cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Splinting After Collagenase Injection

Dupuytren disease is a fibroproliferative condition of the palmar and digital fascia. A collagen containing cord forms which can lead to fixed flexion contracture of one or more fingers. While there is no cure, many treatment options are available to manage symptoms. One of these options is injectable collagenase clostridium histolyticum (CCH). CCH is a combination of two highly selective microbial collagenases that can disrupt collagen types I and III usually found in cords. Current standard of care after receiving a CCH injection is daily hand exercises and use of a static night brace for four months. However, there is limited evidence that use of a night splint after CCH injection has any benefit post-treatment. The goal of our randomized, controlled trial, is to determine the clinical effectiveness of splinting after CCH injection. Study subjects will be adults 18 years of age or older with Dupuytren disease and contracture of one or more digits. Treatment includes collagenase clostridium histolyticum injection for Dupuytren flexion contraction, with randomization to static night splint or no splint.

Patients with Dupuytren disease that meet inclusion criteria will be consented to participate. All patients will be randomized to splint or no splint group prior to treatment. Baseline data will be collected prior to treatment and will include demographics, measurement of joint flexion contracture(s) with a standard finger goniometer, and QuickDASH scores. All patients that participate will receive 1 injection of 0.58 mg of CCH into cord. After 24-48 hours, if needed, patient will return to clinic for extension manipulation of treated finger(s) to help facilitate rupture of cord. Following injection and/or manipulation, all patients will be instructed to perform a series of finger exercises daily that they will receive from a hand therapist. In addition, patients assigned to the splint group will be fitted for a static night splint that they will be instructed to wear nightly for 4 months. Splint compliance will be recorded by a survey at each follow up visit. Patients will return to clinic for routine follow up care at 1 month and 4 months during which their degree of contracture(s) and outcomes will be measured and recorded. The primary outcome measures of this study are improvement in active extension deficit of each joint and total active extension of each digit, in degrees. The secondary outcome measures are QuickDASH scores and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Contracture of 1 or more digits caused by palpable cord
* PIP joint flexion contracture of 20 degrees or more or;
* MCP joint flexion contracture of 20 degrees or more

Exclusion Criteria:

* Age less than 18 years
* Prior CCH injection for contracture less than 1 year before start of study
* Prior surgical intervention for contracture less than 1 year before start of study
Clozapine-Augmentation With Ziprasidone or Risperidone, a Randomized, Prospective Trial

We aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Partial response of schizophrenic psychoses to a monotherapy with clozapine is a frequent problem of clinical psychiatry. Current problems are treatment resistant positive and/or negative symptoms, as well as side effects. Therefore, different strategies of augmentations have been applied. Based on successful experiences in case reports and results of other work groups, we aim to compare the augmentation of clozapine with ziprasidone or risperidone in a randomized, prospective manner.

Eligibility Criteria:
Inclusion Criteria:

* Treatment resistant schizophrenic or schizoaffective disorder under therapy with clozapine,
* Age between 18 and 70,
* Informed consent

Exclusion Criteria:

* No informed consent,
* Intolerance with respect to ziprasidone or risperidone,
* Contraindications with respect to these substances,
* Gravidity or missing anticonceptive safety
* Substance dependance (excluded nicotin)
Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

Mind-body exercise improves symptom of negative moods, dyspnea and quality of life in chronic diseases, but these improvements for chronic obstructive pulmonary disease (COPD) are unproven. This study aims to examine the effects of dyspnea, exercise capacity, heart rate variability(HRV), anxiety, depression, interoceptive awareness, quality of life(QoL) in patients with COPD across a three-month mind-body exercise program.

Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by airflow limitation, has a high prevalence of morbidity and mortality, and results in negative physical, psychological, and quality of life (QoL) impacts. Patients with COPD typically experience dyspnea, exercise intolerance, autonomic dysfunction, anxiety, depression, and poor QoL. Mind-body intervention with walking, breathing, and mindfulness is beneficial for the health of patients with COPD. However, the result of mind-body walking intervention for patients with COPD is not clear. Thus, this study will evaluate the effects of mind-body walking exercise (MBWE) on the physical psychological wellbeing and QoL of patients with COPD.

