cyrilzakka/clinical-trials huggingface dataset:
Physiological and Dietary Characteristics of Boys and Girls High School Basketball Players

In a population of boys and girls high school basketball players, the primary objectives are to assess 1) bone mineral density and vitamin D status, and 2) energy intake and dietary quality.

The secondary objectives are to assess 1) nutrients related to bone health (calcium, magnesium, vitamin K, protein) and 2) protein intake over the day.

Data collection takes place pre-, mid-, and post-season.

This study will assess the dietary intake male and female 14-19 year old student athletes, specifically energy intake and dietary quality (i.e. how closely do their diets meet recommendations).

Investigators hypothesize that vitamin D status will be suboptimal in most participants though bone density will be normal.

Investigators hypothesize that participants will maintain energy balance over the course of the season (no significant changes to body mass or body composition) but dietary quality will not meet recommendations.

Eligibility Criteria:
Inclusion Criteria:

1. Females and males between the ages of 14-19 years old.
2. Non-smoker
3. Currently enrolled in the IMG basketball program.
4. Willing to fast overnight prior to testing.
5. Willing to do a finger stick for the Vitamin D assessment.
6. Able to give verbal and written informed consent for participation as well as obtain parental consent if \<18 years of age.
7. If an athlete would like to participate but English is not their first language, we will liaise with an interpreter on the IMG campus to inform him / her of the study protocol and procedures.

Exclusion Criteria:

1. Expulsion from school for any reason.
2. Leaving the IMG basketball program.
3. Pregnant or planning to become pregnant
Clinical Study of Curcumin in Preventing Postoperative Adhesion of Bilateral Vocal Cords

To provide a novel therapy idea and method to solve the clinical problem of postoperative adhesion of bilateral vocal cords, patients enrolled in this study will be applied with curcumin on both wound sites of bilateral vocal cords after the surgery on the bilateral vocal cord endoscopically.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with bilateral vocal cord diseases who are going to undergo resection of bilateral vocal cord lesions endoscopically.
2. Patients with bilateral vocal cord adhesion who are going to undergo incision of bilateral vocal cord adhesion endoscopically.

Exclusion Criteria:

1. Patients with other laryngeal diseases.
2. Patients with cardiac and pulmonary insufficiency.
3. Patients unable to cooperate with the follow-up on time after surgery.
4. Patients who refuse to sign the informed consent after notification.
5. Patients who have a severe allergic disease or allergic history to a variety of drugs.
6. Other circumstances that are not appropriate to be included in the clinical trial.
Neuropsychological Rehabilitation of Spontaneous Confabulation: a Replica Study

Confabulators consistently generate false memories without intention to deceive and with great feeling of rightness. However, there is currently no known effective treatment for them. In order to fill this gap, we performed a neuropsychological treatment in two groups of confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).

Now, we intend to replicate the treatment with a larger sample of confabulators and with other two control groups: non-confabulator patients with brain injury and healthy individuals

The treatment consisted of some brief material that patients had to learn and recall at both immediate and delayed moments. After both recollections, patients were given feedback about their performance (errors and correct responses). Pre-treatment and post-treatment measurements were administered.

Non-confabulator patients and healthy participants performed only the pre-treatment measurement.

Eligibility Criteria:
Inclusion Criteria:

* The presence of spontaneous confabulations after acute brain injury, for at least three months and without clinical improvement (interfering with the patient's daily life with frequent arguments and exhaustive supervision).
* The presence of momentary confabulations in the Spanish adaptation of Dalla Barba provoked confabulation interview.
* Prior to injury, all patients should be completely independent for daily living.

Exclusion Criteria:

* The presence of impairment in alertness.
* Dementia.
* Acute confusional state.
* A history of drug abuse.
* Psychiatric antecedents.
Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy

The objective of this clinical trial was to investigate the effects of cervical spine exercises combined with nerve mobilization in patients with radiculopathy.

The main questions it aims to answer are:

1. Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.
2. Is there any difference between cervical spine operation combined with nerve mobilization and single method? The participants were patients with cervical radiculopathy and were divided into three groups in this study.

