as defined by the PHQ-9 cutting scores) voluntarily participated in our comparative trial.

A control group (waiting list) of n = 16 including 8 severely depressed and 8 moderately depressed participants received no physical exercise.

For the remaining 44 participants (26 with moderate-intensity depressive symptoms and 18 with high-intensity depressive symptoms), two weekly Nordic Walking sessions of 1h were performed for 10 consecutive weeks.

Depressive symptoms were assessed using standard self-report questionnaires at various time points: 1/ enrollment (using the PHQ-9), and then (2) just before the beginning of the exercise intervention (pre-intervention; using the BDI-II), 2/ at the end of Week 5 (mid-intervention; using the BDI-II), and 3/ the day following the end of the exercise program (post-intervention)

Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 (Kroenke et al., 2001) score of 10 or above

Exclusion Criteria:

* medical contraindication to moderate-intensity aerobic exercise
* inability to read French language
Growth and Safety of a Two-stage Feeding System in Preterm Infants

This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
2. Infant's birth weight ≤1500 g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart.
3. Infant's gestational age ≥ 27 weeks and ≤ 32 weeks.
4. Infant is clinically stable.
5. Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life.

Exclusion Criteria:

1. Parents not willing / not able to comply with the requirements of study protocol.
2. Infants experiencing early onset sepsis.
3. Major congenital or chromosomal abnormality known to affect growth.
4. Preterm infants experiencing liver failure.
5. Peri-/intra-ventricular haemorrhage.
6. Infant requiring prolonged (more than 3 doses) of steroid treatment.
7. Infants' participation in another interventional clinical trial.
Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs

hCG and GnRH agonist can be used to induce final oocyte maturation and ovulation in IVF cycles. These two approaches will be compared in this study in terms of pregnancy rates and embryological data using patients with hyper-response to IVF drugs.

hCG is commonly used for the substitution of the endogenous LH surge to induce oocyte maturation and ovulation induction in ovarian hyperstimulation protocols for in vitro fertilization (IVF). However, hCG is related to the occurrence of the ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening complication and hyper-responding patients are particularly in high risk. An alternative to exogenous hCG is the administration of a GnRH agonist inducing an endogenous rise in both LH and FSH levels due to the initial flare effect.

Comparisons: Pregnancy rates and embryological data will be compared from hyper-responding patients receiving either GnRH agonist (Arvekap) or hCG (Pregnyl) for ovulatrion induction following a GnRH antagonist treatment cycle.

Eligibility Criteria:
Inclusion Criteria:

* Hyper-responder patients (\>20 oocytes retrieved)

Exclusion Criteria:

* Normal responders
* Poor responders
* PCOS
Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections

Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.

This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.

Eligibility Criteria:
Inclusion Criteria: Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.

-

Exclusion Criteria: Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.

-
Development of Exercise Protocol for Scoliosis Using Surface Electromyography(S-EMG)

There has been much effort in recent years to better understand the causes of idiopathic scoliosis (IS). Some studies suggested muscle imbalance as a cause of scoliosis based on asymmetric muscular activation. Surface electromyography can evaluate asymmetrical muscular weakness. Therefore, the peak amplitude values can be used to compare the side to side differences in paraspinal muscles. From these findings the investigators improve the exercise method of IS according to muscle weakness and curve pattern.

Design: Prospective study Setting: hospital rehabilitation department the investigators will check the muscular activation at bilateral paraspinal muscles with surface electromyography and curve type with simple radiography.

Intervention: After that the investigators educate asymmetrical stabilization exercise according to muscle weakness and curve pattern.

Main outcome measures: Cobb angle

Eligibility Criteria:
Inclusion Criteria:

* X-ray shows a cobb angle of 10 degrees or higher.
* Patients 8 and older.

