cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Volunteers

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.

The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers aged 19 years old to under 55.
* BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
* Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
* Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
* Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
* Refusal to abstain from alcohol, caffeine, or other xanthines, or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
* Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
Evaluation of Impulsivity on Cocaine and Crack Addicts

This study main objective is investigating impulsivity on cocaine or crack addicts. The investigators main hypothesis is that different measures (such as scales or behavioral tasks, for example) of impulsivity may produce distinct outcomes, and they might also differ among cocaine (sniffed) and crack users. Thus, it would be of great value to compare such measures once these data are often interpreted as the same phenomenon.

Drug dependence is characterized by a sum of cognitive, behavioral and physiological symptoms. Among these symptoms are the lack of control over ones own behavior and substance use even in face of significant issues related to it. Impulsivity (expressed as impulsive choice or fail on behavioral inhibition) is important in crucial phases of drug dependence development. Both behavioral and neurobiological studies have confirmed the association between impulsivity and addictive behaviors. Thus a high impulsivity level might have influence on patients' treatment. Even though, several questions on this matter remain unclear for humans, such as the differences on impulsivity between users of different forms of cocaine (either sniffed or smoked). This kind of difference could establish distinct ways of treatment and then enable developing better treatments for drug users. For this study it will be recruited 60 non-treated dependent patients, among them 30 cocaine users and 30 crack users. These individuals will be selected based on DSM-IV dependence criteria. The instruments used will be scales to measure compulsion and consumption of cocaine/crack, a pharmacological screening for psychotropic drugs and a cognitive evaluation. As impulsivity measures are Barratt Impulsivity Scale (BIS 11), a reward discounting questionnaire and a computer-based behavioral test on "ProgRef v3" software. For data analysis the impulsivity measures will be compared with the behavioral and cognitive instruments through the Pearson's correlation matrix. An ANOVA will be also performed to verify any differences between cocaine and crack dependents on the impulsivity and compulsion tests. When it is appropriate subsequent Newman-Keuls post-hoc test will be performed. Significance level adopted is 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-50 years old
* Cocaine/ Crack dependence criteria according to DSM-IV
* Have at least high school education level

Exclusion Criteria:

* Present dependence criteria for other drugs, except for Nicotine/tabacco
* Have any other psychiatric conditions
Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor

The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination)
* Aged 18-40 years old
* Single, term pregnant with normal fetal heart rate
* Request neuroaxial analgesia

Exclusion Criteria:

* Parturient who refuses to participate,
* American Society of Anesthesiologists (ASA) physical status \>II,
* Body mass index more than 35 kg/m2
* Severe pre-eclampsia or eclampsia
* Uncontrolled thyrotoxicosis
* Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy)
* Increased intracranial tension due to a space-occupying lesion
* Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery.
* Hypersensitivity to the study drugs
* Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation
Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants

The purpose of this study is to evaluate the pharmacokinetics and safety of VX-548 and its metabolite in the absence and presence of omeprazole or rifampin, in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight greater than (\>) 50 kg

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* History of cardiovascular disease
* Participants of child-bearing potential

Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.

This study is a single blind prospective randomized trial. To measure and compare the effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and combination of gentamicin and cephazolin this study is designed.

The patients are grouped randomly in to two groups:

* Group1;intravenous cefazolin sodium
* Group2;topical gentamicin
* Group3:topical gentamicin and intravenous cefazolin sodium

As a control group we decided to use the data of control groups ( without any prophylactic agent usage ) of previous studies done in our clinic and medical data base reviews.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of inguinal hernia

Exclusion Criteria:

* Femoral hernia
* Emergency cases
Evaluation of the Efficacy and Safety of AL2846 Capsule Combined With TQB2450 Injection Compared to Docetaxel Injection in Advanced Non-small Cell Lung Cancer Patients Who Have Failed With Immunotherapy.

To investigate the efficacy of AL2846 capsules in combination with TQB2450 injection or Docetaxel injection in patients with advanced NSCLC who have previously failed immune checkpoint inhibitors (anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody), regardless of new anti-tumor treatment and early termination of treatment.