1. Experimental group: received cervical spine operation combined with nerve mobilization 2. Control group 1: cervical spine exercises were performed 3. Control group 2: received neuromobilization

After being informed of the risks, participants are required to sign an informed consent form. Eligible participants will be randomly assigned to cervical spine operation combined with nerve mobilizatio or cervical spine exercises or neuromobilization on a 1:1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of CSR and have no other complications;
2. Age 18-65 years old, gender unlimited;
3. No other treatment for cervical spondylosis in the last 1 month;
4. No previous surgical treatment for cervical spondylosis;
5. Good compliance;
6. Good mental state, no history of mental illness;
7. Informed consent, and sign the informed consent.

Exclusion Criteria:

1. does not meet the diagnostic criteria;
2. Women during pregnancy;
3. severe stenosis of the foramen;
4. osteoporosis combined with spinal cord tumor, osteomyelitis;
5. infectious diseases, skin defects, allergies;
6. have serious heart, lung and other important organ dysfunction;
7. unable to cooperate.
Gait Retraining to Reduce Joint Loading, Inflammation, and PTOA Risk

The purpose of this study is to determine changes to knee joint loading, biological markers, and cartilage structure following a novel active feedback gait retraining program in anterior cruciate ligament reconstructed patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18-40 years
* history of primary ACLR with or without meniscal repair
* full weight-bearing status
* neutral to varus knee alignment
* plans to remain in the area for at least 8 months.

Exclusion Criteria:

* Kellgren-Lawrence (KL) radiographic grade \> 2
* additional injury or surgery to the involved knee
* BMI \>30 kg/m2
* use of walking, orthopedic, or prosthetic assistive device
* pregnancy
* inability to have MRI
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)

There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.

The main hypotheses are:

1. Aripiprazole will significantly reduce maniac scores compared to placebo
2. Aripiprazole will significantly reduce ADHD scores compared to placebo

Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of children and adolescents. The disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is also associated with high rates of comorbidity, especially with Attention-Deficit Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in 5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and adolescents with comorbid BD and ADHD. A retrospective chart review, recently published, suggests the efficacy of this drug in children with BD. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and adolescents (age range: 08 to 17 years-old) with Bipolar Disorder comorbid with ADHD. The study design is an 6-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo. The hypotheses are: 1) Aripiprazole will significantly reduce maniac scores compared to placebo; 2)Aripiprazole will significantly reduce ADHD scores compared to placebo; 3) Aripiprazole will not be significantly associated to weight gain compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age: 8-17
* BD type I or II comorbid with ADHD
* Baseline score in the YMRS \> or = 20

Exclusion Criteria:

* IQ \< 70
* Pharmacologic treatment in the last month
* Pregnancy or absence of a contraceptive method in fertile girls
* Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency
* Risk of suicide or homicide
* Clinical condition that might interfere in the study
* Known sensibility to aripiprazole
Patient Satisfaction ,Marginal Integrity ,Shade Matching and Gingival Health of Zirconia Reinforced Lithium Silicate Bridges Cemented Using Bioactive Cement and Adhesive Resin Cement

Bioactive cement have been introduced recently into the market according to the manufacture it is assumed that it stimulates mineral apatite formation and the natural remineralization process at the material-tooth interface that knits together the restoration and the tooth, penetrates and fills micro-gaps, reduces sensitivity, guards against secondary caries, and seals margins against microleakage

To evaluate the cement type (bioactive cement and adhesive resin cement ) on Patient satisfaction ,marginal integrity ,shade matching and gingival health of cemented zirconia reinforced lithium silicate restoration .

PICOTS:

P: patients with missing anterior teeth that needs fixed restoration . I: Bioactive cement. C: adhesive resin cement. O: patient satisfaction ,margin integrity ,shade matching and gingival health T: 1 year

Eligibility Criteria:
Inclusion Criteria:" Permanent anterior teeth. " Vital teeth with Absence of clinical diagnosis of pulp exposure, periapical pathosis, fistula, swelling of periodontal tissues, abnormal tooth mobility, and history of spontaneous pain or sensitivity to pressure.

" Healthy appearance of adjacent gingiva.

-

Exclusion Criteria:

* Periapical pathosis, Signs of pulpal pathology, Severe periodontal affection these cases are not indicated for full coverage restoration.
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.

Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cesarean section

Exclusion Criteria:

* Patients with severe pre-eclampsia
* Patients with contraindications for spinal anesthesia
* Patients with multiple pregnancy
* Patients with gestation \<38w
Database for Interstitial Lung Disease

The purpose of this study is to establish a clinical database for patients bearing at risk for ILD (Interstitial Lung Disease) and to set up a prospective ILD Screening program for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* patients with a known systemic disease bearing a risk for ILD
* signed informed consent (for prospective part)

Exclusion Criteria:

* Age \< 18 years
* comorbidities severely limiting life-expectancy (e.g. severe cardiovascular conditions, malignant disease)
Impact of Metformin on Immuno-virologic Parameters in HIV

Non-diabetic, aviremic HIV-infected individuals on antiretroviral therapy (ART) will be randomized to metformin therapy or to observation for 72 weeks. Primary objective is to assess change over 72 weeks in CD4 T cell negative checkpoint receptors (PD-1 and TIGIT). As secondary objectives the study will look at 72 week change in other immuno-virologic parameters (CD8 T cell negative checkpoint receptors, plasma indoleamine 2,3-dioxygenase (IDO) levels and CD4 T cell and monocyte intracellular HIV DNA and HIV RNA. The study will also explore the 72 week impact of metformin on change in carotid intima-media thickness (cIMT) as a surrogate marker of atherosclerosis, on neuropsychological (NP) performance, strength, and change in body composition.


Eligibility Criteria:
Inclusion Criteria:

* HIV+
* On suppressive ART stable for \> 1 year
* Plasma HIV RNA \< 50 copies/mL within 3 months of entry, with no HIV RNA \> 200 copies/mL within the past 6 months prior to entry
* Age \>40 years
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Uncontrolled chronic medical condition or cancer
* Acute illness within 2 weeks of entry
* Diagnosis of diabetes by history, fasting blood glucose \>126, or by HgbA1c \> 6.5
* Chronic, uncontrolled diarrhea
* Known hypersensitivity or contraindication to metformin use
* Current presence of hepatitis C including currently on or intent to start therapy for hepatitis C within the 48 week duration of study.
* Serum B12 level below the reference normal range as listed by the commercial lab utilized for this study (Diagnostic Laboratory Services)
* Pregnancy, or intent to become pregnant or nursing an infant
* Any immunomodulator, HIV vaccine, any other vaccine, or investigational therapy within 30 days of study entry.
* Current uncontrolled coronary artery disease or NYHA Class 3 or 4 congestive heart failure
* History of liver cirrhosis
* Current use of zidovudine, stavudine or didanosine
* The following lab values

  * Hemoglobin \< 9.0 g/dL
  * Absolute neutrophil count \< 1000/μL
  * Platelet count \< 50,000/μL
  * AST (SGOT) and ALT (SGPT) \> 5x upper limit of normal (ULN)
  * Calculated creatinine clearance (Cockcroft and Gault) \< 50 ml/min
* Active or recent past history (within past 2 years) of illicit substance or alcohol use or abuse which, in the judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements
* Patients, who, in the opinion of the Investigator, are unable to comply with the dosing schedule and protocol evaluation or for whom the study may not be advisable
Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study

Acute appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France.

It concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Acute appendicitis has a significant morbidity rate of 8% and a mortality rate under 0.1%.

10 to 25% of the children admitted to emergency rooms for abdominal pain have appendicitis.

In 20 to 30% of the cases, the initial symptoms are atypical, which explains the difficulty in diagnosing.

The purpose of our study is to evaluate the quality of general practitioners in the diagnosis of acute appendicitis, its severity and the diagnostic criteria used.

Furthermore, it is not as easy to evaluate pain or examine a complaint in children as it is in adults.

Appendicectomy is the treatment of choice for all acute appendicitis. The importance of early diagnosis and treatment is, therefore, essential. Many predictive diagnostic scores have been studied over the years. The Pediatric Appendicitis Score (PAS) using typical symptoms of acute appendicitis and biological items was published in 2002. Nowadays, it is still considered as a reference and has been validated by other studies.

Most of the patients suffering from abdominal pain first consult their general practitioner.


Eligibility Criteria:
Inclusion Criteria:

* Child \<16 years
* abdominal symptoms
* consulting in the pediatric emergency department of Limoges University center.

Exclusion Criteria:

* Child \>=16 years
The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications

Post-cesarean section wound infections are responsible for longer hospital stays, readmissions, and ultimately, increased costs to the healthcare system. Silver-containing dressings may prevent wound infections. The purpose of the current study is to determine if the use of a silver-impregnated dressing decreases the occurence of wound infection following cesarean delivery.