Exclusion Criteria:

* Patients with spinal surgery
* Patients with scoliosis caused by cerebral palsy, muscle paralysis, polio, congenital spinal cord abnormalities, etc.
* Cobb angle less than 10 degrees and more than 40 degrees
* Patients with acute back pain
Study of Circulating Markers in Serum of Patients Treated for Metastatic Colorectal Cancer

The primary purpose of the study is to confirm the results of previous study about the usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer (J Clin Oncol 2008;26:3681-6). The secondary purpose is to evaluate the value of circulating free mutant DNA and circulating tumor cells (CTC) and their variations during the treatment.

Prospective cohort study of patients treated with systemic chemotherapy for unresectable metastatic colorectal cancer. The chemotherapy monitoring is currently based on radiological evaluation (RECIST criteria) and clinical evaluation. Circulating markers as CEA, free mutant DNA, CTC represent an alternative approach. A previous study on usefulness of the serum Carcinoembryonic antigen (CEA) kinetic for chemotherapy monitoring in patients with unresectable metastasis of colorectal cancer has been published (J Clin Oncol 2008;26:3681-6). The present study is designed to validate the previous data. The secondary purpose is to evaluate variations of free mutant DNA and CTC during the chemotherapy. Patients will be included prospectively in 4 centers in Normandy. All systemic chemotherapy and biotherapy validate in this clinical situation by the French National Cancer Institute (INCa) is accepted. Evaluation of response based on RECIST criteria will be performed every 3 months. Blood samples for CEA and CA 19-9 levels will be performed every courses of chemotherapy during first 3 months. Blood samples for detection of free mutant DNA and CTC will be performed at day 1 and 42 of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patient has Stage IV colorectal adenocarcinoma histologically proved
* Patient has at least one measurable lesion
* Patient has performance status 0-2 on the WHO performance scale
* Patient is male or female, and \> 18 years of age
* Patient has agree to participate by giving written informed consent

Exclusion Criteria:

* Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Laparoscopic Lens Defogging Using Anti-fog Solution, waRm Saline, and Chlorhexidine Solution

The aim of this study is to compare three popular methods of minimizing or reducing laparoscopic lens fogging (LLF) by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.

The physiology behind laparoscopic lens fogging (LLF) is well understood based on meticulous experiments outlining the role of temperature and humidity. Despite many efforts, including uses of warm saline, various anti-fog agents, chlorhexidine, betadine, and rubbing the lens on serosal surfaces, to reduce LLF, there remains no consensus as to which method is superior to prevent LLF. Furthermore, most previous studies were experimental trials conducted in a simulation model or a non-human in vivo model or an expert's commentary based on their clinical experiences , and there was no randomized controlled trial focusing LLF in human model. Therefore, this randomized trial aimed to compare three popular methods of minimizing or reducing LLF by heating lens using warm saline, applying anti-fog agent to lens, and rubbing lens with chlorhexidine in laparoscopic gynecologic surgery.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* the absence of pregnancy at the time of surgery

Exclusion Criteria:

* allergy to chlorhexidine or anti-fog solution
* anticipating cases of abrupt change in intra-abdominal humidity such as hemoperitoneum and profuse ascites
* extremely short or long operative time (\<20 min or \> 180 min) affecting the frequency of LLF
* unavailability of the surgical recording equipment for laparoscopic procedure.
Deep Brain Stimulation in Patients With Dystonia

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN)for primary dystonia.

Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). Deep brain stimulation (DBS) has been shown to be an effective treatment in patients with medically refractory dystonia and is currently approved for both the GPi and STN targets under a humanitarian device exemption (HDE) for use in segmental and generalized primary dystonia as well as focal cervical dystonia. GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study are to evaluate the safety and efficacy of STN DBS for dystonia. Up to twenty-five patients will be screened, consented, and enrolled in this study. All patients will undergo bilateral STN DBS for dystonia. Participants will be evaluated pre- and postoperatively with standard dystonia rating scale Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects and will be logged for safety monitoring. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.

