cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Versus Robotic Assisted Laparoscopic Sacrocolpopexy for Vaginal Prolapse

The purpose of this study is to conduct a trial of robotic assisted versus traditional laparoscopic sacrocolpopexy in the treatment of patients with vaginal prolapse.

Although laparoscopic sacrocolpopexy (LscASC) has been demonstrated to yield comparable success rates to abdominal sacrocolpopexy (93-99%) for the surgical treatment of pelvic organ prolapse, it has not been widely adopted due to the increased operating time and steep learning curves associated with laparoscopic suturing and knot-tying. For these reasons, robotic systems have been advocated for this technique. The objective of this study is to conduct a prospective single-blinded randomized controlled trial of robotic assisted versus traditional LscASC in the treatment of patients with apical vaginal prolapse stages II-IV (prolapse from 1 cm proximal to the hymen to all points distal).

This is a prospective single-blinded randomized controlled trial. Robotic assisted LscASC will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) in a similar manner as that described above for conventional laparoscopy. Data points recorded during the procedure will include: operating room time of entry and exit, time from incision to closure and time taken for the suturing aspect of the case. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital will be studied as will cost-effectiveness and impact on HRQOL

Eligibility Criteria:
Inclusion Criteria:

* Women who are 21 years of age or greater
* Status post hysterectomy with apical vaginal prolapse POPQ stages II-IV (prolapse from 1cm proximal to the hymen to all points distal) that desire laparoscopic surgical management.

Exclusion Criteria:

* Patients that are not candidates for general anesthesia
* Inability to consent
* History of prior sacralcolpopexy
* Suspicious adnexal masses or other factors that may indicate pelvic malignancy
* History of pelvic inflammatory disease
* Morbid obesity (body mass index greater than or equal to 40)
* History of prior or need for concomitant rectopexy with sigmoid resection.
Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant

The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a patients undergoing allogeneic transplantation.

The primary objective of this study is to define the safety and efficacy of recombinant human growth hormone (rh-GH, Genotropin) in a population of patients undergoing allogeneic stem cell transplant. The secondary objectives of this study are: to evaluate the incidence of mortality due to opportunistic infections in the first 6 months, to evaluate the incidence and severity of infectious complications, to assess laboratory parameters of post-transplant immune recovery in patients on GH therapy and to determine the probability and time of neutrophil and platelet recovery on GH therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥12
* \<90 days following Allogeneic Transplantation.
* ANC\>500/ul for 3 consecutive days.
* ≥50% donor cells in all cellular fractions tested.
* No active grade II or higher acute graft versus host disease
* Receiving ≤ 1 mg/kg/day Methylprednisolone or equivalent
* Documentation of morphologic or radiographic remission within 45 days of protocol enrollment

Exclusion Criteria:

* Patients with acute organ dysfunction requiring monitoring in the Intensive Care unit or receiving invasive interventions that may include, Hemodialysis ,CVVHD, or any form of mechanical ventilation including CPAP/BiPap at the time of starting therapy.
* Pregnant or lactating patients and those without a negative pregnancy test.
* Patients must have a life expectancy of at least 3 months.
* Patients must be HIV negative.
* Patients must not be receiving investigational agents for treatment of GVHD.
* Patients with severe veno-occlusive disease as determined by standard criteria.
* Patients with Type 1 Diabetes at the time of initiation of stem cell transplantation.
Photobiomodulation for Management of Temporomandibular Disorder Pain

Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years and older
* Meets the CATI pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)\].
* Willing to provide signed and dated informed consent
* Willing to to comply with all study procedures and to be available for the duration of the study
* Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
* Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100

Exclusion Criteria:

* Active rheumatologic disease
* Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, or uncontrolled seizures) that precludes participation as determined by the investigator
* Initiated occlusal appliance therapy within 30 days prior to CATI
* Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
* Is in active orthodontic treatment
* Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
* Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
* Has a history of psychiatric hospitalization within one year prior to CATI
* Currently pregnant or lactating
* Has a known hypersensitivity to laser therapy
* Currently being treated with chemotherapy or radiation therapy
* Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
* Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator
Temporal Trends in Nonattendence Rate for Scheduled Outpatient Appointments.

Ecological time-series study using secondary databases.

A time-series study will be conducted to evaluate nonattendance over time. The unit of analysis will be the appointment.

