cyrilzakka/clinical-trials huggingface dataset:
Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery

The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.

It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.

Eligibility Criteria:
Inclusion Criteria:

* CHildren 1 - 10 years old.
* ASA I E II ( American Society of Anesthesiology)
* hypospadias surgery

Exclusion Criteria:

* parents refuse
* Infection
* Coagulation disorders
* Allergy to anesthetics
* Abnormalities of the sacral spine
Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning

The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.

Several indications exist in urologic practice where urinary drainage via a urethral catheter is required and an estimated 4 million patients in the United States undergo urinary catheterization per year.(1) Though it is common for urine to be continually collected in a bag attached to the catheter by plastic tubing, catheter valves offer an alternative method of storing and voiding urine. Catheter valves are small devices that fit into the external end of the urethral catheter. Rather than continuous drainage, urine is stored in the bladder and emptied on regular intervals by opening the valve.

This method of drainage may offer several benefits including preserving bladder capacity, function and tone, reducing catheter blockage in cases of urine bacterial colonization, and decreasing traction forces on the bladder neck by removing the downward weight of a collecting bag.(2-4) The use of a catheter valve may offer improvements in social functioning and mobility.(5) Studies to date suggest that catheter valves are well tolerated by patients, but these studies have used non-standardized questionnaires and have not assessed overall quality of life.(5, 6) Additionally, there may be an associated cost benefit to utilizing catheter valves compared to drainage bags.(5)

Further study in this area, focusing on quality of life and social functioning, will enable the clinician to better counsel patients on the risks and benefits of the various methods of urinary drainage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing brachytherapy or cryotherapy for prostate cancer
2. Patients undergoing thermal therapy for benign prostatic hyperplasia
3. Patients undergoing catheterization to relieve urinary retention

Exclusion Criteria:

1. Patients with neurogenic bladder
2. Patients with urinary tract infection
3. Patients with gross hematuria
4. Patients undergoing surgery with risk of urinary leak (ex: urethroplasty, radical prostatectomy, bladder repair)
5. Female patients
Combined Tooth-implant Supported Prostheses

The goal of this clinical study is to evaluate clinical performance of combined tooth-implant supported 3 unit fixed partial dentures in the posterior mandible and was to compare and evaluate them with the complications of 3 unit fixed partial dentures supported with free standing dental implants.The main question\[s\] it aims to answer are:

1.Is there any difference in terms of mechanical and biological complications as well as marginal bone level between free standing and combined tooth-implant supported 3 unit Fixed Partial Dentures in posterior mandible.

Participants will receive either 2 dental implants(Control group) or 1 standart length dental implants to be combine with abutment tooth or 1 short dental implant to be combine with abutment tooth for supporting 3 unit fixed partial dentures.

Purpose: The aim of the study was to evaluate clinical performance of combined tooth-implant supported 3 unit fixed partial dentures in the posterior mandible and was to compare and evaluate them with the complications of 3 unit fixed partial dentures supported with free standing dental implants.

Material and methods: 78 partially edentulous patients in the posterior mandible (Kennedy 1 and Kennedy 2), age between 18-65 with no systemic disorders were recruited for the study (n=26). Group 1served as control group and received 2 dental implants for supporting 3 unit fixed partial dentures (FPD). In group 2 dental implants longer than 8 mm and in group 3 shorter than 8 mm were inserted to replace first or second molar combined with first or second premolar respectively to support cement retained 3 units FPD. Periapical radiographs were taken with parallel technique for evaluation of marginal bone resorption (CBL) and modified plaque index (MPI), bleeding index (BI) and sulcus depth of abutment teeth was recorded at the time of FPD insertion, 6 months after FPD insertion and annually. Abutment tooth intrusions, de-cementation of the restoration, porcelain chipping/delamination, framework fracture, abutment screw loosening, abutment and abutment screw fracture, implant fracture were also recorded as complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with no systemic disorders,
2. Partial edentulous in the posterior mandible unilaterally or bilaterally with maxillary arch fully dentate or have teeth and/or implant supported FPD,
3. At least 3 months of healing after tooth extraction on implant site,
4. Periodontally and endodontically healthy abutment tooth to be combined with implant,
5. Patients who have good oral hygiene habits,
6. Patients smoking less than 10 cigarettes/day,
7. More than 2mm of keratinized gingiva on implant site
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria (all subjects)

* Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA.
* Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area.
* A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
* PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
* PGA score of at least mild on scalp at SV1, SV2 and V1.
* A serum albumin-corrected calcium below the upper reference limit at SV2.