Eligibility Criteria:
Inclusion Criteria:

* Refractory primary dystonia diagnosed by a movement disorders neurologist
* Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
* Age 7-80 years (UCSF patients) and 18-80 (VA patients)

Exclusion Criteria:

* Patients considered at high risk for elective neurosurgery because of co-morbid conditions
* Brain MRI showing extensive brain atrophy or small vessel ischemic disease
* Pregnancy
* Inability to tolerate awake microelectrode-guided neurosurgery
* Inability to follow up with post-operative study visits
* Inability to speak or read English
* Patients with a score of 4.5 or lower on the BFMDRS movement scale
* Patients with Secondary dystonia
Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth

This study aimed to compare the effects of mandibular and intraligamentary anesthesia techniques on pain scores during restorative treatment of permanent mandibular molars in pediatric patients. Additionally, comparing the anesthesia techniques in terms of injection pain, the success of anesthesia, postoperative complications, and the subjects' preference was planned.

This randomized, controlled, cross-over, single-blind, split-mouth study was conducted on 78 subjects aged 6 to 12 years. Subjects with enamel-dentin caries on the bilateral permanent mandibular molar were included.

First, the subjects who met the inclusion criteria in the study were included in 2 study groups according to age, gender, dental experience, DMFT / dmft values, and ICDAS II and radiographic evaluation criteria. Two different anesthesia techniques were applied to the right / left permanent first molar teeth of the patients included in the study, with an interval of one week. The subjects have been divided into two groups as 39 subjects were Group 1 received intraligamentary anesthesia in the first visit, and 39 subjects were Group 2 received mandibular anesthesia in the first session. The pain perception rates of the patients during the injection and treatment phases were recorded subjectively using a visual analog scale and Wong-Baker FACES pain rating scale. Heart rate and arterial oxygen saturation were determined as the physiological parameters. The quality of anesthesia and success were evaluated by the operation at the end of each visit. Complications (pain, raised teeth, hematoma, trauma due to lip/tongue bites, swelling, infection, and bleeding) were explained to the patients after anesthesia. They were asked to take note of the complications they encountered. Postoperative complications were recorded by calling the cases 1 day after the 1st and 2nd visits. At the end of the second visit, anesthesia preference of the patient was asked and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with American Society of Anesthesiologists score I (ASA I)
* Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
* Subjects with indication of similar restoration treatment on bilateral first permanent mandibular molars
* Subjects whose plaque index score of 0 (no plaque) and 1
* Subjects whose gingival index score of 0

Exclusion Criteria:

* Allergic to the local anesthetics or sulfites
* Subjects with cholinesterase deficiency
* Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
* Subjects who need to use sedatives or other medications during dental procedures
Serial Measurement of Capillary Blood Lactate in the Management of Sepsis

Determination of capillary lactate by using "point-of-care" technique is accessible, fast and allows to quantify the circulatory and metabolic dysfunction caused by sepsis. Compared to conventional assay techniques in arterial blood, capillary assay technique may have an increased susceptibility to metabolic alterations induced by sepsis in its initial stages. This increased sensitivity is not necessarily relevant in the management of the most serious patients for whom the diagnosis is obvious, but it could be very useful in patients for whom a diagnosis of severe sepsis or shock have not yet been adopted, particularly to help better identify patients who would require intensive management and avoid the installation of these serious disorders.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Installation without any plausible explanation of at least one of the following clinical criteria:

  * Chills, fever, mottling, respiratory rate\> 20/min; Sat02 \< 90% or \> 94% with more than 4l O2, heart rate \> 90/min,systolic blood pressure \< 100 mmHg or 40 mmHg lower compared with normal values, Glasgow coma score \< 14. or: .a combination of two (or more) of clinical and laboratory criteria for sepsis.
* Signed informed consent form

Exclusion Criteria:

* Need in its current treatment of aerosol administration of beta agonists at a frequency greater than one per 8 hours;
* Targeted therapeutic measures have already stated for more than 60 minutes;
* Diagnosis other than Sepsis;
* Malignant neoplasm or other progressive disease and expected survival was less than 3 months.