cyrilzakka/clinical-trials huggingface dataset:
Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)

Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD.

This double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and ADHD. Participants will be randomly assigned on receive placebo or Dextroamphetamine SR (60 mg/day) during a 12-week study period. All participants will receive weekly cognitive behavioral therapy.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent
* Generally good health except for problems related to drug use
* Meet DSM criteria for cocaine dependence and ADHD
* Have stable living situation

Exclusion Criteria:

* DSM diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine)
* Current use of prescription medications
* Females who are currently pregnant or nursing
* History of significant acute or chronic physical illness
* History of or current liver disease
* Existing cardiovascular disease
* Plans to leave metropolitan area within 3 months
* Probation or parole with constraints that preclude full study participation
Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery

Emergency laparotomies, which most often is performed due to high risk disease (bowel obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency surgical departments, however, give rise to 80 % of all postoperative complications. The 30-day mortality rates in relation to these emergent procedures have been reported between 14-30 %, with even higher numbers for frail and older patients. The specific reasons for these outcomes are not yet known, however, a combination of preexisting comorbidities, acute illness, sepsis, and the surgical stress response that arise during- and after the surgical procedure due to the activation of the immunological and humoral system, is most likely to blame. The complex endocrinological response and consequences of this response to emergency surgery are sparsely reported in the literature.

The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial and immunological changes after major emergency abdominal surgery, and to associate these changes with clinical postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
* Major gastrointestinal surgery on the gastrointestinal tract (see intervention definition)

Exclusion Criteria:

* Not capable of giving informed consent after oral and written information
* Previously included in the trial
* Elective laparoscopy
* Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
* Appendectomy +/- drainage or Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
* Non-elective hernia repair without bowel resection.
* Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
* Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
* Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma, esophageal pathology, pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
Study to Investigate Adrenal Crisis (Six-year Follow-up)

Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).

Despite established hormone replacement therapy, patients with chronic adrenal insufficiency are at risk of suffering from life threatening adrenal crisis with a considerable mortality. A former prospective study revealed a frequency of about 8 adrenal crisis/ 100 patient years and a crisis associated mortality of 0.5 per 100 patient years for patients; furthermore, patients with a previous adrenal crisis were at higher risk of crisis. The aim of the current trial was to reevaluate the frequency of adrenal crisis and risk factors by contacting the patients of the initial prospective study (see above) within a six-years follow-up. Patients are contacted by questionnaire and additionally by phone (in case of an adrenal crisis or implausible statements).

Eligibility Criteria:
Inclusion Criteria:

* Chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone)
* Written informed consent

Exclusion Criteria:

* Adrenal insufficiency due to adrenocortical carcinoma
* Adrenal insufficiency due to long-term pharmacological glucocorticoid treatment
* Glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency
* Age younger than 18 years
Effectiveness of Physical Exercise in Women With Fibromyalgia

Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.

This study will evaluate and compare the effectiveness of a supervised resistance muscular exercise (RME) , walking program (WP)and control group (just observation) in women with FMS during 16 weeks, on decrease of pain.

Participants will undergo an assessment including medical some questionnaires to assess their FMS symptoms at baseline, after 8 weeks, 16 weeks and 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Criteria diagnosis according ACR 1990
* Wash-out of medication specific for fibromyalgia for 1 month
* Only paracetamol 750mg will be allowed during the period of study.

Exclusion Criteria:

* Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation
The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection

Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and opioid-sparing effect. This study investigate the effect of intraopertaive ketamine administration on immune function in patients undergoing laparoscopic colorectal cancer resection.


Eligibility Criteria:
Inclusion Criteria:

* patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ
* patient scheduled for laparoscopic colorectal cancer resection

Exclusion Criteria:

* ASA physical status Ⅳ
* severe hepatorenal disease
* heart failure
* infection
* increased intracranial pressure, seizure
* preoperative chemotherapy
* immune or endocrine disease
* metastasis to other organ
* problem with communication
* pregnancy
* body mass index \> 35 kg/m2
EHR Embedded Comparative Effectiveness Studies--WWC

Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

EHR Embedded Comparative Effectiveness Studies-WWC will be held in the Weight and Wellness Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.

