cyrilzakka/clinical-trials huggingface dataset:
Treatment of Negative Symptoms and Schizophrenia

The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.


Eligibility Criteria:
* Inclusion Criteria:

  * Schizophrenia with prominent negative symptoms
* Exclusion Criteria:

  * other psychiatric or neurological diseases
  * specific tDCS limitations
Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG

This single-center prospective study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from 14\~65-year-old patients with drug-resistant epilepsy.

Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.

Direct Electrical Stimulation (DES) is a neurosurgical technique that involves delivering electrical impulses to specific brain regions through implanted electrodes to map critical functional areas and to study the connectivity of brain regions.

This study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from patients aged 14 to 65 implanted intracranial electrodes , with a specific focus on electrodes targeting the claustrum. This research forms part of a broader initiative to explore the functions of cortical and subcortical regions based on SEEG.

Eligibility Criteria:
Inclusion Criteria:

1. The patients were diagnosed with drug-resistant epilepsy.
2. The patients underwent stereoelectroencephalography (SEEG) implantation for pre-surgical evaluation of epilepsy, with at least one electrode target reaching the claustrum
3. Participants/parents/legal guardian provide informed consent for inclusion

Exclusion Criteria:

1. Subjects that experience surgical complications during the implant procedure will be excluded from the study
Meibomian Gland Dysfunction Treatment

The purpose of this study is to evaluate the effectiveness of treatments for Meibomian Gland Dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* evidence of meibomian gland obstruction in both eyes
* dry eye symptoms per DEQ-5

Exclusion Criteria:

* active ocular infection
* previous LipiFlow treatment
* beginning new oral or other systemic medications within prior 3 months
* beginning new or changing dosages of ocular medications within prior 3 months
* previous ocular surgery, trauma, herpes, recurrent inflammation, punctal plugs in prior 3 months
* habitual contact lens wear in prior 3 months
* women who are pregnant or nursing
An Extension Study of CORLUX in the Treatment of Endogenous Cushing's Syndrome

Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.

Up to 50 subjects will receive mifepristone daily. Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) will be eligible to continue treatment for an additional 1 year. Assessments of safety, as evaluated by physical examinations, vital signs, laboratory tests and adverse events, will be made. Persistence of improvement in response to mifepristone treatment will also be evaluated during this extension study by assessing the continued or sustained improvement in the signs and symptoms of Cushing's syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the Week 24 visit and the 6-Week Follow-up visit of Corcept Study C-1073-400 (NCT00569582).
* In the opinion of the Investigator, are expected to maintain clinical benefit from mifepristone.
* Women of childbearing potential have a negative serum pregnancy test at Entry.
* Women of childbearing potential must be willing to use non-hormonal, medically acceptable methods of contraception during the study.
* Are able to provide written informed consent
* Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
* Will not use systemic estrogens during the study.

Exclusion Criteria:

* Have an acute or unstable medical problem, which could be aggravated by mifepristone treatment.
* Are taking medications within 14 days of the Entry visit that a) have a large first pass metabolism that is largely mediated by CYP3A4 and which have a narrow therapeutic margin; and/or b) are strong CYP3A4 inhibitors.
* Female patients of reproductive potential, who are pregnant or who are unable or unwilling to use medically acceptable, non-hormonal methods of contraception during the study.
* Have received investigational treatment (drug, biological agent or device) other than CORLUX (mifepristone) within 30 days of Entry
* Have a history of an allergic reaction or intolerance to CORLUX (mifepristone)
* Have uncorrected hypokalemia (potassium level of \<3.5 mEq/L) at Entry. Spironolactone or eplerenone is allowed to control hypokalemia.
* Postmenopausal women with a history of endometrial hyperplasia with atypia or pathological features consistent with endometrial carcinoma.
* Thickened endometrium on the Entry Visit transvaginal ultrasound that has not resolved after induction of menstrual bleeding with progesterone.
* Uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
* Any woman with an intact uterus who has a hemorrhagic disorder or is being treated with an anticoagulant (e.g. warfarin, heparin).
* Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
* Elevated total bilirubin \>1.5 ULN, elevated ALT or AST ≥3X the upper limit of normal.
Multimodal Intervention in Allogeneic Stem Cell Transplantation

Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. It was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 yrs
* patients undergoing allogeneic stem cell transplantation

Exclusion Criteria:

* recent cardiovascular or pulmonary disease
* abnormal EKG
* psychiatric disorder
* motor function, musculoskeletal or neurological disturbances
* bony metastasis
Attitudes About Organ Transplantation

The study evaluates the knowledge, attitude and practice about organ transplantation among medical students and medical staff.

Globally, almost every second a transplanted kidney comes from a living donor (LDTx); in Europe it is 18.1%, but in Poland it is only 2% (0.6 for 1 million from living donors). The number of patients awaiting on kidney transplantation (KTx) is increasing, and the number of deceased donors is constantly at a low level. This disturbing situation should motivate the entire interdisciplinary health team to seek new solutions.