This study will be a randomized controlled trial. Data will collect from the pulmonary clinics of a medical center in northern Taiwan. The participants will recruit and randomly assign into the MBWE group or the control group. Participants in the control group will receive their usual care. Participants in the MBWE group will receive not only their usual care but also a MBWE program, consisting of walking, breathing, and mindfulness activities, for 30 min per day, 5 days per week, for 8 weeks. Data will collect at baseline and follow up on week 4 (WK 4), week 8 (WK 8), and week 12 (WK12). The primary outcome is dyspnea using modified Borg scale. The secondary outcomes are dyspnea in daily life using modified Medical Research Council (mMRC), exercise capacity using six minute walk distance (6MWD), Heart rate variability (HRV), anxiety and depression using the Hospital Anxiety and Depression scale (HADS), interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness- Chinese version (MAIA-C), QoL using COPD Assessment Tes (CAT). The independent t-test and Chi-square test were used to examine the homogeneity of the demographic characteristics of two groups. Generalized estimating equations were used to examine the data from repeated measurements.

Eligibility Criteria:
Inclusion Criteria:

1.mild to severe COPD

Exclusion Criteria:

1. Patients visited the emergency room or were hospitalized previous month;
2. Long-term oxygen therapy;
3. Atrial fibrillation;
4. Severe cognitive impairment;
5. Great than class II heart failure as defined by the New York Heart Association functional classification in previous six months;
6. Pacemaker were excluded;
7. Received cancer treatment
8. Participated in other exercise trials
Pelvic Exenteration and Laterally Extended Pelvic Resection

Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.

All consecutive patients who are planned to undergo pelvic exenteration or laterally extended pelvic resection at Policlinico Agostino Gemelli IRCCS, will undergo ultrasound scan at the time of the pre-operative anesthetic assessment or the day before the planned surgery. A pre-defined case report form (CRF) will be filled by the ultrasound examiner. The ultrasound characteristics will be compared with the final histology (considered the referral standard).

The ultrasound examinations will be carried out using high-end ultrasound equipment. The frequency of the vaginal probes varied between 5.0 and 9.0 MHz. All examinations will be performed by a specialist obstetrics and gynecology with expertise in gynecologic oncology ultrasound scan. A subjective semi-quantitative assessment of the amount of blood flow within the examined lesion will be made (color score): a score of 1 was recorded when no blood flow could be found; 2 when only minimal/moderate flow could be detected; 3 when very strong blood-flow signals were present.

All patients will undergo pre-operative MRI scan and PET/CT scan. Pelvic exenteration and laterally-extended pelvic resection will be performed with the aim to remove en bloc the recurrent or persistent disease with a free-of-tumor margin.

Eligibility Criteria:
Inclusion Criteria:

All consecutive patients with histologically-proven recurrent or persistent gynecological cancer who are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and with palliative intent.

* Anterior/total pelvic exenteration
* Laterally extended endopelvic resection (LEER)
* Laterally extended pelvic resection (LEPR) is defined as an en bloc lateral resection of a pelvic tumor involving sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure
* With or without stoma formation

Exclusion Criteria:

* Radical hysterectomy without lateral resection
* Rectal resection only (posterior exenteration)
A Study to Evaluate the Safety and Effectiveness of PCV Chemotherapy in Patients With Recurrent High-grade Glioma With IDH1/2 Mutation

This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation.

This trial is aimed at evaluating the safety and effectiveness of PCV chemotherapy in patients with recurrent high-grade glioma with IDH1/2 mutation. And, this trial is approved by medical ethics committee of hebei yanda hospital. Also, the trial has got a registry code "ChiCTR-OOC-15005759" in China clinical trial registry. Researchers will conduct thsi trial from 2015/02 to 2017/12, and 100 recurrent high-grade glioma with IDH1/2 mutation patients will be recruited. Patients who are recruited will get PCV chemotherapy in ether Hebei Yanda Hospital or Beijing Tiantan hospital, and get follow-ups from clinicians.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of high-grade glioma was established by pathological method,and the recurrency of the disease is ongoing.
* The report of the pathological diagnosis contained the status of IDH gene, and showed that IDH1/2 mutation existed.
* The age of the patient is between 18 years old and 70 years old.
* The condition of the patient permits the procedure of chemotherapy using PCV schema.
* The patient is informed consent, and willing to join in this research.