Inclusion Criteria (for subjects performing HPA axis assessment)

* Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA.
* Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area.
* PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1.
* PGA score of at least moderate on scalp at SV1, SV2 and V1.
* Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).

Exclusion Criteria (all subjects):

* A history of hypersensitivity to any component of LEO 90100.
* Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:

  1. etanercept - within 4 weeks prior to V1
  2. adalimumab, infliximab - within 2 months prior to V1
  3. ustekinumab - within 4 months prior to V1
  4. experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1
* Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
* PUVA therapy within 4 weeks prior to V1.
* UVB therapy within 2 weeks prior to V1 or during the trial.

Exclusion Criteria (for subjects performing HPA axis assessment):

* A history of serious allergy, allergic asthma or serious allergic skin rash.
* Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
* Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
* Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer

Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).


Eligibility Criteria:
Inclusion Criteria:

* histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
* measurabel disease by CT and/or MRT and/or FDG-PET-CT
* fit for chemotherapy
* no prior radiotherapy or major surgery in the head/neck region
* Karnofsky Index \> 60%
* informed consent

Exclusion Criteria:

* uncontrolled secondary cancer
* distant metastases
* pregnancy
* expected malcompliance
Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis

The research group intends to carry out a case-control study to recruit IBS-D patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then discover the characteristics of molecular level changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism of comorbid anxiety and depression and IBS, and discover potential targets for effective treatment. This project can help to construct the colonic single-cell map of IBS-D patients and explore the differentially expressed genes in the colon of IBS patients and their signaling pathways related to neuroregulation, providing an effective therapeutic target for the treatment of comorbid anxiety and depression and IBS.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
2. Aged between 18 and 65 years old (inclusive), male or female;
3. HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points

Exclusion Criteria:

1. Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);
2. Abnormal liver and kidney function (ALT or AST \> 1.5 times the upper limit of normal, or T-Bil \> 1.5 times the upper limit of normal, or Cr more than the upper limit of normal), hematopoietic system diseases and tumors;
3. Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);
4. Previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.;
5. Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome;
6. Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis;
7. Previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;
8. 4. Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;
9. 4. Patients who have taken antidepressant drugs and psychotropic drugs before treatment;
10. 4. Use drugs that affect gastrointestinal motility and function, such as prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators and antibiotics;
11. Allergic constitution;
12. Pregnant and lactating women; Others that may affect study compliance or adversely affect the results as judged by the investigator.
Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel.

Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.


Eligibility Criteria:
Inclusion Criteria:

* Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
* Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
* Clinically stable

Exclusion Criteria:

* Has a hypersensitivity to the active substance or to any of the excipients
* No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
* Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement

Other protocol-defined inclusion/exclusion criteria apply
Core Training to Improve Abdominal Strength Strength and Ankle Proprioception in Basketball Players

Introduction. The prevalence of ankle injuries in basketball are high. The lack of balance in the ankle is one of the main causes that produces these injuries. The goal of core training is to increase the physical capacities of resistance strength in the abdomen and analyze if it produces improvement in proprioception in the ankle joint in basketball players.

Objective. To evaluate the effectiveness of Core training to improve the strength of the abdomen and analyze if it produces improvement in proprioception in ankle of basketball players.

Study design. Randomized, multicentric, single-blind clinical study with a follow-up period.