Eligibility Criteria:
Inclusion Criteria: Adults (\>18) able to consent, with sufficient fluency in English; Able to be appropriately treated with either the Healthy Lifestyles Program or Obesity Medicine Program as determined by a WWC provider -

Exclusion Criteria: Pregnant women; Prisoners; Children (\<18)

-
Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants

Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.

The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.

Eligibility Criteria:
Inclusion Criteria:

* Non-syndromic Infants with complete BCLP infants
* Infants less than 1 month of age.
* Males and females.
* Infants with displaced premaxilla
* Patients whose parents provided written consent for the study.

Exclusion Criteria:

* Patients above 1 month of age.
* Syndromic and systemically ill infants.
* Patients with unilateral cleft lip and palate.
* Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
* Medically compromised patients
* Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.
Machine Learning-based Early Clinical Warning of High-risk Patients

Through the early warning platform for inpatients established by our hospital, the various indicators of patients collected in real time are carried out for automated intelligent evaluation and analysis, early warning of high-risk patients to assess the impact on patient prognosis and the impact on the occurrence of adverse events in inpatients.

Build the early warning system.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who use ECG monitoring
2. Age ≥ 18 years old
3. Understand and sign an informed consent form

Exclusion Criteria:

* Pregnancy or lactation
Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19

A protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of COVID-19 disease

All COVID-19 patients who were admitted to emergency departments presenting with emergency surgical conditions were evaluated for assurance of having COVID-19 disease. Then, the appropriate anesthetic procedure was applied and the appropriate surgical intervention was performed.

Eligibility Criteria:
Inclusion Criteria:

* Assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

* No
AP Metabolism Transcriptomics

It is known from the literature that treatment with antipsychotic drugs (AP) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear cells.

In this pilot study we intend to evaluate the transcriptomic profile of children and adolescents who are undergoing treatment with antipsychotics and show metabolic disorders, in order to compare it to the profile of similar patients who do not use antipsychotics, but show metabolic disorders, or who use antipsychotics, but do not show metabolic disorders.

The hypothesis is that a different transcriptomic profile can be identified between the three populations under study, such as to allow to hypothesize that a series of transcripts can be used as early biomarkers of whether treatment with antipsychotics can induce metabolic disorders in the individual patient or not. This information could be used to improve the management of antipsychotic therapies in the direction of personalized medicine, reducing metabolic risks.


Eligibility Criteria:
Inclusion Criteria:

* age 5-17 years;
* group 1: antipsychotic users with metabolic disorders;
* group 2: antipsychotic users without metabolic disorders;
* group 3: non-antipsychotic users with metabolic disorders. The definition of antipsychotic use includes daily use for at least 3 months prior to enrollment.

The definition of metabolic disorders includes: BMI-Z for age, sex and height \> +1 Waist circumference \> 90th percentile for age, sex and height Diastolic or systolic blood pressure \> 90th percentile for age, sex and height Fasting blood glucose \> 99 mg/dl Fasting triglycerides \> 149 mg/dl Fasting cholesterol \< 41 mg/dl.

Patients with metabolic disorders are defined as those who meet at least one of the above criteria.

Patients without metabolic disorders are defined as those who do not present any of the above criteria.

Exclusion Criteria:

* presence of diagnosed genetic conditions known to alter energy metabolism and/or nutrition;
* presence of diagnosed eating disorders;
* habitual use of supplements known to alter energy metabolism and/or nutrition;
* concomitant use of drugs known to alter energy metabolism and/or nutrition.
PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

This is a randomized, double-blind, placebo-controlled, multicenter study. The key measure of effectiveness of the study drug will be determined using a 6-minute walk test. Eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase study (PHIRST-2). Study procedures for both studies (PHIRST-1 and PHIRST-2) will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age.
* Body weight at least 40 kg (approximately 88 pounds).
* Pulmonary hypertension (PAH) that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting SaO2 greater than or equal to 88%); with surgical repair, of at least 1 year duration, of a congenital systemic-to-pulmonary shunt.
* If on bosentan, must be at the maximal dose of 125 mg twice daily for a minimum of 12 weeks prior to screening and have an AST/ALT less than 3 times normal.
* History of PAH established by a resting mean pulmonary artery pressure greater than or equal to 25 mm Hg, pulmonary artery wedge pressure less than or equal to 15 mm Hg, and pulmonary vascular resistance greater than or equal to 3 Wood units via right heart catheterization
* Have World Health Organization functional class I, II, III or IV status.
* Have a qualifying 6-minute walk test distance at screening
* Have no evidence of significant parenchymal lung disease

Exclusion Criteria:

* Are nursing or pregnant.
* PAH due to conditions other than noted in the above inclusion criteria.
* History of left-sided heart disease.
* History of atrial septostomy within 3 months before study entry
* History of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug.
* History of symptomatic coronary disease.
* Have any therapy with a prostacyclin or analogue, L-arginine, phosphodiesterase (PDE) inhibitor, or investigational drug within 4 weeks before administration of study drug.
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)

This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.


Eligibility Criteria:
Inclusion Criteria:

* Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

  * According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
  * Height velocity (HV) ≤5.0 cm/yr.
  * GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma\<10.0ng/ml.
  * Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
* Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
* Receive no prior GH treatment within 6 months.
* Sign informed consent.

Exclusion Criteria:

* People with abnormal liver or kidney function (ALT\> 2 times the upper limit of normal value, Cr\> the upper limit of normal value).
* Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
* People with known highly allergic constitution or allergy to the drug of the study.
* People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
* Diabetic.
* Potential tumor patients (family history).
* Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
* Subjects took part in other clinical trial study within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Rabies Virus Neutralizing Activity and Safety of CL184, a Monoclonal Antibody Cocktail, in Simulated Rabies Post-Exposure Prophylaxis in Healthy Adults

Study design:

Single-blind (subject and observer-blinded), active-controlled, randomized \[6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV\], mono-center study

Study objectives:

Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects.

Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs).

This study was designed to explore and obtain further safety and RVNA data on CL184 in comparison to HRIG and placebo as part of a classical post-exposure prophylaxis (PEP) regimen. This regimen will be applied as simulated PEP regimen to healthy subjects (i.e. in a pre-exposure setting) in this study. A comparison with placebo combined with each rabies vaccine was included to differentiate between the contribution of immune globulin and vaccine and to investigate potential interactions between immune globulin and vaccine. RVNA provided by CL184 or HRIG, as well as vaccination response will be checked regularly during the study and booster doses can be applied after the study, if necessary. In addition pharmacokinetic data will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged ≥18 to ≤55 years
* Subjects free of obvious health-problems or with stable conditions or medications
* Body mass index between ≥18 to ≤30 kg/m2
* Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90
* Male subjects must agree that they will not donate sperm from the first check-in until Day 90
* Subject signed written informed consent

Exclusion Criteria:

* Prior history of active or passive rabies immunization
* Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing
* History and/or family history of clinically significant immunodeficiency or auto-immune disease
* Planned immunization with live vaccines during the coming 3 months after first dosing
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
Laparoscopic-robotic Hysterectomy for Uterine Transplantation in Live-donor Patient.

Currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. The aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.

Few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. This is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. In the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.

Eligibility Criteria:
Inclusion Criteria:

* Desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient);
* At least one pregnancy before

Exclusion Criteria:

* comorbidities that contraindicate a surgical procedure
* Women who do not understand the study;
* Women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.)
* ABO blood test mismatch between donor and recipient patient.
Investigation of Factors Affecting Upper Extremity Function in Healthy Young Adults

The aim of this study was to determine the effects of grip strength, motor imagery and two-point discrimination on upper extremity function in healthy young adults.


Eligibility Criteria:
Inclusion Criteria:

* Being a university student,
* Being between the ages of 18-35
* Not having any known upper extremity problems

Exclusion Criteria:

* Upper extremity surgery history
* Neurological problems
* Chronic diseases
Evolution of EIFL Following PPV

Various classification systems have been described for epiretinal membrane (ERM). One of them is a new OCT-based staging scheme based on displacement and reorganization of inner retinal layers called ectopic inner retinal layers (EIFL). We evaluated pre-and perioperative factors related to time for evolution of EIFL.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing idiopathic epiretinal membrane surgery

Exclusion Criteria:

* Patients undergoing seconder epiretinal membrane surgery