A single-centered, single-arm clinical trial was originally designed to investigate the effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated dressing in preventing surgical site infection (SSI) in women delivered by primary cesarean section (CS). We sought to determine if the incidence of SSIs, would be lower in patients who received a silver-impregnated dressing as compared to those who received a standard dressing, when used as part of the overall hospital protocol for reducing SSIs. Given the addition of adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of membranes prior to undergoing a non-elective CS right at the time of initiation of the study to our institution perioperative bundle, we also elected to undertake further analyses of observational data on those with the same study inclusion criteria receiving standard dressing undergoing primary CS with subcuticular skin closure during the same time period, rather than limiting comparisons of our outcomes solely to our historical SSI rates. In order to have this comparison group, patients who declined participation in the experimental groups were selected as our non-randomized control group, given fiscal restraints precluded conducting a randomized clinical trial (RCT). Demographic, labor, delivery, intraoperative and postoperative characteristic data were collected in a de-identified fashion. Medical record review and data entry were conducted by trained research personnel. All study procedures were approved by the Investigational Review Board.

Eligibility Criteria:
Inclusion Criteria:

* Consent to undergo cesarean delivery
* Between the ages of 18 and 45
* Primary C-section
* Subcuticular skin closure
* Able to consent, fill out study documents, and complete all study procedures and follow-up visits

Exclusion Criteria:

* Patients with an allergy to silver
* Inability to obtain informed consent
* Staples
* Repeat C-section
* Vertical skin incision
* Intrapartum fever of 100F or \>
Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth

The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection.

There is a lack of literary evidence for assessment of the properties of Bioflx crowns and their effect on clinical outcomes and parental satisfaction compared to traditionally available options including stainless steel crowns and zirconia crowns. Hence, this study plans to assess the clinical performance and child and parental satisfaction of Bioflx compared to the "gold standard" stainless steel crowns in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: Children age group 3-7 yrs old
* Primary molars affected with caries or hypoplastic defect.
* Occlusion: Primary molar must have antagonist tooth.
* Consent of parent (legal guardians) and child assent for 7 years.
* Multi-surface dental caries observed in more than one tooth, in either side of the same arch (maxilla or mandible) or opposite arch (maxilla or mandible)
* Status: Asymptomatic or symptomatic teeth with signs of reversible pulpitis

Exclusion Criteria:

* Teeth with advanced stages of resorption (more than 2/3rd)
* Teeth exhibiting irreversible pulpitis.
* Teeth for which pulpotomy is done.
* Molar in infraocclusion
* Medically compromised children (ASA 3 or 4)
* History of grinding or pathological attrition
* Adverse gingival or periodontal conditions
Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

The Veress needle is the laparoscopic entry technique most commonly used among gynecologists. Direct trocar entry is another method to gain entry to the abdomen that is uncommon to gynecologists.

This prospective and randomized study will compare the two entry techniques with regard to:

* Complications related to the entry technique and previous surgeries
* Time taken to enter the abdomen
* The number of attempts taken to enter the abdomen

Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for gynecological purposes will participate in the study. Patients with previous middle laparotomies or 3 or more abdominal suregeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the two arms of the trial. All patient information will be confidential and only be available to researches involved in the study.

Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.

300 women will be recruited over a two year period and the data will be analysed by a statistician.

Eligibility Criteria:
Inclusion Criteria:

* Any woman suitable for laparoscopic gyneacological surgery

Exclusion Criteria:

* Previus supra-infra umbilical laparotomy
* three or more previous abdominal surgeries
FINRISK 2002 Re-examination

The project aims to fill in the existing gaps in the study of the microbiome as a cardiometabolic driver 1) by determining the key demographic, environmental, genetic, dietary, and metabolic correlates of long-term within-individual microbiome and microbial metabolite changes; and 2) by assessing how the gut microbiome, microbial metabolites, and their long-term changes are prospectively related to the risk factors, surrogate markers, and overt outcomes of CMD. To achieve this goal, repeat stool samples will be collected of \~2300 Finnish individuals who gave stool samples in the year 2002. In addition, \~300 individuals will undergo a in-depth health examination in 2024.


Eligibility Criteria:
Inclusion Criteria:

* Participation in FINRISK 2002 fecal sampling