Exclusion Criteria:

* The diagnosis is not recurrent high-grade glioma.
* The diagnosis of high-grade glioma was not established by pathological method.
* No molecular neuropathological report is available, or the report showed that IDH1/2 mutation did not exist.
* The age of the patient does not meet the requirement of this research.
* The condition of the patient does not permit the procedure of chemotherapy using PCV schema.
* There are other conditions that the clinicians believe that the PCV chemotherapy is not appropriate for the patient.
* The patient is not willing to join in this research.
Osteopathy of Post Cesarean Section Adhesions

Chronic low back pain post cesarean section adhesions represents a restricting dysfunction, mainly influences abdominal fascia that leads to major welfare and economic restrictions. Osteopathic manipulation is a drug-free non-invasive is the therapeutic application of manually guided forces to improve physiologic function and support homeostasis. The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain

Chronic low back pain is a common musculoskeletal disorder affects adults with 84% prevalence. It influences lower back, and lasts at least 12 weeks. Where increased annual cesarean section rates up to 19.1% associated with scar, pelvic, abdominal and low back pain disorders (Chia et al., 2016). From the fascial point of view, abdominal muscles are in continuity with the thoracolumbar fascia and the pelvic floor. It has been demonstrated that they work with great synergy and guaranteed by fascial continuity (Fan et al., 2018).

Osteopathic manipulative technique consists of a range of direct, indirect, combined, fluid and reflex-based manual techniques that are applied specifically to a joint or non-specifically to a body area. Direct techniques apply thrust, impulse, muscle contraction, fascial loading or passive range of motion (Fan et al., 2018).The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain. Up on that 30 post cesarean women suffering from low back pain at least for 6 months from the Outpatient Clinic of Mitghamer Hospital, El-Daqahlia. Their age range 20-35 years old, BMI range≤ 25 kg /m2. They will be allocated into control group will receive analgesics. Study group will receive four weeks of analgesics, plus osteopathic manipulations once per week.

Eligibility Criteria:
Inclusion Criteria:

* They suffered from low back pain and undergoes cesarean section at least 6 months before entry into study.
* Their body mass index (BMI) will be ≤ 25 kg /m2.
* Their age will range from 20 to 35 years.
* They would not use any other analgesic drugs during the study period.

Exclusion Criteria:

* Pregnancy or suspected pregnancy.
* Recent abdominal surgery
* Patients with severe spinal pathology (cauda equine syndrome, spinal canal stenosis, fracture of spine, discitis, infectious disease of spine).
* Cancer.
* Abdominal and pelvic infection, open wound, burn and skin irritation.
Clinical Study on the Safety of CNT-02 for TGCV and NLSD-M

This study is planning to evaluate the safety and clinical efficacy of medium-chain fatty acid capsules (food-grade CNT-02) in subjects with primary triglyceride deposit cardiomyovasculopathy (TGCV) and neutral lipid storage disease with myopathy (NLSD-M) associated with adipose triglyceride lipase (ATGL) genetic defects.


Eligibility Criteria:
Inclusion Criteria:

1. Patients for whom ATGL gene deletion has been previously confirmed.
2. Patients who can take the investigational product orally.
3. Male and female who are at least 20 years old at the time of consent.
4. Patients who gave written informed consent.

Exclusion Criteria:

1. Patients with diabetic ketoacidosis.
2. Patients with the possibility of diabetic ketoacidosis (patients with poorly controlled diabetes mellitus \[HbA1c\>8.4%, NGSP\])
3. Patients with terminal malignancy.
4. Pregnant or lactating women.
5. Patients who do not consent to using contraception while participating in this study.
6. Patients allergic to MCT oil.
7. Patients participating in other clinical trial.
8. Otherwise, patients determined to be ineligible for this study by the investigator or sub-investigator.
Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment

This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.

Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery.

The trial will consist of recording EII data from:

1. In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected
2. Resected ex vivo prostate following extraction from the abdomen (in the OR)
3. Resected ex vivo prostate when transferred to Pathology, post-RARP

The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of prostate cancer requiring RARP.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Age ≥ 18 years old

Exclusion Criteria:

1. Adults with implanted electrical devices such as pacemakers
2. Prisoners
3. Adults with impaired decision-making capacity
4. Any condition for which, in the opinion of the investigator, contraindicates study participation.
FAmily Oriented Mindfulness Informed Legal Education (FAMiLE) Programme for Parent or Carers Affected by Incarceration and Improving Parenting in Nigeria

Incarceration is a prevalent problem globally and in Nigeria. Its effect significantly impacts left behind parent or primary care givers and also the wellbeing of the families and children. Limited access to support has posed a constraint in effectively addressing the issues suffered by affected families in Nigeria. In addition, having a family member incarcerated could affect parenting due to factors such as anxiety, trauma, depression, poor social support, awareness of legal channels for complaint and harsh parenting to children. The implication is that it could not only have a negative impact on the affected victim but also on their parenting styles or caring responsibilities, which could be detrimental to children\&#39;s development and wellbeing and resort to criminal behaviours. In essence this study seeks to examine the feasibility and acceptability of a brief FAmily oriented Mindfulness informed Legal Education (FAMiLE) intervention in comparison to the waitlist control group (who will be administered the intervention at a later date) in improving parenting, legal awareness, social cohesion, wellbeing and reducing trauma and anxiety as a result of the effect of having a family member incarcerated.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and above
* Parent or carer with child(ren) or with caring responsibilities for children affected by incarceration.
* Able to provide full consent for their participation.
* A resident of the study areas (Delta, Jos or Lagos State)

Exclusion Criteria:

* Less than 18 years
* Unable to consent
* Currently undergoing severe mental health treatment
* Unable to speak the English language fluently
Transcranial Direct Current Stimulation in a Smoking Cessation Trial

The purpose of this study is to determine the effectiveness of transcranial direct current stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine dependent smokers.

BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that involves the application of brief weak electric current to the scalp. tDCS may induce neuroplasticity, thereby engaging some of the same systems that figure prominently in the pathological neuroplasticity caused by addictive drugs.

OBJECTIVE: To assess whether tDCS delivered along with nicotine patch reliably increases a) quit rates, b) duration of abstinence, and c) percentage of participants abstinent at follow-up.

METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres.

HYPOTHESES:

1. Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation protocol relative to a sham procedure.
2. The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right).

Eligibility Criteria:
Inclusion Criteria:

* nicotine dependent
* treatment-seeking
* smoke minimum of 15 cigarettes per day
* able to provide written informed consent
* able and willing to attend weekly appointments, inter-treatment and follow-up assessment
* able and willing to wear nicotine patch

Exclusion Criteria:

* currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor agonists/antagonists, SSRIs, L-dopa, anticholinergics
* pregnancy or lactation
* any serious medical condition requiring treatment or medication including high blood pressure, heart problems, asthma, epilepsy
* brain/neurological injury/disease/disorder
* skin disease
* current DSM-IV Axis I psychiatric disorder
* metal or medical device implants
* current treatment for alcohol or drug use
* current use of herbal/holistic preparations
* current use of recreational drugs
Effectiveness of a Digital Therapeutic on Type 2 Diabetes

A clinical study evaluating a three month digitally delivered lifestyle change program in adults with Type 2 Diabetes. The FareWell Program (the "Program") aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. The current study is designed to evaluate to what degree adults with Type 2 Diabetes engaged with the Program can improve glycemic control and/or decrease medication needs.

The Program aims to reduce well-established biomarkers of cardiometabolic diseases, weight, and medications. It includes meal planning tools, smart shopping lists, recipes curated by a physician, dietitian and chef educator, daily self-monitoring features with personalized weekly goals, bi-weekly live one-on-one health coaching and support from an online member community, and an educational curriculum. Subjects in the Program may receive support from other members of a Care Team (lifestyle medicine physician, chef educator, registered dietitian and/or psychologist/psychiatrist) as needed. The Care Team does not provide medical advice, nor replace traditional medical care. Instead, the Care Team encourages behavior change by providing support and sharing its expertise.

Study participants will have access to the Program for a twelve week period and will be asked to complete short health surveys at baseline and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes

Exclusion Criteria:

* Inability to understand, consent to, or comply with the study protocol for any reason, including inability to read or comprehend English.
* Does not have a smartphone (either an iPhone or Android phone)