cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency

The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with Zinc Deficiency.


Eligibility Criteria:
Inclusion Criteria:

The serum zinc concentrations are under the normal level before registration

Exclusion Criteria:

1. Heavy hepatitis
2. Malignant tumor
3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
4. The serum albumin under 2.8 g/dL
5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
7. Pregnant, suspected pregnant, lactating, patients who wish to have a child
8. Patient who participated in other clinical trials within 12 weeks before registration
9. Unsuitable as a target of this clinical trial judged by doctor
Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease

A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease.

Two groups of subjects - one including healthy individuals and the other - treatment-naive patients with incident Parkinson's disease - will fill in the food frequency questionnaire, SF-36 questionnaire, HADS questionnaire and the physical activity questionnaire. All subjects must have 0-3 points on Hoehn and Yahr scale and more than 22 points on MoCA scale. DNA microarray genotyping will be used to process the DNA samples of the participants. The data on the composition of the participants' gut microbiota will be obtained through 16S rRNA sequencing of their stool samples.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 45 years and over who have been diagnosed with Parkinson's disease
* Subject signed informed consent

Exclusion Criteria:

* Gastroenterological diseases such as ulcerative colitis, Crohn's disease, celiac disease, gallbladder diseases (calculous cholecystitis, cholangitis, etc.) that are not related to functional disorders, a liver diseases or pancreas in medical history
* Exacerbations of chronic gastroenterological diseases
* Mental illness
* Oncology diseases
* Mental disorders
* Rheumatoid arthritis or other autoimmune diseases
* Acute infectious diseases or exacerbation of any diseases
* Recent (\<3 months) administration of proton pump inhibitors, antimicrobial therapy or surgical intervention
* Recent (\<3 weeks) use of probiotics, antacids, nonsteroidal anti-inflammatory drugs, laxatives
* Recent (\<14 days) administration of laxatives (excluding prucaloprid)
* Recent (\< 3 months) surgical intervention
* Pregnancy, planning to be pregnant or breast feeding at any point during the study or study enrollment
* Current alcohol/drug abuse (more than 3 points for women and 4 for men according to AUDIT-C questionnaire and/or more than 7 points on the AUDIT questionnaire) or addiction therapy within 12 months prior to screening
* Planned relocation from the home region during the study
* Stroke in medical history
* Any surgical intervention in the central nervous system
* Morbid obesity, BMI\> 35 kg / m2
* A medical history of carriage or disease associated with a history of human immunodeficiency viruses, hepatitis B, C or Treponema pallidum
* The patient's inability to understand the essence of the study and agree to participate in it. MoCA scores \<22
* 4-5 stage of the disease according to the Hen and Yara scale
* Severe somatic pathologies or any factors that, in the opinion of the doctor, may prevent the patient from being included in the study
* A medical history of serious head injuries
* Rheumatoid arthritis
* Tuberculosis
How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?

The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.

The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) III or IV risk group patients, 18 years of age or older, who will undergoing foot, ankle, or toe amputation.

Supparaneural injection (Group S) and interneural injection method (Group I) will the two research groups to which patients were randomly allocated.

Every 5 minutes following LA injection, an investigator who will blind to randomization will assess the sensory and motor blockage in the operated foot. The study will documented the operative time, block characteristics, such as the duration of block administration, sensory and motor block start and regression times, the time of extra analgesic required, and the occurrence of complications.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* Planned foot, ankle or toe amputation
* ASA III-IV risk group
* Patients who agreed to be included in the study

Exclusion Criteria:

* People with neurological and psychiatric diseases
* Using opioids or another analgesic for chronic pain
* Allergic to local anesthetics
* Pregnant or breastfeeding
* Those with infection or sepsis in the application area
* Patients who did not agree to be included in the study
Construction and Application of Precise Health Education Model for Patients With PICC Tube

1. In this study, the risk factors leading to catheter-related complications in the daily life behavior habits of patients with PICC catheter were identified, refined and initially established, and the Delphi method (expert consultation method) was used to further identify the existing and potential risk factors leading to PICC catheter-related complications in the daily life behavior habits of patients. To develop individualized and precise health education programs for risk factors, in order to build an accurate health education model centered on improving patients' daily life and behavior habits.
2. To conduct clinical empirical study to evaluate the feasibility and effectiveness of precise health education program for PICC patients with catheter, and to observe the impact of this health education model on the knowledge, attitude and practice level of daily management, self-management efficacy and the incidence of related complications after catheter insertion in PICC patients, so as to provide a reference for health education of PICC patients.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients undergoing chemotherapy in our hospital with ≥6 cycles of chemotherapy;
* Patients with PICC implanted for the first time and maintained at our hospital;
* Aged 18-60 years;
* The material and performance of PICC catheter are silicone three-way valve catheter;
* Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
* Clear consciousness, good language communication skills and normal comprehension ability;
* Informed consent and voluntary participation in the study.

Exclusion Criteria:

* Persons with self-care ability defects;
* Puncture times more than 1 time.
Pharmacokinetic Study of Paracetamol.

Brief Summary:

The study evaluate the absorption rate and pharmacodynamic of different formulation of paracetamol either in the form of normal tablets or a new rapid absorbable gelation capsule formulation "Paracetamol1523" by determining T-max and area under the response curve of paracetamol in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project

Detailed Description:

Twelve healthy young volunteers are recruited, and the experiments begin at 07:45 after an overnight fast. Clinical data are recorded and a catheter is inserted in an antecubital vein for blood samples.

At 08.00 paracetamol (500 mg) taken as tablet or a "Paracetamol1523" c in random order. Subsequently, blood samples are taken every 3 minute for one hour minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every 10 minute the first hour, and then every 30 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.

The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 4 hours in which blood samples are taken as described above, and blood pressure and records are stored .

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Diabetes
* Thyroid disease
* any medial treatment
Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache

Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture.

Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes.

Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial.

it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption.

The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.


Eligibility Criteria:
Inclusion Criteria:

* Women had CS under spinal anesthesia;
* Women started to complain of PDPH;
* Women were free of exclusion criteria.

Exclusion Criteria:

* Women had prior history of PDPH or headache for any cause;
* Women had essential hypertension;
* Women with previous history of habitual hypotension or accidental syncope secondary to postural hypotension;
* Women with tempromandibular disorders;
* Women who refused to participate in the study were excluded.
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder

The purpose of the study is to evaluate the efficacy of quetiapine or placebo added to baseline treatment of SSRI/clomipramine for the treatment of OCD in adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine

Exclusion Criteria:

* Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intolerance or lack of response to quetiapine, use of antihypertensive medication with changing doses
Effycacy of Rifaximin on Reverse Minimal Hepatic Encephalopathy and Elimation Small Intestinal Bacterial

A total of 46 patients diagnosed with liver cirrhosis will be recruited. All patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (MHE). A breath test sample will be performed in all patients with MHE with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (SIBO). Patients diagnosed with EHM and SIBO will be randomized to receive per day 1200 mg of rifaximin (group A) or placebo (group B) for 2 weeks. A complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. Besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.

MHE impairs the quality of life, increases the risk of motor vehicle accidents, and mortality. Currently, there is no consensus on treatment and yet there are few proven treatment options. Among the factors associated with MHE, is the small intestinal bacterial overgrowth (SIBO) present in 38.6% of patients with MHE. Rifaximin is a broad spectrum antimicrobial administered orally, with low risk of inducing bacterial resistance, and has been used in the treatment of MHE. It is unknown if the beneficial effect on MHE is associated with the elimination of SIBO and its efficacy when administered in patients with simultaneous diagnosis of MHE and SIBO was never been evaluated. The aim of our study is to evaluate the effect of rifaximin on MHE and SIBO in patients with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis of any etiology
* Men and women between 18 and 70 years.
* Patients diagnosed with minimal hepatic encephalopathy and small intestinal bacterial overgrowth
* Right-holders of the Mexican Social Security Institute
* Patients who agree to participate in the study and signed the informed consent

Exclusion Criteria:

* Recent history of alcohol abuse and/or drugs (less than 6 weeks).
* Illiterate
* Alcoholic cirrhosis
* History and/or diagnosis of overt hepatic encephalopathy
* Consumption of psychotropic medications (benzodiazepines, antiepileptics)
* Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements.
* History of chronic renal disease or heart failure
* Patients with gastrointestinal bleeding
* History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests
* Patients with diarrhea
* Diagnosis of liver cancer
* Patients with ophthalmologic disorders
* Patients taking antibiotics 30 days before the study
The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep

Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.

Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Babies in the first week of postpartum
* Healthy babies,
* Therm (37-40 W),
* The baby should be at normal birth weight (2500-4000gr),
* Mothers who know how to read and writ

Exclusion Criteria:

* Mothers with communication problems,
* Individuals whose mother or baby are monitored in intensive care after birth
* If the mother has a physical disability or any chronic disease (hypertension, diabetes mellitus, etc.),
* Psychological illness in the mother (major depression, psychosis, etc.),
* Pregnancy through assisted reproductive techniques,
* Mothers who are diagnosed with a sleep disorder and who have their babies treated for this reason.
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.


Eligibility Criteria:
Inclusion Criteria:

* positive rapid antigen test for influenza A
* onset of symptoms of influenza (fever, at least one respiratory symptom) \</=48 hours

Exclusion Criteria:

* clinical suspicion of infection with a respiratory virus other than influenza
* suspicion of invasive bacterial infection
* evidence of poorly controlled underlying disease
* known immunosuppression
* known allergy to Oseltamivir
* women who are pregnant or planning to get pregnant during the study
Longitudinal Quantitative Susceptibility Mapping (QSM) in Alzheimer 's Disease

In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50 age-matched control subjects will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI). Regional differences of susceptibility and R2\* relaxation rates in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline.

Abnormally increased brain iron accumulation in deep gray matter is a common finding in Alzheimer's disease (AD) and amyloid protein precursor and tau proteins were linked to disrupted iron homeostasis. Validation studies showed that brain iron can be measured precisely by the novel magnetic resonance imaging (MRI) technique quantitative susceptibility mapping (QSM) in vivo, thus, enabling reliable and precise longitudinal investigations.

It is hypothesized that pathologic brain iron accumulation can be assessed with higher sensitivity with QSM than with current MRI techniques such as R2\* relaxation rate mapping and that regional QSM is a predictor for cognitive decline and disability.

This explorative longitudinal study is including 50 patients with AD and age-matched control subjects which will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla MRI. Regional differences of susceptibility and R2\* in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline. Follow-up MRI and clinical data with multivariate regression analysis serve to investigate the dynamics of AD-related changes of susceptibility, and their relation to cognitive functioning.

In conclusion, this explorative longitudinal study in a patient cohort aims to clarify whether regional QSM changes are potential biomarkers for AD progression.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of dementia according to DSM-IV and NINCDS-ADRDA criteria
* the patient lives either with the family or has less than 40h/week of external care
* the patients is able to understand the role in this study and is willing to participate
* the physician in charge of this study confirms that the patients understands the study and its aims according to cognitive and clinical testing

Exclusion Criteria:

* are other disorders
* participation in a clinical drug trial (phase 1-3)
Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery

All patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Elkins Park will be offered participation into the study. Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders will be excluded from the study. Risks and benefits of the study as well as risks and benefits of the procedure will be discussed with the patient by one of the investigators. If the patient elects to participate in the study, they will be assigned to incisional dressing at the time of operation with either in-line or perpendicular placement of Steri-Strips based on the patient's computer-generated randomization assignment. The patient's chart will be reviewed to determine the patient's age and comorbid conditions including obesity (pre-operative BMI), diabetes mellitus, use of anti-platelet or anticoagulant medication, or smoking. This information will be utilized to ensure that our study groups are similar in baseline demographics and pre-existing conditions. Additionally, the primary medical reason for needing breast surgery will be reviewed as well as treatment with pre-operative or post-operative chemotherapy or radiation therapy to the breast. Steri-Strips will not be removed and will be allowed to fall off naturally. At regularly scheduled 30-day and 90-day follow-up appointments, pictures will be taken of the incisional area. These photographs will be reviewed by a blinded, independent surgeon who will grade each incision according to the modified Hollander Cosmesis Scale. Statistical analysis with t-testing of the means and chi-squared testing of dichotomous variables will be performed to determine significance of the findings.


Eligibility Criteria:
Inclusion Criteria:

- All adult patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at Einstein Medical Center Philadelphia, Einstein Medical Center Montgomery, Center One, or Einstein Medical Center Elkins Park will be offered participation into the study.

Exclusion Criteria:

* Patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders
* members of vulnerable populations such as adults who are unable to consent, individuals who are not yet adults, pregnant women, or prisoners