Methods. The 30 participants recruited will be randomly assigned to the two study groups: experimental (Core training for strength in the abdomen) and control (without intervention). The treatment will last 4 weeks, with 3 weekly sessions, approximately 20 minutes each. There will be three evaluations (pre-intervention, post-intervention and follow-up). On the dependent variables: strength core resistance (evaluated with Trunk Flexor Test, Trunk Extender Test, and Side Bridge Test) and proprioception (measured with the Star Excursion Balance tests and Romberg test) With the Kolmogorov Smirnov statistical test we will calculate the normality and with the t-student test of paired data and an ANOVA of repeated measures, we will obtain the difference between the three evaluations and the intra and intersubject effect, respectively.

Expected results. To observe improvement in strength in the abdomen and analyze if it produces improvement in proprioception in the ankle of basketball players.


Eligibility Criteria:
Inclusion Criteria:

* Basketball players
* Federated in the Community of Madrid
* Male
* With an age range of 18 to 40 years.

Exclusion Criteria:

* Who have a musculoskeletal injury at the time of the study or who have suffered a lower limb injury in a period of three months before the study
* That they are in an individualized personal training
* Not signed the informed consent document.
Physiological Responses in Tobacco Chippers

This study will analyze a series of biological and behavioral markers in different populations of smokers. The study groups will differ in their cigarette consumption and level of nicotine dependence. This analysis will help to identify factors that might be important for smoking behavior and nicotine addiction. The results from this study will contribute to improve campaigns for smoking prevention and treatments for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* age 25-55

Exclusion Criteria:

* alcohol or drug addiction
* unstable significant medical problems
* neurologic disease
* medications known to affect CNS function or impact physiologic parameters measured in the study
* significant visual impairment
* breath carbon monoxide (BCO) level of less than 10 ppm for smokers
* breath carbon monoxide (BCO) level of more than 5 ppm for non-smokers
* for heavy regular smokers: erratic smoking history (i.e. they must have smoked an average of 15 cigarettes daily for at least one year)
Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty

In this observational study, the investigators will evaluate potential risk factors associated with urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal Graft during the past 10 years. Patients' medical files will be reviewed for data relevant to demographics, clinical and operative characteristics. data will be analyzed using the appropriate statistical tests and the independent predictors of urethroplasty outcome will be identified.

In this series, the investigators will study different factors related to the stricture and to the patients to identify the independent predictors of urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal graft.

A retrospective review of medical records will be performed to identify patients who underwent augmented anastomotic anterior urethroplasty with dorsal onlay graft at Al-Azhar University Hospitals in Egypt since 2010. Patients will be included only if they were two or more years out of surgery. The data will be recorded without patients' identification.

Data to be collected are patient age, body mass index (BMI), smoking status, diabetes status, overall comorbidity, stricture etiology, prior endoscopic treatment and open urethroplasty, urethral stricture length and location, degree of urethral obliteration, urethral plate width, presence and degree of spongiofibrosis. estimated intraoperative blood loss, catheter size, overall operative time, hospital stay and early postoperative complications.

The diagnosis of urethral stricture recurrence is based on the radiological and endoscopic features of stricture recurrence. Time to recurrence will be calculated from the date of surgery till the date restricture diagnosis.

Univariate and multivariate regression analysis will be performed and factors predicting urethral stricture recurrence will be identified.

Eligibility Criteria:
Inclusion Criteria:

* patients who will be 2 years or more out of surgery

Exclusion Criteria:

* patients with incomplete medical records or follow-up informations
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma

This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection.

The primary endpoint: 2-year DFS rate; The second endpoint: DFS


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged ≥18 and ≤75 years old；
2. ECOG performance status score 0-1；
3. Stage ⅠB-ⅡA（according to the 8th Edition of the AJCC Staging system）；
4. Complete surgical resection of the primary NSCLC is mandatory；
5. Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces \[STAS\], etc.);
6. The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
7. Normal organ and bone marrow function measured before the study as defined below:

1) Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0\~10×10\^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10\^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio（INR）≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN 8. No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded; 9. Subjects have voluntarily participated, signed and dated informed consent.

Exclusion Criteria:

1. Double primary lung cancer or multiple primary lung cancer;
2. Subjects with mental illness;
3. Presence or concomitant hemorrhagic diseases;
4. Pregnancy or lactation;
5. Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.