In the study the investigators are examining how medical students and medical staff feel about the issues of organ transplantation, especially: organ shortage, cost of organ transplantation, definition of brain death.

The investigators are planning to focus on the following specific questions:

What is the level of knowledge about organ donation among participants? What are the sociodemographic, sociocultural and socioeconomic characteristics of listed as an Organ Donor and non-listed as an Organ Donor among medical staff and medical students? Evidence on the role of financial and other incentives in eliciting organ donation.

Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study

Exclusion Criteria:

* Not meet the above criteria
Effects of a Pectoralis Minor Muscle Stretching Protocol

The purpose of this study is to verify the effects of a stretching protocol for the pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened pectoralis minor.

Fifty subjects (25 symptomatic and 25 asymptomatic for shoulder pain) will be recruited. All of them will be initially assessed twice with one week between the assessments. On each day, they will complete two questionnaires (DASH and SPADI) to assess pain and shoulder function. The resting length of the pectoralis minor muscle and scapular kinematics data during arm flexion will also be measured using an electromagnetic tracking system. Initially, the resting length of the pectoralis minor will be measured, and then 3 repetitions of arm elevation in the sagittal plane will be completed. The stretching protocol will be performed daily for 6 weeks. The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions. After the 6 weeks, the subject will have the same variables from the initial assessments reassessed. For the questionnaires and length of pectoralis minor a two-way ANOVA for repeated measures will be used to check the main effects of group and evaluation and whether there is interaction between them. For scapular internal/external rotation, upward/downward rotation, and tilt anterior/posterior a three-way ANOVA for repeated measures will use to analyze the main effects of group (symptomatic and asymptomatic), elevation angle of the arm (30°, 60°, 90° and 120°) and evaluation (1, 2 and 3) and whether there is evaluation x group x angle interaction. A p value less than 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

Asymptomatic subjects were included if they did not have any positive test for SIS.

The subjects with shoulder pain were included if:

1. they had history of shoulder, at least one week;
2. 18 - 45 years;
3. range of motion \> 150° evaluated with digital inclinometer;
4. one or more impingement tests positive - Neer (Neer, 1972), Hawkins (Hawkins and Kennedy, 1980) and Jobe (Jobe and Moynes, 1982) - associated with painful arc during arm elevation, or during external rotation with 90° of arm elevation;
5. Individuals from both groups also had to present with shortened PM muscle length.

Exclusion Criteria:

Individuals from both groups were excluded if they:

1. BMI (body mass index) \> 28kg/m2;
2. irradiated shoulder pain;
3. scoliosis;
4. history of shoulder pain with beginning traumatic;
5. history of fracture or surgery in upper limb and rotator cuff;
6. systemic illnesses;
7. tape allergy;
8. were pregnant;
9. physiotherapy at least 6 months.
Extremely Low Gestatonal Age Infants' Paracetamol Study

In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.

The purpose of this randomized, placebo-controlled, double-blind, phase 2, one center clinical trial is to study the efficacy and safety of early (\< 96 h) intravenous paracetamol in prophylactic closure of ductus arteriosus in extremely premature (gestational age \<28+0 wk, ELGA) or low birth weight (\<1000 g, ELBW) infants. The infants born extremely preterm or low birth weight are a focus of the study, since a small phase 2 study on paracetamol failed to demonstrate contraction of ductus arteriosus.

In the investigator's previous cohort of ELGA/ELBW infants, the numbers of patients who needed any therapies for patent ductus arteriosus (PDA) were 29 (23%) in the paracetamol exposed group, and 90 (54%) in the control group. As demonstrated in a phase 2 study, the early paracetamol treatment induced the closure of ductus arteriosus: the mean (SD) ductal closure age was 177 (338) h in the whole paracetamol group. However, in the subgroup of ELGA infants born before 28 gestation weeks (n=14), the mean (SD) ductal closure ages in the paracetamol and placebo groups were 491 (504) h and 858 (719) h, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g

Exclusion Criteria:

* Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

This is a phase 1/2 study in which healthy adult subjects and subjects with chronic hepatitis B virus (HBV) infection will receive VIR-2218 or placebo and will be assessed for safety, tolerability, pharmacokinetics, and antiviral activity (only in subjects with chronic HBV).

In the single ascending dose (SAD) part, Part A, healthy adult subjects will receive one dose of VIR-2218 or placebo, administered subcutaneously (SC). In the multiple ascending dose (MAD) parts, Part B \& Part C, subjects with chronic HBV infection will receive two doses of VIR-2218 or placebo every 4 weeks administered SC.