Eligibility Criteria:
Inclusion Criteria:

* Appointments scheduled for outpatient medical care across all settings and specialties from January 1, 2016, to December 31, 2023

Exclusion Criteria:

* Cancelled appointments, including cancellations made by the patient, medical team, and the appointment management system.
* Appointments that do not correspond to scheduled in-person care (Teleconsultations,
* Appointments for walk-in demand).
* Scheduled appointments that are not for medical care (Health coverage or specialties that do not correspond to scheduled medical care, Appointments for procedures,
* Appointments for complementary exams, Appointments for treatments such as speech therapy, physiotherapy, or other therapies).
* Spontaneous overflow appointments where the patient spontaneously presents for care at that moment. These appointments cannot be absent as the present and the appointment are assigned simultaneously.
* System errors that do not correspond to actual patient medical care appointments (Duplicate cancellations, Appointments where patient and physician coincide).
Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.

Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
* Patients with moderato to severe spontaneous pain
* Mandibular molars
* Patients with the ability to understand and use the pain scale
* Patients accepting enrollment in the study

Exclusion Criteria:

* Patients allergic to any medication or material to be used in the study
* Pregnant and lactating females
* Patients taking medications affecting pain perception in the last 12 hours
* Patients having more than one symptomatic molar in the same quadrant
* Patients with contributory medical history (ASA \> II)
Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics

Observational, retrosopective, single-centre, non-profit study focused on the frequency of Central Precocious Puberty idiopathic, or associated to Neurodevelopmental Syndromes and Pathologies, and comparison of diagnostic and developmental characteristics of patients.

The study enrolls both male and female patients referred to the Pediatrics Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico di Sant'Orsola between 01/01/2013 and 31/12/2023 for Central Precocious Puberty and treated with GnRH analouge. The primary aim of the study is to Assess the frequency of diagnosis of idiopathic or syndromic Central Precocious Puberty in the last decade. The secondary aims are to Compare clinical, laboratory and instrumental characteristics at diagnosis and in follow-up between patients with idiopathic and syndromic PPC, and to identifying possible pathogenetic factors characterising different forms of Central Precocious Puberty.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Central Precocious Puberty presenting an indication to undertake treatment with GnRH analogue: Appearance of secondary sexual characteristics (thelarche or gonadarche) before the age of 8 for females and 9 for males; Acceleration of the rate of statural growth and advancement of bone age one year older than the chronological age; LH peak \> 5 IU/L on GnRH test and a longitudinal uterine diameter \> 36 mm in females, with or without the appearance of endometrial rhyme;
* Age at onset of entral Precocious Puberty between 2 and 8 years (females) or between 2 and 9 years (males);
* Age at enrollment \< 18 years;
* Follow-up of at least 12 months;
* Obtaining informed consent from parents/legal guardian of peduatric patients.

Exclusion Criteria:

* Isolated telarche and/or pubarche;
* Peripheral forms of precocious puberty;
* Patients diagnosed with primary organic Central Precocious Puberty due to tumour- or non-tumour-causing hypothalamic lesions.
Summative Evaluation to Validate the LEAFix Device With Users

The Laryngeal Endo-tracheal Airway Fixator(LEAFix) is a single use product designed to secure airway devices to patients during anaesthesia, with better infection control management and interaction with the patients skin. This study investigates the users of the LEAFix device interacting with the LEAFix device, its packaging and a simulated patient through different scenarios of securing an airway device. The aim is to understand the risks associated with the use of the device for CE marking purposes. This study is funded by Innovel Ltd. the manufacturer of the device.


Eligibility Criteria:
Inclusion Criteria:

* Member of staff trained in placing airways

Exclusion Criteria:

* Previous knowledge of the device
Pharmacokinetics of Itraconazole in Pediatric Cancer Patients

This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the development of invasive fungal disease.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who are under chemotherapy, and receive itraconazole.

Exclusion Criteria:

1. Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

   * Heart : fractional shortening \< 30%, ejection fraction \< 45%
   * Liver : total bilirubin ≥ 2 x upper limit of normal (ULN) ; aminotransferase ≥ 3 x ULN
   * Kidney : creatinine ≥ 2 x normal or GFR ≤ 60㎖/min/1.73㎡
2. Patients with hypersensitivity to azoles.
3. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
4. Pregnant or nursing women.
5. Psychiatric disorder that would preclude compliance.
Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections

The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Women assigned to undergo cesarean section

Exclusion Criteria:

* All others
ABF Tourette's Disorder Post Marketing Surveillance Study

This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).

This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients 6 to 18 years of age with Tourette's Disorder
* Patients who are prescribed Abilify® treatment as per investigator's medical judgment.
* Patients who gave written authorization to use their personal and health data
* Patients starting Abilify® treatment after agreement is in place

Exclusion Criteria:

* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify®
* Patients who have been treated with Abilify®
* Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption
* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S
* Patients participating in other clinical trial
VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria

The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20 mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria (MAU).


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate hypertension with a mean sitting diastolic blood pressure (MSDBP) \> 85 and \< 110 mmHg for non-treated patients. Previously treated patients with MSDBP \< 110 mmHg. Treated is defined as having taken medication until \< 2 days prior to Visit 1
* Positive urine spot test with Micral dipstick (detection of urinary albumin concentration of at least 50 mg/l) at Visit 1 (day -21).
* Confirmation of MAU of at least 2 out of 3 measurements determined in the first morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day -7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) \> 2.5 mg/mmol and \< 25.0 mg/mmol and for female patients as UACR \> 3.5 mg/mmol and \< 35.0 mg/mmol at both visits.

Exclusion Criteria:

* Evidence of renal impairment as determined by any one of the following:

  * serum creatinine clearance \< 30 ml/min as determined by Cockroft and Gault formula \[Cockroft and Gault, 1976\] and/or
  * serum creatinine \> 1.25 x ULN at Visit 1,
  * a history of dialysis, or
  * a history of nephrotic syndrome.
* Serum potassium values \<3.5 mmol/l or \>5.5 mmol/l at Visit 1
* Any medical condition which might significantly alter the urinary excretion of albumin

Other protocol-defined exclusion criteria may apply.
Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine

The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Severe peripheral vascular disease not amenable to bypass or angioplasty
* Age \>40 years old
* Normal renal function (creatinine \< 1.6)
* Non pregnant female
* Lifespan \> 6 months

Exclusion Criteria:

* Age \<40 years old
* Refusal to give informed consent and/orCognitively disabled
* Congestive heart failure or stroke in the last 3 months
* History of cancer or myeloproliferative disorders
* Proliferative retinopathy
* Pregnancy
* Positive screening test for HIV, Hepatitis B or Hepatitis C
* Buerger patient
* Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue
* Pregnancy or lactation
* Having been non controlled severe pathology
A Randomized Control Trial of Enhanced Cognitive Behavioural Group Therapy for Older Adults with Depression: Efficacy Across Older Age-Groups

This study is on a type of psychotherapy to treat depression in older adults called Cognitive Behavioural Therapy (CBT-OA). CBT is based on the idea that changing thoughts and behaviours can improve mood. CBT has been shown to treat depression in many types of people. CBT-OA changes the usual approaches used for older adults and offers the therapy in a group settings for 8 weeks, for 2 hours a week.

Participants will be randomly (by chance) placed into one of two study groups. One group will receive CBT-OA treatment right away. The other group (Treatment As Usual) will receive standard care from their doctor during the 12-week study period. Both groups will be closely monitored during the study period. The standard care group will be offered CBT-OA in a future session outside of the study.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients 65+ years of age and diagnosed with MDE per DSM-V criteria by a geriatric psychiatrist using a standard clinical biopsychosocial assessment and a Beck Depression Inventory (BDI) of \>12.

Exclusion Criteria:

* Patients with psychosis, those undergoing acute inpatient care or electroconvulsive therapy (ECT), those with dementia (Mini-Mental Status Examination (MMSE) score of \< 26), and those with chronic personality disorders
Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
* Willing to provide proof of identity;
* Without vaccination history of pneumococcal vaccine;
* None-pregnancy or do not plan to pregnancy recently;;
* Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
* Volunteers of 8-17 years old and their guardians who willing sign informed consent;
* Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
* Able and willing comply with the requirements of the protocol ;

Exclusion Criteria:

* Volunteers whose axillary body temperature was \>37.0℃ before vaccination
* Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
* Volunteers who has a history of epilepsy, convulsions or psychosis;
* -Allergic person;
* Any prior administration of blood products in last 3 month;
* Any prior administration of other research medicines in last 1 month;
* Plans to participate in or is participating in any other drug clinical study;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Had fever before vaccination, Volunteers with temperature \>37.0°C on axillary setting;
* According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial
A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome

To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).


Eligibility Criteria:
Inclusion Criteria:

Female patients who meet the following criteria:

1. Patients satisfying the Rome III Diagnostic Criteria
2. Patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools
3. Patients who have abdominal pain or discomfort
4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion Criteria:

Patients who meet any of the following criteria:

1. Patients with a history of surgical resection of the stomach,gallbladder, small intestine or large intestine
2. Patients with a history or current evidence of inflammatory bowel disease
3. Patients with a history or current evidence of colitis ischemic
4. Patients with concurrent infectious enteritis
5. Patients with concurrent hyperthyroidism or hypothyroidism
6. Patients with concurrent active peptic ulcer
7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort