cyrilzakka/clinical-trials huggingface dataset:
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections

* This is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency.
* Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.

\*10 consenting adults (18 or older) will receive IgIV (Gamunex 10%) monthly at a dose of 400mg/kg body weight IV at 3ml/minute. Comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. There is also a 3 month follow-up visit after completion of therapy. Specific xrays will be done at the beginning and with the last treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 or older) with deficiency in one or more IgG subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin.

Exclusion Criteria:

* Patients with panhypogammaglobulinemia or selective IgA deficiency.
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.

The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.

Eligibility Criteria:
Inclusion Criteria:

Waist circumference \>102 cm (40 inches) males, \>88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.

* CHD equivalents:

  * Recent (within 3 years)documented heart attack
  * Documented symptomatic coronary artery disease
  * Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)
  * Documented symptomatic peripheral arterial disease
* Major risk factors:

  * Documented type 2 diabetes mellitus
  * Metabolic syndrome (NCEP criteria)
  * Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
  * Elevated high-sensitivity C-reactive protein
  * Age \> or = 65 years for males, age \> or = 70 years for females

Exclusion Criteria:

* Obesity of known endocrine origin
* Pregnant or breastfeeding women
* Very low calorie diet or weight loss surgery within past 6 months
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
* Likely cardiovascular intervention within next 1 month
* Allergy to rimonabant or excipients, or prior participation in a rimonabant trial
* Receipt of investigational product within past 30 days
Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult patients with NBCCS. This was an exploratory study designed to demonstrate preliminary efficacy of LDE225 in this indication. This study included a Screening period of approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of approximately 6-8 weeks followed by a long-term follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple basal cell carcinomas (at least two) and typical presentation of NBCCS.
* Female patients must be women of non-childbearing potential (WONCBP).

Exclusion Criteria:

* Use of any topical treatment to treat BCCs, including prescription and over the counter in the 4 weeks prior to first dose of study drug.
* Use of photodynamic therapy (PDT), radiation or systemic treatment known to affect BCCs or neoplasm in the 12 weeks prior to first dose of study drug.
* Patients receiving medications that are recognized to cause rhabdomyolysis or patients with a prior history of rhabdomyolysis.
* Patients with a histologically confirmed diagnosis of locally advanced or metastatic BCC.

Other protocol-defined inclusion/exclusion criteria may apply
Dental Implants in Patients Under Oral Anticoagulant Therapy

This study evaluated the outcomes in the post-operative recovery following dental implant surgery in patients who continued on oral anticoagulated therapy (OAT) with warfarin. The primary outcome of this study was to evaluate bleeding within the first 5 days post-surgery and presence of intraoral/extraoral hematomas in skin and mucosa oral.

The aim of this study was compare: 1) the frequency of immediate and short term postoperative bleeding using tranexamic acid (TXAg), bismuth subgallate (BSg) or dry gauze (DGg) as local hemostatic 2) explore the relation between bleeding and the occurrence of hematomas, with length of incision, duration of surgery, and alveolar ridge recontouring. 80 surgical procedures performed in a total of 71 patients (20 surgical procedures in 18 patients not on OAT and 60 surgical procedures performed in 53 patients on OAT) that were assigned to one of four groups, so that each group included 20 procedures. The control group (Cg) comprised 20 procedures performed in patients not on OAT. The 60 procedures to be performed in patients on OAT were randomly to one of the three following experimental groups: 1) TXAg group, OAT plus TXA as local hemostatic agent; 2) BSg group, OAT plus BS as local hemostatic agent; 3) DGg group, OAT plus compression with dry gauze as local hemostatic agent. Outcomes variables were:

Intraoperative variables: length of incision expressed (Li) alveolar ridge recontouring (Arr), total duration of surgery (Ds), surgical quadrant and implant location.

Postoperative variables: immediate postoperative bleeding (within the first 30 minutes after surgery), short-term bleeding: within the first 5 days post-surgery, determined according to the index described by Bacci, presence of intraoral/extraoral hematomas in skin or mucosa. Descriptive statistical, analysis of variance and regression logistic analysis was performed. Statistical significance was set at a value of p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

Subjects:

* Systemically healthy.
* Healthy periodontal tissues or well-controlled periodontal health.
* In need of a maximum of two dental implants per hemiarcade,
* Showing ≥8mm bone height and ≥6 horizontal bone width.
* Needing a maximum of two surgical procedures.
* Who had written consent from the referring service to undergo the surgical procedure.

Exclusion Criteria:

Subjects:

* Requiring implant placement immediately after extraction.
* Systemic disease contraindicating implant surgery.
* Mental disability preventing them from complying with the protocol.
* Hematological, metabolic, autoimmune or bone diseases.
* Hepatic alterations or receiving medication affecting liver function.
* Receiving corticoid therapy, chemotherapy, or anticoagulant therapy within 10 days prior to the surgery.
* Taking antibiotics that interact with oral anticoagulants.
* Requiring vertical or periosteal incisions.
* Requiring bone regeneration strategy.

When treatment involved placing an implant in more than one hemiarcade, the corresponding surgeries were scheduled 30 days apart.
Transfer of Frozen Embryos in Natural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate

The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is aged between 18 and 40
* Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient using donated oocytes
* Necessity of pre-implantation diagnosis
* Patients with stage 3 or 4 endometriosis or adenomyosis
Detection of Disease in the Upper Tract

An observational study of Cxbladder performance for detection or rule-out of upper tract urothelial cancer. Subjects will be prospectively recruited to a single arm observational study to validate the performance characteristics of Cxbladder for suspected (UTUC) or for patients with a history of UTUC and are under surveillance for recurrence of disease.

This is a single arm observational study prospectively recruiting eligible subjects with no apparent UC of the bladder following white light cystoscopy who have positive or suspicious urine cytology or imaging results.

Participants will undergo all clinical investigations as prescribed by the physician as per standard of care with addition of urine sampling to enable Cxbladder and central urine cytology testing. A mid-stream voided urine sample collected at the time of appointment will be used for Cxbladder and central urine cytology testing. Cxbladder and central cytology results will not be reported to the physician.

Urine sample testing will occur at Pacific Edge Ltd laboratories (Dunedin, New Zealand). Central urine cytology will be processed by an independent testing laboratory (Southern Community Laboratories, Dunedin, New Zealand). The remainder of the urine sample will be used for dipstick analysis of Specific Gravity, Leucocytes, Nitrites, Blood, Haemoglobin, and pH. The unused portion of this sample will be used for local cytology and any other analysis as deemed clinically appropriate. Central urine cytology results are not available to physicians.

Eligibility Criteria:
Inclusion Criteria:

1. Suspected to have UTUC following negative cystoscopy but positive or suspicious imaging and/or urine cytology.
2. Under surveillance for UTUC following a previous confirmed diagnosis of UTUC
3. Able to provide a voided urine sample of the required 30 ml minimum volume
4. Able to give written consent
5. Able and willing to comply with study requirement
6. Aged 18 years or older

Exclusion Criteria:

1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
2. Total cystectomy of the bladder with bowel urinary diversion
3. Pregnancy
Lung Ultrasound, Cholecystectomy, Atelectasis

Atelectasis is an important complication that can be seen during general anesthesia, especially in patients with lung problems and in patients having pneumoperitoneum. Application of PEEP during anesthesia may reduce the incidence of atelectasis.Lung ultrasonography is a tool that is easily accessible, can be applied at the bedside, is non-invasive, does not cause radiation exposure, and is increasingly used in daily practice in operating rooms. In this study, it was aimed to evaluate the occurrence of atelectasis by using lung ultrasound, and to investigate the effectiveness of ultrasound in determining the risk of developing atelectasis in patients ventilated with different PEEP values during general anesthesia. The study was conducted in 60 patients aged 18 and over, from ASA I-III groups, who were planned to undergo laparoscopic cholecystectomy surgery at the Istanbul Medeniyet University Göztepe Training and Research Hospital General Surgery Clinic, and their written and verbal informed consents were obtained. The patients included in the study were divided into 2 groups. Among the patients who were going to be operated, 5 PEEP were applied to Group I (n=30) cases, and 10 PEEP to Group II (n=30) cases during ventilation with anesthesia device. All patients were evaluated by transthoracic lung ultrasonography before anesthetic induction, after tracheal intubation, after pneumoperitoneum, and 15 minutes after recovery from anesthesia. According to the lung USG protocol, a total of 6 regions, including 2 quadrants of each hemi-thorax anterior wall, 2 right and left lateral walls, and 2 quadrants of the posterior wall, a total of 12 regions in each patient were scanned, and the images were evaluated. According to the modified lung USG scoring system, each region was scored between 0-3 consistent with the degree of atelectasis. The total score was calculated for each patient. Hemodynamic follow-up of the patients was performed. Anesthesia times, surgery times, and pneumoperitoneum times were recorded and compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients are aged 18 and over, from ASA I-III groups, who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria:

* Patients who do not give consent
* Patients who have previously undergone thoracic surgery
* Patients with a body mass index \> 40 kg/m²
* Patients with severe COPD
* Patients with serious pulmonary diseases
* Patients diagnosed with obstructive sleep apnea syndrome
* ASA IV patients
* Patients with advanced cardiac and neurological diseases
* Patients with mental retardation and limited cooperation
* Patients who terminate their participation in the study for any reason during the trial
* Pediatric age group Pregnant women
Airway Responses to Montelukast and Desloratadine.

Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. This project is being conducted to determine if these drugs are effective, either alone or in combination, on controlling asthma that is triggered by allergies.


Eligibility Criteria:
Inclusion Criteria:

* baseline FEV1 \> or = 65% predicted
* positive methacholine challenge (i.e. methacholine PC20 \< or = 16mg/ml
* positive allergen challenge

Exclusion Criteria:

* negative skin prick test
* lung condition/disease other than asthma
* currently use montelukast and/or desloratadine
A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors

Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, locally-advanced or metastatic malignancy
* Standard treatment is not available or patient declines
* Adequate organ function

Exclusion Criteria:

* Active brain metastases from non-brain tumors.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
* Other protocol specified criteria
Interference by Activated Protein C Resistance in the Determination of Protein S Activity

Protein S is an anticoagulant protein and a cofactor of protein C. It is recommended to explore it first by a functional (chronometric) technique by assessing its cofactor activity of activated protein C. Existing tests measure the prolongation of a coagulation time. These tests are all dependent on factor V, but some patients have mutations in factor V (including V Leiden) that make them resistant to activated protein C activity. It is suspected that these mutations lead to underestimations of protein S activity by chronometric technique.


Eligibility Criteria:
Inclusion criteria:

* Patient of legal age (≥ 18 years)
* Patient for whom a sample has been sent to the HUS Hematology Laboratory for measurement of protein S activity between 28/12/2009 and 29/12/2020
* Patient who does not object to the reuse of his/her medical data for scientific research purposes.

Exclusion criteria:

* Minor patient
* Patient with incomplete data
Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum

Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB) treatment on retinal functions, especially the cone function, and retinal structure in patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial

Setting: Primary Care clinical trial

Participants: 120 RP subjects will be recruited from Ophthalmology department at The University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1 year. After the 1st year, both groups will stop the treatment and all subjects will also have the same eye exam in 6-month period for the 2nd year.

Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 \& 60-4 programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual acuity.

The study was a randomized controlled trial with a double-masked, placebo-controlled design. All the subjects were randomly allocated into either LB (treatment) group or placebo (control) group.

All the eligible subjects had the eye examination, including VA using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, refractions, tonometry, external and internal ocular health assessments, and fundus photo-documentation. Three additional tests were conducted to investigate the functional and structural changes in the RP patients, including Ganzfeld Electroretinogram, Humphrey Visual Field Analyser (Zeiss, Dublin, USA) and Spectral-domain Optical Coherent Tomography (SD-OCT) (Heidelberg Engineering, USA).

Eligibility Criteria:
Inclusion Criteria:

Ocular conditions:

* Retinitis pigmentosa;
* best corrected VA LogMAR 0.20 or better;
* Humphrey Visual Field Analysis (HVFA) 30-2 total mean defect \> or = 250 Decibel;
* Intra-ocular pressure (IOP) \<21 mmHg;
* van Herrick ratio \< or = 0.5;
* no other ocular diseases

Dietary conditions:

* Fruit and vegetable intake \<10 servings/day;
* spinach or kale intake \< or = serving/day;
* dietary lutein intake \< or = 5.4mg/day;
* no intake of cod liver oil or omega-3 capsules;
* dietary Lycium barbarum intake \< or =10 fruits/week;
* supplement intake \< or = 5000 IU/day of Vit. A and \< or = 30 IU/day of Vit. E;
* alcoholic consumption \< or = 3 beverages/day

Exclusion Criteria:

* BMI \> 40;
* intake of any anticoagulants (especially Warfarin),
* pregnant or planning to be pregnant;
* smoking;
* other clinically significant systemic diseases, eg. diabetes, liver disease and heart disease
Quality of Life in Adults Impaired Functioning - A Randomized Controlled Trial of Bidet vs Usual Toileting

Our expectations (hypotheses) are:

Primary outcome

1. Regular bidet use will improve quality of life around elimination in adults with impaired functional status. Functional status will be measured by activities of daily living (ADL).
2. Regular bidet use by adults with impaired functional status will improve the quality of life around toileting for their caregivers.

   Secondary
3. Regular bidet use will reduce the incidence, frequency and severity of constipation (as measured by self-report) in adults with impaired functional status.
4. Regular bidet use will reduce the incidence of urinary tract infection (UTI) in adult women with impaired functional status.

The study will assess the use of a bidet (a device that is attached to the toilet which allows a person to wash their genitalia after elimination) in improving toilet related quality of life for functionally impaired individuals as measured by ADLs and caregivers of functionally impaired adults. We also want to see if bidet use is effective in lowering the incidence of urinary tract infections in this high risk population.

Functional impairment around toileting has been shown to negatively impact quality of life (QOL) for both patients and their caregivers. We hope to learn if the use of bidet will improve QOL in this population.

Urinary tract infections increase the risk of morbidity and mortality in women with impaired functional status. Specifically the risk of hospitalization, sepsis, kidney failure and other complications. There are not currently effective forms of non-pharmaceutical prevention. Bidets are safe, inexpensive and hygienic. Individuals with functional impairment often have difficulty maintaining their hygiene due to frailty and functional limitations. It is our hope that addressing these issues will lead to a reduced incidence of UTI.

Constipation is a common problem in elderly adults and in adults with impaired functional status. It is our hope that the bidet will reduce the frequency and severity of constipation (as measured by self report).

Eligibility Criteria:
Inclusion Criteria:

Sample 1 (adults with impaired functional status):

Age: 55-95 Sex: Female Ethic background: Reflecting the population at Stanford Hospital and Clinics who meet the inclusion criteria and who agree to participate.

Sample 2 (caregivers of participants in Sample 1) Adults over the age of 21 caring for an adult with impaired functional status who has enrolled in this randomized controlled trial. Sex and ethnic background will reflect the demographic of the caregivers for the population in Sample 1.

Exclusion Criteria:

Participants not meeting the inclusion criteria.

Additional exclusion criteria:

1. Life expectancy less than 2 years
2. The inability to read and write English.
3. Patients with indwelling urinary (e.g. Foley) catheters
4. Use of any water based cleaning system after toileting at home in the past 12 months (bidet, water pot, douche etc).
5. Fully incontinent (eg diaper use)
6. Moderate to severe cognitive impairment (15 or lower on the MOCA)