Eligibility Criteria:
Inclusion Criteria:

* The subjects voluntarily joined the study, signed an informed consent form, and had good compliance
* Age: 18-75 years; Eastern Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; BMI ≥ 17 at baseline;
* Patients with histologically or cytologically confirmed inoperable and inoperable locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) nonsmall-cell lung cancer (NSCLC) who cannot receive radical concurrent chemoradiotherapy;
* Failure of platinum-based chemotherapy and immune checkpoint inhibitors for incurable locally advanced or metastatic or recurrent NSCLC;
* Number of lines of prior systemic therapy received for locally advanced or metastatic/recurrent disease that is unresectable/not amenable to radical chemoradiation;
* Confirmed to have at least one measurable lesion according to Response Evaluation Criteria In Solid Tumours（ RECIST 1.1） standard;
* Adequate major organ function;

Exclusion Criteria:

* Patients who Have been diagnosed or currently had other malignant tumors;
* Presence of epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, c-ros oncogene 1 (ROS1) fusion and other significant driver gene mutations;
* Factors affecting oral drugs;
* Major surgical treatment, incisional biopsy or obvious traumatic injury and long-term uncured wound or fracture within 28 days before the start of study treatment;
* Hyperactive/venous thrombotic events within 6 months;
* Subjects with any severe and/or uncontrolled disease;
* Previously received other immunotherapy and Research Advance of Small Molecular Targeted Anti-Tumor Agents Tyrosine kinase inhibitors (TKIs);
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the subject's safety or affect the completion of the study, or there are other reasons that are not suitable for the subject;
99mTc-rhAnnexin V-128 in Diagnosis of Spondyloarthritis

This single center, open-label, proof of concept (PoC) Phase II study aimed to assess the investigational imaging agent 99mTc-rhAnnexin V-128 in detecting spondyloarthritis (SpA) lesions.

Overall, it was planned to recruit 20 adults with suspected or confirmed SpA. First, 5 patients were enrolled into a "proof of concept" phase, to assess the imaging potential of 99mTc-rhAnnexin V-128 in terms of imaging quality, disease-lesion radiotracer uptake and medical relevance. Based on these results the Data Monitoring Committee (DMC) was to decide whether to terminate the study or whether to continue and enroll the next 15 planned patients.

The study was prematurely terminated by the sponsor after the first 5 patients completed the PoC phase based on strategic considerations.

Novartis acquired Advanced Accelerator Applications SA.

Eligibility Criteria:
Inclusion Criteria:

For the first 5 patients enrolled in the POC part:

1. Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASA criteria with active symptoms including back, hip or buttock pain prior to:

* A change in NSAID therapy or
* A change in non-biologic DMARD or
* A start of non-biologic DMARD.

For the next 15 patients enrolled in the Phase II part:

1. Patients with clinical suspicion or confirmed diagnosis of SpA, based on the ASAS criteria with active symptoms including back, hip or buttock pain prior to:

   * A change in NSAIDs therapy
   * A change in non-biologic DMARD
   * A start of non-biologic DMARD
   * A start of biologic DMARD

   For all patients:
2. Age over 18 years old.
3. Signed Informed Consent Form

Exclusion Criteria:

1. Pregnancy or lactation
2. Liver impairment (ALT, AST or Bilirubin \> 2 ULN) at screening visit or baseline
3. Kidney impairment (serum creatinine \> 1.5 mg/dL)
4. History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
5. Known hypersensitivity to the investigational drug or any of its components
6. Contraindication(s) to the MRI procedure (claustrophobia, prosthetic valve, pacemaker, inability to lie still in a supine position)
7. Participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
Effect of Stitch Technique on the Occurrence of Incisional Hernia After Abdominal Wall Closure

The major long term complication of abdominal wall closure after a median laparotomy is the development of an incisional hernia. Several suture technique and suture material have been used but the incidence of this complication still lies between 9 -20%. Synthetic suture material which have become available over the last decades have the advantage that they are degraded by the body system and fully absorbed within 70-180 days; however they loss 50% of their initial strength already after 14-30 days and may not be the optimal suture material for abdominal wall closure. A new suture material (Monomax®) was developed with an extra-long absorption profile, high elasticity and with a superior initial strength. Therefore, the ESTOIH-Study was designed to investigate the influence of the stitch length on the occurrence of incisional hernia using the extra-long term absorbable, elastic, monofilament suture (Monomax®).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients undergoing an elective, primary median laparotomy with an incision length of ≥ 15 cm
* Expected survival time longer than 1 year
* ASA I-III
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Patient undergoing surgery due to a pancreas carcinoma
* Patients who will be operated due to an abdominal aortic aneurysm
* Peritonitis
* Coagulopathy
* Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin)
* Chemotherapy within the last 2 weeks before operation
* Radiotherapy of the abdomen within the last 6 weeks before operation
* Pregnant women (pregnancy test has to be performed)
* Severe neurologic and psychiatric disease
* Lack of compliance
Effects of tDCS on Anaerobic Power of Lower Limb Muscles

Anaerobic power and capacity are essential in many human activities, especially during sports practice that demand a high strength and power of the limbs. Transcranial direct current stimulation is a noninvasive technique that can modulate motor brain areas involved in motor functions and has the potential to optimize muscle capacity. However, their effects on mechanical power are lacking.

This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on mechanical power in healthy subjects.

In this study, a randomized, crossover, double-blind, placebo-controlled experimental design will be used. The 50 participants will be randomized into two groups: (1) Anodal tDCS(real) and (2) Sham tDCS. A single session of anodal and sham tDCS will be performed on each task (pre and post-jump test).

All evaluations will be performed by a single researcher who, like the participants, will not know which stimulation group will be participating. Subjects who agree to the conditions and sign the consent form may participate in the study. Participants who meet the eligibility criteria will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no complaints of pain or any kind of discomfort in the musculoskeletal system

Exclusion Criteria:

* Musculoskeletal or neurological disorder
* Under medication
* Previous treatment with tDCS
A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata

Primary:

• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA)

Secondary:

• To evaluate key clinical outcome assessments

Primary:

• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA)

Secondary:

• To evaluate key clinical outcome assessments

Eligibility Criteria:
Inclusion Criteria:

1. Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current areas of spontaneous regrowth.
2. Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp hair loss determined by the study investigator at baseline.
3. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years.
4. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication.

Exclusion Criteria:

1. Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.
2. Diffuse alopecia areata.
3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.).
4. Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
5. Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA or interfere with the study conduct or evaluations.
6. The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?

Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.

The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve


Eligibility Criteria:
Inclusion criteria:

* non-pregnant adults (age ≥18 years)
* healthy
* total 25(OH)D level between 20 to 65 nmol/L.
* living in Riyadh area

Exclusion criteria:

* consumption of more than one serving of milk daily
* taking vitamin D supplements
* habitual weekly sun exposure of 10 hours or more
* history of granulomatous, liver, or kidney disease
* taking anticonvulsants, barbiturates, or steroids
PreFER Managed Ventricular Pacing (MVP) For Elective Replacement

The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.

A number of clinical studies (Danish I, Danish II, David, MOST) over the past few years have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can cause a variety of detrimental effects, including atrial fibrillation (AF), left ventricular (LV) dysfunction, and congestive heart failure (CHF). These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic, single-site, apical ventricular stimulation.

Therefore a new pacing modality, Managed Ventricular Pacing (MVP), was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing. This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs.

MVP is an atrial-based dual-chamber pacing mode that provides functional AAI/R pacing with ventricular monitoring and back-up DDD/R pacing only as needed during episodes of AV block.

The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited \[VDD\]) for a minimum time duration of 2 years
* Planned to be replaced or replaced with a device including the MVP feature
* Have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
* Pacing should not be caused by a switch to the single chamber pacing (VVI) mode because of battery depletion
* Have signed the informed consent
* Have no need to change the pacing mode or the atrioventricular (AV) intervals.

Exclusion Criteria:

* Patients with a cardiac resynchronization therapy (CRT) indication
* Permanent AF
* Permanent AV block
* Inability to complete follow-up visits at a study center.
* Unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
* Planned cardiovascular intervention
* Inclusion in another clinical trial that will affect the objectives of this study
* Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.