Eligibility Criteria:
Part A SAD:

Inclusion Criteria:

* Male or female age 18 - 55
* BMI 18 - 32 kg/m\^2

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* History or evidence of drug or alcohol abuse
* History of intolerance to SC injection

Parts B/C MAD:

Inclusion Criteria:

* Male or female age 18 - 65
* BMI 18 - 32 kg/m\^2
* Chronic HBV infection for \>/= 6 months

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation
* Significant fibrosis or cirrhosis
* History or evidence of drug or alcohol abuse
* History of intolerance to SC injection
* History of chronic liver disease from any cause other than chronic HBV infection
* History of hepatic decompensation
Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who were randomized into study N01280 \[NCT00419094\], and completed the 2 week up titration period

Exclusion Criteria:

* Subjects who did not meet the inclusion/exclusion criteria for N01280 \[NCT00419094\]
* Subjects who were discontinued prior to the end of titration period
Efficacy Study of a Low Volume of Water Intake and Mosapride for Endoscopy in Patients With Subtotal Gastrectomy

A low volume of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.

We evaluate that a 500mL of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer. We plan to compare this method with routine midnight fasting method for endoscopy in patients with subtotal gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients who had subtotal gastrectomy for gastric cancer

Exclusion Criteria:

* Pregnancy
* Lactation
* History of anastomotic stricture
* Recurrent advanced gastric cancer
* Poor general condition( \> 2 ECOG)
* Other disseminated malignancy
* Significant renal failure or congestive heart failure (CHF)
* Liver failure
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
* Must have moderate to severe alopecia areata:

Exclusion Criteria:

* History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
* Infected with hepatitis B or hepatitis C viruses.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
* Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.
Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis

To assess and describe real-life treatment choices for rFⅧ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China (2007-2013)


Eligibility Criteria:
Inclusion Criteria:

* Male, 2-\<18 years Hemophilia A, based on documented prior testing and/or screening laboratory Patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%\[10\] , and total duration ≥12 weeks. During the regular prophylaxis period, if there were consecutive 4 weeks that \<2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis.

Available patient medical data record Written informed consent by parent/legal representative. Consent should be sought from subjects if appropriate

Exclusion Criteria:

* Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation (≥0.6BU by Bethesda assay at two different time points, documentation must be available) Any individuals with another bleeding disease that is different from hemophilia A (e.g, von Willebrand disease, hemophilia B)
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis

This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-3 fibrosis. As secondary end point target engagement and fibrosis improvement will be assessed.

This is a prospective phase 1/2a, randomized, double-blinded, placebo-controlled, single center study of safety and efficacy of oral idebenone in adults 18 years of age or older with non-alcoholic steatohepatitis (NASH). Following IRB approval and written informed consent, 45 participants will be enrolled in the study and randomized in a 1:2 ratio on REDCap data capturing software. Participants will be randomized to two groups and receive the following tablets: placebo, idebenone at escalating doses of 200mg by mouth (P.O.) once a day for 2 weeks, then 200 mg twice a day for 2 weeks, then 3 times per day for the remainder of the study (up to 48 weeks). Monitoring and safety evaluation will continue for 12 weeks after the final dose. The study will investigate the safety and tolerability as primary end point and assess target engagement and fibrosis improvement as secondary end points.

Eligibility Criteria:
Inclusion Criteria:

* 1) Male or non-pregnant/ non-lactating women ≥ 18 years of age
* 2) Diagnosis of NASH: NAFLD activity score (NAS) of 4 or greater with a score of 1 for each of the following (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2):

  * Steatosis
  * Lobular inflammation
  * Hepatocyte ballooning 3) Fibrosis (Ishak fibrosis score ≥1 on liver biopsy) within 6 months of enrollment with MELD\<10, or based on MRE

Exclusion Criteria:

* Presence of any other form of liver disease, including viral hepatitis, autoimmune hepatitis, alcoholic liver disease, genetic causes of chronic liver disease):
* Subjects with other etiologies of chronic liver disease, such as chronic hepatitis B and C; autoimmune hepatitis; and inherited liver disease.
* ALT\>300 U/l
* Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients excepted)
* International Normalized Ratio (INR) ≥ 1.3
* MELD\>10
* Serum creatinine \>2.0mg/dl
* Known alcohol abuse or alcohol use disorder:

  * \>20 g/day for women
  * \>30 g/day for men
* Active substance abuse
* Any medical condition that prevents MRE, MR-PDFF
* Platelet count ≤100//mm3
* Decompensated cirrhosis
* Hemoglobin \<11 g/dl in females or \<12 g/dl in males
* Presence/history of HCC
* History of liver transplantation
* History of bariatric surgery
* History of inflammatory bowel disease
* History of cardiovascular disease, long QT syndrome.
* Subjects who have participated in investigational drug trials and took any investigational drugs within 60 days prior to the first dose of Idebenone. History of receiving other investigations drug within 30 days prior to enrollment
* Any concerns regarding compliance by enrolling physician
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults

This study is a randomized Trastuzumab-controlled double-blind parallel-group study.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Japanese male adults
2. Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/\[Height (m)\]²
3. The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.

Exclusion Criteria:

1. History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug
2. Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
3. History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
4. History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia