cyrilzakka/clinical-trials huggingface dataset:
A Study of SPG Block for Opioid Withdrawal

Medication is the most efficacious treatment of an opioid use disorder, including methadone, buprenorphine, and naltrexone. However, many patients experience withdrawal symptoms, which prevents them from being successfully inducted onto medication for opioid use disorder. This study is a pilot study investigating whether blocking the SPG helps reduce withdrawal symptoms in OUD. This study does not involve treatment or induction onto medications. It is a proof of principal study only. We will recruit non-treatment seeking subjects with OUD who are admitted to the research unit for all procedures.

The sphenopalatine ganglion (SPG) is a collection of neurons involved in autonomic regulation (which refers to bodily processes that are automatic like heart rate and blood pressure). Blocking the SPG is used to treat disorders, such as migraines or cluster headaches (short, severe headaches that occur together). The procedure will be performed by a doctor (specialized in ear, nose throat surgery) and would first involve the application of numbing nasal spray to both nostrils, which lasts about two hours and might reduce smell during that time. This is followed by an injection of a stronger numbing agent (similar to the type used by dentists) to the nerve bundles in the back of the nasal passages (one side at a time) via a tool, known as an endoscope which is a rigid tube with a camera on the end. The procedure is not painful. Previous studies have shown that clonidine, which inhibits the autonomic nervous system, is helpful for reducing the symptoms of opioid withdrawal. However, the dosing of clonidine is limited by side effects (lowered blood pressure and heart rate) and compliance. Furthermore, withdrawal is among the most significant barriers to substance treatment and ultimately overcoming a substance use disorder. Thus, we would like to explore whether a more targeted intervention would improve rates of successful acute detoxification while overcoming the aforementioned challenges of systemic side effects and compliance issues observed with the use of oral agents.

Eligibility Criteria:
Inclusion Criteria:

* Opioid Use Disorder, moderate to severe
* Ages 22 to 50
* Lives in New York City, able to travel for visits
* Willing to be admitted to an inpatient unit

Exclusion Criteria:

* Medical disorder, for who study participation could be deleterious (neurologic, cardiac, renal or infectious disease
* Hypertension: BP \> 150/100
* Elevated liver function tests (AST, ALT) \> 3x normal
* Having a painful medical illness for which opioids are needed (including upcoming surgery).
Novel Alpha-Glucan Metabolism

These are the characteristics of the project:

Monocentric:

Double blind randomized and crossover: you will test all the 3 products in random order.

This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design. Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system

1. 50 g novel alpha glucan
2. 50 g (rapidly digestible control)
3. 15 g (dietary fiber)

Eligibility Criteria:
Inclusion Criteria:

Healthy status (based on anamnesis) Body mass index (BMI) between 18.5 and 29.9 kg/m2 Able to understand and sign informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women
2. Type I and type 2 diabetes
3. Known food allergy or intolerance to test product
4. Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
5. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
6. Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test
7. Recent episode of an acute gastrointestinal illness
8. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
9. Smokers
10. Volunteer who cannot be expected to comply with the protocol
11. Family or hierarchical relationships with Clinical Innovation Lab team
International Registry of Patients With Alpha Thalassemia

This is an international prospective registry of patients with Alpha thalassemia to understand the natural history of the disease and the outcomes of fetal therapies, with the overall goal of improving the prenatal management of patients with Alpha thalassemia.

The aim of this registry is to prospectively and retrospectively collect data on patients who are diagnosed with alpha thalassemia major and other alpha thalassemia mutations. Data collected will be used to:

1. Identify patient outcomes of therapies.
2. Improve clinical management of patients with ATM.
3. Improve medical decision making.
4. Improve quality of care.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of alpha thalassemia (prenatal or postnatal) with genotype consistent with ATM or BHFS phenotype
* referred to the University of California, San Francisco Fetal Treatment Center for fetal diagnosis, management and/or evaluation for the ongoing in utero stem cell transplantation clinical trial

Exclusion Criteria:

- none
The Impact of Anticipatory Guidance on Early Childhood Caries: a Quasi-experimental Study

This study aimed to compare the impact of anticipatory guidance on the caries incidence of 2-3-year-old preschool children and their 4-6-year-old siblings, as well as on their mothers' oral health literacy, as compared to the conventional Ministry of Health (MOH) programme.

This quasi-experimental study was conducted at two government dental clinics in Batu Pahat District, Malaysia. The samples comprised of 478 mother-child-sibling trios (233 families in the intervention group, and 245 families in the control group). An oral health package named the Family Dental Wellness Programme (FDWP) was designed to provide anticipatory guidance to the intervention group at six-month intervals over three years. The control group received the standard MOH oral health education activities. The impact of FDWP on net caries increment, caries prevented fraction, and mother's oral health literacy was assessed after three years of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Children between the age of 2-3 years old
* Older sibling aged 4 to 6 years categorized as having high caries risk based on a Caries Risk Assessment tool adapted from the American Association of Paediatric Dentistry
* Mothers who were willing to participate in the study

Exclusion Criteria:

• Medically compromised children
A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients

The goal of this research study is to find out if a novel phone-based positive psychology intervention that focuses on improving health behaviors and positive emotions can help improve mood, health related quality of life, and overall function in patients who have just undergone hematopoietic stem cell transplantation as part of blood cancer treatment.

Hematopoietic stem cell transplantation (HSCT) is a rigorous treatment for blood cancer patients that can be life-saving, but often causes psychological distress. The investigators hope that this study will help the research team to develop and implement a positive psychological intervention designed to help HSCT patients increase positive emotions such as hope, gratitude, and fulfillment while recovering from a stem cell transplant. Participants will be selected after receiving an allogeneic hematopoietic stem cell transplant treatment in the past 30 days at the Dana-Farber Cancer Institute (DFCI).

In this project, the investigators hope to:

1. Test the feasibility and acceptability of a novel, 8-week, phone-based positive psychology intervention in a small cohort of post-HSCT patients (N = 20).
2. Explore potential benefits of completing the intervention on outcomes of interest, such as positive affect and overall function.

Baseline information about enrolled participants will be obtained from patients from the electronic medical record as required for characterization of our population. This information will include data regarding medical history, current medical variables, medications, and sociodemographic data.

Participants will be approached upon nearing their discharge from the hospital, approximately 30 days after their transplant. Between the time of their discharge and their 100-day post-transplant visit, there will be three check-in/psychosocial support phone calls at weeks 4, 8, and 12 after discharge to build rapport and discuss their recovery. Then, at week 14, participants will meet with the principal investigator to complete self-assessment questionnaires. The participants will then complete an 8-week phone-based positive psychology intervention, at the end of which the self-assessment questionnaires will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hematologic malignancies hospitalized for allogeneic HSCT at the DFCI inpatient units who are medically stable and appropriate for study approach
* Ability to speak, read and write English
* Access to a telephone

Exclusion Criteria:

* Current major depressive episode, bipolar disorder, psychosis or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI)
* Cognitive deficits impeding a study participant's ability to provide informed consent or participate adequately in the study assessed via the Brief Interview for Mental Status (BIMS)
* Medical conditions precluding interviews
Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan

To study the association between aristolochic acid and urothelial carcinoma in Taiwan


Eligibility Criteria:
Inclusion Criteria:

* the resected kidney tissue in the tissue bank

Exclusion Criteria:

* the patients who had been ever exposed to arsenics, rubber, chemicals, irradiation for pelvis, or received chemotherapy.
Oval Abutment Versus a Circular Abutment in Dental Implants in the Anterior Maxillae

Objetive: The main objective of this clinical trial is to assess whether the oval section abutment of a 2.9mm implant achieves a greater covering of the tooth-implant papilla compared to a circular section abutment in 3.3mm implants in upper lateral incisors and lower central / lateral incisors.

Material and methods: fourty patients received unitary implants of 3.3mm or 2.9 mm diameter to replace the absence of upper lateral incisor or lower central/lateral incisor with an edentulous space of at least 6.4mm (mesio-distally). Esthetic and clinical parameters were evaluated 12 months after installation of the prosthesis.

Condition or disease: dental implants

Intervention/treatment: 3.3 or 2.9 mm diameter dental implants

Phase: Not Applicable

The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth.

The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).

The main objective was the papillary index (PI) (Jemt, 1997). It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.

The secondary objectives are (a) to observe the stability of the soft and hard tissues after one year in function, (b) to assess the success and survival rate of the implants, (c) to assess the stability of the implants and their evolution and (d) to analyze the degree of patient satisfaction with the aesthetic result.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Absence of upper lateral incisors or lower central / lateral incisors with an edentulous space of at least 6.4mm (mesio-distally).
* The teeth adjacent to the edentulous space must be natural.
* Patients who are in periodontal health.
* Signing of informed consent before entering the study.

Exclusion Criteria:

* Patients with any systemic condition or disease that may interfere with oral surgery.
* History of radiotherapy.
* Patients smoking more than 20 cigarettes per day.
* Pregnant or breastfeeding patients.
3D Printed Donor Tooth Replica in Autotransplantation of Teeth

3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate.

This technique of autotransplantation has been innovated using 3-dimensional (3D) imaging and rapid prototyping.The use of a 3D-printed replica of the donor tooth is thought to minimize the risk of iatrogenic damage to the actual donor tooth. Nevertheless, no large prospective and comparative studies are available to assess the outcomes using these 3D techniques. Therefore, this study aimed to compare 3D printed replicas in autotransplantation of teeth, compared to the conventional technique. The present study will evaluate the feasibility, clinical satisfied accuracy, and stability of a novel approach for computer-aided autotransplantation of teeth. This new approach facilitated the surgical procedure and might be a viable and predictable method for autotransplantation of teeth.

Application of printed 3D replicas of transplanted teeth facilitates surgical preparation of the recipient site, shortens the extra-alveolar time, and reduces the minimum the number of attempts of the donor tooth insertion at the prepared socket. Their use can significantly decrease the risk of damage to the root surface of a transplant, thus increasing the chance of success.

Eligibility Criteria:
Inclusion Criteria:

1. patient presenting with decayed first molars
2. autotransplantation of third molar at the recipient site

Exclusion Criteria:

1. Diabetic, pregnant patients
2. other autotransplantations (other than first molar recipient and third molar donor)
Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump

This clinical study assesses the feasibility of implementing the inControl automated insulin delivery algorithm with Dexcom continuous glucose monitoring and a compatible insulin pump in adults with type 1 diabetes. It additionally provides pilot efficacy outcomes for interoperable automated insulin delivery.

Self-management of type 1 diabetes is challenging, efforts to optimise time spent in the target range can result in hypo- and hyperglycaemia. Structured education, glucose monitoring and advances in insulin delivery can increase time in range and reduce exposure to extremes of glucose and recent data confirm that automated insulin delivery can enable further increases in time spent in the target range of 3.9 to 10mmol/L (70 - 180mg/dL).

The inControl algorithm, developed by TypeZero technologies is embedded in the Tandem X2 insulin pump and operates with the Dexcom G6 continuous glucose sensor and transmitter in a CE-marked and commercially available system (known as Control-IQ). This system optimises time in range compared with sensor-augmented pump therapy, and the improvement was maintained when participants were further randomised to predictive low glucose suspend or automated insulin delivery. The United States Food and Drug Administration has defined interoperable standards for automated insulin delivery systems, including the iCGM designation for continuous glucose sensors, the interoperable automated glycaemic controller designation, and alternate controller enabled insulin pumps. However, while standards have been defined, to date, interoperability of automated insulin delivery components has not been demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years of age or older
* Type 1 diabetes confirmed on the basis of clinical features
* Type 1 diabetes for greater than 1 year
* On an intensified insulin regimen with multiple dose injection or insulin pump for \> 3 months
* HbA1c \>7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L \<52% for participants already using a continuous glucose sensor)

Exclusion Criteria:

* Total daily insulin dose greater than 100 units
* Weight greater than 140kg
* Pregnant or planning pregnancy
* Have active malignancy or under investigation for malignancy
* Severe visual impairment
* Reduced manual dexterity
* Use of any automated insulin delivery system
* Unable to participate due to other factors, as assessed by the Chief Investigator
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.

Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".

To adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.

Stereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.

Given the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria
* Single nodule, 3 to 8 cm of largest diameter
* Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization

Exclusion Criteria:

* Performance status \> 2
* Severe comorbidity with contraindication for either surgery or radiation therapy
* Decompensated liver cirrhosis (Child-Pugh B or C)
* Neoplastic portal vein thrombosis or extra-hepatic metastases
* Previous anticancer therapy within the last 5 years
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer

The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).

Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proved stage IV or pleural stage III NSCLC (neoplastic pleurisy confirmed).
* Metastatic relapses allowed in not irradiated area.
* Age between 18 and 70 years
* Chemonaïve patients
* At least one measurable target lesion according to recist criteria in non previously irradiated area.
* Performance status \< 2
* Normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l.
* Written informed consent.
* Life expectancy \> 12 weeks.

Exclusion Criteria:

* SCLC, bronchial-alveolar and neuro-endocrine carcinoma.
* Previous chemotherapeutic treatment.
* Symptomatic brain metastases.
* Superior vena cava syndrome.
* Other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction.
* Peripheral neuropathy grade ≥2.
* Past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma.
* Hypersensitivity to paclitaxel or polysorbate 80.
* Pregnancy or breast feeding.
* Any concomitant radiotherapy, except palliative bone irradiation.
* Follow-up of the patient impossible.
* Prisoners.